fluoride: the ultimate cluster-flux, folder 1a

Fluoride: The Ultimate Cluster-Flux

And the Players Involved

A Compilation of Documents and Articles

Relating to Fluoride

This collection is dedicated to those who wrote the original works and

made them available on the internet. I have spent countless hours

searching for information on fluoride and it is my wish, by assembling

these works, to enable others to save time looking and make available

more time for them to ‘do’.

If you are sickened and appalled by the approved use of fluoride in

food, beverage and other consumer products then I ask that you spread

this knowledge on to others and contact your local representatives in the

hopes that one day fluoride will be more strictly regulated or, banned

altogether.

These documents are listed in roughly the order I found them. It would

be nearly impossible to group them in some kind of order since they are

all linked together – a cluster-flux of monumental proportions.

I would like to thank (or curse) Christopher Bryson whose excellent

book, The Fluoride Deception, opened my eyes to fluoride and started

me on this journey of uncovering the truth.

For more information on fluoride, I would recommend the Fluoride Action

Network (FAN) http://www.fluoridealert.org/ as a good place to start.

NOTICE

In accordance with Title 17 U.S.C., section 107, some material on this web site is provided without permission from the copyright owner, only for purposes of criticism, comment, news reporting,

teaching, scholarship and research under the "fair use" provisions of federal copyright laws. These materials may not be distributed further, except for "fair use" non-profit educational purposes,

without permission of the copyright owner.

COPYRIGHT 2005 Mothering Magazine http://www.accessmylibrary.com/coms2/summary_0286-19173790_ITM

John Ruby was angry.

So outraged, in fact, that the associate professor of pediatric dentistry from the University of Alabama at Birmingham found himself hanging a provocative poster on the general bulletin

board at the American Academy of Pediatric Dentistry's annual meeting in May 2003. The poster disappeared, and when Ruby put up another, he was told by the executive director of

AAPD to take it down or be thrown out of the conference. The poster featured the familiar Coca-Cola logo in a black circle with a thick diagonal line across it, Ghostbusters style. Across

the top Ruby had written "Coca-Cola, Nutritional Trash" and had provided information about the high sugar content of the soda and its high acidity, which can rot teeth. (1) Ruby was

protesting the $1 million grant from Coca-Cola that AAPD, the nation's leading pediatric dental

association, had accepted in March 2003. (2)

Along with many other dentists, Ruby was concerned about the spectacular jump in soda

intake among children and adolescents that has occurred over the past five decades. Since

1950, per-capita soda consumption in children has increased by a factor of nearly five. (3) Many doctors believe this rise in soda consumption is contributing to the rapid increase in

obesity and type 2 diabetes that has been observed in American children over the past two

decades. (4) Recent research suggests that soda consumption is also contributing to high blood pressure in adolescents, especially teenagers of color. (5) Dentists, of course, are

concerned about soft drinks and cavities, or caries. (6)

We first met Dr. Ruby when our group, the Campaign for a Commercial-Free Childhood, was collecting signatures from dentists for a letter asking AAPD to return the grant from Coca-

Cola. In our letter to AAPD, we noted that it was difficult "to imagine a research funder less

appropriate for AAPD than Coca-Cola, the world's most popular brand of soda." (7) We went on to say that the AAPD-Coca-Cola partnership sends a message to the American public that

soda drinks are not harmful; if they were, surely pediatric dentists wouldn't team up with

Coke. We wondered if this message did not fly in the face of recent policy statements by the

American Dental Association (ADA) and AAPD itself recommending that soda intake be limited, because drinking sugared beverages, as AAPD put it, "contributes to the initiation and

progression of dental caries." (8,9)

In short, we believed AAPD was selling out. Despite its protests to the contrary--AAPD insisted

it was not endorsing any of Coca-Cola's products--the fact remained that Coke could use the grant to counter claims that it did not care about children's health. AAPD knew Coke was likely

to do this when it signed on. But still, we were curious: Did the rest of the dental world share our opinion?

Dental Group Is Under Fire For Coke Deal

By MARIAN BURROS Published: March 4, 2003 New York Times

In one of the more unlikely industry-health partnerships, a soft drink

company will give about $1 million to an organization dedicated to

the health of children's teeth to promote health education and

research.

The charitable arm of the American Academy of Pediatric Dentistry

has signed an agreement with the Coca-Cola Foundation, and Coke

will distribute the academy's education messages. The academy

would not say how that would be done. Coca-Cola would not

comment.

''There is such an important message our organization is trying to get

to the public and Coke has an exceptional reach to consumers and the

opportunity is there to help us reach them,'' Dr. David Curtis,

president of the academy, said.

But Dr. Michael Biermann, a member of the academy and of the

board of trustees of the American Dental Association, said the deal

''leaves the implication that there is something shady going on.'' He

said: ''It just doesn't look right and I just don't like the association

with any commercial product like that casting a shadow on our

industry.''

Dr. Jonathan Shenkin, a second-year resident at the department of

pediatric dentistry at the University of Iowa, is also concerned about

the partnership. ''Such an arrangement presents a clear conflict of

interest,'' he said.

Some academic pediatric dentists who were asked for comment said

they had been told by their universities that they could not speak

about the partnership arrangement.

Others fear retribution from the academy.

Generally, pediatric dentists in private practice who were willing to

talk appeared to be torn by conflict about the arrangement. They say

they can see the value in having the money to educate parents and

children about oral hygiene, but they worry about appearances.

''Really it's a hot potato and I'm not sure what side of the fence I fall

on,'' said Dr. John Willis, who practices in South Portland, Me., and

who, along with the Maine Dental Association, is backing the state's

legislative effort to get soft drinks out of the schools.

Whether consumption of soft drinks causes cavities is still a matter of

dispute. From 1977 to 1996, consumption of soft drinks among 12-to

19-year-old boys who drank soda increased to 28 ounces a day from

16; among girls, it rose to 21 ounces a day from 15. A study published

last October in General Dentistry, written by Dr. Shenkin and three of

his professors, concludes: ''This increase in soft-drink consumption

has been paralleled by increasing rates of obesity in children and

reports of rampant tooth decay.''

The soft drink association vigorously disagrees, and in a recent letter

to a reporter said, ''A growing body of scientific evidence shows that

soft drinks do not cause obesity, dental cavities or any other health

problems.''

Some dentists do not think that soft drinks are any more of a problem

than other sweets but children consume larger quantities of sodas

than other cavity-producing foods.

Dr. Willis said: ''I do think there is something wrong with sugar in the

soft drinks and some have three acids in them, and I think we know

scientifically that the frequency of sugar and acid insults play a key

role in cavity activity. We have kids drinking a six-pack or two a day,

and that's poor health.''

In a letter to the academy, Dr. Michael Jacobson, executive director of

the Center for Science in the Public Interest, a health-based advocacy

group, said: ''Though the A.A.P.D. may contend that a deal would not

represent an endorsement of Coca-Cola's soft drinks, many people

will see that as a difference without a distinction. Furthermore, you

can bet that Coca-Cola will ballyhoo to the skies its close relationship

with the A.A.P.D., hoping to gain 'innocence by association' with a

hitherto credible health professional organization.''

ADA wiki

http://en.wikipedia.org/wiki/American_Dental_Association

The American Dental Association (ADA) is an American professional association established in 1859 and has more than 152,000 members. Based in Chicago, the ADA is the world's largest and oldest national dental association and promotes good oral health to the public while representing the dental profession.

The ADA publishes a monthly journal of dental related articles named the Journal of the American Dental Association.

The ADA was founded August 1859, at Niagara Falls, New York, by twenty-six dentists who represented various dental societies in the United States. Today, the ADA has more than 152,000 members, 55 constituent (state-territorial) and 545 component (local) dental societies. It is the largest and oldest national dental association in the world.

The Association has more than 400 employees at its headquarters in Chicago and its office in Washington, D.C. The Paffenbarger Research Center (PRC), located on the campus of the National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland, is an agency of the American Dental Association Foundation (ADAF) and a Department of the Division of Science. PRC scientists conduct basic and applied studies in clinical research, dental chemistry, polymer chemistry and cariology. The ADA established rigorous guidelines for testing and advertising of dental products and the first ADA Seal of Acceptance was awarded in 1931. Today, about 350 manufacturers participate in the voluntary program and more than 1300 products have received the Seal of Acceptance. The Board of Trustees, the administrative body of the Association, is composed of the President, the President-elect, two Vice Presidents and 17 trustees from each of the 17 trustee districts in the United States. The Treasurer and Executive Director serve as ex officio members.

The House of Delegates, the legislative body of the Association, is composed of 460 delegates representing 53 constituent societies, five federal dental services and the American Student Dental Association. The House meets once a year during the Association's annual session.

The Association's 11 councils serve as policy recommending agencies. Each council is assigned to study issues relating to its special area of interest and to make recommendations on those matters to the Board of Trustees and the House of Delegates.

The Association's official publication is The Journal of the American Dental Association. Other publications include the ADA News and the ADA Guide to Dental Therapeutics.

The Commission on Dental Accreditation, which operates under the auspices of the ADA, is recognized by the U.S. Department of Education as the national accrediting body for dental, advanced dental and allied dental education programs in the United States.

The ADA formally recognizes 9 specialty areas of dental practice: dental public health, endodontics, oral and maxillofacial pathology, oral and maxillofacial surgery, orthodontics and dentofacial orthopedics, pediatric dentistry, periodontics, prosthodontics, and oral and maxillofacial radiology.

The ADA library has an extensive collection of dental literature with approximately 33,000 books and 17,500 bound journal volumes. The ADA library also subscribes to more than 600 journal titles.

The ADA Foundation is the charitable arm of the Association. The Foundation provides grants for dental research, education, scholarships, access to care and charitable assistance programs such as relief grants to dentists and their dependents who are unable to support themselves due to injury, a medical condition or advanced age; and grants to those who are victims of disasters.

[edit] Advocacy

The ADA is a vociferous promoter of water fluoridation.[1] The ADA has purchased internet websites with names that mimic those of prominent websites that do not favor fluoridation. The ADA redirects visitors from the websites flouridation.com fluoridealert.com and fluoridealert.net to their own pro-fluoridation pages. The domain names of these websites are intentional misspellings of advocacy websites fluoridation.com and fluoridealert.org that do not favor fluoridation.[2][3]

In November of 2006, the ADA began recommending to parents that infants from 0 through 12 months of age have their formula prepared with water that is fluoride-free or contains low levels of fluoride to reduce the risk of fluorosis.[4]

[edit] Significant events

• 1840: First dental college, the Baltimore College of Dental Surgery; American Society of Dental Surgeons is established.

• 1845: American Society of Dental Surgeons ask members to sign a mandatory pledge promising not to use amalgam fillings.

• 1856: American Society of Dental Surgeons, because of its stance against dental amalgam, is disbanded in 1856 due to loss of membership.

• 1859: Twenty-six dentists meet in Niagara Falls, New York to form a professional society.

• 1860: First ADA constitution and bylaws are adopted. • 1897: ADA merges with the Southern Dental Association to form the National

Dental Association (NDA). • 1908: NDA publishes the first patient dental education pamphlet. • 1913: NDA adopts a new constitution and bylaws, establishing the House of

Delegates and Board of Trustees. • 1913: The Journal of the National Dental Association is first published under the

title, Bulletin of the National Dental Association • 1922: NDA is renamed the American Dental Association (ADA). • 1928: ADA affiliates with the NBS; National Board of Dental Examiners is

established. • 1930: Council of Dental Therapeutics established to oversee the evaluation of

dental products. The Council establishes the ADA's Seal Program. • 1931: First ADA Seal of Approval awarded; ADA headquarters located on north

side of Chicago. • 1936: ADA Council on Dental Education is formed. • 1948: The National Institute of Dental Research (NIDR) is established (since

renamed the NIDCR (National Institute of Dental and Craniofacial Research)). • 1950: ADA works with Congress to proclaim February 6 as National Children's

Dental Health Day; ADA endorses fluoridation. • 1964: ADA produces the first color television Public Service Announcement by a

non-profit health agency; ADA establishes the ADA Health Foundation, a501 (c)(3) non-profit organization for the purpose of engaging in dental health research and educational programs.

• 1970: ADA News is first published. • 1978: Council on Dental Practice established. • 1979: The Commission on Dental Accreditation established. • 1987: ADA Commission on the Young Professional is formed (later becomes the

Committee on the New Dentist). • 1991: First woman ADA president, Dr. Geraldine Morrow. • 1995: ADA Web site, ADA ONLINE, created (later becomes ADA.org) • 2002: First minority ADA president, Dr. Eugene Sekiguchi. • 2003: First “Give Kids a Smile” day held as part of National Children’s Dental

Health Month.

New York Times article: http://www.nytimes.com/2005/12/13/science/13narw.html?pagewanted=3

The investigators zeroed in on the riddle with sophisticated instruments at the Paffenbarger Research Center of the National Institute of Standards and

Technology, a federal organization in Gaithersburg, Md. The American Dental Association finances the research center.

NIST wiki: http://en.wikipedia.org/wiki/National_Institute_of_ Standards_and_Technology

The National Institute of Standards and Technology (NIST), known between 1901 and 1988 as the National Bureau of Standards (NBS), is a measurement standards laboratory which is a non-regulatory agency of the United States Department of Commerce. The institute's mission is to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve quality of life.

NIST had an operating budget for fiscal year 2007 (October 1, 2006-September 30, 2007) of about $843.3 million.[1] NIST employs about 2,900 scientists, engineers, technicians, and support and administrative personnel. About 1,800 NIST associates (guest researchers and engineers from American companies and foreign nations) complement the staff. In addition, NIST partners with 1,400 manufacturing specialists and staff at nearly 350 affiliated centers around the country.

NIST's headquarters are in Gaithersburg, Maryland. It also has laboratories in Boulder, Colorado. NIST has four major programs through which it helps U.S. industry: the NIST Laboratories (physics, information technology, chemical science and technology, electronics and electrical engineering, materials science and engineering, manufacturing engineering, and building and fire research); the Hollings Manufacturing Extension Partnership (HMEP), a nationwide network of centers to assist small manufacturers; the Advanced Technology Program (ATP), a grant program where NIST and industry partners cost share the early-stage development of innovative but high-risk technologies; and the Malcolm Baldrige National Quality Award program, the nation's highest award for performance and business excellence.

NIST's Boulder laboratories are best known for NIST-F1, one of the world's two most accurate atomic clocks. (The other is in Paris, France). NIST-F1 serves as the source of the nation's official time. From its precise measurement of the natural resonance frequency of cesium—which is used to define the second —NIST broadcasts time signals via longwave radio station WWVB at Fort Collins, Colorado, and shortwave radio stations WWV and WWVH, located at Fort Collins, Colorado and Kekaha, Hawaii, respectively.

NIST manages some of the world’s most specialized measurement facilities—including a cost effective NIST Center for Neutron Research (NCNR) user facility where cutting edge research is done on new and improved materials, advanced fuel cells, and biotechnology. The SURF III Synchrotron Ultraviolet Radiation Facility is the world's senior dedicated source of synchrotron radiation, in continuous operation since 1961.

SURF III now serves as the US primary national standard for source-based radiometry throughout the generalized optical spectrum: from infrared through extreme ultraviolet.

NIST's Advanced Measurement Laboratory (AML) is among the most technically advanced research facilities of its kind in the world. The AML offers American researchers opportunities to make the most sensitive and reliable measurements. This is important as new technologies become more complex and smaller.

Based in the AML is the Center for Nanoscale Science and Technology (CNST). The CNST's prime objective is to lay the technical groundwork necessary to translate nanotechnology’s many anticipated offerings into practical realities—manufacturable, market-ready products. To accomplish this goal, the center leverages and combines the diverse knowledge and capabilities of NIST, industry, academia, and other government agencies to support all phases of nanotechnology development. The CNST features a Nanofabrication (Nanofab) Facility. CNST's “clean room” is equipped with an array of state-of-the-art tools for making, testing, and characterizing prototype nanoscale devices and materials. These instruments will be available to collaborators and outside users through a proposal process.

As part of its mission, NIST supplies industry, academia, government and other users with over 1,300 Standard Reference Materials (SRMs) of the highest quality and metrological value. These artifacts are certified as having specific characteristics or component content, making them valuable as calibration standards for measuring equipment and procedures, quality control benchmarks for industrial processes, and experimental control samples for all kinds of laboratories. For example, NIST SRMs for the food manufacturing sector include:

• Typical diet (SRM 1548a, $624) • Non-fat milk powder (SRM 1549, $318, 100 g) • Oyster tissue (SRM 1566b, $540, 25 g) • Wheat flour (SRM 1567a, $418, 80 g) • Rice flour (SRM 1568a, $390, 80 g) • Bovine liver (SRM 1577b, $261, 50 g) • Tomato leaves (SRM 1573A, $332, 50 g) • Natural water (SRM 1640, $198, 250 mL) • Peanut butter (SRM 2387, $501, three 6 oz (170 g) jars)

NIST has 7 standing committees:

• Technical Guidelines Development Committee (TGDC) • Advisory Committee on Earthquake Hazards Reduction (ACEHR) • National Construction Safety Team Advisory Committee (NCST Advisory

Committee) • Information Security and Privacy Advisory Board (ISPAB) • Visiting Committee on Advanced Technology (VCAT)

• Baldrige National Quality Program Board of Overseers (BNQP Board of Overseers)

• Manufacturing Extension Partnership National Advisory Board (MEPNAB)

NIST is currently developing government-wide identification card standards for federal employees and contractors to prevent unauthorized persons from gaining access to government buildings and computer systems.

In 2002 the National Construction Safety Team Act mandated NIST to conduct an investigation into the collapse of the World Trade Center, as well as the 47-story 7 World Trade Center. The investigation covered three aspects, including a technical building and fire safety investigation to study the factors contributing to the probable cause of the collapses of the WTC Towers (WTC 1 and 2) and WTC 7. NIST also established a research and development program to provide the technical basis for improved building and fire codes, standards, and practices, and a dissemination and technical assistance program to engage leaders of the construction and building community in implementing proposed changes to practices, standards and codes. NIST also is providing practical guidance and tools to better prepare facility owners, contractors, architects, engineers, emergency responders, and regulatory authorities to respond to future disasters. The investigation portion of the response plan is scheduled to be completed in 2008 with the release of the final report on 7 World Trade Center. The final report on the WTC Towers – including 30 recommendations for improving building and occupant safety – was released on October 26, 2005.[2]

NIST works in conjunction with the Technical Guidelines Development Committee of the Election Assistance Commission to develop the Voluntary Voting System Guidelines for voting machines and other election technology.

Further information: certification of voting machines

Three researchers at NIST have been awarded Nobel Prizes for their work in physics, William D. Phillips in 1997, Eric A. Cornell in 2001 and John L. Hall in 2005. Other notable people who have worked at NIST include

• Milton Abramowitz • James S. Albus • Ferdinand Brickwedde • Lyman James Briggs • John W. Cahn • William Coblentz • Keith Codling • Ronald Colle • Philip J. Davis • Hugh L. Dryden • Ugo Fano • Charlotte Froese Fischer

• Douglas Hartree • Magnus Hestenes • Cornelius Lanczos • Theodore Madey • Wilfrid Mann • William Meggers • Frank W. J. Olver • Ward Plummer • Jacob Rabinow • Charlotte Moore Sitterly • Irene Stegun • Bill Stone

The director of NIST is a Presidential appointment and confirmed by the Senate. Thirteen persons have held the position (in addition to three acting directors who served temporarily). They are:

• Samuel W. Stratton, 1901-1922 • George K. Burgess, 1923-1932 • Lyman J. Briggs, 1932-1945 • Edward U. Condon, 1945-1951 • Allen V. Astin, 1951-1969 • Lewis M. Branscomb, 1969-1972 • Richard W. Roberts, 1973-1975 • Ernest Ambler, 1975-1989 • John W. Lyons, 1990-1993 • Arati Prabhakar, 1993-1997 • Raymond G. Kammer, 1997-2000 • Karen Brown (acting director), 2000-2001 • Arden L. Bement Jr., 2001-2004 • Hratch Semerjian (acting director), 2004-2005 • William Jeffrey, 2005-2007 • James Turner (acting director), 2007-Present

ADA website: http://www.ada.org/prof/resources/pubs/adanews/adanewsarticle.asp?articleid=742

Honolulu's city council votes to ban fluoridation Bill could affect 80-90 percent of Hawaii's populat ion

Posted Feb. 20, 2004

Honolulu — A bill to ban fluoridation of the water supply h ere passed the Honolulu City Council Jan. 28 by a vote of 7-2.

Disguised as a “pure water” bill, the ban prohibits “any product, substance or chemical... for the purpose of treating or affecting the physical or me ntal functions of the body or any person” from being added to the city's water supply.

“They snuck up on us on this one,” says Dr. Norman Chun, legislative chair of the Hawaii Dental Association. “It stayed under the radar for several months. Although it was supposedly introduced last October, we didn't know about it until 10 days before the vote, and neither did any of the other pro-fluoridation groups that we work with who also monitor this type of activity. We knew right away the vote would go against fluoridation because ther e are a greater number of antis on the city council than in the state legislature.”

The bill is now on the mayor's desk, notes Dr. Chun , “and we are pulling out all stops to get it vetoed. We have a few more days to work on this.”

Dr. Chun urges dentists to be watchful for this typ e of legislation being introduced at their own city and county government levels.

“The antifluoridationists didn't have success at th e state level,” said Dr. Kim Lawler, president of t he Hawaii Dental Association, “but by targeting Honolu lu, they've still affected 80 to 90 percent of Hawaii's population.”

In New Hampshire, for example, a similar antifluori dation bill remains in committee and “it doesn't look like it's going to come out,” says Dr. Alphons e Homicz, president-elect of the New Hampshire Dental Society.

New Hampshire House Bill 1209 would prohibit any su bstance from being added to a public drinking water supply that “is intended to treat people and not water, or to fulfill a health claim,” unless th e added substance has been approved by the U.S. Food and Drug Administration for safety and effectiveness for all ages, health conditions and l evels of water consumption.

Thanks to information received from the ADA, Dr. Ho micz stresses, New Hampshire dentists were able to testify against the bill, educating legisla tors about the fact that the FDA does not have jurisdiction over water fluoridation chemicals.

“We went in with strong data from the ADA and succe ssfully argued against the substance of the legislation.”

In a recent letter to the mayor of Honolulu, the AD A provided clarification on the regulation of fluoride chemicals. Proposals requiring the U.S. Fo od and Drug Administration to approve chemicals used in fluoridation are targeted at the wrong jurisdiction. The FDA does not, and will not in the foreseeable future, have jurisdiction over w ater fluoridation chemicals. The only way this could happen would be through an act of Congress.

To help insure the public's safety, the American Wa ter Works Association and the American National Standards Institute set standards for all chemicals used in the water treatment plant, including fluoride chemicals. The National Sanitation Foundat ion also sets standards and does product certification for products used in the water indust ry, including fluoride chemicals.

This type of bill has been introduced in five other state legislatures since 2000 — California, Hawaii , Oregon, Utah and Washington — but all failed to pas s. So, Dr. Chun warns, antifluoridationists are quietly introducing so-called “pure water” bills at the city council or county level.

Better known as the Fluoride Product Quality Contro l Act, these bills would require all fluoride compounds used in water fluoridation to be approved by the U.S. Food and Drug Administration.

Another city-level fluoridation challenge in Watson ville, Calif., still awaits final resolution.

For more information regarding fluoride and fluorid ation visit the ADA's Fluoride and Fluoridation Web page .

**

National Sanitation Foundation – NSF http://en.wikipedia.org/wiki/NSF_International

Board of Directors

• Charles Depew (Chairman of the Board)- GlaxoSmithKline, Vice President, Worldwide Regulatory Affairs

• Mary Jane England - Regis College, President, Cleary University, Board of Trustees

• Nina McClelland - NSF International, President 1980-1994, previously Gelman Sciences

• Kevan Lawlor - NSF International, President 2003-present; Cleary University, Board of Trustees

• Brenda L. Jones - Arbortext (now PTC), Vice President • Leslie L. Loomans - Detroit Edison, Retired • Dennis Mangino - NSF International, President 1995-2003, previously Weirton

Steel

**

ANI board of directors: http://publicaa.ansi.org/sites/apdl/Documents/About%20ANSI/Governance/ANSI_Board_Directors-2008.pdf.pdf

Sharon K Stanford, Chair, ADA

**

American Waterworks Association: http://en.wikipedia.org/wiki/American_Water_Works_A ssociation

Drinking water standard development

In May 1985, the United States Environmental Protection Agency entered into a cooperative agreement with a consortium led by NSF International to develop voluntary third-party consensus standards and a certification program for all direct and indirect drinking water additives. Other members of the consortium include AWWA. The

consortium is responsible for the cooperative effort of manufacturers, regulators, product users and other interested parties that develop and maintain the NSF standards.

**

http://www.ingentaconnect.com/content/wef/wefproc/2004/00002004/00000011/art00009

Abstract:

There is no shortage of challenges facing today's water and wastewater utilities. The demand to increase efficiency and productivity comes from many factions, including elected and appointed officials, management and ratepayers. The workforce and customer base are changing as a result of an aging population, different attitudes and perceptions, and dramatic shifts in demographics. New and more stringent regulations are requiring more resources, demands for greater monitoring and innovative solutions. The infrastructure that utilities operate and maintain is aging and will require a greater level of investment than in the past. With all of these challenges, customers still expect safe water, effective wastewater treatment, and rates that hold steady and remain relatively inexpensive compared to other vital commodities. Over the last ten years, waterborne disease outbreaks in the United States and Canada have challenged the confidence of the public to the extent that new laws have been enacted and additional ones proposed requiring accreditation of water service providers. Confidence questions have, in part, spurred bottled water sales and achieving customer satisfaction is more challenging than ever. At the same time, the International Organization of Standardization (ISO) is developing new standards specific to water and wastewater utility operations. The combination of these events may suggest the beginnings of a trend toward more certification or accreditation of utilities. Utility continuous improvement programs are crucial to meet growing demands for demonstrable accountability.

Document Type: Research article

DOI: 10.2175/193864704784136216

http://www.ingentaconnect.com/content/wef/wefproc;jsessionid=5bu0qs27c9pa6.alice

Summary:

The ADA does not answer to the FDA. It is under the jurisdiction of the AWWA, ANSI and the NSI.

The Paffenbarger Research Center of the National Institute of Standards and Technology, a federal organization in Gaithersburg, Md. is financed by the ADA.

American Dental Association

Constitution

and

Bylaws

Revised to January 1, 2008

Contents Constitution of American Dental Association.......................................... 3 Amendments, Article VIII ............................................................ 5 Annual Session, Article VI ........................................................... 4 Government, Article IV................................................................ 4 Name, Article I ............................................................................ 3 Object, Article II .......................................................................... 3 Officers, Article V........................................................................ 4 Organization, Article III ............................................................... 3 Principles of Ethics and Code of Professional Conduct, Article VII................................................................... 5 Bylaws of American Dental Association ................................................. 6 Alliance of the American Dental Association, Chapter XVIII ...........................................................................77 Amendments, Chapter XXI .........................................................78 American Dental Association Foundation, Chapter XIII..............................................................................68 Appointive Officer, Chapter IX ...................................................49 Board of Trustees, Chapter VII....................................................37 Commissions, Chapter XIV.........................................................69 Component Societies, Chapter III ................................................23 Conflict of Interest, Chapter VI ...................................................36 Constituent Societies, Chapter II .................................................18 Construction, Chapter XX ...........................................................78 Councils, Chapter X ....................................................................50 Elective Officers, Chapter VIII ....................................................45 Finances, Chapter XVII...............................................................76 House of Delegates, Chapter V....................................................26 Indemnification, Chapter XIX .....................................................77 Membership, Chapter I................................................................. 6 Principles of Ethics and Code of Professional Conduct and

Judicial Procedure, Chapter XII ………………….……… ……63 Publications, Chapter XVI...........................................................75 Scientific Session, Chapter XV....................................................75 Special Committees, Chapter XI..................................................63 Trustee Districts, Chapter IV .......................................................24

Articles of Incorporation of American Dental Association……..……….79

Bylaws 6

Constitution

• • • • • • • • • • • • • • • • • • • • • • • • • •

ARTICLE I • NAME

The name of this organization shall be the American 1 Dental Association, hereinafter referred to as “the 2 Association” or “this Association.” 3

ARTICLE II • OBJECT

The object of this Association shall be to encourage 4 the improvement of the health of the public and to 5 promote the art and science of dentistry. 6

ARTICLE III • ORGANIZATION

Section 10. INCORPORATION: This Association is 7 a non-profit corporation organized under the laws of 8 the State of Illinois. If this corporation shall be 9 dissolved at any time, no part of its funds or property 10 shall be distributed to, or among, its members but, 11 after payment of all indebtedness of the corporation, 12 its surplus funds and properties shall be used for 13 dental education and dental research in such manner 14 as the then governing body of the Association may 15 determine. 16

Section 20. HEADQUARTERS OFFICE: The 17 registered office of this Association shall be known 18 as the Headquarters Office and shall be located in the 19 City of Chicago, County of Cook, 20 State of Illinois. 21

Section 30. BRANCH OFFICES: Branch offices of 22 this Association may be established in any city of the 23 United States by a majority vote of the House of 24 Delegates. 25

Section 40. MEMBERSHIP: The membership of this 26 Association shall consist of dentists and other 27 persons whose qualifications and classifications shall 28 be as established in Chapter I of the Bylaws. 29

Section 50. CONSTITUENT SOCIETIES: 30 Constituent societies of this Association shall be 31

Constitution 3

Bylaws 7

those dental societies or dental associations chartered 32 as such in conformity with Chapter II of 33 the Bylaws. 34

Section 60. COMPONENT SOCIETIES: Component 35 societies of this Association shall be those dental 36 societies or dental associations organized as such in 37 conformity with Chapter III of the Bylaws of this 38 Association and in conformity with the bylaws of 39 their respective constituent societies. 40

Section 70. TRUSTEE DISTRICTS: The constituent 41 societies of the Association and the federal dental 42 services shall be grouped into seventeen (17) trustee 43 districts, as provided in Chapter IV of the Bylaws. 44

ARTICLE IV • GOVERNMENT

Section 10. LEGISLATIVE BODY: The legislative 45 and governing body of this Association shall be a 46 House of Delegates which may be referred to as “the 47 House” or “this House,” as provided in Chapter V of 48 the Bylaws. 49

Section 20. ADMINISTRATIVE BODY: The 50 administrative body of this Association shall be a 51 Board of Trustees, which may be referred to as “the 52 Board” or “this Board” as provided in Chapter VII of 53 the Bylaws. 54

ARTICLE V • OFFICERS

Section 10. ELECTIVE OFFICERS: The elective 55 officers of this Association shall be a President, a 56 President-elect, a First Vice President, a Second Vice 57 President, a Treasurer and a Speaker of the House of 58 Delegates, each of whom shall be elected by the 59 House of Delegates as provided in Chapter VIII of 60 the Bylaws. 61

Section 20. APPOINTIVE OFFICER: The 62 appointive officer of this Association shall be an 63 Executive Director who shall be appointed by the 64 Board of Trustees as provided in Chapter IX of the 65 Bylaws. 66

ARTICLE VI • ANNUAL SESSION

The annual session of this Association shall be 67 conducted in accordance with Chapters V and XV of 68 the Bylaws. 69

4 Constitution

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ARTICLE VII • PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT

The Principles of Ethics and Code of Professional 70 Conduct of this Association and the codes of ethics 71 of the constituent and component societies which are 72 not in conflict with the Principles of Ethics and Code 73 of Professional Conduct of this Association, shall 74 govern the professional conduct of all members. 75

ARTICLE VIII • AMENDMENTS

This Constitution may be amended by a two-thirds 76 (2/3) affirmative vote of the delegates present and 77 voting, provided that the proposed amendments have 78 been presented in writing at any previous session of 79 the House of Delegates. 80 This Constitution may also be amended at any 81

session of the House of Delegates by a unanimous 82 vote, provided the proposed amendments have been 83 presented in writing at a previous meeting of such 84 session.85

Constitution 5

Bylaws 6

Bylaws

• • • • • • • • • • • • • • • • • • • • • • • • • •

CHAPTER I • MEMBERSHIP

Section 10. CLASSIFICATION: The members of this 86 Association shall be classified as follows: 87

Active Members 88 Life Members 89 Retired Members 90 Nonpracticing Dentist Members 91 Student Members 92 Honorary Members 93 Provisional Members 94 Associate Members 95 Affiliate Members 96

Section 20. QUALIFICATIONS, PRIVILEGES, 97 DUES AND SPECIAL ASSESSMENTS: 98

A. ACTIVE MEMBER. 99 a. QUALIFICATIONS. An active member shall be 100 a dentist who is licensed to practice dentistry (or 101 medicine provided the physician has a D.D.S. or 102 D.M.D. or equivalent dental degree) in a state or 103 other jurisdiction of the United States and shall be a 104 member in good standing of this Association as that 105 is defined in these Bylaws. In addition, a dentist 106 shall be a member in good standing of this 107 Association’s constituent and component societies, 108 unless: 109

(1) the dentist is in the exclusive employ of, or is 110 serving on active duty in, one of the federal 111 dental services. A dentist is considered to be in 112 the exclusive employ of one of the federal dental 113 services when the dentist is under contract to 114 provide dental services to the beneficiaries of the 115 federal agency on a full-time basis and does not 116 engage in private practice within the jurisdiction 117 of a constituent or component society; 118 (2) the dentist is practicing in a country other than 119 the United States and consequently is ineligible 120 for membership in a constituent or component 121 society; or 122 (3) the dentist is working as a dental school 123 faculty member, dental administrator or 124 consultant within the territorial jurisdiction of a 125 constituent society and is ineligible for active126


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membership in the constituent or component 127 society because the dentist is not licensed in the 128 territorial jurisdiction of that constituent. 129

Explanatory Notes: The term “other jurisdiction of 130 the United States” as used in this Constitution and 131 Bylaws shall mean the District of Columbia, the 132 Commonwealth of Puerto Rico, the Commonwealth 133 of the Northern Mariana Islands and the territories 134 of the United States Virgin Islands, Guam and 135 American Samoa. 136

The term “federal dental services” as used in this 137 Constitution and Bylaws shall mean the dental 138 departments of the Air Force, the Army, the Navy, 139 the Public Health Service, the department of 140 Veterans Affairs and other federal agencies. 141

The term “direct member” as used in this 142 Constitution and Bylaws shall mean a member in 143 good standing who pursuant to Chapter I of these 144 Bylaws does not hold membership in any 145 constituent society of this Association. 146 b. PRIVILEGES. 147 (1) An active member in good standing shall 148 receive annually a membership card and The 149 Journal of the American Dental Association, the 150 subscription price of which shall be included in the 151 annual dues. An active member shall be entitled to 152 attend any scientific session of this Association and 153 receive such other services as are provided by the 154 Association. 155 (2) An active member in good standing shall be 156 eligible for election as a delegate or alternate 157 delegate to the House of Delegates and for election 158 or appointment to any office or agency of this 159 Association, except as otherwise provided in these 160 Bylaws. 161 (3) An active member under a disciplinary sentence 162 of suspension shall not be privileged to hold office, 163 either elective or appointive, including delegate and 164 alternate delegate, in such member’s component 165 and constituent societies and this Association, or to 166 vote or otherwise participate in the selection of 167 officials of such member’s component and 168 constituent societies and this Association. 169 c. DUES AND SPECIAL ASSESSMENTS. 170 Beginning January 1, 2006, and each year 171 thereafter, the dues of active members shall be the 172 amount established annually by the House of 173 Delegates in accordance with the procedure set 174 forth in Chapter V, Section 130Ad of these Bylaws. 175 In addition to their annual dues, active members 176 shall pay any special assessments levied by the 177 House of Delegates, due January 1 of each year. 178 However, any dentist, who satisfies the eligibility 179 requirements for active membership and any of the 180


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following conditions shall be entitled to pay the 181 reduced active member dues and any special 182 assessment stated under such satisfied condition so 183 long as that dentist maintains continuous 184 membership, subject to the further reductions 185 permitted under the provisions of Chapter I, Section 186 20Ad of these Bylaws: 187 (1) Dentists, when awarded a D.D.S. or D.M.D. 188 degree, shall be exempt from the payment of active 189 member dues and any special assessment for the 190 remaining period of that year and the following first 191 full calendar year. Dentists shall pay twenty-five 192 percent (25%) of active member dues and special 193 assessment for the second full calendar year 194 following the year in which the degree was 195 awarded, fifty percent (50%) of active member dues 196 and special assessment in the third year, seventy-197 five percent (75%) of active member dues and 198 special assessment in the fourth year and one 199 hundred percent (100%) in the fifth year and 200 thereafter. Eligibility for this benefit shall be 201 conditioned on maintenance of continuous 202 membership or payment of reduced dues and 203 special assessment(s) for the years not previously 204 paid, at the rates current during the missing year(s). 205 (2) The dentist who is engaged full-time in (a) an 206 advanced training course of not less than one (1) 207 academic year’s duration in an accredited school or 208 a residency program in areas neither recognized by 209 this Association nor accredited by the Commission 210 on Dental Accreditation or (b) a residency program 211 or advanced education program in areas recognized 212 by this Association and in a program accredited by 213 the Commission on Dental Accreditation shall pay 214 thirty dollars ($30.00) due on January 1 of each 215 year until December 31 following completion of 216 such program. For the dentist who enters such a 217 course or program while eligible for the dues 218 reduction program set forth in the foregoing 219 condition (1), the applicable reduced dues rate shall 220 be tolled until completion of that program. Upon 221 completing the program, the dentist shall pay dues 222 and any special assessments for active members at 223 the reduced dues rate where the dentist left off in 224 the progression under condition (1). Eligibility for 225 this benefit shall be conditioned on maintenance of 226 continuous membership or payment of post-227 graduate student dues and active member dues and 228 special assessment(s) for years not previously paid, 229 at the rates current during the missing years. The 230 dentist who is engaged full-time in (a) an advanced 231 training course of not less than one (1) academic 232 year’s duration in an accredited school or residency 233 program in areas neither recognized by this 234 Association nor accredited by the Commission on 235 Dental Accreditation or (b) a residency program or 236


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advanced education program in areas recognized by 237 this Association and in a program accredited by the 238 Commission on Dental Accreditation shall be 239 exempt from the payment of any active member 240 special assessment then in effect through December 241 31 following completion of such course or program. 242 (3) A graduate of a non-accredited dental school 243 who has recently been licensed to practice dentistry 244 in a jurisdiction in which there is a constituent 245 dental society of the American Dental Association 246 shall be exempt from payment of active member 247 dues and any special assessment for the remaining 248 period of the year in which the license was issued 249 and the following first full calendar year. The 250 newly licensed graduate of a non-accredited school 251 shall pay twenty-five percent (25%) of active 252 member dues and any special assessment the 253 second calendar year following the year in which 254 the license was obtained, fifty percent (50%) of 255 active member dues and any special assessment in 256 the third year, seventy-five percent (75%) of active 257 member dues and any special assessment in the 258 fourth year and one hundred (100%) in the fifth 259 year and thereafter. 260 (4) A licensed dentist who has never been an active 261 member of this Association and is ineligible for 262 dues reduction as a new graduate under this Section 263 of the Bylaws, shall pay fifty percent (50%) of 264 active member dues and any special assessment in 265 the first year of membership, and shall pay one 266 hundred percent (100%) of active member dues and 267 any special assessment in the second year and each 268 year thereafter. 269 (5) The Board of Trustees may authorize limited 270 dues reduction, up to fifty percent (50%) of active 271 member dues and any special assessments for the 272 purposes of promoting active membership in target 273 U.S. markets through marketing campaigns 274 recommended by the Council on Membership. This 275 reduction of active member dues and any special 276 assessments shall be on a one-time only basis for 277 these members. 278 d. ACTIVE MEMBERS SELECTED AFTER 279 JULY 1 AND OCTOBER 1. Those members 280 selected to active membership in this Association 281 after July 1, except for those whose membership 282 has lapsed for failure to pay the current year’s dues 283 and/or special assessments, shall pay one half (1/2) 284 of the current year’s dues and one half (1/2) of any 285 active member special assessment then in effect, 286 and those selected after October 1, shall be exempt 287 from the payment of the current year’s dues and any 288 active member special assessment then in effect on 289 a one-time only basis. 290


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B. LIFE MEMBER. 291 a. QUALIFICATIONS. A life member shall be a 292 member in good standing of this Association who 293 (1) has been an active and/or retired member in 294 good standing of this Association for thirty (30) 295 consecutive years or a total of forty (40) years of 296 active and/or retired membership or has been a 297 member of the National Dental Association for 298 twenty-five (25) years and subsequently held at 299 least ten (10) years of membership in the American 300 Dental Association; (2) has attained the age of 301 sixty-five (65) years in the previous calendar year; 302 and (3) has submitted an affidavit attesting to the 303 qualifications for this category through said 304 component and constituent societies, if such exist. 305

A dentist who immigrated to the United States may 306 receive credit for up to twenty-five (25) consecutive 307 or total years of membership in a foreign dental 308 association in order to qualify for the respective 309 requirements for life membership. 310 Years of student membership shall not be counted 311 as active membership for purposes of establishing 312 eligibility for life membership unless the dentist was 313 an active member in good standing prior to 314 becoming a student member. 315 The Association will give notification to members 316 who are eligible for life membership. Life 317 membership shall be effective the calendar year 318 following the year in which the requirements are 319 fulfilled. Maintenance of membership in good 320 standing in the member’s constituent and component 321 societies, if such exist, shall be a requisite for 322 continuance of life membership in this Association. 323 b. PRIVILEGES. A life member in good standing of 324 this Association shall receive annually a membership 325 card. A life member shall be entitled to all the 326 privileges of an active member, except that a retired 327 life member shall not receive The Journal of the 328 American Dental Association except by subscription. 329 A life member under a disciplinary sentence of 330 suspension shall not be privileged to hold office, 331 either elective or appointive, including delegate and 332 alternate delegate, in such member’s component and 333 constituent societies and this Association, or to vote 334 or otherwise participate in the selection of officials 335 of such member’s component and constituent 336 societies and this Association. 337 c. DUES AND SPECIAL ASSESSMENTS. 338 (1) ACTIVE LIFE MEMBERS. Regardless of a 339 member’s previous classification of membership, the 340 dues of life members who have not fulfilled the 341 qualifications of retired membership pursuant to 342 Chapter I, Section 20C of these Bylaws with regard 343 to income related to dentistry shall be fifty percent 344 (50%) of the dues of active members, due January 1 345 of each year. In addition to their annual dues, active 346


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life members shall pay fifty percent (50%) of any 347 active member special assessment levied by the 348 House of Delegates, due January 1 of each year. 349 (2) RETIRED LIFE MEMBERS. Life members who 350 have fulfilled the qualifications of Chapter I, Section 351 20C of these Bylaws with regard to income related to 352 dentistry shall be exempt from payment of dues and 353 any special assessment levied by the House of 354 Delegates. 355 (3) ACCEPTANCE OF BACK DUES AND 356 SPECIAL ASSESSMENTS. For the purpose of 357 establishing continuity of active membership to 358 qualify for life membership, back dues and special 359 assessments, except as otherwise provided in these 360 Bylaws, shall be accepted for not more than the three 361 (3) years of delinquency prior to the date of 362 application for such payment. The rate of such dues 363 and/or special assessments, except as otherwise 364 provided in these Bylaws, shall be in accordance 365 with Chapter I, Section 40 of these Bylaws. 366 For the purpose of establishing continuity of active 367 membership in order to qualify for life membership, 368 an active member, who had been such when entering 369 upon active duty in one of the federal dental services 370 but who, during such federal dental service, 371 interrupted the continuity of active membership 372 because of failure to pay dues and/or special 373 assessments and who, within one year after 374 separation from such military or equivalent duty, 375 resumed active membership, may pay back dues and 376 special assessments for any missing period of active 377 membership at the rate of dues and/or special 378 assessments current during the missing years of 379 membership. 380

C. RETIRED MEMBER. 381 a. QUALIFICATIONS. A retired member shall be 382 an active member in good standing of this 383 Association who is now a retired member of a 384 constituent society, if such exists, and is no longer 385 earning income from the performance of any 386 dentally related activity, and has submitted an 387 affidavit attesting to qualifications for this category 388 through said component and constituent society, if 389 such exist. Maintenance of active or retired 390 membership in good standing in the member’s 391 component society and retired membership in good 392 standing in the member’s constituent, if such exist, 393 entitling such member to all the privileges of an 394 active member, shall be requisite for entitlement to 395 and continuance of retired membership in this 396 Association. 397 b. PRIVILEGES. A retired member in good 398 standing shall receive annually a membership card. 399 A retired member shall be entitled to all the 400 privileges of an active member. 401


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A retired member under a disciplinary sentence of 402 suspension shall not be privileged to hold office, 403 either elective or appointive, including delegate and 404 alternate delegate, in such member’s component 405 and constituent societies and this Association, or to 406 vote or otherwise participate in the selection of 407 officials of such member’s component and 408 constituent societies and this Association. 409 c. DUES AND SPECIAL ASSESSMENTS. The 410 dues of retired members shall be twenty-five 411 percent (25%) of the dues of active members, due 412 January 1 of each year. In addition to their annual 413 dues, retired members shall pay twenty-five percent 414 (25%) of any active member special assessment 415 levied by the House of Delegates, due January 1 of 416 each year. 417

D. NONPRACTICING DENTIST MEMBER. 418 a. QUALIFICATIONS. A nonpracticing dentist 419 member shall be a dentist who is ineligible for 420 any other classification of membership and: 421 (1) has a dental degree from any country; 422 (2) resides in the United States or its territories; 423 (3) does not hold a dental license in the United 424 States nor has a revoked U.S. dental license; 425 (4) is not delivering patient care as a dentist for 426 remuneration; and 427 (5) is a member in good standing of this 428 Association, and the Association’s constituent 429 and component societies, if such exists. 430 b. PRIVILEGES. 431 (1) A nonpracticing dentist member in good 432 standing shall receive annually a membership 433 card and The Journal Of The American Dental 434 Association, the subscription price of which shall 435 be included in the annual dues. A nonpracticing 436 dentist member shall be entitled to attend any 437 scientific session of this Association and receive 438 such other services as are authorized by the 439 Association. 440 (2) A nonpracticing dentist member in good 441 standing shall be eligible for election to any 442 council. 443 (3) A nonpracticing dentist member shall also be 444 eligible for appointment as an additional member 445 to any council, provided the council requests such 446 additional nonpracticing membership 447 representation and the Board of Trustees 448 approves the council’s request. Such members 449 shall be appointed by the Board of Trustees. The 450 tenure of an additional council member shall be 451 one (1) term of four (4) years. 452 (4) A nonpracticing dentist member under a 453 disciplinary sentence of suspension shall not be 454 privileged to serve as a member of any council. 455 c. DUES AND SPECIAL ASSESSMENTS. The 456


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dues of nonpracticing dentists shall be fifty 457 percent (50%) of the dues of active members, due 458 January 1 of each year. In addition to their 459 annual dues, nonpracticing dentists shall pay fifty 460 percent (50%) of any active member special 461 assessment levied by the House of Delegates, due 462 January 1 of each year. 463

E. STUDENT MEMBER. 464 a. QUALIFICATIONS. A student member shall be 465 a predoctoral student of a dental school accredited 466 by the Commission on Dental Accreditation of this 467 Association, a predoctoral student of a dental 468 school listed in the World Directory of Dental 469 Schools compiled by the FDI World Federation or a 470 dentist eligible for membership in this Association 471 who is engaged full time in an advanced training 472 course of not less than one academic year’s 473 duration in an accredited school or residency 474 program. 475 b. PRIVILEGES. A student member in good 476 standing of this Association shall receive annually a 477 membership card and The Journal of the American 478 Dental Association, the subscription price of which 479 shall be included in the annual dues. A student 480 member shall be entitled to attend any scientific 481 session of this Association. 482 A student member under a disciplinary sentence of 483

suspension shall not be privileged to serve as the 484 American Student Dental Association’s delegate or 485 alternate delegate in this Association’s House of 486 Delegates. 487 c. DUES AND SPECIAL ASSESSMENTS. 488 (1) PREDOCTORAL STUDENT MEMBERS: The 489 dues of predoctoral student members shall be five 490 dollars ($5.00) due January 1 of each year. Such 491 student members shall be exempt from the payment 492 of any special assessment levied by the House of 493 Delegates. 494 (2) POSTDOCTORAL STUDENTS AND 495 RESIDENTS: The dues of dentists who are student 496 members pursuant to Chapter I, Section 20E shall 497 be thirty dollars ($30.00) due January 1 of each 498 year. Such student members shall be exempt from 499 the payment of any special assessment levied by the 500 House of Delegates. 501 (3) Student membership terminates on December 502 31 after graduation or after completion of a 503 residency or graduate work. 504

F. HONORARY MEMBER. 505 a. QUALIFICATIONS. An individual who has 506 made outstanding contributions to the advancement 507 of the art and science of dentistry, upon election by 508 the Board of Trustees, shall be classified as an 509 honorary member of this Association. 510 b. PRIVILEGES. An honorary member shall 511


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receive a membership card and The Journal of the 512 American Dental Association. An honorary member 513 shall be entitled to attend any scientific session of 514 this Association and receive such other services as 515 are authorized by the Board of Trustees. 516 c. DUES AND SPECIAL ASSESSMENTS. 517 Honorary members shall be exempt from payment 518 of dues and any special assessment levied by the 519 House of Delegates. 520

G. PROVISIONAL MEMBER. 521 a. QUALIFICATIONS. A provisional member 522 shall be a dentist who: 523 (1) has received a D.D.S. or D.M.D. degree from a 524 dental school accredited by the Commission on 525 Dental Accreditation of the American Dental 526 Association or shall be a graduate of an 527 unaccredited dental school who has recently been 528 licensed to practice dentistry in a jurisdiction in 529 which there is a constituent dental society; 530 (2) has not established a place of practice; and 531 (3) shall have applied for provisional membership 532 within 12 months of graduation or licensure. 533 Provisional membership shall terminate December 534 31 of the second full calendar year following the 535 year in which the degree was awarded. 536 b. PRIVILEGES. A provisional member in good 537 standing shall be entitled to all the privileges of an 538 active member except that, notwithstanding 539 anything in these Bylaws to the contrary, a 540 provisional member shall have no right to appeal 541 from a denial of active membership in the 542 Association. 543 A provisional member under a disciplinary 544 sentence of suspension shall not be privileged to 545 hold office, either elective or appointive, including 546 delegate and alternate delegate, in such member’s 547 component and constituent societies and this 548 Association, or to vote or otherwise participate in 549 the selection of officials of such member’s 550 component and constituent societies and this 551 Association. 552 c. DUES AND SPECIAL ASSESSMENTS. The 553 dues and/or special assessments of provisional 554 members shall be the same as the dues and/or 555 special assessments of active members. 556

H. ASSOCIATE MEMBER. 557 a. QUALIFICATIONS. An associate member shall 558 be a person ineligible for any other type of 559 membership in this Association, who contributes to 560 the advancement of the objectives of this 561 Association, is employed in dental-related 562 education or research, does not hold a dental license 563 in the United States, and has applied to and been 564


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approved by the Board of Trustees.* 565 b. PRIVILEGES. An associate member in good 566 standing shall receive annually a membership card 567 and The Journal of the American Dental 568 Association, the subscription price of which shall be 569 included in the annual dues. An associate member 570 shall be entitled to attend any scientific session of 571 this Association and receive such other services as 572 are authorized by the Board of Trustees. 573 c. DUES AND SPECIAL ASSESSMENTS. The 574 dues of associate members shall be twenty-five 575 percent (25%) of the dues of active members, due 576 January 1 of each year. In addition to their annual 577 dues, associate members shall pay twenty-five 578 percent (25%) of any active member special 579 assessment levied by the House of Delegates, due 580 January 1 of each year. 581

I. AFFILIATE MEMBER. 582 a. QUALIFICATIONS. An affiliate member shall 583 be a dentist who is ineligible for any other 584 classification of membership and: 585 (1) is practicing in a country other than the United 586 States; 587 (2) has been classified as an affiliate member upon 588 application to and approval by the Board of 589 Trustees; and 590 (3) is a member in good standing of this 591 Association. 592 b. PRIVILEGES. An affiliate member in good 593 standing shall receive annually a membership card, 594 have access to the members-only content areas of 595 ADA.org, be entitled to attend any scientific session 596 of this Association, purchase items through the 597 ADA Catalog at the member rate and receive such 598 other services as are authorized by the Board of 599 Trustees. 600 c. DUES AND SPECIAL ASSESSMENTS. The 601 dues of affiliate members shall be twelve dollars 602 ($12.00) for those members practicing in least 603 developed and low income countries eligible for 604 special fee criteria as established by the Fédération 605 Dentaire Internationale and seventy-five dollars 606 ($75.00) for other such members, due January 1 of 607 each year. Affiliate members shall be exempt from 608 the payment of any special assessment levied by the 609 House of Delegates. 610

* Individuals who are classified as associate members of this Association prior to the 1996 annual session of the House of Delegates but who are not employed full-time in dentally-related education or research by an accredited institution of higher education, may maintain their associate membership so long as other eligibility requirements are met and current dues and special assessments are paid.


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Section 30. DEFINITION OF “IN GOOD 611 STANDING”. A member of this Association whose 612 dues and special assessments for the current year have 613 been paid shall be in good standing; provided, 614 however, that a member, to remain in good standing 615 may be required under the bylaws of the member’s 616 constituent or component society, to meet standards 617 of continuing education, pay special assessments, 618 cooperate with peer review bodies or committees on 619 ethics, or attend, if a newly admitted active member, a 620 stated number of membership meetings between the 621 date of admission and the completion of the first 622 calendar year of active membership. If under a 623 disciplinary sentence of suspension, such member 624 shall be designated as a “member in good standing 625 temporarily under suspension” until the member’s 626 disciplinary sentence has terminated. 627 The requirement of paying current dues does not 628 apply to retired life, honorary and those members of 629 this Association who pursuant to Section 50 of this 630 Chapter have been granted dues waivers for the 631 purpose of determining their good standing. The 632 requirement of paying special assessments does not 633 apply to retired life, honorary, affiliate, student and 634 those members of this Association who pursuant to 635 Section 50 of this Chapter have been granted special 636 assessment waivers for purposes of determining their 637 good standing. 638

Section 40. LAPSE OF MEMBERSHIP AND 639 REINSTATEMENT. 640

A. LAPSE OF MEMBERSHIP. Any member whose 641 dues and special assessments have not been paid by 642 March 31 of the current year shall cease to be a 643 member of this Association. Further, an associate 644 member who terminates employment in dental-related 645 education or research shall cease to be an associate 646 member of this Association December 31 of that 647 calendar year. 648

B. REINSTATEMENT. Reinstatement of active, life, 649 retired, nonpracticing dentist, student or affiliate 650 membership may be secured on payment of 651 appropriate dues and special assessments of this 652 Association by any former member and on 653 compliance by any former member with the pertinent 654 bylaws and regulations of the constituent and 655 component societies involved and this Association. 656

Section 50. DUES OR SPECIAL ASSESSMENT 657 RELATED ISSUES. 658 A. PAYMENT DATE AND INSTALLMENT 659 PAYMENTS. Dues and special assessments of all 660 members are payable January 1 of each year, except 661 for active and active life members who may 662 participate in an installment payment plan. Such plan 663 shall be sponsored by the members’ respective 664


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constituent or component dental societies, or by this 665 Association if the active or active life members are in 666 the exclusive employ of, or are serving on active duty 667 in, one of the federal dental services. The plan shall 668 require monthly installment payments that conclude 669 with the current dues and special assessment amount 670 fully paid by June 30. Transactional costs may be 671 imposed, prorated to this Association and the 672 constituent or component dental society. The 673 installment plan shall provide for the expeditious 674 transfer of member dues and special assessments to 675 this Association and the applicable constituent or 676 component dental society, if such exists, as soon as 677 commercially feasible. 678

B. FINANCIAL HARDSHIP WAIVERS. Those 679 members who have suffered a significant financial 680 hardship that prohibits them from payment of their 681 full dues and/or special assessments may be excused 682 from the payment of fifty percent (50%), seventy-five 683 percent (75%) or all of the current year’s dues and/or 684 special assessment(s) as determined by their 685 constituent and component dental societies. The 686 constituent and component society secretaries shall 687 certify the reason for the waiver, and the constituent 688 and component societies shall provide the same 689 proportionate waiver of their dues as that provided by 690 this Association.* 691

C. WAIVERS FOR ACTIVE MEMBERS 692 TEMPORARILY ACTIVATED TO FEDERAL 693 SERVICE. An active member in good standing who 694 pursuant to Chapter I of these Bylaws holds 695 membership in a constituent and component society 696 and is temporarily called to active duty with a federal 697 dental service on a non-career basis shall be exempt 698 from the payment of dues to this Association during 699 such military duty, but not to exceed a period of three 700 years. 701

D. WAIVERS FOR ACTIVE MEMBERS 702 WORKING FOR A CHARITABLE 703 ORGANIZATION. An active member who is 704

* Members with disabilities who were granted dues and special assessment disability waivers prior to the 2007 House of Delegates may continue to receive such waivers provided they are unable to practice dentistry within the definition of these Bylaws and they submit through the member’s component and constituent societies, if such exist, to this Association, a medical certificate attesting to the disability and a certificate from said component and constituent societies, if such exist, attesting to the disability, upon request of the Association, during the exemption period.


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serving the profession by working full-time for a 705 charitable organization and is receiving neither 706 income nor a salary for such charitable service other 707 than a subsistence amount which approximates a cost 708 of living allowance shall be exempt from the payment 709 of dues and any special assessment then in effect 710 through December 31 following completion of such 711 service provided that such charitable service is being 712 performed continuously for not less than one (1) year 713 and provided further that such member does not 714 supplement such subsistence income by the 715 performance of services as a member of the faculty of 716 a dental or dental auxiliary school, as a dental 717 administrator or consultant, or as a practitioner of any 718 activity for which a license to practice dentistry or 719 dental hygiene is required. 720

E. CALCULATING PERCENTAGE DUES OR 721 SPECIAL ASSESSMENTS. In establishing the dollar 722 rate of dues or special assessments in this chapter 723 expressed as a percentage of active member dues or 724 special assessments, computations resulting in 725 fractions of a dollar shall be rounded up to the next 726 whole dollar. 727

Section 60. INTERIM SERVICES FOR 728 APPLICANTS. A dentist who has submitted a 729 complete application for active membership in this 730 Association and the appropriate constituent and 731 component societies, if such exist, may on a one- 732 time, interim basis: receive complimentary copies of 733 the Journal of the American Dental Association and 734 the ADA News, have access to the ADA.org member-735 only content areas and purchase items at a member 736 rate through the ADA Catalog. Such interim services 737 shall terminate when the membership application has 738 been processed or within six (6) months of the 739 application submission, whichever is sooner. 740 Applicants shall have no right of appeal from a denial 741 of membership in the Association. 742

CHAPTER II • CONSTITUENT SOCIETIES

Section 10. ORGANIZATION: A constituent society 743 may be organized and chartered, subject to the 744 approval of the House of Delegates, upon application 745 of at least one hundred (100) dentists, practicing in 746 any state or other jurisdiction of the United States 747 who are active, life or retired members of the 748 Association in good standing. No such society shall 749 be chartered in any state or other jurisdiction of the 750 United States in which a constituent society is already 751 chartered by this Association. 752

Section 20. NAME: A constituent society shall take 753 its name from the state or other jurisdiction of the 754 United States. 755

CHAPTER I • MEMBERSHIP CHAPTER II • CONSTITUENT SOCIETIES


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Section 30. POWERS AND DUTIES: 756 A. A constituent society shall have the power to 757 select its active, life, and retired members as active 758 members of this Association within the limits of 759 Section 40 of this Chapter. 760 B. It shall have the power to organize its members 761 into component societies within the limits imposed 762 by Chapter III, Section 10 of these Bylaws. 763 C. It shall have the power to provide for its financial 764 support and to establish bylaws, rules and regulations 765 to govern its members provided such bylaws, rules 766 and regulations do not conflict with, or limit, these 767 Bylaws. 768 D. It shall have the power to discipline any of its 769 members subject to the provisions in Chapter XII, 770 Section 20 of these Bylaws. 771 E. It shall be its duty to collect membership dues and 772 special assessments for this Association in 773 conformity with Chapter I, Section 20, of these 774 Bylaws. 775 F. It shall have the power to establish committees, 776 councils and commissions of the constituent 777 society; to designate their power and duties; and to 778 adopt reasonable eligibility requirements for service 779 thereon. 780

Section 40. MEMBERSHIP: 781 A. The active, life, and retired membership of each 782 constituent society, except as otherwise provided in 783 these Bylaws, shall consist solely of dentists 784 practicing within the territorial jurisdiction of the 785 constituent society; dentists retired from active 786 practice; dentists engaged in activities furthering the 787 object of this Association; dentists serving on the 788 faculty of a dental school or receiving compensation 789 as a dental administrator or consultant within the 790 jurisdiction of the constituent society but are licensed 791 in another jurisdiction; and dentists in a federal dental 792 service (provided that the federal dentist is either 793 licensed in or serving within the confines of the 794 constituent society’s jurisdiction), provided that such 795 dentists are active, life or retired members in good 796 standing of a component of the constituent (except for 797 the federal dentists), if such exists, and this 798 Association. 799

Explanatory Note: A dentist who has retired from 800 active practice or who is engaged in activities 801 furthering the object of this Association shall be 802 considered to be practicing dentistry within the 803 meaning of this section. 804

B. REMOVAL FROM ONE JURISDICTION TO 805 ANOTHER. A member who has changed the location 806 of the member’s practice from the jurisdiction of one 807 constituent society to that of another constituent 808 society may maintain active membership in the 809


Bylaws 20

constituent society in which membership is being 810 held for the calendar year following that of the 811 member’s removal from the jurisdiction of such 812 society. The same privilege shall apply to a member 813 who is separated from a federal dental service and 814 who enters practice in an area under the jurisdiction 815 of a constituent society or a member who is retired 816 from a federal dental service and who is serving on a 817 faculty of a dental school, or is receiving 818 compensation as a dental administrator or consultant, 819 or is engaged in any activity in the area under the 820 jurisdiction of a constituent society for which a 821 license to practice dentistry or dental hygiene is 822 required by the state or other jurisdiction of the 823 United States wherein the activity is conducted. A 824 dentist who retires from active practice and 825 establishes residence in an area outside of the 826 jurisdiction of the constituent society in which the 827 dentist holds membership shall be permitted to 828 continue membership in such constituent society for 829 the period of retirement. 830 A member who is unsuccessful in transferring 831

membership from one constituent society to another 832 shall be entitled to a hearing (by either the component 833 or constituent society), on the decision denying the 834 member’s application for transfer of membership and 835 to appeal to the constituent society to which transfer 836 is sought, if applicable, and thereafter to the Council 837 on Ethics, Bylaws and Judicial Affairs of this 838 Association in accordance with the procedures in 839 Chapter XII, Section 20C and D of these Bylaws even 840 though a disciplinary penalty is not involved. 841

C. PRIVILEGES. An active, life, or retired member 842 in good standing shall enjoy all privileges of 843 constituent society membership except as otherwise 844 provided by these Bylaws. 845

D. MULTIPLE JURISDICTIONS. A member may 846 hold membership in more than one constituent society 847 with the consent of the constituent society involved. 848 A member is required to maintain active membership 849 in the constituent society, if accepted therein, in 850 whose jurisdiction the member maintains or practices 851 dentistry at a secondary or “branch” office. In order to 852 meet the requirement of tripartite membership, a 853 member must also maintain active membership in one 854 component society of each constituent society into 855 which the member is accepted, if such exist. If such a 856 member is accused of unethical conduct and 857 disciplinary proceedings are brought, then those 858 proceedings shall be instituted in the component or 859 constituent society where the alleged unethical 860 conduct occurred. A disciplinary ruling affecting 861 membership in one constituent society shall affect 862 membership in both societies and in the Association. 863 A member shall have the right of appeal as provided 864


Bylaws 21

in Chapter XII of the Bylaws. Such member shall pay 865 dues in this Association only through the constituent 866 society in whose jurisdiction the member conducts 867 the major part of the member’s practice. 868

Section 50. OFFICERS: The officers of a constituent 869 society shall be president, secretary, treasurer and such 870 others as may be prescribed in its bylaws. 871

Section 60. SESSIONS: A constituent society shall 872 hold a business session at least once each calendar 873 year. 874

Section 70. CONSTITUTION AND BYLAWS: Each 875 constituent society shall adopt and maintain a 876 constitution and bylaws which shall not be in conflict 877 with, or limit, the Constitution and Bylaws 878 of this Association and shall file a copy thereof and 879 any changes which may be made thereafter, with the 880 Executive Director of this Association. 881

Section 80. “PRINCIPLES OF ETHICS AND CODE 882 OF PROFESSIONAL CONDUCT”: The Principles of 883 Ethics and Code of Professional Conduct of this 884 Association and the code of ethics adopted by the 885 constituent society shall be the code of ethics of that 886 constituent society for governing the professional 887 conduct of its members. 888

Section 90. RIGHT OF HEARING AND APPEAL: 889 Disputes arising between constituent societies or 890 between a constituent society and one or more of its 891 component societies may be referred to the Council 892 on Ethics, Bylaws and Judicial Affairs of this 893 Association for hearing and decision as provided in 894 Chapter X, Section 120Gd in accordance with the 895 procedure of Chapter XII, Section 20C and D of these 896 Bylaws even though a disciplinary penalty is not 897 involved. 898

Section 100. PRIVILEGE OF REPRESENTATION: 899 Each constituent society shall be entitled to two (2) 900 delegates in the House of Delegates, except that one 901 (1) delegate shall be allocated to the Virgin Islands 902 Dental Association. The Air Force Dental Corps, the 903 Army Dental Corps, the Navy Dental Corps, the 904 Public Health Service and the Department of 905 Veterans Affairs shall each be entitled to two 906 delegates, one of which shall be elected by the 907 respective service, without regard to the number of 908 members. The remaining number of delegates shall 909 be allocated as provided in Chapter V, Sections 10C 910 and 10D. 911 Each constituent society and each federal dental 912

service may select from among its active, life and 913 retired members the same number of alternate 914 delegates as delegates and shall designate the 915 alternate delegate who shall replace an absent 916 delegate. 917


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Section 110. CHARTERED CONSTITUENT 918 SOCIETIES: The Executive Director of the 919 Association is authorized to issue a charter to each 920 constituent society denoting its name and territorial 921 jurisdiction. The following societies are chartered as 922 constituent societies of this Association: 923

Alabama Dental Association 924 Alaska Dental Society 925 Arizona State Dental Association 926 Arkansas State Dental Association 927 California Dental Association 928 Colorado Dental Association 929 Connecticut State Dental Association, The 930 Delaware State Dental Society 931 District of Columbia Dental Society, The 932 Florida Dental Association 933 Georgia Dental Association 934 Hawaii Dental Association 935 Idaho State Dental Association 936 Illinois State Dental Society 937 Indiana Dental Association 938 Iowa Dental Association 939 Kansas Dental Association 940 Kentucky Dental Association 941 Louisiana Dental Association, The 942 Maine Dental Association 943 Maryland State Dental Association 944 Massachusetts Dental Society 945 Michigan Dental Association 946 Minnesota Dental Association 947 Mississippi Dental Association, The 948 Missouri Dental Association 949 Montana Dental Association 950 Nebraska Dental Association, The 951 Nevada Dental Association 952 New Hampshire Dental Society 953 New Jersey Dental Association 954 New Mexico Dental Association 955 New York State Dental Association 956 North Carolina Dental Society, The 957 North Dakota Dental Association 958 Ohio Dental Association 959 Oklahoma Dental Association 960 Oregon Dental Association 961 Pennsylvania Dental Association 962 Puerto Rico, Colegio de Cirujanos Dentistas de 963 Rhode Island Dental Association 964 South Carolina Dental Association 965 South Dakota Dental Association 966 Tennessee Dental Association 967 Texas Dental Association 968 Utah Dental Association 969 Vermont State Dental Society 970

CHAPTER II • CONSTITUENT SOCIETIES CHAPTER III • COMPONENT SOCIETIES

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Virgin Islands Dental Association 971 Virginia Dental Association 972 Washington State Dental Association 973 West Virginia Dental Association 974 Wisconsin Dental Association 975 Wyoming Dental Association 976

CHAPTER III • COMPONENT SOCIETIES

Section 10. ORGANIZATION: Component societies 977 may be organized in conformity with a plan approved 978 by the constituent society of which they shall be 979 recognized entities provided, however, that the active, 980 life or retired members of each component society 981 shall consist of dentists who are members in good 982 standing of their respective constituent societies and 983 of this Association. The plan adopted by the 984 constituent society may or may not limit active 985 membership in a component society to dentists who 986 reside or practice within the geographic area of that 987 component society. Each component society shall 988 adopt and maintain a constitution and bylaws, which 989 shall not be in conflict with, or limit, the Constitution 990 and Bylaws of this Association or that of its 991 constituent society, and shall file a copy thereof and 992 any changes which may be made thereafter with the 993 Executive Director of this Association. 994

Section 20. POWER AND DUTIES: 995

A. A component society shall have the power to 996 select its active, life, and retired members as active 997 members of the constituent society in accordance 998 with Chapter II, Section 40, of these Bylaws. 999

B. It shall have the power to provide for its financial 1000 support, to establish bylaws, rules and regulations, not 1001 in conflict with, or limiting, the Constitution and 1002 Bylaws of this Association or that of its constituent 1003 society and to adopt a code of ethics not in conflict 1004 with the Principles of Ethics and Code of 1005 Professional Conduct of this Association or code of 1006 ethics of its constituent society. 1007

C. It shall have the power to discipline any of its 1008 members subject to the provisions in Chapter XII, 1009 Section 20 of these Bylaws. 1010

D. It shall have the power to establish committees, 1011 councils and commissions of the component society; 1012 to designate their powers and duties; and to adopt 1013 reasonable eligibility requirements for service 1014 thereon. 1015

Section 30. PRIVILEGES OF MEMBERSHIP: An 1016 active, life, or retired member in good standing shall 1017 have the opportunity of enjoying all privileges of 1018 component society membership except as otherwise 1019 provided by these Bylaws. 1020

CHAPTER III • COMPONENT SOCIETIES CHAPTER IV • TRUSTEE DISTRICTS

Bylaws 24

Section 40. TRANSFER FROM ONE COMPONENT 1021 TO ANOTHER: 1022

A member who has changed residence or location of 1023 practice within the jurisdiction of a constituent 1024 society so that the member no longer fulfills the 1025 membership requirements of the component society 1026 of which he or she is a member may maintain active 1027 membership in that component society for the 1028 calendar year following such change of residence or 1029 practice location. 1030 A member who is required to transfer membership 1031

from one component society to another and whose 1032 application for transfer of membership is denied shall 1033 be entitled to a hearing (by either the component or 1034 constituent society), on the decision denying the 1035 member’s application for transfer of membership and 1036 to appeal to the member’s constituent society, if 1037 applicable, and the Council on Ethics, Bylaws and 1038 Judicial Affairs of this Association in accordance 1039 with the procedures in Chapter XII, Section 20C and 1040 D of these Bylaws even though a disciplinary 1041 penalty is not involved. A component society which 1042 receives an application for transfer of membership 1043 from a dentist who has moved from the jurisdiction of 1044 another constituent society is governed by Chapter II, 1045 Section 40B of these Bylaws. 1046

CHAPTER IV • TRUSTEE DISTRICTS

Section 10. ORGANIZATION: The constituent 1047 societies and the federal dental services shall be 1048 organized into seventeen (17) trustee districts. 1049

Section 20. PURPOSE: The purpose of establishing 1050 trustee districts is to provide representation of the 1051 members of the constituent societies and the federal 1052 dental services on the Board of Trustees. 1053

Section 30. COMPOSITION: The trustee districts are 1054 numbered and composed as follows: 1055

DISTRICT 1 1056 Connecticut State Dental Association, The 1057 Maine Dental Association 1058 Massachusetts Dental Society 1059 New Hampshire Dental Society 1060 Rhode Island Dental Association 1061 Vermont State Dental Society 1062

DISTRICT 2 1063 New York State Dental Association 1064

DISTRICT 3 1065 Pennsylvania Dental Association 1066

DISTRICT 4 1067 Air Force Dental Corps 1068

CHAPTER IV • TRUSTEE DISTRICTS

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Army Dental Corps 1069 Delaware State Dental Society 1070 District of Columbia Dental Society, The 1071 Maryland State Dental Association 1072 Navy Dental Corps 1073 New Jersey Dental Association 1074 Public Health Service 1075 Puerto Rico, Colegio de Cirujanos Dentistas de 1076 Veterans Affairs 1077 Virgin Islands Dental Association 1078

DISTRICT 5* 1079 Alabama Dental Association 1080 Georgia Dental Association 1081 Mississippi Dental Association, The 1082

DISTRICT 6 1083 Kentucky Dental Association 1084 Missouri Dental Association 1085 Tennessee Dental Association 1086 West Virginia Dental Association 1087

DISTRICT 7 1088 Indiana Dental Association 1089 Ohio Dental Association 1090

DISTRICT 8 1091 Illinois State Dental Society 1092

DISTRICT 9 1093 Michigan Dental Association 1094 Wisconsin Dental Association 1095

DISTRICT 10 1096 Iowa Dental Association 1097 Minnesota Dental Association 1098 Nebraska Dental Association, The 1099 North Dakota Dental Association 1100 South Dakota Dental Association 1101

DISTRICT 11 1102 Alaska Dental Society 1103 Idaho State Dental Association 1104 Montana Dental Association 1105 Oregon Dental Association 1106 Washington State Dental Association 1107

DISTRICT 12 1108 Arkansas State Dental Association 1109 Kansas Dental Association 1110 Louisiana Dental Association, The 1111 Oklahoma Dental Association 1112

DISTRICT 13 1113 California Dental Association 1114

DISTRICT 14 1115 Arizona State Dental Association 1116 Colorado Dental Association 1117 Hawaii Dental Association 1118

CHAPTER IV • TRUSTEE DISTRICTS CHAPTER V • HOUSE OF DELEGATES

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Nevada Dental Association 1119 New Mexico Dental Association 1120 Utah Dental Association 1121 Wyoming Dental Association 1122

DISTRICT 15 1123 Texas Dental Association 1124

DISTRICT 16 1125 North Carolina Dental Society, The 1126 South Carolina Dental Association 1127 Virginia Dental Association 1128

DISTRICT 17* 1129

Florida Dental Association 1130

CHAPTER V • HOUSE OF DELEGATES

Section 10. COMPOSITION. 1131

A. VOTING MEMBERS. The House of Delegates 1132 shall be limited to four hundred sixty (460) voting 1133 members for the two years 2004 to 2005 inclusive. 1134 Thereafter, the number of voting members shall be 1135 determined by the methodologies set forth in Section 1136 10C of this Chapter. It shall be composed of the 1137 officially certified delegates of the constituent dental 1138 societies, two (2) officially certified delegates from 1139 each of the five (5) federal dental services and five (5) 1140 student members of the American Student Dental 1141 Association who are officially certified delegates 1142 from the American Student Dental Association. 1143

B. EX OFFICIO MEMBERS. The elective and 1144 appointive officers and trustees of this Association 1145 shall be ex officio members of the House of Delegates 1146 without the power to vote. They shall not serve as 1147 delegates. Past presidents of this Association shall be 1148 ex officio members of the House of Delegates without 1149 the power to vote unless designated as delegates. 1150

C. REPRESENTATIONAL REQUIREMENTS AND 1151 GOALS. Each constituent society shall be entitled to 1152

* In order to establish the required pattern of four, four, four and five members respectively retiring from councils and commissions each year, members of councils and commissions from the new 5th and 17th districts who are in office at the time this footnote becomes effective shall finish their terms in accordance with their scheduled term completion dates. Councils and commissions that have incumbent members from the new 5th district shall add a new member from the 17th district to a full four-year term. Councils and commissions that have incumbent members from the new 17th district shall add a new member from the new 5th district to a full four-year term.

CHAPTER IV • TRUSTEE DISTRICTS CHAPTER V • HOUSE OF DELEGATES

Bylaws 27

two (2) delegates, except that one (1) delegate shall 1153 be allocated to the Virgin Islands Dental Association. 1154 The Air Force Dental Corps, the Army Dental Corps, 1155 the Navy Dental Corps, the Public Health Service and 1156 the Department of Veteran Affairs shall each be 1157 entitled to two (2) delegates, one of which shall be 1158 elected by the respective service, without regard to 1159 the number of members. 1160

For the two years 2004-2005 inclusive, the 1161 remaining number of delegates shall be allocated to 1162 the constituent societies, through their trustee districts 1163 based on the representational goals that each trustee 1164 district's representation in the House of Delegates 1165 shall vary by no more or less than 0.3% from its 1166 active, life or retired membership share in this 1167 Association, based on the Association's December 31, 1168 2002 membership records, and that no district or 1169 constituent shall lose a delegate from its 2003 1170 allocation. Thereafter, to allow for changes in the 1171 delegate allocation due to membership fluctuations, 1172 the Board of Trustees shall use this variance method 1173 of district delegate allocation (a variance of no more 1174 than 0.3% of its active, life and retired membership 1175 share in the Association) at subsequent intervals of 1176 three (3) years, with the first such review occurring 1177 for the 2006 House of Delegates. Such reviews shall 1178 be based on the Association's year-end membership 1179 records for the calendar year preceding the review 1180 period in question. No district shall lose a delegate 1181 unless their membership numbers are at least one 1182 percent less than their membership numbers of the 1183 prior three years. Any changes deemed necessary 1184 shall be presented to the House of Delegates in the 1185 form of a Bylaws' amendment to Section 10D of this 1186 Chapter. 1187

D. DELEGATE ALLOCATION. Based on the 1188 representational requirements and goals set forth in 1189 Section 10C, the delegates are allocated as follows: 1190

DISTRICT 1 1191 Connecticut State Dental Association, The, 1192 7 delegates 1193 Maine Dental Association, 3 delegates 1194 Massachusetts Dental Society, 13 delegates 1195 New Hampshire Dental Society, 3 delegates 1196 Rhode Island Dental Association, 3 delegates 1197 Vermont State Dental Society, 2 delegates 1198 District Total: 31 delegates 1199

DISTRICT 2 1200 New York State Dental Association, 41 delegates 1201 District Total: 41 delegates 1202

DISTRICT 3 1203 Pennsylvania Dental Association, 18 delegates 1204 District Total: 18 delegates1205



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DISTRICT 4 1206 Air Force Dental Corps, 2 delegates 1207 Army Dental Corps, 2 delegates 1208 Delaware State Dental Society, 2 delegates 1209 District of Columbia Dental Society, The, 1210 2 delegates 1211 Maryland State Dental Association, 7 delegates 1212 Navy Dental Corps, 2 delegates 1213 New Jersey Dental Association, 12 delegates 1214 Public Health Service, 2 delegates 1215 Puerto Rico, Colegio de Cirujanos Dentistas de, 1216 2 delegates 1217 Veterans Affairs, 2 delegates 1218 Virgin Islands Dental Association, 1 delegate 1219 District Total: 36 delegates 1220

DISTRICT 5 1221 Alabama Dental Association, 5 delegates 1222 Georgia Dental Association, 9 delegates 1223 Mississippi Dental Association, The, 3 delegates 1224 District Total: 17 delegates 1225

DISTRICT 6 1226 Kentucky Dental Association, 6 delegates 1227 Missouri Dental Association, 7 delegates 1228 Tennessee Dental Association, 7 delegates 1229 West Virginia Dental Association, 3 delegates 1230 District Total: 23 delegates 1231

DISTRICT 7 1232 Indiana Dental Association, 9 delegates 1233 Ohio Dental Association, 16 delegates 1234 District Total: 25 delegates 1235

DISTRICT 8 1236 Illinois State Dental Society, 19 delegates 1237 District Total: 19 delegates 1238

DISTRICT 9 1239 Michigan Dental Association, 17 delegates 1240 Wisconsin Dental Association, 9 delegates 1241 District Total: 26 delegates 1242

DISTRICT 10 1243 Iowa Dental Association, 5 delegates 1244 Minnesota Dental Association, 9 delegates 1245 Nebraska Dental Association, The, 3 delegates 1246 North Dakota Dental Association, 2 delegates 1247 South Dakota Dental Association, 2 delegates 1248 District Total: 21 delegates 1249

DISTRICT 11 1250 Alaska Dental Society, 2 delegates 1251 Idaho State Dental Association, 3 delegates 1252 Montana Dental Association, 2 delegates 1253 Oregon Dental Association, 6 delegates 1254 Washington State Dental Association, 10 delegates 1255 District Total: 23 delegates 1256


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DISTRICT 12 1257 Arkansas State Dental Association, 4 delegates 1258 Kansas Dental Association, 4 delegates 1259 Louisiana Dental Association, The, 6 delegates 1260 Oklahoma Dental Association, 5 delegates 1261 District Total: 19 delegates 1262

DISTRICT 13 1263 California Dental Association, 63 delegates 1264 District Total: 63 delegates 1265

DISTRICT 14 1266 Arizona State Dental Association, 6 delegates 1267 Colorado Dental Association, 8 delegates 1268 Hawaii Dental Association, 3 delegates 1269 Nevada Dental Association, 3 delegates 1270 New Mexico Dental Association, 3 delegates 1271 Utah Dental Association, 4 delegates 1272 Wyoming Dental Association, 2 delegates 1273 District Total: 29 delegates 1274

DISTRICT 15 1275 Texas Dental Association, 23 delegates 1276 District Total: 23 delegates 1277

DISTRICT 16 1278 North Carolina Dental Society, The, 9 delegates 1279 South Carolina Dental Association, 5 delegates 1280 Virginia Dental Association, 10 delegates 1281 District Total: 24 delegates 1282

DISTRICT 17 1283 Florida Dental Association, 21 delegates 1284 District Total: 21 delegates 1285

AMERICAN STUDENT DENTAL 1286 ASSOCIATION, 5 delegates 1287

E. ALTERNATE DELEGATES. Each constituent 1288 dental society and each federal dental service may 1289 select from among its active, life and retired members 1290 the same number of alternate delegates as delegates. 1291 The American Student Dental Association may select 1292 from among its active members the same number of 1293 alternate delegates as delegates. 1294

F. SELECTION OF AMERICAN STUDENT 1295 DENTAL ASSOCIATION DELEGATES AND 1296 ALTERNATE DELEGATES. The American Student 1297 Dental Association shall select its five (5) delegates 1298 from its even numbered regions in even numbered 1299 years, and the odd numbered regions in odd 1300 numbered years, with their alternate delegates 1301 selected from the opposite groups of regions. 1302

Section 20. ELECTION OF DELEGATES AND 1303 ALTERNATE DELEGATES: The officially certified 1304 delegates and the alternate delegates of each 1305 constituent society shall be elected by one or more of 1306


Bylaws 30

the following methods: 1307 1. By the membership at large of that constituent 1308 society 1309 2. By the constituent society’s governing legislative 1310 body 1311 3. By a component with respect to the delegates 1312 representing that component 1313

Each federal dental service and the American Student 1314 Dental Association may establish its own method for 1315 selecting delegates. 1316

Section 30. CERTIFICATION OF DELEGATES 1317 AND ALTERNATE DELEGATES: The executive 1318 director or equivalent chief executive officer of each 1319 constituent society, the ranking administrative officer 1320 of each federal dental service, and the secretary of the 1321 American Student Dental Association shall file with 1322 the Executive Director of this Association, at least 1323 sixty (60) days prior to the first day of the annual 1324 session of the House of Delegates, the names of the 1325 delegates and alternate delegates designated by the 1326 society, service or association. The Executive 1327 Director of this Association shall provide each 1328 delegate and alternate delegate with credentials which 1329 shall be presented to the Committee on Credentials, 1330 Rules and Order of the House of Delegates. In the 1331 event of a contest over the credentials of any delegate 1332 or alternate delegate, the Committee on Credentials, 1333 Rules and Order shall hold a hearing and report its 1334 findings and recommendations to the House of 1335 Delegates for final action. 1336

Section 40. POWERS: 1337

A. The House of Delegates shall be the supreme 1338 authoritative body of this Association. 1339

B. It shall possess the legislative powers. 1340

C. It shall determine the policies which shall govern 1341 this Association in all of its activities. 1342

D. It shall have the power to enact, amend and repeal 1343 the Constitution and Bylaws. 1344

E. It shall have the power to adopt and amend the 1345 Principles of Ethics and Code of Professional 1346 Conduct for governing the professional conduct of the 1347 members. 1348

F. It shall have the power to grant, amend, suspend or 1349 revoke charters of constituent societies. It shall also 1350 have the power by a two-thirds (2/3) affirmative vote 1351 of the delegates present and voting to suspend the 1352 representation of a constituent society in the House of 1353 Delegates upon a determination by the House that the 1354 bylaws of the constituent society violate the 1355 Constitution or Bylaws of this Association providing, 1356 however, such suspension shall not be in effect until 1357 the House of Delegates has voted that the constituent 1358


Bylaws 31

society is in violation and has one year after 1359 notification of the specific violation in which to 1360 correct its constitution or bylaws. 1361

G. It shall have the power to create special 1362 committees of the Association. 1363

H. It shall have the power to establish branch offices 1364 of the Association. 1365

I. It shall have the power to approve all memorials, 1366 resolutions or opinions issued in the name of the 1367 American Dental Association. 1368

Section 50. DUTIES: It shall be the duty of the House 1369 of Delegates: 1370

A. To elect the elective officers. 1371

B. To elect the members of the Board of Trustees. 1372

C. To elect the members of the councils and 1373 commissions except as otherwise provided by these 1374 Bylaws. 1375

D. To receive and act upon reports of the committees 1376 of the House of Delegates. 1377

E. To adopt an annual budget and establish the dues 1378 of active members for the following year. 1379

F. To serve as the court of appeal from decisions of 1380 the Council on Ethics, Bylaws and Judicial Affairs 1381 except those decisions involving discipline of 1382 members. 1383

Section 60. TRANSFER OF POWERS AND 1384 DUTIES OF THE HOUSE OF DELEGATES: The 1385 powers and duties of the House of Delegates, except 1386 the power to amend, enact and repeal the Constitution 1387 and Bylaws, and the duty of electing the elective 1388 officers and the members of the Board of Trustees, 1389 may be transferred to the Board of Trustees of this 1390 Association in time of extraordinary emergency. The 1391 existence of a time of extraordinary emergency may 1392 be determined by unanimous consent of the members 1393 of the Board of Trustees present and voting at a 1394 regular or special session. Such extraordinary 1395 emergency may also be determined by mail vote of 1396 the last House of Delegates on recommendation of at 1397 least four (4) of the elective officers. A mail vote to 1398 be valid shall consist of ballots received from not less 1399 than one-fourth (1/4) of the members of the last 1400 House of Delegates. A majority of the votes cast 1401 within thirty (30) days after the mailing of the ballot 1402 shall decide the vote. 1403

Section 70. ANNUAL SESSION: The House of 1404 Delegates shall meet annually. 1405

Section 80. SPECIAL SESSIONS: A special session 1406 of the House of Delegates shall be called by the 1407


Bylaws 32

President on a three-fourths (3/4) affirmative vote of 1408 the members of the Board of Trustees or on written 1409 request of delegates representing at least one-third 1410 (1/3) of the constituent societies and not less than 1411 one-fifth (1/5) of the number of officially certified 1412 delegates of the last House of Delegates. The time 1413 and place of a special session shall be determined by 1414 the President, provided the time selected shall be not 1415 more than forty-five (45) days after the request was 1416 received. The business of a special session shall be 1417 limited to that stated in the official call except by 1418 unanimous consent. 1419

Section 90. OFFICIAL CALL: 1420

A. ANNUAL SESSION. The Executive Director of 1421 the Association shall cause to be published in The 1422 Journal of the American Dental Association an 1423 official notice of the time and place of each annual 1424 session, and shall send to each member of the House 1425 of Delegates an official notice of the time and place 1426 of the annual session at least thirty (30) days before 1427 the opening of such session. 1428

B. SPECIAL SESSION. The Executive Director of 1429 the Association shall send an official notice of the 1430 time and place of each special session and a statement 1431 of the business to be considered to every officially 1432 certified delegate and alternate delegate of the last 1433 House, not less than fifteen (15) days before 1434 the opening of such session. 1435

Section 100. QUORUM: One-fourth (1/4) of the 1436 voting members of the House of Delegates, 1437 representing at least one-fourth (1/4) of the 1438 constituent societies and federal dental services, shall 1439 constitute a quorum for the transaction of business at 1440 any meeting. 1441

Section 110. OFFICERS: 1442

A. SPEAKER AND SECRETARY. The officers of 1443 the House shall be the Speaker of the House of 1444 Delegates and the Secretary of the House of 1445 Delegates. The Executive Director of this Association 1446 shall serve as Secretary of the House of Delegates. 1447 In the absence of the Speaker the office shall be 1448

filled by the President. In the absence of the Secretary 1449 of the House of Delegates the Speaker shall appoint a 1450 Secretary of the House of Delegates pro tem. 1451

B. DUTIES. 1452 a. SPEAKER. The Speaker shall preside at all 1453 meetings of the House of Delegates and, in 1454 accordance with Chapter V, Section 140Bb, 1455 determine the order of business for all meetings 1456 subject to the approval of the House of Delegates, 1457 appoint tellers to assist in determining the result of 1458 any action taken by vote and perform such other 1459


Bylaws 33

duties as custom and parliamentary procedure 1460 require. The decision of the Speaker shall be final 1461 unless an appeal from such decision shall be made 1462 by a member of the House, in which case final 1463 decision shall be by majority vote. In addition, 1464 following adjournment of the Standing Committee 1465 on Constitution and Bylaws, the Speaker and the 1466 Chair of the Council on Ethics, Bylaws and Judicial 1467 Affairs shall be responsible for reviewing and either 1468 approving or redrafting any new resolutions or 1469 changes to resolutions that propose amendments to 1470 the Constitution and Bylaws, in accordance with 1471 Chapter V, Section 140Ab. 1472 b. SECRETARY. The Secretary of the House of 1473 Delegates shall serve as the recording officer of the 1474 House and the custodian of its records, and shall 1475 cause a record of the proceedings of the House to be 1476 published as the official transactions of the House. 1477

Section 120. ORDER OF BUSINESS: The order of 1478 business shall be that order of business adopted by the 1479 House of Delegates in conformity with Chapter V, 1480 Section 110Ba and Chapter V, Section 140Bb. 1481

Section 130. RULES OF ORDER: 1482

A. STANDING RULES AND REPORTS. 1483 a. REPORTS. All reports of elective officers, 1484 councils and committees, except supplemental 1485 reports, shall be sent to each delegate and alternate 1486 delegate at least fourteen (14) days in advance of the 1487 opening of the annual session. All supplemental 1488 reports shall be distributed to each delegate before 1489 such report is considered by the House of Delegates. 1490 b. APPROPRIATION OF FUNDS. Any resolution 1491 proposing an appropriation of funds, except those 1492 relating to the annual budget, shall be referred to the 1493 Board of Trustees for a report at the same session on 1494 the availability of funds for the purpose specified. 1495 c. APPROVAL OF ANNUAL BUDGET. The 1496 proposed annual budget shall be submitted by the 1497 Board of Trustees to the members of the House of 1498 Delegates at least fourteen (14) days prior to the 1499 opening meeting of the annual session, shall be 1500 referred to a special reference committee on budget 1501 for hearings at the annual session and then shall be 1502 considered for approval as a special order of 1503 business at the second meeting of the House of 1504 Delegates. In the event the budget as submitted is 1505 not approved, all recommendations for changes shall 1506 be referred to the Board of Trustees to prepare and 1507 present a revised budget. This procedure shall be 1508 repeated until a budget for the ensuing fiscal year 1509 shall be adopted. 1510 d. APPROVAL OF THE DUES OF ACTIVE 1511 MEMBERS. The dues of active members of this 1512 Association shall be established by the House of 1513


Bylaws 34

Delegates as the last item of business at each annual 1514 session. The resolution to establish the dues of 1515 active members for the following year shall be 1516 proposed at each annual session by the Board of 1517 Trustees in conformity with Chapter VII, Section 1518 100F of these Bylaws, may be amended to any 1519 amount and/or reconsidered by the House of 1520 Delegates until a resolution establishing the dues of 1521 active members is adopted by a two-thirds (2/3) 1522 affirmative vote of the delegates present and 1523 voting. 1524 e. INTRODUCTION OF NEW BUSINESS. No new 1525 business shall be introduced into the House of 1526 Delegates less than 15 days prior to the opening of 1527 the annual session, unless submitted by a Trustee 1528 District. No new business shall be introduced into 1529 the House of Delegates at the last meeting of a 1530 session except when such new business is submitted 1531 by a Trustee District and is permitted to be 1532 introduced by a two-thirds (2/3) affirmative vote of 1533 the delegates present and voting. The motion 1534 introducing such new business shall not be 1535 debatable. Approval of such new business shall 1536 require a majority vote except new business 1537 introduced at the last meeting of a session that 1538 would require a bylaw amendment cannot be 1539 adopted at such last meeting. Reference committee 1540 recommendations shall not be deemed new business. 1541 f. RESOLUTIONS. A resolution becomes the 1542 property of the American Dental Association when 1543 submitted to the ADA House of Delegates for 1544 consideration. If adopted by the House of Delegates, 1545 this Association shall be the sole owner of the 1546 resolution which shall constitute “work made for 1547 hire” under copyright laws. This Association shall 1548 have the exclusive right to seek copyright 1549 registration for the resolution and to secure 1550 copyrights and retain ownership of such copyrights 1551 in its own name. 1552

B. ADDITIONAL RULES. The rules contained in the 1553 current edition of The Standard Code of 1554 Parliamentary Procedure by Alice Sturgis shall 1555 govern the deliberations of the House of Delegates in 1556 all cases in which they are applicable and not in 1557 conflict with the standing rules or these Bylaws. 1558

Section 140. COMMITTEES: The committees of the 1559 House of Delegates shall be: 1560

A. COMMITTEE ON CONSTITUTION AND 1561 BYLAWS. 1562 a. COMPOSITION. The Committee shall consist of 1563 not more than eight (8) nor less than six (6) 1564 members of the Council on Ethics, Bylaws and 1565 Judicial Affairs of this Association appointed by the 1566 President in consultation with the Speaker of the 1567


Bylaws 35

House of Delegates and the Council Chair. 1568 b. DUTIES: Prior to the first meeting of each new 1569 session of the House of Delegates, the Committee 1570 shall review all resolutions proposing amendments 1571 to the Constitution and Bylaws and shall either 1572 approve the text of the amendment as written or 1573 shall redraft the resolution to accomplish the intent 1574 of the maker in the form currently used by the 1575 House of Delegates. The Committee shall file a 1576 report of its findings and actions at the first meeting 1577 of the House of Delegates and then shall adjourn. 1578 Thereafter until the House of Delegates adjourns 1579 sine die, the Speaker of the House and the Chair of 1580 the Council on Ethics, Bylaws and Judicial Affairs 1581 shall be responsible for reviewing any new 1582 resolutions or changes to resolutions that propose 1583 amendments to the Constitution and Bylaws, and 1584 they shall either approve the text of the amendment 1585 as written or shall redraft the resolution to 1586 accomplish the intent of the maker in the form 1587 currently used by the House of Delegates. 1588

B. COMMITTEE ON CREDENTIALS, RULES 1589 AND ORDER. 1590 a. COMPOSITION. The Committee, consisting of 1591 nine (9) members from the officially certified 1592 delegates and alternate delegates, shall be appointed 1593 by the President at least sixty (60) days in advance 1594 of each session. 1595 b. DUTIES. It shall be the duty of the Committee (1) 1596 to record and report the roll call of the House of 1597 Delegates at each meeting; (2) to conduct a hearing 1598 on any contest regarding the certification of a 1599 delegate or alternate delegate and to report its 1600 recommendations to the House of Delegates; (3) to 1601 prepare a report, in consultation with the Speaker 1602 and Secretary of the House of Delegates, on matters 1603 relating to the order of business and special rules of 1604 order; (4) to consider all matters referred to 1605 it and report its recommendations to the House of 1606 Delegates. 1607

C. RESOLUTIONS COMMITTEE. 1608 a. COMPOSITION. The Resolutions Committee 1609 shall consist of the Speaker and the Secretary of the 1610 House of Delegates and the chairs of the reference 1611 committees authorized by Subsection D of this 1612 Chapter. 1613 b. DUTIES. The duties of the Resolutions 1614 Committee shall be to examine resolutions after 1615 action by the reference committees and arrange a 1616 sequence for House action based upon the 1617 importance of the resolutions’ subject matter. 1618

D. REFERENCE COMMITTEES. 1619 a. COMPOSITION. Reference committees, 1620 consisting of nine (9) members from the officially 1621

CHAPTER V • HOUSE OF DELEGATES CHAPTER VI • CONFLICT OF INTEREST

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certified delegates and alternate delegates, shall be 1622 appointed by the President at least sixty (60) days in 1623 advance of each annual session. 1624 b. DUTIES. It shall be the duty of a reference 1625 committee to consider reports referred to it, to 1626 conduct open hearings and to report its 1627 recommendations to the House of Delegates. 1628

E. SPECIAL COMMITTEES. The Speaker, with the 1629 consent of the House of Delegates, shall appoint 1630 special committees to perform duties not otherwise 1631 assigned by these Bylaws, to serve until adjournment 1632 sine die of the session at which they were appointed. 1633

Section 150. ELECTION PROCEDURE: Elective 1634 officers, members of the Board of Trustees and 1635 members of councils and committees shall be elected 1636 by the House of Delegates except as otherwise 1637 provided in these Bylaws. Voting shall be by ballot, 1638 except that when there is only one candidate for an 1639 office, council or committee, such candidate may be 1640 declared elected by the Speaker. The Secretary shall 1641 provide facilities for voting. The polls shall be open 1642 for at least one and one-half (1-1/2) hours. 1643 a. When one is to be elected, and more than one has 1644 been nominated, the majority of the ballots cast shall 1645 elect. In the event no candidate receives a majority 1646 of the votes cast on the first ballot, the two (2) 1647 candidates receiving the greatest number of votes 1648 shall be balloted upon again. 1649 b. When more than one is to be elected, and the 1650 nominees exceed the number to be elected, the votes 1651 cast shall be non-cumulative, and the candidates 1652 receiving the greatest number of votes shall be 1653 elected. 1654

CHAPTER VI • CONFLICT OF INTEREST

It is the policy of this Association that individuals 1655 who serve in elective, appointive or employed offices 1656 or positions do so in a representative or fiduciary 1657 capacity that requires loyalty to the Association. At 1658 all times while serving in such offices or 1659 positions, these individuals shall further the interests 1660 of the Association as a whole. In addition, they shall 1661 avoid: 1662 a. placing themselves in a position where personal or 1663 professional interests may conflict with their duty to 1664 this Association. 1665 b. using information learned through such office or 1666 position for personal gain or advantage. 1667 c. obtaining by a third party an improper gain or 1668 advantage. 1669 As a condition for selection, each nominee, 1670

candidate and applicant shall complete a conflict of 1671 interest statement as prescribed by the Board of 1672 Trustees, disclosing any situation which might be 1673

CHAPTER VI • CONFLICT OF INTEREST CHAPTER VII • BOARD OF TRUSTEES

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construed as placing the individual in a position of 1674 having an interest that may conflict with his or her 1675 duty to the Association. Candidates for offices of 1676 President-elect, Second Vice President, Treasurer, 1677 Speaker of the House, nominees for office of trustee, 1678 and nominees to councils and commissions shall file 1679 such statements with the Secretary of the House of 1680 Delegates to be made available to the delegates prior 1681 to election. As a condition of appointment, 1682 consultants, advisers and staff of Councils, 1683 Commissions and Special Committees, and each 1684 person nominated or seeking such positions, shall file 1685 conflict of interest statements with the executive 1686 director of this Association. 1687 While serving in any elective, appointive or 1688

employed office or position, the individual shall 1689 comply with the conflict of interest policy applicable 1690 to his or her office or position, shall complete and file 1691 a conflict of interest statement for each year of 1692 service, and shall promptly report any situation in 1693 which a potential conflict of interest may arise. 1694 The Board of Trustees shall approve any additional 1695

compliance activities that will implement the 1696 requirements of this chapter. The Board of Trustees 1697 shall render a final judgment on what constitutes a 1698 conflict of interest. 1699

CHAPTER VII • BOARD OF TRUSTEES

Section 10. COMPOSITION: The Board of Trustees 1700 shall consist of one (1) trustee from each of the 1701 seventeen (17) trustee districts. Such seventeen (17) 1702 trustees, the President-elect and the two Vice 1703 Presidents shall constitute the voting membership of 1704 the Board of Trustees. In addition, the President, the 1705 Treasurer and the Executive Director of the 1706 Association, except as otherwise provided in the 1707 Bylaws shall be ex officio members of the Board 1708 without the right to vote. 1709

Section 20. QUALIFICATIONS: A trustee must be 1710 an active, life or retired member, in good standing, of 1711 this Association and an active, life, or retired member 1712 of one of the constituent societies of the trustee 1713 district which the trustee is elected to represent. 1714 Should the status of any trustee change in regard to 1715 the preceding qualifications during the trustee’s term 1716 of office, that office shall be declared vacant by the 1717 President and the President shall fill such vacancy as 1718 provided in Chapter VII, Section 80, of these Bylaws. 1719

Section 30. TERM OF OFFICE: The term of office of 1720 a trustee shall be four (4) years. The tenure of a 1721 trustee shall be limited to one (1) term of four (4) 1722 years.1723


Bylaws 38

Section 40. NOMINATION: 1724 A. SINGLE CONSTITUENT DISTRICT. In trustee 1725 districts consisting of a single constituent dental 1726 society, the trustee nomination procedures shall be 1727 determined by an elective process established by the 1728 constituent dental society which shall produce a 1729 single nominee for trustee. Until such time as the 1730 Speaker declares the nominee elected pursuant to 1731 Paragraph A of Section 50 of this Chapter, the 1732 nomination may be reconsidered by the duly 1733 constituted caucus of the trustee district during the 1734 appropriate annual session, provided that at no time 1735 shall more than one nominee be presented by the 1736 trustee district for election. The House of Delegates 1737 may vote to reject any such nominee and thereby 1738 compel the trustee district caucus to select a different 1739 nominee. 1740

B. MULTIPLE CONSTITUENT DISTRICTS. In 1741 multiple constituent districts, the delegates from the 1742 constituent societies of the trustee district in which 1743 the term of the trustee is to terminate, shall hold a 1744 caucus to select a nominee or nominees for the office 1745 of trustee. Such caucus shall be called by the trustee 1746 whose term is about to expire, or by the trustee’s 1747 designee. The notice of the time and place of such 1748 caucus shall be reported to the Secretary of the 1749 House. 1750 At the caucus the delegates shall nominate one (1) 1751

or two (2) candidates for the office of trustee, whose 1752 name or names shall be presented to the House of 1753 Delegates in accordance with the following rules. An 1754 action taken at a duly constituted caucus of the trustee 1755 district to nominate or select a trustee may be 1756 reconsidered at a later caucus during the appropriate 1757 annual session. 1758 a. A person receiving the unanimous vote of the 1759 delegates present and voting at the caucus shall be 1760 the only nominee presented by the district. 1761 b. In the event that one (1) candidate receives a 1762 majority vote, one (1) or more of the delegates 1763 voting in the minority may select another nominee 1764 and the names of both nominees shall be presented 1765 to the House of Delegates as the nominees of that 1766 district. 1767 c. The number of votes received by each nominee in 1768 the caucus shall be reported to the House of 1769 Delegates. 1770

C. NOMINATING PROCEDURE. Candidates for the 1771 office of trustee shall be nominated from the floor of 1772 the House of Delegates by a simple declaratory 1773 statement, which may be followed by an acceptance 1774 speech not to exceed four (4) minutes by the 1775 candidate from the podium, according to the protocol 1776 established by the Speaker of the House of Delegates. 1777


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Seconding a nomination is not permitted. 1778

Section 50. ELECTION: The trustee shall be elected 1779 by the House of Delegates according to the following 1780 rules: 1781

A. If there is only one (1) nominee from a trustee 1782 district, the Speaker shall declare such nominee 1783 elected. 1784

B. If there are two (2) nominees from a trustee 1785 district, the election shall be by ballot in accordance 1786 with Chapter V, Section 150. The nominee receiving 1787 the larger number of votes cast shall be declared 1788 elected. The method of election set forth in this 1789 paragraph shall not be used for any trustee district 1790 consisting of a single constituent dental society. A 1791 trustee district consisting of a single constituent 1792 dental society may present a single nominee to be 1793 elected pursuant to Paragraph A of this Section. 1794

Section 60. INSTALLATION: The trustee shall be 1795 installed by the President or by the President’s 1796 designee. 1797

Section 70. REMOVAL FOR CAUSE: The House of 1798 Delegates may remove a trustee for cause in 1799 accordance with procedures established by the House 1800 of Delegates, which procedures shall provide for 1801 notice of the charges and an opportunity for the 1802 accused to be heard in his or her defense. A two-1803 thirds (2/3) affirmative vote of the delegates present 1804 and voting is required to remove a trustee from office. 1805 If the House of Delegates elects to remove the trustee, 1806 that action shall create a vacancy on the Board of 1807 Trustees which shall be filled in accordance with 1808 Chapter VII, Section 80. 1809

Section 80. VACANCY: In the event of a vacancy in 1810 the office of trustee, an active, life or retired member 1811 may be appointed by the President to fill the 1812 unexpired term of the vacancy. The appointment shall 1813 be made by the President with the advice and consent 1814 of the former trustee’s district. A trustee district may 1815 file rules with the Association’s Executive Director 1816 setting forth how its nominee shall be chosen. In the 1817 event an appointment to fill the vacancy has not been 1818 made by the time of the next meeting of the House of 1819 Delegates following the occurrence of the vacancy, 1820 then a successor trustee shall be elected for the 1821 remainder of the unexpired term by the House of 1822 Delegates pursuant to the provisions of Chapter VII, 1823 Sections 40 and 50 of these Bylaws. If the term of the 1824 vacated trustee position has less than fifty percent 1825 (50%) of a full four-year term remaining at the time 1826 the successor trustee is appointed or elected, the 1827 successor trustee shall be eligible for election to a 1828 new, consecutive four-year term. If fifty percent 1829 (50%) or more of the vacated term remains to be 1830


Bylaws 40

served at the time of the appointment or election, the 1831 successor trustee shall not be eligible for another 1832 term. 1833

Section 90. POWERS: 1834 A. The Board of Trustees shall be the managing body 1835 of the Association, vested with full power to conduct 1836 all business of the Association, subject to the laws of 1837 the State of Illinois, the Articles of Incorporation, the 1838 Constitution and Bylaws and the mandates of the 1839 House of Delegates. The power of the Board of 1840 Trustees to act as the managing body of the 1841 Association shall not be construed as limiting the 1842 power of the House of Delegates to establish policy 1843 with respect to the governance of this Association in 1844 all its activities, except for areas expressly 1845 reserved in these Bylaws as powers and/or duties of 1846 the Board of Trustees, as the same may be amended 1847 by the House of Delegates from time to time in 1848 accordance with these Bylaws. 1849

B. It shall have the power to establish rules and 1850 regulations not inconsistent with these Bylaws to 1851 govern its organization and procedure. 1852

C. It shall have the power to direct the President to 1853 call a special session of the House of Delegates as 1854 provided in Chapter V, Section 80, of the Bylaws. 1855

D. It shall have full discretionary power to cause to be 1856 published in, or to be omitted from, any official 1857 publication of the Association any article in whole or 1858 in part. 1859

E. It shall have the power to establish ad interim 1860 policies when the House of Delegates is not in session 1861 and when such policies are essential to the 1862 management of the Association provided, however, 1863 that all such policies must be presented for review 1864 and consideration by the House of Delegates at its 1865 next session. 1866

F. It shall have the power to remove a council 1867 member for cause in accordance with procedures 1868 established by the Board of Trustees in its Rules. 1869

G. It shall have the power to elect honorary members. 1870

H. It shall have the power to appoint its members to 1871 committees that shall have the power to perform any 1872 duty that the Board of Trustees may lawfully 1873 delegate. 1874

I. It shall have the interim power to supervise, 1875 monitor and guide the activities of all councils and 1876 special committees in order to ensure the fulfillment 1877 of initiatives and directives assigned to each council 1878 or special committee by the House of Delegates or 1879 Board of Trustees subject to the requirement that all 1880 interim actions of the Board must be approved by the 1881


Bylaws 41

House of Delegates. 1882

J. In accordance with the laws of the State of Illinois, 1883 it shall have the power to transact its business by 1884 unanimous consent via mail ballot, including 1885 electronic mail; to authorize the councils, 1886 commissions and committees of this Association to 1887 transact their business by mail ballot; and to establish 1888 rules and procedures for itself and for councils, 1889 commissions and committees of this Association to 1890 govern the use of ballots circulated and returned by 1891 U.S. mail, overnight courier, facsimile transmission 1892 or electronic mail. 1893

K. It shall have the power to appoint agents and/or 1894 other representatives for the purpose of supervising, 1895 managing and otherwise conducting business under 1896 its direction and in accordance with these Bylaws and 1897 the laws of the State of Illinois. No such appointment 1898 shall relieve the Board of Trustees of its fiduciary 1899 duties as the managing body of the Association as 1900 provided in these Bylaws. 1901

Section 100. DUTIES: It shall be the duty of the 1902 Board of Trustees: 1903

A. To provide for the purchase, sale, mortgage, 1904 maintenance and supervision of the Headquarters 1905 Office and all other property or offices owned or 1906 operated by this Association. 1907

B. To appoint the Executive Director of the 1908 Association. 1909

C. To determine the date and place for convening 1910 each annual session and provide for the management 1911 and general arrangements for each annual session as 1912 provided in Chapter XV, Section 30. 1913

D. To cause to be bonded by a surety company the 1914 Treasurer, the Executive Director and employees of 1915 the Association entrusted with Association funds. 1916

E. To provide guidelines and directives to govern the 1917 Treasurer’s custody, investment and disbursement of 1918 Association funds and other property as provided in 1919 Chapter VIII, Section 90F, of these Bylaws; and to 1920 cause all accounts of the Association to be audited by 1921 a certified public accountant at least once a year. 1922

F. To prepare a budget for carrying on the activities 1923 of the Association for each ensuing fiscal year, and 1924 present for action by each House of Delegates a 1925 resolution setting forth the proposed dues of active 1926 members for the following year. Notice of such a 1927 resolution shall be sent by a certifiable method of 1928 delivery to each constituent society not less than 1929 ninety (90) days before such session to permit 1930 prompt, adequate notice by each constituent society to 1931 its delegates and alternate delegates to the House of 1932


Bylaws 42

Delegates of this Association, and shall be announced 1933 to the general membership in an official publication 1934 of the Association at least sixty (60) days in advance 1935 of the annual session. 1936

G. To establish rules to govern its procedures in 1937 serving as the nominating committee for the office of 1938 Treasurer, and as provided in Chapter VIII of these 1939 Bylaws, to submit in printed form the name(s) and 1940 curriculum vitae of the Board’s nominee(s) to the 1941 House of Delegates in the first mailing to the House 1942 in the year that the incumbent Treasurer’s term is 1943 about to end. 1944

H. To submit to the House of Delegates at the 1945 opening meeting of the annual session, in printed 1946 form, nominations for membership to the councils, 1947 except as otherwise provided in these Bylaws. 1948

I. To appoint annually the chair of each council, 1949 except as otherwise provided in these Bylaws, and to 1950 act upon council, commission, and bureau 1951 nominations for consultants and advisers except as 1952 otherwise provided in these Bylaws. 1953

J. To provide interim guidance and supervision to all 1954 councils and special committees in order to ensure the 1955 fulfillment of initiatives and directives assigned to 1956 each council or special committee by the House of 1957 Delegates or Board of Trustees. 1958

K. To review the reports of councils and special 1959 committees of the Association and to make 1960 recommendations concerning such reports to the 1961 House of Delegates. 1962

L. To act upon applications for active membership 1963 from applicants practicing in dependencies of the 1964 United States in which no constituent society exists or 1965 in federal dental services. 1966

M. To submit an annual report to the House of 1967 Delegates of its activities and those of the Treasurer 1968 and Executive Director. 1969

N. To review the delegate allocations to the House of 1970 Delegates as provided in Chapter V, Section 10C, of 1971 these Bylaws. 1972

O. To elect associate members. 1973

P. To establish other funds as divisions of the General 1974 Fund in accordance with the provisions of Chapter 1975 XVII, Section 30. 1976

Q. To appoint special committees of the Association 1977 in accordance with Chapter XI, Section 10 of these 1978 Bylaws. 1979

R. To perform such other duties as are prescribed by 1980 these Bylaws. 1981


Bylaws 43

S. To establish such administrative agencies of this 1982 Association as may be necessary to implement the 1983 Association’s programs, to assign the duties of such 1984 agencies through the Executive Director of the 1985 Association under whose jurisdiction each shall 1986 operate, and to require reports of such agencies 1987 through the same channels. 1988

Section 110. SESSIONS: 1989

A. REGULAR SESSIONS. The Board of Trustees 1990 shall hold a minimum of three regular sessions each 1991 year. The number of actual regular meetings to be 1992 held in excess of three for the ensuing year shall be 1993 determined in advance by the Board of Trustees. 1994

B. SPECIAL SESSIONS. Special sessions of the 1995 Board of Trustees may be called at any time either by 1996 the President or at the request of five voting members 1997 of the Board, provided notice is given to each 1998 member in advance of the session. 1999

C. PLACE OF MEETINGS: Regular or special 2000 meetings may be held in a single geographic location 2001 within or outside the state of Illinois or from multiple 2002 remote locations through the use of a conference 2003 telephone or other communications equipment by 2004 means of which all members can communicate with 2005 each other; provided, however, special meetings held 2006 through the use of a conference telephone or other 2007 communications equipment may be called by the 2008 President or at the request of five voting members of 2009 the Board of Trustees for matters of the Association 2010 requiring immediate attention. Such meetings shall be 2011 conducted in accordance with rules and procedures 2012 established by the Board of Trustees. 2013

Section 120. QUORUM: A majority of the voting 2014 members of the Board of Trustees shall constitute a 2015 quorum. 2016

Section 130. OFFICERS: 2017

A. CHAIR AND SECRETARY. The officers of the 2018 Board of Trustees shall be the President of the 2019 Association who shall be the Chair, and the Executive 2020 Director of the Association who shall be the 2021 Secretary. 2022 In the absence of the President, the office of Chair 2023

shall be filled by the President-elect and, in his or her 2024 absence, by the First or Second Vice President in that 2025 order and, in their absence, a voting member of the 2026 Board shall be elected Chair pro tem. 2027 In the absence of the Secretary, the Chair shall 2028

appoint a Secretary pro tem. 2029

B. DUTIES. 2030 a. CHAIR. The Chair shall preside at all meetings of 2031 the Board of Trustees. The Chair shall cast the 2032 deciding vote in case of a tie. 2033


Bylaws 44

b. SECRETARY. The Secretary shall serve as the 2034 recording officer of the Board of Trustees and as the 2035 custodian of its records. The Secretary shall cause a 2036 factual record of the proceedings to be published as 2037 the official transactions of the Board. 2038

Section 140. COMMITTEES: The Board of Trustees 2039 shall have a standing Committee on the New Dentist. 2040 The Committee shall consist of one (1) member from 2041 each trustee district who are active members selected 2042 by the Board of Trustees and confirmed by the House 2043 of Delegates. Members of the Committee shall have 2044 received their D.D.S. or D.M.D. degree less than ten 2045 (10) years before the time of selection. The chair of 2046 the Committee shall be appointed annually by the 2047 Board of Trustees. 2048

Members of the Committee shall serve one (1) term 2049 of four (4) years and shall not be eligible for 2050 appointment to a council or commission for a period 2051 of two (2) years after completing service on the 2052 Committee. However, the Board of Trustees shall 2053 stagger the terms of the members of the Committee in 2054 a manner so four (4) members will complete their 2055 terms each year, except every fourth year when five 2056 (5) members shall complete their terms. 2057 The Board of Trustees shall have the power to 2058

remove a Committee member for cause in accordance 2059 with procedures established by the Board in its Rules. 2060 In the event of any vacancy on the Committee, the 2061 Board of Trustees shall select a member of this 2062 Association possessing the same qualifications as 2063 established by these Bylaws for the previous member, 2064 to fill such vacancy for the remainder of the 2065 unexpired term. If the term of the vacated Committee 2066 position has less than fifty percent (50%) of a full 2067 four-year term remaining at the time the successor 2068 member is selected, the successor member shall be 2069 eligible for selection to a new, consecutive four-year 2070 term. If fifty percent (50%) or more of the vacated 2071 term remains to be served at the time of selection, the 2072 successor member shall not be eligible for another 2073 term. 2074 The Committee’s work shall be assigned by the 2075

Board of Trustees, and reports and proposals 2076 formulated by the Committee shall be referred to the 2077 Board for decision and action. The duties of the 2078 Committee shall be: 2079 a. To provide the Board of Trustees with expertise 2080 on issues affecting new dentists less than ten years 2081 following graduation from dental school. 2082 b. To advocate to the Board of Trustees and other 2083 agencies of this Association the perspectives of the 2084 new dentist in the development of policies, 2085 programs, benefits and services of the Association. 2086 c. To identify the needs and concerns of new 2087 graduate dentists and make recommendations for 2088

CHAPTER VII • BOARD OF TRUSTEES CHAPTER VIII • ELECTIVE OFFICERS

Bylaws 45

any programs to assist with their transition to 2089 practice. 2090 d. To stimulate the increased involvement and active 2091 participation of new dentists in organized dentistry. 2092 e. To serve as ex officio members, without the power 2093 to vote, of councils and commissions of this 2094 Association on issues affecting new dentists; these 2095 appointments will be recommended by the 2096 Committee and assigned by the Board of Trustees. 2097 f. To enhance communications with constituent and 2098 component new/young dentist networks. 2099

CHAPTER VIII • ELECTIVE OFFICERS

Section 10. TITLE: The elective officers of this 2100 Association shall be President, President-elect, First 2101 Vice President, Second Vice President, Treasurer and 2102 Speaker of the House of Delegates, as provided in 2103 Article V of the Constitution. 2104

Section 20. ELIGIBILITY: Only an active, life or 2105 retired member, in good standing, of this Association 2106 shall be eligible to serve as an elective officer. 2107 Trustees and elective officers may not apply for the 2108 office of Treasurer while serving in any of those 2109 offices, except that the Treasurer may apply for a 2110 second term pursuant to Chapter VIII, Section 50 of 2111 these Bylaws. 2112

Section 30. NOMINATIONS: 2113

A. Nominations for the offices of President-elect, 2114 Second Vice President and Speaker of the House shall 2115 be made in accordance with the order of business. 2116 Candidates for these elective offices shall be 2117 nominated from the floor of the House of Delegates 2118 by a simple declaratory statement, which may be 2119 followed by an acceptance speech not to exceed four 2120 (4) minutes by the candidate from the podium, 2121 according to the protocol established by the Speaker 2122 of the House of Delegates. Seconding a nomination is 2123 not permitted. 2124

B. Nominations for the office of Treasurer shall be 2125 made in accordance with the order of business. If 2126 there is only one (1) eligible candidate for the office 2127 of Treasurer, the Board of Trustees shall nominate 2128 that individual from the floor of the House of 2129 Delegates by a simple declaratory statement, which 2130 may be followed by an acceptance speech not to 2131 exceed four (4) minutes by the candidate from the 2132 podium, according to the protocol established by the 2133 Speaker of the House of Delegates. If there are two 2134 (2) or more eligible candidates for the office of 2135 Treasurer, the Board of Trustees shall nominate at 2136 least two (2) and not more than three (3) candidates 2137 from the floor of the House of Delegates by a simple 2138 declaratory statement for each nominee, which may 2139


Bylaws 46

be followed by an acceptance speech not to exceed 2140 four (4) minutes by the candidate from the podium, 2141 according to the protocol established by the Speaker 2142 of the House of Delegates. Seconding a nomination is 2143 not permitted. 2144

Section 40. ELECTIONS: The elective officers shall 2145 be elected in accordance with Chapter V, Section 150. 2146

Section 50. TERM OF OFFICE: The President, 2147 President-elect, First Vice President, Second Vice 2148 President and Speaker of the House of Delegates shall 2149 serve for a term of one (1) year, except as otherwise 2150 provided in this chapter of the Bylaws, or until their 2151 successors are elected and installed. The term of 2152 office of the Treasurer shall be three (3) years, or 2153 until a successor is elected and installed. The 2154 Treasurer shall be limited to two (2) consecutive 2155 terms of three (3) years each. 2156

Section 60. INSTALLATION: The elective officers 2157 shall be installed at the last meeting of the annual 2158 session of the House of Delegates. The President-2159 elect shall be installed as President at the next annual 2160 session of the House following election. The Second 2161 Vice President shall be installed as First Vice 2162 President at the next annual session of the House 2163 following election. 2164

Section 70. REMOVAL FOR CAUSE: The House of 2165 Delegates may remove an elective officer for cause in 2166 accordance with procedures established by the House 2167 of Delegates, which shall include notice of the 2168 charges and an opportunity for the accused to be 2169 heard in his or her defense. A two-thirds (2/3) 2170 affirmative vote of the delegates present and voting is 2171 required to remove an elective officer from office. If 2172 the House of Delegates elects to remove the elective 2173 officer, that action shall create a vacancy which shall 2174 be filled in accordance with Chapter VIII, Section 80. 2175

Section 80. VACANCIES: 2176

A. VACANCY OF ELECTIVE OFFICE: In the event 2177 the office of President becomes vacant, the President-2178 elect shall become President for the unexpired portion 2179 of the term. In the event the office of President 2180 becomes vacant for the second time in the same term 2181 or at a time when the office of President-elect is also 2182 vacant, the First Vice President shall become 2183 President for the unexpired portion of the term. In the 2184 event the office of First Vice President becomes 2185 vacant, the Second Vice President shall become the 2186 First Vice President for the unexpired portion of the 2187 term. A vacancy in the office of the Second Vice 2188 President shall be filled by a majority vote of the 2189 Board of Trustees. In the event of a vacancy in the 2190 office of Speaker of the House of Delegates, the 2191


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President, with approval of the Board of Trustees, 2192 shall appoint a Speaker pro tem. In the event 2193 the office of President-elect becomes vacant by 2194 reason other than the President-elect succeeding to 2195 the office of the President earlier than the next annual 2196 session, the office of President for the ensuing year 2197 shall be filled at the next annual session of the House 2198 of Delegates in the same manner as that provided for 2199 the nomination and election of elective officers, 2200 except that the ballot shall read “President for the 2201 Ensuing Year.” A vacancy in the office of Treasurer 2202 shall be filled by a majority vote of the Board of 2203 Trustees until the process of inviting applications, 2204 screening and nominating candidates and electing a 2205 new Treasurer has been completed by the Board of 2206 Trustees and the House of Delegates. The Treasurer 2207 pro tem shall be eligible for election to a new 2208 consecutive three (3) year term. The newly elected 2209 Treasurer shall be limited to two (2) consecutive 2210 terms of three (3) years each. 2211

B. TEMPORARY INCAPACITY OF THE 2212 PRESIDENT: Whenever the President notifies the 2213 Board of Trustees that he or she is unable to discharge 2214 the duties of the office of President due to temporary 2215 incapacity, the President-elect shall assume the duties 2216 of the office of President, as Acting President, until 2217 the President notifies the Board of Trustees that he or 2218 she is prepared to resume the duties of the office of 2219 President. Whenever the voting members of the 2220 Board of Trustees of this Association determine by 2221 majority vote that the President is unable to discharge 2222 the duties of his or her office due to temporary 2223 incapacity, the President-elect shall assume the duties 2224 of the office of President, as Acting President, until 2225 the President satisfies the voting members of the 2226 Board of Trustees that he or she is prepared to resume 2227 the duties of the office of President. 2228

Section 90. DUTIES: 2229

A. PRESIDENT. It shall be the duty of the President: 2230 a. To serve as the primary official representative of 2231 this Association in its contacts with governmental, 2232 civic, business and professional organizations for 2233 the purpose of advancing the objectives and policies 2234 of this Association. 2235 b. To serve as Chair and ex officio member of the 2236 Board of Trustees and to perform such duties as are 2237 provided in Chapters V and VII of these Bylaws. 2238 c. To call special sessions of the House of Delegates 2239 and the Board of Trustees as provided in Chapters V 2240 and VII of these Bylaws. 2241 d. To appoint the members of all committees of the 2242 House of Delegates except as otherwise provided in 2243 these Bylaws. 2244 e. To fill vacancies in the office of trustee as 2245


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provided in Chapter VII, Section 80, of these Bylaws 2246 and to fill other vacancies in accordance with these 2247 Bylaws. 2248 f. To submit an annual report to the House of 2249 Delegates. 2250 g. To perform such other duties as may be provided 2251 in these Bylaws. 2252

B. PRESIDENT-ELECT. It shall be the duty of the 2253 President-elect: 2254 a. To assist the President as requested. 2255 b. To serve as an ex officio member of the House of 2256 Delegates without the right to vote. 2257 c. To serve as an ex officio member of the Board of 2258 Trustees. 2259 d. To succeed to the office of President at the next 2260 annual session of the House of Delegates following 2261 election as President-elect. 2262 e. To succeed immediately to the office of President 2263 in the event of vacancy not only for the unexpired 2264 term but also for the succeeding year. 2265

C. FIRST VICE PRESIDENT. It shall be the duty of 2266 the First Vice President: 2267 a. To assist the President as requested. 2268 b. To serve as an ex officio member of the House of 2269 Delegates without the right to vote. 2270 c. To serve as an ex officio member of the Board of 2271 Trustees. 2272 d. To succeed to the office of President, as provided 2273 in this chapter of the Bylaws. 2274

D. SECOND VICE PRESIDENT. It shall be the duty 2275 of the Second Vice President: 2276 a. To assist the President as requested. 2277 b. To serve as an ex officio member of the House of 2278 Delegates without the right to vote. 2279 c. To serve as an ex officio member of the Board of 2280 Trustees. 2281 d. To succeed to the office of First Vice President at 2282 the next annual session of the House of Delegates 2283 following election as Second Vice President. 2284 e. To succeed immediately to the office of First Vice 2285 President in the event of vacancy not only for the 2286 unexpired term but also for the succeeding term. 2287

E. SPEAKER OF THE HOUSE OF DELEGATES. 2288 The Speaker shall preside at the meetings of the 2289 House of Delegates and shall perform such duties as 2290 custom and parliamentary procedure require. The 2291 Speaker shall not be a member of the Board of 2292 Trustees. 2293

F. TREASURER. It shall be the duty of the 2294 Treasurer: 2295 a. To serve as custodian of all monies, securities and 2296 deeds belonging to the Association which may come 2297 into the Treasurer’s possession. 2298

CHAPTER VIII • ELECTIVE OFFICERS CHAPTER IX • APPOINTIVE OFFICER

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b. To hold, invest and disburse all monies, securities 2299 and deeds, subject to the direction of the Board of 2300 Trustees. 2301 c. To design a budgetary process in concert with the 2302 Board of Trustees. 2303 d. To oversee Association finances and budget 2304 development. 2305 e. To serve as the principal resource person for the 2306 budget reference committee in the House of 2307 Delegates and to help interpret the Association’s 2308 finances for the membership. 2309 f. To review all financial information and data and 2310 report on financial matters to the Board of Trustees 2311 on a quarterly basis. 2312 g. To review travel reimbursement for the elective 2313 officers, trustees and Executive Director. 2314 h. To perform such other duties as may be provided 2315 in these Bylaws. 2316

CHAPTER IX • APPOINTIVE OFFICER

Section 10. TITLE: The appointive officer of this 2317 Association shall be an Executive Director, as 2318 provided in Article V of the Constitution. 2319

Section 20. APPOINTMENTS: While any active, life 2320 or retired member in good standing may be appointed 2321 to the office of Executive Director, the Board of 2322 Trustees may appoint a qualified individual who is 2323 not eligible for membership in this Association. 2324

Section 30. TERM OF OFFICE AND SALARY: The 2325 Board of Trustees shall determine the salary, if any, 2326 and the tenure of the Executive Director, which shall 2327 not exceed three (3) years. The completion of the full 2328 term of any appointment shall be at the discretion of 2329 the Board of Trustees. 2330

Section 40. DUTIES: The Executive Director shall be 2331 the principal agent of the Board of Trustees and 2332 elective officers. As agent and under the direction of 2333 the Board of Trustees and elective officers, the 2334 Executive Director shall be the chief operating officer 2335 of this Association and all its branches. In this 2336 capacity, the Executive Director shall (a) preserve and 2337 protect the Constitution and Bylaws and the standing 2338 rules of this Association; (b) facilitate the activities of 2339 the officers and trustees of this Association in 2340 carrying out their respective administrative 2341 responsibilities under these Bylaws; (c) engage the 2342 staff of this Association and direct and coordinate 2343 their activities; (d) provide leadership in the 2344 formulation and recommendation of new 2345 policies to the Board of Trustees and elective officers; 2346 (e) oversee the management of Association policies 2347 that have been adopted by the Board of Trustees 2348 and/or the House of Delegates; (f) assist the Board of 2349

CHAPTER IX • APPOINTIVE OFFICER CHAPTER X • COUNCILS

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Trustees in supervising, monitoring and providing 2350 guidance to all Association councils, commissions 2351 and committees in regard to their administrative 2352 functions and specific assignments, and to 2353 systematize the preparation of their reports, and to 2354 encourage the exchange of information concerning 2355 mutual interests and issues between councils, 2356 committees and commissions; (g) maintain effective 2357 internal and external relationships through frequent 2358 and comprehensive communication with all officers 2359 and trustees of this Association, the leadership of 2360 related dental organizations, and representatives from 2361 other leading public and private organizations that 2362 interact with this Association; and (h) perform such 2363 other duties as are prescribed by these Bylaws. 2364

CHAPTER X • COUNCILS

Section 10. NAME: The councils of this Association 2365 shall be: 2366

Council on Access, Prevention and Interprofessional 2367 Relations 2368 Council on ADA Sessions 2369 Council on Communications 2370 Council on Dental Benefit Programs 2371 Council on Dental Education and Licensure 2372

Council on Dental Practice 2373 Council on Ethics, Bylaws and Judicial Affairs 2374 Council on Government Affairs 2375 Council on Members Insurance and Retirement 2376 Programs 2377 Council on Membership 2378 Council on Scientific Affairs 2379

Section 20. MEMBERS, SELECTIONS, 2380 NOMINATIONS AND ELECTIONS: 2381

A. The composition of the councils of this 2382 Association shall be as follows: In addition, a council 2383 may request an additional member who shall be a 2384 nonpracticing dentist member appointed in 2385 accordance with Chapter I, Section 20Db of these 2386 Bylaws. Council on Access, Prevention and 2387 Interprofessional Relations shall be composed of one 2388 (1) member from each trustee district whose terms of 2389 office shall be staggered in such a manner that four 2390 (4) members will complete their terms each year 2391 except every fourth year when five (5) members shall 2392 complete their terms. In addition, there shall be one 2393 (1) member who is a physician and one (1) member 2394 who is a health care facility administrator nominated 2395 by the Board of Trustees. 2396

Council on ADA Sessions shall be composed of one 2397 (1) member from each trustee district whose terms of 2398 office shall be staggered in such a manner that four 2399


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(4) members will complete their terms each year 2400 except every fourth year when five (5) members shall 2401 complete their terms. In addition, the General Chair 2402 of the Local Arrangements Committee for the current 2403 year and the General Chair-elect for the succeeding 2404 year shall serve as ex officio members with the right 2405 to vote and shall not be eligible to serve as Council 2406 Chair. 2407

Council on Communications shall be composed of 2408 one (1) member from each trustee district whose 2409 terms of office shall be staggered in such a manner 2410 that four (4) members will complete their terms each 2411 year except every fourth year when five (5) members 2412 shall complete their terms. 2413

Council on Dental Benefit Programs shall be 2414 composed of one (1) member from each trustee 2415 district whose terms of office shall be staggered in 2416 such a manner that four (4) members will complete 2417 their terms each year except every fourth year when 2418 five (5) members shall complete their terms. 2419

Council on Dental Education and Licensure shall be 2420 composed of sixteen (16) members selected as 2421 follows: 2422 a. Nominations and Selection. 2423 (1) Eight (8) members shall be nominated by the 2424 Board of Trustees on a rotational system by trustee 2425 district from the active, life or retired members of 2426 this Association, no one of whom shall be a full-2427 time member of a faculty of a school of dentistry or 2428 a member of a state board of dental examiners or 2429 jurisdictional dental licensing agency. A person 2430 shall be considered to be a full-time member of a 2431 faculty if he or she works for the school of dentistry 2432 more than two (2) days or sixteen (16) hours per 2433 week. 2434 (2) Four (4) members who are active, life or retired 2435 members of this Association shall be selected by the 2436 American Association of Dental Examiners from the 2437 active membership of that body, no one of whom 2438 shall be a member of a faculty of a school of 2439 dentistry. 2440 (3) Four (4) members who are active, life or retired 2441 members of this Association shall be selected by the 2442 American Dental Education Association from its 2443 active membership. These members shall hold 2444 positions of professorial rank in dental schools 2445 accredited by the Commission on Dental 2446 Accreditation and shall not be members of any state 2447 board of dental examiners or jurisdictional dental 2448 licensing agency. 2449 b. Election. The eight (8) members of the Council 2450 on Dental Education and Licensure nominated by 2451 the Board of Trustees shall be elected by the House 2452 of Delegates from nominees selected in accordance 2453


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with this section. 2454 c. Committees. The Council on Dental Education 2455 and Licensure shall establish a standing Committee 2456 on Dental Education and Educational Measurements 2457 and a standing Committee on Licensure, each 2458 consisting of eight (8) members selected by the 2459 Council. The Council may establish additional 2460 committees when they are deemed essential to carry 2461 out the duties of this Council. 2462

Council on Dental Practice shall be composed of one 2463 (1) member from each trustee district whose terms of 2464 office shall be staggered in such a manner that four 2465 (4) members will complete their terms each year 2466 except every fourth year when five (5) members shall 2467 complete their terms. 2468

Council on Ethics, Bylaws and Judicial Affairs shall 2469 be composed of one (1) member from each trustee 2470 district whose terms of office shall be staggered in 2471 such a manner that four (4) members will complete 2472 their terms each year except every fourth year when 2473 five (5) members shall complete their terms. 2474

Council on Government Affairs shall be composed of 2475 one (1) member from each trustee district whose 2476 terms of office shall be staggered in such a manner 2477 that four (4) members will complete their terms each 2478 year except every fourth year when five (5) members 2479 shall complete their terms. In addition, the chair of 2480 the political action committee shall be an ex officio 2481 member of the Council without the power to vote. 2482 Consideration shall be given to a candidate’s 2483 experience in the military or other federal dental 2484 services. Members of the Council shall not be in the 2485 full-time employ of the federal government. 2486 Individuals called to active duty from the military 2487 reserves or national guard forces, providing such 2488 active duty has not been requested by the individual, 2489 shall not be considered to be in the full-time employ 2490 of the federal government. 2491

Council on Members Insurance and Retirement 2492 Programs shall be composed of one (1) member from 2493 each trustee district whose terms of office shall be 2494 staggered in such a manner that four (4) members will 2495 complete their terms each year except every fourth 2496 year when five (5) members shall complete their 2497 terms. 2498

Council on Membership shall be composed of one (1) 2499 member from each trustee district whose terms of 2500 office shall be staggered in such a manner that four 2501 (4) members will complete their terms each year 2502 except every fourth year when five (5) members shall 2503 complete their terms. 2504

Council on Scientific Affairs shall be composed of 2505 sixteen (16) members who shall be selected from 2506


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nominations open to all trustee districts, and the 2507 current recipient of the Gold Medal Award for 2508 Excellence in Dental Research. 2509

B. Nominations for all councils shall be made by the 2510 Board of Trustees except as otherwise provided in 2511 these Bylaws. The Board of Trustees shall adhere to 2512 the systems of nominations provided in Chapter X, 2513 Section 20A of these Bylaws*. The House of 2514 Delegates may make additional nominations pursuant 2515 to the systems for council nominations provided in 2516 Chapter X, Section 20A of these Bylaws. The elective 2517 and appointive officers and the trustees of this 2518 Association shall not serve as members of councils. 2519 Members of councils shall be elected by the House of 2520 Delegates in accordance with Chapter V, Section 150 2521 except as otherwise provided in these Bylaws. 2522

C. REMOVAL FOR CAUSE. The Board of Trustees 2523 may remove a council member for cause in 2524 accordance with procedures established by the Board 2525 of Trustees, which procedures shall provide for notice 2526 of the charges, including allegations of the conduct 2527 purported to constitute each violation, and a decision 2528 in writing which shall specify the findings of fact 2529 which substantiate any and all of the charges, and that 2530 prior to issuance of the decision of the Board of 2531 Trustees, no council member shall be excused from 2532 attending any meeting of a council unless there is an 2533 opportunity to be heard or compelling reasons exist 2534 which are specified in writing by the Board of 2535 Trustees. 2536

Section 30. ELIGIBILITY: 2537

A. All members of councils must be active, life, 2538 retired or nonpracticing dentist members in good 2539 standing of this Association except as otherwise 2540 provided in these Bylaws. 2541

B. No member of a council may serve concurrently as 2542 a member of another council or commission. 2543

* In order to establish the required pattern of four, four, four and five members respectively retiring from councils and commissions each year, members of councils and commissions from the new 5th and 17th districts who are in office at the time this footnote becomes effective shall finish their terms in accordance with their scheduled term completion dates. Councils and commissions that have incumbent members from the new 5th district shall add a new member from the 17th district to a full four-year term. Councils and commissions that have incumbent members from the new 17th district shall add a new member from the new 5th district to a full four-year term.


Bylaws 54

C. A member of the Council on Dental Education and 2544 Licensure who was selected by the American 2545 Association of Dental Examiners and who is no 2546 longer an active member of the American Association 2547 of Dental Examiners, may continue as a member of 2548 the Council for the balance of that member’s term. 2549

D. When a member of the Council on Dental 2550 Education and Licensure who was selected by the 2551 American Dental Education Association, shall cease 2552 to be a member of the faculty of a member school of 2553 that Association, such membership on either council 2554 shall terminate, and the President of the Association 2555 shall declare the position vacant. 2556

E. To be eligible to serve on the Council on Scientific 2557 Affairs, the current recipient of the Gold Medal 2558 Award for Excellence in Dental Research shall be an 2559 active, life, retired or nonpracticing dentist* member 2560 in good standing of this Association if the current 2561 recipient qualifies for such membership. 2562

Section 40. CHAIRS: One member of each council 2563 shall be appointed annually by the Board of Trustees 2564 to serve as chair with exception of the Council on 2565 Dental Education and Licensure. The Chair of the 2566 Council on Dental Education and Licensure shall be 2567 appointed from nominations submitted by the 2568 Council. 2569

Section 50. CONSULTANTS, ADVISERS AND 2570 STAFF: 2571

A. CONSULTANTS AND ADVISERS. Each council 2572 shall have the authority to nominate consultants and 2573 advisers in conformity with rules and regulations 2574 established by the Board of Trustees except as 2575 otherwise provided in these Bylaws. 2576

B. STAFF. The Executive Director shall employ the 2577 staff of councils, in the event they are employees, and 2578 shall select the titles for council staff positions. 2579

Section 60. TERM OF OFFICE: The term of office of 2580 members of councils shall be four (4) years except as 2581 otherwise provided in these Bylaws. The tenure of a 2582 member of a council shall be limited to one (1) term 2583 of four (4) years except as otherwise provided in 2584 these Bylaws. A member shall not be eligible for 2585 appointment to another council or commission for a 2586 period of two (2) years after completing a previous 2587 council appointment. The physician and the health 2588 * The eligibility requirement for nonpracticing dentist membership shall take effect upon completion of the 2006 Gold Medal Award for Excellence in Dental Research recipient’s term on the Council on Scientific Affairs.


Bylaws 55

care facility administrator, nominated by the Board of 2589 Trustees for membership on the Council on Access, 2590 Prevention and Interprofessional Relations, shall be 2591 elected for a one (1) year term; however, such 2592 member shall not be limited as to the number of 2593 consecutive one (1) year terms that he or she may 2594 serve. The current recipient of the Gold Medal Award 2595 for Excellence in Dental Research shall serve on the 2596 Council on Scientific Affairs until the award is 2597 bestowed on the next honoree. 2598

Section 70. VACANCY: In the event of a vacancy in 2599 the membership of any council, the President shall 2600 appoint a member of the Association possessing the 2601 same qualifications as established by these Bylaws for 2602 the previous member, to fill such vacancy until a 2603 successor is elected by the next House of Delegates 2604 for the remainder of the unexpired term. In the event 2605 such vacancy involves the chair of the council, the 2606 President shall have the power to appoint an ad 2607 interim chair. In the event it is the current recipient of 2608 the Gold Medal Award for Excellence in Dental 2609 Research who cannot serve on the Council on 2610 Scientific Affairs, the President, in consultation with 2611 the Board of Trustees, shall have the power to appoint 2612 a prominent research scientist who shall serve until 2613 the award is bestowed on the next honoree. 2614 If the term of the vacated council position has less 2615

than fifty percent (50%) of a full four-year term 2616 remaining at the time the successor member is 2617 appointed or elected, the successor member shall be 2618 eligible for election to a new, consecutive four-year 2619 term. If fifty percent (50%) or more of the vacated 2620 term remains to be served at the time of the 2621 appointment or election, the successor member shall 2622 not be eligible for another term. 2623

Section 80. MEETINGS OF COUNCILS. Each 2624 council shall hold at least one regular meeting 2625 annually, provided that funds are available in the 2626 budget for that purpose and unless otherwise directed 2627 by the Board of Trustees. Meetings may be held in 2628 the Headquarters Building, the Washington Office or 2629 from multiple remote locations through the use of a 2630 conference telephone or other communications 2631 equipment by means of which all members can 2632 communicate with each other. Such meetings shall be 2633 conducted in accordance with rules and procedures 2634 established by the Board of Trustees. 2635

Section 90. QUORUM: Except as otherwise provided 2636 in these Bylaws, a majority of the members of any 2637 council shall constitute a quorum. 2638

Section 100. PRIVILEGE OF THE FLOOR: Chairs 2639 and members of councils who are not members of the 2640 House of Delegates shall have the right to participate 2641 in the debate on their respective reports but shall not 2642


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have the right to vote. 2643

Section 110. ANNUAL REPORT AND BUDGET: 2644

A. ANNUAL REPORT. Each council shall submit, 2645 through the Executive Director, an annual report to 2646 the House of Delegates and a copy thereof to the 2647 Board of Trustees. 2648

B. PROPOSED BUDGET. Each council shall submit 2649 to the Board of Trustees, through the Executive 2650 Director, a proposed itemized budget for the ensuing 2651 fiscal year. 2652


A. COUNCIL ON ACCESS, PREVENTION AND 2654 INTERPROFESSIONAL RELATIONS. The duties 2655 of the Council shall be: 2656 a. To foster improvement in the health of the public 2657 in matters of access to care, prevention of disease and 2658 interprofessional relations by appropriate programs. 2659 b. To recommend policies and formulate programs 2660 relating to community oral health, including access to 2661 care, oral health planning, dental health personnel 2662 resources, preventive dentistry, fluoridation and 2663 nutrition issues. 2664 c. To evaluate for the Association trends in dental 2665 public health and access to care that enhance oral 2666 health on a community level, including public/private 2667 partnerships, tobacco use prevention, volunteerism, 2668 oral cancer prevention and community caries 2669 prevention. 2670 d. To assist constituent and component societies, 2671 public health agencies and others in the management 2672 and coordination of local resources or programs for 2673 access to care, preventive dentistry and other 2674 community health programs. 2675 e. To promote the Association’s position and 2676 maintain liaison with oral health agencies and special 2677 interest organizations regarding access to care, 2678 community oral health and dental health personnel 2679 issues. 2680 f. To serve as liaison for the Association with The 2681 Joint Commission and with corporate members of 2682 The Joint Commission and other national health care 2683 organizations. 2684 g. To recommend policy on issues pertaining to the 2685 relationship of dentistry to medicine, including 2686 interdisciplinary patient management, dentist-2687 physician relations, the oral health needs of medically 2688 compromised patients and the role of physical 2689 evaluation and medical risk management in dental 2690 practice. 2691 h. To conduct activities to improve the health 2692 outcomes of patients requiring cooperative dental-2693 medical management. 2694 i. To conduct activities to increase patient access to 2695


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dental care, including assessing public and private 2696 dental access programs and advising other 2697 Association agencies charged with recommending 2698 policy and legislation on access to care. 2699 j. To conduct activities to increase access to the 2700 benefits of cooperative dental-medical management 2701 in hospitals, ambulatory care centers, long-term care 2702 facilities and other interdisciplinary health care 2703 settings. 2704 k. To foster dentistry’s role in the hospital, including 2705 active medical staff membership and clinical 2706 privileges. 2707 l. To advise other Association agencies charged with 2708 communications, scientific, legislative and legal 2709 activities related to community oral health including 2710 tobacco use prevention, dental health personnel 2711 resources, preventive dentistry, fluoridation and 2712 nutrition issues. 2713

B. COUNCIL ON ADA SESSIONS. The duties of 2714 the Council shall be: 2715 a. To have responsibility for conducting the annual 2716 session of this Association, except the House of 2717 Delegates, subject to approval by the Board of 2718 Trustees as provided in these Bylaws. 2719 b. To plan and coordinate other Association sessions 2720 or regional meetings. 2721

C. COUNCIL ON COMMUNICATIONS. The duties 2722 of the Council shall be: 2723 a. To identify, recommend, and maintain an external 2724 strategic communications plan for the Association to 2725 facilitate other work throughout and on behalf of the 2726 Association. 2727 b. To advise the Association on the external image 2728 and brand implications of Association plans, 2729 programs, services and activities. 2730 c. To provide counsel to the Association on the 2731 priority and allocation of externally focused 2732 communication resources, to advise on their 2733 implications, and to identify the areas where the 2734 greatest strategic communications impact can be 2735 achieved. 2736 d. To identify, recommend, articulate and maintain 2737 strategies for significant external communications 2738 campaigns across the Association. 2739 e. To serve as a strategic communications resource 2740 to other Association agencies on communications to 2741 the profession. 2742 f. To create, implement, monitor and update an 2743 ongoing communication support strategy for the 2744 constituent and component dental societies. 2745

D. COUNCIL ON DENTAL BENEFIT 2746 PROGRAMS. The duties of the Council shall be: 2747 a. To formulate and recommend policies relating to 2748 the planning, administration and financing of dental 2749


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benefit programs. 2750 b. To study, evaluate and disseminate information 2751 on the planning, administration and financing of 2752 dental benefit programs. 2753 c. To assist the constituent societies and other 2754 agencies in developing programs for the planning, 2755 administration and financing of dental benefit 2756 programs. 2757 d. To provide assistance, guidance and support to 2758 constituent and component societies in the 2759 development and management of professional 2760 review systems. 2761 e. To encourage the inclusion of dental benefits in 2762 health benefit plans and to promote dental benefit 2763 plans in accordance with Association policy. 2764 f. To conduct activities and formulate and 2765 recommend policies concerning the assessment and 2766 improvement of the quality of dental care relating to 2767 dental benefit plans. 2768 g. To formulate procedural and diagnostic codes in 2769 conjunction with national dental organizations and 2770 the dental benefits industry that dentists can use to 2771 report patient care on dental benefit claim forms. 2772

E. COUNCIL ON DENTAL EDUCATION AND 2773 LICENSURE. The duties of the Council shall be: 2774 a. To act as the agency of the Association in matters 2775 related to the evaluation and accreditation of all 2776 dental educational, dental auxiliary educational and 2777 associated subjects. 2778 b. To study and make recommendations including 2779 the formulation and recommendation of policy on: 2780 (1) Dental education and dental auxiliary education. 2781 (2) The recognition of dental specialties. 2782 (3) The recognition of categories of dental 2783 auxiliaries. 2784 (4) The approval or disapproval of national 2785 certifying boards for special areas of dental practice 2786 and for dental auxiliaries. 2787 (5) The educational and administrative standards of 2788 the certifying boards for special areas of dental 2789 practice and for dental auxiliaries. 2790 (6) Associated subjects that affect all dental, dental 2791 auxiliary and related education. 2792 (7) Dental licensure and dental auxiliary 2793 credentialing. 2794 c. To act on behalf of this Association in 2795 maintaining effective liaison with certifying boards 2796 and related agencies for special areas of dental 2797 practice and for dental auxiliaries. 2798 d. To monitor and disseminate information on 2799 continuing dental education and to encourage the 2800 provision of and participation in continuing dental 2801 education. 2802

F. COUNCIL ON DENTAL PRACTICE. The duties 2803 of the Council shall be: 2804


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a. To formulate and recommend policies relating to 2805 dental practice. 2806 b. To study, evaluate and disseminate information 2807 concerning various forms of business organization 2808 of a dental practice, economic factors related to 2809 dental practice, practice management techniques, 2810 auxiliary utilization and dental laboratory services to 2811 the end that dentists may continue to improve 2812 services to the public. 2813 c. To develop educational and other programs to 2814 assist dentists in improved practice management, 2815 including practice marketing materials and 2816 continuing education seminars, and to assist 2817 constituent and component societies and other dental 2818 organizations in the development of such programs 2819 so that dentists may continue to improve the 2820 delivery of their services to the public. 2821 d. To encourage and develop satisfactory relations 2822 with the various organizations representing the 2823 dental laboratory industry and craft. 2824 e. To formulate programs for establishing and 2825 maintaining the greatest efficiency, quality and 2826 service of the dental laboratory industry and craft in 2827 their relation to the dental profession. 2828 f. To encourage and develop satisfactory relations 2829 with the various organizations representing dental 2830 auxiliaries. 2831 g. To gather, formulate and disseminate information 2832 related to auxiliary utilization, management and 2833 employment practices. 2834 h. To serve in a consultative capacity to those 2835 educational and promotional activities directed to 2836 the public and the profession and to assess their 2837 impact on dental practice. 2838 i. To provide assistance, education and information 2839 on issues related to dentists’ well being. 2840

G. COUNCIL ON ETHICS, BYLAWS AND 2841 JUDICIAL AFFAIRS. The duties of the Council shall 2842 be: 2843 a. To consider proposals for amending the 2844 Principles of Ethics and Code of Professional 2845 Conduct. 2846 b. To provide advisory opinions regarding the 2847 interpretation of the Principles of Ethics and Code 2848 of Professional Conduct. 2849 c. To consider appeals from members of the 2850 Association, or from component societies subject to 2851 the requirements of Chapter XII, Section 20 of these 2852 Bylaws. 2853 d. To hold hearings and render decisions in disputes 2854 arising between constituent societies or between 2855 constituent and component societies. 2856 e. To discipline any of the direct members of this 2857 Association in accordance with the requirements and 2858 procedures of Chapter XII of these Bylaws, using 2859


Bylaws 60

hearing panels composed of not less than three (3) 2860 of its elected members selected by the Council chair. 2861 The Council may adopt procedures governing the 2862 discipline of direct members of this Association 2863 consistent with Chapter XII of these Bylaws, which 2864 may include the use of an investigating committee 2865 or individual to investigate any complaint made 2866 against such member and report findings to the 2867 hearing panel concerning whether charges should 2868 issue. 2869 f. To review the articles of the Constitution and 2870 Bylaws in order to keep them consistent with the 2871 Association’s program. 2872 g. To recommend editorial changes in the Bylaws to 2873 improve their consistency, clarity and style. 2874 h. Notwithstanding paragraph g of this subsection, 2875 the Council shall have the authority to make 2876 corrections in punctuation, grammar, spelling, name 2877 changes, gender references, and similar editorial 2878 corrections in the Bylaws which do not alter its 2879 context or meaning. Such corrections shall be made 2880 only by a unanimous vote of the Council members 2881 present and voting. 2882 i. To review the rules and bylaws of all commissions 2883 of the Association in order to keep such rules and 2884 bylaws consistent with the Constitution and Bylaws 2885 of this Association. 2886 j. To act as the Standing Committee on Constitution 2887 and Bylaws of the House of Delegates, with the 2888 composition of such committee to be determined in 2889 accordance with Chapter V, Section 140A of these 2890 Bylaws, and to conduct other business it deems 2891 necessary. 2892 k. To provide guidance and advice on ethical and 2893 professional issues to constituent and component 2894 societies. 2895 l. To formulate and disseminate materials related to 2896 ethical and professional conduct in the practice and 2897 promotion of dentistry. 2898

H. COUNCIL ON GOVERNMENT AFFAIRS. The 2899 duties of the Council shall be: 2900 a. To encourage the improvement of the health of 2901 the public and to promote the art and science of 2902 dentistry in matters of legislation and regulations by 2903 appropriate activities. 2904 b. To formulate and recommend policies related to 2905 legislative and regulatory issues and to 2906 governmental agency programs. 2907 c. To formulate proposed legislation, approved by 2908 the Board of Trustees, that may be submitted to 2909 Congress and which will promote the art and science 2910 of dentistry in accordance with Association policies. 2911 d. To disseminate information which will assist the 2912 constituent and component societies involving 2913 legislation and regulation affecting the dental health 2914


Bylaws 61

of the public. 2915 e. To serve and assist the American Dental 2916 Association as a liaison with agencies of the federal 2917 government. 2918 f. To advise other Association agencies charged with 2919 developing, recommending and/or implementing 2920 legislative policies adopted by the House of 2921 Delegates. 2922 g. To serve as liaison for the American Dental 2923 Association with those agencies of the federal 2924 government which employ dental personnel in direct 2925 dental care delivery programs and the dentists in 2926 those services. 2927 h. To recommend programs and policies which will 2928 ensure that eligible beneficiaries of federal dental 2929 service programs have access to quality dental care. 2930 i. To recommend programs and policies which 2931 promote an efficient and effective dental care 2932 delivery system within the federal dental services. 2933 j. To assist in the development of dental workforce 2934 requirements and appropriate mobilization programs 2935 in times of emergency. 2936 k. To formulate and recommend policies which are 2937 designed to advance the professional status of 2938 federally employed dentists. 2939 l. To monitor dental training programs conducted by 2940 the federal dental services. 2941

I. COUNCIL ON MEMBERS INSURANCE AND 2942 RETIREMENT PROGRAMS. The duties of the 2943 Council shall be: 2944 a. To evaluate on a continuing basis all Association 2945 sponsored insurance programs. 2946 b. To examine and evaluate other insurance 2947 programs that might be of benefit to the 2948 membership. 2949 c. To advise and recommend courses of action on 2950 insurance programs. 2951 d. To assist constituent societies in matters related to 2952 insurance programs. 2953 e. To serve as Trustees for the American Dental 2954 Association Members Retirement Program.∗ 2955 f. To advise and recommend courses of action on 2956 retirement programs.** 2957

J. COUNCIL ON MEMBERSHIP. Except as 2958 otherwise provided in these Bylaws, the duties of the 2959 Council shall be: 2960 a. To formulate and recommend policies related to 2961 membership recruitment and retention and other 2962 related issues. 2963 b. To identify and monitor trends and issues that 2964 affect membership recruitment and retention, 2965

∗ This duty shall expire April 30, 2008. ** This duty shall commence April 30, 2008.


Bylaws 62

particularly among under-represented segments, and 2966 to encourage membership involvement throughout 2967 organized dentistry. 2968 c. To support, monitor and encourage membership 2969 activities of constituent and component dental 2970 societies and to enhance cooperation and 2971 communication on tripartite recruitment and 2972 retention efforts. 2973 d. To recommend, monitor and support the 2974 development of membership benefits and services 2975 that respond to identified needs of members. 2976 e. To act as an advocate for membership benefits. 2977

K. COUNCIL ON SCIENTIFIC AFFAIRS. The 2978 duties of the Council shall be: 2979 a. To develop and promote an annual research 2980 agenda with appropriate means for funding. 2981 b. To identify emergent issues and areas of research 2982 that require response from the research community. 2983 c. To report results on the latest scientific 2984 developments to practicing dentists. 2985 d. To evaluate and issue statements to the profession 2986 regarding the efficacy of concepts, procedures and 2987 techniques for use in the treatment of patients. 2988 e. To guide, assist and act as liaison to the American 2989 Dental Association Foundation and serve as its peer 2990 review body. 2991 f. To represent the Association on scientific and 2992 research matters and maintain liaison with related 2993 regulatory, research and professional organizations. 2994 g. To encourage the development and improvement 2995 of materials, instruments and equipment for use in 2996 dental practice, and to coordinate development of 2997 national and international standardization programs. 2998 h. To determine the safety and effectiveness of, and 2999 disseminate information on, materials, instruments 3000 and equipment that are offered to the public or the 3001 profession and further critically evaluate statements 3002 of efficacy and advertising claims. 3003 i. To study, evaluate and disseminate information 3004 with regard to the proper use of dental therapeutic 3005 agents, their adjuncts and dental cosmetic agents 3006 that are offered to the public or the profession. 3007 j. To award the American Dental Association Seal to 3008 dental products that meet the Association’s 3009 requirements for acceptance. 3010 k. To promote efforts to develop dental research 3011 workforce and to involve students in dental research. 3012 l. To study, evaluate and disseminate information on 3013 those aspects of the dental practice environment 3014 related to the health of the public, dentists and dental 3015 auxiliaries. 3016 m. To serve as the primary resource for scientific 3017 inquiries from the public and the profession. 3018

CHAPTER XI • SPECIAL COMMITTEES CHAPTER XII • PRINCIPLES OF ETHICS AND

CODE OF PROFESSIONAL CONDUCT AND JUDICIAL PROCEDURE

Bylaws 63

CHAPTER XI • SPECIAL COMMITTEES

Section 10. APPOINTMENT AND TERM. Special 3019 committees of this Association may be created at any 3020 session of the House of Delegates or, when the House 3021 is not in session, by the Board of Trustees, for the 3022 purpose of performing duties not otherwise assigned 3023 by these Bylaws. Duties otherwise assigned by these 3024 Bylaws solely to one (1) council, commission or other 3025 agency should be assigned to that council, 3026 commission or other agency with the necessary 3027 funding to accomplish the task. If duties are assigned 3028 to a special committee that are assigned under these 3029 Bylaws to more than one (1) council, commission or 3030 other agency, members of the relevant councils, 3031 commissions or other agencies shall be appointed to 3032 serve on the special committee. Such special 3033 committees may serve until adjournment sine die of 3034 the next annual session of the House of Delegates. 3035 The authority for appointing the members of a special 3036 committee and their number shall be set forth in the 3037 resolution creating such committee. 3038

Section 20. PRIVILEGE OF THE FLOOR: Chairs 3039 and members of special committees who are not 3040 members of the House of Delegates shall have the 3041 right to participate in the debate on their respective 3042 reports but shall not have the right to vote. 3043

CHAPTER XII • PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT AND

JUDICIAL PROCEDURE

Section 10. PROFESSIONAL CONDUCT OF 3044 MEMBERS: The professional conduct of a member 3045 of this Association shall be governed by the 3046 Principles of Ethics and Code of Professional 3047 Conduct of this Association and by the codes of 3048 ethics of the constituent and component societies 3049 within whose jurisdiction the member practices, or 3050 conducts or participates in other professional dental 3051 activities. 3052

Section 20. DISCIPLINE OF MEMBERS: 3053

A. CONDUCT SUBJECT TO DISCIPLINE. A 3054 member may be disciplined for (1) having been found 3055 guilty of a felony, (2) having been found guilty of 3056 violating the dental practice act of a state or other 3057 jurisdiction of the United States, (3) having been 3058 discharged or dismissed from practicing dentistry 3059 with one of the federal dental services under 3060 dishonorable circumstances, or (4) violating the 3061 Bylaws, the Principles of Ethics and Code of 3062 Professional Conduct, or the bylaws or code of ethics 3063


JUDICIAL PROCEDURE

Bylaws 64

of the constituent or component society of which the 3064 accused is a member. For a member of a constituent 3065 society, disciplinary proceedings may be instituted by 3066 either the member’s component or constituent 3067 society. Disciplinary proceedings against a direct 3068 member of this Association may be instituted by the 3069 Council on Ethics, Bylaws and Judicial Affairs of this 3070 Association. 3071

B. DISCIPLINARY PENALTIES. A member may be 3072 placed under a sentence of censure or suspension or 3073 may be expelled from membership for any of the 3074 offenses enumerated in Section 20A of this Chapter. 3075 Censure is a disciplinary sentence expressing in 3076

writing severe criticism or disapproval of a particular 3077 type of conduct or act. 3078 Suspension, subject to Chapter I, Section 30 of these 3079

Bylaws, means all membership privileges except 3080 continued entitlement to coverages under insurance 3081 programs are lost during the suspension period. 3082 Suspension shall be unconditional and for a specified 3083 period at the termination of which full membership 3084 privileges are automatically restored. A subsequent 3085 violation shall require a new disciplinary procedure 3086 before additional discipline may be imposed. 3087 Expulsion is an absolute discipline and may not be 3088

imposed conditionally except as otherwise provided 3089 herein. 3090 Probation, to be imposed for a specified period and 3091

without loss of privileges, may be administratively 3092 and conditionally imposed when circumstances 3093 warrant in lieu of a suspended disciplinary penalty. 3094 Probation shall be conditioned on good behavior. 3095 Additional reasonable conditions may be set forth in 3096 the decision for the continuation of probation. In the 3097 event that the conditions for probation are found by 3098 the society which preferred charges to have been 3099 violated, after a hearing on the probation violation 3100 charges in accordance with Chapter XII, Section 20C, 3101 the original disciplinary penalty shall be 3102 automatically reinstated; except that when 3103 circumstances warrant the original disciplinary 3104 penalty may be reduced to a lesser penalty. There 3105 shall be no right of appeal from a finding that the 3106 conditions of probation have been violated. 3107 After all appeals are exhausted or after the time for 3108

filing an appeal has expired, a sentence of censure, 3109 suspension or expulsion meted out to any member, 3110 including those instances when the disciplined 3111 member has been placed on probation, shall be 3112 promulgated by such member’s component and 3113 constituent societies, if such exist, and this 3114 Association. 3115

C. DISCIPLINARY PROCEEDINGS. Before a 3116 disciplinary penalty is invoked against a member, the 3117


JUDICIAL PROCEDURE

Bylaws 65

following procedures shall be followed by the agency 3118 preferring charges: 3119 a. HEARING. The accused member shall be entitled 3120 to a hearing at which the accused shall be given the 3121 opportunity to present a defense to all charges 3122 brought against the accused. The agency preferring 3123 charges shall permit the accused member to be 3124 represented by legal counsel. 3125 b. NOTICE. The accused member shall be notified 3126 in writing of charges brought against the accused 3127 and of the time and place of the hearing, such notice 3128 to be sent by certified—return receipt requested 3129 letter addressed to the accused’s last known address 3130 and mailed not less than twenty-one (21) days prior 3131 to the date set for the hearing. An accused member, 3132 upon request, shall be granted one postponement for 3133 a period not to exceed thirty (30) days. 3134 c. CHARGES. The written charges shall include an 3135 officially certified copy of the alleged conviction or 3136 determination of guilt, or a specification of the 3137 bylaw or ethical provisions alleged to have been 3138 violated, as the case may be, and a description of the 3139 conduct alleged to constitute each violation. 3140 d. DECISION. Every decision which shall result in 3141 censure, suspension or expulsion or in probation 3142 shall be reduced to writing and shall specify the 3143 charges made against the member, the facts which 3144 substantiate any or all of the charges, the verdict 3145 rendered, the penalty imposed or when appropriate 3146 the suspended penalty imposed and the conditions 3147 for probation, and a notice shall be mailed to the 3148 accused member informing the accused of the right 3149 to appeal. Within ten (10) days of the date on which 3150 the decision is rendered a copy thereof shall be sent 3151 by certified—return receipt requested mail to the last 3152 known address of each of the following parties: the 3153 accused member; the secretary of the component 3154 society of which the accused is a member, if 3155 applicable; the secretary of the constituent society of 3156 which the accused is a member, if applicable; the 3157 Chair of the Council on Ethics, Bylaws and Judicial 3158 Affairs of this Association and the Executive 3159 Director of this Association. 3160

D. APPEALS. The accused member under sentence 3161 of censure, suspension or expulsion shall have the 3162 right to appeal from a decision of the accused’s 3163 component society to the accused’s constituent 3164 society by filing an appeal in affidavit form with the 3165 secretary of the constituent society. Such an accused 3166 member, or the component society concerned, shall 3167 have the right to appeal from a decision of the 3168 constituent society to the Council on Ethics, Bylaws 3169 and Judicial Affairs of this Association by filing an 3170 appeal in affidavit form with the Chair of the Council 3171 on Ethics, Bylaws and Judicial Affairs. Where the 3172


JUDICIAL PROCEDURE

Bylaws 66

accused is a direct member of this Association, the 3173 accused member shall have the right of appeal from a 3174 disciplinary decision of a hearing panel of the Council 3175 on Ethics, Bylaws and Judicial Affairs to the Council 3176 by filing an appeal in affidavit form with the Chair of 3177 the Council on Ethics, Bylaws and Judicial Affairs. 3178 Members of the hearing panel shall not have the right 3179 to vote on the Council’s decision on such an appeal. 3180 An appeal from any decision shall not be valid 3181

unless notice of appeal is filed within thirty (30) days 3182 and the supporting brief, if one is to be presented, is 3183 filed within sixty (60) days after such decision has 3184 been rendered. A reply brief, if one is to be presented, 3185 shall be filed within ninety (90) days after such 3186 decision is rendered. A rejoinder brief, if one is to be 3187 presented, shall be filed within one hundred five 3188 (105) days after such decision is rendered. After all 3189 briefs have been filed, a minimum of forty-five (45) 3190 days shall elapse before the hearing date. Omission of 3191 briefs will not alter the briefing schedule or hearing 3192 date unless otherwise agreed to by the parties and the 3193 chair of the appropriate appellate agency. 3194 No decision shall become final while an appeal there 3195

from is pending or until the thirty (30) day period for 3196 filing notice of appeal has elapsed. In the event of a 3197 sentence of expulsion and no notice of appeal is 3198 received within the thirty (30) day period, the 3199 constituent society shall notify all parties of the 3200 failure of the accused member to file an appeal. The 3201 sentence of expulsion shall take effect on the date the 3202 parties are notified. The component and constituent 3203 societies shall each determine what portion of their 3204 current dues and their special assessments, if any, 3205 shall be returned to the expelled member. Dues and 3206 special assessments paid to this Association shall not 3207 be refundable in the event of expulsion. The 3208 following procedure shall be used in processing 3209 appeals: 3210

a. HEARINGS ON APPEAL. The accused member 3211 or the society (or societies) concerned shall be 3212 entitled to a hearing on an appeal, provided that 3213 such appeal is taken in accordance with, and 3214 satisfies the requirements of, Section 20D of this 3215 Chapter. The appellate agency hearing the appeal 3216 shall permit the accused member to be represented 3217 by legal counsel. A party need not appear for the 3218 appeal to be heard by an appellate agency. 3219 b. NOTICE. The appellate agency receiving an 3220 appeal shall notify the society (or societies) 3221 concerned, or where applicable the hearing panel of 3222 the Council on Ethics, Bylaws and Judicial Affairs, 3223 and the accused member of the time and place of 3224 the hearing, such notice to be sent by certified—3225 return receipt requested letter to the last known 3226 address of the parties to the appeal and mailed not 3227 less than thirty (30) days prior to the date set for the 3228


JUDICIAL PROCEDURE

Bylaws 67

hearing. Granting of continuances shall be at the 3229 option of the agency hearing the appeal. 3230 c. PREHEARING MATTERS. Prehearing requests 3231 shall be granted at the discretion of the appellate 3232 agency. In appeals to this Association’s Council on 3233 Ethics, Bylaws and Judicial Affairs, the Council 3234 chair has the authority to rule on motions from the 3235 parties for continuances and other prehearing 3236 procedural matters with advice from legal counsel 3237 of this Association. The Council chair may consult 3238 with the Council before rendering prehearing 3239 decisions. 3240 d. BRIEFS. Every party to an appeal shall be 3241 entitled to submit a brief in support of the party’s 3242 position. The briefs of the parties shall be submitted 3243 to the secretary of the constituent society or the 3244 Chair of the Council on Ethics, Bylaws and Judicial 3245 Affairs of this Association, as the case may be, and 3246 to the opposing party(ies) in accordance with the 3247 prescribed briefing schedule. The party initiating 3248 the appeal may choose to rely on the record and/or 3249 on an oral presentation and not file a brief. 3250 e. RECORD OF DISCIPLINARY 3251 PROCEEDINGS. Upon notice of an appeal the 3252 agency which preferred charges shall furnish to the 3253 appellate agency which has received the appeal and 3254 to the accused member a transcript of, or an 3255 officially certified copy of the minutes of the 3256 hearing accorded the accused member. The 3257 transcript or minutes shall be accompanied by 3258 certified copies of any affidavits or other 3259 documents submitted as evidence to support the 3260 charges against the accused member or submitted 3261 by the accused member as part of the accused’s 3262 defense. Where the agency preferring the charges 3263 does not provide for transcription of the hearing, 3264 the accused member, at the accused’s own expense, 3265 shall be entitled to arrange for the services of a 3266 court reporter to transcribe the hearing. 3267 f. APPEALS JURISDICTION. The agency to 3268 which a decision has been appealed shall be 3269 required to review the decision appealed from to 3270 determine whether the evidence before the society 3271 or agency which preferred charges against the 3272 accused member supports that decision or warrants 3273 the penalty imposed. The appellate agency shall not 3274 be required to consider additional evidence unless 3275 there is a clear showing that either party to the 3276 appeal will be unreasonably harmed by failure to 3277 consider the additional evidence. The parties to an 3278 appeal are the accused member and the society or 3279 agency which preferred charges. In appeals to the 3280 Council on Ethics, Bylaws and Judicial Affairs of 3281 this Association, the society which heard the first 3282 appeal may, at its option, participate in the appeal. 3283 g. DECISION ON APPEALS. Every decision on 3284


JUDICIAL PROCEDURE CHAPTER XIII • AMERICAN DENTAL

ASSOCIATION FOUNDATION

Bylaws 68

appeal shall be reduced to writing and shall state 3285 clearly the conclusion of the appellate agency and 3286 the reasons for reaching that conclusion. The 3287 appellate agency shall have the discretion (1) to 3288 uphold the decision of the agency which preferred 3289 charges against the accused member; (2) to reverse 3290 the decision of the agency which preferred charges 3291 and thereby exonerate the accused member; (3) to 3292 deny an appeal which fails to satisfy the 3293 requirements of Section 20D of this Chapter; (4) to 3294 refer the case back to the agency which preferred 3295 charges for new proceedings, if the rights of the 3296 accused member under all applicable bylaws were 3297 not accorded the accused; (5) to remand the case 3298 back to the agency which preferred charges for 3299 further proceedings when the appellate record is 3300 insufficient in the opinion of the appellate agency to 3301 enable it to render a decision; or (6) to uphold the 3302 decision of the agency which preferred charges 3303 against the accused member and reduce the penalty 3304 imposed. 3305 Within thirty (30) days of the date on which a 3306

decision on appeal is rendered, a copy thereof shall 3307 be sent by certified—return receipt requested mail 3308 to the last known address of each of the following 3309 parties: the accused member, the secretary of the 3310 component society of which the accused is a 3311 member, if applicable, the secretary of the 3312 constituent society of which the accused is a 3313 member, if applicable, the Chair of the Council on 3314 Ethics, Bylaws and Judicial Affairs of this 3315 Association and the Executive Director of this 3316 Association. 3317

E. NON-COMPLIANCE. In the event of a failure of 3318 technical conformance to the procedural requirements 3319 of Chapter XII, the agency hearing the appeal shall 3320 determine the effect of non-conformance. 3321

CHAPTER XIII • AMERICAN DENTAL ASSOCIATION FOUNDATION

Section 10. AGENCIES AND PERSONNEL: The 3322 Research Institute and the Paffenbarger Research 3323 Center at the National Institute of Standards and 3324 Technology will be agencies of the American Dental 3325 Association Foundation and the personnel of these 3326 agencies shall be employees of the Foundation. 3327

Section 20. FINANCIAL SUPPORT: The 3328 Association shall annually furnish sufficient financial 3329 support, as an addition to generated non-Association 3330 funding, to assure the continued viability of the 3331 Foundation’s research activities. 3332

CHAPTER XIII • AMERICAN DENTAL ASSOCIATION FOUNDATION

CHAPTER XIV • COMMISSIONS

Bylaws 69


A. The Foundation, through its agencies, the Research 3334 Institute and the Paffenbarger Research Center at the 3335 National Institute of Standards and Technology shall: 3336 a. Conduct basic and applied research for the 3337 utilization in and development of oral health. 3338 b. Conduct training programs in research disciplines 3339 that relate to the basic and applied problems of oral 3340 health. 3341

B. In addition, the Foundation shall submit, either 3342 through or in cooperation with the Council on 3343 Scientific Affairs, an annual report to the House of 3344 Delegates, interim reports on request to the Board of 3345 Trustees, and an annual budget to the Board of 3346 Trustees for such financial support allocations as the 3347 Board may deem necessary. 3348

C. In addition, the Foundation’s Administrative/ 3349 Charitable group shall submit, through the ADA 3350 Board of Trustees acting as the Member, an annual 3351 report to the House of Delegates, interim reports on 3352 request to the Member, and an annual budget to the 3353 Board of Trustees for such financial support 3354 allocations as the Board may deem necessary. 3355

D. The Foundation also may perform such other 3356 charitable and research functions as permitted under 3357 its articles of incorporation and bylaws and the laws 3358 of the State of Illinois. 3359


Section 10. NAME: The commissions of this 3360 Association shall be: 3361 Commission on Dental Accreditation 3362 Joint Commission on National Dental Examinations 3363

Section 20. MEMBERS, SELECTIONS, 3364 NOMINATIONS AND ELECTIONS: 3365 A. COMMISSION ON DENTAL 3366 ACCREDITATION. The number of members and the 3367 method of selection of the members of the 3368 Commission on Dental Accreditation shall be 3369 governed by the Rules of the Commission on Dental 3370 Accreditation and these Bylaws. 3371

Twelve (12) of the members of the Commission on 3372 Dental Accreditation shall be selected as follows: 3373 (1) Four (4) members shall be selected from 3374 nominations open to all trustee districts from the 3375 active, life or retired members of this Association, 3376 no one of whom shall be a faculty member working 3377 for a school of dentistry more than one day per 3378 week or a member of a state board of dental 3379 examiners or jurisdictional dental licensing agency. 3380 These members shall be nominated by the Board of 3381


Bylaws 70

Trustees and elected by the House of Delegates. 3382 (2) Four (4) members who are active, life or retired 3383 members of this Association shall be selected by 3384 the American Association of Dental Examiners 3385 from the active membership of that body, no one of 3386 whom shall be a member of a faculty of a school of 3387 dentistry. 3388 (3) Four (4) members who are active, life or retired 3389 members of this Association shall be selected by 3390 the American Dental Education Association from 3391 its active membership. These members shall hold 3392 positions of professorial rank in dental schools 3393 accredited by the Commission on Dental 3394 Accreditation and shall not be members of any state 3395 board of dental examiners or jurisdictional dental 3396 licensing agency. 3397

B. JOINT COMMISSION ON NATIONAL 3398 DENTAL EXAMINATIONS. The Joint Commission 3399 on National Dental Examinations shall be composed 3400 of fifteen (15) members selected as follows: 3401 a. Three (3) members shall be nominated by the 3402 Board of Trustees from the active, life or retired 3403 members of this Association and additional 3404 nominations may be made by the House of 3405 Delegates but no one of such nominees shall be a 3406 member of a faculty of a school of dentistry or a 3407 member of a state board of dental examiners or 3408 jurisdictional dental licensing agency. The House of 3409 Delegates shall elect the three (3) members from 3410 those nominated by the Board of Trustees and the 3411 House of Delegates. 3412 b. Six (6) members who are active, life or retired 3413 members of this Association shall be selected by the 3414 American Association of Dental Examiners from the 3415 active membership of that body, no one of whom 3416 shall be a member of a faculty of a dental school. 3417 c. Three (3) members who are active, life or retired 3418 members of this Association shall be selected by the 3419 American Dental Education Association from its 3420 active membership. These members shall hold 3421 positions of professorial rank in the dental schools 3422 accredited by this Association and shall not be 3423 members of any state board of dental examiners or 3424 jurisdictional dental licensing agency. 3425 d. One (1) member who is a dental hygienist shall be 3426 selected by the American Dental Hygienists’ 3427 Association. 3428 e. One (1) member who is a public representative 3429 shall be selected by the Joint Commission on 3430 National Dental Examinations. 3431 f. One (1) member who is a dental student shall be 3432 selected annually by the American Student Dental 3433 Association. 3434

Section 30. REMOVAL FOR CAUSE: The Board of 3435 Trustees may remove a commission member for 3436


Bylaws 71

cause in accordance with procedures established by 3437 the Board of Trustees, which procedures shall provide 3438 for notice of the charges, including allegations of the 3439 conduct purported to constitute each violation, and a 3440 decision in writing which shall specify the findings of 3441 fact which substantiate any and all of the charges, and 3442 that prior to issuance of the decision of the Board of 3443 Trustees, no commission member shall be excused 3444 from attending any meeting of a commission unless 3445 there is an opportunity to be heard or compelling 3446 reasons exist which are specified in writing by the 3447 Board of Trustees. 3448

Section 40. ELIGIBILITY: 3449

A. All members of commissions who are dentists 3450 must be active, life or retired members in good 3451 standing of this Association except as otherwise 3452 provided in these Bylaws. 3453

B. A member of the Joint Commission on National 3454 Dental Examinations, who was selected by the 3455 American Association of Dental Examiners and who 3456 is no longer an active member of that Association, 3457 may continue as a member of the Commission for the 3458 balance of that member’s term. 3459

C. When a member of the Joint Commission on 3460 National Dental Examinations, who was selected by 3461 the American Dental Education Association, shall 3462 cease to be a member of the faculty of a member 3463 school of that Association, such membership on the 3464 Commission shall terminate, and the President of the 3465 American Dental Association shall declare the 3466 position vacant. 3467

D. No member of a commission may serve 3468 concurrently as a member of a council or another 3469 commission. 3470

E. CHAIRS. The Commissions of this Association 3471 shall elect their own chairs who shall be active, life or 3472 retired members of this Association. 3473

Section 50. CONSULTANTS, ADVISERS AND 3474 STAFF: 3475

A. CONSULTANTS AND ADVISERS. Each 3476 commission shall have the authority to nominate 3477 consultants and advisers in conformity with rules and 3478 regulations established by the Board of Trustees 3479 except as otherwise provided in these Bylaws. The 3480 Joint Commission on National Dental Examinations 3481 also shall select consultants to serve on the 3482 Commission’s test construction committees. The 3483 Commission on Dental Accreditation shall have the 3484 power to appoint consultants to assist in developing 3485 requirements and guidelines for the conducting of 3486 accreditation evaluations, including site visitations, of 3487 predoctoral, advanced dental educational, and dental 3488


Bylaws 72

auxiliary educational programs. 3489

B. STAFF. The Executive Director shall employ the 3490 staff of Commissions, in the event they are 3491 employees, and shall select the titles for commission 3492 staff positions. 3493

Section 60. TERM OF OFFICE: The term of office 3494 of members of the commissions shall be four (4) 3495 years except that (a) the term of office of members of 3496 the Commission on Dental Accreditation selected 3497 pursuant to the Rules of the Commission on Dental 3498 Accreditation shall be governed by those Rules and 3499 (b) the term of office of the dental student selected by 3500 the American Student Dental Association for 3501 membership on the Joint Commission on National 3502 Dental Examinations shall be one (1) year. 3503

The tenure of a member of a commission shall be 3504 limited to one (1) term of four (4) years except that 3505 (a) the consecutive tenure of members of the 3506 Commission on Dental Accreditation selected 3507 pursuant to the Rules of the Commission on Dental 3508 Accreditation shall be governed by those Rules and 3509 (b) tenure in office of the dental student selected by 3510 the American Student Dental Association for 3511 membership on the Joint Commission on National 3512 Dental Examinations shall be one (1) term. As of 3513 1990, a member shall not be eligible for appointment 3514 to another commission or council for a period of two 3515 (2) years after completing a previous commission 3516 appointment. 3517

Section 70. VACANCY: In the event of a vacancy in 3518 the office of a commissioner, the following procedure 3519 shall be followed: 3520

A. In the event the member of a commission, whose 3521 office is vacant, is or was a member of and was 3522 appointed or elected by this Association, the President 3523 of this Association shall appoint a member of this 3524 Association possessing the same qualifications as 3525 established by these Bylaws for the previous member, 3526 to fill such vacancy until a successor is elected by the 3527 next House of Delegates of this Association for the 3528 remainder of the unexpired term. 3529

B. In the event the member of a commission whose 3530 office is vacant was selected by an organization other 3531 than this Association, such other organization shall 3532 appoint a successor possessing the same 3533 qualifications as those possessed by the previous 3534 member of the commission. 3535

C. In the event such vacancy involves the chair of the 3536 commission, the President of this Association shall 3537 have the power to appoint an ad interim chair, except 3538 as otherwise provided in these Bylaws. 3539

D. If the term of the vacated commission position has 3540


Bylaws 73

less than fifty percent (50%) of a full four-year term 3541 remaining at the time the successor member is 3542 appointed or elected, the successor member shall be 3543 eligible for election to a new, consecutive four-year 3544 term. If fifty percent (50%) or more of the vacated 3545 term remains to be served at the time of the 3546 appointment or election, the successor member shall 3547 not be eligible for another term. 3548

Section 80. MEETINGS OF COMMISSIONS. Each 3549 commission shall hold at least one regular meeting 3550 annually, provided that funds are available in the 3551 budget for that purpose and unless otherwise directed 3552 by the Board of Trustees. Meetings may be held at the 3553 Headquarters Building, the Washington Office or 3554 from multiple remote locations through the use of a 3555 conference telephone or other communications 3556 equipment by means of which all members can 3557 communicate with each other. Such meetings shall be 3558 conducted in accordance with rules and procedures 3559 established by the Board of Trustees. 3560

Section 90. QUORUM: A majority of the members of 3561 any commission shall constitute a quorum. 3562

Section 100. PRIVILEGE OF THE FLOOR: Chairs 3563 and members of the commissions who are not 3564 members of the House of Delegates shall have the 3565 right to participate in the debate on their respective 3566 reports but shall not have the right to vote. 3567

Section 110. ANNUAL REPORT AND BUDGET: 3568

A. ANNUAL REPORT. Each commission shall 3569 submit, through the Executive Director, an annual 3570 report to the House of Delegates and a copy thereof to 3571 the Board of Trustees. 3572

B. PROPOSED BUDGET. Each commission shall 3573 submit to the Board of Trustees, through the 3574 Executive Director, a proposed itemized budget for 3575 the ensuing fiscal year. 3576

Section 120. POWER TO ADOPT RULES: Any 3577 commission of this Association shall have the power 3578 to adopt rules for such commission and amendments 3579 thereto, provided such rules and amendments thereto 3580 do not conflict with or limit the Constitution and 3581 Bylaws of this Association. Rules and amendments 3582 thereto, adopted by any commission of this 3583 Association, shall not be effective until submitted in 3584 writing to and approved by majority vote of the 3585 House of Delegates of this Association, except the 3586 Joint Commission on National Dental Examinations 3587 shall have such bylaws and amendments thereto as 3588 the House of Delegates of this Association may adopt 3589 by majority vote for the conduct of the purposes and 3590 management of the Joint Commission on National 3591 Dental Examinations. 3592


Bylaws 74


A. COMMISSION ON DENTAL 3594 ACCREDITATION. The duties of the Commission 3595 on Dental Accreditation shall be: 3596 a. To formulate and adopt requirements and 3597 guidelines for the accreditation of dental educational 3598 and dental auxiliary educational programs. 3599 b. To accredit dental educational and dental 3600 auxiliary educational programs. 3601 c. To provide a means for appeal from an adverse 3602 decision of the accrediting body of the Commission 3603 to a separate and distinct body of the Commission 3604 whose membership shall be totally different from 3605 that of the accrediting body of the Commission. 3606 d. To submit an annual report to the House of 3607 Delegates of this Association and interim reports, on 3608 request, and the Commission’s annual budget to the 3609 Board of Trustees of the Association. 3610 e. To submit the Commission’s articles of 3611 incorporation and rules and amendments thereto to 3612 this Association’s House of Delegates for approval 3613 by majority vote either through or in cooperation 3614 with the Council on Dental Education and 3615 Licensure. 3616

B. JOINT COMMISSION ON NATIONAL 3617 DENTAL EXAMINATIONS. The duties of the Joint 3618 Commission on National Dental Examinations shall 3619 be: 3620

a. To provide and conduct written examinations, 3621 exclusive of clinical demonstrations for the purpose 3622 of assisting state boards of dental examiners in 3623 determining qualifications of dentists who seek 3624 license to practice in any state or other jurisdiction 3625 of the United States. Dental licensure is subject to 3626 the laws of the state or other jurisdiction of the 3627 United States and the conduct of all clinical 3628 examinations for licensure is reserved to the 3629 individual board of dental examiners. 3630 b. To provide and conduct written examinations, 3631 exclusive of clinical demonstrations for the purpose 3632 of assisting state boards of dental examiners in 3633 determining qualifications of dental hygienists who 3634 seek license to practice in any state or other 3635 jurisdiction of the United States. Dental hygiene 3636 licensure is subject to the laws of the state or other 3637 jurisdiction of the United States and the conduct of 3638 all clinical examinations for licensure is reserved to 3639 the individual board of dental examiners. 3640 c. To make rules and regulations for the conduct of 3641 examinations and the certification of successful 3642 candidates. 3643 d. To serve as a resource of the dental profession in 3644 the development of written examinations. 3645

CHAPTER XV • SCIENTIFIC SESSION CHAPTER XVI • PUBLICATIONS

Bylaws 75

CHAPTER XV • SCIENTIFIC SESSION

Section 10. OBJECT: The scientific session of this 3646 Association is established to foster the presentation 3647 and discussion of subjects pertaining to the 3648 improvement of the health of the public and the 3649 science and art of dentistry. 3650

Section 20. TIME AND PLACE: The scientific 3651 session of the Association shall be held annually at a 3652 time and place selected by the Board of Trustees. 3653 Such selection shall be made at least one (1) year in 3654 advance. 3655

Section 30. MANAGEMENT AND GENERAL 3656 ARRANGEMENTS: The Board of Trustees shall 3657 provide for the management of, and make all 3658 arrangements for, each scientific session unless 3659 otherwise provided in these Bylaws. 3660

Section 40. TRADE AND LABORATORY 3661 EXHIBITS: Products of the dental trade and dental 3662 laboratories and other products may be exhibited at 3663 each scientific session under the direction of the 3664 Board of Trustees and in accordance with rules and 3665 regulations established by that body. 3666

Section 50. ADMISSION: Admission to meetings of 3667 the scientific sessions shall be limited to members of 3668 this Association who are in good standing and to 3669 others admitted in accordance with rules and 3670 regulations established by the Board of Trustees. 3671

CHAPTER XVI • PUBLICATIONS

Section 10. OFFICIAL JOURNAL: 3672

A. TITLE. This Association shall publish or cause to 3673 be published an official journal under the title of The 3674 Journal of the American Dental Association, 3675 hereinafter referred to as The Journal. 3676

B. OBJECT. The object of The Journal shall be to 3677 report, chronicle and evaluate activities of scientific 3678 and professional interest to members of the dental 3679 profession. 3680

C. FREQUENCY OF ISSUE AND SUBSCRIPTION 3681 RATE. The frequency of issue and the subscription 3682 rate of The Journal shall be determined by the Board 3683 of Trustees. 3684

Section 20. OTHER JOURNALS: The Association 3685 may publish or cause to be published other journals in 3686 the field of dentistry subject to the direction and 3687 regulations of the Board of Trustees. 3688

Section 30. OFFICIAL TRANSACTIONS: The 3689 official transactions of the House of Delegates and the 3690

CHAPTER XVI • PUBLICATIONS CHAPTER XVII • FINANCES

Bylaws 76

Board of Trustees and the reports of officers, councils 3691 and committees shall be published under the direction 3692 of the Executive Director. 3693

Section 40. AMERICAN DENTAL DIRECTORY: 3694 This Association shall cause to be published an 3695 American Dental Directory. 3696

CHAPTER XVII • FINANCES

Section 10. FISCAL YEAR: The fiscal year of the 3697 Association shall begin January 1 of each calendar 3698 year and end December 31 of the same year. 3699

Section 20. GENERAL FUND: The General Fund 3700 shall consist of all monies received other than those 3701 specifically allocated to other funds by these Bylaws. 3702 This fund shall be used for defraying all expenses 3703 incurred by this Association not otherwise provided 3704 for in these Bylaws. The General Fund may be 3705 divided into Operating and Reserve Divisions at the 3706 direction of the Board of Trustees. 3707

Section 30. OTHER FUNDS: The Association may 3708 establish other funds, at the direction of the Board of 3709 Trustees, for activities and programs requiring 3710 separate accounting records to meet governmental 3711 and administrative requirements. Such funds shall 3712 consist of monies and other assets received or 3713 allocated in accordance with the purpose for which 3714 they are established. Such funds shall be used for 3715 defraying all expenses incurred in their operation, 3716 shall serve only as separate accounting entities and 3717 continue to be held in the name of the American 3718 Dental Association as divisions of the General Fund. 3719

Section 40. SPECIAL ASSESSMENTS: In addition 3720 to the payment of dues required in Chapter I, Section 3721 20 of these Bylaws, a special assessment may be 3722 levied by the House of Delegates upon active, active 3723 life, retired and associate members of this Association 3724 as provided in Chapter I, Section 20 of these Bylaws, 3725 for the purpose of funding a specific project of 3726 limited duration. Such an assessment may be levied at 3727 any annual or special session of the House of 3728 Delegates by a two-thirds (2/3) affirmative vote of the 3729 delegates present and voting, provided notice of the 3730 proposed assessment has been presented in writing at 3731 least ninety (90) days prior to the first day of the 3732 session of the House of Delegates at which it is to be 3733 considered. Notice of such a resolution shall be sent 3734 by a certifiable method of delivery to each constituent 3735 society not less than ninety (90) days before such 3736 session to permit prompt, adequate notice by each 3737 constituent society to its delegates and alternate 3738 delegates to the House of Delegates of this 3739 Association, and shall be announced to the general 3740

CHAPTER XVII • FINANCES CHAPTER XVIII • ALLIANCE OF THE AMERICAN DENTAL ASSOCIATION CHAPTER XIX • INDEMNIFICATION

Bylaws 77

membership in an official publication of this 3741 Association at least sixty (60) days in advance of the 3742 session. The specific project to be funded by the 3743 proposed assessment, the time frame of the project, 3744 and the amount and duration of the proposed 3745 assessment shall be clearly presented in giving notice 3746 to the members of this Association. Revenue from a 3747 special assessment and any earnings thereon shall be 3748 deposited in a separate fund as provided in Chapter 3749 XVII, Section 30 of these Bylaws. The House of 3750 Delegates may amend the main motion to levy a 3751 special assessment only if the amendment is germane 3752 and adopted by a two-thirds (2/3) affirmative vote of 3753 the delegates present and voting. The House of 3754 Delegates may consider only one (1) specific project 3755 to be funded by a proposed assessment at a time. 3756 However, if properly adopted by the House of 3757 Delegates, two (2) or more special assessments may 3758 be in force at the same time. Any resolution to levy a 3759 special assessment that does not meet the notice 3760 requirements set forth in the previous paragraph also 3761 may be adopted by a unanimous vote of the House of 3762 Delegates, provided the resolution has been presented 3763 in writing at a previous meeting of the same session. 3764

CHAPTER XVIII • ALLIANCE OF THE AMERICAN DENTAL ASSOCIATION

Section 10. RECOGNITION: The Association 3765 recognizes the Alliance of the American Dental 3766 Association as an organization of the spouses of 3767 active, life, retired or student members in good 3768 standing of this Association, and of spouses of such 3769 deceased members who were in good standing at the 3770 time of death. 3771

Section 20. CONSTITUTION AND BYLAWS: No 3772 provision in the constitution and bylaws of the 3773 Alliance shall be in conflict with the Constitution and 3774 Bylaws of this Association. 3775

CHAPTER XIX • INDEMNIFICATION

Each trustee, officer, council member, committee 3776 member, employee and other agent of the Association 3777 shall be held harmless and indemnified by the 3778 Association against all claims and liabilities and all 3779 costs and expenses, including attorney’s fees, 3780 reasonably incurred or imposed upon such person in 3781 connection with or resulting from any action, suit or 3782 proceeding, or the settlement or compromise thereof, 3783 to which such person may be made a party by reason 3784 of any action taken or omitted to be taken by such 3785 person as a trustee, officer, council member, 3786 committee member, employee or agent of the 3787 Association, in good faith. This right of 3788

CHAPTER XIX • INDEMNIFICATION CHAPTER XX • CONSTRUCTION CHAPTER XXI • AMENDMENTS

Bylaws 78

indemnification shall inure to such person whether or 3789 not such person is a trustee, officer, council member, 3790 committee member, employee or agent at the time 3791 such liabilities, costs or expenses are imposed or 3792 incurred and, in the event of such person’s death, 3793 shall extend to such person’s legal representatives. To 3794 the extent available, the Association shall insure 3795 against any potential liability hereunder. 3796

CHAPTER XX • CONSTRUCTION

Where the context or construction requires, all titles 3797 and personal pronouns used in the Bylaws, whether 3798 used in the masculine, feminine or neutral gender, 3799 shall include all genders. 3800

CHAPTER XXI • AMENDMENTS

Section 10. PROCEDURE: These Bylaws may be 3801 amended at any session of the House of Delegates by 3802 a two-thirds (2/3) affirmative vote of the delegates 3803 present and voting, provided the proposed 3804 amendments shall have been presented in writing at a 3805 previous session or a previous meeting of the same 3806 session. 3807

Section 20. AMENDMENT AFFECTING THE 3808 PROCEDURE FOR CHANGING THE DUES OF 3809 ACTIVE MEMBERS: An amendment of these 3810 Bylaws affecting the procedure for changing the dues 3811 of active members may be adopted only if the 3812 proposed amendment has been presented in writing at 3813 least ninety (90) days prior to the first day of the 3814 session of the House of Delegates at which it is to be 3815 considered. Notice of such a resolution shall be sent 3816 by a certifiable method of delivery to each constituent 3817 society not less than ninety (90) days before such 3818 session to permit prompt, adequate notice by each 3819 constituent society to its delegates and alternate 3820 delegates to the House of Delegates of this 3821 Association, and shall be announced to the general 3822 membership in an official publication of the 3823 Association at least sixty (60) days in advance of the 3824 annual session. 3825 Amendments affecting the procedure for changing 3826 the dues of active members may also be adopted by a 3827 unanimous vote provided that the proposed 3828 amendment has been presented in writing at a 3829 previous meeting of the same session. 3830

Articles of Incorporation 79

Articles of

Incorporation

• • • • • • • • • • • • • • • • • • • • • • • • •

1. NAME. The name of this corporation is 3831 AMERICAN DENTAL ASSOCIATION. 3832

2. DURATION. The duration of the corporation is 3833 perpetual. 3834

3. PURPOSE AND OBJECT. The purpose and object 3835 of this corporation are to encourage the improvement 3836 of the health of the public and to promote the art and 3837 science of dentistry. 3838

4. OFFICE. The principal office of the corporation 3839 shall be in the City of Chicago, Cook County, Illinois. 3840

5. BYLAWS. The bylaws of the corporation shall be 3841 divided into two categories designated, respectively, 3842 “Constitution” and “Bylaws” and each category shall 3843 be amendable from time to time in the manner and by 3844 the method therein set forth, but in case of any 3845 conflict between the Constitution and the Bylaws the 3846 provisions of the Constitution shall control. 3847

6. MEMBERSHIP. The qualifications, the method of 3848 election, designation or selection, the privileges and 3849 obligations, and the voting rights, if any, of the 3850 various classes of members which are established by 3851 the Constitution and Bylaws of the corporation from 3852 time to time shall be set forth in and governed by 3853 such Constitution and Bylaws. 3854

7. EXERCISE OF CORPORATE POWERS. Except 3855 as otherwise provided by law, the affairs of this 3856 corporation shall be governed and the corporate 3857 powers of the corporation shall be exercised by a 3858 Board of Directors (to be known as the Board of 3859 Trustees), House of Delegates, officers, councils, 3860 committees, members, agents and employees as set 3861 forth in the Constitution and Bylaws and the titles, 3862 duties, powers, and methods of electing, designating 3863 or selecting all of the foregoing shall be as provided 3864 therein. 3865

8. VOTING RIGHTS WITH RESPECT TO 3866 ARTICLES OF INCORPORATION. Only those 3867 members of the corporation shall have voting rights in 3868 respect to amendments to the Articles of 3869 Incorporation who shall have a right to vote on 3870 amendments to the Constitution of the corporation. 3871

American Dental Association A current electronic version of this document is available at www.ada.org

American Dental Association Admits: Fluoride of Concern to Kidney Patients

http://www.loveforlife.com.au/node/5036

by Sally Stride

Opednews

29th June 2008

On June 19, 2008 the American Dental Association updated its website reporting that

fluoride is a concern to all kidney patients, not just those on dialysis.

Along with false assurances of safety, fluoride chemicals are added to some public and

bottled water in the unscientific belief it reduces cavities.

Fluoride-induced bone damage could occur in kidney patients who consume even

"optimally" fluoridated water because malfunctioning kidneys do not properly sift fluoride

from the blood and out of the body. Fluoride can build up in bones making them brittle

and fracture

For this reason, the National Kidney Foundation (NKF) withdrew its fluoridation

endorsement in October 2007, which they made public in a fluoride paper dated April 15,

2008 with advice that “individuals with CKD [Chronic Kidney Disease] should be notified

of the potential risk of fluoride exposure.”

After the 2006 National Research Council's (NRC) fluoride toxicology report was brought

to their attention, the NKF withdrew its fluoridation endorsement.

The NRC fluoride report was created by a 12-member panel of scientists to review current

fluoride toxicology data at the request of the Environmental Protection Agency (EPA) to

determine whether the maximum contaminant level goal (4 mg/L) of fluoride in public

water supplies is safe. The NRC says that level must be lowered. But neither the NRC nor

the EPA has defined a safe level.

At least three NRC panel members conclude that water fluoride levels should be close to

zero, not only to protect kidney patients, but also thyroid patients, infants and high water

drinkers

This would effectively shut down fluoridation in the U.S. But organized dentistry isn't

going to let go of its pet project and diminish its political viability by admitting

fluoridation is a failed experiment. So they downplay anything negative about fluoride

and in this case they want you to know that fluoride is only a secondary concern. And, of

course, this writer wants you to know that secondary doesn't mean no concern.

However, even the ADA seems to be covering their legal assets with this statement in

their Fluoridation Facts booklet, “decreased fluoride removal may occur among persons

with severely impaired kidney function who may not be on kidney dialysis.”

Dr. Julie Gerberding, Director, Centers for Disease Control (CDC) claims that the CDC is

"America's health protection leader." The CDC calls fluoridation one of the Ten Great

Public Health Achievements of the last century. But, the CDC has not provided the

fluoride/kidney toxiclogy information on their website. The CDC often follows the lead of

the ADA concerning fluoride and fluoridation. So we'll be watching.

The CDC’s website still erroneously claims, “The findings of the NRC report are consistent

with CDC’s assessment that water is safe and healthy at the levels used for water

fluoridation (0.7–1.2 mg/L)”

The NRC reports “Early water fluoridation studies did not carefully assess changes in

renal [kidney] function...Several investigators have shown that patients with impaired

renal function, or on hemodialysis, tend to accumulate fluoride much more quickly than

normal."

New York State Department of Health employee and dentist, Dr. J. Kumar received the

ADA’s fluoridation award. With money and support from the CDC Kumar is promoting

fluoridation in New York State by conducting fluoridation spokesperson training, among

other activies.

Kumar is ignoring his own 1990 health department report published in Oral Biology and

Medicine which concluded “The available data suggest that some individuals may

experience hypersensitivity to fluoride-containing agents. Further studies on

hypersensitivity are required" and "Studies on the effects of fluoride in individuals with

renal insufficiency are needed."

That advice wasn’t heeded. Those studies were never conducted. But Kumar and the NYS

Department of Health is using our tax money to push even more fluoride into us.

According to the Fluoride Action Network,: “The bone changes

http://www.fluoridealert.org/health/kidney/index.html#osteo commonly found among

patients with advanced kidney disease closely resemble

http://www.fluoridealert.org/health/kidney/index.html#osteo the bone changes found

among individuals with the osteomalacic-type

http://www.fluoridealert.org/health/bone/fluorosis/osteomalacia.html of skeletal fluorosis

http://www.fluoridealert.org/health/bone/fluorosis/ This raises the possibility that some

individuals with kidney disease are suffering from undiagnosed skeletal fluorosis.”

http://www.fluoridealert.org/health/bone/fluorosis

http://www.fluoridealert.org/health/bone/fluorosis/mayo-clinic.html

American Dental Association concedes: Excessive

fluoride a risk to children

http://www.enviroblog.org/2006/11/american_d

ental_association_co.htm

After years of downplaying the risks of excessive fluoride intake, the American Dental Association (ADA) has just released new guidelines

that dramatically reduce the recommended fluoride exposure for infants and children.

Though not ready to condemn fluoride entirely for its role in enamel fluorosis, the ADA

has issued an “interim” advisory on fluoride intake until more research can be done. This is a promising step for the ADA, which has resolutely promoted the fluoridation of water

in the past. While it's commendable that the Association is alerting parents to the risks of

fluorosis, a primarily cosmetic condition, it would be even better to issue a similar moratorium on account of the recent research tying fluoridated water to bone cancer in

boys.

Until further notice, ADA recommends the following measures to reduce the risk of fluorosis:

Infants - Feed infants breast milk whenever possible. - For infants who get most of their nutrition from formula, choose ready-to-feed formula

over formula mixed with fluoridated water. - If liquid or powdered concentrate infant formula is the primary source of nutrition, mix

with water that is fluoride free, including water that is labeled purified, demineralized, deionized, distilled or reverse osmosis filtered water.

Children - Stay away from fluoride toothpaste before two years.

- No fluoride mouth rinse or supplements unless prescribed by a dentist.

- Check with your water supplier to make sure the fluoride level in your drinking water does not exceed the recommended 1.2 parts per million.

American Dental Association http://en.wikipedia.org/wiki/American_Dental_Association

The American Dental Association (ADA) is an American professional association established in 1859 and has more than 152,000 members. Based in Chicago, the ADA is the world's largest and oldest national dental association and promotes good oral health to the public while representing the dental profession.

The ADA publishes a monthly journal of dental related articles named the Journal of the American Dental Association.

The ADA was founded August 1859, at Niagara Falls, New York, by twenty-six dentists who represented various dental societies in the United States. Today, the ADA has more than 152,000 members, 55 constituent (state-territorial) and 545 component (local) dental societies. It is the largest and oldest national dental association in the world.

The Association has more than 400 employees at its headquarters in Chicago and its office in Washington, D.C. The Paffenbarger Research Center (PRC), located on the campus of the National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland, is an agency of the American Dental Association Foundation (ADAF) and a Department of the Division of Science. PRC scientists conduct basic and applied studies in clinical research, dental chemistry, polymer chemistry and cariology. The ADA established rigorous guidelines for testing and advertising of dental products and the first ADA Seal of Acceptance was awarded in 1931. Today, about 350 manufacturers participate in the voluntary program and more than 1300 products have received the Seal of Acceptance. The Board of Trustees, the administrative body of the Association, is composed of the President, the President-elect, two Vice Presidents and 17 trustees from each of the 17 trustee districts in the United States. The Treasurer and Executive Director serve as ex officio members.

The House of Delegates, the legislative body of the Association, is composed of 460 delegates representing 53 constituent societies, five federal dental services and the American Student Dental Association. The House meets once a year during the Association's annual session.

The Association's 11 councils serve as policy recommending agencies. Each council is assigned to study issues relating to its special area of interest and to make recommendations on those matters to the Board of Trustees and the House of Delegates.

The Association's official publication is The Journal of the American Dental Association. Other publications include the ADA News and the ADA Guide to Dental Therapeutics.

The Commission on Dental Accreditation, which operates under the auspices of the ADA, is recognized by the U.S. Department of Education as the national accrediting body for dental, advanced dental and allied dental education programs in the United States.

The ADA formally recognizes 9 specialty areas of dental practice: dental public health, endodontics, oral and maxillofacial pathology, oral and maxillofacial surgery, orthodontics and dentofacial orthopedics, pediatric dentistry, periodontics, prosthodontics, and oral and maxillofacial radiology.

The ADA library has an extensive collection of dental literature with approximately 33,000 books and 17,500 bound journal volumes. The ADA library also subscribes to more than 600 journal titles.

The ADA Foundation is the charitable arm of the Association. The Foundation provides grants for dental research, education, scholarships, access to care and charitable assistance programs such as relief grants to dentists and their dependents who are unable to support themselves due to injury, a medical condition or advanced age; and grants to those who are victims of disasters.

The ADA is a vociferous promoter of water fluoridation.[1] The ADA has purchased internet websites with names that mimic those of prominent websites that do not favor fluoridation. The ADA redirects visitors from the websites flouridation.com fluoridealert.com and fluoridealert.net to their own pro-fluoridation pages. The domain names of these websites are intentional misspellings of advocacy websites fluoridation.com and fluoridealert.org that do not favor fluoridation.[2][3]

In November of 2006, the ADA began recommending to parents that infants from 0 through 12 months of age have their formula prepared with water that is fluoride-free or contains low levels of fluoride to reduce the risk of fluorosis.[4]

• 1840: First dental college, the Baltimore College of Dental Surgery; American Society of Dental Surgeons is established.

• 1845: American Society of Dental Surgeons ask members to sign a mandatory pledge promising not to use amalgam fillings.

• 1856: American Society of Dental Surgeons, because of its stance against dental amalgam, is disbanded in 1856 due to loss of membership.

• 1859: Twenty-six dentists meet in Niagara Falls, New York to form a professional society.

• 1860: First ADA constitution and bylaws are adopted. • 1897: ADA merges with the Southern Dental Association to form the National

Dental Association (NDA). • 1908: NDA publishes the first patient dental education pamphlet. • 1913: NDA adopts a new constitution and bylaws, establishing the House of

Delegates and Board of Trustees.

• 1913: The Journal of the National Dental Association is first published under the title, Bulletin of the National Dental Association

• 1922: NDA is renamed the American Dental Association (ADA). • 1928: ADA affiliates with the NBS; National Board of Dental Examiners is

established. • 1930: Council of Dental Therapeutics established to oversee the evaluation of

dental products. The Council establishes the ADA's Seal Program. • 1931: First ADA Seal of Approval awarded; ADA headquarters located on north

side of Chicago. • 1936: ADA Council on Dental Education is formed. • 1948: The National Institute of Dental Research (NIDR) is established (since

renamed the NIDCR (National Institute of Dental and Craniofacial Research)). • 1950: ADA works with Congress to proclaim February 6 as National Children's

Dental Health Day; ADA endorses fluoridation. • 1964: ADA produces the first color television Public Service Announcement by a

non-profit health agency; ADA establishes the ADA Health Foundation, a501 (c)(3) non-profit organization for the purpose of engaging in dental health research and educational programs.

• 1970: ADA News is first published. • 1978: Council on Dental Practice established. • 1979: The Commission on Dental Accreditation established. • 1987: ADA Commission on the Young Professional is formed (later becomes the

Committee on the New Dentist). • 1991: First woman ADA president, Dr. Geraldine Morrow. • 1995: ADA Web site, ADA ONLINE, created (later becomes ADA.org) • 2002: First minority ADA president, Dr. Eugene Sekiguchi. • 2003: First “Give Kids a Smile” day held as part of National Children’s Dental

Health Month.

ROBERT J. H. MICK, PLAINTIFF-APPELLANT, v. AMERICAN DENTAL ASSOCIATION, A CORPORATION, LON W. MORREY AND HERBERT B. BAIN,

DEFENDANTS-RESPONDENTS

[NO NUMBER IN ORIGINAL]

Superior Court of New Jersey, Appellate Division

49 N.J. Super. 262; 139 A.2d 570; 1958 N.J. Super. LEXIS 548

February 3, 1958, Argued March 13, 1958, Decided

COUNSEL: [***1]

Mr. Harry Green argued the cause for plaintiff-appellant (Mr. Mulford E. Emmel, attorney).

Mr. Frank M. Lario argued the cause for defendants-respondents (Mr. Anthony M. Lario, attorney). JUDGES: Goldmann, Freund and Conford. The opinion of the court was delivered by Freund, J.A.D. OPINIONBY: FREUND OPINION: [*268] [**573] This is an action for libel brought by plaintiff, Robert J. H. Mick, a dentist, against the American Dental Association and its officers, based on a letter written by an official of the Association in response to a communication from Charles W. Yeates, another dentist, and upon a series of articles published by the Association on the subject of fluoridation.

Plaintiff appeals from a judgment of dismissal, with prejudice, entered by the trial judge at the close of plaintiff's case. The judge held that the letter was not libelous as a matter of law but merely an opinion sent to a person [*269] who had a right to be informed, and that it was a non-malicious privileged communication. With respect to the articles, the court concluded that they dealt with subject matter of general public concern, without any direct or indirect reference to plaintiff. [***2]

Robert J. H. Mick has engaged in the general practice of dentistry in Camden County since 1935, except for an interval of about 2 1/2 years, from September 1953 to February 1956, when he was in the military service of the United States with the rank of lieutenant-colonel, and stationed for the most part in Germany. He was associated in the military service with Major Charles W. Yeates. Both are members in good standing of the defendant, American Dental Association, a non-pecuniary professional association.

The fluoridation of potable waters as an effective means of building an immunity in teeth to make them less susceptible to decay has for many years engaged the serious study and investigation of dentists, physicians, their professional organizations, and of public health authorities. Since about 1939 the United States Public Health Service has been making epidemiological surveys. In about 1951, the American Dental Association officially sponsored fluoridation. In this it has the support of the American Medical Association, National Research Council, American Public Health Association, and the public health services of the Federal Government and of various states. The position [***3] taken by the defendants was preceded by extensive discussions in its official publication, The Journal of the American Dental Association, as well as the distribution of pamphlets and brochures on various phases of the problem. Opponents of fluoridation were articulate and vehement and, in some areas, well organized. They, too, disseminated their views widely through all kinds of publications and public forums.

[**574] Plaintiff was among the proponents of fluoridation for about four years, from 1944 to 1948, but then as a result of his independent research, studies and experimental work, he concluded that the artificial use of fluorides was harmful. Plaintiff thereupon embarked on a campaign in violent [*270] opposition to fluoridation. He talked at public forums in various states. He wrote letters to many newspapers, printed and mimeographed pamphlets containing his views and circulated them among newspapers and magazines throughout the United States. One of his letters was published in the Congressional Record. While in the military service in Germany, he wrote a letter to the mayor of the City of Kassel, Germany which had begun to use fluoridation, offering [***4] to go to that city to speak against and present his arguments on the harmful effects of fluoridation.

On December 3, 1954 the plaintiff requested his army associate, Dr. Charles W. Yeates, to write the following letter to the defendant:

"3 December 1954 American Dental Association Bureau of Public Information 222 East Superior Street Chicago 11, Ill. Gentlemen:

From time to time the name of Dr. Robert J. H. Mick has come to my attention as being one of those apparently violently against fluoridation. I have read charges that he has made against our American Dental Association and certain members thereof, the American Medical Association, the United States Public Health Service and certain members thereof. I understand that he has made such accusations over the radio and television also.

I do not believe he is aiding much in the cause of fluoridation.

Is he a member in good standing in the American Dental Association? Do you know anything about him that could be used to discredit him? What is your opinion or answer to the accusations?

If he is wrong -- what can be done to prevent his further connection with the American Dental Association and his [***5] accusations of fluoridation and the members of the American Dental Association and sponsoring same?

Could charges be brought against him?

Awaiting your answer as I need any suggestions that you may have,

Sincerely,

Charles W. Yeates

Major DC

5th General Hospital

APO 154, N.Y., N.Y."

[*271] Plaintiff acknowledged that the foregoing letter was sent by Dr. Yeates at his request evidenced by the following notation in his handwriting on the copy of the letter:

"27, January 1955 -- Above was sent at my request and with my knowledge. (Signed) Robert J. H. Mick."

Dr. Mick testified that he had read that the Bureau of Public Information of the American Dental Association had invited inquiries with respect to the opposition to fluoridation and he requested Dr. Yeates to write the letter because he "was always being kidded [by all his associates] about being opposed to fluoridation * * *" "I had been so active in opposing fluoridation in the Army and before I went into the Service, I wondered if they had anything on me. It was curiosity."

The following reply letter is plaintiff's primary basis for this suit.

"December 21, 1954. Major Charles [***6] W. Yeates, DC 5th General Hospital APO 154 New York, New York. Dear Major Yeates:

This is in reply to your registered letter of December 3 addressed to the American Dental Association in which [**575] you make inquiry regarding Dr. Robert J. H. Mick.

Our records show that Dr. Mick is a member in good standing in the American Dental Association.

As you know Dr. Mick is now on duty with the Armed Forces and I should like to suggest that if you wish an evaluation of Dr. Mick's personal or professional standing that you might make inquiry of the military authorities in charge.

The American Dental Association, of course, is in total disagreement with Dr. Mick's charges relating to fluoridation. The Association believes Dr. Mick's views to be based on complete misinformation and to be totally irresponsible.

Very truly yours,

Herbert B. Bain

Director

Bureau of Public Information."

[*272] The complaint alleges that the last paragraph of defendant's reply letter, and particularly the last sentence, is libelous -- "meaning that plaintiff is incompetent to evaluate scientific data relating to his profession and that plaintiff is irresponsible in his [***7] professional conduct and not a fit person to practice dentistry."

The complaint also alleges that three publications circulated by the defendant, although they do not identify or name the plaintiff, are nevertheless libelous of plaintiff because he is a well-known opponent of fluoridation. In the August 1953 issue of its Journal, defendant published an article entitled "The Irresponsible Opposition to Fluoridation," written by Dr. J. Roy Doty, and containing the following language: "Because of the lies and half truths being disseminated by a relatively small but vocal group which is apparently dedicated to the perpetuation of misinformation," and further describing the leading opponents of fluoridation as "food faddists, purveyors of so called health foods, publicity seekers and writers of sensation articles, together with very few members of the health profession."

Early in 1953 the Association published and distributed a pamphlet entitled How to Obtain Fluoridation For Your Community, in which it described the types and groups of opponents and their untrustworthy sources of information. In January 1955 it distributed a brochure entitled Comments on the Opponents [***8] of Fluoridation, wherein are listed biographical data concerning leading opponents of fluoridation and characterizing them as "quacks," "faith healers," "faddists," or "cultists." The plaintiff is not listed among those named in any of the articles, directly or indirectly, yet he claims that he was included. Plaintiff makes scant reference to this point in his brief. He merely says: "As to

[the] question of applicability of the other publications to plaintiff, it was for [the] jury." Defendant urges that plaintiff should be deemed to have abandoned this portion of his complaint. We infer lack of confidence [*273] by plaintiff on this point, rather than abandonment, and shall deal with it.

Defendants urge the affirmance of the judgment for several reasons: that the letter was not libelous; that it was qualifiedly privileged because it was written in response to a request for an opinion made by plaintiff or by his agent and because the words contained therein constituted fair comment and criticism; and that the publications did not refer, expressly or by implication, to plaintiff.

Preliminarily, we must consider the proper law applicable to the issues presented for [***9] our determination. This question of conflict of laws is not free from difficulty. The Restatement, Conflict of Laws, § 377, p. 457, n. 5 (1934), formulates the rule that "* * * where harm is done to the reputation of a person, the place of wrong is where the defamatory statement is communicated." This view is criticized in 2 Harper and James, Law of Torts (1956), § 30.7, pp. 1700-1704. The Restatement [**576] rule is based upon the general tort principle that the lex loci delicti, the place where the wrong was committed, controls the rights and liabilities of the parties, cf. Clement v. Atlantic Casualty Ins. Co., 13 N.J. 439, 442 (1953), and therefore since the place of publication is generally the place where the tort of defamation is complete, Gnapinsky v. Goldyn, 23 N.J. 243, 252 (1957), that law should govern. See also Goodrich, Conflict of Laws (3d ed. 1949), § 93, p. 264, n. 13.

This rule has not been universally accepted and, as suggested by Professors Harper and James there is strong argument for applying the law of the plaintiff's domicile. Mattox v. News Syndicate Co., Inc., 176 F. 2d 897, [***10] 12 A.L.R. 2d 988 (2 Cir. 1949), certiorari denied 338 U.S. 858, 70 S. Ct. 100, 94 L. Ed. 525 (1949). The rationale of this theory is that plaintiff is best known at his residence or domicile and his reputation is most likely to suffer there. But even this rule has its limitations where the plaintiff is a person of national prominence.

However, in the instant case we need not determine the choice of law question. Since the law of Germany -- [*274] or, for that matter, the law of Illinois where the letter was dictated, in an appropriate case -- was not pleaded or proved, we would be justified in assuming it is the same as the law of the forum. Leary v. Gledhill, 8 N.J. 260, 268-270 (1951); Somerville Container Sales, Inc. v. General Metal Corp., 39 N.J. Super. 348, 358-359 (App. Div. 1956), modified on rehearing, 39 N.J. Super. 562; Uniform Judicial Notice of Foreign Law Act, § 5, 9A U.L.A., p. 329 (1957).

It is generally accepted that words which impute to a dentist a general lack of professional knowledge, information or complete misinformation on a subject pertaining to or necessary for the proper practice of [***11] his profession, or incompetency or irresponsibility, constitute, in the absence of privilege, actionable libel. Such an attack against a practitioner exposes him to ridicule or contempt and subjects him to loss of confidence, one of the most precious assets for the successful practice of any profession.

The natural tendency of such a charge is to cause injury to reputation, and the resultant damage is presumed. It is for the court in the first instance to determine whether the words are reasonably capable of a particular interpretation. If they are unambiguous and open only to a single interpretation -- whether a defamatory or non-defamatory meaning -- the court makes that determination as a matter of law. If the language is ambiguous and is reasonably open to two meanings, one innocent and the other defamatory, then it is for the jury to determine as a question of fact which meaning was understood by those to whom the publication was made. In the evaluation of the issue, the writing must be considered as a whole; words and phrases are not to be taken out of context. These well-settled principles have recently been restated and the authorities collated in Leers v. Green [***12] , 24 N.J. 239, 253, 255 (1957); Herrmann v. Newark Morning Ledger Co., 48 N.J. Super. 420, 430 (App. Div. 1958); Mosler v. Whelan, 48 N.J. Super. 491 (App. Div. 1958).

[*275] Disregarding for the moment the circumstances under which the letter was written and confining our consideration to the question of whether the portion of the letter reading: "The Association believes Dr. Mick's views to be based on complete misinformation and to be totally irresponsible" in context, 1 Harper and James, op. cit., supra, § 5.6, p. 365, was non-defamatory as a matter of law, or whether a jury issue was presented, we hold to the latter view. While we incline to the defendants' factual contention that there was "no attack on the ability or competence of the plaintiff" but rather an assault upon his views and opinions on the subject of fluoridation, nevertheless we conclude that the language was not so unambiguous that a court could [**577] hold as a matter of law that it was capable only of the non-defamatory interpretation. A jury could find that readers of the publication would entertain lessened esteem for a dentist whose views on fluoridation were [***13] "irresponsible" and that his professional reputation would be lowered in their eyes. Therefore, in a non-privileged situation, it would be for a jury to determine whether the recipients of the communication understood the words in an innocent or a defamatory sense.

On the issue of publication of the defendants' reply letter, it is admitted that Dr. Yeates, the addressee, was plaintiff's agent, and that the information supplied by the defendants was in effect solicited.

When the publication of defamatory matter has been invited, instigated or procured by the one defamed, or by someone acting on his behalf, he generally cannot be heard to complain of the resulting injury, Taylor v. McDaniels, 139 Okl. 262, 281 P. 967, 66 A.L.R. 1246 (Sup. Ct. 1929); McDaniel v. Crescent Motors, Inc., 249 Ala. 330, 31 So. 2d 343, 172 A.L.R. 204 (Sup. Ct. 1947); Taylor v. Jones Bros. Bakery, 234 N.C. 660, 68 S.E. 2d 313 (Sup. Ct. 1951); Mims v. Metropolitan Life Ins. Co., 200 F. 2d 800 (5 Cir. 1952); Prosser, Torts (2d ed. 1955), § 95, p. 613; 1 Harper and James, op. cit., supra, § 5.17, pp. 398-402; [***14] 53 C.J.S. Libel and Slander § 80, p. 129, [*276] particularly, when it is elicited for the purposes of predicating an action thereon. Richardson v. Gunby, 88 Kan. 47, 127 P. 533, 42 L.R.A., N.S., 520 (Sup. Ct. 1912); Smith v. Dunlop Tire & Rubber Co., 186 S.C. 456, 196 S.E. 174 (Sup. Ct. 1938); 53 C.J.S. Libel and Slander § 95, p. 151; 33 Am. Jur., Libel & Slander, § 94, p. 106. However, the action would not be

barred if the plaintiff, or someone at his request, made or caused the inquiry to be made in good faith so as to ascertain whether defamatory charges had been made against him or perhaps to seek clarification of an ambiguous remark. Richardson v. Gunby, supra; Smith v. Dunlop Tire & Rubber Co., supra; Prosser, op. cit., supra, § 95, p. 613; 33 Am. Jur., Libel & Slander, §§ 93, 94, pp. 105, 106, Annotation, 172 A.L.R. 208 (1948).

While we are satisfied that, resolving doubts from the evidence in favor of the plaintiff, Gnapinsky v. Goldyn, supra (23 N.J. at page 252), the issue as to whether plaintiff caused the Yeates letter to be sent in order to elicit a basis for the [***15] present action is for the jury, we nevertheless conclude that the action is barred on the theory of invitation or consent. It is offensive to an elementary sense of justice that after securing defendant's candid expression of its opinion of plaintiff's views on fluoridation through his use of Dr. Yeates' letter as a provocative decoy, he should be permitted to sue for the injury he thus invited. We hold that the action of the trial court was justified on this basis, apart from the other defenses discussed hereinafter.

Upon the oral argument, a request was made of counsel to submit supplemental briefs on the question of publication. In addition to the issue of publication to Dr. Yeates, counsel for plaintiff advanced a theory that the publication element of the case was satisfied by publication to a stenographer to whom the letter was dictated and who then transcribed the stenographic symbols. Plaintiff says that these facts were established by defendants' answers to propounded interrogatories.

[*277] Our examination of the record fails to disclose that there was offered in evidence the demand for answers to interrogatories and the answers with regard to this issue, and [***16] therefore they cannot, under basic principles of evidence, now be advanced as proof of this essential element of a prima facie case. Were the case before us in a posture that required disposition of the question, we would follow the rule that dictation of defamatory words to an amanuensis is sufficient publication to support an action. Pullman v. Hill & Co., [**578] [1891] 1 Q.B. 524; Nelson v. Whitten, 272 F. 135 (D.C.E.D.N.Y. 1921); Ostrowe v. Lee, 256 N.Y. 36, 175 N.E. 505 (Ct. App. 1931, Cardozo, C.J.); Restatement, Torts, § 577, comments (e) and (h), pp. 194, 196 (1938); Prosser, op. cit., supra, § 94, p. 597, 1 Harper and James, op. cit., supra, § 5.15, pp. 392-393, n. 16; Annotation, 18 A.L.R. 776 (1922); cf. Murphy v. Johns-Manville Products Corp., 45 N.J. Super. 478 (App. Div. 1957), certification denied 25 N.J. 55 (1957); Mims v. Metropolitan Life Ins. Co., supra.

However, accepting such publication as sufficient, yet if the letter is the subject of a privileged communication between the writer and the addressee, that privilege extends to the dictation. Ostrowe [***17] v. Lee, supra; Boxsius v. Goblet Freres, [1894] 1 Q.B. 842; Osborn v. Boulter & Son, [1930] 2 K.B. 226; 1 Harper and James, op. cit., supra, § 5.15, p. 393, n. 17.

Aside from the questions of publication and consent and assuming the letter to Dr. Yeates to be defamatory or capable of a defamatory purport, we consider the issues of qualified privilege and fair comment. It is urged that the letter falls within the classification of

qualified or conditional privilege because it was (a) a communication between parties having a common interest; or (b) fair comment on a matter affecting the public interest.

The burden of proof is upon the defendants to establish the existence of the common interest and privileged occasion; and, with respect to fair comment, that the subject was a legitimate matter of public concern. These are [*278] questions of law to be decided by the trial judge unless the material facts are in dispute. Once the existence of the privilege is established, the plaintiff bears the burden of proving that it has been abused, by use of the occasion for an improper purpose, or by the lack of belief in the truth of what was said. It [***18] is primarily the duty of the judge to determine whether there is any evidence of abuse of privilege for the jury's determination and, if he finds that there is none, to decide for the defendant. Leers v. Green, supra (24 N.J. at page 255); Murphy v. Johns-Manville Products Corp., supra (45 N.J. Super. at page 492); Dressler v. Mayer, 22 N.J. Super. 129 (App. Div. 1952); Prosser, op. cit., supra, § 95, p. 629; Annotation, 26 A.L.R. 830 (1923).

Both plaintiff and Dr. Yeates, as noted, are members in good standing of the defendant Association. Plaintiff testified that he frequently wrote defendant to "ask for various information" and further:

"Q. And as a member of the American Dental Association you are entitled to write and expect an answer on matters concerning dentistry? A. On matters pertaining to anything they have.

Q. Anything that would be in their official capacity? A. What they consider in their official capacity."

Communications between the Association and its members, on a matter of common interest pertinent to the group or affecting their mutual interests, are qualifiedly privileged. McKnight [***19] v. Hasbrouck, 17 R.I. 70, 20 A. 95 (Sup. Ct. 1890). The classic definition, as stated by Baron Parke in Toogood v. Spyring, 1 C.M. & R. 181, 149 Eng. Rep. 1044, 1050 (1834), was that a communication is privileged if "fairly made by a person in the discharge of some public or private duty, whether legal or moral, or in the conduct of one's own affairs in matters where his interest is concerned." Recently the opinions in Jorgensen v. Pennsylvania R.R. Co., 25 N.J. 541 (1958), and in Murphy v. Johns-Manville Products Corp., supra (45 N.J. Super. at page 492) restated and applied the principle which is established [*279] law that "a communication, made bona fide, upon any subject matter in which the party communicating has an interest, or in reference to which he has a duty, is privileged, [**579] if made to a person having a corresponding interest or duty, although it contain criminatory matter which, without this privilege, would be actionable." King v. Patterson, 49 N.J.L. 417 (E. & A. 1887); Rothholz v. Dunkle, 53 N.J.L. 438, 440 (E. & A. 1891); Finkelstein v. Geismar, 91 N.J.L. 46, 48 (Sup. [***20] Ct. 1917), affirmed 92 N.J.L. 251 (E. & A. 1918); Evans, "Legal Immunity for Defamation," 24 Minn. L. Rev. 607 (1940).

Unlike absolute privilege, which affords complete protection, qualified privilege affords immunity only if there is no ill motive or malice in fact, and can be lost by abuse on the part of the defendant. Rainier's Dairies v. Raritan Valley Farms, Inc., 19 N.J. 552, 558 (1955).

The facts presented during the plaintiff's case clearly indicate that the occasion of the publication of the letter by the American Dental Association to Dr. Yeates, a member of that professional group, was such as to give rise to the complete defense of qualified or conditional privilege as stated by the cited authorities. See also Restatement, Torts, § 596, p. 255 (1938). Nor do we have any facts showing express malice indicating an abuse of the afforded immunity. On this point alone, the trial court's decision in dismissing plaintiff's action, at least insofar as it proceeds on the allegedly libelous letter, must be affirmed.

There is, furthermore, a more significant matter of general public concern that must be considered -- the defense of fair [***21] comment.

The defendants, in advancing the argument that the publication of the letter to Dr. Yeates was fair comment, suggest that they consider this a matter of qualified or conditional privilege. There is a difference of opinion among the authorities as to the rationale of the rule. One view regards fair comment as a question of qualified privilege; the other places the defense entirely outside the scope of libel by stating that writings which come within the ambit [*280] of fair comment as opposed to unfair comment are not libelous. 1 Harper and James, op. cit., supra, § 5.28, p. 456 et seq. The theory which regards this as a question of privilege seems to us sound. Ibid. For example, proof of express malice will defeat this defense as it will the qualified privilege we have discussed. Leers v. Green, supra (24 N.J. at pages 254-255).

However, this problem is not a matter of first impression, and under stare decisis we must follow the rule established and iterated by our highest courts. The recent decision in Leers v. Green, supra, firmly indicates that words which constitute fair comment are not defamatory, citing Schwarz Bros. [***22] Co. v. Evening News Publishing Co., 84 N.J.L. 486 (Sup. Ct. 1913); Merrey v. Guardian Printing & Publishing Co., 79 N.J.L. 177, 184 (Sup. Ct. 1909), affirmed 81 N.J.L. 632 (E. & A. 1911), and Campbell v. Spottiswoode, [1863] 32 L.J.Q.B. 185, 201 (3 B. & S. 769, 122 Eng. Rep. 288, 292 (1863)), albeit there is no discussion of the rationale underlying the result. In whatever manner one may characterize the issues, it is obvious that the result achieved is substantially the same, and so we will proceed to the merits of this defense.

Fluoridation of drinking water, which affects the health of citizens in a community, is clearly a subject of wide public interest. The publication of scientific data, the evaluation thereof, and the arguments pro and con on the merits and effectiveness of fluoridation, by dental and medical associations, their members and other interested individuals and groups, are highly desirable and the question becomes a proper subject of public comment. The difficulty arises in distinguishing between misstatements of facts from statements of opinion. The distinction between "fact" and "comment" is not always

[***23] clear; most communications contain an element of each, [**580] and the determination of what is fact or comment depends on what is said in the entire article. The immunity applies to bona fide opinion, comment or criticism, but not to false assertions of fact. By taking an active contentious position on a subject concerning [*281] the public welfare, plaintiff invited public controversy and is regarded as having invited public judgment. He is in no position to complain if that judgment, opinion, comment or criticism is adverse. One may criticize with severity but may not make false or libelous charges. "Criticism 'cannot be used as a cloak for mere invective, nor for personal imputations not arising out of the subject-matter or not based on fact'; 'invective is not criticism.' McQuire v. Western Morning News Co., [1903] 2 K.B. 100, 108." Leers v. Green, supra (24 N.J. at page 255). Merrey v. Guardian Printing & Publishing Co., supra; Schwarz Bros. Co. v. Evening News Publishing Co., supra; Prosser, op. cit., supra, § 95, p. 621.

"Where the subject matter thus concerns the general welfare, it follows that however the conduct be assessed, [***24] * * * the question is whether the impugned statements are true in fact and the comment made has the essential quality of fairness, an attribute that is not necessarily tested by the choice of words or nicety of expression, but rather by the substance of the observations considered in context.' Leers v. Green, supra (24 N.J. at page 259).

Fair comment must be based on facts truly stated or if not sufficiently stated, they must be identified by clear reference.

"In either case, the defendant enables his readers to judge for themselves how far his opinion is well founded; and, therefore, what would otherwise have been an allegation of fact becomes merely a comment. But if he asserts that the plaintiff has been guilty of disgraceful conduct and does not state what that conduct was, this is an allegation of fact for which there is no defense but privilege or truth.

The same considerations apply where a defendant has drawn from certain facts an inference derogatory to the plaintiff. If he states the bare inference without the facts on which it is based, such inference will be treated as an allegation of fact. But if he sets out the facts correctly, and then gives [***25] his inference, stating it as his inference from those facts, such inference will, as a rule, be deemed a comment." Odgers, Libel and Slander (6th ed. 1929), p. 166.

See also Leers v. Green, supra (24 N.J. at page 251); 1 Harper and James, op. cit., supra, § 5.28, p. 459, n. 14, 15. Moreover it [*282] "must not contain imputations of corrupt or dishonourable motives on [the part of] the person whose conduct or work is criticised, save in so far as such imputations are warranted by the facts, and (c) must be the honest expression of the writer's real opinion; and if the comment complies with these conditions, it is fair comment, however incorrect

be the views expressed by the critic, or however exaggerated or even prejudiced be the language of the criticism; the 'limits of criticism are exceedingly wide.' Gatley, Libel and Slander, sections 344, 354." Leers v. Green, supra (24 N.J. at pages 254-255).

In the instant case, while the alleged defamatory letter from the defendants did not itself set forth the facts upon which they based their statements, there was sufficient identification of them. The [***26] letter from Dr. Yeates inviting the response read:

"From time to time the name of Dr. Robert J. H. Mick has come to my attention as being one of those apparently violently against fluoridation. I have read charges that he has made against [**581] our American Dental Association and certain members thereof, the American Medical Association, the United States Public Health Service and certain members thereof. I understand that he has made such accusations over the radio and television also.

I do not believe he is aiding much in the cause of fluoridation * * *."

This letter exhibits not only a knowledge of the facts but also the public nature of the subject-matter and plaintiff's violent opposition and activity in the arena of public communication.

Whether the matter commented upon is of public concern and whether there is any evidence of unfairness are primarily questions of law for the trial judge; and, when there are issues of fact, it is for the jury to determine whether the words are allegations of fact or expressions of opinion, and if the latter, whether or not they are fair comment. If the alleged libel does not exceed the bounds of fair comment or if [***27] there is no evidence upon which a rational verdict for plaintiff can be founded, judgment for defendant should be entered. Leers v. Green, supra (24 N.J. at page 255).

There is perhaps no area of human activity more vital than that of public health. Honest and fearless investigation, [*283] professional discussion and challenge of means and methods for the cure and prevention of disease should be encouraged and not suppressed for fear of libelous action. The road of medical history in the conquest of disease is marked with signposts indicating that the most far-reaching and beneficial scientific achievements and their discoverers were subjected to violent attack. The discovery of vaccination for smallpox by Edward Jenner (1749-1823) in England met vehement opposition. In France, Louis Pasteur (1822-1895) was at first ridiculed and medical journals contained attacks upon his theories and experimentation with inoculation of cultures against anthrax. The techniques introduced by Ignaz Semmelweiss (1818-1865) in Hungary for the prevention of puerperal fever were mercilessly derided. The pioneers in the discovery of anesthetics and the dentists who first used them [***28] encountered much opposition. These few instances illustrate the survival against attack of medical discoveries which ultimately were proved beneficent to mankind. Undoubtedly, other

proposals for prevention or cure were shown to be harmful and valueless as a result of challenge and assault.

Scientific knowledge is only relative and partial, but we constantly seek more knowledge. In the midst of successes there are frequent failures. Indications of the present public controversy over the subject of fluoridation can be seen almost daily in various media. The point is that the widest freedom of discussion and publication of views and their exchange on every side of such questions of public interest should be permitted and even encouraged within the limits of fair comment, and this is the ultimate purpose of the rule.

In discussing the parallel defense of qualified privilege as applied to quasi-judicial proceedings, Justice Jacobs well expressed this philosophy when in Rainier's Dairies v. Raritan Valley Farms, Inc., supra (19 N.J. at pages 557-558), he said:

"Occasionally, however, that policy [freedom from defamatory remarks] conflicts with a counter-policy [***29] which suggests that in certain situations there is a paramount public interest that persons be [*284] permitted to speak or write freely without being restrained by the possibility of an ensuing defamation action." See also 1 Harper and James, op. cit., supra, § 5.28, p. 456.

We are not unmindful that this case is before us upon an involuntary dismissal at the conclusion of plaintiff's case. Under oft-cited principles we are impelled on review of an involuntary dismissal, R.R. [**582] 4:42-2, as noted above in our discussion of the purpose of Dr. Yeates' solicitation of information, to give the plaintiff every legitimate inference, but such inferences as may be drawn "must be rooted in evidence." Gnapinsky v. Goldyn, supra (23 N.J. at page 252). Cf. Melone v. Jersey Central Power & Light Co., 18 N.J. 163, 170 (1955).

The burden of proving the situation giving rise to the occasion of fair comment is on the defendant. Prosser, op. cit., supra, § 95, p. 629. Cf. King v. Patterson, supra (49 N.J.L. at pages 419-420). But as we have stated, where the facts are undisputed this is a matter of law for the court. [***30] Once the evidence shows that the situation is of such import that it becomes a matter for public comment, and such comment is made by the defendant, then the burden of proof is on the plaintiff to show express malice, the "unfairness" of the comment, or any other matter by way of avoidance of the defense. Ibid.

The facts here conclusively establish the nature of plaintiff's position as coming within the scope of those situations giving rise to permissible fair comment and criticism. So, too, there is no evidence whatsoever that negates this total defense. The dismissal of the action with regard to the letter on the ground of fair comment was proper.

One further issue remains to be considered and that is the Association's publications in which plaintiff is not named, directly or indirectly, but which he contends pertain to him

as one of the group opposing fluoridation. The Association did not refer to or characterize the plaintiff among the "quacks," "faith-healers," "faddists" or "cultists," but he [*285] claims that he "was none the less damaged by these publications in that he was and still is widely known as an opponent to the fluoridation program." Actually, it [***31] distributed a brochure listing and furnishing biographical data on the individuals who were so characterized. By the absence of plaintiff's name from this compilation, one would think that he was not included, but since he himself charges that he was within this group, despite denial, the question is whether he has a cause of action.

When defamatory words are directed at a group or class of persons rather than an individual, the plaintiff must show that he is a member of the defamed class and must establish some reasonable application of the words to himself.

"The size of the group to which the defamatory allusion is made has been the most significant factor in determining whether relief should be granted. Where the group is small there is great likelihood that others will understand that the defendant intended to attribute certain qualities, beliefs, or acts to each member. Moreover, others are more likely to believe the statement to be based on information concerning each particular individual rather than that it is a generalization drawn from the observation of a few. As the group becomes larger, it is less likely that the statement will be understood as referring to [***32] each member of the group and its character as a generalization becomes clearer." Note, "Developments in the Law -- Defamation," 69 Harv. L. Rev. 875, 894 (1956). See also authorities cited in Golden North Airways v. Tanana Publishing Company, 218 F. 2d 612 (9 Cir. 1954). "If the group is a very large one, as in the case of such words as 'all lawyers are shysters,' they are considered to have no application to anyone in particular, since one might as well defame all mankind. Not only does the group as such have no action, but the plaintiff does not establish any personal reference to himself. But if the plaintiff is the only lawyer present, or for some other reason the words are understood by the hearers to be directed individually at him, the personal application may appear.

[**583] The rule has been applied quite uniformly to comparatively large groups or classes of a definite number, exceeding, say twenty-five persons. When the group becomes smaller than that * * * the courts have been willing to permit the conclusion that the finger of defamation is pointed at each individual member." Prosser, op. cit., supra, § 92, pp. 583-584. [***33]

[*286] See also 1 Harper and James, op. cit., supra, § 5.7, p. 367; Restatement, Torts, § 564, comment (c), pp. 151-152 (1938); Annotation, 97 A.L.R. 281 (1935).

If the group is sufficiently small, and a particular member is by proper colloquium or innuendo shown to be referred to, such person has a right of action. 1 Harper and James, ubi cit., supra.

Proper appreciation of this rule can be had only by a case-by-case analysis of applicable New Jersey and other authorities.

In Gnapinsky v. Goldyn, supra, where a slanderous statement was allegedly made against "Mary" and where there was no evidence that it referred to plaintiff or was reasonably believed by some person who heard the remark that plaintiff was in fact intended, a judgment of dismissal was affirmed. Chief Justice Weintraub said:

"It must appear that the third person understood the communication to relate to plaintiff * * * the identification of the person defamed may be so evident and the extent of publication such as to warrant an inference that the published statement was understood by at least some third person to bear upon plaintiff. But where, as here, the [***34] statement refers merely to 'Mary,' more than mere publication must be proved to warrant the inference that the listener in fact understood plaintiff was meant."

The opinion in Merrey v. Guardian Printing & Publishing Co., supra, reveals a situation where there were two sets of accusations. One was confined to the city counsel and the other referred to "city officials" of Paterson, New Jersey. The plaintiff, who was city counsel, asserted that he was included in the term "city officials." There was sufficient evidence to sustain the innuendo concerning city officials and the court held that "whether a libel was published of the plaintiff, or whether by the persons mentioned in the libel the plaintiff was intended, is a question of fact for the jury."

In Reilly v. Curtiss, 83 N.J.L. 77 (Sup. Ct. 1912), defendant made an accusation against the election board of the City of Elizabeth. There the court held:

[*287] "A sweeping charge of misconduct leveled against a public board without exception, necessarily points the finger of condemnation at every member thereof, though none are named, and every member of the board may maintain an action therefor." [***35]

In Kilpatrick v. Edge, 85 N.J.L. 7 (Sup. Ct. 1913), plaintiff, the owner of a public bath in Atlantic City, brought suit against the publisher of a local newspaper by reason of an article describing an orgy in a Turkish bath. The court held that the fact that plaintiff was not specifically named was not an adequate defense and permitted recovery.

Lastly, in Neiman-Marcus v. Lait, 13 F.R.D. 311 (D.C.S.D.N.Y. 1952), an action was brought by saleswomen and salesmen of a department store against the author of a book which stated that "most of the salesmen are fairies" and that some of the salesgirls were "call girls." The court held that the salesmen had a cause of action under New York law

but the saleswomen, in absence of anything tending to identify them individually from the large class of saleswomen, had no cause of action.

The facts here are readily distinguishable from the cited cases. The groups or classes described in the articles are so [**584] amorphous and extensive as to preclude the maintenance of an action by plaintiff through claim of association with them because of his common opposition to the cause of fluoridation.

The trial judge's [***36] action in granting an involuntary dismissal at the conclusion of the plaintiff's case is affirmed.

Return to Fluoride-Related Court Cases Return to Fluoridation page Return to ACTION Center Homepage

http://www.actionpa.org/fluoride/lawsandcourts/nj-libel-mick.html

http://www.actionpa.org/fluoride/lawandcourts/index.html#courtcases

Methamphetamine Destroys Your Teeth

"Meth mouth" is too dry

http://news.softpedia.com/news/Methamphetamine-Destroy-Your-Teeth-36398.shtml American Dental Association (ADA) says that your teeth can be destroyed by

methamphetamine, a powerfully addictive drug.

Once it enters a person's body, it provokes a release of a great amount of

dopamine, leading to the typical euphoria. Short-term effects include extreme wakefulness, a lasting boost of energy and a lack of appetite. Long-

term effects include a high blood pressure, stroke and serious heart problems.

Methamphetamine (also known as meth, crank, crystal and speed) has been used by more than 12 million people in US. It can be taken orally, injected,

snorted or smoked. Most users are 18 to 34 years old. In just one year, the drug users can achieve sensitive teeth to tooth loss, a condition called " meth mouth".

Meth mouth robs people, especially young people of their teeth and

frequently leads to full-mouth extractions and a lifetime of wearing dentures," says Robert M. Brandjord, ADA president. "Meth mouth is characterized by rampant tooth decay and teeth described by meth users as

blackened, stained, rotting, crumbling or falling apart."

The drug inhibits salivary glands' activity. Without the diluting saliva, food or bacteria produced acids in your mouth start dissolving tooth enamel. Moreover, the drug users may neglect their oral hygiene.

And methamphetamine effect can last for 12 hours. During this time,

personal hygiene may not enter on the view of the drugged person. Dr. Brandjord explains, "The extensive tooth decay of meth mouth is attributed to the drug's dry-mouth effect and its propensity to cause cravings

for high-calorie carbonated beverages, tooth grinding and clenching, and extended periods of poor oral hygiene."

"Very few people understand the broad dangers methamphetamine poses to the public health of our communities in addition to meth users themselves,"

says Stephen Pasierb, president and CEO, The Partnership for a Drug-Free

America.

"The ADA's warning should serve as a wake-up call to those who use this

insidious drug as well as family and friends who are witness to this behavior, but not powerless to intervene and get the user the help they need. There is no safe level of meth use, but treatment and recovery are possible."

Alcoa From Wikipedia, the free encyclopedia

Alcoa, Inc.

Type Public (NYSE: AA)

Founded Pittsburgh, Pennsylvania, U.S. (1888)

Founder Charles Martin Hall

Headquarters New York, New York

Pittsburgh, Pennsylvania

Area served Worldwide

Key people

Alain J. P. Belda

(Chairman)

Klaus Kleinfeld

(CEO), (President) & (Director)

Industry Aluminum

Market cap US$ 21.90 billion (2008)

Revenue ▲ US$ 30.748 billion (2007)

Operating income ▲ US$ 4.491 billion (2007)

Net income ▲ US$ 2.564 billion (2007)

Total assets ▲ US$ 38.803 billion (2007)

Total equity ▲ US$ 16.016 billion (2007)

Employees 107,000 (2008)

Subsidiaries

Reynolds Metals

Halco Mining

Kawneer

Howmet Castings

Website Alcoa.com

Alcoa, Inc. (NYSE: AA) is the world's third largest producer of aluminum, behind Rio Tinto Alcan and Rusal. [3] Alcoa leads the world in alumina production and capacity. From its operational headquarters in Pittsburgh, Pennsylvania, Alcoa conducts operations in 44 countries. In May 2007 Alcoa made a hostile $27 billion bid for Alcan, a former subsidiary, aiming to unite the two companies and form the world's largest aluminum producer. The takeover bid was withdrawn after Alcan announced a friendly takeover by Rio Tinto in July 2007.

Among Alcoa's other businesses are fastening systems, building products (Kawneer), Howmet Castings, and electrical distribution systems for cars.[4] The sale of the packaging unit was announced on December 21, 2007[5] and closed in the first quarter of 2008.

History

In 1886, Charles Martin Hall, a graduate of Ohio's Oberlin College, discovered the process of smelting aluminum, almost simultaneously with Paul Héroult in France. He realized that by passing an electrical current through a bath of cryolite and aluminum oxide, the then semi-rare metal aluminum remained as a byproduct. This discovery, now called the Hall-Héroult process, is still the only process used to make aluminum worldwide.

Probably fewer than ten sites in the United States and Europe produced any aluminum at the time. In 1887, Hall made an agreement to try his process at the Electric Smelting and Aluminum Company plant in Lockport, New York but it was not used and Hall left after one year. On Thanksgiving day 1888, with the help of Alfred E. Hunt, started the Pittsburgh Reduction Company with an experimental smelting plant on Smallman Street in Pittsburgh, Pennsylvania. In 1891, the company went into production in New Kensington, Pennsylvania. In 1895 a third site opened at Niagara Falls. By about 1903, after a settlement with Hall's former employer, and while its patents were in force, the company was the only legal supplier of aluminum in the US.[6][7]

"The Aluminum Company of America" -- became the firm's new name in 1907. The acronym "Alcoa" was coined in 1910, given as a name to two of the locales where major corporate facilities were located (although one of these has since been changed), and in 1999 was adopted as the official corporate name.

It has been suggested that this section be split into a new article entitled United States v. Alcoa .

Under President Franklin D. Roosevelt, the Justice Department charged Alcoa with illegal monopolization, and demanded that the company be dissolved. Trial began on June 1, 1938.

Four years later, the trial judge dismissed the case. The government appealed.

Two more years passed, and in 1944, the Supreme Court announced that it couldn’t assemble a quorum to hear the case so it referred the matter to the U.S. Court of Appeals for the Second Circuit.

The following year, the year the world weary of war at last had a chance at peace, was also appropriately enough the year this litigation came to its end. Learned Hand wrote the opinion for the Second Circuit.

Hand wrote that he could consider only the percentage of the market in "virgin aluminum" for which Alcoa accounted. Alcoa had argued that it was in the position of having to compete with scrap. Even if the scrap was aluminum that Alcoa had manufactured in the first instance, it no longer controlled its marketing. But no, Hand defined the relevant market narrowly in accord with the prosecution's theory.

Alcoa said that if it was in fact deemed a monopoly, it acquired that position honestly, through outcompeting other companies through greater efficiencies. Hand applied a rule concerning practices that are illegal per se here, saying that it doesn’t matter how Alcoa became a monopoly, since its offense was simply to become one. Indeed, Hand seemed to be saying that in some circumstances inefficiency may be a requirement of the law.

Hand acknowledged the possibility that a monopoly might just happen, without anyone's having planned for it. If it did, then there would be no wrong, no liability, and no need to remedy the result. But that acknowledgement has generally been seen as an empty one in the context of the rest of the opinion, because of course rivals in a market routinely plan to outdo one another, at the least by increasing efficiency and appealing more effectively to actual and potential customers. If one competitor succeeds through such plans to the extent of 90% of the market, that planning can be described given Hand's reasoning as the successful and illegal monopolization of the market.

This leaves the question, what is the proper remedy once a wrongful monopolization is found? Here Hand remanded the matter to the trial court, and the whole narrative comes to an unsatisfactory conclusion – more of a dissipation, really, than a conclusion. In 1947, Alcoa made the argument to the court that there were two effective new entrants into the aluminum market – Reynolds and Kaiser – as a result of demobilization after the war and the government's divestiture of defense plants. In other words, the problem had solved itself and no judicial action would be required. On this basis, the district court judge ruled against divestiture in 1950, but the court retained jurisdiction over the case for five years, so that it could look over Alcoa's shoulder and ensure that there was no re-monopolization.

Until 1950, Alcoa was concerned with its domestic market, while its Canadian subsidiary Aluminum Limited (Alcan) took care of the international markets. Alcoa, Reynolds, and Kaiser were soon joined in the growing market by Anaconda Aluminum Company, a subsidiary of the copper-industry giant. In 1958 Harvey Machine Tools Company began

primary aluminum production, marking the end of Alcoa's monopoly over the process which had led to its domination of the American market.

Noted economist and former Federal Reserve chairman Alan Greenspan criticized the judgment of monopoly against Alcoa (Capitalism: The Unknown Ideal; see[8]) quotes Learned Hand, the judge in U.S. v Alcoa, who remarked, "It was not inevitable that it should always anticipate increases in the demand for ingot and be prepared to supply them. Nothing compelled it to keep doubling and redoubling its capacity before others entered the field. It insists that it never excluded competitors; but we can think of no more effective exclusion than progressively to embrace each new opportunity as it opened, and to face every newcomer with new capacity already geared into a great organization, having the advantage of experience, trade connections and the elite of personnel." Greenspan believes that the characterization of Alcoa as a threat to competition is erroneous, as "ALCOA is being condemned for being too successful, too efficient, and too good a competitor. Whatever damage the antitrust laws may have done to our economy, whatever distortions of the structure of the nation's capital they may have created, these are less disastrous than the fact that the effective purpose, the hidden intent, and the actual practice of the antitrust laws in the United States have led to the condemnation of the productive and efficient members of our society because they are productive and efficient." Greenspan grants that Alcoa was a monopoly, but maintains that it was not a coercive monopoly and, hence, should not have been subject to anti-trust action.

Alcoa established an 8% stake in China's state-run aluminum industry and has formed a strategic alliance with Aluminium Corporation of China (Chalco), China's largest aluminum producer, at its Pingguo facility. Alcoa sold this stake on September 12, 2007.[9]

Alcoa has also acquired two facilities in Russia, at Samara and Belaya Kalitva. Alcoa recently launched an offer to purchase the remaining 18% of the Belaya Kalitva plant from minority shareholders, giving it complete ownership in the facility.

In 2004, Alcoa's specialty chemicals division was sold, taking on the name Almatis, Inc..

In 2005, under heavy criticism by local and international NGOs related to a controversial dam project exclusively dedicated to supplying electricity to this smelter, Alcoa began construction in Iceland on Alcoa Fjardaal, a state-of-the-art aluminum smelter and the company's first greenfield smelter in more than 20 years. Alcoa also signed a memorandum of understanding with the government of the Republic of Trinidad and Tobago to build a low-emissions aluminum smelter and related facilities there. However, there has been strong objection of this by the residents of the area of the proposed smelter sparking protests and marches frequently.Also, Alcoa is working with the government of Ghana on the development of the aluminum industry in that country. Furthermore, Alcoa has completed or is undergoing primary aluminum expansion projects in Brazil, Jamaica, and Pinjarra, Western Australia.

In 2006, Alcoa relocated its top executives from its headquarters in Pittsburgh to New York City. Although the company's principal office is located in New York City, the company's operational headquarters are still located at its Corporate Center in Pittsburgh. Alcoa employs approximately 2,000 people at its Corporate Center in Pittsburgh and 60 at its principal office in New York.[10]

Alcoa was named one of the top three most sustainable corporations in the world at the World Economic Forum in Davos, Switzerland.

On 8 May 2008, Klaus Kleinfeld was appointed new CEO of ALCOA substituting Alain Belda.

Environmental record

Alcoa is ranked 9th in the Political Economy Research Institute's (PERI) Toxic 100 of 2002. The company released 9.88 million pounds of toxic air in 2002.[11] In April 2003, Alcoa Inc. agreed to spend an estimated $330 million to install a new coal-fired power plant with state-of-the-art pollution controls to eliminate the vast majority of sulfur dioxide and nitrogen dioxide emissions from the power plant at Alcoa's aluminum production facility in Rockdale, Texas. The settlement was the ninth case the Bush Administration pursued to bring the coal-fired power plant industry into full compliance with the Clean Air Act. Alcoa was unlawfully operated at the Rockdale facility since it overhauled the Rockdale power plant without installing necessary pollution controls and without first obtaining proper permits required by "New Source Review" program of the Clean Air Act.[12] In February 1999, Alcoa cleaned soils and sediment contaminated with polychlorinated biphenyls (PCB) and lead at the York Oil federal Superfund site in Moira, New York in accordance with the Environmental Protection Agency. The site, a former waste oil recycling storage facility, accepted waste oil from a number of companies, including Alcoa. The facility was improperly managed and operated and, as a result, soils on the York Oil Property and nearby wetlands sediments and groundwater were contaminated. The EPA issued a Superfund Unilateral Order on December 31, 1998 requiring Alcoa to excavate, treat and dispose of the contaminated wetlands sediments.[13]

On the other hand, In 2005, BusinessWeek magazine, in conjunction with the Climate Group, ranked Alcoa as No.5 of "The Top Green Companies." in cutting their carbon gas emissions[14][15].

Alcoa in Ghana

Alcoa's affiliate in Ghana, the Volta Aluminum Company, was completely closed between May 2003 and early 2006, due to problems with its electricity supply.[16][17]

Alcoa in Iceland

By the middle of September, over 50% of the Alcoa Fjardaál smelter construction in Iceland has been finished. The total workforce on site is 1,750 people, of which 80% are of Polish origin.[citation needed] It is expected to be on line by 2007. Alcoa and the government of Iceland have signed an agreement on instigating a thorough feasibility study for a new 250,000 tpy (Tons Per Year) smelter in Bakki by Húsavík in Northern Iceland. In order to power Alcoa's new smelters in Iceland, tracts of wilderness are being flooded to provide hydroelectric energy.[citation needed] Alcoa does not own the kárahnjúkar powerplant.[citation needed]

Fjardaral, which is owned by Alcoa, created jobs in the nearby town of Reyðarfjörður for people that lost their jobs when the Icelandic government decided to lower their fishing quota.[citation needed]

Alcoa In South Wales (Swansea)

On November 21, 2006, Alcoa announced that it planned to close the Waunarlwydd works in Swansea, with the loss of 298 jobs. Production ceased at the Swansea plant on January 27, 2007. Decommissioning works are currently taking place. Although rolling operations at the plant have now ceased, a small workforce is still employed in homogenisation, where heat treatment takes place for the Kitts Green plant.[18][19]

Alcoa in Australia

Alcoa operates bauxite mines, alumina refineries and aluminum smelters through Alcoa World Alumina and Chemicals, which is a joint venture between Alumina Limited and Alcoa. Alcoa operates two bauxite mines in Western Australia - the Huntly and Willowdale mines. Alcoa World Alumina and Chemicals owns and operates three alumina refineries in Western Australia: Kwinana, Pinjarra and Wagerup. Two aluminum smelters are also operated in the state of Victoria at Portland and Point Henry.

Alcoa in the United States

ALCOA created a plant just outside of Maryville, TN in Blount County, Tennessee, which was the biggest provider of aluminum in the South. The area needed housing for workers, so ALCOA built many houses. The area eventually turned into a city and decided to name its self after the company. Alcoa, Tennessee, was founded 1919.[citation

needed]

Alcoa maintains several Research and Development Centers in the United States. The largest one, Alcoa Technical Center, is located East of its Pittsburgh Headquarters at Alcoa Center, PA. The "Tech Center" is as large as some college campuses, has its own Zip Code and maintains an extensive intellectual and physical resource for innovation. Alcoa's extensive safety program continuously improves safety at the Tech Center while enhancing quality of life and efficiency for the hundreds of elite level Researchers who are creating new avenues of business growth and technological development for the

Company. Some experimental processes can be dangerous but Alcoa's 6S Culture of Safety and Environmental Responsibility has ensured Researcher safety and minimized environmental impact while enhancing cost effectiveness of development work and accelerating time to market.[citation needed]

The Physical plant of the Tech Center is situated in a rural area and has managed to cultivate a large wooded area which acts as a nature preserve, sheltering deer and other wildlife. It is not uncommon to see Deer and other wildlife freely circulating through the environs of the Tech Center at all hours of the day.[citation needed]

Alcoa World Alumina and Chemicals

Alcoa owns and operates the majority of its alumina refineries through its 60% share of Alcoa World Alumina and Chemicals.

Alcoa Primary Aluminum smelters

Alcoa has interests in 25 primary aluminum smelters in 8 countries.

Alcoa smelters[20][21]

Country Location Equity ownership

Plant Total Nameplate capacity (kt per year)

Alcoa's Capacity (kt per year)

Point Henry 100% 185 185

Portland 55% 353 194

Poços de Caldas 100% 96

São Luís (Alumar) 60% 438 263

Baie Comeau 100% 438 438

Bécancour 75% 409 307

Deschambault 100% 254 254

Fusina 100% 44 44

Portovesme 100% 150 150

Avilés 100% 90 90

A Coruña 100% 84 84

San Cibrao 100% 225 225

Alcoa Operations, TN

100% 215 215

Badin, NC 100% 60 60

Evansville, IN (Warrick)

100% 309 309

Ferndale, WA (Intalco)

100% 279 279

Frederick, MD (Eastalco)

100% 195 195

Massena (East Plant), NY

100% 125 125

Massena (West Plant), NY

100% 130 130

Mount Holly, SC 50% 229 115

Rockdale, TX 100% 267 267

Wenatchee, WA 100% 184 184

Tema 10% 200 20

Lista 50% 94 47

Mosjøen 50% 188 94

See also

• Alumina • List of alumina refineries • Alcoa World Alumina and Chemicals • Alcoa, Tennessee • List of aluminum smelters

References

1. ^ "It all starts with dirt". Alcoa, Inc.. Retrieved on 2008-08-07. 2. ^ "Alcoa, Inc.". Google Finance. Retrieved on 2008-08-07. 3. ^ "Gimme Smelter". The Economist (2007-07-19). Retrieved on 2007-10-15. 4. ^ "Alcoa About Alcoa". Alcoa, Inc.. Retrieved on 2007-10-15. 5. ^ Alcoa, Inc.. "Form 8-K". United States Securities and Exchange Commission.

Retrieved on 2007-12-31. 6. ^ Hachez-Leroy, Florence. "Aluminum industry: a Heritage for Europe" (PDF).

Proceedings, TICCIH Congress. Retrieved on 2007-11-03. 7. ^ Rosenbaum, David Ira (1998). Market Dominance: How Firms Gain, Hold, or Lose It

and the Impact on Economic Performance. Praeger Publishers via Greenwood Publishing Group, 56. ISBN 0275956040. Retrieved on 2007-11-03.

8. ^ Antitrust by Alan Greenspan 9. ^ Alcoa: News: News Releases: Alcoa Sells Its Stake in Chalco; Will Continue Its

Commitment to Chinese Aluminum Industry 10. ^ Alcoa's HQ relocation to NYC no big surprise 11. ^ PERI - Political Economy Research Institute: Toxic 100 Table

12. ^ U. S. Announces Clean Air Act Coal-fired Power Plant Settlement with Alcoa - Settlement Will Reduce Nitrogen Oxide and Sulfur Dioxide Emissions from Facility by More than 90 P...

13. ^ Alcoa To Carry Out EPA's Order and Expand Cleanup at Superfund Site in Moira, New York To Contaminated Wetlands Sediments | Newsroom | US EPA

14. ^ Unknown Author (December 6, 2005). "DuPont Tops BusinessWeek Ranking of Green Companies". GreenBiz News.

15. ^ Green Leaders Show The Way Business Week 16. ^ [1] 17. ^ Alcoa in Ghana: News: News From Ghana: Alcoa, Government of the Republic of

Ghana Agree to Re-Start Valco Smelter 18. ^ BBC News 19. ^ Forum for former workers from the Swansea plant 20. ^ "Alcoa smelting capacity". Retrieved on 2007-08-20. 21. ^ "Alcoa: Worldwide: Markets: Aluminum Ingot Products: Global Capacity". Retrieved

on 2007-08-28.

American Water Works Association http://www.awwa.org/Membership/Content.cfm?ItemNumber=6023&NavItemNumber=29252

Applications: Individual, North America Individual Membership provides numerous career and educational opportunities.

For information on Individual Membership benefits, please visit our Membership Benefits page.

If you're ready to apply, there are two ways you can do so for Individual Membership.

• Apply Online: To apply online, please be aware that you will be asked for a login account username and password before you get to the application.

� If you have already created a login account, simply enter your username and password on the screen, and your contact information will automatically populate in the application.

� If you do not yet created have a login account, follow the steps shown on the next screen to create one. The information you provide in that process will help populate your membership application. Your login username and password will be good for all your future visits to the AWWA website!

• Apply via PDF: The PDF application is "writable," meaning when you open the document and fill in the information, you can simply click the "SUBMIT" button located at the end of the form to send us your information. You will need Adobe Reader software on your computer to open this PDF file. If you do not have Adobe Reader, you can download it for free from Adobe's website.

AWWA Warned Not to Remove or Destroy Evidence for Water Fluoridation Injury Legal Actions June 9, 2008 http://fluoridealert.org/press/awwa.html

Media Release from The Lillie Center, Inc

June 9, 2008

Giant Water Group Warned Not to Remove or Destroy Evidence for Water Fluoridation Injury Legal Actions

Ellijay, GA: June 9, 2008 – The largest association of water professionals in the world has been notified not to destroy, remove, or tamper with documents or video recordings in its possession that may be used in legal actions on behalf of persons injured by drinking fluoridated water.

Robert Reeves, an attorney whose work helped force FDA to concede potential harm from mercury in dental filling s, sent a fluoride evidence preservation letter to the Denver-based 60,000-member American Water Works Association. The letter listed AWWA’s headquarters office, its regional section offices, and national and regional officers personally as “potentially responsible parties” that may be the subject of legal actions by kidney patients and others harmed by ingesting fluorides.

The development comes on the heels of last week’s dramatic news that the National Kidney Foundation has admitted that chronic kidney di sease patients “should be notified of the potential risk” from ingesting fluorides and fluoridated water.

Kathleen Thiessen, PhD, one of the members of a National Research Council panel that issued a 500-page report on fluorides in 2006, says, “The NRC report indicated that kidney patients, diabetics, infants, and other groups are susceptible population groups. I am also personally concerned that black and other minority Americans are disproportionately harmed by fluoride, and I believe there is a potential risk of thyroid damage for overexposed Americans in general.”

In a January 2008 Scientific American article about fluorides, toxicologist John Doull, the chairman of the NRC panel, admitted, “The thyroid changes do worry me.”

Reeves’ letter demonstrates that attorneys across the country are becoming educated about fluoride, a substance acknowledged to rival arsenic and lead in toxicity. The letter also zeroes in on AWWA’s slogan that it is “The Authoritative Resource on Safe Water.” Reeves points out that AWWA doesn’t claim to be the authoritative resource on “pure or compliant” water, but on “safe” water, putting the organization and its directors in a position of “top tier accountability and responsibility” to disseminate even the bad news about fluoride.

“Looks like AWWA has painted a made-for-plaintiff-attorneys bulls-eye on themselves,” observes Daniel Stockin of The Lillie Center, Inc., a Georgia-based public health training firm that is working

to end water fluoridation.

AWWA chose not to include scientists opposing fluoridation in a web-cast about fluoridation in 2006.

In AWWA’s written response to Reeves, the organization wrote, “AWWA looks to the medical and dental communities, the U.S. EPA, the Centers for Disease Control, and other…organizations for their information and research on medical and dental health.”

“Well, which is it?” Stockin questions. “Either AWWA is ‘The Authoritative Resource on Safe Water’ or it isn’t,” he states. “AWWA apparently ignored the rather obvious conflicts of interest of dental and health organizations that gave glowing reports on the safety of fluorides. If AWWA doesn’t quickly distance itself from the old-school idea that fluoride is safe even for sensitive populations, it will probably result in AWWA member water districts being forced to name the headquarters or regional staff or offices of AWWA as third party defendants when they’re sued by kidney patients and other groups.”

A growing number of cities have recently rejected water fluoridation, including the Canadian city of Quebec and Juneau, the capital of Alaska.

For more information, contact:

Daniel G. Stockin, MPH The Lillie Center, Inc. P.O. Box 839 Ellijay GA 30540 Ph: 706.669.0786 // Fax: 706.635.8170 Email: [email protected]

• Attorney Robert Reeves’ letter to AWWA

available at: http://fluoridealert.org/reeves.pdf

• Video and news related to the National Kidney Foundation’s changed position on fluorides for kidney patients can be viewed at: http://www.fluoridealert.org/press/nfk2.html

Fluoride Action Network | 802-338-5577 | [email protected]

Advertising: Bernays Discounts Persuasion http://www.nytimes.com/books/98/08/16/specials/bernays-discounts.html

B September 26, 1962

y PETER BART

Edward L. Bernays, the public relations man, is in a state of transition these days. He is moving his base of operations from New York to Cambridge, Mass., where he

plans to slacken his pace and write his memoirs.

All this will represent a change for the 70-year-old Mr. Bernays, who has operated a public relations counseling company in New York since 1919.

The other day Mr. Bernays, who is a nephew of Sigmund Freud, paused for a few minutes to offer some provocative observations about the business of "paid persuasion."

Mr. Bernays said the weight of persuasive material hurled at the consumer by advertising and public relations men amounted to "a basic attack on the human personality."

Impact Weakened

Persuasion has become such a massive industry, he observed, that its impact is often negated.

A basic reason for this phenomenon, he said, was that business fails to understand the true nature of persuasion and communication. Too many advertisers believe that it is possible to change any consumer's mind if enough money is allocated for the purpose, he said.

According to Mr. Bernays, this notion runs counter to all that is known about psychology and group dynamics. People have habits and preconceived ideas, he noted.

No advertisement, no matter how shrewdly conceived, will convert a person who is passive and disinterested toward a product into a potential customer, according to Mr. Bernays.

Persuasion Overdone

And no public relations campaign, he said, will succeed in improving a company's "image" if that company's actions create an unfavorable impression.

Mr.Bernays said he was dismayed by the role of public relations. Public relations men function merely as paid persuaders, he said, when persuasion should be only a small part of their role.

The job of the public relations man, he said, should be to "study public opinion and social psychology" and to counsel his company on how to adjust to these "societal forces and to enlist public support for services, products and ideas."

The public relations man's principal impact should be on corporate policy, Mr. Bernays said. The process of communicating to the public should be a secondary aim.

Licenses Suggested

All this may sound high-minded, but to Mr. Bernays, the public relations business will never reach maturity until it functions in this manner.

As one step in this direction, Mr. Bernays said public relations men should be licensed by the state. This process would do much to keep out "marginal operators" who use the techniques of public relations for purposes that are "not in the public interest," he said.

"Today's communicator has no sense of values whatsoever," Mr. Bernays said. "He simply does what he is hired to do. This is a distortion of the public relations function."

Mr. Bernays also criticized the emphasis on corporate images. "All this is medicine man abracadabra," he remarked. "It represents a flight from reality. The job of the communicator should be to convey reality through words and pictures, not to practice medicine man incantations."

Mr. Bernays, who has served such clients as the General Motors Corporation, the United Fruit Company, the American Tobacco Company and the Bank of America, said he found his new surroundings highly congenial to writing.

"New York is hectic and full of tensions," he said. "In Cambridge if people know you are trying to do a book they do not look at you peculiarly. Cambridge is free of many of New York's pressures."

Are We Victims of Propaganda? http://www.smokershistory.com/propagan.htm

Exerpts from: Are We Victims of Propaganda? A Debate. Everett Dean Martin and Edward L. Bernays. Reprinted from The Forum Magazine, 1929 March.

I. Our Invisible Masters, by Everett Dean Martin. "...To the extent that present methods of propaganda operate to increase general knowledge and to keep open in public life an arena in which truth may have a fair deal in its endless contest with ignorance and falsehood, no reasonable mind could possibly object to it. I am convinced, however, that propaganda does not often serve these ends. It is not designed, even at its best, for such service, but for something quite the reverse. Its aim is to 'put something over' on people, with or without their knowledge and consent, and its result is to produce a social situation in which neither truth nor the basic values of civilization get a fair hearing....

"Who, then decides whether the ulterior end to which the public is to be led or driven, with or without its assent, is good? Decision in this all important matter is left to a few people -- the very ones who have something to gain by manipulating the public. Furthermore, the identity of these people is seldom disclosed and they are responsible to no one. Propaganda is making these irresponsible and unknown persons the real rulers in American democracy. Let me quote a few passages from Mr. Edward L. Bernays' charmingly written book in defense of propaganda: (Propaganda; Liveright, 1928.)

• For the masses promised to become king.... To-day, however, a reaction has set in. The minority has discovered a powerful help in influencing majorities. It has been found possible so to mould the mind of the masses that they will throw their newly gained strength in the desired direction.... The important thing is that it (propaganda) is universal and continuous, and in its sum total it is regimenting the public mind every bit as much as an army regiments the bodies of its soldiers....

• There are invisible rulers who control the destiny of millions. It is not generally realized to what extent the words and actions of our most influential public men are dictated by shrewd persons operating behind the scenes.... In some departments of our daily life in which we imagine ourselves free agents, we are ruled by dictators exercising great power.... The invisible government tends to be concentrated in the hands of the few because of the expense of manipulating the social machinery which controls the opinions and habits of the masses.

"What are the qualifications of these invisible governors? Who are they that they should command? In what virtue or wisdom are they eminent? If there is to be any stability or order in society, those who rule must at least be known and something must be required

of them; otherwise their rule is pure impertinence. When before have the governing few been unknown and hence so irresponsible? When before have the rewards been so great for wrong doing, or the means so certain and easy for those who have the power? It is not enough for gentlemen to say, 'Oh, yes, we admit that propaganda is sometimes abused.' An enterprise so uncontrollable, so susceptible of abuse, and so constantly under the temptation to abuse, is a public menace....

"But I am concerned about the methods and ultimate effects of propaganda even at its best. One effect of propagandist methods is greatly to increase the susceptibility of the public to slogans, catchwords, and vulgarly stated half-truths. Every real educator and political philosopher in history has noted the danger of this popular tendency. Now the 'knowing ones' are urged to see this mob psychology, not as a social menace, but as a natural resource to be exploited for private gain. Mr. Bernays says:

• It was, of course, the astounding success of propaganda during the war that opened the eyes of the intelligent few in all departments of life to the possibilities of regimenting the public mind.... The manipulators of patriotic opinion made use of the mental cliches and emotional habits of the public to produce a mass reaction against alleged atrocities, the terror and tyranny of the enemy. It was only natural after the war ended that intelligent persons should ask themselves whether it was not possible to apply a similar technique to the problems of peace.

"Precisely! The propagandist has learned to apply a wartime psychology to the accomplishment of any ends whatsoever! He proceeds by utilizing, for ulterior ends, the prejudices and passions and fixed ideas of the mob -- a new role, I assure you, for the 'intelligent few' in the history of civilization. Not even Machiavelli quite dared to propose such procedure. The intelligence of the community is thus told to abandon its historic role of keeping alive the values of civilization, and, by turning demagogue and sycophant, to pander ignorance in return for vulgar favors -- which means that prejudice and the well-known weaknesses of human nature are to be exploited and thus encouraged. Moreover, the regimentation of opinion so achieved (for a consideration) means standardization on a low level and greater conformity to herd opinion. This accounts, in part, for the astounding growth of intolerance in American democracy after the war. In this way also, fundamentalism, censorship, and other forms of organized crowd insanity have now become a serious menace to American liberty.

"It must be borne in mind that everything the propagandist does or says is for effect -- most commonly the effect on fools. The public wants not truth but a show? Very well, he will play the mountebank. The responsibility for the intellectual integrity of the intelligent few is now for the first time in history passed on to the public. In the future, as Mr. Bernays says, "If the public becomes more intelligent in its commercial demands, commercial firms will meet new standards." So with all propagandists. This is to say, as long as the public may be manipulated by misrepresentation and by appeal to ignorance and prejudice, it is the public's own fault if the 'knowing ones' make use of questionable methods. Why worry about being decent, so long as the opposite cause has public approval? Just now it is the rule to be 'low brow,' to come down to the level of the man in

the street. In striving for mass action, intelligence exhausts itself in the methods of gaining the attention of the ignorant and stupid...

"Perhaps the most deadly thing about propaganda is that as it more and more organizes the vast agencies for communication and human intercourse in the interest of power and success and the dominance of certain influential groups, appealing always to 'cliches and emotional attitudes,' it sets up a vast system which excludes everything that is rare and challenging -- except that which may produce insignificant popular sensation. Mr. Bernays says that every means of human association and communication may be made a means of propaganda -- that is, may be organized for ulterior ends. Try to picture this state of affairs. This means that as such social forces become organized and controlled by the unknown few who can pay for such a vast enterprise, ideas that may not be utilized to the ends for which such organization exists cannot gain a hearing. Already we see many instances of censorship by such a controlling power. As Mr. Bernays says, 'of late a reaction has set in.'

"When the future historian, an American Sallust or Tacitus, records the downfall of our republic and its loss of liberty, he will point out the leading place that organized propaganda played in this unhappy business. Sallust tells us how such propagandist tricks as the Roman manipulators discovered -- bread and circuses -- brought about an unholy alliance between the passions of the mob and the ambitions of 'the intelligent few.' Tacitus tells us that when Augustus assumed divine attributes, and tyranny and persecution were later universal, these evils were possible because no one was able to protest. This is also the inevitable end of modern organized propaganda. Once we had an uncomplimentary word for such an industry. We called it 'intrigue.' The ambitious few who destroyed the freedom of the ancients won over the mob by making themselves visible. To-day, as Mr. Bernays says, their successors are setting up an 'invisible government.' Republica Americana delenda est.

"P.S. They got the job!

III -- Rebuttal by Everett Dean Martin.

"I specifically stated that I would discuss the evils of propaganda at its best; Mr. Bernays replies that I am like one who, in writing about the medical profession, 'would discuss only the fakers and quacks.' I quoted passages from Mr. Bernays' recent book to show that propaganda tends to set up an invisible and irresponsible government. The language quoted is plain....

"Mr. Bernays does not really discuss my argument, that the methods used by propagandists, even at best, in the necessary attempt to translate all things into such terms that one hundred and twenty millions of people can be 'reached,' make for cheapness, insincerity, and intolerance. His argument is in substance that propaganda serves the truth by giving both sides of an issue a hearing. But is it true that, as things are, each side of an issue gains a fair and equal hearing? Is it not a fact that the little business and the unpopular cause -- those that have not the money to pay for the services of high-pressure

salesmen and large-circulation advertising, however worthy they may be -- are increasingly unable to compete for a hearing with forces organized on a nationwide scale?...

"I did not, as Mr. Bernays seems to think, bring severest criticism against propaganda in business. I am primarily interested in preserving our cultural inheritance. Doubtless propaganda in the form of advertising works less harm than elsewhere. The man who advertises soap generally sells what he advertises. Even the sale of an occasional gold brick is not the worst evil of propaganda. What I object to is the nation-wide sale of cultural gold bricks.

Cover Page - Are We Victims of Propaganda? / American Memory US Govt

Every word of this is a precise fit for the way the secret government of anti-smoking vermin has rammed its will down our throats! And with our own tax dollars, no less! Anti-smoker America is an utterly evil tyranny, and deserves to be wiped off the face of the earth.

Sample Anti-smoking Hate Propaganda

From a description of an anti-secondhand smoke commercial in Wisconsin:

• A man and a woman are in a car, driving along quietly. The woman is driving, the man is in the passenger seat. They both appear to be about thirty. The man pulls out a cigarette and lights it. The woman driver gives him a dirty look and then suddenly swerves off the road and hits the gas. The car heads over a bump and goes airborne. Then she heads straight for a tree, just barely avoiding it at the last second. The man is screaming in horror as this crazy woman, driving like a mountain rally professional, has one near fatal miss after another. When the car finally stops, the man, wide-eyed and clearly terrorized, yells, "What are you dpoing?" The woman gives him a fully disgusted, condescending look and replies, "You endangered my life, didn't you?"

It is not intended as mere hyperbole. These vermin demand that public policymakers treat this despicable crap as literal truth. They trot out slimy, corrupt physicians to make pretenses like this. And as for a fair and equal hearing, forget it! Their filthy media whores only trot out stupid, ignorant, credulous, sniveling, despicable little worms, who crawl on their bellies and prattle about how they want to quit smoking.

Throughout history, there have been inquisitions, persecutions, and repressions, and every one of them has been caused by subhuman excrement like the anti-smoker. Their kind are the very essence of evil! We should be proud to go to war against them!

A California psychotic gibbers, "Children are effectively smoking a pack and a half a day for every hour they are exposed to smoke in a car."

And out of respect for these nonsensical ravings, the California State Senate voted 23-14 to ban smoking in cars. The subhuman filth are so irrational they can't figure out that not even a smoker is exposed to a pack and a half a day for every hour they are in a car. (Senate votes to ban smoking in cars carrying young kids. By Steve Lawrence, AP. San Jose Mercury News, Aug. 28, 2006.) SPEWING LIES IS WHAT THE REPUBLICAN AND DEMOCRATIC PARTIES STAND FOR! Al-Qaida has the right plan: smash their putrid culture to rubble!

Senate votes to ban smoking in cars carrying young kids, Aug. 28, 2006 / San Jose Mercury News

The Lasker Syndicate PR Conspiracy The Anti-Smokers' Obsession With Advertising

The anti-smokers' obsession with tobacco industry advertising makes no sense from a practical point of view. After all, plenty of people smoked cigarettes in communist countries where advertising was forbidden. The tobacco industry is clearly not dependent upon advertising for its existence. Their obession actually reflects the anti-smoking movement's insecurity about its own shady origins and dependence on constant hype. Mary Woodard Lasker's husband, Albert D. Lasker, had headed the biggest advertising agency in the world. The American National Business Hall of Fame credits his efforts for Lord and Thomas' success, and acclaims him as "the Founder of Modern Advertising."

Edward L. Bernays

Albert Lasker is given undue credit for supposed advertising genius for his advertising slogan for Lucky Strike cigarettes aimed at women. The story is that 1930s surveys showed that many women didn't buy that brand merely because the green color of the package didn't go with their wardrobes, so, in 1934, advertising huckster Edward L. Bernays set out to make green a fashionable color. "Under the auspices of a local charity, Bernays planned a Green Ball and dispatched a well-connected society matron to the Paris couturiers to coax them into providing green gowns for the event. He convinced a leading textile manufacturer to sponsor a Green Fashions Fall luncheon for fashion editors and invited an art historian and a psychologist to expatiate on the significance of green. He organized a Color Fashion Bureau, which disseminated trends to the press, naturally emphasizing the popularity of the color green."

"Using green paper, he concocted a letter-writing campaign to interior decorators, art-industry groups, department stores and clubwomen describing the sudden 'dominance' of green. He induced department stores to feature green dresses and suits in their window displays, and he persuaded the Reinhardt Galleries to hold a "Green Exhibition" of

paintings. The result of this six-month flurry: green became the hot new color of fashion." (The Lives They Lived: Edward L. Bernays and Henry C. Rogers; The Fathers of P.R. By Neal Gabler. The New York Times 1995 Dec. 31.)

Gabler / The New York Times 1995

Note that Mary Woodard was employed at Reinhardt Galleries, and Paul Reinhardt was her first husband. Furthermore, she was for many years the only art dealer in New York with a degree in art history, and fashion magnate Eleanor Lambert was one of her close friends.

The rest of the story about the Green Ball

The Green Ball was held the night of Oct. 25, 1934, at the Waldorf-Astoria. It was actually a charity benefit for the New York Infirmary for Women and Children. Mrs. Frank A. Vanderlip, the president of the infirmary, was the honorary chairman. Mrs. Harold E. Talbott Jr. was executive chairman, with somewhere between six and ten assistants. Members of the younger set of "Society" posed in scenes from famous paintings, and the Radio City Music Hall ballet entertained at supper. The illustrious box-holders included Mrs. Frank C. Altschul, Mrs. George F. Baker [Jr.], Mrs. Walter P. Chrysler, Mrs. William Randolph Hearst, Mrs. William Goadby Loew [Florence Baker], Mrs. William S. Paley, and Mrs. Alfred P. Sloan. (Society Prepares Gala Green Ball. New York Times, Sep. 30, 1934; 1,000 See Tableaux at the Green Ball. New York Times, Oct. 26, 1934.) It was just one-shot publicity by and for wealthy and connected socialites, and the fashion world promptly returned to normal. (First Night. White Fox on Black Velvet is Liked. By Virginia Pope. New York Times, Nov. 11, 1934.) In 1938, Mrs. Bernays was on the board of the Infirmary, along with Mrs. Frank Altschul, Paul D. Cravath, Mrs. Marshall Field, Mrs. William Randolph Hearst, and Miss Elizabeth Lamont. (Spring Style Show to Help Infirmary. New York Times, Apr. 17, 1938.) Marshall Field's investment banking firm was a financier of Tobacco & Allied Stocks, which eventually took over Philip Morris.

Mrs. Bernays (Doris E. Fleischman) had been involved in recent past fund-raisers for the Infirmary, along with such persons as Mrs. Alan A. Ryan Jr., Mrs. David Sarnoff, and Eleanor Lambert. Their patrons included Mrs. Juan T. Trippe, Mrs. Clendenin J. Ryan, Mrs. W. Goadby Loew, Mrs. August Belmont, and Mrs. William Randolph Hearst. (Two Social Events to Help Infirmary. New York Times, Apr. 15, 1934.) Mrs. Everett Dean Martin was among the Infirmary crowd. (Spring Fête to Aid Infirmary. New York Times, Feb. 26, 1933.) Doris Fleischman, fashion fascist, deplored diversity of style and proclaimed that "You can create fashions by coordinating your ideas, and you can create acceptance of them by coordinating your propaganda," and called for the creation of a "supercontrol" committee to centrally dictate fashions. (Style Curbs Are Urged. New York Times, Oct. 31, 1935.)

Edward L. Bernays had been a member of the American Commission to Negotiate Peace in 1919, some of whom, including Bernays, Frank L. Polk, Bernard M. Baruch, Allen W.

Dulles, and Christian Herter, later organized "a permanent but informal alumni group." (Organize Alumni of 1919 Peace Group. New York Times, Apr. 29, 1929.) Bernays was public relations counsel for the American Committee on Medical Costs, formed to support Secretary of the Interior Ray Lyman Wilbur, which advocated group medical care for the masses. (Prepare to Defend Socialized Medicine. New York Times, Dec. 1, 1932.) Bernays and William Green of the AFL were elected the board of directors of the Arthritis and Rheumatism Foundation, headed by Floyd B. Odlum. (Green, Bernays Elected. New York Times, Dec. 1, 1948.)

Bernays and wife were friends of Prof. James Harvey Rogers of Yale University. (Dinner for Prof. Rogers. New York Times, Oct. 20, 1934.) Rogers was active in the Economic Committee of the League of Nations. (Dinner for Prof. J.H. Rogers. New York Times, Nov. 2, 1935.) They were also friends of cancer researcher Dr. Isabel Knowlton, who was married at their apartment. (Dr. Isabel Knowlton Wed. New York Times, Oct. 14, 1934; Dr. Isabel Knowlton Feted. New York Times, Nov. 14, 1935.) Their daughter, Doris Fleischman Bernays, married Richard M. Held, a teaching fellow in psychology at Harvard who recently received a grant in psychological research from the U.S. Public Health Service. (Doris F. Bernays Married in Home. New York Times, Jun. 30, 1951.)

The ideology of deceit of Bernays and his co-conspirators: "Throughout our conversation, Bernays conveyed his hallucination of democracy: a highly educated class of opinion-molding tacticians are continuously at work, analyzing the social terrain and adjusting the mental scenery from which the public's mind, with its limited intellect, derives its opinions." (PR! A Social History of Spin. By Stuart Ewen, 1996. Chapter 1, Visiting Edward Bernays.) Actually, it is not a hallucination, but a description. It is those who imagine this corrupt system to be a democracy who are deluded. The anti-smoking movement, with its endless stream of smoking prevalence surveys and opinion polls and strategy evaluations and low-brow hate propaganda, illustrates this mentality so crassly and flagrantly that only a drooling imbecile could miss it. Furthermore, these manipulators are not the "highly educated" elite that they fancy themselves, but a bunch of shallow, charlatan-worshiping mediocrities, who use their financial and conspiratorial control to ensure that their lackeys and fellow travelers dominate the scene.

PR! A Social History of Spin / Ewen

"The Power of Public Relations," a discussion between Bernays; host David Suskind; Irwin Ross of the New York Post; and Rodger Tubby, former State Department press officer and press secretary to President Truman. (Radio Reports. for Hill & Knowlton Inc., on "Open End," Dec. 13, 1959, over WNTA-TV, Newark NJ.)

The Power of Public Relations, 1959 / tobacco document

Bernays' support of John Banzhaf's anti-smoking group ASH

Bernays was a longtime sponsor of anti-smoker lawyer John Banzhaf's group, ASH. The group was created to manufacture hate propaganda after Newton Minow stacked the

Federal Communications Commission with cronies from the Ford Foundation, who delivered the infamous "Fairness Doctrine" ruling to subsidize the anti-smokers.

The Fairy Tale of John Banzhaf and the Fairness Doctrine Kloepfer Informational Memorandum, Tobacco Institute, 1968 / tobacco document

John Banzhaf's letter to the Federal Trade Commission, Sep. 20, 1977, with list of Trustees and Sponsors, including Bernays et al.

Banzhaf - ASH letter, 1977 / tobacco document

Bernays is listed as a sponsor of ASH in the group's "Smoking and Health Review," May 1985.

Smoking and Health Review, May 1985 / tobacco document

Bernays participated in the 1981 National Conference on Smoking or Health

Edward L. Bernays was a member of Work Group 8, "Countering Cigarette Advertising and Supporting the Rights of Nonsmokers Through the Media" -- that is how this nest of subhuman vermin mischaracterize their campaign of systematic psychopathic lies and defamations -- of the 1981 National Conference on Smoking or Health.

Work Group 8, NCSH 1981 / tobacco document

Project HOPE

Mrs. Edward L. Bernays and Sen Jacob K. Javits were on the New York Committee for Project HOPE in 1964. Mary Lasker was a member of the Benefit Committee, along with Mrs. and Mrs. William Randolph Hearst Jr.; Hon. and Mrs. Robert B. Meyner (in that year, he was the first and only administrator of the Cigarette Advertising Code); Mrs. William S. Paley; and Mrs. Lowell P. Weicker. Patrons and sponsors of the organization included Mrs. John T. Cahill (wife of Albert Lasker's attorney); the Hearsts; Mary Lasker; Mr. and Mrs. Samuel I. Rosenman; Mrs. Stanley M. Rumbough Jr. (wife of the American Health Foundation trustee); and Mrs. Weicker.

New York Committee for Project HOPE, 1964 / tobacco document Other Committees, Project HOPE / tobacco document

cast 07-08-07

How Tobacco and PR Grew Up Together

http://www.sourcewatch.org/index.php?title=How_Tobacco_and_PR_Grew_Up_Together

The recent public controversy over tobacco companies and their role in misleading the public about the effects of smoking looks remarkably similar to the controversies of 40 years ago.

The first scientific studies documenting tobacco's role in cancer and other fatal illness began to appear in the early 1950s. Internal memos from the industry-funded Tobacco Institute refer to the PR fallout from this discovery as the "1954 emergency."

Fighting desperately for its economic life, the tobacco industry launched what must be considered the costliest, longest-running and most successful PR 'crisis management' campaign in history. In the words of the industry itself, the campaign was aimed at "promoting cigarettes and protecting them from these and other attacks," by "creating doubt about the health charge without actually denying it, and advocating the public's right to smoke, without actually urging them to take up the practice."[1]

Welcome to the 20th Century

The symbiotic relationship between cigarettes and PR goes back even further than the 1950s, to the early 20th century when both were fledgling industries, and the tobacco companies used PR's psychological marketing skills to first 'hook' women and then children to their drug.

Edward Bernays, Ivy Lee and John Hill today are legends within the PR profession. Bernays in particular is often referred to as the "father of PR." All three worked on PR for tobacco, pioneering techniques that today remain the PR industry's stock in trade: third party advocacy, subliminal message reinforcement, junk science, phony front groups, advocacy advertising, and buying favorable news reporting with advertising dollars.

During the Roaring Twenties, the American Tobacco Company turned to PR to develop a vast new market--American women--for sales of its Lucky Strike cigarettes. The company first hired adman A.D. Lasker, whose

advertisements featured female opera stars, their soprano voices somehow unaffected by their love for Luckies.

Lasker portrayed Lucky Strikes as a healthy cigarette by concocting surveys using spurious data to claim that doctors preferred Luckies as the "less irritating" brand. However, his most effective campaign urged women to "Reach for a Lucky instead of a sweet." The campaign increased Lucky sales threefold in just twelve months. (The message, "cigarettes help keep you thin," reverberates today in the brand name Virginia Slims.)

What Do Women Want?

It was Edward Bernays, however, who built both the theoretical and practical foundation of modern public relations, beginning with his promotion of women's smoking. Bernays was a nephew of Sigmund Freud who how to apply psychology on a mass scale while serving on the World War I Committee on Public Information. He never disguised the purpose of PR, saying those "who understand the mental processes and social patterns of the masses ... pull the wires which control the public mind."

On behalf of Lucky Strike, Bernays sought the advice of the psychoanalyst A.A. Brill. Brill's message to Bernays and the American Tobacco company was "freedom": sell cigarettes to women as a symbol of liberation.

Following this advice, Bernays staged a legendary publicity event that is still taught as an example in PR schools. He hired beautiful fashion models to march in New York's prominent Easter parade, each waving a lit cigarette and wearing a banner proclaiming it a "torch of liberty." Bernays made sure that publicity photos of his smoking models appeared world-wide.

To his credit, an older Bernays expressed regret at his work, saying if he'd known of the dangers of tobacco he would have refused the account. His admission and opinion remains rare among PR practioners.

Thanks to Bernays and other early pioneers of public relations, cigarettes built a marketing juggernaut upon an unshakeable identification with sex, youth, vitality and freedom. The work for the tobacco industry, in turn, earned PR widespread credibility and launched the rise of today's multi-billion dollar public relations industry.

Decades of saturation cigarette advertising and promotion continued into the 1950s via billboards, magazine, movies, TV and radio.

The Truth Hurts

In 1952, smoking's link to lung cancer began receiving major media attention. Reader's Digest ran an influential article titled, "Cancer by the Carton." A 1953 report by Dr. Ernst L. Wynder heralded to the scientific community a definitive link between cigarette smoking and cancer. Over the next 24 months, dozen of articles appeared in the New York Times and other major public

publications: Good Housekeeping, the New Yorker, Look, Woman's Home Companion. Sales of cigarettes went into an unusual, sudden decline.

The tobacco czars were in a panic. For help, they turned to John Hill, the founder of the PR megafirm, Hill & Knowlton. Hill designed a brilliant and expensive campaign that the tobacco industry is still using today in its fight to save itself from public rejection and governmental action.

Hill is remembered today as a shrewd but ethical businessman who tried to keep "quacks" out of the PR profession. In a letter, he once stated, "It is not the work of public relations ... to outsmart the American public by helping management build profits."

Yet Hill's work to save tobacco in the 1950s is such an egregious example of "outsmarting the American public ... to build profits" that his company is still in court today answering criminal charges. Hill & Knowlton's role is described as follows in a 1993 lawsuit, State of Mississippi vs. the Tobacco Cartel:

The presidents of the leading tobacco manufacturers ... hired the public relations firm of Hill & Knowlton. ... As a result of these efforts, the Tobacco Industry Research Committee (TIRC), an entity later know as The Council for Tobacco Research (CTR), was formed.

The Tobacco Industry Research Committee immediately ran a full-page promotion in more than 400 newspapers aimed at an estimated 43 million Americans ... entitled "A Frank Statement to Cigarette Smokers."...

In this advertisement, the participating tobacco companies recognized their "special responsibility" to the public, and promised to learn the

facts about smoking and health. The participating tobacco companies promised to sponsor independent research on the subject. ... The participating tobacco companies also promised to cooperate closely with public health officials....

After thus beginning to lull the public into a false sense of security concerning smoking and health, the Tobacco Industry Research Committee continued to act as a front for tobacco industry interests. Despite the initial public statements and posturing, and the repeated assertions that they were committed to full disclosure and vitally concerned, the TIRC did not make the public health a primary concern....

In fact, there was a coordinated, industry-wide strategy designed actively to mislead and confuse the public about the true dangers associated with smoking cigarettes. Rather than work for the good of the public health as it had promised, and sponsor independent research, the tobacco companies and consultants, acting through he tobacco trade association, refuted, undermined, and neutralized information coming from the scientific and medical community.

There is no question that the tobacco industry knew what scientists were learning about tobacco. The TIRC maintained a library with cross-indexed medical and scientific papers from 2,500 medical journals; as well as press clippings, government reports and other documents. TIRC employees culled this library for scientific data with inconclusive or contrary results regarding tobacco and the harm to human health. These were compiled into a carefully selected 18-page booklet, titled "A Scientific Perspective on the Cigarette Controversy," which was mailed to over 200,000 people, including doctors, members of Congress and the news media.

Bringing in the Sheaves

During the 1950s, tobacco companies more than doubled their advertising budgets, going from $76 million in 1953 to $122 million in 1957. The TIRC spent another $948,151 in 1954 alone, of which one-fourth went to Hill & Knowlton, another fourth went to pay for media ads, and most of the remainder went to administrative costs. Despite TIRC's promise to "sponsor independent research," Only $80,000, or less than 10% of the total budget for the year, actually went to scientific projects.

Hill's work on behalf of tobacco was successful. For forty years now, thanks to Hill and the PR industry, the tobacco manufacturers have staved off serious regulation. Even today, as the annual global carnage amounts to millions of tobacco deaths, the modern tobacco barons are sitting pretty.

Sitting pretty? Yes, because smoking's bottom line is that the industry makes more money off tobacco than ever, and is now opening up the vast Asian market to its deadly addiction. The future for tobacco profits are bright, thanks in very large part to public relations.

External links

Scott M. Cutlip, "The Tobacco Wars: A Matter of Public Relations Ethics," Journal of Corporate Public Relations, 1992-93, Volume 3.

Richard W. Pollay, "Propaganda, Puffing and the Public Interest," PR Review, Fall, 1990.

The Doors Of Perception:

Why Americans Will Believe Almost Anything http://www.opednews.com/oshea%20doors_of_perception.htm

by Dr. Tim O'Shea (www.thedoctorwithin.com)

We are the most conditioned, programmed beings the world has ever known. Not only are our thoughts and attitudes cont inually being shaped and molded; our very awareness of the whole design seems like it is being subtly and inexorably erased.

The doors of our perception are carefully and preci sely regulated. Who cares, right?

It is an exhausting and endless task to keep explai ning to people how most issues of conventional wisdom are scientifically im planted in the public consciousness by a thousand media clips per day. In an effort to save time, I would like to provide just a little background on the handling of information in this country.

Once the basic principles are illustrated about how our current system of media control arose historically, the reader might be more apt to question any given story in today's news.

If everybody believes something, it's probably wron g. We call that Conventional Wisdom.

In America, conventional wisdom that has mass accep tance is usually contrived: somebody paid for it. Examples:

• Pharmaceuticals restore health • Vaccination brings immunity • The cure for cancer is just around the corner • When a child is sick, he needs immediate antibiotic s • When a child has a fever he needs Tylenol • Hospitals are safe and clean. • America has the best health care in the world.

• And many many more

This is a list of illusions, that have cost billion s and billions to conjure up. Did you ever wonder why you never see the President speaking publicly unless he is reading? Or why most people in this co untry think generally the same about most of the above issues?

How This Set-Up Got Started

In Trust Us We're Experts, Stauber and Rampton pull together some compelling data describing the science of creating public opinion in America.

They trace modern public influence back to the earl y part of the last century, highlighting the work of guys like Edward L. Bernays, the Father of Spin. From his own amazing chronicle Propaganda, we learn how Edward L. Bernays took the ideas of his famous uncle Sigmu nd Freud himself, and applied them to the emerging science of mass persua sion.

The only difference was that instead of using these principles to uncover hidden themes in the human unconscious, the way Fre udian psychology does, Bernays used these same ideas to mask agendas and to create illusions that deceive and misrepresent, for market ing purposes.

The Father Of Spin

Bernays dominated the PR industry until the 1940s, and was a significant force for another 40 years after that. (Tye) During all that time, Bernays took on hundreds of diverse assignments to create a public perception about some idea or product . A few examples:

As a neophyte with the Committee on Public Informat ion, one of Bernays' first assignments was to help sell the First World War to the American public with the idea to "Make the World Safe for De mocracy." (Ewen)

A few years later, Bernays set up a stunt to popula rize the notion of women smoking cigarettes. In organizing the 1929 Easter P arade in New York City, Bernays showed himself as a force to be reckoned with .

He organized the Torches of Liberty Brigade in whic h suffragettes marched in the parade smoking cigarettes as a mark of women 's liberation. Such publicity followed from that one event that from th en on women have felt secure about destroying their own lungs in public, the same way that men have always done.

Bernays popularized the idea of bacon for breakfast .

Not one to turn down a challenge, he set up the adv ertising format along with the AMA that lasted for nearly 50 years provin g that cigarettes are beneficial to health. Just look at ads in issues of Life or Time from the 40s and 50s.

Smoke And Mirrors

Bernay's job was to reframe an issue ; to create a desired image that would put a particular product or concept in a desi rable light. Bernays described the public as a 'herd that needed to be l ed.' And this herdlike thinking makes people "susceptible to leadership."

Bernays never deviated from his fundamental axiom t o "control the masses without their knowing it." The best PR happens with the people unaware that they are being manipulated.

Stauber describes Bernays' rationale like this:

"the scientific manipulation of public opinion was necessary to overcome chaos and conflict in a democratic society." Trust Us p 42

These early mass persuaders postured themselves as performing a moral service for humanity in general - democracy was too good for people; they needed to be told what to think , because they were incapable of rational thought by themselves. Here's a paragraph from Bernays' Propaganda:

"Those who manipulate the unseen mechanism of socie ty constitute an invisible government which is the true ruling power of our country. We are governed, our minds molded, our tastes formed, our ideas suggested largely by men we have never heard of.

This is a logical result of the way in which our de mocratic society is organized. Vast numbers of human beings must cooper ate in this manner if they are to live together as a smoothly functioning society.

In almost every act of our lives whether in the sph ere of politics or business in our social conduct or our ethical think ing, we are dominated by the relatively small number of persons who understa nd the mental processes and social patterns of the masses. It is they who pull the wires that control the public mind."

Here Comes The Money

Once the possibilities of applying Freudian psychol ogy to mass media were glimpsed, Bernays soon had more corporate clie nts than he could handle. Global corporations fell all over themselve s courting the new Image Makers. There were dozens of goods and services and ideas to be sold to a susceptible public . Over the years, these players have had the money to make their images happen. A few examples:

Philip Morris Pfizer Union Carbide

Allstate Monsanto Eli Lilly

tobacco industry Ciba Geigy lead industry

Coors DuPont Chlorox

Shell Oil Standard Oil Procter & Gamble

Boeing General Motors Dow Chemical

General Mills Goodyear

The Players Though world-famous within the PR industry, the com panies have names we don't know, and for good reason.

The best PR goes unnoticed.

For decades they have created the opinions that mos t of us were raised with, on virtually any issue which has the remotest commercial value, including:

pharmaceutical drugs vaccines

medicine as a profession alternative medicine

fluoridation of city water chlorine

household cleaning products tobacco

dioxin global warming

leaded gasoline cancer research and treatment

pollution of the oceans forests and lumber

images of celebrities, including damage control crisis and disaster management

genetically modified foods aspartame

food additives; processed foods dental amalgams

Lesson #1

Bernays learned early on that the most effective wa y to create credibility for a product or an image was by " independent third-party " endorsement.

For example, if General Motors were to come out and say that global warming is a hoax thought up by some liberal tree-h uggers, people would suspect GM's motives, since GM's fortune is made by selling automobiles.

If however some independent research institute with a very credible sounding name like the Global Climate Coalition com es out with a scientific report that says global warming is really a fiction , people begin to get confused and to have doubts about the original issu e.

So that's exactly what Bernays did. With a policy i nspired by genius, he set up "more institutes and foundations than Rockefelle r and Carnegie combined." (Stauber p 45)

Quietly financed by the industries whose products w ere being evaluated, these "independent" research agencies would churn o ut "scientific" studies and press materials that could create any image their handlers wanted . Such front groups are given high-sounding names l ike:

Temperature Research Foundation Manhattan Institute

International Food Information Council Center for Produce Quality

Consumer Alert Tobacco Institute Research Council

The Advancement of Sound Science Coalition Cato Institute

Air Hygiene Foundation American Council on Science and Health

Industrial Health Federation Global Climate Coalition

International Food Information Council Alliance for Better Foods

Sound pretty legit don't they?

Canned News Releases

As Stauber explains, these organizations and hundre ds of others like them are front groups whose sole mission is to advance t he image of the global

corporations who fund them, like those listed on pa ge 2 above.

This is accomplished in part by an endless stream o f 'press releases' announcing "breakthrough" research to every radio s tation and newspaper in the country. (Robbins) Many of these canned repo rts read like straight news, and indeed are purposely molded in the news f ormat.

This saves journalists the trouble of researching t he subjects on their own, especially on topics about which they know very lit tle. Entire sections of the release or in the case of video news releases, the whole thing can be just lifted intact, with no editing, given the byli ne of the reporter or newspaper or TV station - and voilá! Instant news - copy and paste. Written by corporate PR firms.

Does this really happen? Every single day, since th e 1920s when the idea of the News Release was first invented by Ivy Lee. (Stauber, p 22) Sometimes as many as half the stories appearing in an issue of the Wall St. Journal are based solely on such PR press releases. . (22)

These types of stories are mixed right in with legitimately researched stories . Unless you have done the research yourself, you w on't be able to tell the difference.

The Language Of Spin

As 1920s spin pioneers like Ivy Lee and Edward Bern ays gained more experience, they began to formulate rules and guidelines for creating public opinion . They learned quickly that mob psychology must foc us on emotion, not facts. Since the mob is incapable of r ational thought, motivation must be based not on logic but on presen tation. Here are some of the axioms of the new science of PR:

• technology is a religion unto itself • if people are incapable of rational thought, real d emocracy is

dangerous • important decisions should be left to experts • when reframing issues, stay away from substance; cr eate images • never state a clearly demonstrable lie

Words are very carefully chosen for their emotional impact. Here's an example. A front group called the International Foo d Information Council handles the public's natural aversion to geneticall y modified foods.

Trigger words are repeated all through the text. Now in the case of GM foods, the public is instinctively afraid of these experimental new creations

which have suddenly popped up on our grocery shelve s which are said to have DNA alterations. The IFIC wants to reassure th e public of the safety of GM foods, so it avoids words like:

Frankenfoods Hitler biotech

chemical DNA experiments

manipulate money safety

scientists radiation roulette

gene-splicing gene gun random

Instead, good PR for GM foods contains words like:

hybrids natural order beauty

choice bounty cross-breeding

diversity earth farmer

organic wholesome

It's basic Freudian/Tony Robbins word association . The fact that GM foods are not hybrids that have been subjected to t he slow and careful scientific methods of real crossbreeding doesn't re ally matter. This is pseudoscience, not science. Form is everything and substance just a passing myth. (Trevanian)

Who do you think funds the International Food Infor mation Council? Take a wild guess. Right - Monsanto, DuPont, Frito-Lay, Co ca Cola, Nutrasweet - those in a position to make fortunes from GM foods. (Stauber p 20) Characteristics Of Good Propaganda

As the science of mass control evolved, PR firms de veloped further guidelines for effective copy. Here are some of the gems:

• dehumanize the attacked party by labeling and name calling • speak in glittering generalities using emotionally positive words • when covering something up, don't use plain English ; stall for time;

distract • get endorsements from celebrities, churches, sports figures, street

people - anyone who has no expertise in the subject at hand • the 'plain folks' ruse: us billionaires are just li ke you • when minimizing outrage, don't say anything memorab le, point out

the benefits of what just happened, and avoid moral issues

Keep this list. Start watching for these techniques . Not hard to find - look at today's paper or tonight's TV news. See what they'r e doing; these guys are good!

PAGE 2 http://articles.mercola.com/sites/articles/archive/ 2001/08/15/perception2.aspx

Science For Hire

PR firms have become very sophisticated in the prep aration of news releases. They have learned how to attach the names of famous scientists to research that those scientists have not even loo ked at. (Stauber, p 201)

This is a common occurrence. In this way the editor s of newspapers and TV news shows are often not even aware that an indi vidual release is a total PR fabrication. Or at least they have "deniab ility," right?

Stauber tells the amazing story of how leaded gas c ame into the picture. In 1922, General Motors discovered that adding lead to gasoline gave cars more horsepower.

When there was some concern about safety, GM paid t he Bureau of Mines to do some fake "testing" and publish spurious rese arch that 'proved' that inhalation of lead was harmless. Enter Charles Kett ering.

Founder of the world famous Sloan-Kettering Memoria l Institute for medical research, Charles Kettering also happened to be an executive with General Motors.

By some strange coincidence, we soon have the Sloan Kettering institute issuing reports stating that lead occurs naturally in the body and that the body has a way of eliminating low level exposure.

Through its association with The Industrial Hygiene Foundation and PR giant Hill & Knowlton, Sloane Kettering opposed all anti-lead research for years. (Stauber p 92). Without organized scientific opposition, for the next 60 years more and more gasoline became leaded, until by the 1970s, 90% of our gasoline was leaded.

Finally it became too obvious to hide that lead was a major carcinogen, and leaded gas was phased out in the late 1980s. But du ring those 60 years, it is estimated that some 30 million tons of lead were released in vapor form onto American streets and highways. 30 million tons .

That is PR, my friends.

Junk Science

In 1993 a guy named Peter Huber wrote a new book an d coined a new term. The book was Galileo's Revenge and the term was jun k science. Huber's shallow thesis was that real science supports techn ology, industry, and progress.

Anything else was suddenly junk science. Not surpri singly, Stauber explains how Huber's book was supported by the indu stry-backed Manhattan Institute.

Huber's book was generally dismissed not only becau se it was so poorly written, but because it failed to realize one fact: true scientific research begins with no conclusions. Real scientists are see king the truth because they do not yet know what the truth is .

True scientific method goes like this:

1. Form a hypothesis 2. Make predictions for that hypothesis 3. Test the predictions 4. Reject or revise the hypothesis based on the res earch findings

Boston University scientist Dr. David Ozonoff expla ins that ideas in science are themselves like "living organisms, that must be nourished, supported, and cultivated with resources for making them grow and flourish ." (Stauber p 205)

Great ideas that don't get this financial support b ecause the commercial angles are not immediately obvious - these ideas wi ther and die.

Another way you can often distinguish real science from phony is that real science points out flaws in its own research. Phony science pretends there were no flaws.

The Real Junk Science

Contrast this with modern PR and its constant prete nsions to sound science. Corporate sponsored research, whether it's in the area of drugs, GM foods, or chemistry begins with predetermined co nclusions.

It is the job of the scientists then to prove that these conclusions are true, because of the economic upside that proof will brin g to the industries paying for that research. This invidious approach t o science has shifted the entire focus of research in America during the past 50 years, as any true scientist is likely to admit.

Stauber documents the increasing amount of corporat e sponsorship of university research. (206) This has nothing to do w ith the pursuit of knowledge. Scientists lament that research has beco me just another commodity, something bought and sold. (Crossen)

The Two Main Targets Of "Sound Science"

It is shocking when Stauber shows how the vast majo rity of corporate PR today opposes any research that seeks to protect

• public health • the environment

It's a funny thing that most of the time when we se e the phrase "junk science," it is in a context of defending something that may threaten either the environment or our health.

This makes sense when one realizes that money chang es hands only by selling the illusion of health and the illusion of environmental protection. True public health and real preservation of the earth's environment have very low market value.

Stauber thinks it ironic that industry's self-procl aimed debunkers of junk science are usually non-scientists themselves. (255 ) Here again they can do this because the issue is not science, but the c reation of images.

The Language Of Attack

When PR firms attack legitimate environmental group s and alternative medicine people, they again use special words which will carry an emotional punch:

outraged sound science

junk science sensible

scaremongering responsible

phobia hoax alarmist hysteria

The next time you are reading a newspaper article a bout an environmental or health issue, note how the author shows bias by using the above terms. This is the result of very specialized training .

Another standard PR tactic is to use the rhetoric of the environmentalists themselves to defend a dangerous and untested produ ct that poses an actual threat to the environment. This we see constantly in the PR smokescreen that surrounds genetically modified foo ds.

They talk about how GM foods are necessary to grow more food and to end world hunger, when the reality is that GM foods act ually have lower yields per acre than natural crops. (Stauber p 173)

The grand design sort of comes into focus once you realize that almost all GM foods have been created by the sellers of herbic ides and pesticides so that those plants can withstand greater amounts of herbicides and pesticides. (The Magic Bean)

Kill Your TV?

Hope this chapter has given you a hint to start rea ding newspaper and magazine articles a little differently, and perhaps start watching TV news shows with a slightly different attitude than you h ad before.

Always ask, what are they selling here, and who's s elling it? And if you actually follow up on Stauber & Rampton's book and check out some of the other resources below, you might even glimpse the p ossibility of advancing your life one quantum simply by ceasing to subject your brain to mass media .

That's right - no more newspapers, no more TV news, no more Time magazine or Newsweek. You could actually do that. J ust think what you could do with the extra time alone.

Really feel like you need to "relax" or find out "w hat's going on in the world" for a few hours every day? Think about the n ews of the past couple of years for a minute.

Do you really suppose the major stories that have d ominated headlines and TV news have been "what is going on in the world?" Do you actually think there's been nothing going on besides the contrived tech slump, the contrived power shortages, the re-filtered accounts of foreign violence and disaster, and all the other non-stories that the pu ppeteers dangle before us every day?

What about when they get a big one, like with OJ or Monica Lewinsky or the Oklahoma city bombing? Do we really need to kno w all that detail, day after day? Do we have any way of verifying all that detail , even if we wanted to? What is the purpose of news?

To inform the public? Hardly. The sole purpose of n ews is to keep the public in a state of fear and uncertainty so that they'll watch again tomorrow and be subjected to the same advertising.

Oversimplification? Of course. That's the mark of m ass media mastery - simplicity. The invisible hand. Like Edward Bernays said, the people must be controlled without them knowing it.

Consider this: what was really going on in the worl d all that time they were distracting us with all that stupid vexatious daily smokescreen? Fear and uncertainty -- that's what keeps people coming back for more.

If this seems like a radical outlook, let's take it one step further:

What would you lose from your life if you stopped w atching TV and stopped reading newspapers altogether?

Would your life really suffer any financial, moral, intellectual or academic loss from such a decision?

Do you really need to have your family continually absorbing the illiterate, amoral, phony, uncultivated, desperately brainless values of the people featured in the average nightly TV program? Are the se fake, programmed robots "normal"?

Do you need to have your life values constantly spo on-fed to you?

Are those shows really amusing, or just a necessary distraction to keep you from looking at reality, or trying to figure th ings out yourself by doing a little independent reading?

Name one example of how your life is improved by wa tching TV news and reading the evening paper.

What measurable gain is there for you?

Planet of the Apes?

There's no question that as a nation, we're getting dumber year by year . Look at the presidents we've been choosing lately. Ever notice the blatant grammar mistakes so ubiquitous in today's advertisi ng and billboards?

Literacy is marginal in most American secondary sch ools. Three fourths of California high school seniors can't read well enou gh to pass their exit exams. (SJ Mercury 20 Jul 01)

If you think other parts of the country are smarter , try this one: hand any high school senior a book by Dumas or Jane Austen, and ask them to open to any random page and just read one paragraph out loud. Go ahead, do it. SAT scales are arbitrarily shifted lower and lower to disguise how dumb kids are getting year by year.

At least 10% have documented "learning disabilities ," which are reinforced and rewarded by special treatment and special drugs . Ever hear of anyone failing a grade any more?

Or observe the intellectual level of the average mo vie which these days may only last one or two weeks in the theatres, esp ecially if it has insufficient explosions, chase scenes, silicone, fa ke martial arts, and cretinesque dialogue.

Radio? Consider the low mental qualifications of th e falsely animated corporate simians they hire as DJs -- they're only allowed to have 50 thoughts, which they just repeat at random.

And at what point did popular music cease to requir e the study of any musical instrument or theory whatsoever, not to men tion lyric? Perhaps we just don't understand this emerging art form, right ? The Darwinism of MTV - apes descended from man.

Ever notice how most articles in any of the glossy magazines sound like they were all written by the same guy? And this guy just graduated from junior college? And yet he has all the correct opin ions on social issues, no original ideas, and that shallow, smug, homogenized corporate omniscience, which enables him to assure us that ev erything is going to be fine...

All this is great news for the PR industry - makes their job that much easier. Not only are very few paying attention to the proce ss of conditioning; fewer are capable of understanding it even if somebody ex plained it to them .

Tea In the Cafeteria

Let's say you're in a crowded cafeteria, and you bu y a cup of tea. And as you're about to sit down you see your friend way ac ross the room. So you put the tea down and walk across the room and talk to your friend for a few minutes.

Now, coming back to your tea, are you just going to pick it up and drink it? Remember, this is a crowded place and you've just l eft your tea unattended for several minutes. You've given anybody in that r oom access to your tea.

Why should your mind be any different? Turning on t he TV, or uncritically absorbing mass publications every day - these activ ities allow access to our minds by "just anyone" - anyone who has an agen da, anyone with the resources to create a public image via popular medi a.

As we've seen above, just because we read something or see something on TV doesn't mean it's true or worth knowing. So the idea here is, like the te a, the mind is also worth guarding, worth limiting acc ess to it.

This is the only life we get. Time is our total cap ital. Why waste it allowing our potential, our personality, our values to be sh aped, crafted, and limited according to the whims of the mass panderers?

There are many important issues that are crucial to our physical, mental, and spiritual well-being. If it's an issue where mo ney is involved, objective data won't be so easy to obtain. Remember, if every body knows something, that image has been bought and paid for.

Real knowledge takes a little effort, a little exca vation down at least one level below what "everybody knows."

Cargill From Wikipedia, the free encyclopedia http://en.wikipedia.org/wiki/Cargill

Cargill, Incorporated is a privately held, multinational corporation, and is based in the state of Minnesota in the United States. It was founded in 1865, and has grown into the country's second largest privately held corporation (in terms of revenue).[1] Were it a publicly held company, it would rank in the top 20 companies in the Fortune 500. Cargill's business activities include purchasing, processing, and distributing grain and other agricultural commodities, and the manufacture and sale of livestock feed and ingredients for processed foods and pharmaceuticals. It also operates a large financial services arm, which manages financial risks in the commodity markets for the company. In 2003 it split out a portion of its financial operations into a hedge fund called Black River Asset Management, with about $10 billion of assets and liabilities[1]. It owns 2/3 of the shares of The Mosaic Company, one of the world's leading producers and marketers of concentrated phosphate and potash crop nutrients.

Currently the second largest privately owned company in the United States[2] (behind Koch Industries), Cargill declared revenues of $120 billion USD, and earnings of $3.64 billion USD in the 2008 fiscal year.[3] Employing over 160,000 employees at 1,100 locations in 67 countries[2], it is responsible for 25 percent of all United States grain exports. The company also supplies approximately 22 percent of the United States domestic meat market, exporting more product from Argentina than any other company and is the largest poultry producer in Thailand. All of the eggs used in McDonald's restaurants in the United States pass through Cargill's plants. It is the only producer of Alberger process salt in the U.S.A., which is highly prized in the fast and prepared food industries. It operates a unique (and antique) plant in St. Clair in the Thumb of Michigan.

Despite its size, the corporation is still a family owned business; descendants of the founder (from the Cargill and MacMillan families) own about 85% of the company. This means that most of its growth has been due to reinvestment of the company's own earnings, rather than public financing. Greg Page is the chief executive officer of Cargill who succeeded Warren Staley in mid 2007.

History

Cargill was founded in 1865 by W. W. Cargill when he bought a grain flat house in Conover, Iowa. A year later W.W. was joined by his brother Sam forming W. W. Cargill and Brother. They built grain flat houses and opened a lumberyard. In 1875 W.W. moved to La Crosse, Wisconsin and brother James joined the family business. The city of La Crosse was strategically located at the junction of the Milwaukee Road and the Southern Minnesota Division. Sam left La Crosse in 1887 and moved to Minneapolis to manage the office there, which was identified as an important emerging grain center. Three years later the Minneapolis operation incorporated under Cargill Elevator Co., years after that the La Crosse operation was incorporated under W. W. Cargill Company of La Crosse,

Wisconsin. In 1898 John H. MacMillan, Sr. and his brother Daniel began working for W.W. John Sr. would marry W.W.'s eldest daughter, Edna. Sam's death in 1903 W.W. became the solo own of the La Crosse office. John Sr. was named as general manager of Cargill Elevator Co. and moved his family to Minneapolis. W.W. died in 1909 creating a fiscal crisis for the company. John Sr. worked to resolve the credit issues and to force his brother-in-law, William S. out of the company. The current owners are descended from John Sr. two sons, John H. MacMillan Jr. and Cargill MacMillan Sr., and his youngest brother-in-law, Austen S. Cargill I.

John Sr. ran the company until his retirement in 1936. Under his leadership Cargill grew several fold, expanding out of the Midwest by opening its first East coast offices in New York in 1923 and first Canadian, European and Latin American office in 1928, 1929 and 1930. During this time Cargill saw both record profits and major cash crunches. The first of these crisis was the debt left by the death of W.W. The company issued $2.25 million in Gold Notes, back by Cargill stock to pay off its creditors. The Gold Notes were due in 1917. But thanks for record grain prices caused by World War I all debts were paid back in 1915. As World War I continued into 1917 Cargill made record earning and faced criticisms of war profiteering. Four years later as a fallout from the financial crash of 1920 Cargill posted its first loss.

One of the company's biggest criticisms has been its perceived arrogance. The MacMillans' aggressive management style led to a decades long feud with the Chicago Board of Trade. The feud began in 1934 when Cargill was denied membership by the Board. The U.S. government over turned the Board's ruling and force them to accept Cargill as member. The 1936 corn corp failed and with the 1937 crop unavailable until October, the Chicago Board of Trade ordered Cargill to sell some of its corn. Cargill refused to comply. Cargill was then accused of trying to corner the corn market by the U.S. Commodity Exchange Authority and Chicago Board of Trade. In 1938 the Chicago Board of Trade suspended Cargill and three of its officers trading floor. When the Board lifted its suspension a few years later, Cargill refused to rejoin. Cargill instead traded through independent traders. In 1962 Cargill did rejoin the Chicago Board of Trade, two years after the death of John Jr.

Cargill's quarterly profits crossed $1 billion for the first time during the quarter ending on February 29, 2008 ($1.03 billion); the 86% rise was credited to global food shortages and the expanding biofuels industry that in turn caused a rise in demand for Cargill's core areas of agricultural commodities and technology.[4]

Business Strategy

Cargill's long-term business strategy is to shift its business from trading and processing large volumes of agricultural commodities, to higher margin activities. One of them is the research and development of advanced processing techniques, particularly at its plant in Eddyville, Iowa. For example, in a joint venture with Hoffman-LaRoche, it has developed a process for converting a waste by-product of soybean oil refining into vitamin E. It also produces fuel-grade ethanol, citric acid, and phytosterol esters from

grain. The company intends to work as consultants for its customers to create new ingredients and new food processing methods.

Political and Economic views

Cargill is an active proponent of free trade policies. It lobbied for China's membership in WTO, as well as for increased trade with Cuba and Brazil. Cargill's position is based on its strong support of neo-liberal economic principles. First, lesser trade barriers in countries where Cargill does business will lower prices on Cargill's products, and likely increase their volume of business. Second, the decreases in the cost of food in developing countries theoretically result indirectly in higher income per capita but lower income for local farmers. Cargill benefits from increases in consumer income, because better-paid consumers become inclined to eat a diet higher in wheat, protein, vegetable oil, and processed foods. This improves opportunities for Cargill to sell its products. Cargill's economists have reasoned that this is true of the lower income countries in particular. As a developing country grows from $1,000 to $6,000 in mean income per capita, Cargill expects the greatest profit growth from its businesses in that country.

Cargill has maintained a 100% rating on the Corporate Equality Index (CEI) released by the Human Rights Campaign since 2003.

Countries in Which Cargill Operates

Asia

• Australia • China • India • Indonesia • Japan • Malaysia • Pakistan • Philippines • South Korea • Singapore • Taiwan • Thailand • Vietnam

Africa

• Cote d'Ivoire • Ghana • Kenya • Malawi • Morocco

• Nigeria • South Africa • Tanzania • Zimbabwe

Central America/Caribbean

• Bonaire • Costa Rica • Dominican Republic • Guatemala • Honduras • Nicaragua

Europe

• Austria • Belgium • Denmark • Finland • France • Germany • Greece • Hungary • Ireland • Italy • Netherlands • Poland • Portugal • Romania • Russian Federation • Spain • Sweden • Switzerland • Turkey • Ukraine • United Kingdom

Middle East

• Egypt • United Arab Emirates

North America

• Canada

• Mexico • United States of America

South America

• Argentina • Bolivia • Brazil • Chile • Colombia • Paraguay • Peru • Uruguay • Venezuela

Criticism

Deaths and Injuries

Mercury Poisoning in Iraq

In 1970, Cargill sold 63,000 tons of seed grain to Basra, Iraq. Although banned in many Western countries - Cargill agreed to treat the seed grain with Methylmercury. The shipment was sprayed red to mark its danger and indicate that it was not intended for human or animal consumption but only for use in agriculture. Once it arrived in Iraq in early October however, the surplus seed was given away by the government, and a number of recipients used it as food, since the only printed warnings about the poison were written in English and Spanish, as warnings to American dock workers. This led to the deaths of 93 people.[5]

2007 Beef Recall

In October 2007 Cargill announced the recall of nearly 850 000 frozen beef patties produced at its packing plant in Butler, Wisconsin. The patties, processed between the 9th and 17th of August 2007, were suspected of being contaminated with E. coli. [6] The beef was sold mainly at Walmart and Sam's Club stores.

Human Rights Abuses against Malian Children

In July 2005, the International Labor Rights Fund filed suit against Cargill, Nestle and Archer Daniels Midland in Federal District Court in Los Angeles on behalf of a class of Malian children who were trafficked from Mali into the Ivory Coast and forced to work twelve to fourteen hours a day with no pay, little food and sleep, and frequent beatings. The three children acting as class representative plaintiffs are proceeding anonymously, as John Does, because of feared retaliation by the farm owners where they worked. The

complaint alleges their involvement in the trafficking, torture, and forced labor of children who cultivate and harvest cocoa beans which the companies import from Africa. [7]

Uzbek Cotton

Cargill operates in Uzbekistan despite admissions made by two of its representatives on separate occasions that the company is concerned about the possible use of child labor in the production of its crops. Their concerns have been public since 2005 however they have not yet taken action to investigate or correct any possible labor violations existent in their Uzbek operations. [8]

The Environmental Justice Foundation named Cargill as a major buyer of Uzbek cotton, which is produced widely using uncompensated workers and is implicated in human rights abuses.[9] Cargill claims to have no knowledge of misconduct in either case.

Environmental Damage

Broken Wastewater Pipeline in Australia

June 2007 the Australian operation of Cargill was fined $37,500 (AUD) by the New South Wales Land and Environment Court after a waste water pipeline ruptured in January 2006 which flowed into a stormwater system and into the Bomen wetland[10].

Filling of San Francisco Bay Wetlands

In 2008, an issue has arisen concerning proposed filling of a large marsh and wetland along San Francisco Bay, which had been used by Cargill in its salt operations (Cargill Salt, the former Leslie Salt Company, puchased by Cargill in 1978[11][12]). It has been reported that Cargill Inc. is planning to build a massive development on more than 1,400 acres (5.7 km2) of Bayfront salt ponds in Redwood City. Groups opposing the proposed development are planning action against Cargill on developing on the site.[13] They assert that the wetland should be aggregated into a national wildlife refuge, and not filled.[14][15]

Cargill's supposed policy of only dealing with ethical companies has also been called into question recently after its biggest UK Customer of Oils and Fats, KTC, was discovered to have had 34 illegal immigrants working for them and living in appalling conditions.[16]

In the U.S., anti-GMO activists object to Cargill's marketing of genetically modified (GMO) seeds.[citation needed]

Cargill has been criticized for using contract labor rather than maintaining regular employees. Cargill outsourced a small portion of their information technology operations to Electronic Data Systems or EDS in 2007.[citation needed]

Controversy around Santarém port and Amazon deforestation

In 2003, Cargill completed a port for processing soya in Santarém in the Amazon region of Brazil. The port dramatically increased soya production in the area due to the proximity of easy transport and processing facilities. Although Cargill complied with state legislation, they failed to comply with a federal law requiring an Environmental Impact Statement. In late 2003 Greenpeace launched a campaign claiming the new port sped up deforestation of local rain forest as farmers have cleared land to make way for crops.[3]

In February 2006, the federal courts in Brazil gave Cargill six months to complete an environmental assessment (EA), different from an Environmental Impact Statement (EIS). This ruling came as part of a broader popular backlash against the port; while it was initially supported by locals who hoped for jobs, opinion has turned against it as the jobs have not appeared. In July 2006, federal prosecutor Felicia Pontes Jr. suggested they were close to shutting down the port.[4]

Cargill responded to criticisms of the port by focusing on the need for economic development for the local province, one of the poorest in Brazil. They claimed that "extreme measures" such as closing the port are not necessary because "Soy occupies less than 0.6 percent of the land in the Amazon biome today." They also pointed to their partnership with The Nature Conservancy to encourage farmers around Santarém to comply with Brazilian law that requires 80% of forest to be left intact in forest areas.[5]

In April 2006, Greenpeace released another report criticising Cargill's report for its alleged role in deforestation of the Amazon. The report traced animal feed made from Amazonian soya to European food retailers who bought chicken and other meat raised on the feed. Greenpeace took its campaign to these major food retailers and quickly won agreement from McDonalds along with UK-retailers Asda, Waitrose and Marks & Spencer to stop buying meat raised on Amazonian soya. These retailers in turn put pressure on Cargill and Archer Daniels Midland, Bunge, André Maggi Group and Dreyfus to prove their soya was not grown on recently deforested land in the Amazon.

In July 2006, the Star Tribune newspaper of Minneapolis reported that Cargill had joined other soy businesses in Brazil in enacting a two-year moratorium on the purchase of soybeans from newly deforested land [6].

Damage to Santarem archaeological site

In addition to the criticisms of Cargill lanced in the public lawsuits by a public prosecutor on behalf of the "Ministerio Publico Federal do Brasil", it was stated that Cargill also violated Brazilian law about the preservation of archaeological sites. The city of Santarem and its Port is one of the larger archaeological sites in Brazil, apparently the center of an expansive late prehistoric culture named after the city. According to the suits, the company did not comply with Brazilian law about the necessity of obtaining an archaeological impact statement and any subsequent necessary protection or salvage of

archaeological deposits when it excavated a large area of the Santarem Port site to place some of its soy storage building near the shore.[citation needed]

Cargill has denied that there was any archaeological deposit where it excavated for the foundation of its building but archaeologists working at Santarem under Brazilian government authorizations have reported and photographed archaeological deposits at that site in various years.[citation needed]

The company is also facing its first-ever markets campaign, as the activist group Rainforest Action Network is pressuring Cargill to stop expanding into tropical ecosystems to grow soy and palm oil.[17]

References

1. ^ Forbes.com - The Largest Private Companies 2. ^ The Ten Largest Private Companies - Forbes.com 3. ^ Cargill reports fourth-quarter and fiscal 2008 earnings 4. ^ Matt McKinney, At $471,611 an hour, Cargill posts fine quarter, Star Tribune,

April 15, 2008. 5. ^ Broehl, Wayne G., Jr. (1998) Cargill: Going Global. University Press of New.

England, Hanover, NH. Pages 167-171, 6. ^ Wisconsin Firm Recalls Ground Beef Products Due to Possible E. coli O157:H7

Contamination 7. ^ ADM, Nestle & Cargill Sued for Sourcing Cocoa Beans for Chocolate from

Slave Labor Plantations in Africa 8. ^ Ethical Corporation: Europe - Uzbekistan cotton – A thread of hope in the retail

fabric 9. ^ "The Curse of Cotton: Central Asia's Destructive Monoculture," International

Crisis Group, February 28, 2005, p. 39. http://www.crisisgroup.org/home/index.cfm?id=3294 see also page 2.

10. ^ "Meat processor fined after polluting wetland". Australian Broadcasting Corporation. Retrieved on 2008-03-24.

11. ^ Corporate Profile for Cargill Salt, dated Aug. 21, 1998, Business Wire, August 21, 1998. Accessed online at FindArticle 26 October 2008.

12. ^ Lorna Fernandes, Cargill Salt markets sweet bayfront site, Silicon Valley / San Jose Business Journal, June 28, 1996. Accessed online 26 October 2008.

13. ^ Cargill: Don't Fill San Francisco Bay!, Bay Area News items, Indybay, February 2, 2008. Accessed online 26 October 2008.

14. ^ Cargill: Don't Fill San Francisco Bay, Save The Bay webpage devoted to the issue. Accessed online 26 October 2008.

15. ^ See also Save The Bay's Flickr Photoset. 16. ^ Richard Down, 34 illegal workers found in raid on docks firm, Liverpool Echo

(UK), March 20, 2008. Accessed online 26 October 2008. 17. ^ Rainforest Action Network

CDC Fluoride http://www.enotalone.com/article/10674.html

August 2005 - Tooth decay, also known as dental caries, is a health problem that has plagued humankind for

centuries. Until as recently as 60 years ago, the damage caused by caries was an inevitable fact of life for most

people. The disease often meant many visits to the dentist to have damage and painful teeth repaired or removed.

Today, primarily as a result of fluoride, damage caused by decay can be reduced and, in many instances,

prevented.

Fluoride's benefits for teeth were discovered in the 1930s. Dental scientists observed remarkably low decay rates

among people whose water supplies contained significant amounts of natural fluoride. Several studies conducted

during the 1940s and 1950s confirmed that when a small amount of fluoride is added to the community water

supply, decay rates among residents of that community decrease. Although these studies focused primarily on the

benefits of water fluoridation for children, more recent studies demonstrate that decay rates in adults are also

reduced as a result of fluoride in the drinking water.

Water fluoridation (fluoride in water) prevents tooth decay two ways: primarily through direct contact with teeth

throughout life, and when consumed by children during the tooth forming years. The most inexpensive way to

deliver the benefits of fluoride to all residents of a community is through water fluoridation. All water naturally

contains some fluoride. When a community fluoridates its water, it adjusts the level of fluoride in the water to the

optimal level for preventing tooth decay. Currently, more than 170 million people in the United States using public

water supplies drink water containing enough fluoride to protect teeth.

One of the health objectives contained in Healthy People 2010, the plan that sets health goals for the nation for

the year 2010, calls for at least 75 percent of the population served by community water systems to receive

optimal levels of fluoride. The current level is 67 percent. To reach this goal, approximately 14.3 million more

people must gain access to fluoridated water through public water systems.

Other sources of fluoride are also available. Fluoride can be applied directly to teeth through toothpaste, mouth

rinses, and professionally applied fluoride treatments available in the dental office. Children who have been

evaluated by their dentists as being at high risk for tooth decay and whose home water supplies contain low

amounts of fluoride can take dietary fluoride supplements. This daily supplement, which can be prescribed by a

dentist or a physician, should be taken only by children if the home water supply has been verified to contain a

low concentration of fluoride. These methods of delivering fluoride are more expensive than water fluoridation and

require a conscious decision to use them. However, the widespread availability of fluorides, via water fluoridation,

toothpaste, and other sources, has resulted in the steady decline of dental caries throughout the United States.

The Benefits of Fluoride

Community water fluoridation is an effective, safe, and inexpensive way to prevent tooth decay. This method of

fluoride delivery benefits Americans of all ages and socioeconomic status. Brushing twice a day with a fluoride

toothpaste is an easy way to prevent tooth decay.

Fluoridation, which was started in Grand Rapids, Michigan in 1945, has been used successfully in the United States

for more than 50 years. It benefits both children and adults. Fluoride works by stopping or even reversing the

decay process. It keeps tooth enamel strong and solid.

Community water fluoridation is considered one of 10 great public health achievements of the 20th century. Of the

50 largest cities in the United States, 42 have community water fluoridation (and 2 cities are have natural fluoride

levels that are optimal). Fluoridation reaches 67 percent of the population on public water supplies - more than

170 million people.

The annual cost of fluoridation is approximately $0.50 in communities of ≥ 20,000 to approximately $3.00 per

person in communities ≤ 5,000 (in 1995 dollars) for all but the smallest water systems. Even so, 100 million

Americans do not have access to fluoridated water.

Communities with fluoridated drinking water in the United States, Australia, Britain, Canada, Ireland, and New

Zealand show striking reductions in tooth decay - those with fluoridated drinking systems have 15-40 percent less

tooth decay.

Nearly all tooth decay can be prevented when fluoridation is combined with dental sealants and other fluoride

products, such as toothpaste.

Fluoride dietary supplements can provide fluoride to those who do not have adequate levels in their drinking

water. They are available as tablets, drops, or lozenges.

Over-the-counter fluoride dental products such as toothpastes and mouth rinses are effective in preventing decay.

Products with high concentrations of fluoride that are applied in the dental office or prescribed for home use offer

additional protection for those at increased risk of tooth decay.

Because older Americans are now keeping their teeth longer, fluoride will continue to be important for preventing

tooth decay in this age group. Older Americans are especially susceptible to tooth decay because of exposed root

surfaces and mouth dryness that may result from many medications.

In the United States, water fluoridation is not the only form of fluoride delivery that is effective in preventing tooth

decay in people of all ages. Use the information listed below to compare the other fluoride products that may

lower the risk for tooth decay, especially for people who are at higher risk for decay:

• Fluoride toothpaste

• Fluoride mouthrinse

• Fluoride supplements

• Fluoride gel and foam - professionally applied

• Fluoride varnish

Although all of these products reduce tooth decay, combined use with fluoridated water offers protection greater

than any of these products used alone.

Fluoride Toothpaste

Concentrations of fluoride in toothpaste sold in the United States range from 1,000-1,500 ppm.

Most people report brushing their teeth at least once per day, but more frequent use can offer additional

protection. Fluoride in toothpaste is taken up directly by the dental plaque and demineralized enamel and also

increases the concentration of fluoride in saliva.

Fluoride toothpaste is available over-the-counter and makes up more than 95% of toothpaste sales in the United

States.

For most people (children, adolescents, and adults) brushing at least twice a day with a fluoride toothpaste -

when you get up in the morning and before going to bed - is recommended.

Advice for Parents

For children aged 6 years and younger, some simple recommendations are advised to reduce the risk of enamel

fluorosis. Supervise brushing to discourage swallowing toothpaste. Place only a small pea-size amount of fluoride

toothpaste on your child's toothbrush. Seek advice from a dentist or other health care professional before

introducing fluoride toothpaste to children under 2 years of age.

Fluoride Mouthrinse

Fluoride mouthrinse is a concentrated solution intended for daily or weekly use. The most common fluoride

compound used in mouthrinse is sodium fluoride. Over-the-counter solutions of 0.05% sodium fluoride (230 ppm

fluoride) for daily rinsing are available for use by persons older than 6 years of age. Solutions of 0.20% sodium

fluoride (920 ppm fluoride) are used in supervised, school-based weekly rinsing programs. Other concentrations

also are available.

Rinses are used daily or weekly for a prescribed amount of time. The fluoride from mouthrinse is retained in

dental plaque and saliva to help prevent tooth decay.

Mouthrinses intended for home use can be purchased over-the-counter. Higher strength mouthrinses for those at

high risk of tooth decay must be prescribed by a dentist or physician.

Children younger than 6 years of age should not use fluoride mouthrinse without consultation with a dentist or

other health care provider because enamel fluorosis could occur if such mouthrinses are repeatedly swallowed.

Because fluoride mouthrinse has resulted in only limited reductions in tooth decay among schoolchildren,

especially as their exposure to other sources of fluoride has increased, its use should be targeted to individuals or

groups at high risk for decay.

Fluoride Supplements

Tablets, lozenges, or liquids (including fluoride-vitamin preparations) are available. Most supplements contain

sodium fluoride as the active ingredient. Tablets and lozenges are manufactured with 1.0, 0.5, or 0.25 mg

fluoride.

Fluoride supplements can be prescribed for children at high risk for tooth decay and whose primary drinking water

has a low fluoride concentration. To maximize the topical effect of fluoride, tablets and lozenges are intended to

be chewed or sucked for 1-2 minutes before being swallowed.

All fluoride supplements must be prescribed by a dentist or physician. The prescription should be consistent with

the 1994 dosage schedule developed by American Dental Association (ADA), American Academy of Pediatric

Dentistry (AAPD), and American Academy of Pediatrics (AAP).

For children aged less than 6 years, the dentist, physician, or other health care provider should weigh the risk for

tooth decay without fluoride supplements, the decay prevention offered by supplements, and the potential for

enamel fluorosis. Consideration of the child's other sources of fluoride, especially drinking water, is essential in

determining this balance. Parents and caregivers should be informed of both the benefit of protection against

tooth decay and the possibility of enamel fluorosis (reducing the risk of fluorosis). When practical, supplements

should be prescribed as chewable tablets or lozenges to maximize the topical effects of fluoride.

Fluoride Gel and Foam

Fluoride gel is often formulated to be highly acidic (pH of approximately 3.0). Products available in the United

States include gel of acidulated phosphate fluoride (1.23% [12,300 ppm] fluoride), gel or foam of sodium fluoride

(0.9% [9,040 ppm] fluoride), and self-applied (i.e., home use) gel of sodium fluoride (0.5% [5,000 ppm]

fluoride) or stannous fluoride (0.15% [1,000 ppm] fluoride).

In a dental office, fluoride gel is applied for 1-4 minutes. Home use follows instructions provided on the

prescription.

Most fluoride gel and foam applications are delivered in a dental office by a dental professional. These higher

strength products, if used in the home, must be prescribed by a dentist or physician.

Because these applications are relatively infrequent, generally at 3 to 12-month intervals, fluoride gel poses little

risk for enamel fluorosis, even among patients younger than 6 years of age. Routine use of professionally applied

fluoride gel or foam likely provides little benefit to persons not at high risk for tooth decay, especially those who

drink fluoridated water and brush daily with fluoride toothpaste.

Fluoride Varnish

Varnishes are available as sodium fluoride (2.26% [22,600 ppm] fluoride) or difluorsilane (0.1% [1,000 ppm]

fluoride) preparations.

High-concentration fluoride varnish is painted by dental or other health care professionals directly onto the teeth.

Fluoride varnish is not intended to adhere permanently; this method holds a high concentration of fluoride in a

small amount of material in close contact with the teeth for many hours. Varnishes must be reapplied at regular

intervals with at least 2 applications per year required for effectiveness. All fluoride varnish must be applied by a

dentist or other health care provider.

No published evidence indicates that professionally applied fluoride varnish is a risk factor for enamel fluorosis,

even among children younger than 6 years of age. Proper application technique reduces the possibility that a

patient will swallow varnish during its application and limits the total amount of fluoride swallowed as the varnish

wears off the teeth over several hours.

Although it is not currently cleared for marketing by the Food and Drug Administration (FDA) as an anti-caries

agent, fluoride varnish has been widely used for this purpose in Canada and Europe since the 1970s. Studies

conducted in Canada and Europe have reported that fluoride varnish is as effective in preventing tooth decay as

professionally applied fluoride gel.

About the Author

www.cdc.gov

The Centers for Disease Control and Prevention (CDC) is one of the 13 major

operating components of the Department of Health and Human Services (HHS),

which is the principal agency in the United States government for protecting the

health and safety of all Americans and for providing essential human services,

especially for those people who are least able to help themselves.

Background: Infant Formula and the Risk for Enamel Fluorosis

The proper amount of fluoride from infancy through old age helps prevent and control tooth decay. In a minority of children, fluoride exposure during the ages when teeth are forming (from birth through age 8) also can result in a range of changes within the outer surface of the tooth called enamel fluorosis. Recent evidence suggests that mixing powdered or liquid infant formula concentrate with fluoridated water on a regular basis may increase the chance of a child developing the faint white markings of very mild or mild enamel fluorosis. This occurs on baby and permanent teeth while they are forming under the gums. Once the teeth come into the mouth, they are no longer able to develop this condition. Typically, very mild or mild fluorosis is barely noticeable, if noticed at all. Studies have not shown that teeth are likely to develop more esthetically noticeable forms of fluorosis, even with regular mixing of formula with fluoridated water.

In children younger than 8 years of age, combined fluoride exposure from all sources—water, food, toothpaste, mouth rinse, or other products—contributes to enamel fluorosis. Currently one-third (33%) of children aged 12 to 15 years in the United States have very mild to mild forms of this condition. It is important to understand that some fluoride exposure to developing teeth also plays a long-term role in preventing tooth decay. Parents and health providers should weigh the balance between a child’s risk for very mild or mild enamel fluorosis and the benefit of fluoride for preventing tooth decay and the need for dental fillings.

The possibility of an association between fluoride in infant formula and the risk for enamel fluorosis has been studied for many years. Until now, most researchers concluded that fluoride intake during a child's first 10 to12 months had little impact on the development of this condition in permanent teeth. A recent study, however, has raised the possibility that fluoride exposure during the first year of life may play a more important role on fluorosis development than was previously understood. It now appears that the amount of the fluoride contained in the water used for mixing infant formula may influence a child’s risk for developing enamel fluorosis, particularly if the child’s sole source of nutrition is from reconstituted infant formula.

CDC will continue to assess the science regarding the use of fluoride in preventing tooth decay while limiting enamel fluorosis, and will modify its recommendations as warranted. CDC believes that community water fluoridation is safe and healthy and promotes its use for people of all ages.

• What is the best source of nutrition for infants? • What type of water does CDC recommend for mixing infant formula? • Why is there a focus on infant formula as a source of fluoride? • What types of infant formula may increase the risk for enamel fluorosis? • What is enamel fluorosis? • Should all parents consider mixing formula with water from sources other

than tap water? • How can I find out what the concentration of fluoride is in my tap water? • My city has community water fluoridation (adjusted fluoride in the public

water supply). Is it safe to use this tap water for my baby? • Is all bottled water low in fluoride? • Can mixing formula with optimally fluoridated tap w ater cause moderate or

severe fluorosis? • Are children today at greater risk for developing fluorosis from infant

formula mixed with fluoridated water than children in the past? • Will using only low fluoride water to mix formula eliminate the risk for

fluorosis? • What can be done to reduce my child’s chance of developing fluorosis?

What is the best source of nutrition for infants?

Breastfeeding is ideal for infants. CDC is committed to increasing breastfeeding rates throughout the United States and to promoting optimal breastfeeding practices. Both babies and mothers gain many benefits from breastfeeding. Breast milk is easy to digest and contains antibodies that can protect infants from bacterial and viral infections. More can be learned about this subject at http://www.cdc.gov/breastfeeding/ If breastfeeding is not possible, several types of formula are available for infant feeding. Parents and caregivers are encouraged to speak with their pediatrician about which type of infant formula is best suited for their child.

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What type of water does CDC recommend for mixing infant formula?

Parents should follow the advice of the formula manufacturer and their child’s doctor for the type of water appropriate for the formula they are using. Parents and caregivers of infants fed primarily with formula from concentrate who are concerned about the effect that mixing their infant’s formula with fluoridated water may have in developing enamel fluorosis can lessen this exposure by mixing formula with low fluoride water most or all of the time. This may be tap water, if the public water system is not fluoridated (check with your local water utility). If tap water is fluoridated or has substantial natural fluoride (0.7 mg/L or higher), a parent may consider using a low-fluoride alternative water source. Bottled water known to be low in fluoride is labeled as purified, deionized, demineralized, distilled, or prepared by reverse osmosis. Most grocery stores sell these types of low-fluoride water. Ready to feed (no-mix) infant formula typically has little fluoride and may be preferred for use at least some of the time.

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Why is there a focus on infant formula as a source of fluoride?

Infant formula manufacturers take steps to assure that infant formula contains low fluoride levels—the products themselves are not the issue. Although formula itself has low amounts of fluoride, when infant formula concentrate is mixed with fluoridated water and used as the primary source of nutrition, it may introduce fluoride at levels above the amount recommended to minimize the risk for fluorosis. Infants consume little other than breast milk or formula during the first four to six months of life, and continue to have a high intake of liquids during the entire first year. Therefore, proportional to body weight, fluoride intake from liquids is generally higher for younger or smaller children than for older children, adolescents, or adults. Mixing concentrate with fluoridated tap water on an occasional basis is unlikely to be of much risk. However, when used consistently as the primary source of nutrition over longer periods of the first year, a child may receive enough fluoride to increase his/her chances of developing very mild or mild fluorosis.

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What types of infant formula may increase the risk for enamel fluorosis?

There are three types of formula, including powder, which comes in bulk or single serve packets, concentrated liquid, or ready-to-feed formula. Ready-to-feed formula is more convenient, but also more expensive. Powder formula is usually the least expensive, but requires mixing with water, as does the liquid concentrate.

Ready-to-feed formula contains little fluoride and does not contribute to enamel fluorosis. Those types of formula that require mixing with water—powdered or liquid concentrates—can be the child’s main source of fluoride intake (depending upon the water source) and may contribute to this condition.

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What is enamel fluorosis?

Enamel fluorosis is a hypomineralization of the enamel surface of the tooth that develops during tooth formation. Clinically, this appears as a range of cosmetic changes varying from barely noticeable white lines or spots to pitting and staining of the outer enamel layer. More cosmetically objectionable forms of this condition can occur when young children consume excess fluoride from all sources during critical periods of tooth development. More can be learned about enamel fluorosis at http://www.cdc.gov/fluoridation/safety/enamel_fluorosis.htm.

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Should all parents consider mixing formula with water from sources other than tap water?

There is no evidence that water containing low concentrations of fluoride introduces a risk for enamel fluorosis in the developing teeth of young children. Some tap water and most bottled water contain low concentrations of fluoride. Mixing concentrate with fluoridated tap water on an occasional basis is unlikely to be of much consequence. For infants whose primary nutrition source is formula from concentrates, parents should take into consideration the fluoride concentration in their water source when making decisions about mixing formula.

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How can I find out what the concentration of fluoride is in my tap water?

The best source of information on fluoride levels in your water system is your local water utility. Other knowledgeable sources may be a local public health authority, dentist, dental hygienist, or physician. My Water’s Fluoride on the CDC Web site allows consumers in currently participating states to learn the fluoridation status of their water system. Nearly all tap water contains some natural fluoride, but, depending on the water system, the concentration can range from very low (0.2 mg/L fluoride or less) to very high (2.0 mg/L fluoride or higher). Approximately 67% of all public water systems serving about 170 million people have optimally adjusted fluoride in their water—that is between 0.7 and 1.2 mg/L fluoride.

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My city has community water fluoridation (adjusted fluoride in the public water supply). Is it safe to use this tap water for my baby?

Water fluoridation is safe, effective, and healthy. Water fluoridated at a level optimal for oral health poses no known health risks for infants. However, some children may develop enamel fluorosis, a cosmetic condition. All persons should know whether the fluoride concentration in their primary source of drinking water is below optimal (less than 0.7 mg/L fluoride), optimal (0.7–1.2 mg/L fluoride), or above optimal (greater than 1.2 mg/L fluoride). Use of water below 0.7 mg/L fluoride contributes to a very small risk of developing this condition. The risk increases with an increasing level of fluoride and depends on other factors, such as age and weight of the child and how much formula they drink each day. Knowledge of the fluoride level in the drinking water is also the basis for other individual and professional decisions regarding use of fluoride products by children, such as fluoride toothpaste, mouth rinses, or dietary supplements. In addition, people living in areas where naturally occurring fluoride levels in drinking water are greater than 2 mg/L should consider an alternative water source or home water treatments to reduce the risk of fluorosis for young children. Contact your local water company or utility to learn the fluoride level in your water supply.

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Is all bottled water low in fluoride?

Most bottled water contains low fluoride concentrations; however, much variation exists—some brands may contain optimal or higher levels. Because there currently is no requirement to display the fluoride concentration on bottle labels, you may need to contact the bottler to learn the level of fluoride in bottled drinking water. Certain types of bottled water are, by definition, always low in fluoride and can reliably be used for mixing formula. Water labeled as purified, distilled, deionized, demineralized, or produced through reverse osmosis are always low in fluoride.

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Can mixing formula with optimally fluoridated tap w ater cause moderate or severe fluorosis?

For decades, parents have been mixing infant formula with optimally fluoridated tap water (a level determined by the U.S. Public Health Service between 0.7 mg/L fluoride and 1.2 mg/L fluoride and maintained by your water utility to maximize decay prevention and limit fluorosis potential) and no association has been observed between infant formula use and an increased risk for moderate or severe fluorosis. There is no clear evidence that using infant formula from concentrates as the primary souce of nutrition increases a child’s chances of developing the more severe forms of fluorosis; however, there may be an increased risk for very mild to mild forms.

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Are children today at greater risk for developing fluorosis from infant formula mixed with fluoridated water than children in the past?

Children today are at no greater risk of developing enamel fluorosis from infant formula than children in previous generations. Little has changed with regard to the amount of fluoride consumed or the concentration of fluoride in the formula. There has always been some level of very mild and mild fluorosis in children, but it was thought to be caused by fluoride intake after age one. However, new evidence indicates that fluoride exposure during the first year of life may play a greater role in developing fluorosis than was previously thought, so parents may consider reducing the potential for this condition by limiting fluoride from this source.

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Will using only low fluoride water to mix formula eliminate the risk for fluorosis?

Using only water with low fluoride levels to mix formula will not eliminate the risk of enamel fluorosis. But following such a practice may reduce the chance of fluorosis

occurring. This condition occurs among some children in all communities, even in communities with a low natural concentration of fluoride in the water. Other factors that contribute to developing fluorosis include swallowing of toothpaste and use of dietary supplements that include fluoride (tablets or drops). Learn more about simple steps to take care of children’s teeth. (PDF–170K)

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What can be done to reduce my child’s chance of developing fluorosis?

CDC has developed recommendations to reduce the risk for enamel fluorosis. Remember, fluorosis can only occur during the time of enamel formation, before the teeth come into the mouth. Young children who use multiple sources of fluoride such as fluoride toothpaste, dietary supplements, and water with optimal or higher natural fluoride have a higher risk for this condition. Community water fluoridation is a safe, effective, and inexpensive way to prevent tooth decay, and CDC recommends continuing and extending this practice. Steps can be taken to reduce the potential for enamel fluorosis associated with drinking water and other fluoride products. Learn more about recommendations on how to reduce the risk for enamel fluorosis.

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Date last reviewed: October 8, 2008 Date last modified: August 9, 2007 Content source: Division of Oral Health, National Center for Chronic Disease Prevention and Health Promotion

Page Located on the Web at http://www.cdc.gov/FLUORIDATION/safety/infant_formu la.htm

(CDC) policy on "sensitive but unclassified" information FAS Note: This revised Centers for Disease Control and Prevention (CDC) policy on "sensitive but unclassified" information was posted on the CDC intranet in February 2006. There are several links to the CDC intranet that are embedded in the text below. These links cannot be accessed from outside the CDC. A prior edition of this policy, dated July 2005, may be found here.

CDC has revised the policy titled Sensitive But Unclassified Information. The purpose of this revision is to provide policy and procedures that allow CDC to accomplish its public health mission while safeguarding data and documents that are sensitive enough to require protection but that may not otherwise be designated as classified information. This policy contains guidance on:

• Establishment of coordinating center and national center- and office-level document control officers.

• Policy and procedures for document control officers to review and designate documents as sensitive but unclassified.

• Storage, dissemination, and protection requirements of sensitive but unclassified information.

• Roles and responsibilities regarding implementation of the program.

To go directly to the policy, enter the following [CDC Intranet] URL into the location line of your browser: http://intraspn.cdc.gov/maso/policy/Doc/policy464.htm The Office of Security and Emergency Preparedness is the proponent for this policy. If you have questions or comments about this policy, you may contact policy analyst Tom Jones at 404-498-1516, or send an e-mail message to the CDC Policy e-mailbox. James D. Seligman Chief Information Officer

SENSITIVE BUT UNCLASSIFIED INFORMATION

SECTIONS I. PURPOSE AND SCOPE II. BACKGROUND

III. ACRONYMS AND DEFINITIONS

IV. POLICY

V. RESPONSIBILITIES

VI. PROCEDURES

VII. REFERENCES

VIII. ADDITIONAL RESOURCES

I. PURPOSE AND SCOPE

The purpose of this issuance is to provide policy and procedures that allow the Centers for Disease Control and Prevention (CDC)[1] to accomplish its public health mission while safeguarding data and documents that are sensitive enough to require protection but that may not otherwise be designated as classified information.

This policy applies to all employees, fellows, guest researchers, attached uniformed service members (United States Public Health Service [USPHS] Commissioned Corps, Department of Defense employees, and service members) contractors, subcontractors, or any other individual working at CDC or under the auspices thereof.

II. BACKGROUND

CDC is required by OMB Circular A-130, Management of Federal Information Resources, to

“Protect government information commensurate with the risk and magnitude of harm that could result from the loss, misuse, or unauthorized access to or modification of such information.”

Security programs and procedures already exist to protect classified matters. However, information generally available to the public as well as certain detectable activities may reveal the existence of, and sometimes details about, classified or sensitive information or

undertakings. Such indicators may assist those seeking to neutralize or exploit U.S. Government actions (National Security Decision Directive Number 298). This policy is intended to minimize this risk.

III. ACRONYMS AND DEFINITIONS

A. For the purposes of this policy, the following acronyms apply:

1. CC/CO – coordinating centers and coordinating offices

2. CISO – Chief Information Security Officer

3. DCO – document control officer

4. HHS – Department of Health and Human Services

5. FOIA – Freedom of Information Act

6. ITSO – Information Technology Services Office

7. NC – national center

8. NSDD – National Security Decision Directive

9. OSEP - Office of Security and Emergency Preparedness

10. SDT – HHS Office of Security and Drug Testing

11. SBU – sensitive but unclassified

B. For the purposes of this policy, the following definitions apply:

1. Document control officer

a. NC[2]- and office-level DCO – Employees at the NC or office level who are given responsibility by their NC or office director for the proper maintenance of records related to monitoring, safeguarding, storing, transmitting, and destroying information that is categorized as SBU in compliance with NSDD-189, National Policy on the Transfer of Scientific, Technical, and Engineering Information.

b. CC/CO DCO – Employees at the CC/CO-level who are given responsibility by their CC/CO director to review decisions made and/or to provide guidance to the NC or office DCO level.

c. OSEP DCO – When questions of sensitivity arise that cannot be decided at the NC, office, or CC/CO levels, the OSEP DCO shall serve as the final approval authority. The OSEP DCO shall also be responsible for conducting necessary training related to this policy.

2. Electronic media

Electronic media include magnetic tape reels, disk packs, diskettes, compact discs, removable hard disks, disk cartridges, optical disks, paper tape, reels, magnetic cards, tape cassettes, micro cassettes, videotapes, and any other device on which data are stored and that normally is removable from the system by the user or operator.

3. Exclusion area

An exclusion area is a security area with barriers that identify the boundaries and encompass the designated space and includes access controls and intrusion detection to provide reasonable assurance that only authorized personnel are allowed to enter and exit the area without escort. Access to an exclusion area requires a proximity card, access authorization, and a demonstrated need to know. The CDC’s current and proposed select agent laboratories are designated as exclusion areas.

4. Export controlled information or material

Export controlled information or material is information or material that cannot be released to foreign nationals or representatives of a foreign entity without first obtaining approval or license from the Department of State. This pertains to items controlled by the International Traffic in Arms Regulations or the Department of Commerce and includes items controlled by the Export Administration Regulations. Export controlled information must be controlled as SBU information and marked accordingly.

5. Freedom of Information Act

The law that requires the release of publicly requested information with several exceptions:

a. Exemption 1: Information that is currently and properly classified.

b. Exemption 2: Information that pertains solely to the internal rules and practices of the agency and disclosure of which would allow circumvention of agency regulations.

c. Exemption 3: Information specifically exempted by a statute establishing particular criteria for withholding. The language of the statute must clearly state that the information will not be disclosed.

d. Exemption 4: Information such as trade secrets and commercial or financial information obtained from a company on a privileged or confidential basis that, if released, would result in competitive harm to the company, impair the government's ability to obtain like information in the future, or impair the government's interest in compliance with program effectiveness.

e. Exemption 5: Intra-agency memoranda that are deliberative in nature. This exemption is appropriate for internal documents that are part of the decision-making process and contain subjective evaluations, opinions, and recommendations.

f. Exemption 6: Information that, if released, could reasonably be expected to constitute a clearly unwarranted invasion of the personal privacy of individuals.

g. Exemption 7: Records or information compiled for law enforcement purposes that:

i. could reasonably be expected to interfere with law enforcement proceedings;

ii. would deprive a person of a right to a fair trial or impartial adjudication;

iii. could reasonably be expected to constitute an unwarranted invasion of personal privacy of others;

iv. discloses the identity of a confidential source;

v. discloses investigative techniques and procedures; or

vi. could reasonably be expected to endanger the life or physical safety of any individual.

h. Exemption 8: Certain records of agencies responsible for supervision of financial institutions.

i. Exemption 9: Geological and geophysical information concerning wells.

6. Limited area

A limited area is a security area residing within the property protection area (see definition of property protection areas) with barriers that identify its boundaries and encompass the designated space. The perimeter of a building often defines the boundaries of a limited area. It has access controls and intrusion detection in place to provide reasonable assurance that only authorized personnel are allowed to enter and exit the area without escort. Access to a limited area requires a proximity card and access authorization.

7. Property protection areas

Property protection areas are defined by the outermost perimeter of the CDC facility, and this security area is established to protect against damage, destruction, and theft of CDC-owned property. At the Roybal

site, the perimeter fence establishes the property protection area; it defines the boundaries of the Roybal Campus and controls personnel and vehicle access.

8. Proprietary Information

Proprietary information is information such as trade secrets and commercial or financial information obtained from a company on a privileged or confidential basis that, if released, would result in competitive harm to the company, impair the government's ability to obtain like information in the future, or impair the government's interest in compliance with program effectiveness.

9. Sensitive but unclassified

The “sensitive but unclassified” designation is applied to unclassified information that may be exempt from mandatory release to the public under FOIA. (For the nine FOIA exemptions, see the FOIA definition in this section.) SBU is the formal designation for information that, by law or regulation, requires some form of protection but is outside the formal system of classification, in accordance with Executive Order 12958, as amended.

10. Special exclusion area

A special exclusion area is a security area with barriers that identify its boundaries and encompass the designated space. Further, it includes access controls to provide reasonable assurance that only authorized personnel are allowed to enter and exit the area without escort. Access to a special exclusion area requires a proximity card, access authorization, demonstrated need to know, and intrusion detection. Personnel authorized for access to these areas are required to hold the appropriate level of security clearance.

IV. POLICY

All CDC employees and otherwise affiliated persons shall protect SBU information by following the procedures contained in this policy document and/or related policies of CDC, HHS, Executive Orders, other Presidential Directives, United States Federal Court rulings, and applicable laws of the United States of America.

V. RESPONSIBILITIES

A. Responsibilities of CDC OSEP Director (or the director’s designee) with regard to SBU information

1. Appoint one or more OSEP DCO(s) to implement this policy and procedures.

2. Conduct SBU training.

3. Provide guidance and advice to CC/CO and NC and office DCOs.

4. Form an appeal board, as needed, to render timely judgments concerning appeals to sensitivity determinations.

5. Forward challenges to sensitivity decisions to the SDT.

B. Responsibilities of CC/CO directors (or their designees) with regard to SBU information

Each CC/CO director (or the CC/CO director’s designee) shall appoint one or more CC/CO DCO(s) to review decisions made at the NC or office DCO level and to provide guidance to NC and office DCOs.

C. Responsibilities of NC and office directors (or their designees) with regard to SBU information

Each NC or office director (or the NC or office director’s designee) shall appoint one or more NC or office DCO(s) to review all submitted materials; render a sensitivity determination; and maintain records related to monitoring, safeguarding, storing, transmitting, and destroying information that is categorized as SBU in conformance with NSDD-189, National Policy on the Transfer of Scientific, Technical, and Engineering Information.

D. Responsibilities of NC and office DCO(s) with regard to SBU information

The NC and office DCO(s) shall review all submitted materials and render a sensitivity determination in accordance with this policy and applicable other laws, orders, rules, and regulations. Sensitivity determinations shall be documented in writing. Files will be maintained in accordance with the CDC Records Control Schedule.

NC- and office-level DCOs are responsible for reviewing and approving information for internal release, Web site content, and to clear policies and procedures for posting on the Intranet.

NC- and office-level DCOs are authorized to make sensitivity determinations ensuring that certain information is not for public release, and that information should be marked as SBU. However, any request for

information from the public must be forwarded to the FOIA office for a determination and response.

E. Responsibilities of CC/CO DCO(s) with regard to SBU information

The CC/CO DCO(s) shall review decisions made by the NC or office DCO, as necessary, and will provide guidance to the NC or office DCO, as appropriate.

F. Responsibilities of OSEP DCO(s) with regard to SBU information

The OSEP DCO(s) shall implement this policy and related procedures; conduct necessary training; and provide guidance and advice to CC/CO and NC or office DCOs. When questions of sensitivity arise that cannot be decided upon at the NC, office, or CC/CO level, the OSEP DCO shall serve as the final decision-making authority.

G. Responsibilities of supervisors with regard to SBU information

Supervisors shall ensure that only authorized individuals – as identified in this policy –have access to SBU information. On an annual basis, and more often if necessary, supervisors shall inform their employees of the need to protect SBU information and of the requirement to have all documents that they create that might contain SBU should be sent to the NC- or office-level DCO(s) for a sensitivity determination. Supervisors shall enforce the procedures of this policy among their employees and within the work spaces for which they are responsible. Supervisors shall report suspected or known violations of this policy or procedures to the CC/CO DCO(s) immediately.

H. Responsibilities of employees and affiliated persons with regard to SBU information

Employees and affiliated persons, as provided in Section I of this policy, shall become knowledgeable of this policy and procedures and comply with the requirements established.

I. Responsibilities of CDC FOIA Officer with regard to SBU information

The CDC FOIA Officer shall provide advice, assistance, policy, and technical guidance on FOIA SBU issues to DCOs and management, as needed. The CDC FOIA Officer will obtain a sensitivity determination prior to a final FOIA decision to release or deny CDC records to the public.

J. Responsibilities of CDC CISO with regard to SBU information

The CDC CISO shall provide advice, assistance, policy, and technical guidance on information systems security with emphasis on Federal Information Security and Management Act of 2002, and the Computer Security Act of 1987.

VI. PROCEDURES

The following procedures should be followed with regard to SBU:

A. Review and approval of information prior to public release

The CC/CO and NC- or office-level DCOs are authorized to review and approve information for posting on the CDC Intranet Web site and to make sensitivity determinations to ensure that certain information is not for public release and that the information is marked as SBU.

CC/CO and NC- or office-level DCOs are responsible for establishing submission procedures and making these procedures known to affected personnel.

Marking information SBU does not automatically qualify it for a public release exemption. If a public request for a SBU document is received, the information should be reviewed by the CC/CO DCO to determine if it actually qualifies for exemption. However, only the CDC FOIA Officer is delegated the authority to approve withholding information requested by the public under FOIA.

In reviewing documents, the absence of the SBU or other related marking does not necessarily mean the information should be publicly released. Some types of records (e.g., most human resources and financial information) are not normally marked SBU but may still qualify for withholding under FOIA, unless otherwise authorized for release by the individual. Therefore, all information should be reviewed and approved prior to its public release.

The requirement for a sensitivity review applies equally to hard copy and electronic documents. Electronic documents that require sensitivity review include, but are not limited to, submissions to online publications; documents that are drafted or stored on a publicly accessible home page; and submissions to another Internet site, regardless of site or location.

When any portion of information proposed to be disclosed "might" be covered by a nondisclosure agreement, there must be no steps taken toward public disclosure until written permission from the OSEP DCO is received. This is a lifetime obligation that remains in effect as long as the information remains sensitive.

B. Pre-publication review of Web site content

Information on the Internet may be intended for a limited audience; however, it actually becomes available to a world-wide audience. The World Wide Web was not

designed with security in mind, and unencrypted information is at high risk of compromise. CDC CISO and ITSO guidelines take into account what security access controls, if any, are in effect for specific sites, the sensitivity of the information, and the target audience to which the information is intended.

Most types of SBU information shall not go on a Web site unless that site is protected by encryption.

Before putting unmarked information on a Web site, the information should receive a sensitivity review by the NC or office DCO and/or the CC/CO DCO to which the information belongs. The CC/CO director or the director’s representative may also conduct a review of the information.

CDC sensitivity determinations and classification decisions require that when judgments are made that consideration should be given to the potential consequences of aggregation. The term "sensitive by aggregation" refers to the fact that information on one Web site may seem unimportant, but, when combined with information from other Web sites, it may form a larger and more complete picture than was intended or desired. Similarly, the compilation of a large amount of information together on one site may increase the sensitivity of that information and make it more likely that the Web site will be accessed by those seeking information that can be used against CDC.

Personal information – such as addresses; telephone numbers, other than those readily available to the public; social security numbers; dates of birth; names of family members in biographical summaries, etc. – should not be posted on the Internet.

C. Sensitivity decision and notification

If a sensitivity decision is in question after review by the NC- or office-level DCO and the CC/CO DCO, the decision should be referred by the CC/CO DCO to the OSEP DCO via e-mail or inter-office mail. The OSEP DCO shall issue a decision within 15 working days as to the sensitivity of information of a draft document. If a decision cannot be made, or if it is determined that the information should be classified, the document will be sent to either a security review panel at CDC OSEP and/or forwarded to SDT for a sensitivity determination. The originator will be promptly notified as to the status of the document by the OSEP DCO.

D. Appeal of sensitivity decision

Sensitivity determinations may be appealed by a formal written request via e-mail or inter-office mail from the originator through the affected CC/CO director and sent to the Director of OSEP for a final determination.

E. Categories of SBU Information

Sensitive information consists of any information exempted from FOIA and includes, but is not limited to, information related to personnel, security, and select agents.

Examples include, but are not limited to:

1. Personnel

General personnel information such as evaluation and performance data; security information, including background investigation results and adjudication, and infractions/incident reports; personal information, when associated with an individual’s work on topics where security is involved (e.g., names and details of those working with select agents, classified data, counterintelligence) or with those individuals who are authorized to have a level of access beyond the average CDC employee/contractor/visitor.

2. Security

Facility blueprints and other detailed facility information; databases associated with the physical security system; vulnerabilities of such facilities or sensitive information; network security information; security procedures; access codes (combinations or passwords); badge design information; security audit results; physical security performance test results; results of response force exercises; incident reports and disciplinary actions; response force capabilities; and security plans.

3. Select agents

Databases and lab records associated with the select agent program including, but not limited to, inventory databases and chain of custody records; select agent transfer records; documentation associated with an experiment resulting in an unexpected result banned by 9 CFR § 121.10; and information deemed too sensitive for public release by a review and approval panel.

F. SBU mandatory release exemptions under FOIA

Information in either electronic or hard copy form determined to be SBU must fall within one or more of the nine FOIA exemption categories identified in Section II. B. 5. to be exempt from mandatory release to the public.

G. SBU personnel access requirements

United States citizen direct-hire supervisory employees are responsible for access, dissemination, and release of SBU material. Employees will limit access to protect SBU information from unintended public disclosure.

Employees may circulate SBU materials to others, including non-United States citizens, to carry out an official United States Government function, if not otherwise prohibited by law, regulation, or interagency agreement.

H. SBU safeguarding and storage requirements

1. Protection of SBU information while in use

Reasonable precautions should be taken to prevent access to sensitive information by persons who do not require the information to perform their jobs (e.g., sensitive documents should not be read in a public place or taken home).

2. Storage rules for SBU information

Sensitive information, both in hard copy and electronic form, should be physically protected and should be stored in limited areas. Exclusion areas and special exclusion areas are also acceptable storage locations, but high containment laboratories should only be used as storage areas for sensitive information when absolutely necessary. Storing sensitive information in a property protection area or a public area is only acceptable if additional protections are taken to increase protection to a level comparable to that in a limited area.

All sensitive information existing in hard copy should be stored within a locked container in a limited or exclusion area, an access controlled electronic environment, or under the physical control of an authorized individual. On occasions when an individual is traveling within the United States and limited or exclusion areas are not available, a locked container within a locked room will suffice (e.g., locked briefcase or suitcase within a locked hotel room or vehicle). Sensitive information should not be taken outside the United States.

Information handled electronically and transmitted over the network is at a higher risk of being released or altered. Sensitive information stored on the CDC network should be protected at a level that can ensure that only those who are authorized to view the information are allowed access (e.g., machine-generated passwords, encryption). The CDC network systems should maintain a high level of electronic protection (e.g., firewalls, intrusion detection, defense-in-depth, isolation of sensitive information, good practices network administration) to ensure the integrity of sensitive information and to prevent unauthorized access into these systems. Regular review of the protection methods used and system auditing are also critical to maintain protection of these systems.

The physical elements of the network systems that store and transmit sensitive information or that have direct access to sensitive information should be secured within a limited area or exclusion area. The more central the information resource is (e.g., a network or security system control room), the higher the level of access control that should be applied.

I. SBU marking requirements

Information that has been determined to be SBU should be designated as SBU with the following appropriate markings and labels:

1. Documents

Documents containing sensitive information should be covered with a “Sensitive But Unclassified” cover page, and the outside of the back cover should be marked “Sensitive But Unclassified.”

Internal pages of the document should be marked “Sensitive But Unclassified” at the top and bottom of each page in letters clearly distinguishable from the text. The acronym SBU may be used when space does not permit spelling out “Sensitive But Unclassified.”

The first page should contain the following statement at the lower left hand corner and should be completed with the applicable FOIA exemption number(s):

“Sensitive But Unclassified (SBU) This document contains information that may be

exempt from public release under the Freedom of Information Act (FOIA) (5 U.S.C. 552),exemption(s) ______ apply. Approval by the Centers for Disease Control and Prevention Document Control Officer, Office of Security and Emergency Preparedness, and the CDC FOIA Officer, prior to public release via the FOIA Office is required.“

2. Electronic media

Electronic media containing sensitive information should be labeled “Sensitive But Unclassified.” The label should be plainly visible and should be applied in a way that does not interfere with the drive mechanism. The outer covering for any of the above removable storage media should also be marked “Sensitive But Unclassified.”

Videotapes should also contain “Sensitive But Unclassified” at the beginning and end of the played video, if possible. Audio cassettes, if possible, should contain an audible statement at the beginning and end of the played portion that informs the listener that the tape contains SBU information.

3. Blueprints, engineering drawings, charts, and maps

Blueprints, engineering drawings, charts, and maps containing sensitive information should be marked “Sensitive But Unclassified - Building Information” or "SBU-BI" at the top and bottom of each page. If the blueprints, drawings, charts, or maps are large enough that they are likely to be rolled or folded, “Sensitive But Unclassified - Building

Information” should be placed so that the marking is visible when the item is rolled or folded.

4. Photographs and negatives

Photographs containing sensitive information should be marked “Sensitive But Unclassified” on the face, if possible. If this cannot be done, the marking should be placed on the reverse side. Negatives, positives, or other film containing sensitive information should be marked “Sensitive But Unclassified” on the film itself, if possible; otherwise, it should be protected inside a marked container.

J. Reproduction of SBU information

SBU documents may be reproduced without the permission of the originator to the extent necessary to carry out official CDC activities. Copies should be protected in the same manner as originals. In the event of a copy machine malfunction, the copy machine should be cleared and all paper paths checked for papers containing sensitive information.

K. SBU transfer requirements

1. Communicating sensitive information

Sensitive information may be communicated in the following ways:

From person to person in direct contact with one another; over a land-line telephone; via first class, priority, or overnight mail; via fax machine; via e-mail to and from CDC e-mail addresses that reside completely within the CDC network ([...]@cdc.gov); via e-mail to and/or from an e-mail address outside of the CDC network, provided that the sensitive data is encrypted and authenticated.

2. Discussing sensitive information via telephone or video conference

Although sensitive information may be discussed on landline telephones, sensitive information should not be discussed on cellular phones. Sensitive information should not be transmitted via open network communication channels, including online video conferencing unless such a conference is held on a restricted network.

3. Mailing of sensitive information

Transmission of sensitive information should be done in a manner that informs those with a need-to-know of the level of sensitivity while not advertising the fact to the general public. It is also important to use a reliable means of shipping. These considerations help to avoid unauthorized disclosure or dissemination of sensitive information.

4. Internal mail

Before transmitting sensitive information through the CDC internal mail, the information should have appropriate markings and cover sheet and should be placed in a SBU envelope.

5. External mail

Sensitive information sent outside CDC premises should be transmitted via first class mail, priority, or overnight mail. The outer wrapping should not be marked in a manner that would reveal the contents of the envelope or package to unauthorized personnel.

6. Faxing of sensitive but unclassified Information

Prior to faxing sensitive information, the sender should confirm that an authorized person will be present to accept the transmittal at the receiving end, or the sender should verify that the receiving facility is protected in a manner sufficient to preclude unauthorized access to the transmitted material.

7. Electronic transmission

Sensitive information should be encrypted and authenticated if it is sent from the CDC network to an unsecured (non-CDC) network. Sensitive information should never be communicated over wireless technologies, such as cellular or cordless telephones or wireless data devices (e.g., BlackBerry™ devices).

L. SBU disposal and destruction requirements and methods

Sensitive information should be destroyed by shredding or burning; paper containing sensitive information should not be recycled.

Deleting, erasing, or formatting will not sufficiently remove sensitive information from electronic storage formats. Instead, files should be removed by using multiple passes (10 times minimum) of a hard drive wiping program. Electronic or removable media should be physically damaged to the point of inoperability, via shredding, degaussing, melting, or other such methods before disposal.

M. Enforcement

A violation of this policy may be cause for punitive administrative action, including termination of employment, dismissal, or discharge from USPHS Commissioned Corps. Further civil and criminal prosecution may be sought under one or more of the laws codified in the United States Code of Federal Regulations.

N. Implementation

Marking requirements identified in this policy apply to documents produced after this policy’s implementation date. However, all items, regardless of when they were produced, are subject to the remaining provisions of this policy effective upon the date of this policy’s implementation.

VII. REFERENCES

A. CDC Freedom of Information Policy. March 19, 2002.

B. CDC Records Control Schedule. May 15, 1998.

C. Computer Security Act of 1987, Public Law 100-235 (H.R. 145). January 8, 1988.

D. Executive Order 12958, National Security Information. April 17, 1995.

E. Export Administration Regulations. January 27, 2006.

F. Federal Information Security Management Act of 2002. December 2002.

G. Freedom of Information Act. September 18, 1996.

H. International Traffic in Arms Regulations. April 1, 1992.

I. National Institute of Standards and Technology: Computer Security. July 2003.

J. NSDD-189, National Policy on the Transfer of Scientific, Technical, and Engineering Information. September 21, 1985.

K. United States Code of Federal Regulations (1996-present). February 1, 2006.

VIII. ADDITIONAL RESOURCES

A. Arms Export Control Act. 1994.

B. CDC-IR-2002-06, Protection of Information Resources. CDC, April 2002.

C. CDC-IR-2002-03, Classified Material. CDC, April 2002.

D. CDC-IS-2005-03, Use of CDC Information Technology Resources. CDC, August 2005.

E. CDC-AM-2004-02, Procurement Integrity Restrictions. CDC, February 2004.

F. CDC-GA-2005-06, Clearance Of Information Products Distributed Outside CDC for Public Use. CDC, July 2005.

G. CDC-GA-2000-01, Privacy Act. CDC, November 2000.

H. CDC-GA-2002-02, Freedom of Information Act. CDC, March 2002.

I. CDC-GA-1998-01, Export Controls for Biological, Chemical, and Related Technical Data and Equipment. CDC, June 1998.

J. CDC-GA-2000-02, Federal Advisory Committee Meeting Minutes. CDC, December 2000.

K. CDC-GA-2005-14, CDC/ATSDR Policy on Releasing and Sharing Data. CDC, September 2005.

[1] References to CDC also apply to the Agency for Toxic Substances and Disease Registry (ATSDR).

[2] For ease of reference within policy documents, “NC” will refer collectively to CDC’s national centers, institute, the National Immunization Program, the Office of Genomics and Disease Prevention, and the Agency for Toxic Substances and Disease Registry (an independent Health and Human Services Agency that is led by the CDC director and for which CDC provides administrative services).

Why is the CDC Covering Up a Fifty Year Old Mistake?

by Roger D. Masters, PhD, Professor, Dartmouth College Published on: September 20, 2001

Dartmouth professor, Roger Masters, criticizes the U.S. Centers for Disease Control (CDC) for conspicuously excluding t he name of the fluoride chemicals used to fluoridate most of Ameri ca’s drinking water, while the CDC carefully details the various fluorid e compounds contained in all other dental products mentioned in their recent report “Recommendations for Using Fluoride to Prevent and Control Dental Caries in the United States.” The reason might be t hat the silicofluorides, used by most fluoridating communit ies, hav e never been safety tested in humans or animals. Masters’ recent studies show how silicofluorides can be harming our children -

Controversy over "fluoridating" public water suppli es has been on the agenda for half a century.

Although the specific chemicals in use raise genuin e scientific questions, most proponents (from the Surgeon Genera l to the American Dental Association) and critics talk about "fluorid ation" without discussing the difference between sodium fluoride, familiar in toothpaste, and fluosilicic acid or sodium silicofl uoride (jointly called "silicofluorides"), which are the main chemicals us ed for water fluoridation in the U.S.

Does the difference matter? If so, why does a long- delayed CDC (Centers for Disease Control) report on fluoride tr eatments carefully list the chemicals in fluoridated gels and mouthwash, bu t refuse to mention the chemicals used in our water supplies?

Water fluoridation was begun in the mid 1940's as a ten year experiment to see if drinking-water with sodium fluoride would reduce tooth decay. All tests of safety were conducted on sodium fluori de. In 1950, however, the Public Health Service authorized the substituti on of silicofluorides, even though they had never been tested for effects on health and behavior. Today, over 90% of fluoridated water (del ivered to over 140 million Americans) is treated with one of the silic ofluorides.

The switch to silicofluorides about 50 years ago ma y have been an enormous mistake. Three years of intensive research , supported by the Earhart Foundation, has indicated that

1. Silicofluorides have never been tested for healt h and safety, and the EPA admits it now has no information on the effects of "chronic

exposure" to water treated with them.

2. Silicofluorides do not dissociate completely aft er injection in public water supplies and their biochemical effects are no t benign.

3. Extensive data analysis (based on three large sa mples of over 400,000 children) reveals that where silicofluorides are in use, children absorb significantly higher levels of lead from environmen tal sources (such as old housing).

4. Additional studies show that where silicofluorid es are in use, there are higher rates of behavioral problems that have b een linked to lead toxicity (including hyperactivity and other learnin g disabilities, substance abuse, and violent crime). These findings are based on a "cumulative loading" model of environmental risk fa ctors (for the foregoing see http://www.dartmouth.edu/~rmasters/ahabs...

The CDC and EPA have constantly refused to support objective scientific testing and have apparently engaged in a cover-up of data suggesting toxicity and harmful effects due to sili cofluorides.

The pattern evident in prior reports and funding de cisions is especially noteworthy in the long-delayed CDC report on "Recom mendations for Using Fluroide to Prevent and Control Dental Caries in the United States" (MMWR, Aug. 17, 2001, 50 [RR14] 1-42). This document is silent on the different health and behavioral effects of s ilicofluoride treated water compared to that treated with sodium fluoride .

Although the report identifies the specific chemica ls used to add fluoride to mouth rinse (sodium fluoride), dietary fluoride supplements (sodium fluoride), gel and foam (acidulated phospha te fluoride, sodium fluoride, or stannous fluoride) or fluoride varnish (sodium fluoride or difluorsilane), there is no mention of the specific chemicals used to fluoridate public water supplies or toothpaste (the two principal sources of fluoride for caries control).

Given the foregoing information, informed observers suspect that the CDC intentionally omitted information to "cover up" the fact that silicofluorides, although used in over 90 percent o f water fluoridation in the U.S., have never been subjected to the tests co nducted on sodium fluoride or other health products and medicines. So me CDC personnel know the research questioning silicofluorides, and in one case attended a presentation of research on their dangers.

It is time to discuss openly a toxin that could wel l contribute to higher rates of hyperactivity (ADHD) and crime in many Ame rican communities.

Why should we allow bureaucrats to block discussion of the differences between either fluosilicic acid or sodium silicofluoride (toxic byproducts of manufacturing phosphate fertilizer as well as nu clear fuel and warheads) and sodium fluoride? Since silicofluoride s have never been tested, shouldn't there be a moratorium on their us e until their safety has been proven?

If you live in Manhattan, you can choose non-fluori dated toothpaste but not non-fluoridated tap water.

It's time for Congressional hearings on an issue th at could help our children at virtually no cost (except for lost reve nue to some chemical corporations and embarrassment to the CDC, EPA, and American Dental Association).

For more information about Roger Masters and his wo rk: http://www.dartmouth.edu/~rmasters/ahabs...

Gazette Front Page Water Links

See Gazette Fair Use Policy

2008 Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special

Nutritionals, and Cosmetics)

Special Nutritional Products and Cosmetics:

Aspire36, Aspire Lite Dietary Supplements (posted 03/04/2008) "Blue Steel" and "Hero" Dietary Supplement Products (posted 03/25/2008) Calcilo XD Low-Calcium & Vitamin D-Free Infant Form ula With Iron Powder (posted 06/02/2008) Herbal Science International, Inc. Dietary Herbal S upplements (posted 04/14/2008) Infant Formula Manufactured in China (posted 09/12/2008; UPDATE 09/22/2008) Rize 2 The Occasion Capsules and Rose 4 Her Capsule s (posted 07/02/2008; UPDATE 07/30/2008) Total Body Formula, Total Body Mega Formula (posted 03/28/2008; UPDATED 05/01/2008) Viapro 375mg Capsules (posted 07/31/2008) Viril-ity Power (VIP) Tablets (posted 05/30/2008) Xiadafil VIP Tablets (posted 05/27/2008)

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Drugs and Therapeutic Biological Products (CDER):

2% Chlorhexidine Gluconate Cloth Patient Preoperati ve Skin Preparation Product (posted 06/30/2008) Abacavir (marketed as Ziagen) and Abacavir-containi ng Medications (posted 07/24/2008) Amiodarone (used with simvastatin) (posted 08/08/2008) Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% (posted 09/18/2008) Antiepileptic Drugs (posted 01/31/2008) Antipsychotics, Conventional and Atypical (posted 05/29/2008) Avandia (rosiglitazone maleate) (posted 02/26/2008) Avastin (bevacizumab) (posted 07/14/2008) B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sod ium Chloride Injection Solution (posted 03/21/2008) Bisphosphonates (marketed as Actonel, Actonel+Ca, A redia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa) (posted 01/07/2008) Botox, Botox Cosmetic (Botulinum toxin Type A ), Myobloc (Botulinum toxin Type B) (posted 02/06/2008) Byetta (exenatide) (posted 02/27/2008; UPDATE 08/18/2008) Cardinal Alcohol-Free Mouthwash (posted 05/06/2008; UPDATE 05/19/2008) CellCept (mycophenolate mofetil) (posted 04/10/2008; UPDATE 06/26/2008)

Colchicine, Injectable (including drugs containing colchicine) (posted 02/06/2008) Compounded Menopause Hormone Therapy Drugs (posted 01/10/2008) Cubicin (daptomycin for injection) (posted 04/09/2008) Desmopressin Acetate (marketed as DDAVP Nasal Spray , DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray ) (UPDATED 08/07/2008) Dextroamphetamine Sulfate 5mg Tablets (posted 10/16/2008) Digitek (digoxin tablets, USP) (posted 04/28/2008) Duragesic 25 mcg/hr (fentanyl transdermal system) C II Pain Patches (posted 02/15/2008) Edetate Disodium (marketed as Endrate and generic p roducts) (posted 01/16/2008) Enbrel (etanercept) (posted 05/01/2008) Epoetin alfa - Early Communication about an Ongoing Safety Review (posted 09/26/2008) Erythropoiesis Stimulating Agents: Aranesp (darbepo etin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) (posted 07/31/2008; UPDATED 08/08/2008) Erythropoiesis Stimulating Agents: Aranesp (darbepo etin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) (posted 03/12/2008) Exubera (insulin human rDNA origin) Inhalation Powd er (posted 04/09/2008) Ezetimibe/Simvastatin (marketed as Vytorin), Simvas tatin (marketed as Zocor), and Ezetimibe (marketed as Zetia): Early Co mmunication About an Ongoing Safety Review (posted 08/21/08) Ezetimibe/Simvastatin (marketed as Vytorin), Ezetim ibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Early Communic ation about an Ongoing Data Review (posted 01/25/2008) Fentanyl transdermal system CII Patches (posted 02/19/2008; UPDATED 03/03/2008) Fluoroquinolone Antimicrobial Drugs (posted 07/08/2008) Foradil (formoterol fumarate inhalation powder) Cap sules (posted 02/29/2008) Heparin Sodium USP Pre-Filled Syringes (Posted 04/02/2008) Heparin Sodium Injection (Posted 02/11/2008, UPDATED 02/28/2008, 03/11/2008, 04/29/2008; 05/09/2008; 05/15/2008) Heparin Sodium Injection 1000 units/mL 1OmL and 30 mL Vials (posted 01/19/2008; updated 01/29/2008) Herceptin 440 mg and Herceptin BWFI diluent (posted 07/08/2008) Leukine (sargramostim) (posted 01/19/2008) Long-Acting Hydrocodone-Containing Cough Product (m arketed as Tussionex Pennkinetic Extended-Release Suspension) (posted 03/11/2008; UPDATE 04/24/2008) Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Per flutren Protein- Type A Microspheres for Injection) (posted 07/17/2008)

Mitoxantrone Hydrochloride (marketed as Novantrone and generics) (posted 07/29/2008) MOM Enterprises Mommy's Bliss Nipple Cream (posted 05/29/2008) Morphine Sulfate 60 mg Extended Release Tablets (posted 06/10/2008) Mycophenolate Mofetil [MMF] (marketed as CellCept) (posted 05/16/2008) Mycophenolic Acid [MPA] (marketed as Myfortic) (posted 05/16/2008) Myfortic (mycophenolate acid) (posted 04/10/2008; UPDATED 07/01/2008) Neupro (rotigotine transdermal system) (posted 04/09/2008) NuCel Labs Eye Drops and Eye/Ear Wash Products (posted 01/31/2008) Ortho Evra Contraceptive Transdermal Patch (posted 01/19/2008) Over The Counter Cough and Cold Medications (posted 10/09/2008) Phosphocol P 32 (Chromic Phosphate P 32 Suspension) (posted 09/18/2008) Prezista (darunavir) (posted 03/12/2008; UPDATED 03/21/2008) Raptiva (efalizumab) (posted 10/17/2008) Regranex (becaplermin) Gel (posted 03/27/2008; UPDATED 06/06/2008) Relenza (zanamivir) (posted 04/02/2008) Simvastatin Used With Amiodarone (posted 08/08/2008) Singulair (montelukast) (posted 03/27/2008) Sodium Polystyrene Sulfonate Suspension (posted 07/16/2008) Solodyn (minocycline HCL) Extended Release Tablets 90 mg (posted 05/19/2008) Spiriva (tiotropium bromide inhalation powder) Caps ules (posted 02/29/2008) Tamiflu (oseltamivir phosphate) (posted 03/04/2008) Tarceva (erlotinib) (posted 09/23/2008) Tiotropium (marketed as Spiriva HandiHaler) (posted 03/18/2008; UPDATED 10/07/2008) Trasylol (aprotinin injection) (UPDATE 05/14/2008) Tumor necrosis factor- α blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), a nd Remicade (infliximab) (posted 09/04/2008) Rituxan (rituximab) (posted 09/11/2008) Tumor Necrosis Factor Blockers (marketed as Remicad e, Enbrel, Humira, and Cimzia) (posted 06/03/2008) Tysabri (natalizumab) (posted 08/25/2008) Tysabri (natalizumab) (posted 02/27/2008) Unapproved Over The Counter Drugs Marketed for Prev ention and Treatment of STDs (posted 03/06/2008) Varenicline (marketed as Chantix) (posted 02/01/2008) Videx (didanosine) (posted 03/27/2008) Vivitrol (naltrexone) (posted 08/12/2008) Ziagen (abacavir) (posted 03/27/2008)

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Medical Devices:

Blood Glucose Meters and Test Strips (posted 03/11/2008) Boston Scientific NexStent Monorail (posted 08/14/2008) Chattem Icy Hot Heat Therapy Products (posted 02/11/2008; UPDATED 03/11/2008) Cordis Corporation Dura Star RX and Fire Star RX PT CA Balloon Catheters (posted 01/25/2008; updated 01/28/2008) Denture Cleanser Allergic Reactions and Misuse (posted 02/26/2008) Disposable Battery Operated Lavage System (BOLS) (posted 09/08/2008) Electronic Medical Devices (posted 07/16/2008) Heparin and Normal Saline Pre-Filled Flushes (posted 01/18/2008; updated 01/28/2008, updated 01/30/2008) Heparin Sodium Injection (Baxter) (Posted 02/11/2008, UPDATED 02/28/2008, 03/11/2008, 04/29/2008, 05/09/2008) Levitronix CentriMag Extracorporeal Blood Pumping S ystem: CentriMag Primary Console (with v200 Application Software) (posted 08/01/2008) LifePak CR Plus Automated External Defibrillators (posted 09/11/2008) Medtronic AneuRx Stent Graft System (posted 03/18/2008) Medtronic INDURA 1P Intrathecal Catheter, Sutureles s Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Rev ision Kit (posted 10/02/2008) Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps (posted 03/21/2008) Medtronic SynchroMed EL Implantable Infusion Pump (posted 02/04/2008) Nebion HLX-8 Magnetic Resonance Device (posted 10/03/2008) Pacific Consolidated brand Mobile Oxygen Storage Ta nk (posted 08/28/2008) Radio Frequency Ablation Devices (UPDATE to 12/12/2007 MedWatch notice, posted 09/26/2008) Recombinant Human Bone Morphogenetic Protein in Cer vical Spine Fusion (posted 07/02/2008) Thoratec HeartMate II Left Ventricular Assist Syste m (posted 10/28/2008)

Transvaginal Placement of Surgical Mesh (posted 10/21/2008) Unretrieved Device Fragments (posted 01/15/2008) Vibe Technologies Vibrational Integrated Bio-photon ic Energizer Machine Multi-Frequency Field Generator (posted 10/31/2008)

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2008 Medical Product Safety Alerts, listed in rever se chronological order (most recent first). For an alphabetical listing, r eturn to the categories on this page. You may also search the entire MedWatch site by keyword at

the top of this Safety Information page.

= Adobe Acrobat file (.pdf file), viewed with free Ac robat Reader software. For more information, go to the MedWatch "downloads" page at http://www.fda.gov/MedWatch/getforms.htm

Vibe Technologies Vibrational Integrated Bio-photon ic Energizer Machine Multi-Frequency Field Generator

Audience: Healthcare professionals [Posted 10/31/2008] FDA notified healthcare profess ionals of a Class I Recall of the Vibe Technologies Vibrational Integ rated Bio-photonic Energizer Machine Multi-Frequency Field Generator. This device has not been approved by FDA, lacks safety and effectiv eness data, and is not manufactured under current good manufacturin g practices. The manufacturer has submitted no evidence to FDA t o support any of their claims that the product could treat or cur e such diseases as cancer, depression, infection and pain. Individuals with the device should stop using it immediately and contact the ma nufacturer to make arrangements to return the device. [October 31, 2008 - Recall Notice - FDA]

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Thoratec HeartMate II Left Ventricular Assist Syste m Audience: Cardiologists, cardiovascular surgeons, h ospital risk managers [Posted 10/28/2008] Thoratec Corporation notified h ealthcare professionals of a worldwide correction of the Hear tMate II Left Ventricular Assist System (HM II LVAS), of all seri al numbers (having Catalogue No. 1355 or 102139), distributed since th e beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage tha t could interrupt pump function, require reoperation to replace the p ump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneou s lead damage is 1.3% at 12 months, 6.5% at 24 months, and 11.4% at 36 months. Healthcare professionals with patients supported by a HeartMate II

LVAS should assess the wear and fatigue of the perc utaneous lead and provide proper instruction to patients on the m anagement and care of the lead. [October 24, 2008 - Press Release - FDA]


Transvaginal Placement of Surgical Mesh Audience: Hospital surgical staff, OB/GYN physician s, other healthcare professionals [Posted 10/21/2008] FDA informed healthcare profess ionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (P OP) and stress urinary incontinence (SUI). Over the past three yea rs, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent compl ications included erosion through vaginal epithelium, infect ion, pain, urinary problems, and recurrence of prolapse and/or inconti nence. There were also reports of bowel, bladder, and blood vess el perforation during insertion. In some cases, vaginal scarring a nd mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA pro vided recommended actio ns for both physicians and patients to reduce the risks. [October 21, 2008 - Public Health Notification - FDA]


Raptiva (efalizumab) Audience: Dermatological healthcare professionals, patients [Posted 10/17/2008] FDA notified healthcare profess ionals of extensive labeling changes, including a Boxed Warni ng, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progress ive multifocal leukoencephalopathy and other opportunistic infecti ons with the use of Raptiva. In addition, the prescribing informatio n will be updated to describe a potential risk for the permanent suppres sion of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.

Doctors and other prescribers should carefully eval uate and weigh the risk/benefit profile of Raptiva for patients wh o would be more susceptible to these risks. Health care professiona ls should monitor patients treated with Raptiva for the signs and sym ptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Patients identi fied to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Patients with pre-existing infections or who have a compromised immune system should notify their health care profe ssional before beginning treatment with Raptiva. [October 16, 2008 - News Release - FDA] [October 2008 - Prescribing Information - Genentech]


Dextroamphetamine Sulfate 5mg Tablets Audience: Pharmacists, other healthcare professiona ls, patients [Posted 10/16/2008] Ethex Corp and FDA notified hea lthcare professionals of a voluntary recall of three lots o f Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active i ngredient. Taking a higher than expected dose of Dextroamphetamine Su lfate may be associated with an increased risk of adverse effect s such as tachycardia, hypertension, tremors, decreased appet ite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with a ny questions. [October 15, 2008 - Press Release - Ethex]

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Over The Counter Cough and Cold Medications Audience: Pediatric and primary healthcare professi onals, consumers [Posted 10/09/2008] FDA notified healthcare profess ionals and consumers that the Consumer Healthcare Products Ass ociation (CHPA) is voluntarily modifying the product labels for consumers of

over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inf orm consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of thes e products and to revise its OTC list of approved ingredients and amo unts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompa nies OTC cough and cold medications before giving the product to c hildren, and should consult their healthcare professionals if th ey have any questions or concerns. [October 09, 2008 - News Release - FDA]


Nebion HLX-8 Magnetic Resonance Device Audience: Healthcare professionals, consumers [Posted 10/03/2008] FDA notified healthcare profess ionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Dev ice. The manufacturer of the device made unsupported claims that the product could be used to treat many different medic al conditions and diseases such as cancer (including breast, bone, lu ng, and pancreatic), carpel tunnel syndrome, migraines, pre menstrual syndrome, rheumatoid arthritis, ruptured disks, shi ngles, and sports injuries and sprains. The device was not approved b y FDA, lacked safety and effectiveness data, and was not manufact ured under current good manufacturing practices. Individuals w ith the device should stop using it immediately and contact the ma nufacturer to make arrangements to return the device. [October 03, 2008 - Recall Notice - FDA]

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Medtronic INDURA 1P Intrathecal Catheter Sutureless Pump Connector Revision Kit Intrathecal Catheter Pump Segment Revision Kit

Audience: Physical medicine and rehabilitation spec ialists, anesthesia healthcare professionals, hospital surgi cal service managers [Posted 10/02/2008] Medtronic and FDA notified heal thcare professionals of the Class I Recall of several Medt ronic intrathecal

catheters and intrathecal catheter revision kits us ed with the implanted Medtronic SyncroMed II, SynchroMed EL, an d IsoMed infusion pumps that store and deliver parenteral dr ugs to the intrathecal space. The products were recalled becau se of potential misconnections of the Medtronic Sutureless Connecto r Catheters from the catheter port on the pump. These misconnec tions have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection fro m the pump connector. See the FDA Recall Notice for recommenda tions for healthcare professionals. [October 01, 2008 - Recall Notice - FDA]


Statin drugs and amyotrophic lateral sclerosis (ALS ) Audience: Neurologists, cardiologists, consumers [Posted 09/30/2008] An FDA analysis provides new ev idence that the use of statins does not increase incidence of amyot rophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertake n after the agency received a higher than expected number of re ports of ALS in patients on statins, is based on data from 41 long- term controlled clinical trials. The results showed no increased in cidence of the disease in patients treated with a statin compared with placebo. The FDA is anticipating the completion of a case-co ntrol or epidemiological study of ALS and statin use. Result s from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patient s taking statins. Based on currently available information, health ca re professionals should not change their prescribing practices for s tatins and patients should not change their use of statins. [September 29, 2008 - News Release - FDA]


Epoetin alfa - Early Communication about an Ongoing Safety Review Audience: Neurological healthcare professionals [Posted 09/23/2008] FDA has been made aware of prel iminary safety

findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerab ly higher than the doses recommended for the treatment of anemia as de scribed in the FDA-approved labeling for the product. Over a perio d of ninety days after the start of the trial, there were more death s in the group of patients who received epoetin alfa compared to pati ents who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days af ter starting the drug, with death from intracranial hemorrhage (blee ding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the plac ebo group. FDA anticipates the receipt of additional data with in the next several weeks. As soon as the review of these data is compl ete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients rece iving epoetin alfa in the German trial suggests the need to closely mo nitor patients enrolled in other ongoing trials for adverse outcom es and t o evaluate whether the potential benefits for enrolled patient s outweigh the risks in these trials. [September 26, 2008 - Early Communication about an Ongoing Safety Review - FDA]


Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Audience: Hospital ER and ICU medical and nursing p ersonnel, risk managers [Posted 09/23/2008] Ucyclyd Pharma, Inc. informed h ealthcare professionals of the detection of particulate matte r in the Ammonul Injection product. This particulate matter may impa ct the safe use of Ammonul. To ensure optimal patient care, healthcare providers are being instructed to use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm ) during the admixture process when injecting Ammonul into the 10% Dextrose IV bag. Since this pa rticulate matter may not be readily seen on visual inspection, a fil ter must be employed in all cases regardless of whether particu late matter is seen in the vial. Testing has confirmed the removal of this specific particulate when using this filter to admix Ammonul . Contact Ucyclyd Pharma, 1-888-829-2593, or 1-800-900-6389 - - a representative is available 24 hours, seven days a week. [September 15, 2008 - Letter - Ucyclyd Pharma, Inc.]


Tarceva (erlotinib) Audience: Oncological healthcare professionals [Posted 09/23/2008] OSI and Genentech notified heal thcare professionals that cases of hepatic failure and hep atorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hep atic impairment. Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product sh ould be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range. New information from a pharmacokineti c study in patients with moderate hepatic impairment associate d with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections . [September 2008 - Letter - OSI Pharmaceuticals, Inc. and Genentech, Inc.] [September 12, 2008 - Label - OSI Pharmaceuticals, Inc. and Genentech, Inc.]


Phosphocol P 32 (Chromic Phosphate P 32 Suspension) Audience: Oncologists, other healthcare professiona ls [Posted 09/18/2008] Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety in formation in prescribing Phosphocol P 32. Phosphocol P 32 is app roved for the intracavitary instillation for the treatment of per itoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situation s. Two children (ages 9 and 14) with hemophilia developed acute lym phocytic leukemia approximately 10 months after intra-articu lar injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). This drug is not indicated in the intra-articular treatment of hemar throses. Additionally, post marketing experience identified radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritonea l cavity. Healthcare

professionals should refer to the product's revised prescribing information for updated information regarding the a ppropriate use of Phosphocol P 32. [August 29, 2008 - Letter – Covidien] [August 2008 - Label – Covidien]


Infant Formula Manufactured in China Audience: Consumers, pediatricians [UPDATE 10/03/2008] FDA issued the results of its i nterim safety and risk assessment that evaluated the melamine exposur e in infant formula and in other foods. FDA is currently unable to establish any level of melamine and melamine- related compounds in infant formula that does not raise public health concerns. FDA con tinues to advise consumers not to purchase infant formula manufactur ed in China from internet sites or from other sources and to co ntact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s he alth status. [UPDATE 09/22/2008] FDA contacted companies who man ufacture infant formula for distribution in the United State s and has learned that they are not importing formula or source mater ials from China. FDA, in conjunction with state and local officials, began a nation-wide investigation to check Asian markets for Chine se-manufactured infant formula and have not found Chinese infant fo rmula present on shelves in these markets. FDA is advising consumers not to purchase infant formula manufactured in China from internet sites or from other sources. [Posted 09/12/2008] FDA issued a Health Information Advisory to consumers and healthcare professionals regarding mi lk-based infant formula manufactured in China. The Chinese manufact ured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can cause kidney diseases. Currently, no Chinese manufacturers of infant formu la have fulfilled the requirements to sell this product in the United States. FDA officials are investigating whether or not infant f ormula manufactured in China is being sold in specialty ma rkets which serve the Asian community. Caregivers should not fe ed infant formula manufactured in China to infants and should replace any product from China with an appropriate infant formu la manufactured in the United States. Individuals should contact th eir health care professional if they have questions regarding their infant’s health or

if they note changes in their infant’s health statu s. [October 03, 2008 - News Release - FDA] [September 20, 2008 - Statement - FDA] [September 12, 2008 - News Release – FDA]

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LifePak CR Plus Automated External Defibrillators Audience: Emergency medical personnel, other health care professionals [UPDATE 09/16/2008] Recall classified by FDA as Cla ss I. See the Recall notice for product numbers affected by this recall. [Posted 09/11/2008] Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), us ed by emergency or medical personnel to treat adults in cardiopulmo nary arrest. The product was recalled because the AED instructs the responder by voice prompts to press the shock button which is no t visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be rem oved from service, or the manufacturer-provided diagram shoul d be consulted to remove and discard the shock button cover. [September 11, 2008 - Recall Notice – FDA]


Rituxan (rituximab) Audience: Oncologists, rheumatologists, other healt hcare professionals, consumers [Posted 09/11/2008] Genentech informed healthcare p rofessionals of revisions to prescribing information for Rituxan re garding a case of progressive multifocal leukoencephalopathy (PML) le ading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. The patient d eveloped a JC virus infection with resultant PML and death 18 mon ths after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient pre sentin g with new onset neurologic manifestations. Additionally, cons ultation with a neurologist, brain MRI and lumbar puncture should b e considered as clinically indicated.

[September 2008 - Letter – Genentech] [September 2008 - Label – Genentech, Biogen Idec]


Disposable Battery Operated Lavage System (BOLS) Audience: Operating room, outpatient and emergency room supervisory staff and physicians, risk managers [Posted 09/08/2008] FDA notified healthcare profess ionals about the potential for sparks, fires, toxic fumes, and explo sions when disposable battery operated lavage systems’ (BOLS) cables are cut. BOLS are used in the OR, ER, burn units, and nursin g units. The cutting of the battery pack's cable can lead to a s hort circuit, causing the batteries to discharge rapidly, producing inten se heat and flammable gases with a resulting explosion that exp els flammable gases and toxic chemicals endangering both patients and staff. Recommendations for avoiding this risk are provided in the medical device safety alert. [September 04, 2008 - Medical Device Safety (Reprinted Article) – FDA]

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Tumor necrosis factor- alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), a nd Remicade (infliximab)

Audience: Rheumatological, gastroenterological and infectious disease healthcare professionals [Posted 09/04/2008] FDA notified healthcare profess ionals that pulmonary and disseminated histoplasmosis, coccidio idomycosis, blastomycosis and other opportunistic infections ar e not consistently recognized in patients taking tumor ne crosis factor- α blockers (TNF blockers). This has resulted in delay s in appropriate treatment, sometimes resulting in death. For patien ts taking TNF blockers who present with signs and symptoms of pos sib le systemic fungal infection, such as fever, malaise, weight lo ss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other ser ious systemic illness with or without concomitant shock, healthca re professionals should ascertain if patients live in or have travel ed to areas of endemic mycoses. For patients at risk of histoplas mosis and other invasive fungal infections, clinicians should consi der empiric antifungal treatment until the pathogen(s) are iden tified.

[September 4, 2008 - Information for Healthcare Professionals - FDA] [September 4, 2008 - Press Release - FDA] Previous MedWatch Alerts: [June 3, 2008 ]


Pacific Consolidated brand Mobile Oxygen Storage Ta nk Audience: Emergency healthcare professionals, milit ary emergency/disaster/field hospital/aviation personne l [Posted 08/28/2008] Pacific Consolidated Industries , LLC, and FDA notified healthcare professionals of the Class I Re call of the Mobile Oxygen Storage Tank manufactured and distributed be tween January - March 2007, because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. The mobile oxygen storage ta nk is used in military aircraft for treating wounded patients and in disaster areas to quickly supply oxygen to patients. Facilities wi th the Mobile Oxygen Storage Tank should keep the device in quara ntine until arrangements are made to ship the device back to th e manufacturer. [August 28, 2008 - Recall Notice - FDA]


Tysabri (natalizumab) Audience: Neurologists, other healthcare profession als, patients [Posted 08/25/2008] FDA informed healthcare profess ionals of two new cases of progressive multifocal leukoencephalop athy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year. PML, which is usu ally fatal, is a known risk of Tysabri treatment, but previous cases in patients with multiple sclerosis were seen in combination with ot her immunomodulatory therapies. Approximately 39,000 pa tients have received treatment with Tysabri worldwide, with app roximately 12,000 patients receiving treatment for a least one year. No new cases have been seen in the US, where about 7,500 p atients have received the drug for greater than one year and app roximately 3,300 patients have received the drug for at least one an d one- half years. In the U.S., Tysabri is available only to patients wit h relapsing multiple

sclerosis or Crohn's disease who are enrolled in th e risk minimization plan called the TOUCH Prescribing Program. Under this program, every Tysabri-treated patient is closely m onitored and followed for the occurrence of PML and other seriou s opportunistic infections. While the two patients who developed PM L were on monotherapy, the FDA still believes that Tysabri mo notherapy may confer a lower risk of PML than when Tysabri is use d together with other immunomodulatory medications. Prescribing inf ormation for Tysabri will be revised to include information info rming prescribers and patients that cases of PML have occurred in pat ients taking Tysabri as monotherapy. Healthcare professionals sh ould continue to monitor patients for sign and symptoms of PML. A dditionally, Tysabri should not be infused if PML is suspected. [August 25, 2008 - Information for Healthcare Professionals - FDA] Previous MedWatch Alert: [February 27, 2008 ]


Ezetimibe/Simvastatin (marketed as Vytorin) Simvastatin (marketed as Zocor) Ezetimibe (marketed as Zetia)

Audience: Endocrinologists, cardiologists, other he althcare professionals, patients [Posted 08/21/2008] FDA informed healthcare profess ionals that the Agency is investigating a report from the Simvastat in and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible assoc iation between the use of Vytorin and a potentially increased incidenc e of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the li ver and inhibit the absorption of cholesterol in the intestine to reduc e LDL-cholesterol levels and reduce the risk of cardiovascular events . Recently, FDA obtained preliminary results from the SEAS trial. T he clinical trial tested whether lowering LDL-cholesterol with Vytori n would reduce the risk of cardiovascular events in individuals wi th aortic stenosis. A lower overall cardiovascular risk was not found w ith Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were di agnosed with and died from all types of cancer combined when compare d to placebo during the 5-year study.

FDA anticipates receiving a final SEAS study report in about 3

months and the Agency's review and evaluation of th e clinical trial data and other relevant information should take app roximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare profession als and caregivers should continue to monitor patients taki ng Vytorin and report side effects from the use of this drug to th e Agency. [August 21, 2008 - Early Communication about an Ongoing Safety Review - FDA] Previous MedWatch Alerts: [January 25, 2008 ]


Boston Scientific NexStent Monorail NexStent Carotid Stent and Monorail Delivery System

Audience: Cardiologists, hospital risk managers [Posted 08/14/2008] Boston Scientific and FDA infor med healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System , distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery dise ase. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This co uld lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. This recall does not affect stents that have already been implanted. Pat ients should contact their healthcare professional if they have any questions. [August 14, 2008 - Recall Notice - FDA]


Vivitrol (naltrexone) Audience: Primary healthcare physicians, internists, other he althcare professionals [Posted 08/12/2008] FDA informed healthcare profess ionals of the risk of adverse injection site reactions in patient s receiving naltrexone. Naltrexone is indicated for the treatme nt of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment . Naltrexone is administered as an intramuscular gluteal injection and should not be

administered intravenously, subcutaneously, or inad vertently into fatty tissue. Physicians should instruct patients t o monitor the injection site and contact them if they develop pai n, swelling, tenderness, induration, bruising, pruritus, or redn ess at the injection site that does not improve or worsens within two we eks. Physicians should promptly refer patients with worsening injec tion site reactions to a surgeon. Read the FDA recommendation s for healthcare professionals to consider regarding the use of Naltrexone injection. [August 12, 2008 - Drug Information Page - FDA] [August 12, 2008 - Information for Healthcare Professionals - FDA]


Simvastatin Used With Amiodarone Audience: Cardiologic healthcare professionals, pha rmacists, other healthcare professionals [Posted 08/08/2008] FDA notified healthcare profess ionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. Th is risk is dose-related and increases when a dose of simvastatin gre ater than 20 mg per day is given with amiodarone. Although a revisi on of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvas tatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently wit h amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone. [August 08, 2008 - Drug Information Page - FDA] [August 08, 2008 - Information for Healthcare Professionals - FDA] [Labels - Simvastatin - DailyMed] [Labels - Amiodarone - DailyMed]


Levitronix CentriMag Extracorporeal Blood Pumping S ystem: CentriMag Primary Console (with v200 Application Software)

Audience: Cardiothoracic healthcare professionals, perfusionists, hospital risk managers, biomedical e ngineers [Posted 08/01/2008] Levitronix and FDA notified hea lthcare

professionals of a Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & B ackup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland and distributed from January, 2001 through March, 2 008. The Blood Pumping System is used to provide short-term extrac orporeal circulatory support during cardiac and other types of surgeries. This device temporarily replaces the function of the hea rt and lungs in order to maintain the appropriate circulation of bl ood and oxygen levels in the body during the surgical procedure. A July 24, 2008 Levitronix device correction letter informed physic ians not to use Valleylab Force FX-C or SSE2L electrosurgery device s with the CentriMag Blood Pumping System because use may resu lt in stoppage of the pump and may cause serious injury o r death. This recall action is an interim fix while the firm furt her investigates the source of the problem. [August 01, 2008 - Recall Notice - FDA] [July 24, 2008 - Letter - Levitronix]


Viapro 375mg Capsules Audience: Consumers, healthcare professionals [Posted 07/31/2008] EG Labs, LLC, notified consumer s and healthcare professionals not to buy or use Viapro 3 75mg Capsules because one lot of the product was found to contain a potentially harmful undeclared ingredient, thio-methisosildenaf il, an analog of sildenafil, a FDA approved product used to treat er ectile dysfunction in men to enhance sexual performance. The undeclare d ingredient may interact with nitrates found in some prescripti on drugs (such as nitroglycerin) and can lower blood pressure to dang erous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrat es. Consumers who have this product should discontinue using it a nd consult their healthcare professional if they experience any prob lems that may be related to taking Viapro. [July 23, 2008 - Press Release - FDA]


Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Ara nesp)

Audience: Oncologists, other healthcare professiona ls [Posted 07/31/2008] FDA informed healthcare profess ionals of

modifications to certain sections of the Boxed Warn ings, Indications and Usage, and Dosage and Administration sections o f prescribing information for Erythropoiesis Stimulating Agents ( ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosi ng to state the hemoglobin level at which treatment with an ESA sho uld be initiated. Additional revisions to prescribing information tha t ESAs are not intended for use in patients receiving myelosuppres sive therapy when the expected outcome is cure and when to initi ate and discontinue ESA dosing will be forthcoming. FDA con tinues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, th e benefits of treatment with ESAs and the potential and demonstra ted risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival t ime. [August 7, 2008 - Letter - Amgen, Ortho Biotech] [July 30, 2008 - Follow Up to Ongoing Safety Review - FDA] [July 30, 2008 - Label - Aranesp] [July 30, 2008 - Label - Procrit] [July 30, 2008 - Label - Epogen]

Previous MedWatch Alerts:

[03/12/2008] [01/03/2008]


Mitoxantrone Hydrochloride (marketed as Novantrone and generics) Audience: Neurological and Oncological healthcare p rofessionals, risk managers [Posted 07/29/2008] FDA reminded health care profes sionals who treat patients with mitoxantrone about recommendati ons that left ventricular ejection fraction (LVEF) be evaluated b efore initiating treatment and prior to administering each dose of m itoxantrone. FDA offered additional recommendations for cardiac moni toring to detect late-occurring cardiac toxicity, and provided infor mation for patients with multiple sclerosis who receive the drug.

These recommendations were established in 2005 in r esponse to postmarketing reports and case reports in the medical l iterature that described decreases in LVEF or frank congestive hea rt failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m 2. Since that time, FDA has received information from a post-marketing safe ty study that

demonstrated there is poor adherence to these recom mendations in clinical practice. FDA is working with the manufact urers to educate healthcare providers to adhere to cardiac monitorin g recommendations for patients with MS.

[July 29, 2008 - Information for Healthcare Professionals - FDA] [March 2005 - Label - Novantrone - Serono, Inc.]


[05/24/2005]


Abacavir (marketed as Ziagen) and Abacavir-containi ng Medications Audience: Infectious disease and medical genetics h ealthcare professionals [Posted 07/24/2008] FDA informed healthcare profess ionals that serious and sometimes fatal hypersensitivity reacti ons (HSR) caused by ab acavir therapy are significantly more common in pat ients with a particular human leukocyte antigen (HLA) allele, HL A-B*5701. FDA reviewed data from two studies that support a recom mendation for pre-therapy screening for the presence of the HLA-B *5701 allele and the selection of alternative therapy in positive su bjects. Genetic tests for HLA-B*5701 are available and all patients shoul d be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Develo pment of clinically suspected abacavir HSR requires immediat e and permanent discontinuation of abacavir therapy in al l patients, including patients negative for HLA-B*5701. [July 24, 2008 - Information for Healthcare Professionals - FDA]


Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Per flutren Protein- Type A Microspheres for Injection)

Audience: Radiological healthcare professionals, ca rdiologists, hospital risk managers [Posted 07/17/2008] FDA is updating healthcare prof essionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing infor mation for micro-bubble contrast agents, a sterile suspension of per flutren gas microspheres, indicated for use in certain patients with suboptimal

echocardiograms, to opacify the left ventricular ch amber and to improve the delineation of the left ventricular end ocardial border.These changes reflect conclusions of FDA rev iews of information received following the addition of new Contraindications and Warnings in October 2007. The revised Boxed War ning and Warnings highlight the risk of serious cardiopulmon ary reactions during or within 30 minutes following the administr ation of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post a dministration of these contrast agents. In addition, several of the Contraindications that were added to the labeling in October, 2007 we re removed because FDA determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopul monary reactions, even among some patients at particularly high risk for these reactions. [July 17, 2008 - Information for Healthcare Professionals - FDA] [June 2008 - Dear Healthcare Professional Letter - GE] [May 2008 - Dear Healthcare Professional Letter - Lantheus Medical Imaging]


[10/12/2007]


Electronic Medical Devices Audience: Radiologists, surgeons, hospital risk man agers, other healthcare professionals [Posted 07/16/2008] FDA informed healthcare profess ionals of the possibility that x- rays used during CT examinations may cause some implanted and external electronic medical devices t o malfunction. Most patients with electronic medical devices under go CT scans without any adverse consequences. However, the Agen cy has received a small number of reports of adverse event s in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and i mplanted or externally worn drug infusion pumps. FDA is continu ing to investigate the issue and is working with the manuf acturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event rep orts and recommendations regarding reducing the potential ri sk to patients.

[July 14, 2008 - Public Health Notification - FDA]


Sodium Polystyrene Sulfonate Suspension Audience: Pharmacists, hospital risk managers, othe r healthcare professionals [Posted 07/16/2008] Roxane Laboratories, Inc. infor med healthcare professionals of the recall of two lots of Sodium P olystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bot tles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693 A Exp May 2010), a product used to treat hyperkalemia. A sample of o ne of the affected lots tested positive for a strain of yeast, which c ould potentially affect immunocompromised patients. Symptoms of a ye ast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their phys ician. Pharmacists should determine if any of the referenc ed product has been dispensed and retrieve it. Additionally, pharm acists and wholesalers of the product should discontinue distr ibution and use of the referenced lots immediately and contact the manufacturer regarding returning the product. [July 14, 2008 - Recall - Roxane Laboratories, Inc.]


Avastin (bevacizumab) Audience: Oncologists, other healthcare professiona ls [Posted 07/14/2008] Genentech, Inc. informed health care professionals of reports of several cases of microa ngiopathic hemolytic anemia (MAHA) in patients with solid tumo rs receiving Avastin in combination with sunitinib malate. Avast in is not approved for use in combination with sunitinib mala te and this combination is not recommended. Twenty- five patients were enrolled in a Phase I dose-escalation study combining Avasti n and sunitinib malate. The study consisted of 3 cohorts using a fi xed dose of Avastin at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe wit h evidence of thrombocytopenia, anemia, reticulocytosis, reductio ns in serum haptoglobin, schistocytes on peripheral smear, mode st increases in serum creatinine levels, and severe hypertension, r eversible posterior leukoencephalopathy syndrome, and protein uria. The

findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional in terventions. Healthcare professionals should report cases of MAH A or any serious adverse events suspected to be associated w ith the use of Avastin. [July 11, 2008 - Dear Healthcare Professional Letter - Genentech]


Herceptin 440 mg Vials and BWFI Diluent Audience: Healthcare professionals [Posted 07/10/2008] Genentech informed healthcare p rofessionals that an increased number of complaints were receive d regarding damaged and broken vials of Herceptin 440 mg and BW FI (bacteriostatic water for injection) diluent. The a ffected vials are NDC# 50242-0134-68, List # 15534. There is a risk t hat damaged vials may lead to a loss in sterility, which can cause in fections in patients. Healthcare professionals should inspect cartons of the product for signs of leakage, cracks and other damage to the vi als, observe the vials during reconstitution, and check for loss of vacuum in the vials. See the manufacturer's letter for specific details and recommendations, including instructions in the even t a compromised vial is discovered. [June 28, 2008 - Dear Healthcare Professional Letter - Genentech]


Fluoroquinolone Antimicrobial Drugs Audience: Healthcare professionals, consumers [Posted 07/08/2008] FDA notified healthcare profess ionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warn ings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use. Fluoroquinolones are associated with an increased r isk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipient s, and with use of concomitant steroid therapy. Physicians should advi se patients, at the first sign of tendon pain, swelling, or inflamm ation, to stop taking the fluoroquinolone, to avoid exercise and use of t he affected area, and to promptly contact their doctor about changing to a non-

fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection sho uld be limited to those conditions that are proven or strongly suspec ted to be caused by bacteria. [July 08, 2008 - Drug Information Page - FDA] [July 08, 2008 - Information for Healthcare Professionals - FDA] [July 08, 2008 - News Release - FDA]


Rize 2 The Occasion Capsules Rose 4 Her Capsules

Audience: Consumers, healthcare professionals [UPDATE 07/30/2008] Jack Distribution, LLC, announc ed a nationwide recall of all lot numbers of the company 's supplement products sold under the brand names Rize 2 The Occa sion and Rose 4 Her. Lab analysis by FDA of samples of random lot s found the product contains a potentially harmful, undeclared ingredient, thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for erectile dysfunction. [Posted 07/02/2008] Jack Distribution, LLC issued a voluntary nationwide recall of selected lots of Rize 2 The Oc casion Capsules and Rose 4 Her Capsules, marketed as dietary supple ments. The products were recalled because certain lots contain ed thiomethisosildenafil, an undeclared ingredient tha t is an analog of sildenafil, a FDA-approved drug used for Erectile D ysfunction. This undeclared chemical poses a potential threat to con sumers because it may interact with nitrates found in some prescri ption drugs (such as nitroglycerin) and may lower blood pressure to d angerous levels. Consumers who have one of the above products should stop using them immediately and contact their physician if the y have experienced any problems that may be related to tak ing the products. See the manufacturer's press release for the specific lot numbers of the recalled products. [July 28, 2008 - Press Release - Jack Distribution, LLC] [July 01, 2008 - Press Release - Jack Distribution, LLC]


Recombinant Human Bone Morphogenetic Protein in Cer vical Spine Fusion Audience: Orthopedic surgeons, neurosurgeons, hospi tal risk managers, surgical service staff

[Posted 07/02/2008] FDA informed healthcare profess ionals of reports of life-threatening complications associate d with recombinant human Bone Morphogenetic Protein (rhBMP ) when used in the cervical spine. The safety and effectiv eness of rhBMP in the cervical spine have not been demonstrated and t hese products are not approved by FDA for this use. There have be en at least 38 reports of complications during the last 4 years wi th the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological struc tures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as inv estigators in approved clinical studies. FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure es tablished by your facility. Reporting adverse events is everyone ’s responsibility, even if the event involves off-label use of medical devices. [July 01, 2008 - Public Health Notification - FDA]

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2% Chlorhexidine Gluconate Cloth Patient Preoperati ve Skin Preparation Product

Audience: Hospital risk managers, pharmacists [Posted 06/30/2008] Sage Products informed healthca re professionals of the voluntary recall of limited lo ts of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. The product was recalled because certain l ots were found positive for Burkholderia cepacia (B. cepacia). B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as a weakened immune system or chronic lung diseases, particularly cystic fibrosis (CF) ma y be more susceptible to infections with B. cepacia. This org anism is a known cause of infections in hospitalized patients and it s effects range from no symptoms to serious respiratory infections, espe cially in patients with CF.

The product was distributed to U.S. hospitals and m edical centers nationwide and w as shipped between 4/28/08 and 6/19/08. Healthcare professionals should stop using the product and coo rdinate the return of the product with the manufacturer.

[June 27, 2008 - Press Release - Sage Products]


Antipsychotics, Conventional and Atypical Audience: Neuropsychiatric and geriatrics healthcar e professionals [Posted 06/16/2008] FDA notified healthcare profess ionals that both conventional and atypical antipsychotics are associ ated with an increased risk of mortality in elderly patients tre ated for dementia-related psychosis. In April 2005, FDA notified heal thcare professionals that patients with dementia-related p sychosis treated with atypical antipsychotic drugs are at an increas ed risk of death. Since issuing that notification, FDA has reviewed a dditional information that indicates the risk is also associa ted with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescr ibing information for all antipsychotic drugs will now in clude the same information about this risk in a BOXED WARNING and the WARNINGS section. [June 16, 2008 - Information for Healthcare Professionals - FDA] [June 16, 2008 - News Release - FDA]


Morphine Sulfate 60 mg Extended Release Tablets Morphine Sulfate 30 mg Extended Release Tablets

Audience: Pharmacists, other healthcare professiona ls [UPDATE 06/16/2008] Additional lots of morphine sul fate 60 mg extended release tablets, and specific lots of morp hine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets. The recalled lots were distri buted by ETHEX Corporation under an “ETHEX” label between June 200 6 and May 2008. [Posted 06/10/2008] ETHEX Corporation notified heal thcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversi zed tablets may contain as much as two times the labeled level of a ctive morphine sulfate. The lot was distributed by ETHEX Corporati on under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (di fficulty or lack

of breathing), and low blood pressure. Many patient s for whom this product is prescribed are likely to be highly debil itated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questi ons about the recall, they should call their physician, pharmacis t, or other health care provider. [June 13, 2008 - Press Release - ETHEX Corp.] [June 09, 2008 - Press Release - ETHEX Corp.]


Tumor Necrosis Factor (TNF) Blockers (marketed as R emicade, Enbrel, Humira, and Cimzia)

Audience: Rheumatologists, gastroenterologists, onc ologists, other healthcare professionals [Posted 06/03/2008] FDA issued an Early Communicati on About an Ongoing Safety Review to inform healthcare professi onals that the Agency is investigating a possible association betw een the use of Tumor Necrosis Factor (TNF) blockers and the develo pment of lymphoma and other cancers in children and young ad ults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten- year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occur ring in children and young adults who began taking TNF blockers (alo ng with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or les s, to treat juvenile idiopathic arthritis, Crohn's disease or o ther diseases. Approximately half of the cancers were lymphomas, i ncluding both Hodgkin's and non-Hodgkin's lymphoma. Long-term stu dies are necessary to provide definitive answers about wheth er TNF blockers increase the occurrence of cancers in children beca use cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthc are providers, parents, and caregivers should be aware of the poss ible risk of lymphoma and other cancers in children and young ad ults when deciding how to best treat these patients. [June 04, 2008 - Early Communication About an Ongoing Safety Review of TNF Blockers - FDA]

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Calcilo XD Low-Calcium & Vitamin D-Free Infant Form ula With Iron Powder Audience: Consumers, pediatricians, other healthcar e professionals [Posted 06/02/2008] Abbott notified consumers and h ealthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/vitamin D-Free Infant Formula with Iron pow der, a low-calcium and Vitamin D-free infant formula specifica lly designed for the nutrition support of infants and children with hypercalcemia. The product, distributed in the United States between 0 6/06/06 and 04/17/08, is being recalled because small amounts o f air may have entered the can, resulting in product oxidation. Co nsumption of highly oxidized foods can cause gastrointestinal sy mptoms such as nausea, vomiting, and diarrhea. Parents should cont act their healthcare professional if they have any questions or concerns. [May 30, 2008 - Press Release - FDA]


Viril-ity Power (VIP) Tablets Audience: Consumers, healthcare professionals [Posted 05/30/2008] International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals tha t the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. The product is being recalled because one lot was found to contain a potentially harmful undeclared ingredient, hydroxyhomosildenafil, an analog of sil denafil. Sildenafil is the active ingredient in Viagra, an FDA-approved drug used for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and may lower blood pressure to life-threatening le vels. Consumers with diabetes, high blood pressure, high cholestero l, or heart disease often take such nitrates. Consumers who hav e Viril-ity Power (VIP) Tablets should stop using it immediatel y and contact their healthcare professional if they experience an y problems that may be related to taking this product. [May 29, 2008 - Press Release - International Pharmaceuticals, Ltd.]


Mommy's Bliss Nipple Cream Audience: Nursing mothers, pediatricians, other hea lthcare professionals [Posted 05/29/2008] FDA informed consumers not to u se or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterpr ises, Inc.,

because the product contains potentially harmful in gredients that may cause respiratory distress or vomiting and diar rhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Potentially harmful ingredi ents in the product are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause slow or shallow breathing in infants. Phenoxy enthanol, a preservative that is primarily used in cosmetics an d medications, can also depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydratio n in infants. Mothers and caregivers should seek immediate medica l attention if their child shows signs and symptoms of decreases i n appetite, difficulty in awakening, limpness of extremities or a decrease in an infant's strength of grip and a change in skin colo r. [May 23, 2008 - News Release - FDA]


Xiadafil VIP Tablets Audience: Consumers, healthcare professionals [Posted 05/27/2008] FDA alerted consumers and healt hcare professionals not to buy or use Xiadafil VIP Tablet s sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablet s (Lot# 6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement a nd to treat erectile dysfunction (ED). The product contains a p otentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analo g of sildenafil, the active ingredient in Viagra, an FDA approved pr escription drug for ED. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressur e to life-threatening levels. Consumers with diabetes, high b lood pressure, high cholesterol, or heart disease often take nitra tes. Consumers who have used the product should discontinue use im mediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product. [May 27, 2008 - News Release - FDA]


Solodyn (minocycline HCL) Extended Release Tablets 90 mg

Audience: Pharmacists, other healthcare professiona ls [Posted 05/19/2008] Medicis and FDA notified health care professionals of the recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of Solodyn Extended Release Ta blets. The product was recalled because one of the bottles con tained Azasan (azathioprine tablets) 75mg instead of Solodyn 90mg Tablets. Azasan is an immunosuppressive agent used in transplant pa tients to prevent kidney rejection and for the treatment of r heumatoid arthritis. Taking Azasan instead of Solodyn present s a health hazard and safety risk to patients. Side effects associate d with the use of Azasan, particularly in the elderly, include myelos uppression, infection, bleeding, chills, nausea, vomiting and d iarrhea. Joint and muscle pain are also common side effects. Additiona lly, unanticipated interactions with other drugs may als o lead to serious adverse events. The recall is limited to the lots r eferenced above. Healthcare professionals are urged to check their i nventory and pull the referenced lot numbers from their stock and mak e arrangements with the manufacturer to return the product. [May 16, 2008 - Press Release - Medicis]


Mycophenolate Mofetil [MMF] (marketed as CellCept) Mycophenolic Acid [MPA] (marketed as Myfortic) Inosine Monophosphate Dehydrogenase Inhibitors (IMP DH) Immunosuppressants

Audience: Transplantation specialists, infectious disease sp ecialists, other healthcare professionals [Posted 05/16/2008] FDA is aware of reports of infa nts born with serious congenital anomalies, including microtia an d cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF, the active drug substance in CellCe pt, is an ester of the active metabolite mycophenolic acid (MPA), t he active drug substance in Myfortic. In most cases, the mothers w ere taking MMF following an organ transplant to prevent organ reje ction. However, some mothers taking MMF were being treated for immu ne-mediated conditions such as systemic lupus erythematosus (SL E) and erythema multiforme. Treatment began before their p regnancies and continued into the first trimester or until the pre gnancy was detected. MMF and MPA increase the risk of spontane ous abortion in the first trimester and can cause congenital malfor mations in the offspring of women who are treated during pregnancy . FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of

fetal exposure. See the FDA Healthcare Professional Information Sheet containing considerations and recommend ations for clinicians prior to prescribing MMF or MPA to women of childbe aring potential. [May 16, 2008 - Healthcare Professional Sheet - FDA]


[04/10/2008] [11/27/2007] [10/29/2007] [02/22/2007]


Cardinal Alcohol-Free Mouthwash Audience: Consumers, hospital and nursing home risk managers, healthcare professionals [UPDATE 05/19/2008] Hydrox Labs issued a voluntary recall of another lot of Alcohol-Free Mouthwash because sampl es of the product tested were positive for Burkholderia cepacia (B. cepacia). The affected product lot number is 26230. [Posted 05/06/2008] Hydrox Labs issued a voluntary recall of Cardinal Health labeled alcohol- free mouthwash because the product was found to contain Burkholderia cepacia (B. cepacia). The affected product lot number is 26228. B. cepacia poses little medical risk to healthy individuals. However, people who have certa in health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with this organism. Consumers and facili ties with the recalled alcohol-free mouthwash should stop using t he product and contact Cardinal Health for instructions on how to return the product. [May 16, 2008 - Press Release - Hydrox Labs] [May 02, 2008 - Press Release - Hydrox Labs]


Enbrel (etanercept) Audience: Rheumatologists, dermatologists, other he althcare professionals, patients [Posted 05/01/2008] Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribin g information for

Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitaliza tion or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADV ERSE REACTIONS section of the label was updated to inclu de information regarding global clinical studies and the rate of o ccurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infe ction before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and sy mptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for approp riate antimicrobial treatment and, in patients who develo p a serious infection, Enbrel should be discontinued. [March 14, 2008 - Dear Healthcare Professional Letter - Amgen/Wyeth] [February, 2008 - Label - Amgen/Wyeth]


Digitek (digoxin tablets, USP) Audience: Cardiologists, family physicians, pharmac ists, other healthcare professionals, patients [Posted 04/28/2008] Actavis Totowa LLC notified hea lthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abn ormal heart rhythms. The products are distributed by Mylan Phar maceuticals Inc., under a “Bertek” label and by UDL Laboratorie s, Inc. under a “UDL” label. The product is being recalled due to t he possibility that tablets with double the appropriate thickness may c ontain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in paten ts with renal failure. Digitalis toxicity can cause nausea, vomiting, dizz iness, low blood pressure, cardiac instability and bradycardia. Seve ral reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions. [April 25, 2008 - Press Release - Actavis Totowa LLC]


Herbal Science International, Inc. Dietary Herbal S upplements Audience: Consumers, healthcare professionals

[Posted 04/14/2008] Herbal Science International, I nc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain e phedra, aristolochic acid or human placenta because they ma y present a serious health hazard to consumers. FDA has long re garded dietary supplements containing ephedra, a botanical that co ntains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2 004 prohibiting the sale of dietary supplements containing ephedrin e alkaloids because they present an unreasonable risk of illnes s or injury. Two of the recalled products contain aristolochic a cid which is a potent carcin ogen and nephrotoxin. This chemical can cause serio us kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contai ns human placenta, an ingredient which may transmit disease. Dietary s upplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connecti on with the recalled products and distribution of all of the pr oducts has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place o f purchase. [April 10, 2008 - Press Release - Herbal Science International]

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CellCept (mycophenolate mofetil) Myfortic (mycophenolate acid)

Audience: Transplantation specialists, infectious disease sp ecialists, other healthcare professionals [Update] Novartis informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the Myfortic prescribing information. The changes are based on p ostmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with Myfortic. [Update] Roche Laboratories informed healthcare pro fessionals of changes to the WARNINGS and ADVERSE REACTIONS secti ons of the CellCept prescribing information. The changes a re based on postmarketing data regarding cases of Progressive M ultifocal Leukoencephalopathy (PML) in patients treated with CellCept. [Posted 04/10/2008] FDA informed healthcare profess ionals that the Agency is investigating a potential association bet ween the use of

CellCept and Myfortic, medicines used to prevent or gan rejection, and the development of progressive multifocal leuko encephalopathy (PML), a life-threatening disease. PML is a rare di sorder that affects the central nervous system usually occurring in pat ients with immune systems suppressed by disease or medicines. FDA is reviewing data submitted by Roche, including postma rketing reports it has received of PML in patients who took CellCep t or Myfortic, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information. FDA anticipates it may take about 2 m onths to compl ete its review of the postmarketing reports and the pro posed revisions to the prescribing information. As soon as the rev iew is completed, FDA will communicate the conclusions and recommenda tions to the public.

Until further information is available, patients an d healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the sett ing of a suppressed immune system, including during therapy with CellCept and Myfortic. [June 2008 -- Dear Healthcare Professional Letter - Novartis] [June 2008 -- Dear Healthcare Professional Letter - Roche] [April 10, 2008 - Communication About an Ongoing Safety Review - FDA] Previous MedWatch Alerts: [11/27/2007] [10/29/2007] [02/22/2007]

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Neupro (rotigotine transdermal system) Audience: Neurologists, other healthcare profession als, patients [Posted 04/09/2008] Schwarz Pharma informed healthc are professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson’s disease, at the end of April 2008, beca use of the formation of rotigotine crystals in the patches. Wh en the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcar e professionals should not initiate any new patients on Neupro and should begin to

down-titrate all patients currently using the produ ct per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neurolep tic malignant syndrome or akinetic crises. [April 8, 2008 - Drug Shortage Information - FDA.]


Exubera (insulin human rDNA origin) Inhalation Powd er Audience: Endocrinologists, pulmonologists, pharmac ists, patients [Posted 04/09/2008] Pfizer informed healthcare prof essionals and patients of updated safety information in the WARNI NGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inh aler that helps to control high blood sugar in adults with diabetes . There have been 6 newly diagnosed cases of primary lung malignancie s in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also b een 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whet her the emergence of these events is related to Exubera. Al l patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of limited availability of Exubera , healthcare professionals should seek alternative treatment opt ions to maintain patients' glycemic control. [April 9, 2008 - Dear Healthcare Professional Letter - Pfizer, Inc.] [April 9, 2008 - Dear Patient Letter - Pfizer, Inc.]


Cubicin (daptomycin for injection) Audience: Infectious disease healthcare professiona ls, hospital risk managers, and nursing service managers [Posted 04/09/2008] Cubist Pharmaceuticals, Inc. in formed healthcare professionals that a potentially signifi cant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusio n pumps manufactured by Cardinal Health, Inc. MBT is used i n the manufacture of rubber and has been reported to leac h from rubber stoppers and syringe components into medicinal prod ucts in the

past. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. No MBT has been identified in reconstituted Cubicin in other standard types of infusion systems that have been t ested. Healthcare professionals are advised to discontinue using Read yMED elastomeric infusion pumps with Cubicin until the i ssue has been addressed. [April, 2008 - Letter - Cubist Pharmaceuticals, Inc.]

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Heparin Sodium USP Pre-Filled Syringes Audience: Surgeons, hospital risk managers, pharmac ists, other healthcare professionals [Posted 04/02/2008] Covidien notified healthcare pr ofessionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a hepa rin-like contaminant. To date, Covidien has not received any adverse event reports related to this i ssue. See the manufacturer's press release for the list of specific lots of the product affected b y the recall. Use of the recalled product should be discontinued immedia tely. Patients should contact their physician if they experience a ny problems associated with the use of the product. [March 28, 2008 - Press Release - Covidien]


Relenza (zanamivir) Audience: Pediatric and infectious disease healthca re professionals [Posted 04/01/2008] GlaxoSmithKline informed health care professionals of changes to the WARNINGS AND PRECAU TIONS sections of prescribing information for Relenza reg arding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who are receiving neuraminidase inhibitor s, including Relenza. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid re solution. The contribution of Relenza to these events has not bee n established. Influenza can be associated with a variety of neuro logic and behavioral symptoms which can include seizures, hal lucinations,

delirium, and abnormal behavior, in some cases resu lting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occ ur, the risks and benefits of continuing treatment should be eval uated for each patient. [March, 2008 - Letter - GlaxoSmithKline] [Feb, 2008 - Label - GlaxoSmithKline]


Total Body Formula, Total Body Mega Formula Audience: Consumers, healthcare professionals [UPDATE 05/01/2008] FDA notified healthcare profess ionals and consumers that the Agency's final analysis of certa in flavors of "Total Body Formula" and "Total Body Mega Formula" detected hazardous amounts of chromium in addition to seleni um. Excessive consumption of chromium can cause fatigue, muscle c ramps, hyperactivity, hypoglycemia, renal failure and live r toxicity. Excessive chromium intake can also interfere with c ertain medications. FDA continues to investigate how exces sive amounts of selenium and chromium got into the products. [UPDATE 04/10/2008] The FDA notified healthcare pro fessionals and patients that it has found hazardous levels of sele nium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." Analyses of samples by FDA have found most of the samples contain extremel y high levels of selenium -- up to 200 times the amount of seleni um indicated on the labels of the products. The FDA has received 43 reports of persons f rom nine states who experienced serious adverse rea ctions using these products. The adverse reactions general ly occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joi nt pain, deformed fingernails, and fatigue. Consumers should stop tak ing the products and consult their healthcare professional if they e xperience any adverse events associated with the use of the produ cts. [Posted 03/28/2008] The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products Total Body Formula in the flavo rs of Tropical

Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The Florida Department of Health recently provided reports to the FDA on 23 individuals who e xperienced serious reactions to these products seven to 10 day s after ingestion. In all cases, the reactions included significant ha ir loss, muscle cramps, diarrhea, joint pain and fatigue. FDA labor atories are analyzing samples of the products to identify the c ause of the reactions. [May 01, 2008 - News Release - FDA] [April 09, 2008 - News Release - FDA] [March 27, 2008 - News Release - FDA]


Ziagen (abacavir) Videx (didanosine)

Audience: Infectious disease specialists, other hea lthcare professionals, patients [Posted 03/27/2008] The FDA issued an Early Communi cation about recent findings of The Data Collection on Adverse E vents of Anti- HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who we re taking Ziagen (abacavir) or Videx (didanosine) as part of their d rug therapy. The study is a large observational study of 33,347 HIV- 1 infected patients living in North America, Europe and Australia. Pati ents in this study are being followed to evaluate the short and long t erm adverse effects of treatment with anti-HIV drugs. FDA conti nues to evaluate the overall risks and benefits of abacavir and dida nosine. This evaluation may result in the need to revise labelin g for the products. Until the FDA’s review is complete, health care pro fessionals should evaluate the potential risks and benefits of each H IV-1 antiretroviral drug their patients are taking. This early communication is in keeping with FDA’s c ommitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate th e conclusions and recommendations to the public. [March 27, 2008 - Early Communication About an Ongoing Safety Review - FDA]


Regranex (becaplermin) Gel Audience: Endocrinologists, other healthcare profes sionals, patients [UPDATE 06/06/2008] FDA informed healthcare profess ionals that a Boxed Warning was added to prescribing information for Regranex that describes an increased risk of death from canc er in patients treated with three or more tubes of Regranex compar ed with those patients who did not use the product. FDA recommend s that Regranex be used only when the benefits can be expe cted to outweigh the risks. [Posted 03/27/2008] The FDA is conducting a safety review based on study data suggesting there may be an increased ris k of death from cancer in diabetic patients using Regranex (becaple rmin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professiona ls discuss the potential risks and benefits of using Regranex with their patients. This communication is in keeping with FDA’s commitm ent to inform the public about its ongoing safety reviews of drug s. As soon as this review is complete, FDA will communicate the conclu sions and recommendations to the public. [June 06, 2008 - Drug Information Page - FDA] [March 27, 2008 - Communication About an Ongoing Safety Review - FDA]


Singulair (montelukast) Audience: Pulmonologists, respiratory therapists, o ther healthcare professionals, patients [Posted 03/27/2008] FDA informed healthcare profess ionals and patients of the Agency's investigation of the possi ble association between the use of Singulair and behavior/mood chan ges, suicidality (suicidal thinking and behavior) and suicide. Singu lair is a leukotriene receptor antagonist used to treat asthm a and the symptoms of allergic rhinitis, and to prevent exerc ise-induced asthma. Patients should not stop taking Singulair b efore talking to their doctor if they have questions about the new i nformation. Healthcare professionals and caregivers should moni tor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood. This early communication is in keeping with FDA’s c ommitment to

inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates t hat it may take up to 9 months to complete the ongoing evaluations. As s oon as this review is complete, FDA will communicate the conclu sions and recommendations to the public. [March 27, 2008 - Early Communication About an Ongoing Safety Review - FDA]


"Blue Steel" and "Hero" Dietary Supplement Products Audience: Consumers [Posted 03/25/2008] The U.S. Food and Drug Administ ration is advising consumers not to purchase or use "Blue Ste el" or "Hero" products, marketed nationally as dietary supplement s, because these products contain undeclared ingredients, whic h may dangerously affect a person’s blood pressure level. They are considered unapproved drugs and have not been prove n to be safe or effective. These products are promoted and sold over the Internet for the treatment of erectile dysfunction [ED] and for sexual enhancement. They contain undeclared and unapproved substances similar in chemical structure to sildenafil, the ac tive ingredient in an FDA-approved prescription drug for ED. The undeclar ed ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. [March 25, 2008 - Press Release - FDA]


B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sod ium Chloride Injection Solution

Audience: Surgeons, dialysis center staff, hospital risk managers, other healthcare professionals [Posted 03/21/2008] B. Braun Medical Inc. was notif ied by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lo ts manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notifica tion received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by

B. Braun has a heparin-like contaminant. FDA has re ceived reports of serious injuries and/or deaths in patients who h ave been administered Heparin injectable products of other c ompanies containing this contaminant. [March 21, 2008 - Press Release - B. Braun Medical]


Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps

Audience: Physiatry and Pain management healthcare professionals [Posted 03/21/2008] FDA and Medtronic notified heal thcare professionals of the Class 1 recall of Medtronic Ne uromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the de vices to include current patient management and treatment recommenda tions. The company received reports of inflammatory mass forma tions at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On J anuary 16, 2008, Medtronic sent a letter to doctors who implant thes e devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient manag ement, recommendations and next steps. [March 21, 2008 - Recall Notice - FDA] [January, 2008 - Dear Healthcare Professional Letter - Medtronic]


Tiotropium (marketed as Spiriva HandiHaler) Audience: Pulmonary care health professionals and p atients [UPDATE 10/07/2008] FDA informed healthcare profess ionals that FDA has reviewed preliminary data from UPLIFT (Unde rstanding the Potential Long-Term Impacts on Function with Tiotro pium), a large, 4-year, placebo controlled clinical trial with Spir iva HandiHaler in approximately 6000 patients with chronic obstructiv e pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo. Two recent publications reported increased risk for mortality and/or

cardiovascular events in patients who received tiot ropium or inhaled anticholinergics. Both studies examined cardiovascu lar outcomes. FDA expects to receive the complete report for UPLI FT in November 2008. Results from this trial will also help to ad dress some issues raised about tiotropium in the two recent publicati ons. Due to the amount of data collected in UPLIFT, a complete revi ew of the results could take several months, at which time FDA will u pdate this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk. [Posted 03/18/2008] Boehringer Ingelheim and FDA no tified healthcare professionals that ongoing safety monito ring has identified a possible increased risk of stroke in p atients who take Spiriva. This product contains tiotropium bromide a nd is used to treat bronchospasm associated with chronic obstruct ive pulmonary disease. Boehringer Ingelheim reported to the FDA t hat it has conducted an analysis of the safety data from 29 pl acebo controlled clinical studies (“pooled analysis”). Based on dat a from these studies, the preliminary estimates of the risk of s troke are 8 patients per 1000 patient s treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. Th is means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period. It is important to interpret these preliminary resu lts with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. F DA has not confirmed these analyses and while pooled analyses can provide early information about potential safety issues, th ese analyses have inherent limitations and uncertainty that require f urther investigation using other data sources. Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information. This early communicatio n is in keeping with FDA’s commitment to inform the public about it s ongoing safety reviews of drugs. [UPDATE October 07, 2008 - Early Communication about an Ongoing Safety Review - FDA]


Medtronic AneuRx Stent Graft System Audience: Vascular surgery healthcare professionals , hospital surgical service managers

[Posted 03/18/2008] FDA issued a Public Health Noti fication to inform healthcare professionals of an update to earlier FD A safety information on this product. The notification re-em phasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mor tality risks associated with the use of the AneuRx Stent Graft S ystem to prevent abdominal aortic aneurysm rupture. [March 17, 2008 - Public Health Notification - FDA] Previous MedWatch Alerts: [12/17/2003] [04/30/2001]


Erythropoiesis Stimulating Agents: Aranesp (darbepo etin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)

Audience: Oncological healthcare professionals [Posted 03/12/2008] Amgen and FDA notified healthca re professionals of changes to the Boxed Warnings/WARN INGS: Increased Mortality and/or Tumor Progression sectio n of the Aranesp and EPOGEN/PROCRIT labeling to update infor mation describing the results of two additional studies sh owing increased mortality and more rapid tumor progression in patie nts with cancer receiving ESAs. Based on the results of these studi es, the prescribing information has been revised as follows : ESAs shortened overall survival and/or time to tumor pro gression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL. [March 07, 2008 - Dear Healthcare Professional Letter - Amgen] Previous MedWatch Alert: [11/08/2007]


Prezista (darunavir) Audience: Infectious disease healthcare professiona ls

[UPDATE 3/21/2008] FDA issued a new "Information fo r Healthcare Professionals" sheet highlighting the addition of h epatotoxicity information to the WARNINGS section of prescribing information for Prezista. [Posted 03/12/2008] FDA and Tibotec Therapeutics no tified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) ta blets regarding the risk of hepatotoxicity. In clinical trials and post marketing experience, drug induced hepatitis has been reported in patient s receiving combination therapy with Prezista/ritonavir. Approp riate laboratory testing should be conducted prior to initiating the rapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered i n patients with underlying chronic hepatitis, cirrhosis, or in pati ents who have pretreatment elevations of transaminases, especiall y during the first several months of Prezista/ritonavir treatment. [March 21, 2008 - Information for Healthcare Professionals - FDA] [March 2008 - Dear Healthcare Professional Letter - Tibotec] [February 2008 - Prescribing Information - Tibotec]


Long-Acting Hydrocodone-Containing Cough Product (m arketed as Tussionex Pennkinetic Extended-Release Suspension)

Audience: Healthcare professionals, pharmacists, pa tients [UPDATE 04/24/2008] Dear Healthcare Professional Le tter issued by UCB, Inc. [Posted 03/11/2008] FDA informed healthcare profess ionals of life-threatening adverse events and death in patients, i ncluding children, who have received Tussionex Pennkinetic Extended-Re lease Suspension (Tussionex). The reports indicate that h ealthcare professionals have prescribed Tussionex for patient s younger than the approved age group of 6 years old and older, an d more frequently than the labeled dosing interval of ever y 12 hours. Tussionex is contraindicated for use in patients le ss than 6 years of age because of their susceptibility to life-threate ning and fatal respiratory depression. Patients have administered the incorrect dose due t o misinterpretation of the dosing directions, and hav e used inappropriate devices to measure the suspension. Ov erdose of Tussionex in older children, adolescents, and adult s has also been

associated with life-threatening and fatal respirat ory depression. Prescribers should be familiar with the dosing reco mmendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to me asure Tussionex to prevent overdose. [April 16, 2008 - Dear Healthcare Provider Letter - UCB] [March 11, 2008 - Drug Information Page - FDA] [March 11, 2008 - Public Health Advisory - FDA] [January 2008 - Prescribing Information - UCB]


Blood Glucose Meters and Test Strips Audience: Diabetes healthcare professionals, pharma cists and patients [Posted 03/11/2008] FDA reminded glucose meter user s to only use strips recommended for their specific brand of mete r and to read the instructions for use carefully. It is important for users to understand that if they use a test strip that is not recommend ed for their meter, the device may fail to give results or may generate inaccurate results. While this problem has been identified rec ently as occurring with a unique meter-strip configuration, FDA recogn izes that similar problems can also occur if other brands and models of meters and strips are not used in proper combination. [March 10, 2008 - News Release - FDA/CDRH/OIVD]


Unapproved Over The Counter Drugs Marketed for Prev ention and Treatment of STDs

Audience: Healthcare professionals, consumers [Posted 03/06/2008] FDA advised healthcare professi onals and consumers that the Agency issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the internet to U.S. consumer s for the prevention and treatment of sexually transmitted di seases (STDs). The products are marketed under the names Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrie nt, Qina, and SlicPlus. The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The products pose a seriou s health threat

to unsuspecting consumers who don't know that these products are not FDA approved and have not been proven safe or e ffective. Consumers who are currently using these products sh ould stop using them immediately and consult their healthcare professional if they have experienced any adverse effects that they suspect are related to the use of these products. [March 06, 2008 - News Release - FDA]


Aspire36, Aspire Lite Dietary Supplements Audience: Consumers, healthcare professionals [Posted 03/04/2008] Palo Alto Labs and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of two dietary supplements, Aspire36 and Aspire Lite. The products were recalled because they were found to contain Aildena fil in trace amounts and Dimethyl sildenafil thione, an analog o f Sildenafil, a drug used to treat erectile dysfunction. The presen ce of these ingredients in the dietary supplements may pose a t hreat to consumers because the analogue may interact with ni trates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have As pire36 and Aspire Lite in their possession should stop using t he products and return any unused product to the place of purchase. [February 28, 2008 - Press Release - Palo Alto Labs]


Tamiflu (oseltamivir phosphate) Audience: Pediatric and infectious disease healthca re professionals [Posted 03/04/2008, UPDATED 03/04/2008] Roche and F DA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza.The label has been revised as follows: Influenza can be associated wit h a variety of neurologic and behavioral symptoms which can includ e events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur withou t obvious severe disease. There have b een postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza

who were receiving Tamiflu. Because these events we re reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on Tamifl u usage data. These events were reported primarily among pediatri c patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to these events has not been established. P atients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the r isks and benefits of continuing treatment should be evaluated for eac h patient. [February, 2008 - Dear Healthcare Professional Letter - Roche] [January, 2008 - Tamiflu Prescribing Information - Roche] Previous MedWatch alert: [November 13, 2006 ]


Spiriva (tiotropium bromide inhalation powder) Caps ules Foradil (formoterol fumarate inhalation powder) Cap sules

Audience: Pulmonologists, respiratory therapists, pharmacists , other healthcare professionals, patients [Posted 02/29/2008] FDA informed healthcare profess ionals and consumers of the correct way to use Spiriva and For adil inhalation powder capsules. FDA and the American Association o f Poison Control Center’s (AAPCC) National Poison Data Syste m have received many reports of patients swallowing Spiriv a and Foradil capsules rather than placing the capsules in the in halation devices. Both products are to be used in the HandiHaler (Spi riva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in i ndividuals affected by chronic obstructive lung disease and br onchitis. Both products will not treat a patient's breathing condi tion if the contents of a capsule are swallowed rather than inhaled. Hea lthcare professionals should discuss with patients how to c orrectly use the Spiriva HandiHaler or Foradil Aerolizer. See the Pu blic Health Advisory for important information on the correct u se of both products. [February 29, 2008 - Public Health Advisory - FDA]


Tysabri (natalizumab) Audience: Neurologists, other healthcare profession als, patients [Posted 02/27/2008] Biogen Idec, Elan and FDA notif ied healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevate d total bilirubin, occurre d as early as six days after the first dose of Tysa bri. The combination of transaminase elevations and elev ated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to d eath or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of signifi cant liver injury. Physicians should inform patients that Tysabri may cause liver injury. [February, 2008 - Letter - Biogen Idec, Elan] [January, 2008 - Prescribing Information - Biogen Idec, Elan]


Denture Cleanser Allergic Reactions and Misuse Audience: Dental healthcare professionals, patients [Posted 02/26/2008] FDA notified dental health care professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdomina l pain, vomiting, seizures, hypotension and difficulty brea thing, have occurred both when the product has been used proper ly as well as from improper use. These events can occur soon afte r first use or after years of use. FDA believes that the ingredien t responsible for these reactions is persulfate, a known allergen. Pe rsulfates are used in most denture cleansers to help clean and bleach the dentures. FDA has provided specific recommendations for denta l healthcare professionals and an 'Advice for Patients' document that can be accessed at the links below. FDA is recommending that all manufacturers of dentu re cleansers modify their labeling to include warning informatio n that the product contains persulfates and recommends improving the d irections for use on their labeling in order to reduce misuse. [February 25, 2008 - Public Health Notification - FDA] [February 25, 2008 - Advice for Patients - FDA]

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Avandia (rosiglitazone maleate) Audience: Endocrinologists, pharmacists, patients [Posted 02/26/2008] FDA and GlaxoSmithKline notifie d pharmacists and physicians of a new Medication Guide for Avandi a (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a M edication Guide to be provided with each prescription that is dispe nsed for products that FDA determines pose a serious and significant public health concern . A list of currently approved Medication Guides ar e available at http://www.fda.gov/cder/Offices/ODS/medication_guid es.htm . The Medication Guide and current Prescribing Informatio n for Avandia are provided below. [February, 2008 - Medication Guide - GlaxoSmithKline] [January, 2008 - Prescribing Information - GlaxoSmithKline]


Fentanyl transdermal System CII Patches Audience: Pain management specialists, risk manager s, other healthcare professionals, patients [UPDATED 08/12/2008] Watson Pharmaceuticals, Inc., issued a voluntary recall of one lot of 75mcg/hr Fentanyl Tr ansdermal System patches (lot 92461850; Expiration Date: 8/31/2009) sold in the United States between January 30, 2008, and March 19, 2008 . The product was recalled because a small number of the patches were leaking and may expose patients or caregivers directly to f entanyl gel. [UPDATED 03/03/2008] Actavis Inc. has voluntarily r ecalled of all lots of Fentanyl Transdermal System CII patches sold in the United States. [Posted 02/19/2008] Actavis Inc. announced a nation wide recall of certain lots of Fentanyl transdermal system CII Pat ches sold in the United States and labelled with an Abrika or Actavi s label. The product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl gel may lead to serious advers e events, including respiratory depression and possible overd ose, which may be fatal. The lots covered by this recall include d oses of 25, 50, 75, and 100 mcg/hr and are listed in the firm's press r elease. [August 08, 2008 - Press Release - Watson] [March 01, 2008 - Press Release - Actavis]

[February 17, 2008 - Press Release - Actavis]


Duragesic 25 mcg/hr (fentanyl transdermal system) C II Pain Patches Audience: Pain management specialists, other health care professionals, patients [Posted 02/15/2008] PriCara and Sandoz Inc. announc ed a nationwide recall of all lots of 25 mcg/hr Duragesic Patches s old in the United States. The product is being recalled because the p atches may have a cut along one sid e of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by AL ZA Corporation. [February 12, 2008 - Press Release - PriCara] Previous MedWatch alert: [December 21, 2007 ]


Heparin Sodium Injection Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals [UPDATE 05/15/2008] Atrium Medical Corporation anno unced that it is initiating a voluntary and precautionary recall of selected lots of Hydraglide Brand Heparin-Coated Thoracic Drainage C atheters. Limited lots were manufactured with heparin found t o have been contaminated with oversulfated chondroitin sulfate (OSCS). [UPDATE 05/15/2008] Medtronic Inc., initiated a vol untary recall of selected products featuring the Carmeda BioActive s urface. The recalled products are used during cardiopulmonary b ypass heart surgeries. Limited lots of Carmeda-coated products were manufactured with heparin found to have been contam inated with oversulfated chondroitin sulfate (OSCS). It is uncl ear if exposure to

Carmeda-coated medical devices, made with small amo unt of heparin, could cause adverse events similar to thos e observed with injectable heparin formulations. Patient risk assoc iated with the presence of OSCS in heparin- coated medical devices is not known at this time.

Medtronic is also advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. The amount of heparin on the product is signi ficantly lower than that contained on the Carmeda product. Based o n current data, the benefit of using the affected products outweigh s any potential risk to patients. The maximum possible patient expo sure to heparin from Trillium is extremely low; therefore, customer s can continue to use the affected Trillium products until a replacem ent is available. [UPDATE 05/09/2008] FDA requested that health profe ssionals and facilities review and examine all drug/device stora ge areas, including emergency kits, dialysis units and automated drug s torage cabinets to ensure that all recalled heparin products have b een removed and are no longer available for patient use. In additio n, FDA informed health professionals about other types of medical d evices that contain, or are coated with, heparin. [UPDATE 04/29/2008] Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products. [UPDATE 02/28/2008] Baxter Healthcare Corporation h as voluntarily recalled all of their multi-dose and single- use vials of heparin sodium for injection, and their heparin lock flush solutio ns. [Posted 02/11/2008] FDA informed healthcare profess ionals of important warnings and instructions for Heparin Sod ium Injection use. There have been reports of serious adverse eve nts including allergic or hypersensitivity-type reactions, with s ymptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, an d cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a d elayed response has not been excluded. The reports have largely involve d use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blo od thinner) that is used in patients undergoing kidney dialysis, cer tain types of cardiac surgery, and treatment or prevention of oth er serious medical conditions, including deep venous thrombosi s and pulmonary emboli. Heparin treatment is initiated us ing high doses

(5000-50,000 units) given directly into the blood s tream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses. The manufacture of multiple-dose vials of heparin s odium has been suspended pending the completion of an extensive on going investigation to determine the root cause of the pr oblem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a su dden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendatio ns to healthcare professionals on the use of heparin sodi um for injection. [May 12, 2008 - Press Release - Atrium] [May 07, 2008 - Press Release - Medtronic] [April 25, 2008 - Information on Heparin Sodium Injection - FDA/CDER] [April 25, 2008 - Update to Healthcare Facilities and Healthcare Professionals - FDA/CDRH] [March 07, 2008 - Updated Questions and Answers - FDA] [February 28, 2008 - Public Health Update - FDA] [February 28, 2008 - Press Release - Baxter] [February 11, 2008 - Public Health Advisory - FDA] UPDATED 02/28/2008 [February 11, 2008 - Questions and Answers - FDA] [February 11, 2008 - News Release - FDA] Previous MedWatch alert: [January 18, 2008 ]


Chattem Icy Hot Heat Therapy Products Audience: Consumers, healthcare professionals [UPDATED 03/11/2008] FDA issued a Class II Recall o f all Icy Hot Heat Therapy products. [Posted 02/11/2008] Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer "samp les" that were included on a limited promotional basis in cartons of its 3 oz Aspercreme product. The products were recalled beca use of consumer reports of first, second and third degree burns as well as

skin irritation. All lots and sizes of the followin g Icy Hot Heat Therapy products were recalled: Icy Hot Heat Therapy Air Activated Heat - Back Icy Hot Heat Therapy Air Activated Heat - Arm, Neck , and Leg Icy Hot Heat Therapy Air Activated Heal - Arm, Neck , and Leg single consumer use "samples" on a limited promotional bas is in cartons of 3 oz. Aspercreme Pain Relieving Cream. Consumers who have the Icy Hot Heat Therapy product s under this recall should immediately stop using the products, discard them, and /or return them to the manufacturer. [March 10, 2008 - Recall Notice - FDA] [February 25, 2008 - Consumer Questions and Answers - FDA] [February 08, 2008 - Press Release - Chattem, Inc.]


Botox, Botox Cosmetic (Botulinum toxin Type A), Myo bloc (Botulinum toxin Type B)

Audience: Cosmetic Surgeons, neurologists, other he althcare professionals, consumers [Posted 02/07/2008] FDA issued an early communicati on about an ongoing safety review regarding Botox and Botox Cos metic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unap proved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes t hat included hospitalization and death, and occurred mostly in c hildren treated for cerebral palsy-associated limb spasticity. Use of b otulinum toxins for treatment of limb spasticity (severe arm and le g muscle spasms) in children or adults is not an approved use in the U.S. See the FDA's "Early Communication about an Ongoing Safety Review " for Agency recommendations and additional information for heal thcare professionals. [February 08, 2008 - Early Communication about an Ongoing Safety Review - FDA]


Injectable Colchicine (including drugs containing c olchicine) Audience: Healthcare professionals [Posted 02/0 6/2008] FDA announced its intention to take enforce ment action against companies marketing unapproved, inje ctable colchicine, a drug used to treat gout. Colchicine i s a highly toxic drug that can easily be administered in excessive d oses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that ca n result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intraveno us colchicine, including 23 deaths. Potentially fatal effects incl ude low blood cell counts, cardiac events, and organ failure. This act ion does not affect colchicine products that are dispensed in tablet fo rm. Individuals and companies must stop making these pr oducts within 30 days and stop shipping the product within 180 da ys or face regulatory action. After these dates, all injectabl e colchicine drug products must have FDA approval to be manufactured or shipped interstate. [February 06, 2008 - News Release - FDA] [February 06, 2008 - Questions and Answers - FDA] Previous MedWatch alert: [05/02/2007]


Medtronic SynchroMed EL Implantable Infusion Pump Audience: Pain management specialists, risk manager s, other healthcare professionals, patients [Posted 02/04/2008] FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626 -10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and can cer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The mode ls were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactur ed before September 1999. If a pump motor stalls, drug delive ry will stop suddenly and without warning. This stoppage will re sult in loss of therapy, return of the patient's symptoms, and/or s ymptoms of drug

under infusion or withdrawal. Healthcare profession als and patients with questions should contact the manufacturer. [February 04, 2008 - Recall Notice - FDA]


Varenicline (marketed as Chantix) Audience: Neuropsychiatric and other healthcare pro fessionals, consumers [Posted 02/01/2008] FDA informed healthcare profess ionals and consumers of important revisions to the WARNINGS an d PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experie nced in patients taking Chantix. These symptoms include cha nges in behavior, agitation, depressed mood, suicidal ideat ion, and attempted and completed suicide. While some patient s may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix w ho experienced serious neuropsychiatric symptoms and events had no t yet discontinued smoking. In most cases, neuropsychiatr ic symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using Chantix therapy for patients. [February 01, 2008 - Public Health Advisory - FDA] [February 01, 2008 - Prescribing Information - Pfizer] [February 01, 2008 - Healthcare Professional Information Sheet - FDA]


Antiepileptic Drugs Audience: Neuropsychiatric healthcare professionals , other healthcare professionals, patients [Posted 01/31/2008] FDA informed healthcare profess ionals that the Agency has analyzed reports of suicidality (suicida l behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disor ders, and other conditions. In the FDA's analysis, patients receivi ng antiepileptic drugs had approximately twice the risk of suicidal behavior or

ideation (0.43%) compared to patients receiving pla cebo (0.22%). The increased risk of suicidal behavior and suicidal id eation was observed as early as one week after starting the an tiepileptic drug and continued through 24 weeks. The results were ge nerally consistent among the eleven drugs. The relative ris k for suicidality was higher in patients with epilepsy compared to pa tients who were given one of the drugs in the class for psychiatric or other conditions. Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergen ce or worsening of suicidal thoughts or behavior or depression. The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegr etol, Tegretol XR) Felbamate (marketed as Felbatol) Gabapentin (marketed as Neurontin) Lamotrigine (marketed as Lamictal) Levetiracetam (marketed as Keppra) Oxcarbazepine (marketed as Trileptal) Pregabalin (marketed as Lyrica) Tiagabine (marketed as Gabitril) Topiramate (marketed as Topamax) Valproate (marketed as Depakote, Depakote ER, Depak ene, Depacon) Zonisamide (marketed as Zonegran) Although the 11 drugs listed above were the ones in cluded in the analysis, FDA expects that the increased risk of su icidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. [January 31, 2008 - Healthcare Professional Information Sheet - FDA]


NuCel Labs Eye Drops and Eye/Ear Wash Products Audience: Consumers, ophthalmologists, optometrists , other healthcare professionals [Posted 01/31/2008] NuCel Labs and FDA informed con sumers and healthcare professionals of a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash Products. The products were recalled after

testing indicated the presence of bacteria and part iculate matter, deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness. No illnesses or injuries h ave been reported to date. There are no lot numbers or expiration dat es on the products. Consumers who have the product should dis continue use of the product and return it to NuCel Labs. See the manufacturer's press release for return shipping information. [January 31, 2008 - Press Release - NuCel Labs]


Ezetimibe/Simvastatin (market ed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Early Communic ation about an Ongoing Data Review

Audience: Cardiovascular healthcare professionals a nd patients [Posted 01/25/2008] FDA provided healthcare profess ionals with an early communication about an ongoing data review fo r Ezetimibe/Simvastatin (marketed as Vytorin), Ezetim ibe (marketed as Zetia), and Simvastatin (marketed as Zocor). This e arly communication is in keeping with FDA’s commitment t o inform the public about ongoing postmarketing drug issues. Merck/Schering Plough Pharmaceuticals reported prel iminary results from the Effect of Combination Ezetimibe and High- Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Proces s in Patients with Heterozygous Familial Hypercholesterolemia (EN HANCE) trial. This trial was designed to evaluate the amou nt of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients trea ted with Vytorin (ezetimibe plus simvastatin) or simvastatin alone. Merck/Schering Plough stated that there was no significant differe nce between Vytorin and simvastatin in the amount of atheroscle rotic plaque in the inner walls of the carotid (neck) arteries desp ite greater lowering of LDL-cholesterol (bad cholesterol) with Vytorin c ompared to simvastatin. Once Merck/Schering Plough completes t he analysis of the unblinded data from ENHANCE, it will submit a f inal study report to FDA. Once FDA receives the final study report, F DA estimates it will take approximately 6 months to fully evaluate the data. After reviewing the data from the ENHANCE study, and cons idering all other available information about the link between LDL lowering and reduction of cardiovascular events, FDA will determ ine whether any further regulatory action is warranted with regard to Zetia and Vytorin and also whether any changes to FDA’s curre nt approach to

drugs that lower LDL cholesterol are warranted. Patients should talk to their doctors if they have any questions ab out the information from the ENHANCE trial. [January 25, 2008 - Early Communication about an Ongoing Data Review - FDA]


Cordis Corporation Dura Star RX and Fire Star RX PT CA Balloon Catheters Audience: Cardiovascular healthcare professionals, hospital risk managers [Posted 01/25/2008] Cord is Corporation and FDA informed healthcare professionals of a Class I recall of All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a med ical procedure (known as percutaneous transluminal coronary angioplasty o r PTCA) to open narrowed or blocked blood vessels or arteri es of the heart. The product has a potential for slow deflation or n o deflation of the angioplasty balloon when inserted into the artery o r other blood vessels. This may potentially result in a total blo ckage of the artery or blood vessels, resulting in a change in the hear t rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death. [January 25, 2008 - Recall Notice - FDA]


Leukine (sargramostim) Audience: Oncologists, hematologists, other healthc are professionals [Posted 01/24/2008] Bayer and FDA informed healthca re professionals of the market withdrawal of the curre nt liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward tren d in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate di sodium (EDTA). The upward trend in adverse reaction reporting rate s has not been observed with the use of lyophilized Leukine. Healt hcare

professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer. [January 23, 2008 - Dear Healthcare Professional Letter - Bayer Healthcare]


Ortho Evra Contraceptive Transdermal Patch Audience: Reproductive healthcare professionals, pa tients [Posted 01/19/2008] FDA modified the prescribing in formation for the Ortho Evra Contraceptive Transdermal (Skin) Patch t o include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing ser ious blood clots, also known as venous thromboembolism (VTE), than wo men using birth control pills. VTE can lead to pulmonary embo lism. The label changes are based on a study conducted by the Bosto n Collaborative Drug Surveillance Program on behalf o f Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said wo men in this group were at higher risk for VTE. FDA believes that Ortho Evra is a safe and effectiv e method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider ab out using Ortho Evra versus other contraceptive options. [January 18, 2008 - News Release - FDA] [January 18, 2008 - Questions and Answers - FDA]


Heparin Sodium Injection 1000 units/mL 1OmL and 30 mL Vials Audience: Pharmacists, hospital risk managers, othe r healthcare professionals [Posted 01/18/2008; updated 01/29/2008] Baxter Heal thcare and FDA notified healthcare professionals of a voluntary re call of certain lots of Heparin as a precaution due to an increase in re ports of adverse patient reactions associated with these lots. Baxte r is in the process of an in-depth investigation to determine the root cause of the reported reactions.

Reported adverse events include abdominal pain, dec reased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flus hing, headache, hyperhidrosis, hypoesthesia, hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, pal pitations, paresthesia, pharyngeal edema, restlessness, vomiti ng/retching, stomach discomfort, tachycardia, thirst, trismus, a nd unresponsiveness to stimuli. There have been no rep orts involving fatality. See the recall notice for a list of affec ted lots. [January 25, 2008 - Press Release - Baxter Healthare] [January 17, 2008 - Recall Notice - Baxter Healthcare]


Heparin and Normal Saline Pre-Filled Flushes Audience: Pharmacists, hospital risk managers, othe r healthcare professionals, patients [Posted 01/18/2008; updated 01/30/2008] AM2 PAT, In c., notified healthcare professionals and patients of a nationwi de recall of all lots of both Heparin and Normal Saline pre-filled f lushes. These products are distributed under two brand names, Sie rra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Sal ine. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) wa s contaminated with Serratia marcescens which has resulted in patient infections. This type of bacterial infection could present a se rious adverse health consequence that could lead to life- threatening injuries and/or death. User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and re turn the product to their respective distributor. For a complete lis t of the recalled products, see the Recall Notice. [January 30, 2008 - Class 1 Recall - FDA] [January 25, 2008 - News Release - FDA] [January 18, 2008 - Press Release - AM2 PAT, Inc.] [January 18, 2008 - Press Release - B. Braun] Previous MedWatch alert: [December 21, 2007 ]

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Cough and Cold Medications in Children Less Than Tw o Years of Age Audience: Consumers, pediatric and primary care hea lthcare professionals [Posted 01/17/2008] FDA informed consumers and heal thcare professionals that the Agency has completed its rev iew of information regarding the safety of over-the-counte r (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat ch ildren in this age group because serious and potentially life-thre atening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 200 7, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about t he safety of OTC cough and cold medicines in children 2 through 11 y ears of age. See the FDA Public Health Advisory for Agency recommend ations regarding this issue. [January 17, 2008 - Public Health Advisory - FDA] Previous MedWatch alert: [Jan 12, 2007]


Edetate Disodium (marketed as Endrate and generic p roducts) Audience: Hospital Risk Managers, pharmacists, othe r healthcare professionals, patients [Posted 01/16/2008] FDA notified healthcare profess ionals and patients about important safety information concern ing Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodi um instead of Edetate Calcium Disodium (Calcium Disodium Versenat e) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Edetate Disodium was approved as an emergency treatment for certain patients with hypercalcemia (very high levels of calcium in the blood) or certa in patients with heart rhythm problems as a result of very high amou nts of digitalis in the blood. Edetate Calcium Disodium was approved to reduce dangerously high blood lead levels (severe lead poi soning).

The two drugs have very similar names and are commo nly referred to only as EDTA. As a result, the two products are easily mistaken for each other when prescribing, dispensing, and ad ministering them. Edetate Disodium and Edetate Calcium Disodium works by binding with heavy metals or minerals in the body a llowing them to be passed out of the body through the urine. Read t he FDA Public Health Advisory for recommended and important safet y considerations for healthcare professionals until t he FDA's ongoing evaluation of the risks and benefits of Edetate Dis odium is complete. [January 16, 2008 - Public Health Advisory - FDA] [January 16, 2008 - Questions and Answers - FDA]


Unretrieved Device Fragments Audience: Radiologists, surgeons, hospital risk man agers, other healthcare professionals [Posted 01/15/2008] FDA advised healthcare professi onals of serious adverse events associated with unretrieved device f ragments (UDFs). A UDF is a fragment of a medical device tha t has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The FDA Ce nter for Devices and Radiological Health receives nearly 1000 advers e event reports each year related to UDFs. The adverse events repor ted included local tissue reaction, infection, perforation and o bstruction of blood vessels, and death. Contributing factors may includ e biocompatibility of the device materials, location of the fragment, potential migration of the fragment, and patient an atomy. During MRI procedures, magnetic fields may cause metallic frag ments to migrate, and radiofrequency fields may cause them t o heat, causing internal tissue damage and/or burns. See the FDA Pu blic Health Notification for the Agency's recommendations regar ding this issue. [January 15, 2008 - Public Health Notification - FDA]

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Compounded Menopause Hormone Therapy Drugs Audience: Healthcare Professionals, patients [Posted 01/10/2008] FDA informed healthcare profess ionals and patients that the Agency sent letters warning seven pharmacy operations that the claims they make about the safe ty and

effectiveness of their so-called "bio-identical hor mone replacement therapy," or "BHRT" products are unsupported by med ical evidence, and are considered false and misleading by the agen cy. The pharmacy operations improperly claim that their dru gs, which contain hormones such as estrogen, progesterone, an d estriol (which is not a component of an FDA-approved drug a nd has not been proven safe and effective for any use) are sup erior to FDA-approved menopausal hormone therapy drugs and preve nt or treat serious diseases, including Alzheimer's disease, st roke, and various forms of cancer. FDA is concerned that the claims f or safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and oth er healthcare professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness. Patients who use compounded hormone therapy drugs s hould discuss menopausal hormone therapy options with the ir healthcare provider to determine if compounded drugs are the b est option for their specific medical needs. [January 09, 2008 - News Release - FDA]


Bisphosphonates (marketed as Actonel, Actonel+Ca, A redia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)

Audience: Orthopedic Surgeons, other healthcare providers, pa tients [Posted 01/07/2008] FDA informed healthcare profess ionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain i n patients taking bisphosphonates. Although severe musculoskeletal pa in is included in the prescribing information for all bisphosphona tes, the association between bisphosphonates and severe musc uloskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and n ecessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphon ates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others ha ve reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphos phonates are unknown. Healthcare professionals should consider whether bi sphosphonate use might be responsible for severe musculoskeleta l pain in patients

who present with these symptoms and consider tempor ary or permanent discontinuation of the drug. [January 07, 2008 - Drug Information page - FDA]

Agricultural Chemical Industry Sector Notebook Project

EPA Office of Compliance Sector Notebook Project

Profile of the Agricultural Chemical, Pesticide, and Fertilizer Industry

September 2000

Office of ComplianceOffice of Enforcement and Compliance Assurance

United States Environmental Protection Agency1200 Pennsylvania Avenue, NW (MC 2221-A)

Washington, DC 20460


This report is one in a series of volumes published by the United States Environmental Protection Agency (EPA) to provide information of general interest regarding environmental issues associated with specific industrial sectors. The documents were developed under contract by Abt Associates (Cambridge, MA), Science Applications International Corporation (McLean, VA), and Booz-Allen &Hamilton, Inc. (McLean, VA). A listing of available Sector Notebooks is included on the following page.

Obtaining copies:

Electronic versions ofall sector notebooks are available via Internetonthe Enviro$en$e World Wide Web at www.epa.gov/oeca/sector. Enviro$en$e is a free, public, environmental exchange system operated by EPA's Office of Enforcement and Compliance Assurance and Office of Research and Development. The Network allows regulators, the regulated community, technical experts, and the general public to share information regarding: pollution prevention and innovative technologies; environmental enforcement and compliance assistance; laws, executive orders, regulations, and policies; points of contact for services and equipment; and other related topics. The Network welcomes receiptofenvironmental messages, information, and data fromanypublic or private person or organization. Direct technical questions to the “Feedback” button on the bottom of the web page.

Purchase printed bound copies fromthe Government Printing Office (GPO) byconsulting the order form at the back of this document or order via the Internet by visiting the on-line GPO Sales Product Catalog at https://orders.access.gpo.gov/su_docs/sale/prf/prf.html. Search using the exact title of the document “Profile of the XXXX Industry” or simply “Sector Notebook.” When ordering, use the GPO document number found in the order form at the back of this document.

Complimentary volumes are available to certain groups or subscribers, including public and academic libraries; federal, state, tribal, and local governments; and the media from EPA’s National Service Center for Environmental Publications at (800) 490-9198. When ordering, use the EPA publication number found on the following page.

The Sector Notebooks were developed by the EPA’s Office of Compliance. Direct general questions about the Sector Notebook Project to:

Seth Heminway, Coordinator, Sector Notebook ProjectUS EPA Office of Compliance1200 Pennsylvania Avenue, NW (2223-A)Washington, DC 20460(202) 564-7017

For further information, and for answers to questions pertaining to these documents, please refer to the contact names listed on the following page.

Sector Notebook Project i September 2000


SECTOR NOTEBOOK CONTACTS

Questions and comments regarding the individual documents should be directed to the specialists listed below. See the Notebook web page at: www.epa.gov/oeca/sector for the most recent titles and staff contacts.

EPA Publication Number Industry Contact Phone (202)

EPA/310-R-95-001. Profile of the Dry Cleaning Industry Joyce Chandler 564-7073EPA/310-R-95-002. Profile of the Electronics and Computer Industry* Steve Hoover 564-7007EPA/310-R-95-003. Profile of the Wood Furniture and Fixtures Industry Bob Marshall 564-7021EPA/310-R-95-004. Profile of the Inorganic Chemical Industry* Walter DeRieux 564-7067EPA/310-R-95-005. Profile of the Iron and Steel Industry Maria Malave 564-7027EPA/310-R-95-006. Profile of the Lumber and Wood Products IndustrySeth Heminway564-7017EPA/310-R-95-007. Profile of the Fabricated Metal Products Industry*Scott Throwe564-7013EPA/310-R-95-008. Profile of the Metal Mining Industry Maria Malave 564-5027EPA/310-R-95-009. Profile of the Motor Vehicle Assembly Industry Anthony Raia 564-6045EPA/310-R-95-010. Profile of the Nonferrous Metals Industry Debbie Thomas 564-5041EPA/310-R-95-011. Profile of the Non-Fuel, Non-Metal Mining Industry Rob Lischinsky 564-2628EPA/310-R-95-012. Profile of the Organic Chemical Industry * Walter DeRieux 564-7067EPA/310-R-95-013. Profile of the Petroleum Refining Industry Tom Ripp 564-7003EPA/310-R-95-014. Profile of the Printing Industry Ginger Gotliffe 564-7072EPA/310-R-95-015. Profile of the Pulp and Paper Industry Seth Heminway 564-7017EPA/310-R-95-016. Profile of the Rubber and Plastic Industry 564-2310EPA/310-R-95-017. Profile of the Stone, Clay, Glass, and Concrete Ind.Scott Throwe564-7013EPA/310-R-95-018. Profile of the Transportation Equip. Cleaning Ind. Virginia Lathrop 564-7057EPA/310-R-97-001. Profile of the Air Transportation Industry Virginia Lathrop 564-7057EPA/310-R-97-002. Profile of the Ground Transportation Industry Virginia Lathrop 564-7057EPA/310-R-97-003. Profile of the Water Transportation Industry Virginia Lathrop 564-7057EPA/310-R-97-004. Profile of the Metal Casting Industry Steve Hoover 564-7007EPA/310-R-97-005. Profile of the Pharmaceuticals Industry Emily Chow 564-7071EPA/310-R-97-006. Profile of the Plastic Resin and Man-made Fiber Ind. Sally Sasnett 564-7074EPA/310-R-97-007. Profile of the Fossil Fuel Electric Power Generation Rafael Sanchez 564-7028

IndustryEPA/310-R-97-008. Profile of the Shipbuilding and Repair IndustryEPA/310-R-97-009. Profile of the Textile IndustryEPA/310-R-98-001. Profile of the Aerospace IndustryEPA/310-R-97-010. Sector Notebook Data Refresh-1997 **EPA/310-R-99-006. Profile of the Oil and Gas Extraction IndustryEPA/310-R-00-003. Profile of the Agricultural Chemical, Pesticide, and

Fertilizer Industry EPA/310-R-00-001 Profile of the Agricultural Crop Production Industry EPA/310-R-00-002 Profile of the Agricultural Livestock Production

Industry

Government Series EPA/310-R-99-001. Profile of Local Government Operations

* Spanish translations available.

Anthony Raia 564-6045 564-2310

Anthony Raia 564-6045 Seth Heminway 564-7017 Dan Chadwick 564-7054 Michelle Yaras 564-4153

Ginah Mortensen 913-551-5211 Ginah Mortensen 913-551-5211

564-2310

** This document revises compliance, enforcement, and toxic release inventory data for all profiles published in 1995.

Sector Notebook Project ii September 2000


TABLE OF CONTENTS

LIST OF FIGURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

LIST OF TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

LIST OF ACRONYMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

I. INTRODUCTION TO THE SECTOR NOTEBOOK PROJECT . . . . . . . . . . . . . . . . . . . . . . . . 1I.A. Summary of the Sector Notebook Project . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1I.B. Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

II. INTRODUCTION TO THE AGRICULTURAL CHEMICAL INDUSTRY . . . . . . . . . . . . . . . . 3II.A. Introduction, Background, and Scope of the Notebook . . . . . . . . . . . . . . . . . . . . . . . 3II.B. Characterization of the Fertilizer, Pesticide, and Agricultural Chemical Industry . . . 4

II.B.1. Product Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5II.B.2. Industry Size and Geographic Distribution . . . . . . . . . . . . . . . . . . . . . . . . 19II.B.3. Economic Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

III. INDUSTRIAL PROCESS DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27III.A. Nitrogenous Fertilizers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

III.A.1. Synthetic Ammonia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27III.A.2. Nitric Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32III.A.3. Ammonium Nitrate and Urea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

III.B. Phosphatic Fertilizers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40III.B.1. Phosphoric Acid (Wet Process) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40III.B.2. Ammonium Phosphate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43III.B.3. Normal Superphosphate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44III.B.4. Triple Superphosphate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

III.C. Fertilizer Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49III.D. Pesticide Formulating Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

III.D.1. Liquid Formulating and Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53III.D.2. Dry Formulating and Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54III.D.3. Aerosol Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56III.D.4. Pressurized Gas Formulating and Packaging . . . . . . . . . . . . . . . . . . . . . . 57III.D.5. Repackaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

III.E. Raw Material Inputs and Pollution Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59III.E.1. Fertilizers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59III.E.2. Pesticide Formulating, Packaging, and Repackaging . . . . . . . . . . . . . . . . 68

III.F. Management of Chemicals in Wastestream . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

IV. CHEMICAL RELEASE AND TRANSFER PROFILE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78IV.A. EPA Toxic Release Inventory for the Fertilizer, Pesticide, and Agricultural

Chemical Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81IV.B. Summary of Selected Chemicals Released . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95IV.C. Other Data Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99IV.D. Comparison of Toxic Release Inventory Between Selected Industries . . . . . . . . 101

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V. POLLUTION PREVENTION OPPORTUNITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104V.A. Equipment Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108V.B. Process Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112V.C. Good Housekeeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

VI. Summary of Applicable Federal Statutes and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . 120VI.A. General Description of Major Statutes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Imports and Exports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122VI.B. Industry Specific Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138VI.C. State Regulation of Pesticides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150VI.D. Pending and Proposed Regulatory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 152

VII. COMPLIANCE AND ENFORCEMENT HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155VII.A. Fertilizer, Pesticide, and Agricultural Chemical Industry Compliance History

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159VII.B. Comparison of Enforcement Activity Between Selected Industries . . . . . . . . . . 161VII.C. Review of Major Legal Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

VII.C.1. Review of Major Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166VII.C.2. Supplementary Environmental Projects (SEPs) . . . . . . . . . . . . . . . . . . 170

VIII. COMPLIANCE ASSURANCE ACTIVITIES AND INITIATIVES . . . . . . . . . . . . . . . . . . 171VIII.A. Sector-Related Environmental Programs and Activities . . . . . . . . . . . . . . . . . . 171VIII.B. EPA Voluntary Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173VIII.C. Trade Association/Industry Sponsored Activity . . . . . . . . . . . . . . . . . . . . . . . . 178

VIII.C.1. State Advisory Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178VIII.C.2. Trade Associations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

IX. CONTACTS/ACKNOWLEDGMENTS/RESOURCE MATERIALS . . . . . . . . . . . . . . . . . 187

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LIST OF FIGURES

Figure 1: Number of Facilities and Value of Shipments of the Fertilizer, Pesticide, and Agricultural Chemical Manufacturing Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Figure 2: Product Distribution for SIC 2873, Nitrogenous Fertilizers . . . . . . . . . . . . . . . . . . . . 9Figure 3: Product Distribution for SIC 2874, Phosphorous Fertilizers . . . . . . . . . . . . . . . . . . 11Figure 4: Product Distribution for SIC 2879, Pesticides and Miscellaneous Agricultural

Chemicals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Figure 5: Geographic Distribution of the Fertilizer Industry (SIC 2873, 2874, 2875) . . . . . . . 20Figure 6: Geographic Distribution of the Pesticide Formulating and Miscellaneous

Agrichemical Formulating Facilities (SIC 2879) . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Figure 7: Typical Process of Ammonia Synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Figure 8: Typical Process of Dual-Stage, Weak Nitric Acid Production . . . . . . . . . . . . . . . . . 35Figure 9: Typical Process Diagram of High Strength Nitric Acid Production . . . . . . . . . . . . . 36Figure 10: Typical Process for Ammonium Nitrate and Urea Manufacturing . . . . . . . . . . . . . . . 39Figure 11: Typical Process of a Wet Process Dihydrate Phosphoric Acid Plant . . . . . . . . . . . . 42Figure 12: Typical Vacuum Evaporator Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Figure 13: Simplified Process Flow Diagram of Diammnonium Phosphate Production . . . . . . . 44Figure 14: Typical Process for Normal Superphosphate Manufacturing . . . . . . . . . . . . . . . . . . 46Figure 15: Typical Process for Triple Superphosphate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Figure 16: Typical Process for Liquid Formulating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Figure 17: Typical Process for Dry Formulating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Figure 18: Raw Material Flowchart for Principal Fertilizer Materials . . . . . . . . . . . . . . . . . . . 59Figure 19: Summary of 1995 TRI Releases and Transfers by Industry . . . . . . . . . . . . . . . . . . . 102

Sector Notebook Project v September 2000


LIST OF TABLES

Table 1: Nitrogenous Fertilizer Products (SIC 2873) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Table 2: Phosphatic Fertilizer Products (SIC 2874) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Table 3: 1990 Direct vs Mixed Application of Primary Fertilizer Nutrients . . . . . . . . . . . . . . 12Table 4: SIC 2879 Pesticides and Miscellaneous Agricultural Chemicals, List of Products . 13Table 5: Establishment Counts Based on Product Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Table 6: Facility Size Distribution for the Fertilizer, Pesticide, and Agricultural Chemical

Manufacturing Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Table 7: States with the Largest Number of Fertilizer Manufacturing Facilities . . . . . . . . . . . 21Table 8: Top United States Agricultural Chemical Companies . . . . . . . . . . . . . . . . . . . . . . . . 23Table 9: Fertilizer Materials Used in Bulk Blends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Table 10: Approximate Quantities of Most Commonly Used Conventional Pesticides in United

States Agricultural Crop Production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Table 11: Summary of Potential Pollution Outputs for the Agricultural Chemical Industry . . . . 73Table 12: Source Reduction and Recycling Activity for the Fertilizer Industry as Reported

within TRI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75Table 13: Source Reduction and Recycling Activity for the Pesticide and Miscellaneous

Agricultural Chemicals Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76Table 14: 1996 TRI Releases for Agricultural Chemicals Facilities (SICs 2873,2874,2875)

by Number of Facilities Reporting (Releases reported in pounds/year) . . . . . . . . . . 84Table 15: 1996 TRI Transfers for Agricultural Chemicals Facilities (SICs 2873,2874,2875)

by Number and Facilities Reporting (Transfers reported in pounds/year) . . . . . . . . 85Table 16: 1996 TRI Releases for Agricultural Chemicals Facilities (SIC 2879) by Number of

Facilities Reporting (Releases reported in pounds/year) . . . . . . . . . . . . . . . . . . . . . 86Table 17: 1996 TRI Transfers for Agricultural Chemicals Facilities (SIC 2879)

by Number and Facilities Reporting (Transfers reported in pounds/year) . . . . . . . . 89Table 18: Top 10 TRI Releasing Fertilizer Manufacturing and Mixing Facilities

(SIC 2873, 2874, 2875) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Table 19: Top 10 TRI Releasing Facilities Reporting Fertilizer Manufacturing and Mixing SIC

Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Table 20: Top 10 TRI Releasing Pesticide and Miscellaneous Agricultural Chemicals Facilities

(SIC 2879) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94Table 21: Top 10 TRI Releasing Facilities Reporting Pesticide and Miscellaneous Agricultural

Chemicals SIC Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94Table 22: Air Pollutant Releases by Industry Sector (tons/year) . . . . . . . . . . . . . . . . . . . . . . . 100Table 23: 1995 Toxics Release Inventory Data for Selected Industries . . . . . . . . . . . . . . . . . 102Table 24: Waste Minimization Methods for the Fertilizer, Pesticide, and Agricultural Chemical

Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Table 25: Five-Year Enforcement and Compliance Summary for the Fertilizer, Pesticide, and

Agricultural Chemical Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160Table 26: Five-Year Enforcement and Compliance Summary for Selected Industries . . . . . . 162Table 27: One-Year Enforcement and Compliance Summary for Selected Industries . . . . . . . 163Table 28: Five-Year Inspection and Enforcement Summary by Statute for Selected

Industries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164Table 29: One-Year Inspection and Enforcement Summary by Statute for Selected

Industries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

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Table 30: Fertilizer, Pesticide, and Agricultural Chemical Industry Participation in the 33/50 Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

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LIST OF ACRONYMS

AAEA American Agricultural Economics AssociationAAPCO Association of American Pesticide Control OfficialsAAPFCO Association of American Plant Food Control OfficialsACPA American Crop Protection AssociationAFS AIRS Facility Subsystem (CAA database)AI Active IngredientAIRS Aerometric Information Retrieval System (CAA database)ASA American Society of AgronomyBIFs Boilers and Industrial Furnaces (RCRA)BOD Biochemical Oxygen Demand CAA Clean Air ActCAAA Clean Air Act Amendments of 1990CERCLA Comprehensive Environmental Response, Compensation and Liability ActCERCLIS CERCLA Information SystemCFA California Fertilizer AssociationCFCs ChlorofluorocarbonsCMA Chemical Manufacturers AssociationCO Carbon Monoxide COD Chemical Oxygen Demand CSI Common Sense Initiative CSMA Chemical Specialties Manufacturers AssociationCWA Clean Water ActDAP Diammonium PhosphateDOT Department of TransportationD&B Dun and Bradstreet Marketing IndexEPA United States Environmental Protection AgencyEPCRA Emergency Planning and Community Right-to-Know ActFFDCA Federal Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide ActFINDS Facility Indexing SystemFIRT Fertilizer Industry Round TableFQPA Food Quality Protection ActHAPs Hazardous Air Pollutants (CAA)HSDB Hazardous Substances Data Bank IDEA Integrated Data for Enforcement AnalysisIFDC International Fertilizer Development CenterLDR Land Disposal Restrictions (RCRA)LEPCs Local Emergency Planning Committees MACT Maximum Achievable Control Technology (CAA)MAP Monoammonium PhosphateMCLGs Maximum Contaminant Level Goals MCLs Maximum Contaminant LevelsMEA Monoethanolamine MEK Methyl Ethyl KetoneMSDSs Material Safety Data Sheets

Sector Notebook Project viii September 2000


NACD National Association of Chemical DistributorsNASDA National Association of State Departments of AgricultureNASHA North American Horticultural Supply Association NCDB National Compliance Database (for TSCA, FIFRA, EPCRA)NCP National Oil and Hazardous Substances Pollution Contingency Plan NEC Not Elsewhere ClassifiedNEIC National Enforcement Investigation Center NESHAP National Emission Standards for Hazardous Air PollutantsNO2 Nitrogen DioxideNOV Notice of Violation NOX Nitrogen Oxide NPCA National Pest Control AssociationNPDES National Pollution Discharge Elimination System (CWA)NPK Nitrogen-Phosphorous-PotassiumNPL National Priorities List NRC National Response Center NRDC National Resources Defense CouncilNSP Normal SuperphosphateNSPS New Source Performance Standards (CAA)OECA Office of Enforcement and Compliance AssuranceOMB Office of Management and BudgetOPA Oil Pollution ActOPPTSOffice of Prevention, Pesticides, and Toxic SubstancesOSHA Occupational Safety and Health Administration OSW Office of Solid WasteOSWER Office of Solid Waste and Emergency ResponseOW Office of WaterP2 Pollution PreventionPCS Permit Compliance System (CWA Database)PRP Potentially Responsible PartyPOTW Publicly Owned Treatments Works PPI Potash and Phosphate InstituteRCRA Resource Conservation and Recovery ActRCRIS RCRA Information SystemSARA Superfund Amendments and Reauthorization Act SDWA Safe Drinking Water ActSEPs Supplementary Environmental Projects SERCs State Emergency Response Commissions SFIREG State FIFRA Issues Research and Evaluation GroupSIC Standard Industrial Classification SO2 Sulfur Dioxide SOX Sulfur OxidesTOC Total Organic Carbon TFI The Fertilizer Institute TRI Toxic Release InventoryTRIS Toxic Release Inventory System TCRIS Toxic Chemical Release Inventory System

Sector Notebook Project ix September 2000


TSCA Toxic Substances Control ActTSP Triple SuperphosphateTSS Total Suspended Solids TVA Tennessee Valley AuthorityUIC Underground Injection Control (SDWA)UPFDA United Products Formulators and Distributors AssociationUSDA United States Department of AgricultureUST Underground Storage Tanks (RCRA)VOCs Volatile Organic CompoundsWCPA Western Crop Protection Association

Sector Notebook Project x September 2000


I. INTRODUCTION TO THE SECTOR NOTEBOOK PROJECT

I.A. Summary of the Sector Notebook Project

Integrated environmental policies based upon comprehensive analysis of air, water and land pollution are a logical supplement to traditional single-media approaches to environmental protection. Environmental regulatory agencies are beginning to embrace comprehensive, multi-statute solutions to facility permitting, enforcement and compliance assurance, education/outreach, research, and regulatory development issues. The central concepts driving the new policy direction are that pollutant releases to each environmental medium (air, water and land) affect each other, and that environmental strategies must actively identify and address these inter-relationships by designing policies for the “whole” facility. One way to achieve a whole facility focus is to design environmental policies for similar industrial facilities. By doing so, environmental concerns that are common to the manufacturing of similar products can be addressed in a comprehensive manner. Recognition of the need to develop the industrial “sector-based” approach within the EPA Office of Compliance led to the creation of this document.

The Sector Notebook Project was originally initiated by the Office of Compliance within the Office of Enforcement and Compliance Assurance (OECA) to provide its staff and managers with summary information for eighteen specific industrial sectors. As other EPA offices, states, the regulated community, environmental groups, and the public became interested in this project, the scope of the original project was expanded to its current form. The ability to design comprehensive, common sense environmental protection measures for specific industries is dependent on knowledge of several inter-related topics. For the purposes of this project, the key elements chosen for inclusion are: general industry information (economic and geographic);a descriptionof industrial processes; pollution outputs; pollution prevention opportunities; federal statutory and regulatory framework; compliance history; and a description of partnerships that have been formed between regulatory agencies, the regulated community and the public.

For any given industry, each topic listed above could alone be the subject of a lengthy volume. However, in order to produce a manageable document, this project focuses on providing summary information for each topic. This format provides the reader with a synopsis of each issue, and references where more in-depth information is available. Text within each profile was researched froma variety of sources, and was usually condensed from more detailed sources pertaining to specific topics. This approach allows for a wide coverage of activities that can be further explored based upon the citations and references listed at the end of this profile. As a check on the informationincluded, eachnotebookwent through an external review process. The Office of Compliance appreciates the efforts ofall those thatparticipated

Sector Notebook Project 1 September 2000


in this process who enabled us to develop more complete, accurate and up-todate summaries. Many of those who reviewed this notebook are listed as contacts in Section IX and may be sources of additional information. The individuals and groups on this list do not necessarily concur with all statements within this notebook.

I.B. Additional Information

Providing Comments

OECA’s Office of Compliance plans to periodically review and update the notebooks and will make these updates available both in hard copy and electronically. If you have any comments on the existing notebook, or if you would like to provide additional information, please send a hard copy and computer disk to the EPA Office of Compliance, Sector Notebook Project (2223-A), 1200 Pennsylvania Avenue, NW, Washington, DC 20460. Comments can also be uploaded to the Enviro$en$e World Wide Web for general access to all users of the system. Follow instructions in Appendix A for accessing this system. Once you have logged in, procedures for uploading text are available from the on-line Enviro$en$e Help System.

Adapting Notebooks to Particular Needs

The scope of the industry sector described in this notebook approximates the national occurrence of facility types within the sector. In many instances, industries within specific geographic regions or states may have unique characteristics that are not fully captured in these profiles. The Office of Compliance encourages state and local environmental agencies and other groups to supplement or repackage the information included in this notebook to include more specific industrial and regulatory information that may be available. Additionally, interested states may want to supplement the “SummaryofApplicable Federal Statutes and Regulations” sectionwith state and local requirements. Compliance or technical assistance providers may also want to develop the “Pollution Prevention” section in more detail. Please contact the appropriate specialist listed on the opening page of this notebookif your office is interested in assisting us in the further development of the information or policies addressed within this volume. If you are interested in assisting in the development of new notebooks for sectors not covered in the original eighteen, please contact the Office of Compliance at 202-564-2310.


Agricultural Chemical Industry Introduction and Scope

II. INTRODUCTION TO THE AGRICULTURAL CHEMICAL INDUSTRY

This section provides background information on the size, geographic distribution, employment, production, sales, and economic condition of the fertilizer, pesticide, and agricultural chemical industry. Facilities described within this document are described in terms of their Standard Industrial Classification (SIC) codes whenever possible.

II.A. Introduction, Background, and Scope of the Notebook

The scope of this Sector Notebook covers the manufacturing and production of fertilizers, the formulation of pesticide chemicals (both agricultural and non-agricultural) manufactured at separate facilities, and the production of other miscellaneous agricultural chemicals. It does not include the use, sale, distribution, or storage of such chemicals.

The Fertilizer, Pesticide, and Agricultural Chemical Industry is classified by the Office of Management and Budget (OMB) under Standard Industrial Classification (SIC) Industry Group Number 287. This classification corresponds to SIC codes which were established by the OMB to track the flow of goods and services within the economy. Industry Group Number 287 includes SIC codes:

2873-- Nitrogenous Fertilizers 2874-- Phosphatic Fertilizers2875-- Fertilizers, Mixing Only2879-- Pesticides and Agricultural Chemicals, Not Elsewhere Classified (n.e.c)

This notebook covers both fertilizer manufacturing and formulating operations including ammonia synthesis, nitric and phosphoric acid production, and the mixing, preparing, and packaging of nitrogenous and phosphatic fertilizers. Establishments engaged in manufacturing fertilizer materials or mixing fertilizers produced at the same establishment are classified under SIC codes 2873 and 2874. Mixing of fertilizer materials, such as compost, potting soil, and fertilizers made in plants not manufacturing fertilizer materials, is classified under SIC code 2875. This notebook does not include the mining or grinding of phosphate rock, which is classified under SIC code 1475, and it also does not include the use or application of fertilizers.

SIC code 2879, pesticides and agricultural chemicals notelsewhere classified (n.e.c.), hereafter referred to as pesticides and miscellaneous agricultural chemicals, covers onlythe formulating, preparing, and packaging of ready-to-use agricultural and household pestcontrol chemicals. This industry code also includes establishments primarily engaged in the manufacturingor formulating of agricultural chemicals, not elsewhere classified, such as minor or trace elements and soil conditioners. This notebook does not discuss the use or



application of pesticide products. Establishments primarily engaged in the manufacturing of basic or technical agricultural pesticides are classified in IndustryGroup 281 if the chemicals produced are inorganic or IndustryGroup 286 if the chemicals produced are organic. This notebook also does not cover the agricultural supply sector, SIC 5191, which is engaged in the wholesale and distribution of various agricultural supplies including fertilizers and pesticides. Also, there is little discussion of the potassium fertilizer industry as potash is classified under SIC 2819, Inorganic Chemicals n.e.c.

Federal government agencies, including United States EPA, are beginning to implement an industrial classification system developed by OMB to replace the SIC code system. The new system, which is based on similar production processes, is called the North American Industrial Classification System (NAICS). In the NAIC system, the manufacturing of nitrogenous fertilizers (SIC 2873) is classified as NAIC 325311, phosphatic fertilizers (SIC 2874) as NAIC 325312, and fertilizer mixing only (SIC 2875) as NAIC 325314. Pesticide formulating and agricultural chemicals n.e.c. (SIC 2879) is classified under NAIC 32532. Because EPA databases, and other databases used in this document, are still using the SIC system, the industry sectors described in this Sector Notebook are described in terms of their SIC codes.

II.B. Characterization of the Fertilizer, Pesticide, and Agricultural Chemical Industry

As the world population increases, crop lands are unable to meet the growing demand for food without employing some method of crop enhancement. There are five common practices used to meet the growing demand:

C increasing tilled acreageC improving plant strainsC introducing or expanding irrigationC controlling pest by chemical or biological methodsC initiating or increasing fertilizer usage

Increased utilization of the last two methods has created a large agrichemical industry which produces a wide variety of products designed to increase crop production and protect crops fromdisease and pests (Kent, 1992). Together, the production of fertilizers and the formulation of pesticides was a $18.8 billion industry in 1992, employing over 40,000 people (USDOC, 1995).

Plants require 18 elements to grow, the most important being oxygen, carbon, hydrogen, nitrogen, phosphorous, and potassium. Oxygen, carbon, and hydrogen are obtained from the atmosphere and water, while nitrogen, phosphorous, and potassium are naturallyobtained fromsoil. However, under current high yield production methods, soils are stripped of the essential nutrients, requiring the additionoffertilizers (primarilyconsisting of nitrogen, phosphorous, and potassium) to resupply the land. The additional 12 essential nutrients are generally maintained in soil at sufficient levels for plant growth,



but they may be added to some fertilizers (Kent, 1992).

Even before the addition of nutrients to farm lands, farmers were forced to protect their crops againstpests withchemicals. References to pesticide usage date backto 1000 B.C. Pests are continuously adapting to pesticide chemicals requiring new pesticides and the usage of multiple chemical agents. The industry is rapidly changing due to biological adaptation of pests, laboratory discoveries, and government regulation (Kent, 1992). The pesticide industry is faced with the need for new formulations and the abundance of possible combinations, but restricted by cost factors and a sometimes lengthy registration process.

Pesticides are applied on about three-quarters of United States farms and households. Farmers’ expenditures on pesticides were equal to 4.6 percent of total farm production expenditures in 1995, up from 3.9 percent in 1993. About one billion pounds of active ingredient of conventional pesticides are used annually in the United States; this usage involves about 21,000 pesticide products (including non-agricultural products) and 875 active ingredients registered under the Federal Pesticide Law, according to the 1994 and 1995 Market Estimates for Pesticides Industry Sales and Usage (Aspelin, 1997).

II.B.1. Product Characterization

This notebook covers all aspects of fertilizer production and pesticide formulating and packaging. However, because the industrial processes, pollutant outputs, economics, size, and geographic distribution of the two industries are different, theyare dealt with separately throughout the notebook.

Figure 1 compares the number of manufacturing facilities and value of shipments for each of the major sectors within the Fertilizer, Pesticide, and Agricultural Chemical Industry, as reported by the United States Bureau of Census. The figure shows that the fertilizer mixing industry has the largest number of facilities but the smallest value of shipments. This reflects that, compared to other sub-sectors withinthe Fertilizer, Pesticide and Agricultural Chemical Industry, these facilities produce a relatively small volume of product and sell a relatively low value product. Phosphatic fertilizer producers, on the other hand, comprise the smallest number of facilities but have a relatively large share of the industry’s value of shipments, reflecting that individual facilities produce a relatively large volume of product.



Figure 1: Number of Facilities and Value of Shipments of the Fertilizer, Pesticide, and Agricultural Chemical Manufacturing Industry

Source: 1992 Census of Manufacturers, Industry Series: Agricultural Chemicals, United States Department of Commerce, Bureau of the Census, May 1995. * United States EPA has identified over 8,000 establishments that could fall within this SIC code as it is defined by the OMB. See discussion in text below.

The Census of Manufacturers reports 263 establishments that can be defined as producing pesticides and miscellaneous agricultural chemicals. These establishments reportedly account for almosthalfof the value of shipments for the sector. There are over 8,000 establishments identified by the United States EPA thatmanufacture, formulate and package pesticides and other agricultural chemicals and thatcould fall withinOMB’s SIC code definitionfor this sector. Manyof these are small establishments and establishments thathave a primary line of business other than producing pesticides and other miscellaneous agricultural chemicals. The Census only counts those facilities which report an SIC code as their primary line of business, thus the number of facilities shownabove is notinclusive ofall facilities involved in agricultural chemical production. Under the “Pesticides and Miscellaneous Agricultural Chemicals” heading later in this section, other pesticide producing establishment counts are presented based on EPA estimates and reporting under section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act.



Nitrogenous Fertilizers

The nitrogenous fertilizer industry includes the production of synthetic ammonia, nitric acid, ammonium nitrate, and urea. Synthetic ammonia and nitric acid, however, are used primarily as intermediates in the production of ammonium nitrate and urea fertilizers. Table 1 lists specific products classified as nitrogenous fertilizers by OMB.

Table 1: Nitrogenous Fertilizer Products (SIC 2873)

Ammonia liquor Ammonium nitrate Ammonium sulfate Anhydrous ammonia Aqua ammonia Fertilizers, mixed, produced in nitrogenous fertilizer plants Fertilizers, natural Nitric acid Nitrogen fertilizer solutions Plant foods, mixed in nitrogenous fertilizer plants Urea

Source: Standard Industrial Classification Manual, Office of Management and Budget, 1987.

Synthetic Ammonia Synthetic ammonia refers to ammonia that has been synthesized from natural gas. In this process, natural gas molecules are reduced to carbon and hydrogen. The hydrogen is then purified and reacted with nitrogen to produce ammonia. Approximately 75 percent of the synthetic ammonia produced in the United States is used as fertilizer, either directlyas ammonia or indirectlyafter fertilizer synthesis into urea, ammonium nitrate, and monoammonium or diammonium phosphates. One-third of the fertilizer nitrogen is applied directly to the land as anhydrous ammonia. The remaining 25 percent of ammonia produced in the United States is used as raw material in the manufacture of polymeric resins, explosives, nitric acid, and other products (USEPA, 1993a).

Nitric AcidNitric acid is formed by concentration, absorption, and oxidation of anhydrousammonia. About 70 percent of the nitric acid produced is consumed as anintermediate in the manufacture of ammonium nitrate (NH4NO3), which isprimarily used in fertilizers. Another 5 to 10 percent of the nitric acidproduced is used in adipic acid manufacturing, an intermediate in nylonproduction. Explosive manufacturing utilizes nitric acid for organic nitrationsto produce nitrobenzene, dinitrotoluenes, and other chemical intermediates.Other end uses ofnitric acid are gold and silver separation, militarymunitions,



steel and brass pickling, photoengraving, and acidulation of phosphate rock (USEPA, 1993a).

Ammonium Nitrate Ammonium nitrate is produced by neutralizing nitric acid with ammonia. Approximately 15 to 20 percent of ammonium nitrate is used for explosives and the balance for fertilizer. Ammonium nitrate is marketed in several forms, depending upon its use. Liquid ammonium nitrate may be sold as a fertilizer, generally in combination with urea. Liquid ammonium nitrate may also be concentrated to form an ammonium nitrate “melt” for use in solids formation processes. Solid ammonium nitrate may be produced in the form of prills, grains, granules or crystals. Prills, round or needle-shaped aggregates, canbe produced in either high or low density form, depending on the concentration of the melt. High density prills, granules and crystals are used as fertilizer, grains are used solely in explosives, and low density prills can be used as either fertilizer or explosives (USEPA, 1993a).

UreaUrea, also knownas carbamide or carbonyl diamide, is produced by reactingammonia with carbon dioxide. Eighty-five percent of urea solution producedis used in fertilizer mixtures, with three percent going to animal feedsupplements and 12 percent is used for plastics and other uses. Urea ismarketed as a solution or in solid form. Most solids are produced as prills orgranules for use as fertilizer or protein supplement in animal feed, and inplastics manufacturing (USEPA, 1993a).

Ammonium sulfateIt is not economically feasible to produce ammonium sulfate for use as afertilizer. However, ammonium sulfate is formed as a by-product of otherprocess such as acid scrubbing of coke oven gas, synthetic fiber production,and the ammoniation of process sulfuric acid (Hoffmeister, 1993). Therefore,the production of ammonium sulfate is not described in this notebook.



Figure 2: Product Distribution for SIC 2873, Nitrogenous Fertilizers

Source: Fertilizer Institute data as reported in Chemical and Engineering News, June 23, 1998. Figures are based on Fertilizer Institute surveys and may not represent the entire industry.

Phosphatic Fertilizers

The phosphatic fertilizer industry can be divided into three major segments: phosphoric acid, granular ammonium phosphate, and normal and triple superphosphate. Table 2 lists these, and a few additional, less common products classified as phosphatic fertilizers by OMB.

Table 2: Phosphatic Fertilizer Products (SIC 2874)

Ammonium phosphates Calcium meta-phosphates Defluorinated phosphates Diammonium phosphates Fertilizers, mixed, produced in phosphatic fertilizer plants Phosphoric acid Plant foods, mixed in phosphatic fertilizer plants Superphosphates, ammoniated and not ammoniated




Phosphoric AcidPhosphoric acid (H3PO4) can be manufactured using either a wet or a thermalprocess to react phosphate rock with sulfuric acid. Approximately 96 percentof the phosphoric acid produced in the United States is produced using the wetprocess. Wet process phosphoric acid has a phosphorous concentrationtypically ranging from 26-30% as phosphorous pentoxide (P2O5) and is usedin the production of ammonium phosphates and triple superphosphates.Thermal process phosphoric acid is commonlyused in the manufacture of highgrade chemicals requiring a much higher purity.

Ammonium Phosphates Ammonium phosphate (NH4H2PO4) is produced by reacting phosphoric acid with anhydrous ammonia. Both solid and liquid ammonium phosphatic fertilizers are produced in the United States The most common ammonium phosphatic fertilizer grades are monoammonium phosphate (MAP) and diammonium phosphate (DAP). DAP has become one of the most commonly used fertilizers because it provides a large quantity of plant food, is compatible with most mix fertilizer ingredients, and is nonexplosive. It may be directly applied or used in irrigation systems as it is completely soluble in water. DAP is also preferred over MAP because it is capable of fixing twice as much ammonia per phosphorous pentoxide in solid form (Nielson, 1987.) MAP contains a higher concentration of phosphorous pentoxide than DAP. It is favored for use with alkaline soils and may be applied either directly or in a dry blend.

Normal Superphosphates Like phosphoric acid, normal, or “ordinary,” superphosphate fertilizers are produced by reacting phosphate rock with sulfuric acid. However, normal superphosphate (NSP) retains calcium sulfate which forms by the reaction between phosphate rock and sulfuric acid. For this reason NSP retains its importance wherever sulphur deficiency limits crop yields (UNEP, 1996). NSP refers to fertilizer material containing 15 to 21 percent phosphorous as phosphorous pentoxide (P2O5). As defined by the Census Bureau, NSP contains not more than 22 percent of available P2O5 (USEPA, 1993a). ProductionofNSP has givenwayto the higher-yielding triple superphosphates and ammonium phosphates. In 1990, production of NSP accounted for only one percent by weight of the phosphorous fertilizer industry. Because of its low P2O5 concentration, shipping can be prohibitively expensive due to the large volumes required. NSP is favored in low cost Nitrogen-Phosphorous-Potassium (NPK) mixes because it is a less expensive form of phosphorous, however, it is unacceptable for higher-grade mixes (Kent, 1992).

Triple SuperphosphatesTriple superphosphates (TSP) are produced by reacting ground phosphate rockwith phosphoric acid. Triple superphosphate is also knownas double, treble,or concentrated superphosphate. The phosphorus content of triplesuperphosphates is over 40 percent, measured as phosphorus pentoxide (P2O5),



whichis its mainadvantage over other phosphatic fertilizers (USEPA, 1993a). TSP began to be produced in large quantities when wet process phosphoric acid production became available commercially. It is commonly produced along with phosphoric acid near phosphate rock supplies. TSP may be applied directly or as a bulk blend (Kent, 1992).

Figure 3: Product Distribution for SIC 2874, Phosphorous Fertilizers

Source: Chemical and Engineering News, June 23, 1998. Figures are based on Fertilizer Institute surveys and may not represent the entire industry.

Fertilizers, Mixing Only

A significant part of the fertilizer industry only purchases fertilizer materials in bulk from fertilizer manufacturing facilities and mixes them to sell as a fertilizer formulation.

Phosphorous is the single nutrient most likely to be applied in a fertilizer mixture, as seen in Table 3.



Table 3: 1990 Direct vs Mixed Application of Primary Fertilizer Nutrients

Nutrient

Method, % applied

Direct Mixtures

Nitrogen 80 20

Phosphorous 8 92

Potassium 65 35

TOTAL 61 39

Source: Hoffmeister, G., “Fertilizers,” Kirk-Othmer Encyclopedia of Chemical Technology, V. 10, 1993.

Although the Bureau of the Census onlycounts 401 facilities reporting the SIC code for fertilizer mixing (2875) in 1992, other sources estimated the true number of fertilizer mixing facilities to be closer to five or six thousand in 1984 (Adrilenas and Vroomen, 1990). About half of applied fertilizers are bulk blends. Fertilizer mixing facilities generally serve a small area such as farms within a tento fifty mile radius. The processes involved are simple and relatively little value is added to the raw materials purchased by mixing facilities. Nevertheless, there are many of these facilities and volume of production results in a $1.8 billion industry (value of annual shipments). The industrial process is simple and resembles that of the pesticide formulating sector. A brief discussion of fertilizer mixing processes is included in this notebook.

Pesticides and Miscellaneous Agricultural Chemicals

The pesticides and agricultural chemicals n.e.c. (referred to here as pesticides and miscellaneous agricultural chemicals) industry group (SIC 2879) formulates and prepares ready to use agricultural and household pesticides and other agricultural chemicals. The manufacture of pesticide active ingredients is classified under either Industry Group 281 for inorganic chemicals or 286 for organics which are not covered by this notebook. (See Profile of the Inorganic Chemicals Industry and Profile of the Organic Chemicals Industry Sector Notebooks.) In the United States, over 850 different pesticide formulations and preparations are produced. In 1995, 31 new active ingredients were registered in the United States (Aspelin, 1997). Mostof these pesticides can be classified as either insecticides, herbicides, or fungicides, although manyother minor classifications exist. Also included in this category are blends of fertilizers and pesticides produced at pesticide formulating and



mixing facilities. Table 4 lists the pesticides and other products included in SIC 2879.

Table 4: SIC 2879 Pesticides and Miscellaneous Agricultural Chemicals, List of Products

Agricultural disinfectants Agricultural pesticides Arsenates and arsenites Bordeaux mixture Cattle dips and sheep dips DDT Defoliants Fly sprays Fungicides Growth regulants Herbicides

Insecticides, agricultural and household Lime-sulfur, dry and solution Lindane, formulated Moth repellants Nicotine and salts Paris green Pesticides, household Phytoactin Plant hormones

Poison, household Pyrethrin Rodenticides Rotenone Soil conditioners Sulfur dust Thiocyanates Trace elements (agrichemical) Xanthone


In 1995, 77 percent (byvolume) ofall pesticides were used for agriculture, 12percent for industrial, commercial, or governmental lands or facilities, and 11percent for homes and gardens (Aspelin, 1997). Non-agricultural pesticidesand miscellaneous agricultural chemicals are included in the data presented forsales, production, waste management, and enforcement and compliance.However, since they represent a relatively small partof the industryand covera wide range of chemicals and production processes, these products are notcovered in the Industrial Processes and Pollutant Outputs sections of thisdocument.

HerbicidesHerbicides (inboth value and quantity) are the largest class of pesticides usedin the United States, as well as in the world. This class of pesticides, whichaccounts for approximately fifty percent of the value of aggregate worldpesticide usage, is used to destroy or control a wide variety of weeds andother unwanted plants. Because of its demonstrated farm labor savings, nearlyall the agricultural land in the United States is currently being treated withsome type of herbicide. In recent years, approximately fifty percent of totalUnited States pesticide consumption (by value) was herbicides (USITC,1994).

InsecticidesInsecticides are the second largest pesticide category (by value) used in theUnited States and in the world. In the early 1990s, insecticides accounted forapproximatelytwenty-nine percent of the total value of United States pesticideconsumption. Historically, the category of synthetic organic insecticides hasbeen divided into one of four major chemical groups:

C organochlorines (e.g., DDT and chlordane)



C organophosphates (e.g., parathion and diazinon)C carbamates (e.g., carbaryl)C pyrethroids (e.g., natural and synthetic)

Several compounds, discovered during the 1950s, found widespread use in agriculture because of their high toxicity to a variety of insects. However, the qualities that made these chemicals so desirable also led to their eventual removal fromthe market, as these products also proved harmful to humans and to the environment. Spurred in part by increased environmental concern, researchers developed a new series of less toxic synthetic compounds called pyrethroids. These compounds are based on the natural pyrethroids, which are found in such plants as the chrysanthemum (USITC, 1994).

Fungicides In recent years, fungicides accounted for approximately ten percent of the value of total United States pesticide consumption. Fungicides are used today primarily to protect agricultural crops and seeds from various fungi; farmers previously used inorganic products, such as elemental sulfur and copper sulfate. Initially, synthetic products were commercially unsuccessful, because of their high manufacturing costs. By the 1940s, however, newer, less expensive products became commercially successful. Today, fungicides are manufactured from a variety of chemical classes. Commercially, the most important fungicides are halogenated compounds, the carbamates and dithiocarbamates, and organophosphates (USITC, 1994).

Other PesticidesAlthough small in total quantity consumed, a number of other classes ofpesticide products are onthe market. Some of these pesticides are not coveredby this Notebook.

C Biologicalpesticides, also known as biopesticides, include true biological agents, living or reproduced biological entities suchas viruses or bacteria, and naturally occurring biochemicals such as plant growth regulators, hormones, and insect sexual attractants (pheromones) that function by modes of action other than innate toxicity. At the end of 1998, there were approximately 175 registered biopesticide active ingredients and 700 products. Generally, biological pesticides pose little or no risk to human health or the environment. Accordingly EPA generally requires much less data to register a biopesticide than to register a conventional pesticide (USEPA, 1999). To further facilitate the registration of biopesticides, in 1994, EPA established the Biopesticides and Pollution Prevention Division in the Office of Pesticide Programs.

C Plant growth regulators have been developed by many companies to improve crop production. Plant growth regulators are produced for a variety of purposes, including loosening ripened fruits for faster harvest; controlling the size and firmness of fruits; and regulating the size of a plant



to increase branching. These products account for a small portion of world and United States usage. Future development will probably be directed toward selected crops for whichthe applicationof these specialty products is found to be the most cost effective (USITC, 1994).

C Sex attractants may be used to attract insects to traps or to confuse specific male insects, making it difficult to locate females for mating. Commercially available sexual attractants are synthetically produced compounds. Insect growth regulators, such as juvenile growth hormones, are synthetic compounds similar to the natural chemicals that regulate insect growth.

C Genetically modified plants are plants developed through the use of biotechnology. There are three types of plants that are relevant to pest control: herbicide-tolerant plants (which can tolerate certain types of herbicides), insect-resistant plants (whichcanwithstand attacks bycertain insects), and virus- and other pest-resistant plants (which are immune to some types of plant viruses and other plant pests). As of September 1994, several genetically modified plants had been commercialized and had elicited optimism that genetically modified plants would become an important new approach to controlling pests (USDA, 1995).

The environmental benefits of reduced use of chemical pesticides are alsosignificant. Environmental side effects of traditional pesticides include thecost of providing alternative sources of drinking water, increased treatmentcosts for public and private water systems, lost boating and swimmingopportunities, worker safety concerns, exposure to nearby residents, increasedexposures for farm children, possible loss of biodiversity, pressure onthreatened and endangered species, and damage to recreational and fisheryresources (USDA, 1995).

Pesticide FormulationsPesticide formulations may exist in any of the three following physical states:liquid, dry, and pressurized gas. The liquid formulation may be applieddirectly in liquid form or propelled as an aerosol. Some common dry-basedformulations are dusts, wettable powders, granules, treated seed, bait pellets,encapsulated, and cubes. Pressurized gas formulations are used primarily forsoil fumigation (USEPA, 1996). Gaseous pesticides can be subjected to highpressures which oftenconvert the formulation to a liquid which can be stored,transported and applied from gas cylinders.

Repackaging of pesticide formulations is common when materials are to be transferred from bulk storage to a smaller scale of packaging for use by a consumer. Products are typically repackaged in smaller containers and consumer-specific labeling is added (USEPA, 1996).

In 1995, roughly 79 percent of all pesticides were used on agricultural



cropland. The remainder were used in private homes and gardens and on commercial and industrial property (Aspelin, 1997). Therefore, although non-agricultural pesticides are included in SIC code 2879 and thus the notebook, the specific packaging or formulating requirements of those products are not included. However, the sales, production, pollutant releases, and enforcement and compliance data reflectnon-agricultural pesticides as well as agricultural pesticides.

The majority of pesticides were used on only a few major crops: cotton, corn, soybeans, and apples. The major pesticide chemicals used in United States agricultural crop production are atrazine, metolachlor, metamsodium, methyl bromide1, and dichloropropene (Aspelin, 1997).

Figure 4: Product Distribution for SIC 2879, Pesticides and Miscellaneous Agricultural Chemicals

Source: American Crop Protection Association, as reported in Chemical and Engineering News, June 23, 1998.

Establishment Reporting Under FIFRA Section 7

Information reported under section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act(FIFRA) is another source of facility level data for the pesticides

1 Production and importation of methyl bromide is currently being phased out. It will be reduced from 1991 levels and will be completely phased out in 2005.



industry. All establishments that produce pesticides in the United States or that import pesticides into the United States are required to register and report their production volume to the EPA. These data differ from the Census of Manufacturers data presented above for the agricultural chemical industry as a whole. The Census of Manufacturers data only covers facilities that are manufacturing these products, while the FIFRA data systemmore broadly includes establishments that “produce” these products. The term, “produce” has been defined under FIFRA and 40 CFR Part 167 to mean “to manufacture, prepare, propagate, compound, or process any pesticide, including any pesticide produced pursuant to section 5 of FIFRA, any active ingredient, or device, or to package, repackage, label, relabel, or otherwise change the container of any pesticide or device.” Repackaging or otherwise changing the container of any pesticide or device in bulk amounts constitutes pesticide production. Under FIFRA section 7, products are reported under one of four product types:

1) Technical material or active ingredient 2) End-use blend, formulation, or concentrate 3) Repackaged or relabeled product 4) Device

The total number of establishments, domestic and foreign, that reported to EPA under FIFRA section 7 are presented in Table 5. Although there are approximatelytwelve to thirteen thousand Active Registered Pesticide-Producing Establishments, table 5 below only lists establishments that reported actual production for the calender year 1996. The establishments that reported either zero production or who were non-reporters for calender year 1996 are not included in the establishment number totals in the table. The significant difference between the pesticide producing establishment counts as reported under section 7 (8,612) and the pesticide and agricultural chemical manufacturers n.e.c. reported by the Census (263) canbe attributed to the section7 broad inclusion of producers vs. the relatively narrow, Census inclusion of manufacturers. In addition, the Census of Manufacturers uses SIC code definitions which lump many pesticide active ingredient manufacturers into SIC codes that represent organic or inorganic chemicals. Establishments classified under the first product type, as well as some of the second, may include facilities classified under the chemical manufacturing SIC codes 286 or 281. Also, the Census only counts a facility in an SIC code if theyreporta product in that SIC code as their primary line of business. Therefore, facilities producing a variety of products might not be classified under all applicable SIC codes. For example, a facility which produces many different types of fertilizers as well as some pesticides might only be counted under the fertilizer SIC codes by the Census Bureau to avoid double counting of facilities.



Table 5: Establishment Counts Based on Product Type *

Type Product Total Domestic Foreign

1 Technical Material, Active Ingredient

555 410 145

2 End-Use Blend, Formulation, Concentrate

2,590 2,454 136

3 Repackaged or Relabeled Goods

5,267 5,243 24

4 Devices 200 166 34

Total 8,612 8,273 339

Source: U.S.EPA, Enforcement, Planning, Targeting & Data Division,, FIFRA, section 7 Data System, United States EPA. 1996.



II.B.2. Industry Size and Geographic Distribution

Table 6 lists the facility size distribution within the nitrogenous fertilizer, phosphatic fertilizer, fertilizer mixing, and pesticide and agrichemical formulating industries. For each industry code, the majority of facilities employ less than 50 people.

Table 6: Facility Size Distribution for the Fertilizer, Pesticide, and Agricultural Chemical Manufacturing Industry

Employees per Facility

FERTILIZERS PESTICIDES

Nitrogenous Fertilizers (SIC 2873)

Phosphatic Fertilizers (SIC 2874)

Fertilizers, Mixing only (SIC 2875)

Pesticides and other Agrichemicals (SIC 2879)*

Number of Facilities

Percentage of Facilities

Number of Facilitie s


Number of Facilities


Number of Facilitie s


1-9 60 39% 27 36% 205 51% 108 41%

10-49 47 31% 22 29% 166 41% 95 36%

50-249 43 28% 15 20% 30 8% 45 17%

250-499 1 1% 6 8% 0 0% 7 3%

500-2499 1 1% 5 7% 0 0% 8 3%

Total 152 100% 75 100% 401 100% 263* 100%

Source: 1992 Census of Manufacturers, Industry Series: Agricultural Chemicals, US Department of Commerce, Bureau of the Census, May 1995. Note: 1992 Census of Manufacturers data are the most recent available. Changes in the number of facilities, location, and employment figures since 1992 are not reflected in these data.

* United States EPA has identified over 8,600 registered pesticide producing establishments. The SIC code as it is defined by the OMB only includes 263 of those establishments.



Figure 5 shows the United States distribution of fertilizer manufacturing and mixing facilities. The geographic distribution of nitrogenous and phosphatic fertilizer manufacturers is determined by natural resources and demand. Seventy percent of synthetic ammonia plants in the United States are concentrated in Louisiana, Texas, Oklahoma, Iowa, and Nebraska due to abundant natural gas supplies. The majority of nitric acid plants are located in agricultural regions such as the Midwest, South Central, and Gulf States in order to accommodate the high volume of fertilizer usage. Florida has the largest phosphate rock supply in the United States, thus phosphoric acid manufacturing is concentrated primarily in Florida and spreads into the Southeast.

Figure 5: Geographic Distribution of the Fertilizer Industry (SIC 2873, 2874, 2875)

Source: 1992 Census of Manufacturers, Industry Series: Agricultural Chemicals, United States Department of Commerce, Bureau of the Census, May 1995.



Table 7 further divides the geographic distribution of fertilizer manufacturing and mixing facilities. The top states in which the nitrogenous fertilizer, phosphatic fertilizer, and fertilizer mixing industries are concentrated are given along with their respective number of establishments. Florida’s supply of phosphate rock causes a concentration of phosphatic and mixed fertilizer facilities, while nitrogenous fertilizer plants are often located near sources of raw materials.

Table 7: States with the Largest Number of Fertilizer Manufacturing Facilities

States in which industry is concentrated, based on number of establishments

Nitrogenous Fertilizers (SIC 2873)

Phosphatic Fertilizers (SIC 2874)

Fertilizers, Mixing only (SIC 2875)

Top States

Establishments

Top States

Establishments

Top States

Establishments

California Texas Louisiana

17 12 8

Florida North Carolina

15 9

Florida Ohio Texas

42 31 26

% of total 24% 32% 25%

Source: 1992 Census of Manufacturers, Industry Series: Agricultural Chemicals, US Department of Commerce, Bureau of the Census, May 1995. Note: 1992 Census of Manufacturers data are the most recent available. Changes in the number of facilities, location, and employment figures since 1992 are not reflected in these data.



Figure 6 shows the United States distribution of pesticide formulating and miscellaneous agrichemical formulating facilities. The distribution follows the general distributionof the petrochemical industry(coasts and Great Lakes) which the industry relies on for its raw materials, and the distribution of agricultural productionin the United States (Midwest and Great Plains states).

Figure 6: Geographic Distribution of the Pesticide Formulating and Miscellaneous Agrichemical Formulating Facilities (SIC 2879)*

Source: 1992 Census of Manufacturers, Industry Series: Agricultural Chemicals, United States Department of Commerce, Bureau of the Census, May 1995. * United States EPA has identified over 8,000 establishments that could fall within this SIC code as it is defined by the OMB.



Table 8: Top United States Agricultural Chemical Companies

Rank Company 1997 Sales (millions of

dollars) SIC Code(s) Reported

1 IMC Global - Northbrook, IL 2,981 2874, 2875, 2819, 1474, 1475

2 Zeneca Inc. - Wilmington, DE 2,822 2879, 2834,2899

3 Agrium United States Inc. - Spokane, WA

1,814 2873

4 CF Industries, Inc. - Lake Zurich, IL 1,383 2873, 2874

5 PCS Nitrogen Inc. - Memphis, TN 1,310 2873, 2874

6 Dowelanco (now named Dow AgriSciences) - Indianapolis, IN

1,288 2879

7 The Scotts Company - Marysville, OH 752 2873, 2874, 2879, 0139, 2499, 3524

8 Cargill Fertilizer - Riverview, FL 600 2874

9 ChemFirst Inc. - Jackson, MS 595 2873, 2865, 3567, 3312

10 La Roche Industries Inc. - Atlanta, GA 449 2873, 5191, 2812, 2869, 3291, 3569

Source: Dun & Bradstreet’s Million Dollar Directory, 1997

Note: Not all sales can be attributed to the companies agricultural chemical operations.

Dun & Bradstreet’s Million Dollar Directory, compiles financial data on United States companies including those operating within the Fertilizer, Pesticide, and Agricultural Chemical Industry. Dun & Bradstreet ranks United States companies, whether they are a parent company, subsidiary or division, by sales volume within their assigned 4-digit SIC code. Readers should note that: (1) companies are assigned a 4-digit SIC code that resembles their principal industry most closely; and (2) sales figures include total company sales, including subsidiaries and operations (possibly not related to agricultural chemicals). Additional sources of company specific financial information include Standard & Poor’s Stock Report Service, Ward’s Business Directory of United States Public and Private Companies, Moody’s Manuals, and annual reports.

The Bureau of the Census publishes concentration ratios, which measure the degree of competition in a market. They compute the value of shipments percentage controlled by the top 4, 8, 20, and 50 companies in a given industry. Within the agricultural chemical industry, the phosphatic fertilizer



industry had the highestconcentrationratio for the top four companies in 1992, 62 percent. The pesticide and other agricultural chemicals, nitrogenous fertilizers, and fertilizer mixing industries’ concentration ratios were 53, 48, and 19 percent respectively.

II.B.3. Economic Trends

The United States is a major producer and exporter of agricultural chemicals. It is the largest producer of phosphatic fertilizers and pesticides and the second largest producer of nitrogenous fertilizers in the world (USDOC, 1998).

Domestic Market Trends

The majority of important crops, such as corn and soybeans, are grown using fertilizers and pesticides. As a result, year-to-year changes in the domestic demand for agrichemicals reflect the level of planted acreage, which in turn is affected by grain prices and weather conditions. Increases in planted acreage of corn, feedgrains and other crops in recent years have resulted in increased demand and production of agrichemicals in the United States. Industry shipments of agricultural chemicals should show modest annual growth through the end of the decade (USDOC, 1998).

The Federal Agricultural Improvement and Reform Act of 1996 could have a major long-termimpact on the agricultural chemical industry. This law gives farmers greater flexibility inmakingplanting decisions and allows themto rely more on the marketplace as a guide for crop plantings. The bill eliminates the annual acreage set-aside program, thus potentially boosting the levels of crop acreage (USDOC, 1998).

Agricultural chemical production showed little change between 1995 and 1996. Total production was approximately 103 million pounds each year. However, experts claimthatdue to lower dosage requirements for pesticides, agrichemical demand is actually higher than it would appear. Pesticides saw a six percent rise in production from 1995 to 1996. Nitrogenous fertilizer production was up approximately seven percent, and phosphate production increased slightlyexcept for its major product, diammonium phosphate. Prices for agricultural chemicals rose three percent from 1995 to 1996, while the number of production workers fell two percent (USDOC, 1998).

International Market Trends

The United States accounts for more than 50 percent of world trade in phosphatic fertilizers, with a two-thirds share of total trade in DAP (diammonium phosphate), the principal phosphatic fertilizer product. Exports generally account for about half of total shipments for the United States phosphatic fertilizer industry, with about half of all exports going to China.


Agricultural Chemical Industry Chemical Releases and Transfers

International markets, especially less developed nations in Asia and Latin America, hold greater market potential for the agrichemicals industry as population levels grow, income levels rise, and demands for better standards of living and diets increase the need for grain production. From the current level of about 5.8 billion, the world population is expected to increase by about 80 million each year between 1996 and 2000. Developing nations are becoming more sophisticated in agricultural practices, thus increasing their usage of fertilizers and pesticides to improve production (USDOC, 1998).

The United States has been a net exporter of pesticide chemicals, and this is expected to continue through the turn of the century. Exports of pesticides accounted for about 25 percent of United States pesticide production in 1994, according to The American Crop Protection Association. United States pesticide producers benefit from a highly developed chemical sector and strong demand from developing regions of the world. Nevertheless, export opportunities are being restrained by industry-wide globalization as producers are choosing to site facilities closer to end-use markets. In addition, regulatoryreforms inWesternEurope, suchas the competitive access provider plan, are expected to limit prospects in that region, currently the largest destination for United States produced pesticides (USDOC, 1998).

International competition for the United States phosphatic fertilizer industry generally comes fromcountries with phosphate rock reserves and capacity to convert rock into phosphate chemicals. Diammonium phosphate imports are expected to account for most of the growth in world trade, thus giving the United States a promising outlookfor this product. Morocco possesses at least 50 percent of the world’s rock reserves and is the largest phosphate rock exporter. China and Russia are also major phosphate rock and fertilizer producers, with Russia also a leading exporter of phosphate chemicals. In the world pesticide markets, major competitors are companies based inGermany, France, and Switzerland.

The United States is a net importer of nitrogenous fertilizers. Trinidad and Tobago and Canada are the leading United States suppliers of nitrogen due to their low-cost supplies of natural gas.

Agricultural biotechnology is beginning to play a major role in agricultural pestcontrol, spurred onbygovernment pesticide restrictions, increased insect resistance to pesticides, and farmers’ demand for productivity gains. Genetically engineered plants will be higher yielding, more resistant to disease and insects, and tolerant to herbicides. A number of companies have received approvals for the use of genetically engineered seeds, including corn and cotton, that are resistant to insects and herbicide tolerant. Commercial usage should increase rapidly over the next few years (USDOC, 1998).



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Agricultural Chemical Industry Industrial Process Description

III. INDUSTRIAL PROCESS DESCRIPTION

This section describes the major industrial processes within the Fertilizer, Pesticide, and Agricultural Chemical Industry, including the materials and equipment used, and the processes employed. The section is designed for those interested in gaining a general understanding of the industry, and for those interested in the inter-relationship between the industrial process and the topics described in subsequent sections of this profile pollutant outputs, pollutionpreventionopportunities, and federal regulations. This section does notattemptto replicate published engineering informationthatis available for this industry. Refer to Section IX for a list of resource materials and contacts that are available.

This sectionspecificallycontains a description of commonlyused production processes, associated raw materials, the by-products produced or released, and the materials either recycled or transferred off-site. This discussion, coupled with schematic drawings of the identified processes, provide a concise description of where wastes may be produced in the process. This section also describes the potential fate (via air, water, and soil pathways) of these waste products.

The three mostimportant nutrients for plant growth are nitrogen, phosphorous, and potassium. However, the production of the major potassium fertilizer salts, or potash as they are commonly known, is typically considered an inorganic chemical process (SIC 2819). Therefore, the discussion of fertilizer production in this notebook is restricted to nitrogenous and phosphatic mixtures. The fertilizer, pesticide, and agricultural chemical industry can be divided into Nitrogenous Fertilizers, Phosphatic Fertilizers, Fertilizers (Mixing-only), and the formulating and preparing of pesticides and other agricultural chemicals. A detailed description of the production processes for nitrogenous and phosphatic fertilizers is presented here, along with brief descriptions of the fertilizer mixing and pesticide formulating and preparing industry.

III.A. Nitrogenous Fertilizers

The major nitrogenous fertilizers include synthetic ammonia, ammonium nitrate, and urea. The various industrial processes used to manufacture these products are described, as well as the production process for nitric acid, an important intermediate in nitrogenous fertilizer production.

III.A.1. Synthetic Ammonia

Synthetic ammonia (NH3) is produced by reacting hydrogen with nitrogen at a molar ratio of three to one. Nitrogen is obtained from the air, which is primarily comprised of nitrogen (78 percent) and oxygen(21 percent) (Lewis, 1993). Hydrogen is obtained from either the catalytic steam reforming of



natural gas (methane) or naptha, or as the byproduct from the electrolysis of brine at chlorine plants. In the United States, about 98 percent of the hydrogen used to synthesize ammonia is produced bycatalytic steamreforming ofnatural gas, and only 2 percent is obtained from chlorine plants (USEPA, 1993a).

Six process steps are required to produce synthetic ammonia using the catalytic steam reforming method:

1) natural gas desulfurization 2) catalytic steam reforming 3) carbon monoxide shift 4) carbon dioxide removal 5) methanation 6) ammonia synthesis.

The first, third, fourth, and fifth steps remove impurities such as sulfur, CO,CO2 and water from the feedstock, hydrogen and synthesis gas streams. In thesecond step, hydrogen is manufactured and mixed with air (nitrogen). Thesixth step produces anhydrous ammonia from the synthetic gas. An anhydrouscompound is inorganic and does not contain water either adsorbed on itssurface or combined as water of crystallization. While almost all ammoniaplants use these basic process steps, details such as operating pressures,temperatures, and quantities of feedstock vary from plant to plant. Figure 7shows a simplified process flow diagramofa typical ammonia plant (USEPA,1993a).

Natural gas desulfurizationIn the natural gas desulfurization step, the sulfur content (primarily as H2S) innatural gas feedstock is reduced to below 280 micrograms per cubic meter toprevent poisoning of the catalyst used in the catalytic steam reforming step.Desulfurization can be accomplished by passing the natural gas through a bedof either activated carbon or zinc oxide. In both systems, the hydrogen sulfidein the gas adsorbs to the surface of the activated carbon or zinc oxide mediumand the desulfurized natural gas passes through.

Over 95 percent of the ammonia plants in the United States use activated carbon fortified with metallic oxide additives for feedstock desulfurization. After a certain amount of impurities adsorb to the activated carbon, its effectiveness is reduced and it must be regenerated by passing superheated steam through the carbon bed. The superheated steam strips out the sulfur impurities, is condensed, and sent to the wastewater treatment plant. One disadvantage of the activated carbon system is that some of the heavy hydrocarbons in the natural gas adsorb to the carbon, decreasing its effectiveness and lowering the heating value of the desulfurized gas.

The remaining five percent of plants use zinc oxide for desulfurization. The zinc oxide system is capable of absorbing up to 20 percent sulfur by weight



Sector Notebook Project September 200029

Figure 7:

Source: United States EPA, 1993a.(Hodge, 1994). Zinc oxide is replaced rather than regenerated, which lowers

Typical Process of Ammonia Synthesis


energy consumption and minimizes impact to the atmosphere. The highermolecular weight hydrocarbons are not removed; therefore, the heating valueof the natural gas is not reduced. However, it is impractical and uneconomicalto replace the zinc oxide beds so few plants use it (USEPA, 1993a).

Catalytic steam reformingNext, the desulfurized natural gas is preheated by mixing with superheatedsteam. The mixture of steam and gas enters the primary reformer tubes whichare filled with a nickel-based reforming catalyst, and the tubes are heated bynatural gas or oil-fired burners. Approximately 70 percent of the methane(CH4) is converted to hydrogen (H2) and carbon dioxide (CO 2), according tothe following reaction:

0.88CH4 + 1.26air + 1.24 H2O 6 0.88 CO2 +N2 + 3H2

The remainder of the CH4 is converted to H2 and CO. This process gas is thensent to the secondary reformer, where it is mixed with compressed hot air at540°C (1004°F). Sufficient air is added to produce a final synthesis gashaving a hydrogen-to-nitrogen mole ratio of three to one. The gas leaving thesecondary reformer (primarily hydrogen, nitrogen, CO, CO2, and H20) is thencooled to 360°C (680°F) in a waste heat boiler before being sent to the carbonmonoxide shift (USEPA, 1993a).

Carbon monoxide shiftAfter cooling, the secondary reformer effluent gas enters a high temperature(350-400°C) CO shift converter which converts the CO to CO2, followed bya low temperature (200-250°C) shift converter whichcontinues to convertCOto CO2 (Kroschwitz and Howe-Grant, 1992). The high temperature CO shiftconverter is filled with chromium oxide initiator and iron oxide catalyst. Thefollowing reaction takes place (USEPA, 1993a):

CO + H2O 6 CO2 + H2

The exit gas is then cooled in a heat exchanger before being sent to a low temperature shift converter for ammonia, amines, and methanol where CO continues to be converted to CO2 by a copper oxide/zinc oxide catalyst (Kent, 1992). In some plants, the gas is first passed through a bed of zinc oxide to remove any residual sulfur contaminants that would poison the low temperature shift catalyst. Inother plants, excess low temperature shift catalyst is added to ensure that the unit will operate as expected. Final shift gas from this converter is cooled from 210 to 110°C (410 to 230°F) and unreacted steam is condensed and separated from the gas in a knockout drum. The final shift gas then enters the bottom of the carbon dioxide absorption system. The condensed steam(process condensate) contains ammonium carbonate ([(NH4)2

CO3 • H2O]) from the high temperature shift converter, methanol (CH3OH) from the low temperature shift converter, and small amounts of sodium, iron, copper, zinc, aluminum and calcium. Process condensate is sent to the stripper



to remove volatile gases such as ammonia, methanol, and carbon dioxide. Trace metals remaining in the process condensate are typically removed in an ion exchange unit (USEPA, 1993a).

Carbon dioxide removal In this step, CO2 in the final shift gas is removed. CO2 removal can be done by using one of two methods: monoethanolamine (C2H4NH2OH) scrubbing or hot potassium scrubbing. Approximately 80 percent of the ammonia plants use monoethanolamine (MEA) for removing CO2. In this process, the CO2 gas is passed upward through an adsorption tower countercurrent to a 15 percent to 30 percent solution of MEA inwater fortified with corrosion inhibitors. After absorbing the CO2, the amine-CO2 solution is preheated and regenerated in a reactivating tower. The reacting tower removes CO2 by steam stripping and then by heating. The CO2 gas (98.5 percent CO2) is either vented to the atmosphere or used for chemical feedstock in other parts of the plant complex. The regenerated MEA is pumped back to the absorber tower after being cooled in a heat exchanger and solution cooler (USEPA, 1993a).

MethanationCarbon dioxide absorption is not 100 percent effective in removing CO2 fromthe gas stream, and CO2 can poison the synthesis converter. Therefore,residual CO2 in the synthesis gas must be removed by catalytic methanation.In a reactor containing a nickel catalyst and at temperatures of 400 to 600°C(752 to 1112°F) and pressures up to 3,000 kPa (435 psia) methanation followsthe following reaction steps:

CO2 + H2 6 CO + H2 O

CO + 3H2 6 CH4 + H2O

CH4 + 2H2 O 6 CO2 + 4H2

Exit gas from the methanator is almost a pure three to one mole ratio ofhydrogen to nitrogen (USEPA, 1993a).

Ammonia SynthesisIn the synthesis step, the hydrogen and nitrogen synthesis gas from themethanator is converted to ammonia.

N2 +3H2 6 2NH3

First, the gas is compressed to pressures ranging from 13,800 to 34,500 kPa (2000 to 5000 psia), mixed with recycled synthesis gas, and cooled to 0°C (32°F). This results in a portion of the gas being converted to ammonia which is condensed and separated from the unconverted synthesis gas in a liquid-vapor separator and sent to a let-downseparator. The unconverted synthesis gas is further compressed and heated to 180°C (356°F) before entering a synthesis converter containing anironoxide catalyst. Ammonia gas exiting the



synthesis converter is condensed and separated, then sent to the let-downseparator. A small portionof the overhead gas is purged to prevent the buildupof inert gases such as argon in the circulating gas system. Ammonia in the letdownseparator is flashed to atmospheric pressure (100 kPa (14.5 psia)) at 33°C (-27°F) to remove impurities from the make-up gas. The flash vapor iscondensed in a let-down chiller where anhydrous ammonia is drawn off andstored at low temperature (USEPA, 1993a).

Storage and TransportAmmonia is typically stored at ambient pressure and -33°C (-28°F) in large20,000 ton tanks. Some tanks are built with a double wall to minimize leakageand insulate. If heat leaks into the tank and ammonia is vaporized, the vaporsare typically captured, condensed, and returned to the tank. Ammonia ismostly transported by barge to key agricultural areas, but there is also a smallsystem of interstate ammonia pipelines (Kent, 1992).

III.A.2. Nitric Acid

Nitric acid (HNO3) is produced by two methods. The first method utilizes oxidation, condensation, and absorption of ammonia to produce a “weak” nitric acid. Weak nitric acid has a concentration ranging from30 to 70 percent nitric acid. The second method combines dehydrating, bleaching, condensing, and absorption to produce “high strength” nitric acid from weak nitric acid. High strength nitric acid generally contains more than 90 percent nitric acid (USEPA, 1993a). The following text discusses each of these processes.

Weak Nitric Acid Production

Nearly all the weak nitric acid produced in the United States is manufactured bythe high temperature catalytic oxidation of ammonia as shown schematically in Figure 8. This process typically consists of three steps:

1) ammonia oxidation 2) nitric oxide oxidation 3) absorption.

Each step corresponds to a distinct chemical reaction.

Ammonia OxidationDuring ammonia oxidation, a one to nine ammonia to air mixture is oxidizedat a temperature of 750 to 800°C (1380 to 1470°F) as it passes through acatalytic converter, according to the following reaction:

4NH3 + 5O2 6 4NO + 6H2O

The most commonly used catalyst is made of gauze squares of fine wire constructed of 90 percent platinum and 10 percent rhodium. Under these



conditions the oxidation of ammonia to nitric oxide (NO) proceeds in anexothermic reaction with 93 to 98 percent yield. Higher catalyst temperaturesincrease reaction selectivity toward nitric oxide (NO) production. Lowercatalyst temperatures tend to be more selective toward nitrogen (N2) andnitrous oxide (N 2O) (USEPA, 1993a). The nitric oxide then passes througha waste heatboiler and a platinum filter in order to recover the precious metalplatinum (Kent, 1992).

Nitric Oxide OxidationThe nitric oxide formed during the ammonia oxidation is further oxidized inanother process step. The nitric oxide process stream is passed through acooler/condenser and cooled to 38°C (100°F) or less at pressures up to 800kPa (116 psia). The nitric oxide reacts noncatalytically with residual oxygento form nitrogen dioxide and its liquid dimer, dinitrogen tetroxide:

2NO + O2 6 2NO2 + N2O4

(A dimer is a small polymer whose molecule is composed of two moleculesof the same composition(Lewis, 1993).) This slow, homogeneous reaction istemperature and pressure dependent. Operating at low temperatures and highpressures promotes maximum production of NO2 within a minimum reactiontime (USEPA, 1993a).

Nitrogen dioxide absorptionThe final step introduces the gaseous nitrogen dioxide/dimer mixture into anabsorptionprocess after being cooled. The mixture is pumped into the bottomof an absorption tower with trays, while liquid dinitrogen tetroxide (N2O4) isadded at a higher point. Deionized water enters the top of the column. Bothliquids flow countercurrent to the dioxide/dimer gas mixture. The exothermicreaction occurs as follows (USEPA, 1993a):

3NO2 + H2O 6 2HNO3 + NO

A secondary air streamis introduced into the column to re-oxidize the NO that is formed. This secondary air also removes NO2 from the product acid. Oxidation of NO to NO2 takes place in the free space between the trays, while absorption of NO2 into the water occurs on the trays. An aqueous solution of 55 to 65 percent (typically) nitric acid is withdrawn from the bottom of the tower. The acid concentration can vary from 30 to 70 percent nitric acid depending upon the temperature, pressure, number of absorption stages, and concentration of nitrogen oxides entering the absorber (USEPA, 1993a).

There are two variations of the process described above to produce weak nitric acid: single-stage pressure process and dual-stage pressure process. In the past, nitric acid plants have been operated at a single pressure, ranging from atmospheric pressure to 1400 kPa (14.7 to 203 psia). However, since the oxidation of ammonia is favored by low pressures and the oxidation of



nitric oxide and the absorption of nitrogen dioxide are favored by higher pressures, newer plants tend to operate a dual-stage pressure system, incorporating a compressor between the ammonia oxidizer and the condenser. The oxidation reaction is carried out at pressures from slightly negative to about 400 kPa (58 psia), and the absorption reactions are carried out at 800 to 1,400 kPa (116 to 203 psia) (USEPA, 1993a).

In the dual-stage pressure system, the nitric acid formed in the absorber (bottoms) is usually sent to an external bleacher where air is used to remove (bleach) anydissolved oxides ofnitrogen(NO, NO2, etc.). The bleacher gases are then compressed and againpassed through the absorber. The absorber tail gas (distillate) is sent to an entrainment separator for acid mistremoval. Next, the tail gas is reheated in the ammonia oxidation heat exchanger to approximately 200°C (392°F). The gas is then passed through catalytic reduction units for NOx emissions control. The final step expands the gas in the power-recovery turbine. The thermal energy produced in this turbine can be used to drive the compressor.



Figure 8: Typical Process of Dual-Stage, Weak Nitric Acid Production

Source: United States EPA, 1993a.

High Strength Nitric Acid

High strength nitric acid (98 to 99 percent concentration) can be obtained by concentrating weak nitric acid (30 to 70 percent concentration) using extractive distillation. Extractive distillation is distillation carried out in the presence of a dehydrating agent. Concentrated sulfuric acid (typically 60 percent sulfuric acid) is most commonly used for this purpose. The weak nitric acid cannot be concentrated by simple fractional distillation, in which acid is concentrated byremoving water vapor in a column with trays or plates.



The nitric acid concentration process consists of feeding strong sulfuric acid and 55 to 65 percent nitric acid into the top of a packed dehydrating column at approximately atmospheric pressure. The acid mixture flows downward and concentrated nitric acid leaves the top of the column as 99 percent vapor, containing a small amount of NO2 and O2 resulting fromdissociation of nitric acid. The concentrated acid vapor then goes to a bleacher and a countercurrent condenser system to condense strong nitric acid and the separate out the oxygen and nitrogenoxide by-products. The bleacher uses air to strip nitrogen oxides out of the nitric acid and the countercurrent condenser systemcools the vapor by flowing air through the vapor causing droplets to separate out.

These nitrogenoxide by-products then flow to anabsorptioncolumn where the nitric oxide mixes with auxiliary air to formNO2, which is recovered as weak nitric acid. Inert and unreacted gases are vented to the atmosphere fromthe top of the absorption column. Emissions from this process are relatively small compared to weak acid production (USEPA, 1993a). Figure 9 illustrates a typical high strength nitric acid production process.

Figure 9: Typical Process Diagram of High Strength Nitric Acid Production

Source: Adapted from United States EPA, 1993a.

III.A.3. Ammonium Nitrate and Urea

The manufacture steps for ammonium nitrate (NH4NO2) and urea (CO(NH2)2) are similar. In both cases, several major unit operations are involved, including:

1) solution formation 2) concentration 3) solids formation 4) finishing 5) screening



6) coating 7) product bagging and/or bulk shipping.

These operations are shown schematically in Figure 10. Not all steps are always necessary depending on the end product desired. For example, plants producing ammonium nitrate or urea liquid solutions alone use only the solution formation, solution blending and bulk shipping operations. Plants producing a solid product may employ all of the operations.

Solution synthesis Ammonium nitrate. Ammonium nitrate plants produce an aqueous ammonium nitrate solution through the reaction of ammonia and nitric acid in a neutralizer where water is evaporated by the heat of the reaction as follows:

NH3 + HNO3 6 NH4NO3 + 26 kcal/g mol

The temperature, pressure, and final concentrationof the ammoniumnitrate are interdependent. Higher temperatures and pressures can be used to produce a higher concentration of ammonium nitrate (Hodge, 1994); however, the temperature of the operation should be below 120°C (250°F) in order to prevent explosions. Up to 99.5 percent of the ammonia and nitric acid is typically converted to ammonium nitrate (Kent, 1992). Ammonium nitrate solution can then be used as an ingredient for nitrogen solution fertilizers or concentrated to a solid form.

Urea. In the urea solution synthesis operation, ammonia (NH3) and carbon dioxide(CO2) are reacted to formammonium carbamate (NH 2CO 2NH 4) as follows:

2NH3 + CO2 6 NH2CO2NH4

Typical operating conditions include temperatures from180 to 200°C (356 to 392°F), pressures from14,000 to 25,000 kPa (140 to 250 psia), molar ratios of NH3 to CO2 from3:1 to 4:1, and a retention time of twenty to thirty minutes. The ammoniumcarbamate is thendehydrated to yield 70 to 77 percent aqueous urea solution. This reaction follows: (USEPA, 1993a)

NH2CO2NH4 6 NH2CONH2 + H2O

Urea solution can be used as an ingredient of nitrogen solution fertilizers, or it can be concentrated further to produce solid urea.



Solids Concentration Ammonium nitrate. To produce a solid product, the aqueous ammonium nitrate solution is concentrated in an evaporator or concentrator. The resulting liquid “melt” contains about 95 to 99.8 percent ammonium nitrate at approximately 149°C (300°F). This melt is then used to make solid ammonium nitrate products (USEPA, 1993a).

Urea. The three methods ofconcentrating the urea solutionare vacuumconcentration, crystallization, and atmospheric evaporation. The method chosen depends upon the level of biuret (NH2CONHCONH2) impurity allowable in the end product. Biuret can cause mottling in urea solutions, reducing the fertilizers effectiveness in foliar applications (Kent, 1992). Aqueous urea solution decomposes with heat to biuret and ammonia. Therefore, if only a low level of biuret impurity is allowed in the end product, the method with the least heat requirement will be chosen, such as crystallization and vacuum concentration (Kent, 1992). However, the simplest and most common method of solution concentration is atmospheric evaporation.

Solids Formation Prilling and granulation are the mostcommonprocesses used to produce solid ammonium nitrate and urea. Prills are round or needle-shaped artificially prepared aggregates of a material. To produce prills, concentrated melt is sprayed into the top of a prill tower. In the tower, melt droplets fall countercurrent to a rising air stream that cools and solidifies the falling droplets into prills. Prill density can be varied by using different concentrations of ammonium nitrate melt. Low density prills, in the range of 1.29 specific gravity, are formed from a 95 to 97.5 percent ammonium nitrate melt, and high density prills, in the range of 1.65 specific gravity, are formed from a 99.5 to 99.8 percent melt. Low density ammonium nitrate prills are used for makingblasting agents because theyare more porous thanhighdensity prills and will absorb oil. Most high density prills are used as fertilizers (USEPA, 1993a).

Granulated ammonium nitrate and urea are produced by spraying a concentrated melt (99.0 to 99.8 percent) onto small seed particles of ammonium nitrate or urea in a long rotating cylindrical drum. As the seed particles rotate in the drum, successive layers of the nitrogenous chemical are added to the particles, forming granules. Pan granulators operate on the same principle as drum granulators, except the solids are formed ina large, rotating circular pan. Pan granulators produce a solid product with physical characteristics similar to those of drum granules (USEPA, 1993a).

Although not widely used, additives such as magnesium nitrate or magnesium oxide may be injected directly into the melt stream. Additives can serve three



purposes: to raise the crystalline transition temperature of the final solidproduct in order to retain its strength and density; to act as a desiccant,drawing water into the final product to reduce caking; and to allowsolidification to occur at a low temperature by reducing the freezing point ofmolten ammonium nitrate. (Kent, 1992)

Solids CoolingThe temperature of the nitrogenous product exiting the solids formationprocess is approximately 66 to 124°C (150 to 255°F). To preventdeterioration and agglomeration, the product must be cooled before storageand shipping. Typically, rotary drums or fluidized beds are used to coolgranules and prills leaving the solids formationprocess. Because low densityprills have a high moisture content, they require drying in rotary drums orfluidized beds before cooling (USEPA, 1993a).

Solids ScreeningSince the solids are produced ina wide variety of sizes, they must be screenedfor consistently sized prills or granules. After cooling, off size prills aredissolved and recycled back to the solution concentration process. Granulesare screened before cooling. Undersize particles are returned directly to thegranulator and oversize granules may be either crushed and returned to thegranulator or sent to the solution concentration process (USEPA, 1993a).

Solids CoatingFollowing screening, products can be coated in a rotary drum to preventagglomeration during storage and shipment. The most common coatingmaterials are clays and diatomaceous earth. However, the use of additives inthe melt before solidification may preclude the use of coatings.

The solid product is stored and shipped in either bulk or bags. The majority of solid product is bulk shipped in trucks, enclosed railroad cars, or barges, and approximately ten percent of solid ammonium nitrate and urea produced in the United States is bagged (USEPA, 1993a).



Figure 10: Typical Process for Ammonium Nitrate and Urea Manufacturing


III.B. Phosphatic Fertilizers

The primary products of the phosphatic fertilizers industry are phosphoric acid, ammonium phosphate, normal superphosphate, and triple superphosphate. Phosphoric acid is sold as is or is used as an intermediate in producing other phosphatic fertilizers. Monoammonium phosphate is favored for its high phosphorous content, while diammonium phosphate is favored for its high nitrogencontent. Normal superphosphate has a relatively low concentrationof phosphorous, however it is used in mixtures because of its low cost. Triple superphosphate provides a high concentration ofphosphorous, more than40% phosphorous pentoxide. The industrial processes for each of these products are described below.

III.B.1. Phosphoric Acid (Wet Process)

In a wet process phosphoric acid facility (shownschematically in Figure 11), phosphoric acid is produced by reacting sulfuric acid (H2SO4) with naturally occurring phosphate rock. The phosphate rock is mined, dried, crushed until 60 to 70 percent of the rock is less than 150 µm in diameter, and then continuously fed into the reactor along with sulfuric acid (UNEP, 1996). The reaction also combines calcium fromthe phosphate rock with sulfate, forming calcium sulfate (CaSO4), commonly referred to as gypsum. Gypsum is separated from the reaction solution by filtration.

Facilities in the United States generally use a dihydrate process that produces gypsum in the form of calcium sulfate with two molecules of water (CaSO4 C 2H 2O or calcium sulfate dihydrate). Japanese phosphoric acid facilities use



a hemihydrate process which produces calcium sulfate with a half molecule of water (CaSO4 C ½ H2O). This one-step hemihydrate process has the advantage of producing wet process phosphoric acid with a higher phosphate pentoxide (P2O5) concentrationand less impurities than the dihydrate process. Due to these advantages, some United States companies have recently converted to the hemihydrate process. However, since most wet process phosphoric acid is still produced by the dihydrate process, the hemihydrate process will not be discussed in detail here.

A simplified reaction for the dihydrate process is as follows:

Ca3(PO4)2 + 3H2SO4 6 2H3PO4 + 3[Ca3SO4 • 2H2O] 9

To make the strongest phosphoric acid possible and to decrease evaporation costs, a highlyconcentrated 93 percent sulfuric acid is normallyused. Because the proper ratio of acid to rock in the reactor is critical, precise automatic process control equipment is employed in the regulation of these two feed streams (USEPA, 1993a).

During the reaction, gypsum crystals are precipitated and separated from the acid by filtration. The separated crystals must be washed thoroughly to yield at least a 99 percent recovery of the filtered phosphoric acid. After washing, the slurried gypsum is pumped into a gypsum settling pond for storage. Water is siphoned off and recycled through a surge cooling pond to the phosphoric acid process. Depending on a variety of factors, such as average ambient temperature and annual rainfall, settling and cooling ponds may require between 0.25 and 1.0 acre for each ton of daily P205 capacity (TFI, 1999).

Considerable heat is generated in the reactor when the sulfuric acid and phosphate rock react. In older plants, this heat was removed by blowing air over the hot slurry surface. Modern plants vacuum flash cool a portion of the slurry, and then recycle it back into the reactor.

Wet process phosphoric acid normallycontains 26 to 30 percent P2O5. In most cases, the acid must be further concentrated to meet phosphate feed material specifications for fertilizer production. Depending on the types of fertilizer to be produced, phosphoric acid is usually concentrated to 40 to 55 percent P2O5

by using two or three vacuum evaporators (USEPA, 1993a). These evaporators operate with a forced circulation and generate a vacuum through vacuum pumps, steamejectors, or an entraining condenser downstream of the evaporator. Figure 12 illustrates a vacuum evaporator.



Figure 11: Typical Process of a Wet Process Dihydrate Phosphoric Acid Plant

Source: Adapted from United States EPA, 1993a.

Figure 12: Typical Vacuum Evaporator Process

Source: United States EPA, 1993a



III.B.2. Ammonium Phosphate

Diammonium phosphate (DAP) and monoammonium phosphate are the major types of ammonium phosphatic fertilizer. Ammonium phosphates are produced by reacting phosphoric acid with ammonia. The ammonium phosphate liquid slurryproduced is thenconverted to solid granules. Approximately 95 percent of ammoniation-granulationplants in the United States use a rotary drum mixer developed and patented by the Tennessee Valley Authority (TVA).

In the TVA DAP process, phosphoric acid is mixed in an acid surge tank with 93 percent sulfuric acid (H2SO4) and recycled acid fromwet scrubbers. The mixed acids are then partially neutralized with liquid or gaseous anhydrous ammonia in a brick-lined acid reactor. All of the phosphoric acid and approximately 70 percent of the ammonia needed to complete the reaction are introduced into this vessel. A slurry of ammonium phosphate and 22 percent water are produced and sent through steam-traced lines to the ammoniatorgranulator.

Slurry from the reactor is distributed in the rotary drum granulator, and the remaining ammonia (approximately 30 percent) is sparged under the slurry. The basic rotary drum granulator consists of an open-ended, slightly inclined rotary cylinder, with retaining rings at each end and a scraper or cutter mounted inside the drum shell. A rolling bed of dry material is maintained in the unit while the slurry is introduced through distributor pipes set lengthwise in the drum. Gravity forces the slurry to travel through the turning granulator to the lower end. Moist DAP granules are then discharged into a rotary dryer, where excess water is evaporated and the chemical reaction is accelerated to completion by the dryer heat. Dried granules are cooled and then sized on vibrating screens. The product ranges in granule diameter from one to four millimeters (mm). The oversized granules are crushed, mixed with the undersized, and recycled back to the ammoniator-granulator. Product-size DAP granules are allowed to cool, screened, bagged, and shipped. Before being exhausted to the atmosphere, particulate and ammonia rich off-gases from the granulator, cooler, and screening operations pass through cyclones and wet scrubbers (USEPA, 1993a).

TVA developed two minor modifications in their DAP process to produce MonoammoniumPhosphate (MAP). Inone, the phosphoric acid is ammoniated to an ammonia to phosphoric acid ratio of only 0.6 in the preneutralizer and then 1.0 in the granulator. This compares to a ratio of about 1.4 for DAP. With the second modification, the ammonium to phosphoric acid ratio is brought to 1.4 in the preneutralizer, then additional phosphoric acid is added in the granulator to bring the ratio backto 1.0. The second method is preferred by industry because higher temperatures may be used to dry the MAP, increasing production rates (Kent, 1992).

A schematic diagram of the ammonium phosphate process flow diagram is



shown in Figure 13.

Source: U.S.EPA, 1993a and TFI, 1999

Figure 13: Simplified Process Flow Diagram of Diammnonium Phosphate Production

GYPSUM POND WATER

SECONDARY SCRUBBER

PRIMARY SCRUBBER

ACID SURGE TANK

PHOSPHORIC ACID

SULFURIC ACID

REACTOR

ANHYDROUS AMMONIA

FUEL, AIR

AMMONIATOR GRANULATOR

ROTARY DRYER

SCREENS

CYCLONE

ROTARY COOLER

PRODUCT

DUST SUPPRESSANT

DUST SUPPRESSANT

UNDERSIZE

COOLING AIR

MILL OVERSIZE

III.B.3. Normal Superphosphate

Normal superphosphates (NSP) are prepared by reacting ground phosphate rock with 65 to 75 percent sulfuric acid to produce a solid fertilizer material. NSP is most often used as a high-phosphate additive in the production of granular fertilizers. It can also be granulated for sale as granulated superphosphate or granular mixed fertilizer.

There are two primary types of sulfuric acid used in superphosphate manufacture: virgin and spent acid. Virgin acid is produced from elemental sulfur, pyrites, and industrial gases and is relatively pure. Spent acid is a recycled waste product from various industries that use large quantities of sulfuric acid. Problems encountered with using spent acid include unusual



color, unfamiliar odor, and toxicity. An important factor in the production of normal superphosphates is the amount of iron and aluminum in the phosphate rock. Aluminum (as Al2O3) and iron (as Fe2O3) above five percent imparts an extreme stickiness to the superphosphate and makes it difficult to handle (USEPA, 1993a).

A generalized process diagramofnormal superphosphate productionis shown in Figure 14. Ground phosphate rock is weighed and mixed with sulfuric acid (H2SO4) and held in an enclosed area for about 30 minutes until the reaction is partially completed. The mixing may be done in a cone mixer, which relies on an inputted swirling motion of the acid to mix the rock and acid, a pug mill, which operates with one or two mixing shafts, or a pan mixer, which agitates the solution. The reaction is (AWMA, 1992):

Ca10(PO4)6F2CaCO3 + 11H2SO4 6 6H3PO4 + 11CaSO4*nH2O + 2HF + CO2 + H2O

The mixture is then transferred, using an enclosed conveyer knownas the den, through the cutter which breaks up clumps, and finally to a storage pile for curing. Off-gases from the reactor are typically treated in a wet scrubber. Particulates throughout the process are controlled with cyclones and baghouses (USEPA, 1993a).

To produce granulated normal superphosphate, cured superphosphate is fed through a clod breaker and sent to a rotary drum granulator where steam, water, and acid may be added to aid in granulation. Material is processed through a rotary drum granulator, a rotary dryer, and a rotary cooler, and is thenscreened to specificationsimilar to the process used for ammonium nitrate and urea. Finally, it is stored in bagged or bulk form prior to being sold (USEPA, 1993a).




Figure 14:


Typical Process for Normal Superphosphate Manufacturing


III.B.4. Triple Superphosphate

Triple superphosphate provides a high concentration of phosphorous. Two processes have been used to produce triple superphosphate: run-of-the-pile (ROP-TSP) and granular (GTSP). GTSP yields larger, more uniform particles with improved storage and handling properties than ROP-TSP. At this time, no facilities in the United States are producing ROP-TSP, so only the GTSP process is described here.

Most GTSP material is made with the Dorr-Oliver slurry granulation process, illustrated in Figure 15. This process is similar to that for normal superphosphates with the major exception being that phosphoric acid is used instead of sulfuric acid. In this process, ground phosphate rock or limestone is reacted with phosphoric acid in one or two reactors in series (USEPA, 1993a). The reaction is:

Ca5F(PO4)3+ 7H3PO4 + 5H2O 6 5Ca(H2PO4)2•H2O +HF

(Hodge, 1994) The phosphoric acid used in this process has a relatively low concentration (40 percent P2O5). The lower strength acid maintains the slurry in a fluid state during a mixing period of one to twohours. A small sidestream of slurry is continuously removed and distributed onto dried, recycled fines in a granulator, where it coats the granule surfaces and builds up its size.

Granules are thendried in a rotary dryer, elevated and passed through screens to eliminate oversize and undersize granules. Oversize granules are crushed and sent back to the first screen, while undersize ones are sent into the emission control systems. The granules within the size range of the product are then cooled and stored in a curing pile where the reaction is completed. Particulates from the rock handling, drying, screening, cooling, and storing processes are typically controlled with cyclones and baghouses and off-gases fromthe reactor, granulator, and cyclones and baghouses are typically treated with wet scrubbers (USEPA, 1993a).




Figure 15:

Source: United States EPA, 1993a

Typical Process for Triple Superphosphate


III.C. Fertilizer Mixing

A significant part of the fertilizer industry only purchases fertilizer materials in bulk from fertilizer manufacturing facilities and mixes them to sell as a fertilizer formulation. Fertilizer mixing facilities use many different materials in their blends. The most common granular fertilizer materials are listed in Table 9.

Table 9: Fertilizer Materials Used in Bulk Blends

Typical Grade N-P2O5-K2O

Percent of fertilizer plants using this material

Ammonium nitrate 31-0-0 41%

Urea 46-0-0 66%

Ammonium sulfate 21-0-0 22%

Diammonium phosphate (DAP) 18-46-0 95%

Monoammonium phosphate (MAP) 11-52-0 11%

Triple Superphosphate 0-46-0 78%

Normal superphosphate 0-20-0 4%

Potassium chloride 0-0-60 94%

Source: “Retail Marketing of Fertilizers in the United States,” by Hargett, Norman and Ralph Pay, 1980 .

DAP is favored for fertilizer mixing because of its ease in storage and handling, convenient low nitrogen and high phosphorous content, and compatibility with almost any other material. Granular triple superphosphate is also verypopular, but is incompatible with urea, a commonnitrogensource. Therefore, TSP is commonly used in no-nitrogen blends necessary for legumes. Ammonium sulfate has the lowest nitrogen content of the major nitrogen sources, however its production cost is quite low. Potassium chloride is the only major potassium source used in fertilizer blending. Additional materials may also be added to the blends, such as micronutrients and pesticides (Nielson, 1987).



Inert ingredients may also be added to fertilizer mixtures to improve the consistency or ease of application. Inert ingredients include sands, clays, and water.

Fertilizer mixing plants consist of five primary phases:

1. mixing and storing 2. moving materials to mixers 3. proportioning of materials 4. mixing, and 5. moving the finished blend to holding bins or transport containers

Fertilizer materials may be mixed as bulk blends or formed into granulations by a variety of processes. Bulk blending is a dry process, where different fertilizers are combined. Materials are typically received by rail cars and transferred through elevators to storage areas. Front-end loaders then carry the materials to weighing hoppers which feed into the mixers. There are two types of mixers most commonly used: the horizontal axis rotary drum mixer and the inclined axis rotary drum mixer. The inclined axis mixer is similar to a cement mixer in design and appearance. Ribbon-type bulk-blend mixers are also used in some plants. A ribbon-type mixer has an axial shaft with mixing spokes radiating out of the shaft in a configuration which forces the blend to flow in a ribbon-like pattern through the mixture (Nielson, 1987).

After preparation and initial bulk blending of materials, granulation may be employed in order to form larger fertilizer particles with multi-nutrient compositions. Granulation of mixed fertilizers may be accomplished by steam granulation, slurry granulation, melt, or compaction granulation.

Steam granulation is primarily used in Europe and Australia. The process results in little chemical reaction in order to maintain the P2O5 content of the fertilizer. Plasticity and agglomeration of the fertilizer materials is promoted by the injection of steam into rotating pans, rotary drums, or pug mills. The particles are then dried with heated air in a rotary drum dryer and cooled in a rotary drum cooler. In some cases, particles may be coated with chalk or clay to prevent caking (Hoffmeister, 1993).

Slurry granulation is more commonly used in the United States The process involves a chemical reactionof the feed ingredients. In slurry granulation, one of the feed ingredients is prepared as a slurry and reacted with the others in a preneutralizer. The slurry is then fed to a granulator such as the ammoniatorgranulator developed by the TVA. Fertilizer producers in the United States found that higher concentrations of acid could be fed to this preneutralizergranulator process than to a granulator alone, thus increasing the grades of fertilizers and making the TVA process popular in the United States (Hoffmeister, 1993).



Another granulation process similar to slurry granulation is melt granulation. The slurry feed is replaced by a hot, concentrated, almost anhydrous melt of feed fertilizer, typicallyammoniumphosphate, prepared ina pipe reactor. The hot melt provides the plasticity necessary for granulation. The granules cool first in the granulator and then in the cooler, eliminating the need for a dryer.

Compactiongranulationis based onthe fact thatmostmaterials are semiplastic and whensubjected to highpressures, the materials will compact, deform, and it is possible to roll them out into flat, stable sheets. These sheets are then cracked, forming granule-size chips which are most stable and less prone to caking than other granulations. This process has been successful for many fertilizer mixtures, particularly those including potassium chloride and ammonium phosphates and superphosphates. Ammonium sulfate, however, has limited crystal plasticity, making it unsuitable for compaction granulation (Hoffmeister, 1993).

The mixtures are then typically bagged in woven polypropylene bags for strength and resistance, with liner bags to prevent leaks. The bags are either clamped, tied, heat sealed, or sewn, sewing being the cheapest and most common method (Nielson, 1987).

III.D. Pesticide Formulating Processes

Pesticide formulationinvolves the process of mixing, blending, or diluting one or more pesticide active ingredients (AIs) and inert ingredients to obtain a product used for additional processing or an end-use (retail) product. Formulation does not involve an intended chemical reaction (i.e., chemical synthesis). AIs are produced at separate facilities not included in this notebook. Pesticide formulations take many forms: water-based liquid; organic solvent-based liquid; dry products in granular, powder, and solid forms; pressurized gases; and aerosols. The formulations can be in a concentrated formrequiring dilution before application, or they can be ready to apply. The packaging of the formulated pesticide product depends on the type of formulation. Liquids generally are packaged into jugs, cans, or drums; dry formulations generally are packaged into bags, boxes, drums, or jugs; pressurized gases are packaged into cylinders;and aerosols are packaged into aerosol cans.

Formulating, packaging, and repackaging is performed in a variety of ways, ranging fromverysophisticated and automated formulating and packaging lines to completelymanual lines. Descriptions of liquid formulating and packaging, dryformulating and packaging, aerosol packaging, pressurized gas formulating and packaging, and repackaging operations are provided below.



III.D.1. Liquid Formulating and Packaging

Liquid formulations contain mixtures of several raw materials, including AIs, inert ingredients suchas base solvents, emulsifiers, or surfactants. The solvent must be able to dissolve the AIs and other ingredients. It may be water or an organic chemical, such as isopropyl alcohol or petroleum distillate. In some cases, the formulation is an emulsion and contains both water and an organic solvent. Solid materials, such as powders or granules, may also be used as part of a liquid formulation by dissolving or emulsifying the dry materials to forma liquid or suspension. The formulated product may be in a concentrated form requiring dilution before application, or may be ready to apply.

Typical liquid formulating lines consist of storage tanks or containers to hold active and inert raw materials and a mixing tank for formulating the pesticide product. A storage tank may also be used on the formulating line to hold the formulated pesticide product, prior to a packaging step. Facilities may receive their raw materials in bulk and store them in bulk storage tanks, or they may receive the raw materials in smaller quantities, such as 55-gallon drums, 50-pound bags, or 250-gallon minibulk refillable containers or “totes.” These raw materials are either piped to the formulation vessel from bulk storage tanks or added directly to the vessel from drums, bags, or minibulks. Typically, water or the base solvent is added to the formulation vessel in bulk quantities (USEPA, 1996). A typical liquid formulating line is shown in Figure 16.

The formulating line may also include piping and pumps for moving the raw material fromthe storage tanks to the mixing tank, and for moving formulated pesticide product to the packaging line. Other items that may be part of the line are premixing tanks, stirrers, heaters, bottle washers, and air pollution control equipment. Some lines may also have refrigeration units for formulation and storage equipment, scales, and other equipment.

Many liquid formulations are packaged by simply transferring the final product into containers. Small quantities of product are often manually packaged by gravity feeding the product directly fromthe formulation tank into the product container. For larger quantities, the process is often automated. Formulated product is transferred to the packaging line through pipes or hoses, or is received from a separate formulating facility and placed in a filler tank. A conveyor belt is used to carry product containers, such as jugs, bottles, cans, or drums, through the filling unit, where nozzles dispense the appropriate volume of product. The belt then carries the containers to a capper, which may be automated or manual, and to a labeling unit. Finally, the containers are packed into shipping cases (USEPA, 1996).



Figure 16: Typical Process for Liquid Formulating

Source: United States EPA, 1996

III.D.2. Dry Formulating and Packaging

Dry formulations also contain active and inert ingredients. The final product maybe inmanydifferent forms, such as powders, dusts, granules, blocks, solid objects impregnated with pesticide (e.g., flea collars), pesticides formed into a solid shape (e.g., pressed tablets), microencapsulated dusts or granules (AI coated with a polymeric membrane to prevent premature degradation), or encapsulated water soluble packaging. They are formulated in various ways, including:

C mixing powdered or granular AIs with dry inert carriers;C spraying or mixing a liquid active ingredient onto a dry carrier;C soaking or using pressure and heat to force active ingredients into a solid

matrix; C mixing active ingredients with a monomer and allowing the mixture to

polymerize into a solid; and C drying or hardening an active ingredient solution into a solid form.

These dry pesticide products may be designed to be applied in solid form or dissolved or emulsified in water or solvent prior to application (USEPA, 1996).

Because there are many types of dry pesticide products, dry pesticide formulating lines can vary considerably. In general, though, dry formulating



lines have tanks or containers to hold the active ingredients and inert raw materials, and may include mixing tanks, ribbon blenders, extruding equipment, high pressure and temperature tanks for impregnating solids with active ingredient, vacuums or other types of drying equipment, tanks or bins for storage of the formulated pesticide product, pelletizers, presses, milling equipment, sieves, and sifters (USEPA, 1996).

Raw materials for dry pesticide products may be liquid or solid. Liquid raw materials may be stored in rail tank cars, tank trucks, minibulks, drums, or bottles. Dry raw materials may be stored in silos, rail cars, tank trucks, minibulks, metal drums, fiber drums, bags, or boxes. Liquid raw materials may be pumped, poured or sprayed into formulation vessels, while dry raw materials are frequently transferred to formulation equipment by screw conveyors (consisting of a helix mounted on a shaft and turning in a trough), elevators, or by pouring.

Dry formulating lines may also include piping and pumps to move raw materials from storage tanks to the formulation equipment, and to move formulated pesticide product to the packaging equipment. Other items thatmay be included in the dry pesticide product line are premixing tanks, tanks for storing formulated product prior to packaging, stirrers, heaters, refrigeration units on formulation and storage equipment, scales, and air pollution control equipment (e.g., cyclones, filters, or baghouses) (USEPA, 1996).

Dry pesticide products may be packaged into rail tank cars, tank trucks, totes, and minibulks, but are typically packaged into bags, boxes, and drums. As with many liquid formulations, dry formulations are packaged by simply transferring the final product into boxes, drums, jugs, or bags. Small quantities or bags are typically packaged manually using a gravity feed from the formulating unitinto the containers or bags. Larger quantities may be packaged on an automated line, similar to liquid packaging lines.

Figure 17 illustrates a dry pesticide formulation line.



Figure 17: Typical Process for Dry Formulating

Source: United States EPA, 1996

III.D.3. Aerosol Packaging

Some pesticide products (typicallywater-based or solvent-based liquids) are packaged as aerosols, whichcanbe applied to surfaces or dispersed in the air. The product is placed in spray cans that are put under pressure and a propellant is added, which forces the product out of the can in an aerosol spray. An aerosol packaging line typically includes a filler, a capper, a propellant injector, and a United States Department of Transportation (DOT) test bath. In the filler, formulated pesticide product is dispensed into empty aerosol cans, in much the same way as the liquid packaging lines fill containers. The cans are then sent to the capper, where a cap with a nozzle is placed on the can. The can enters a separate room, where the propellent is injected into the can, a vacuum is pulled, and the cap is crimped to make the can airtight. In order to comply with DOT regulations on the transport of pressurized containers, each can must then be tested for leaks and rupturing in a DOT test bath. Test baths indicate leaks by the appearance of bubbles at the point of leakage on the cylinder. The aerosol packaging line may also include a can washer to remove residue from can exteriors prior to entering the test bath (to reduce contaminant buildup in the bath), a dryer to dry can exteriors, and machinery to package aerosol cans into boxes for shipment (USEPA, 1996).



III.D.4. Pressurized Gas Formulating and Packaging

Some pesticide products are formulated and packaged as pressurized gases, primarilyfor the purpose of soil fumigation. Soil fumigation is used where the nematodic and fungal populations in soil prohibit successful seed planting. Volatile general toxicants, such as low molecular weight halogenated compounds, are typically injected into the soil before planting, but are also occasionally used once plants have reached maturity (Kent, 1992).

The active and inert ingredients are received as liquid, pressurized liquids, or gases, and are stored in tanks, tank trucks, rail cars, or minibulk storage containers. Liquid ingredients are placed in a holding tank prior to formulation. Formulating and packaging operations for these products usually occurs in one step in a closed-loop system. The ingredients are metered by weight throughpressurized transfer lines into DOT-approved steel application cylinders. Other equipment that may be included in a pressurized gas line include pump and piping, and heating and refrigerating units to maintain gas pressures and temperatures in storage (USEPA, 1996).

The cylinders may be refilled at a later date, after they have been tested to ensure that they are still capable of containing pressurized fluids. DOT requires hydrostatic pressure testing, as well as visual examination of the cylinder (USEPA, 1996).

III.D.5. Repackaging

Repackaging operations are similar to packaging operations, except the “raw material” is an already formulated product that has been packaged for sale. Repackagers often purchase formulated pesticide products, transfer the product to new containers with customer-specific labeling, and sell them to distributors (USEPA, 1996).

A separate type of repackaging, called refilling, is usually performed by agrichemical facilities thattransfer pesticide products frombulk storage tanks into minibulks. These refillable containers are typicallyconstructed ofplastic and typically have capacities ranging from100 to 500 gallons. Minibulks may be owned by the refilling establishment, the pesticide registrant, or by the end user. Production lines usually consist of a bulk storage tank, a minibulk tank into which the product is repackaged, and any interconnecting hoses or piping. The bulk storage tanks may be dedicated by product and clustered together in a diked area. The products are dispensed to the minibulks bythe use ofmanual system or a computer-regulated systemof pumps and meters (USEPA, 1996).



III.E. Raw Material Inputs and Pollution Outputs

Raw material inputs and pollution outputs of fertilizer products and pesticide products differ considerably, and, therefore, are discussed separately below. The pollution outputs are discussed both specifically by product as well as generally by process since there are some similarities in the fertilizer and pesticide production processes and pollutant outputs.

III.E.1. Fertilizers

The primary raw materials for fertilizer manufacturing are phosphate rock, natural gas, sulfuric acid, and carbon dioxide. These materials are combined by several methods and in different proportions to produce a variety of fertilizer products, as described in section III.

Figure 18 summarizes the fertilizer material inputs for the principal fertilizer products.

Figure 18: Raw Material Flowchart for Principal Fertilizer Materials

Source: Adapted from Manual on Fertilizer Statistics, Food and Agriculture Organization of the United Nations, Rome 1991.

Because the basic fertilizer nutrients are found in many natural and manmade materials, raw materials for fertilizers canalso be derived fromsources other than the virgin materials described above. Common sources of fertilizer ingredients are sewerage treatment sludges and certain industrial wastes. Although these waste-derived fertilizers may contain essentially the same



nutrients as fertilizers derived from virgin materials, they also may contain additional constituents that were present in the waste material and which may not be beneficial, or are potentially harmful to crops, human health, or the environment. Such constituents may enter the food chain or groundwater and could become concentrated in the soil after repeated use. Lead, cadmium and arsenic are some of the more common fertilizer ingredients that could be harmful if sufficient quantities are present. It should be noted, however, that fertilizers derived from virgin materials also have the potential to contain harmful levels of these constituents if significant quantities are naturally present in the raw materials.

One waste material input which has received some attentionrecentlyis cement kiln dust (CKD). Although there has been a considerable amount of research conducted on CKD use as a fertilizer, existing applications of CKD for this purpose have been mostly anecdotal, and there is only limited evidence that commercial CKD use as a fertilizer is growing significantly (USEPA, 1993b).

Like agricultural lime, CKD is alkaline and contains a number of essential plant nutrients. Because of these parallel characteristics, CKD has been used as an agricultural soil amendment. CKD possesses significant fertilizer potential, particularly because of its high potassium content. Soil scientists have also suggested that other key plant nutrients contained in CKD, such as calcium, phosphorous, and zinc, might be beneficial in some fertilizer applications. However, some concern has been raised over hazardous wastes in CKD (USEPA, 1993b).

Coal combustion by-products are also receiving attention for their potential agricultural benefits., including alleviating soil trace elemental deficiencies, modifying soil pH, and increasing levels of Ca and S, infiltration rates, depth of rooting, and drought tolerance. Flue gas desulfurization residues, which contain gypsum, have the potential to improve water use efficiency, product quality, and productivity of soil-crop systems. The short term benefits of coal combustion by-products usage has been demonstrated, however, long term effects have not been documented. Future hazards and benefits are yet to be determined (Korcak, 1995). Electric-arc furnace dust is also used as a fertilizer ingredient since it contains a number of trace elements required by plants, including zinc.

Pollution outputs are summarized in terms of air emission, wastewater, and residual wastes.

Air Emissions

Synthetic AmmoniaAir pollutants from the manufacture of synthetic anhydrous ammonia areemitted primarily from four process steps:



C regeneration of the desulfurization bed, C heating of the catalytic steam, C regeneration of carbon dioxide scrubbing solution, C steam stripping of process condensate.

More than 95 percent of the ammonia plants in the United States use activatedcarbon fortified with metallic oxide additives for feedstock desulfurization.Vented regeneration steam contains sulfur oxides (SOx) and hydrogen sulfide(H2S), depending on the amount ofoxygenin the steam. Regeneration may alsoemit hydrocarbons and carbon monoxide (CO). The reformer, heated withnatural gas or fuel oil, may emit combustion products such as NOx, CO, SOx,hydrocarbons, and particulates (USEPA, 1993a).

Carbon dioxide (CO2) is removed from the synthesis gas by scrubbing withmonoethanolamine (C2H4NH2OH) or hot potassium carbonate solution.Regeneration of this CO2 scrubbing solution with steam produces emissionsof water, NH3, CO, CO2 and monoethanolamine (USEPA, 1993a).

Cooling the synthesis gas after low temperature shift conversion forms acondensate containing NH3, CO2, methanol (CH3OH), and trace metals.Condensate steam strippers are used to remove NH3 and methanol from thewater, and steam from this may be vented to the atmosphere, emitting NH3,CO2, and methanol (USEPA, 1993a).

Nitric AcidEmissions from nitric acid manufacturing consist primarily of NO and NO2

(which account for visible emissions), and trace amounts of HNO3 mist andNH3. The major source of nitrogen oxides is the tail gas from the acidabsorption tower. In general, the quantity of nitrogen oxides (NOx) emissionsis directly related to the kinetics of the nitric acid formation reaction andabsorption tower design. NOx emissions can increase when there is:

C insufficient air supply to the oxidizer and absorber, C low pressure, especially in the absorber, C high temperatures in the cooler/condenser and absorber, C production of an excessively high-strength product acid, C operation at high throughput rates, C faulty equipment such as compressors or pumps which lead to

lower pressures, leaks, and reduced plant efficiency (USEPA, 1993a).

Comparatively small amounts of nitrogen oxides are also lost from acid concentrating plants. These losses (mostly NO2) are from the condenser system, but the emissions are small enough to be controlled easily by absorbers.

Acid mist emissions do not occur from the tail gas of a properly operated



plant. The small amounts that may be present in the absorber exit gas streams are typicallyremoved by a separator or collector prior to entering the catalytic reduction unit or expander.

The acid production system and storage tanks can be a significant source of visible NOx emissions atnitric acid plants. Emissions fromacid storage tanks are most likely to occur during tank filling (USEPA, 1993a).

Ammonium NitrateThe primary air emissions from ammonium nitrate production plants areparticulate matter (ammonium nitrate and coating materials), ammonia andnitric acid. Ammonia and nitric acid are emitted primarily from solutionformation and granulators. Particulate matter (largely as ammonium nitrate)can be emitted from most of the process operations (USEPA, 1993a).

The emission sources in solution formation and concentration processes are neutralizers and evaporators, emitting nitric acid and ammonia. The vapor stream off the top of the neutralization reactor is primarily steam with some ammonia and NH4NO3 particulates present. Specific plant operating characteristics, however, make these emissions vary depending upon use of excess ammonia or acid in the neutralizer. Particulate emissions from these operations tend to be smaller in size than those from solids production and handling processes and generally are recycled back to the process (USEPA, 1993a).

Emissions from solids formation processes are ammonium nitrate particulate matter and ammonia. The sources of primary importance are prill towers (for high density and low density prills) and granulators (rotary drum and pan). Emissions from prill towers result from carryover of fine particles and fume by the prill cooling air flowing through the tower. These fine particles are from microprill formation, attrition of prills colliding with the tower or one another, and rapid transition of the ammonia nitrate between crystal states (USEPA, 1993a).

Microprill formation resulting from partially plugged orifices of melt spray devices can increase fine dust loading and emissions. Certain designs (spinning buckets) and practices (vibration of spray plates) help reduce plugged orifices and thus microprill formation. High ambient air temperatures can cause increased emissions because of entrainment as a result of higher air flow required to cool prills and because of increased fume formation at the higher temperatures (USEPA, 1993a).

Emissions from screening operations are generated by the attrition of the ammonium nitrate solids against the screens and against one another. Almost all screening operations used in the ammonium nitrate manufacturing industry are enclosed or have a cover over the uppermostscreen. Emissions are ducted from the process for recovery or reuse (USEPA, 1993a).



Bagging and bulk loading operations are also a source of particulate emissions. Dust is emitted from each type of bagging process during final filling when dust laden air is displaced fromthe bag by the ammoniumnitrate. The potential for emissions during bagging is greater for coated than for uncoated material. It is expected that emissions from bagging operations are primarily the kaolin, talc or diatomaceous earth coating matter. About 90 percent of solid ammonium nitrate produced domestically is bulk loaded. While particulate emissions from bulk loading are not generally controlled, visible emissions are within typical state regulatory requirements (below 20 percent opacity) (USEPA, 1993a).

UreaEmissions fromurea manufacture are mainly ammonia and particulate matter.Formaldehyde and methanol, hazardous air pollutants, may be emitted ifadditives are used. FormalinTM, used as a formaldehyde additive, may containup to 15 percent methanol. Ammonia is emitted during the solution synthesisand solids production processes. Particulate matter is emitted during all ureaprocesses (USEPA, 1993a).

In the synthesis process, some emission control is inherent in the recycle process where carbamate gases and/or liquids are recovered and recycled. Typical emission sources from the solution synthesis process are noncondensable vent streams from ammonium carbamate decomposers and separators. Emissions from synthesis processes are generally combined with emissions from the solution concentration process and are vented through a common stack. Combined particulate emissions from urea synthesis and concentration operations are small compared to particulate emissions from a typical solids-producing urea plant. The synthesis and concentration operations are usually uncontrolled except for recycle provisions to recover ammonia (USEPA, 1993a).

Uncontrolled emission rates from prill towers may be affected by the following factors:

C product grade being produced C air flow rate through the tower C type of tower bed C ambient temperature and humidity (USEPA, 1993a)

The total of mass emissions per unit is usually lower for feed grade prill production than for agricultural grade prills, due to lower airflows. Uncontrolled particulate emission rates for fluidized bed prill towers are higher than those for nonfluidized bed prill towers making agricultural grade prills, and are approximately equal to those for nonfluidized bed feed grade prills (USEPA, 1993a).

Ambient air conditions can affect prill tower emissions. Available data indicate that colder temperatures promote the formation of smaller particles



in the prill tower exhaust. Since smaller particles are more difficult toremove, the efficiency of prill tower control devices tends to decrease withambient temperatures. This can lead to higher emission levels for prill towersoperated during cold weather. Ambient humidity can also affect prill toweremissions. Air flow rates must be increased with high humidity, and higher airflow rates usually cause higher emissions (USEPA, 1993a).

In the solids screening process, dust is generated by abrasion of urea particlesand the vibrationof the screening mechanisms. Therefore, almost all screeningoperations used in the urea manufacturing industry are enclosed or are coveredover the uppermostscreen. Emissions attributable to coating include entrainedclay dust fromloading, inplant transfer, and leaks fromthe seals of the coater(USEPA, 1993a).

Phosphoric AcidGaseous fluorides such as silicon tetrafluoride (SiF4) and hydrogen fluoride(HF) can be major emissions from wet process acid production. Phosphaterock contains 3.5 to 4.0 percent fluorine. Part of the fluorine from the rock isprecipitated with the gypsum, another part is leached out with the phosphoricacid product, and the remaining portion is vaporized in the reactor orevaporator. The relative quantities of fluorides in the filter acid and gypsumdepend on the type of rock and the operating conditions. Final disposition ofthe volatilized fluoride depends on the design and operation of the plant(USEPA, 1993a).

The reactor in which phosphate rock is reacted with sulfuric acid is the mainsource of emissions. Fluoride emissions accompany the air used to cool thereactor slurry. Vacuum flash cooling has replaced the air cooling method to alarge extent, since emissions are minimized in the closed system.

Acid concentration by evaporation is another source of fluoride emissions.Approximately 20 to 40 percent of the fluorine originally present in the rockvaporizes in this operation. Particulate matter containing fluorides can beemitted directly from process equipment. About three to six percent of theparticulates can be fluorides, as measured at one facility (USEPA, 1993a).

Ammonium PhosphatesThe major sources of air emissions from the production of ammoniumphosphatic fertilizers include the reactor, the ammoniator-granulator, the dryerand cooler, product sizing and material transfer, and the gypsum pond. Thereactor and ammoniator-granulator produce emissions of gaseous ammonia,gaseous fluorides such as hydrogen fluoride (HF) and silicon tetrafluoride(SiF4), and particulate ammonium phosphates. These two exhaust streams aregenerally combined and passed through primary and secondary scrubbers(USEPA, 1993a).

Exhaust gases fromthe dryer and cooler also contain ammonia, fluorides and



particulates, and these streams are commonly combined and passed throughcyclones and primaryand secondaryscrubbers. Particulate emissions and lowlevels of ammonia and fluorides from product sizing and material transferoperations are controlled the same way (USEPA, 1993a).

Normal SuperphosphatesSources ofemissions at a normal superphosphate plant include rockunloadingand feeding, mixingoperations (in the reactor), storage (in the curing building),and fertilizer handling operations. Rock unloading, handling and feedinggenerate particulate emissions of phosphate rock dust. The mixer, den andcuring building emit gases in the formof silicontetrafluoride (SiF4), hydrogenfluoride (HF) and particulates composed of fluoride and phosphate material(USEPA, 1993a).

Triple SuperphosphatesEmissions of fluorine compounds and dust particles occur during theproduction of granulated triple superphosphate. Silicon tetrafluoride (SiF4)and hydrogen fluoride (HF) are released by the acidulation reaction and theyevolve fromthe reactors, den, granulator, and dryer. Evolution of fluoride isessentially finished in the dryer and there is little fluoride evolved from thestorage pile in the curing building (USEPA, 1993a).

Sources of particulate emissions include the reactor, granulator, dryer, screens, cooler, mills, and transfer conveyors. Additional emissions of particulate result fromthe unloading, grinding, storage, and transfer of ground phosphate rock. Facilities may also use limestone, which is received in granulated form and does not require additional milling (USEPA, 1993a).

Wastewater

Wastewater from the fertilizer industry can be classified into four groups:

C process effluents resulting from contact with gas, liquids, or solids

C dedicated effluents which may be separated for use in one process or for recycling at a controlled rate

C effluents fromgeneral services such as cleaning or pretreatment C occasional effluents such as leaks or spills

A number of process wastewater streams from the nitrogenous fertilizer industry have been identified. Frequently these wastewaters contain high levels of nitrogenous compounds such as ammonia, nitrates, and organic nitrogen. In ammonia production, wastewater is generated from process condensate stripping. Ammonium nitrate manufacturing produces process wastewater in the neutralization process, the evaporation unit, and air cooling equipment. The vacuum condenser in urea plants is a source of wastewater. Most scrubbing operations are also a source of wastewater. Nitric acid



production generates relatively little wastewater since there is no process wastewater source. Steam generated in nitrogenous fertilizer processing may contain dissolved and suspended solids, alkalinity, and hardness (USEPA, 1974).

The most common methods for removing nitrogenous compounds include:

C Biological nitrification/denitrificationC Air or steam strippingC Ion exchangeC Breakpoint chlorination(Water Environment Federation, 1994).

The major source of wastewater fromany phosphatic fertilizer manufacturing process is referred to as “pond water.” Phosphoric acid production creates large quantities of pond water for cooling of the process, concentration of the product and for processing and storage of the gypsum byproduct. Gypsum slurry water is decanted from the top of the gypsum stacks and sent to the cooling pond through collection ditches (USEPA, 1993a). Through evaporation and recycling, contaminant concentrations in pond water can reach several grams per liter of phosphates and fluoride. Additional elemental contaminants in pond water which originate in phosphate rock are arsenic, cadmium, uranium, vanadium, and radium (USEPA, 1974).

The most common industry treatment for removing phosphorous is lime neutralization and settling.

Occasional wastewater is generated in any fertilizer production facility by leaks, spills, cleaning, maintenance, and laboratory tests. Cleaning of cooling and pollution control systems also produces process wastewater. Cooling water may contain ammonia, sulfate, chloride, phosphate, chromate, and dissolved solids which become concentrated through evaporation (USEPA, 1974). The laundry of workers’ clothing is another source of wastewater originating outside the actual process.

Solid/Hazardous/Residual Wastes One of the largest solid wastes in the fertilizer industry is phosphogypsum whichis produced during phosphoric acid production. Approximately 1.5 tons of phosphogypsum is produced per tonof phosphate rock fed, or 5 tons per ton of phosphoric acid produced (expressed as P2O5). Gypsum (calcium sulphate dihydrate) is a mineral which also occurs in nature. Phosphogypsum is produced by the reaction of phosphate rock with sulphuric acid during the process of producing phosphoric acid. The term “phosphogypsum” is used to specify the particular gypsum arising fromthe acidulation of phosphate rock, because it contains trace amounts of many of the mineral impurities that accompany phosphate rock. One of these impurities is radium, the parent of radon. Other trace impurities found in phosphogypsum include arsenic, nickel, cadmium, lead, aluminum, fluoride, and phosphoric acid. Mainly because of



the radiumcontent, the EPA restricts use of phosphogypsum and stipulates that no phosphogypsum with radium over tenpCi/gcanbe removed fromthe stacks adjacent to the agricultural chemical plants (UNEP, 1996).

The use of waste phosphogypsum for other purposes has been widely encouraged, but economic and/or quality problems and/or the demand for the resulting products frequently inhibit or prevent this. These problems relate not only to the impurities in the gypsum, but also to its relatively high moisture content. Plasterboard, plaster, and cement are the main possibilities. It is also possible to recycle phosphogypsum in sulphuric acid production. The ready availability of natural gypsum and the high cost of gypsum-based sulphuric acid, as well as the presence of trace contaminants, are the main obstacles to its use (Miller, 1995). However, in countries where gypsum and other sulphurous raw materials are scarce, phosphogypsum has been successfully used for these purposes (UNEP, 1996).

Dumping gypsum on land is not possible everywhere because the material settles and dries slowly and requires an adequate land area and certain climatic and soil conditions where the stack is situated. Gypsum stacks are being increasingly regulated in terms of lining and cap systems to prevent contaminated leaching or runoff (UNEP, 1996).

All phosphate ores contain traces of radioactive elements and a number of metals. During processing, these are partitioned between beneficiation process wastes, the waste from the further processing into intermediate and finished fertilizer production, and some end up in the final product (UNEP, 1996).

Cadmium is a heavy metal which accumulates in living systems and can become toxic above certain limits. The quantity of cadmium contained in a phosphatic fertilizer depends on the source of the rock or waste material from which it was made. The cadmium content of phosphate rocks varies from almost zero to over 300 mg/kg P2O5. The acidulation of phosphate rock partitions the cadmium between the fertilizer product and the by-products, mainly the phosphogypsum arising from phosphoric acid production (UNEP, 1996).

The fertilizer industry has for some decades tried to develop cadmium separationprocesses. Processes studied so far have shown serious limitations and problems, with regard to safety, cost, energy consumption or environmental concerns. Currently available processes are expensive and are not economically viable except for phosphates destined for human or animal consumption, which have a greater added value. A process developed for removing cadmium from phosphoric acid, which is used in the production of many phosphatic fertilizers (except normal superphosphate), has shown promise on a laboratory scale, but needs further testing before being used on an industrial scale (UNEP, 1996).


C

C


Off-specification product, spills, and dusts collected in emission control systems are potential sources of residual wastes. Products are occasionally suspended or canceled, leaving stockpiles of residual product. Other possible sources of solid wastes are spent catalysts, spent containers, wastewater treatment sludges, and spent filters. Many of these wastes are transported off-site for disposal. However, with good housekeeping techniques and dedicated systems, some of these wastes may be recycled back into the process instead of being wasted.

Catalysts used in the steam reforming process need to be replaced every two to sixyears. Spent catalysts contain oxides of hexavalent chromium, zinc, iron, and nickel. They are typically returned to the manufacturer or other metal recovery companies for recycling and reclamation of valuable materials (UNEP, 1996).

III.E.2. Pesticide Formulating, Packaging, and Repackaging

As listed below, input raw materials include the pesticide concentrates from pesticide manufacturing plants as well as diluents and other chemical additives used in the formulating process:

C Active Ingredients Organic/inorganic pesticides: insecticides, herbicides, fungicides, and others. (See Table 10.)

C Formulation and preparation materials Dry formulations:

organic flours, sulfur, silicon oxide, lime, gypsum, talc, pyrophyllite, bentonites, kaolins, attapulgite, and volcanic ash.

Liquid formulations: Solvents: xylenes, kerosenes, methyl isobutyl ketone, amyl acetate, and chlorinated solvents. Propellants: carbon dioxide and nitrogen. Others: wetting and dispersing agents, masking agents, deodorants, and emulsifiers (USEPA, 1990).

In addition to pesticide materials, some facilities listed under SIC code 2879 produce fertilizer/pesticide blends. A variety of nitrogenous, phosphatic, and mixed fertilizers may be inputted into bulk blending tanks to produce these combinations.



Table 10: Approximate Quantities of Most Commonly Used Conventional Pesticides in United States Agricultural Crop Production

Chemical 1995 Consumption (Million pounds active ingredient)

Chemical 1995 Consumption (Million pounds active ingredient)

Atrazine 68-73 Chlorpyrifos 9-13

Metolachlor 59-64 Chlorothalonil 8-12

Metam Sodium 449-54 Copper Hydroxide 7-11

Methyl Bromide 39-46 Propanil 6-10

Dichloropropene 38-43 Dicamba 6-10

2,4-D 31-36 Terbufos 6-9

Glyphosate 25-30 Mancozeb 6-9

Cyanazine 24-29 Fluometuron 5-9

Pendimethalin 23-28 MSMA 4-8

Trifluralin 23-28 Bentazone 4-8

Acetochlor 22-27 Parathion 4-7

Alachlor 19-24 Sodium Chlorate 4-6

EPTC 9-13

Source: Pesticide Industry Sales and Usage, 1994 and 1995 Market Estimates, EPA, August 1997.

Air Emissions

Air emissions can be generated throughout the pesticide formulating and packaging processes, mostly when fine particulates of pesticide dust become suspended in air while the materials are being moved, processed, or stored. Most dust or granule blending mills are equipped with vacuum systems, cyclones, and wet scrubbers to collect fugitive dust. Some vacuumsystems are dedicated to certain processes to facilitate reuse of the dust. Other systems are used to collect dust from a number of areas (USEPA, 1990). Dust generated by pesticide formulation processes contain AIs which may be toxic to humans and the environment. Thus, they are important to contain.

Volatile organic compound (VOC) emissions such as xylene may also arise when solvent-based liquid formulations are produced. VOC emissions may also be generated during equipment cleaning with solvents.



Wastewater

Process wastewater is defined in 40 CFR 122.2 as “any water which, during manufacturing or processing, comes into directcontactwith or results fromthe production or use of any raw material, byproduct, intermediate product, finished product, or waste product.” Wastewater from the pesticide formulating industry is typically due to cleaning of equipment and related process areas and not the actual formulating processes (USEPA, 1996).

Cleaning and decontaminating blending and liquid pesticide mixing and storage equipment generates pesticide-contaminated wastewater or solvent, depending upon whether the equipment is used to formulate water or solvent-based pesticides. Decontamination is performed between batches of different types of formulations to prevent cross contamination of the subsequent batch. Decontaminationis also performed prior to taking the equipment outofservice for maintenance. The decontamination is commonly performed using high pressure water hoses equipped with spraynozzles, portable steamgenerators, or by running a batch of solvent through the formulating equipment (USEPA, 1990).

Active ingredient containers, such as 55-gallon drums, are often decontaminated by triple rinsing. The decontamination is usually performed using a high pressure water hose equipped with a spray nozzle or a portable steamjenny. The containers can then be sold or given to commercial recycling firms, depending on label directions (USEPA, 1990).

Floor, wall, and equipment exterior washing is typically performed using water hoses equipped with spray nozzles. It may also involve the use of mops and squeegees. Wastewater is also generated by clean-up of spills and leaks.

Wastewater fromthese operations typicallycontains AIs, solvents, and wetting agents (USEPA, 1990). Other sources of wastewater include:

C Pollution control scrubber waterC Department of Transportation leak test waterC Safety equipment wash waterC Laboratory equipment wash waterC Shower waterC Laundry waterC Fire protection test waterC Contaminated precipitation runoff (USEPA, 1996)

Solid/Hazardous/Residual Wastes

Residual wastes include containers and container liners potentially contaminated with pesticides, as well as off-spec product, dustcollected from



emission control equipment, and product spills. Contaminated laboratory equipment and protective workers clothing are other potential solid waste sources (USEPA, 1990).

Decontamination of the solid-based pesticide blending mills may generate solid diluent contaminated with pesticides. The diluent typically consists of clay for dust mills and sand for granule mills (USEPA, 1990).

In case of pesticide products which have been suspended or canceled, there may be existing stocks of these products remaining. EPA may allow the use of existing stocks or prohibit such use. State environmental agencies occasionally collect unusable pesticides.

Procedures for pesticide management have been proposed by EPA, as authorized under section 19 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). For more details, refer to section VI.C on pending and proposed regulatory requirements.



Table 11: Summary of Potential Pollution Outputs for the Agricultural Chemical Industry

Process Air Emissions Process Wastewater Residual Waste

Nitric Acid Absorption Tower

NO, NO2, HNO3 in tailgas

NA Spent tower materials, trays

Solution Formulation and Granulation

NH3, HNO3

particulates Condensed steam with NH4NO3 and NH3

NA

Solids Formation Particulates, NOx, SiF4, HF

NA Dusts

Regeneration of Desulfurization and Filter Beds

Hydrocarbons, CO, NH3, CO2

Condensed steam, NH3, CO2

Spent bed material

Screening Dust NA Mixed undersized captured dusts, used screens

Wet Process Phosphoric Acid Production

SiF4, HF Pond water Gypsum

Unloading of materials into blending tanks

Dust/particulates released in transfer

NA Leftover raw material containers

Open processing and storage equipment

VOC’s NA NA

Equipment and facility cleaning

NA Washwater, waste solvent

Waste sands and clays, used mops/ squeegees/etc.

Laboratory procedures

VOC’s and dusts released

Washwater, lab testing water

Off-spec product used for testing/analysis

Spills and runoff Dust/particulates released by spill

Contaminated rainfall/runoff

Contaminated solid product

Pollution control systems

NA Contaminated scrubber water

Spent filter material

Source: Guide to Pollution Prevention, The Pesticide Formulating Industry, Center for Environmental Research Information, United States EPA, Washington D.C., 1990.



III.F. Management of Chemicals in Wastestream

The Pollution Prevention Act of 1990 (PPA) requires facilities to report informationabout the managementofToxic Release Inventory (TRI) chemicals in waste and efforts made to eliminate or reduce those quantities. These data have been collected annually in section 8 of the TRI reporting Form R beginning with the 1991 reporting year. The data summarized below cover the years 1995-1998 and are meant to provide a basic understanding of the quantities of waste handled by the industry, the methods typically used to manage this waste, and recent trends in these methods. TRI waste management data can be used to assess trends in source reduction within individual industries and facilities, and for specific TRI chemicals. This information could then be used as a tool in identifying opportunities for pollution prevention or compliance assistance activities.

While the quantities reported for 1995 and 1996 are estimates of quantities already managed, the quantities listed by facilities for 1997 and 1998 are projections only. The PPA requires these projections to encourage facilities to consider future source reduction, not to establish any mandatory limits. Future-year estimates are not commitments that facilities reporting under TRI are required to meet.

. Fertilizers

Table 12 shows that the TRI reporting fertilizer manufacturing and mixing facilities managed about 566 million pounds of production related wastes (total quantity of TRI chemicals in the waste from routine production operations in column B) in 1996. From the yearly data presented in column B, the total quantity of production related TRI wastes decreased between 1995 and 1996. Production related wastes are projected to increase in 1997 and 1998. Note that the affects of production increases and decreases on the quantities of wastes generated are not evaluated here.

In 1996, about 84 percent of the industry’s TRI wastes were managed on-site through recycling, energy recovery, or treatment as shown in columns C, D, and E, respectively. Most of these on-site managed wastes were recycled on-site. There is a negligible amount (<1%) of wastes being transferred off-site for recycling, energy recovery, or treatment. The remaining portion of the production related wastes (12 percent in 1995 and 16 percent in1996), shown in column I, is either released to the environment through direct discharges to air, land, water, and underground injection, or is transferred off-site for disposal.



Table 12: Source Reduction and Recycling Activity for the Fertilizer Industry as Reported within TRI

A B On-Site Off-Site

I

Year

Quantity of Production-

Related Waste

(106 lbs.)a

% Released and Disposedc Off-

site

C D E F G H

% Recycled

% Energy Recovery % Treated

% Recycled


1995 719 76% 8% 4% 0% 0% 0% 12%

1996 566 77% 1% 6% 0% 0% 0% 16%

1997 606 77% 1% 7% 0% 0% 0% 15%

1998 617 78% 1% 7% 0% 0% 0% 14%

Source: 1996 Toxics Release Inventory Database. a Within this industry sector, non-production related waste < 1% of production related wastes for 1996. b Total TRI transfers and releases as reported in section 5 and 6 of Form R as a percentage of production related wastes. c Percentage of production related waste released to the environment and transferred off-site for disposal.

Pesticides and Miscellaneous Agricultural Chemicals

Table 13 shows thatthe TRI reporting pesticide and miscellaneous agricultural chemicals facilities managed about 252 million pounds of production related wastes (total quantity of TRI chemicals in the waste from routine production operations in column B) in1996. From the yearly data presented in column B, the total quantity of production related TRI wastes increased between 1995 and 1996. Production related wastes were projected to continue to increase in 1997 and 1998. Note that the affects of production increases and decreases on the quantities of wastes generated are not evaluated here.

In 1996, about 95 percent of the industry’s TRI wastes were managed on-site through recycling, energy recovery, or treatment as shown in columns C, D, and E, respectively. Most of these on-site managed wastes were recycled on-site. A small portion of the remaining wastes (4% in 1996) are transferred off-site for recycling, energy recovery, or treatment. The remaining one percent of the production related wastes, shownin column I, is either released to the environment through direct discharges to air, land, water, and underground injection, or is transferred off-site for disposal.



Table 13: Source Reduction and Recycling Activity for the Pesticide and Miscellaneous Agricultural Chemicals Industry as Reported within TRI

A B On-Site Off-Site

I

Year

Quantity of Production-

Related Waste

(106 lbs.)a

% Released and Disposedc Off-

site

C D E F G H

% Recycled

% Energy Recovery

% Treated % Recycled


1995 245 85% 0% 10% 2% 1% 1% 2%

1996 252 84% 0% 11% 2% 1% 1% 1%

1997 266 84% 0% 11% 1% 1% 2% 1%

1998 279 85% 0% 11% 1% 1% 1% 1%

Source: 1996 Toxics Release Inventory Database. a Within this industry sector, non-production related waste < 1% of production related wastes for 1996. b Total TRI transfers and releases as reported in section 5 and 6 of Form R as a percentage of production related wastes. c Percentage of production related waste released to the environment and transferred off-site for disposal.



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IV. CHEMICAL RELEASE AND TRANSFER PROFILE

This section is designed to provide background information on the pollutant releases that are reported by this industry in correlation with other industries. The best source of comparative pollutant release information is the Toxic Release Inventory (TRI). Pursuant to the Emergency Planning and Community Right-to-Know Act, TRI includes self-reported facility release and transfer data for over 600 toxic chemicals. Facilities within SIC Codes 20 through 39 (manufacturing industries) that have more than 10 employees, and that are above weight-based reporting thresholds are required to report TRI on-site releases and off-site transfers. The information presented within the sector notebooks is derived from the most recently available (1996) TRI reporting year (which includes over 600 chemicals), and focuses primarily on the on-site releases reported by each sector. Because TRI requires consistent reporting regardless of sector, it is an excellent tool for drawing comparisons across industries. TRI data provide the type, amount and media receptor of each chemical released or transferred.

Although this sector notebook does not present historical information regarding TRI chemical releases over time, please note that in general, toxic chemical releases have been declining. In fact, according to the 1996 Toxic Release Inventory Public Data Release, reported onsite releases of toxic chemicals to the environment decreased by 5 percent (111.6 millionpounds) between1995 and 1996 (not including chemicals added and removed fromthe TRI chemical list during this period). Reported releases dropped by 48 percent between 1988 and 1996. Reported transfers of TRI chemicals to off-site locations increased by 5 percent (14.3 million pounds) between 1995 and 1996. More detailed information can be obtained from EPA's annual Toxics Release Inventory Public Data Release book (which is available through the EPCRA Hotline at 800-535-0202), or directly from the Toxic Release Inventory System database (for user support call 202-260-1531).

Wherever possible, the sector notebooks present TRI data as the primary indicator of chemical release within each industrial category. TRI data provide the type, amount and media receptor of each chemical released or transferred. When other sources of pollutant release data have been obtained, these data have been included to augment the TRI information.

TRI Data Limitations

Certain limitations exist regarding TRI data. Within some sectors, (e.g. dry cleaning, printing and transportation equipment cleaning) the majority of facilities are not subject to TRI reporting because they are not considered manufacturing industries, or because they are below TRI reporting thresholds. For these sectors, release information from other sources has been included. Inaddition, manyfacilities reportTRI more under thanone SIC code reflecting the multiple operations carried out onsite whether or not the operation is the


--


facilities primary area of business as reported to the U.S. Census Bureau. Reported chemicals are limited to the approximately 600 TRI chemicals. A portionof the emissions fromagricultural chemical facilities, therefore, are not captured by TRI. Also, reported releases and transfers may or may not all be associated with the industrial operations described in this notebook.

The reader should also be aware that TRI “pounds released” data presented within the notebooks is not equivalent to a “risk” ranking for each industry. Weighting eachpound ofrelease equallydoes not factor in the relative toxicity of each chemical that is released. The Agency is in the process of developing an approach to assign toxicological weightings to each chemical released so that one can differentiate between pollutants with significant differences in toxicity. As a preliminary indicator of the environmental impact of the industry’s most commonly released chemicals, the notebook briefly summarizes the toxicological properties of the top five chemicals (by weight) reported by each industry.

Definitions Associated With Section IV Data Tables

General Definitions

SIC Code -- is the Standard Industrial Classification (SIC) code, a statistical classification standard used for all establishment-based federal economic statistics. The SIC codes facilitate comparisons between facility and industry data.

TRI Facilities -- are manufacturing facilities that have 10 or more full-time employees and are above established chemical throughput thresholds. Manufacturing facilities are defined as facilities in Standard Industrial Classification primary codes 20-39. Facilities must submit estimates for all chemicals that are on the EPA’s defined list and are above throughput thresholds.

Data Table Column Heading Definitions

The following definitions are based upon standard definitions developed by EPA’s Toxic Release InventoryProgram. The categories below represent the possible pollutant destinations that can be reported.

RELEASES -- are on-site discharges of a toxic chemical to the environment. This includes emissions to the air, discharges to bodies of water, releases at the facility to land, as well as contained disposal into underground injection wells.

Releases to Air (Point and Fugitive Air Emissions) include all air emissions fromindustry activity. Point emissions occur through confined air streams as found in stacks, vents, ducts, or pipes. Fugitive emissions include


--


equipment leaks, evaporative losses from surface impoundments and spills, and releases from building ventilation systems.

Releases to Water(Surface WaterDischarges) -- encompass any releases going directly to streams, rivers, lakes, oceans, or other bodies of water. Releases due to runoff, including storm water runoff, are also reportable to TRI.

Releases to Land -- occur within the boundaries of the reporting facility. Releases to land include disposal of toxic chemicals in landfills, land treatment/application farming, surface impoundments, and other disposal on land (such as spills, leaks, or waste piles).

Underground Injection -- is a contained release of a fluid into a subsurface well for the purpose of waste disposal. Wastes containing TRI chemicals are injected into either Class I wells or Class V wells. Class I wells are used to inject liquid hazardous wastes or dispose of industrial and municipal wastewaters beneath the lowermost underground source of drinking water. Class V wells are generally used to inject non-hazardous fluid into or above an underground source of drinking water. TRI reporting does not currently distinguish between these two types of wells, although there are important differences in environmental impact between these two methods of injection.

TRANSFERS -- are transfers of toxic chemicals in wastes to a facility that is geographically or physically separate from the facility reporting under TRI. Chemicals reported to TRI as transferred are sent to off-site facilities for the purpose of recycling, energy recovery, treatment, or disposal. The quantities reported represent a movement of the chemical away from the reporting facility. Except for off-site transfers for disposal, the reported quantities do not necessarily represent entry of the chemical into the environment.

Transfers to POTWs -- are wastewater transferred through pipes or sewers to a publicly owned treatments works (POTW). Treatment or removal of a chemical from the wastewater depends on the nature of the chemical, as well as the treatment methods present at the POTW. Not all TRI chemicals can be treated or removed by a POTW. Some chemicals, such as metals, may be removed but not destroyed and may be disposed of in landfills or discharged to receiving waters.

Transfers to Recycling are wastes sent off-site for the purposes of regenerating or recovery by a variety of recycling methods, including solvent recovery, metals recovery, and acid regeneration. Once these chemicals have been recycled, they may be returned to the originating facility or sold commercially.

Transfers to Energy Recovery -- are wastes combusted off-site in industrial



furnaces for energy recovery. Treatment of a chemical by incineration is not considered to be energy recovery.

Transfers to Treatment -- are wastes moved off-site to be treated through a variety of methods, including neutralization, incineration, biological destruction, or physical separation. In some cases, the chemicals are not destroyed but prepared for further waste management.

Transfers to Disposal -- are wastes taken to another facility for disposal, generally as a release to land or as an injection underground.

IV.A. EPA Toxic Release Inventory for the Fertilizer, Pesticide, and Agricultural Chemical Industry

This section summarizes the TRI data of fertilizer manufacturing and mixing facilities reporting SIC codes 2873, 2874, or 2875 as their primary SIC code and of pesticide and miscellaneous agricultural chemicals formulating facilities reporting SIC code 2879 as their primary SIC code.

According to the 1995 Toxics Release Inventory (TRI) data, 190 fertilizer and pesticide facilities reporting SIC 2873, 2874, 2875, or 2879 released (to the air, water, or land) and transferred (shipped off-site or discharged to sewers) a total of 106 million pounds of toxic chemicals during calendar year 1996. This represents approximately 2 percent of the 5.6 billion pounds of releases and transfers from all manufacturers (SICs 20-39) reporting to TRI that year. The top two chemicals released by weight are ammonia and phosphoric acid (both from fertilizer manufacturing). These two account for about 89 percent (82 million pounds) of the industry’s total releases. Xylene, methanol, and ethylbenzene are the three top chemicals transferred by weight (all from pesticide formulating). These three account for about 71 percent (9 million pounds) of the total TRI chemicals transferred by the industries. The variability in facilities’ TRI chemical profiles may be attributed to the variety of processes and products in the industries. Eighty-seven percent of the 243 different chemicals reported were reported by fewer than 10 facilities.

Fertilizers (SIC 2873, 2874, 2875)

According to 1996 TRI data, fertilizer manufacturing and mixing facilities released and transferred approximately93 million pounds of pollutants during calendar year 1996. One hundred and ninety facilities reported TRI emissions for 46 chemicals. Only 13 of the 46 chemicals (28 percent) were reported (as releases and/or transfers) by ten or more facilities, evidence of the diversity of the industry. Fertilizer facilities released an average of 481,000 pounds per facility and transferred an average of 8,000 pounds per facility. The high release per facility values are, in a large part, a result of significant releases for ammonia and phosphoric acid from seventy or more facilities.



Releases

Table 14 presents the number and weights of chemicals released by fertilizer manufacturing and mixing facilities reporting SIC 2873, 2874, and 2875 in 1996. The total quantity of releases was 91.3 million pounds or 98 percent of the total weight of chemicals reported to TRI by the fertilizer industry (i.e., releases and transfers). The top chemical released by this industry is ammonia, accounting for 54 percent of the total releases. Phosphoric acid is the next largest release at 35 percent of the total. Fifty-eight percent of all TRI releases in the fertilizer industry were air emissions, 53 percent as point source and 5 percent as fugitive. Ammonia accounts for 91 percent of air releases. The majority of the other releases were land disposed (32 percent) with phosphoric acid accounting for 99 percent of land disposals. The remaining nine percent was released as water discharges or underground injections.

Transfers

Table 15 presents the number and weights of chemicals transferred off-site by fertilizer manufacturing and mixing facilities reporting SIC 2873, 2874, or 2875 in 1996. The total amount of transfers was about 1.5 million pounds or only two percent of the total amount of chemicals reported to TRI by the fertilizer industry (i.e., releases and transfers). Transfers to recycling facilities accounted for the largest amount, 51 percent of the total transfers. The next greatest percentage went for disposal and the rest to treatment facilities. No energy recovery transfers were reported for this industry. Copper compounds, phosphoric acid, and zinc compounds represented the largest transfers (primarily to recycling), as 60 percent of the total transfers. Ammonia only accounted for 4 percent of the transfers compared to 54 percent of releases.

Pesticides and Miscellaneous Agricultural Chemicals (SIC 2879)

According to 1996 TRI data, pesticide formulating facilities released and transferred approximately13 millionpounds ofpollutants during calendar year 1996. One hundred and ninety-three facilities reported TRI emissions for 197 chemicals in 1996. Only 18 (9 percent) of these chemicals were reported by ten or more facilities, evidence of the particularly diverse nature of the industry. Pesticide formulating facilities released an average of 10,000 pounds of pollutants per facility and transferred an average of 59,000 pounds per facility. The high average transfer per facility is due mostly to high average xylene, ethylbenzene, and methanol transfers.

Releases

Table 16 presents the number and weights of chemicals released by pesticide and miscellaneous agricultural chemicals formulating facilities reporting SIC



2879 in 1996. The total amount of releases was 2.0 million pounds or 15 percent of the total quantity of TRI chemicals reported by the pesticide and miscellaneous agricultural chemicals industry (i.e., releases and transfers). This is substantially less than the 98 percent of reported chemicals released by the fertilizer industry. The top two chemicals released by this industry are methanol (23 percent of releases) and dichloromethane (13 percent of releases).

About 69 percent (1.4 million pounds) of all the chemicals released by the pesticide industry were released to air in the form of point source emissions (50 percent) and fugitive air releases (19 percent). Air releases were primarily comprised of dichloromethane, carbon disulfide, and methyl isobutyl ketone. Approximately 29 percent of the releases were by underground injection, and the remaining releases were to water (2 percent) and land disposal (1 percent). The relatively large number of chemicals reported to TRI under SIC 2879 compared to the fertilizer industry illustrates the variety of chemical formulations produced by the pesticide industry.

Transfers

Table 17 presents the number and weights of chemical transfers by the pesticide and miscellaneous agricultural chemicals formulating facilities reporting SIC 2879 in 1996. The total amount of transfers off-site was 11.3 million pounds or 85 percent of the total amount of chemicals reported to TRI by the pesticide industry (i.e., releases and transfers). Xylene, methanol, and ethylbenzene accounted for 58, 12, and 10 percent, respectively, of the chemical TRI transfers. Transfers to recycling facilities accounted for the largest quantity (51 percent) although only eight facilities reported recycling transfers. Xylene accounted for 84 percent of all recycling transfers. Energy recovery and treatment accounted for 23 and 31 percent respectively. The remainder of transfers consisted of off-site disposals.



Table 14: 1996 TRI Releases for Agricultural Chemicals Facilities (SICs 2873,2874,2875) by Number of Facilities Reporting (Releases reported in pounds/year)

Chemical Name # Reporting

Chemical Fugitive

Air Point

Air Water

Discharges Underground

Injection Land

Disposal Total

Releases

Avg. Releases Per Facility

Ammonia 106 4,590,371 43,967,432 427,065 539,900 78,814 49,603,582 467,958 Phosphoric Acid 72 1,452 8,631 2,939,394 0 29,071,310 32,020,787 444,733 Zinc Compounds 56 3,946 2,969 7,817 65 4,023 18,820 336 Manganese Compounds 43 5,292 1,696 1,500 0 500 8,988 209 Nitrate Compounds 42 1,529 261,250 3,108,211 971,850 125,960 4,468,800 106,400 Copper Compounds 37 1,477 525 1,443 60 528 4,033 109 Sulfuric Acid (1994 and after "Acid Aerosols" Only)

32 3,237 1,435,613 5 15,000 25,587 1,479,442 46,233

Nitric Acid 30 22,388 17,418 10 0 7,655 47,471 1,582 Chlorine 30 5,345 25,787 7,818 0 0 38,950 1,298 Methanol 20 38,447 3,068,775 63,362 20 185 3,170,789 158,539 Formaldehyde 13 730 20,874 10 220 5 21,839 1,680 Chromium Compounds 11 251 0 536 90 1,430 2,307 210 Nickel Compounds 10 255 250 795 270 565 2,135 214 Copper 8 5 10 0 0 0 15 2 Zinc (Fume or Dust) 8 5 8 0 0 0 13 2 Lead Compounds 7 17 270 510 0 0 797 114 Hydrogen Fluoride 7 15,325 13,820 15 0 3,309 32,469 4,638 Diethanolamine 6 5 7,907 31,470 0 0 39,382 6,564 2,4-D 5 21 251 0 0 0 272 54 Manganese 5 5 10 0 0 0 15 3 Diazinon 4 0 2 0 0 0 2 1 Benfluralin 4 445 258 0 0 0 703 176 Atrazine 3 140 0 0 0 0 140 47 Trifluralin 2 239 0 0 0 0 239 120 Chromium 2 400 0 0 0 0 400 200 Cadmium Compounds 1 . . . . . . . Cobalt Compounds 1 . . . . . . . Diisocyanates 1 10 70 0 0 0 80 80 Certain Glycol Ethers 1 0 0 0 0 0 0 0 Carbaryl 1 5 5 0 0 0 10 10 N-butyl Alcohol 1 5 0 0 0 0 5 5 Quintozene 1 0 0 0 0 0 0 0 Mecoprop 1 10 250 0 0 0 260 260 Methoxone 1 5 250 0 0 0 255 255 Ethylene Glycol 1 750 0 13,000 0 250 14,000 14,000 Methyl Isobutyl Ketone 1 73,325 16,241 0 0 0 89,566 89,566 Dicofol 1 250 0 . 0 0 250 250 2,4-DP 1 7 250 0 0 0 257 257 Asbestos (Friable) 1 0 0 0 0 0 0 0 Dicamba 1 12 250 0 0 0 262 262 Nickel 1 400 0 0 0 0 400 400 Vanadium (Fume or Dust) 1 . . . . . . . Hydrochloric Acid (1995 and after "Acid Aerosols" Only)

1 0 0 0 260,000 0 260,000 260,000

Thiophanate-methyl 1 0 0 0 0 0 0 0 Pendimethalin 1 0 0 0 0 0 0 0 Oxyfluorfen 1 0 0 0 0 0 0 0

_________ _________ _________ _________ _________ _________ _________ _________ 190** 4,766,111 48,851,072 6,603,991 1,787,475 29,320,121 91,327,740 480,672

** Total number of facilities (not chemical reports) reporting to TRI in this industry sector.



Table 15: 1996 TRI Transfers for Agricultural Chemicals Facilities (SICs 2873,2874,2875) by Number and Facilities Reporting (Transfers reported in pounds/year)

Chemical Name #

Reporting Chemical

Potw Transfers

Disposal Transfers

Recycling Transfers

Treatment Transfers

Energy Recovery Transfers

Total Transfers

Avg Transfer

Per Facility

Ammonia 106 51600 . . 11477 . 63077 595 Phosphoric Acid 72 0 289528 . 418 . 289946 4,027 Zinc Compounds 56 5 1060 179327 45834 . 226226 4,040 Manganese Compounds 43 0 1000 . 3834 . 4834 112 Nitrate Compounds 42 95000 . 14657 750 . 110407 2,629 Copper Compounds 37 0 11861 384419 11000 . 407280 11,008 Sulfuric Acid (1994 and after "Acid Aerosols" Only)

32 0 . . . . 0 0

Nitric Acid 30 0 250 . . . 250 8 Chlorine 30 25 . . . . 25 1 Methanol 20 1542 . . . . 1542 77 Formaldehyde 13 250 . . . . 250 19 Chromium Compounds 11 0 14207 63230 . . 77437 7,040 Nickel Compounds 10 0 . 81600 20000 . 101600 10,160 Copper 8 0 . 14657 . . 14657 1,832 Zinc (Fume or Dust) 8 0 505 14657 5 . 15167 1,896 Lead Compounds 7 0 10 . . . 10 1 Hydrogen Fluoride 7 0 . . . . 0 0 Diethanolamine 6 19940 . . 20000 . 39940 6,657 2,4-D 5 0 . . 4613 . 4613 923 Manganese 5 0 . . . . 0 0 Diazinon 4 0 . . 4608 . 4608 1,152 Benfluralin 4 0 . . 1250 . 1250 313 Atrazine 3 0 . . 107880 . 107880 35,960 Trifluralin 2 0 . . . . 0 0 Chromium 2 0 . 14657 . . 14657 7,329 Cadmium Compounds 1 . . . . . . . Cobalt Compounds 1 . . . . . . . Diisocyanates 1 0 . . . . 0 0 Certain Glycol Ethers 1 0 . . . . 0 0 Carbaryl 1 0 . . 591 . 591 591 N-butyl Alcohol 1 0 . . . . 0 0 Quintozene 1 0 . . 4358 . 4358 4,358 Mecoprop 1 0 . . 250 . 250 250 Methoxone 1 0 . . 250 . 250 250 Ethylene Glycol 1 0 . 185 . . 185 185 Methyl Isobutyl Ketone 1 0 . . . . 0 0 Dicofol 1 0 250 . . . 250 250 2,4-DP 1 0 . . 250 . 250 250 Asbestos (Friable) 1 0 19300 . . . 19300 19,300 Dicamba 1 0 . . 250 . 250 250 Nickel 1 0 . 14657 . . 14657 14,657 Vanadium (Fume or Dust) 1 . . . . . . . Hydrochloric Acid (1995 and after "Acid Aerosols" Only)

1 0 . . . . 0 0

Thiophanate-methyl 1 0 . . 4358 . 4358 4,358 Pendimethalin 1 0 . . 4358 . 4358 4,358 Oxyfluorfen 1 0 . . 4358 . 4358 4,358

_________ _________ _________ _________ _________ _________ _________ _________ 190** 168,362 337,971 782,046 250,692 0 1,539,071 8,100




Table 16: 1996 TRI Releases for Agricultural Chemicals Facilities (SIC 2879) by Number of Facilities Reporting (Releases reported in pounds/year)


Chemical Fugitive

Air Point

Air Water


Injection Land

Disposal Total

Releases


1,2,4-trimethylbenzene 24 5310 3185 0 0 0 8495 354 Xylene (Mixed Isomers) 24 24494 16327 0 17760 0 58581 2,441 Ethylene Glycol 22 7856 819 2521 2290 7922 21408 973 Naphthalene 21 4536 3402 17 0 20 7975 380 Malathion 17 571 280 10 0 0 861 51 Diazinon 17 21 227 10 0 0 258 15 Ammonia 14 20529 36889 4908 2300 360 64986 4,642 2,4-D 13 1926 1535 5 0 255 3721 286 Carbaryl 12 1005 9005 10 0 2500 12520 1,043 Methanol 12 12434 35850 8217 400300 51 456852 38,071 N-butyl Alcohol 12 1498 1668 0 0 0 3166 264 Captan 12 519 12106 5 5 0 12635 1,053 Quintozene 11 1050 561 0 0 0 1611 146 Trifluralin 11 1304 2578 87 0 0 3969 361 Chlorothalonil 11 622 1005 0 0 1670 3297 300 2,4-d 2-ethylhexyl Ester 11 2160 1065 5 0 0 3230 294 Ethylbenzene 10 1065 421 0 0 0 1486 149 Atrazine 10 4000 2430 5 1 0 6436 644 Copper Compounds 9 547 188 11 0 5 751 83 Zinc Compounds 9 2299 2307 0 0 0 4606 512 Dimethylamine 9 3547 7560 0 250 0 11357 1,262 Arsenic Compounds 8 267 1089 14 0 0 1370 171 Certain Glycol Ethers 8 10501 250 0 0 0 10751 1,344 Lindane 8 255 255 5 0 250 765 96 Bromomethane 8 9398 63421 0 0 0 72819 9,102 Chloropicrin 8 2240 5835 0 0 0 8075 1,009 Cumene 8 108 78 0 0 0 186 23 Permethrin 8 976 509 0 0 0 1485 186 Dicamba 7 348 324 132 59200 0 60004 8,572 Piperonyl Butoxide 6 35 6 0 0 0 41 7 Dimethoate 6 225 260 10 0 0 495 83 Mecoprop 6 510 920 0 0 255 1685 281 Toluene 6 11676 27350 39 536 71 39672 6,612 Thiram 6 510 1000 0 0 0 1510 252 Methyl Parathion 6 716 312 0 0 0 1028 171 Diuron 6 261 1250 8 0 0 1519 253 Prometryn 6 250 268 0 0 0 518 86 Chlorine 6 6020 2455 0 5 0 8480 1,413 Manganese Compounds 5 6657 75 0 0 0 6732 1,346 Nitrate Compounds 5 5 6 22000 0 0 22011 4,402 1,1,1-trichloroethane 5 1729 7400 0 0 0 9129 1,826 Carbon Disulfide 5 6817 112994 0 5 0 119816 23,963 Methoxone 5 265 510 250 0 250 1275 255 Metham Sodium 5 1266 258 1 0 2 1527 305 N-methyl-2-pyrrolidone 5 310 10 5 750 5 1080 216 Carbofuran 5 22 274 1 0 0 297 59 Bromoxynil Octanoate 5 270 251 0 0 0 521 104 Maneb 5 0 0 0 0 0 0 0 Cyanazine 5 285 1625 0 0 0 1910 382 Formaldehyde 4 3020 8018 1083 0 5 12126 3,032 Chloromethane 4 7434 82165 0 0 9 89608 22,402 Dichloromethane 4 12585 256135 100 0 23 268843 67,211 O-xylene 4 5602 35250 5 0 5 40862 10,216 Methyl Isobutyl Ketone 4 105310 58755 5 0 5 164075 41,019 Simazine 4 1005 1005 5 0 0 2015 504 Hydrochloric Acid (1995 and after "Acid Aerosols" Only)

4 3698 48257 0 0 56 52011 13,003

Phosphoric Acid 4 438 0 0 0 0 438 110 Sulfuric Acid (1994 and after "Acid Aerosols" Only)

4 1009 1 0 0 15 1025 256

Metribuzin 4 2 1010 5 0 0 1017 254 Acephate 4 255 1250 0 0 0 1505 376 Chromium Compounds 3 250 88 3 0 0 341 114 Chlorodifluoromethane 3 11406 2441 0 0 0 13847 4,616 Maleic Anhydride 3 1079 2385 5 0 0 3469 1,156 M-xylene 3 508 250 0 0 0 758 253 Dicofol 3 210 0 0 0 0 210 70 Aldicarb 3 21 1205 0 0 5 1231 410 Linuron 3 5 5 5 0 0 15 5 Ethyl Dipropylthiocarbamate 3 6706 619 2 29 0 7356 2,452 Paraquat Dichloride 3 500 500 0 0 0 1000 333





Chemical Fugitive

Air Point

Air Water


Injection Land

Disposal Total

Releases


Propachlor 3 0 0 0 0 0 0 0 Fluometuron 3 260 512 0 0 0 772 257 Dimethylamine Dicamba 3 580 5 0 0 5 590 197 Carboxin 3 8 0 0 0 0 8 3 Copper 3 0 5 0 0 0 5 2 Ethoprop 3 250 615 0 0 0 865 288 Thiophanate-methyl 3 70 9 0 0 0 79 26 Pendimethalin 3 970 260 22 0 140 1392 464 Hexazinone 3 17 283 0 0 0 300 100 Ethylenebisdithiocarbamic Acid, Salts and Esters

2 1057 57 0 0 0 1114 557

Trichlorfon 2 . . . . . . . Parathion 2 . . . . . . . Dichlorvos 2 0 0 0 0 0 0 0 S,s,s-tributyltrithiophosphate 2 1325 473 2 0 8 1808 904 2,4-db 2 470 250 0 0 0 720 360 1,4-dichlorobenzene 2 340 1371 0 0 0 1711 856 1,2-dichloroethane 2 6300 57000 33 0 250 63583 31,792 Chlorobenzene 2 320 0 0 0 0 320 160 Phenol 2 533 0 1 0 0 534 267 Diethanolamine 2 255 255 0 0 0 510 255 2,4-dp 2 250 5 0 0 5 260 130 Naled 2 0 50 0 0 0 50 25 Hydrazine 2 201 12 0 0 0 213 107 1,3-dichloropropylene 2 2301 120 0 0 0 2421 1,211 Propanil 2 250 2627 0 0 0 2877 1,439 Ametryn 2 255 298 5 0 0 558 279 Cycloate 2 0 49 1 2 0 52 26 Bromoxynil 2 5 10 0 0 0 15 8 2,4-d Butoxyethyl Ester 2 262 401 0 0 0 663 332 Sodium Dicamba 2 5 750 0 0 0 755 378 Dipotassium Endothall 2 39 4 0 0 0 43 22 Molinate 2 315 271 1 0 0 587 294 Chlorpyrifos Methyl 2 5 5 0 0 0 10 5 Zinc (Fume or Dust) 2 250 0 . 0 0 250 125 Nitric Acid 2 4000 398 5 0 280 4683 2,342 Resmethrin 2 1 0 0 0 0 1 1 Desmedipham 2 15 0 0 0 0 15 8 Thiophanate Ethyl 2 . . . . . . . Thiobencarb 2 530 281 0 0 0 811 406 Thiodicarb 2 250 1000 0 0 250 1500 750 Propiconazole 2 5 5 0 0 0 10 5 Cyfluthrin 2 3 13 0 0 350 366 183 Fomesafen 2 255 250 0 0 0 505 253 Quizalofop-ethyl 2 1 0 . 0 0 1 1 Lactofen 2 847 29 0 0 0 876 438 Bifenthrin 2 6 1 0 0 0 7 4 Myclobutanil 2 . . . . . . . Antimony Compounds 1 0 2 0 0 0 2 2 Chlorophenols 1 250 250 0 73400 0 73900 73,900 Cyanide Compounds 1 15 41 5 0 5 66 66 Diisocyanates 1 . . . . . . . Lead Compounds 1 130 139 0 0 0 269 269 Carbon Tetrachloride 1 66 41000 0 5 0 41071 41,071 Formic Acid 1 810 700 29 0 0 1539 1,539 Isopropyl Alcohol (Manufacturing, Strong-acid Process Only, No Supplies)

1 0 15 0 0 0 15 15

N,n-dimethylformamide 1 1 38 0 0 0 39 39 Methoxychlor 1 5 5 0 0 0 10 10 Vinyl Chloride 1 552 644 0 0 0 1196 1,196 Tert-butyl Alcohol 1 20 121 0 0 0 141 141 2-methyllactonitrile 1 0 180 0 0 0 180 180 Triphenyltin Hydroxide 1 . . . . . . . Hexachlorocyclopentadiene 1 5 5 0 250 0 260 260 Dicyclopentadiene 1 141 562 0 0 0 703 703 Dimethyl Sulfate 1 . . . . . . . Methyl Ethyl Ketone 1 32 240 0 0 0 272 272 Dichloran 1 . . . . . . . P-xylene 1 5 5 0 0 0 10 10 1,3-butadiene 1 77 1200 0 0 0 1277 1,277 Cyclohexanol 1 0 18 0 0 0 18 18





Chemical Fugitive

Air Point

Air Water


Injection Land

Disposal Total

Releases


N-hexane 1 2910 5560 0 0 0 8470 8,470 Pyridine 1 4836 5617 0 0 0 10453 10,453 Propoxur 1 . . . . . . . Di(2-ethylhexyl) Phthalate 1 10 25 0 0 0 35 35 Hexachlorobenzene 1 5 0 0 0 0 5 5 1,2,4-trichlorobenzene 1 8000 750 0 750 0 9500 9,500 2,4-dichlorophenol 1 2630 250 0 15390 0 18270 18,270 Triethylamine 1 3298 101 0 0 0 3399 3,399 Hydroquinone 1 250 5 0 0 0 255 255 Folpet 1 0 5 0 0 0 5 5 Merphos 1 200 0 0 0 0 200 200 Oxydemeton Methyl 1 . . . . . . . Bromacil 1 6 0 0 0 0 6 6 Methyl Isothiocyanate 1 0 0 0 0 0 0 0 Perchloromethyl Mercaptan 1 0 510 0 0 0 510 510 Methyl Isocyanate 1 0 0 0 0 0 0 0 Pebulate 1 250 250 0 . 0 500 500 Benfluralin 1 . . . . . . . Nitrapyrin 1 . . . . . . . Triallate 1 250 250 0 0 0 500 500 Dodine 1 5 5 0 0 0 10 10 Dimethyl Chlorothiophosphate 1 0 0 0 0 0 0 0 Temephos 1 . . . . . . . Terbacil 1 . . . . . . . Hydrogen Fluoride 1 0 0 0 0 0 0 0 Bromine 1 0 0 0 0 0 0 0 Mevinphos 1 0 0 0 0 0 0 0 Phosphine 1 0 1076 0 0 0 1076 1,076 Creosote 1 15 25 0 0 0 40 40 Zineb 1 . . . . . . . Fenbutatin Oxide 1 . . . . . . . Alachlor 1 2100 0 0 0 0 2100 2,100 Benomyl 1 . . . . . . . Oryzalin 1 . . . . . . . Oxydiazon 1 5 250 0 0 0 255 255 Aluminum Phosphide 1 . . . . . . . Bendiocarb 1 . . . . . . . Pronamide 1 5 250 0 0 0 255 255 Toluene Diisocyanate (Mixed Isomers) 1 . . . . . . . Propetamphos 1 5 5 0 0 250 260 260 Amitraz 1 . . . . . . . Tebuthiuron 1 0 5 0 0 0 5 5 Diflubenzuron 1 . . . . . . . Sulprofos 1 . . . . . . . Dinocap 1 . . . . . . . Fenpropathrin 1 . . . . . . . Profenofos 1 . . . . . . . Oxyfluorfen 1 . . . . . . . Triadimefon 1 . . . . . . . Vinclozolin 1 . . . . . . . Fenvalerate 1 1 0 0 0 0 1 1 Dimethipin 1 . . . . . . . Triclopyr Triethylammonium Salt 1 0 6 0 0 0 6 6 Fenarimol 1 . . . . . . . Acifluorfen, Sodium Salt 1 0 0 2 0 5 7 7 Chlorsulfuron 1 0 1 . 0 0 1 1 Fluvalinate 1 . . . . . . . Chlorimuron Ethyl 1 0 1 . 0 0 1 1 Tribenuron Methyl 1 0 1 . 0 0 1 1

_________ _________ _________ _________ _________ _________ _________ _________ 193** 369,954 995,519 39,600 573,228 15,287 1,993,588 10,329




Table 17: 1996 TRI Transfers for Agricultural Chemicals Facilities (SIC 2879) by Number and Facilities Reporting (Transfers reported in pounds/year)

Chemical Name #

Reporting Chemical

Potw Transfers

Disposal Transfers

Recycling Transfers

Treatment Transfers


Total Transfers

Avg Transfer

Per Facility

1,2,4-trimethylbenzene 24 5 475 . 43314 . 43794 1,825 Xylene (Mixed Isomers) 24 9 2599 4851510 731777 1020414 6606309 275,263 Ethylene Glycol 22 463 3600 16070 11478 . 31611 1,437 Naphthalene 21 0 823 . 6962 45 7830 373 Malathion 17 0 . . 1207 . 1207 71 Diazinon 17 0 . . 3370 . 3370 198 Ammonia 14 25397 . . 47248 . 72645 5,189 2,4-d 13 263 6017 . 8700 . 14980 1,152 Carbaryl 12 5 2750 . 61666 . 64421 5,368 Methanol 12 4367 5 . 126038 1186991 1317401 109,783 N-butyl Alcohol 12 5 584 . 4150 . 4739 395 Captan 12 0 2191 . 2081 . 4272 356 Quintozene 11 4 . . 392714 221410 614128 55,830 Trifluralin 11 5 2278 . 9772 . 12055 1,096 Chlorothalonil 11 255 2005 . 1518 . 3778 343 2,4-d 2-ethylhexyl Ester 11 5 2077 . 23721 . 25803 2,346 Ethylbenzene 10 0 231 807182 150224 214836 1172473 117,247 Atrazine 10 73 5673 . 28161 . 33907 3,391 Copper Compounds 9 0 9267 754 1500 . 11521 1,280 Zinc Compounds 9 5 260 2730 . . 2995 333 Dimethylamine 9 5 . . 520 . 525 58 Arsenic Compounds 8 10 100655 . 231855 . 332520 41,565 Certain Glycol Ethers 8 57107 . . 1132 . 58239 7,280 Lindane 8 0 276 . 1388 . 1664 208 Bromomethane 8 0 . . . . 0 0 Chloropicrin 8 0 . . . . 0 0 Cumene 8 0 5 . 1453 . 1458 182 Permethrin 8 0 1250 . 1617 . 2867 358 Dicamba 7 5 . . 125 . 130 19 Piperonyl Butoxide 6 0 . . 2082 . 2082 347 Dimethoate 6 0 . . 3091 . 3091 515 Mecoprop 6 5 3896 . 2497 . 6398 1,066 Toluene 6 0 . . 2171 . 2171 362 Thiram 6 2 533 . 38081 . 38616 6,436 Methyl Parathion 6 0 360 . 2120 . 2480 413 Diuron 6 250 . . 380 . 630 105 Prometryn 6 12 250 . 6580 . 6842 1,140 Chlorine 6 6319 . . . . 6319 1,053 Manganese Compounds 5 5 5 21 6309 . 6340 1,268 Nitrate Compounds 5 5 5 . . . 10 2 1,1,1-trichloroethane 5 0 . . 22147 . 22147 4,429 Carbon Disulfide 5 0 . . . . 0 0 Methoxone 5 5 4778 . 941 . 5724 1,145 Metham Sodium 5 1 15862 . 4603 557 21023 4,205 N-methyl-2-pyrrolidone 5 0 1770 . 8041 . 9811 1,962 Carbofuran 5 0 . . 17525 . 17525 3,505 Bromoxynil Octanoate 5 0 16605 . 1448 . 18053 3,611 Maneb 5 0 250 . 1108 . 1358 272 Cyanazine 5 62 755 . 13905 . 14722 2,944 Formaldehyde 4 0 1200 . 29000 . 30200 7,550 Chloromethane 4 0 26 . . . 26 7 Dichloromethane 4 0 . 19277 3555 . 22832 5,708 O-xylene 4 0 . . 1310 . 1310 328 Methyl Isobutyl Ketone 4 940 . . 1630 . 2570 643 Simazine 4 5 1255 . 250 . 1510 378 Hydrochloric Acid (1995 and after "Acid Aerosols" Only)

4 0 . . . . 0 0

Phosphoric Acid 4 0 25549 . . . 25549 6,387 Sulfuric Acid (1994 and after "Acid Aerosols" Only)

4 0 . . . . 0 0

Metribuzin 4 0 . . 13213 . 13213 3,303 Acephate 4 250 . . 15800 . 16050 4,013 Chromium Compounds 3 1 11257 . 155 . 11413 3,804 Chlorodifluoromethane 3 0 . . . . 0 0 Maleic Anhydride 3 0 . . . . 0 0 M-xylene 3 0 . . 410 . 410 137 Dicofol 3 0 . . 250 . 250 83 Aldicarb 3 0 . . 32289 . 32289 10,763 Linuron 3 0 . . . . 0 0 Ethyl Dipropylthiocarbamate 3 5 590 . 9610 . 10205 3,402




Chemical Name #

Reporting Chemical

Potw Transfers

Disposal Transfers

Recycling Transfers

Treatment Transfers


Total Transfers

Avg Transfer

Per Facility

Paraquat Dichloride 3 32 5 . 250 . 287 96 Propachlor 3 15 . . 6490 . 6505 2,168 Fluometuron 3 235 1505 . 13785 . 15525 5,175 Dimethylamine Dicamba 3 0 255 . . . 255 85 Carboxin 3 2 384 . 390 . 776 259 Copper 3 0 . . . . 0 0 Ethoprop 3 0 250 . 1105 . 1355 452 Thiophanate-methyl 3 0 1167 . . . 1167 389 Pendimethalin 3 0 . . . . 0 0 Hexazinone 3 250 250 . 250 . 750 250 Ethylenebisdithiocarbamic Acid, 2 0 . . 12830 . 12830 6,415 Trichlorfon 2 0 . . . . 0 0 Parathion 2 . . . . . . . Dichlorvos 2 0 . . 145 104 249 125 S,s,s-tributyltrithiophosphate 2 0 . . 116 . 116 58 2,4-db 2 0 . . 792 . 792 396 1,4-dichlorobenzene 2 0 . . 1365 . 1365 683 1,2-dichloroethane 2 0 . . . . 0 0 Chlorobenzene 2 0 . . 1700 . 1700 850 Phenol 2 0 . . . . 0 0 Diethanolamine 2 5 51 . 5 . 61 31 2,4-dp 2 0 39 . 3 . 42 21 Naled 2 5 . . 3176 . 3181 1,591 Hydrazine 2 0 . . . . 0 0 1,3-dichloropropylene 2 0 . . 51325 . 51325 25,663 Propanil 2 0 . . 1744 . 1744 872 Ametryn 2 0 . . 9700 . 9700 4,850 Cycloate 2 0 28 . 1006 . 1034 517 Bromoxynil 2 0 1388 . 8 . 1396 698 2,4-d Butoxyethyl Ester 2 0 . . 3256 . 3256 1,628 Sodium Dicamba 2 750 . . . . 750 375 Dipotassium Endothall 2 0 . . 250 . 250 125 Molinate 2 0 4405 . 1256 21 5682 2,841 Chlorpyrifos Methyl 2 0 . . 500 . 500 250 Zinc (Fume or Dust) 2 0 . . . . 0 0 Nitric Acid 2 0 . . . . 0 0 Resmethrin 2 0 . . 600 . 600 300 Desmedipham 2 0 . . 492 . 492 246 Thiophanate Ethyl 2 . . . . . . . Thiobencarb 2 0 4930 . . . 4930 2,465 Thiodicarb 2 5 250 . 18411 . 18666 9,333 Propiconazole 2 0 1332 . . . 1332 666 Cyfluthrin 2 0 . . 1019 . 1019 510 Fomesafen 2 0 2501 . 5 . 2506 1,253 Quizalofop-ethyl 2 0 . . . . 0 0 Lactofen 2 0 250 . 3069 . 3319 1,660 Bifenthrin 2 0 . . 48 . 48 24 Myclobutanil 2 . . . . . . . Antimony Compounds 1 0 132 . . . 132 132 Chlorophenols 1 0 2290 . 1198 670 4158 4,158 Cyanide Compounds 1 0 . . 4 . 4 4 Diisocyanates 1 . . . . . . . Lead Compounds 1 0 . 65000 . . 65000 65,000 Carbon Tetrachloride 1 0 . . . . 0 0 Formic Acid 1 0 830 . 2800 . 3630 3,630 Isopropyl Alcohol (Manufacturing, Strong-acid Process Only, No Supplies)

1 0 . . . 529 529 529

N,n-dimethylformamide 1 250 54765 . 4055 2331 61401 61,401 Methoxychlor 1 . . . 500 . 500 500 Vinyl Chloride 1 0 . . . . 0 0 Tert-butyl Alcohol 1 0 . . 416 . 416 416 2-methyllactonitrile 1 0 . . . . 0 0 Triphenyltin Hydroxide 1 . . . . . . . Hexachlorocyclopentadiene 1 0 . . 3735 800 4535 4,535 Dicyclopentadiene 1 0 . . . . 0 0 Dimethyl Sulfate 1 0 . . . . 0 0 Methyl Ethyl Ketone 1 0 . . 814 . 814 814 Dichloran 1 . . . . . . . P-xylene 1 0 . . 250 . 250 250

1 0 . . . . 0 0

Salts and Esters

1,3-butadiene




Chemical Name #

Reporting Chemical

Potw Transfers

Disposal Transfers

Recycling Transfers

Treatment Transfers


Total Transfers

Avg Transfer

Per Facility

Cyclohexanol 1 0 . . 35289 . 35289 35,289 N-hexane 1 0 . . 20740 56 20796 20,796 Pyridine 1 8506 . . . . 8506 8,506 Propoxur 1 . . . . . . . Di(2-ethylhexyl) Phthalate 1 2 . . 1033 . 1035 1,035 Hexachlorobenzene 1 0 . . 3849 2215 6064 6,064 1,2,4-trichlorobenzene 1 0 . . 7920 890 8810 8,810 2,4-dichlorophenol 1 0 . . . . 0 0 Triethylamine 1 0 . . 61668 2568 64236 64,236 Hydroquinone 1 250 . . . . 250 250 Folpet 1 0 . . . . 0 0 Merphos 1 0 . . . . 0 0 Oxydemeton Methyl 1 . . . . . . . Bromacil 1 0 . . 868 . 868 868 Methyl Isothiocyanate 1 0 . . . . 0 0 Perchloromethyl Mercaptan 1 0 . . . . 0 0 Methyl Isocyanate 1 0 . . . . 0 0 Pebulate 1 0 500 . 250 . 750 750 Benfluralin 1 . . . . . . . Nitrapyrin 1 . . . . . . . Triallate 1 0 509 . 676 . 1185 1,185 Dodine 1 0 . . 500 . 500 500 Dimethyl Chlorothiophosphate 1 0 . . . . 0 0 Temephos 1 . . . . . . . Terbacil 1 . . . . . . . Hydrogen Fluoride 1 0 . . . . 0 0 Bromine 1 750 . . . . 750 750 Mevinphos 1 0 . . . . 0 0 Phosphine 1 0 . . . . 0 0 Creosote 1 5 . . 602 . 607 607 Zineb 1 . . . . . . . Fenbutatin Oxide 1 . . . . . . . Alachlor 1 0 . . 8600 . 8600 8,600 Benomyl 1 . . . . . . . Oryzalin 1 . . . . . . . Oxydiazon 1 0 . . 250 . 250 250 Aluminum Phosphide 1 . . . . . . . Bendiocarb 1 . . . . . . . Pronamide 1 0 . . 500 . 500 500 Toluene Diisocyanate (Mixed Isomers) 1 . . . . . . . Propetamphos 1 0 1000 . . . 1000 1,000 Amitraz 1 . . . . . . . Tebuthiuron 1 0 . . 937 . 937 937 Diflubenzuron 1 . . . . . . . Sulprofos 1 0 . . . . 0 0 Dinocap 1 . . . . . . . Fenpropathrin 1 . . . . . . . Profenofos 1 . . . . . . . Oxyfluorfen 1 . . . . . . . Triadimefon 1 0 . . . . 0 0 Vinclozolin 1 . . . . . . . Fenvalerate 1 0 . . 3994 . 3994 3,994 Dimethipin 1 . . . . . . . Triclopyr Triethylammonium Salt 1 0 . . 82 . 82 82 Fenarimol 1 . . . . . . . Acifluorfen, Sodium Salt 1 0 . . . . 0 0 Chlorsulfuron 1 0 . . 9807 . 9807 9,807 Fluvalinate 1 . . . . . . . Chlorimuron Ethyl 1 0 . . 36604 . 36604 36,604 Tribenuron Methyl 1 0 . . 17387 . 17387 17,387

_________ _________ _________ _________ _________ _________ _________ _________ 193** 106,917 306,983 5,762,544 2,494,611 2,654,437 11,325,492 58,681




Top 10 TRI Releasing Agricultural Chemical Companies

The TRI database contains a detailed compilation of self-reported, facility-specific chemical releases. The top reporting facilities for the agricultural chemical industries are listed below in Tables 18,19, 20, and 21. Facilities that have reported the primary SIC codes covered under this notebook appear on Table 18 for fertilizers and Table 20 for pesticides and miscellaneous agricultural chemicals. Tables 19 and 21 contain additional facilities that have reported the SIC codes covered within this report, and one or more SIC codes thatare notwithinthe scope of this notebook. Therefore, the second list includes facilities that conduct multiple operations -- some that are under the scope of this notebook, and some that are not. Currently, the facility-level data do not allow pollutant releases to be broken apart by industrial process.


1

2

3

4

5

6

7

8

9

10

1

2

3

4

5

6


Table 18: Top 10 TRI Releasing Fertilizer Manufacturing and Mixing Facilities (SIC 2873, 2874, 2875)*

Rank Facility Total TRI Releases in Pounds

PCS Phosphate Co., Inc. - Aurora, NC 13,202,617

CF Ind. Inc. - Donaldsonville, LA 5,823,740

Unocal Agricultural Products - Kenai, AK 4,715,420

Terra Nitrogen - Catoosa, OK 4,147,000

PCS Nitrogen Fertilizer LP - Millington, TN 3,957,624

IMC Nitrogen Co. - East Dubuque, IL 3,954,025

IMC-Agrico - Uncle Sam, LA 3,570,548

Triad Chemical - Donaldsonville, LA 3,478,835

IMC-Agrico - Mulberry, FL 3,161,160

Farmland Ind. Inc. - Enid, OK 2,804,790

Total 45,615,759

Source: US Toxics Release Inventory Database, 1996. *Being included on this list does not mean that the release is associated with non-compliance with environmental laws.

Table 19: Top 10 TRI Releasing Facilities Reporting Fertilizer Manufacturing and Mixing SIC Codes *

Rank Facility SIC Codes Reported in TRI Total TRI Releases

in Pounds

PCS Phosphate Co. Inc. - Geismar, LA 2873, 2874, 2819 23,192,580

PCS Phosphate Co. Inc. - Aurora, NC 2874 13,202,617

IMC Agrico Co. - St. James, LA 2873, 2874, 2819 12,794,917

Du Pont - Beaumont, TX 2822, 2865, 2869, 2873 10,880,836

Rubicon Inc. - Geismar, LA 2865, 2869, 2873 8,327,597

Monsanto Co. - Luling, LA 2879, 2834, 2873, 2869, 2819

7,742,540

7 Coastal Chemical Co. - Cheyenne, WY 2813, 2819, 2869, 2873, 2899

7,674,410

8 PCS Phosphate - White Springs, FL 2874, 2819 6,961,770

9 Vicksburg Chemical Co. - Vicksburg, MS 2819, 2873, 2812 6,139,460

10 CF Ind. Inc. - Donaldsonville, LA 2873 5,823,740

Total 102,740,467

Source: US Toxics Release Inventory Database, 1996. * Being included on this list does not mean that the release is associated with non-compliance with environmental laws.


1

2

3

4

5

6

7

8

9

10


Table 20: Top 10 TRI Releasing Pesticide and Miscellaneous Agricultural Chemicals Facilities (SIC 2879)*

Rank Facility Total TRI Releases in Pounds

BASF Corp. - Beaumont, TX 649,472

Rhone-Poulenc Ag. Co. - Woodbine, GA 242,293

American Cyanamid Co. - Palmyra, MO 227,942

Zeneca Inc. - Perry, OH 178,291

Farmland Ind. Inc. - Saint Joseph, MO 162,037

Zeneca Inc. - Pasadena, TX 149,968

Bayer Corp. - Kansas City, MO 45,881

Trical Inc. - Hollister, CA 32,447

FMC Corp. - Institute, WV 22,195

McLaughlin Gormley King Co. - Chaska, MN 21,611

Total 1,732,137


Table 21: Top 10 TRI Releasing Facilities Reporting Pesticide and Miscellaneous Agricultural Chemicals SIC Codes *

Rank Facility SIC Codes Reported in TRI

Total TRI Releases in

Pounds

1 Monsanto Co. - Luling, LA 2879, 2834, 2873, 2869, 2819 7,742,540

2 Monsanto - Alvin, TX 2869, 2819, 2841, 2879 7,718,029

3 Uniroyal Chemical Co. - Geismar, LA 2822, 2869, 2879 2,936,127

4 Du Pont - La Porte, TX 2819, 2869, 2879 2,633,242

5 Dow Chemical USA - Midland, MI 2800, 2819, 2821, 2834, 2869, 2879

1,523,414

6 Novartis Crop Protection Inc. - St. Gabriel, LA

2819, 2865, 2869, 2879 1,488,589

7 Tippecanoe Laboratories - Shadeland, IN 2834, 2879 1,206,435

8 Clinton Laboratories - Clinton, IN 2833, 2879 1,158,105

9 Ciba Specialty Chemicals Corp. - McIntosh, AL

2879, 2821, 2865, 3069 1,067,347

10 Du Pont - Belle, WV 2821, 2869, 2879 795,378

Total 28,269,206




IV.B. Summary of Selected Chemicals Released

The following is a synopsis of current scientific toxicity and fate information for the top chemicals (byweight) thatfacilities withinthis sector self-reported as released to the environment based upon 1995 TRI data. Because this section is based uponself-reported release data, it does not attempt to provide information on management practices employed by the sector to reduce the release of these chemicals. Information regarding pollutant release reduction over time may be available from EPA’s TRI and 33/50 programs, or directly from the industrial trade associations that are listed in Section IX of this document. Since these descriptions are cursory, please consult these sources for a more detailed description of both the chemicals described in this section, and the chemicals that appear on the full list of TRI chemicals appearing in Section IV.A.

The brief descriptions provided below were taken from the Hazardous Substances Data Bank (HSDB) and the Integrated Risk Information System (IRIS), both accessed via TOXNET.2 The discussions of toxicity describe the range of possible adverse health effects that have been found to be associated with exposure to these chemicals. These adverse effects may or may not occur at the levels released to the environment. Individuals interested in a more detailed picture of the chemical concentrations associated with these adverse effects should consult a toxicologist or the toxicity literature for the chemical to obtain more information. The effects listed below must be taken in context of these exposure assumptions that are explained more fully within the full chemical profiles in HSDB. For more information on TOXNET, contact the TOXNET help line at 1-800-231-3766.

2 TOXNET is a computer system run by the National Library of Medicine that includes a number of toxicological databases managed by EPA, National Cancer Institute, and the National Institute for Occupational Safety and Health. For more information on TOXNET, contact the TOXNET help line at 800-231-3766. Databases included in TOXNET are: CCRIS (Chemical Carcinogenesis Research Information System), DART (Developmental and Reproductive Toxicity Database), DBIR (Directory of Biotechnology Information Resources), EMICBACK (Environmental Mutagen Information Center Backfile), GENE-TOX (Genetic Toxicology), HSDB (Hazardous Substances Data Bank), IRIS (Integrated Risk Information System), RTECS (Registry of Toxic Effects of Chemical Substances), and TRI (Toxic Chemical Release Inventory). HSDB contains chemical-specific information on manufacturing and usage, chemical and physical properties, safety and handling, toxicity and biomedical effects, pharmacology, environmental fate and exposure potential, exposure standards and regulations, monitoring and analysis methods, and additional references.



Ammonia3 (CAS: 7664-41-7)

Sources. Ammonia is the primary nitrogen source for all nitrogenous fertilizers and ammonium phosphatic fertilizers.

Toxicity. Anhydrous ammonia is irritating to the skin, eyes, nose, throat, and upper respiratory system.

Ecologically, ammonia is a source ofnitrogen(anessential element for aquatic plant growth), and may therefore contribute to eutrophication of standing or slow-moving surface water, particularly innitrogen-limited waters suchas the Chesapeake Bay. In addition, aqueous ammonia is moderately toxic to aquatic organisms.

Carcinogenicity. There is currently no evidence to suggest that ammonia is carcinogenic.

EnvironmentalFate. Ammonia combines with sulfate ions in the atmosphere and is washed out by rainfall, resulting in rapid return of ammonia to the soil and surface waters.

Ammonia is a central compound in the environmental cycling of nitrogen. Ammonia in lakes, rivers, and streams is converted to nitrate.

PhysicalProperties. Ammonia is a colorless gas atatmospheric pressure, but is shipped as a liquefied compressed gas. It is soluble to about 34 percent in water and has a boiling point of -28 degrees F. Ammonia is corrosive and has a pungent odor.

Phosphoric Acid (CAS: 7664-38-2)

Sources. Phosphoric acid is the primary phosphorous source used for phosphatic fertilizers.

Toxicity. Phosphoric acid is toxic by ingestion and inhalation, and is an irritant to skin and eyes. The toxicity of phosphoric acid is related to its corrosivity as an acid, with ulceration of membranes and tissues with which it comes in contact. Because it is a source of phosphorous, an essential element for aquatic plant growth, phosphoric acid may contribute to eutrophication of standing or slow-moving surface water, particularly in phosphorous-limited waters such as the Great Lakes.

3 The reporting standards for ammonia were changed in 1995. Ammonium sulfate is deleted from the list and threshold and release determinations for aqueous ammonia are limited to 10 percent of the total ammonia present in solution. This change will reduce the amount of ammonia reported to TRI. Complete details of the revisions can be found in 40 CFR Part 372.



Carcinogenicity. There is currently no evidence to suggest that phosphoric acid is carcinogenic.

EnvironmentalFate. The acidity of phosphoric acid may be reduced readily by natural water hardness minerals. The phosphate will persist until used by plants as a nutrient.

Physical Properties. Phosphoric acid is a thick, colorless, and odorless crystalline solid, often used in an aqueous solution. Its boiling point is 415° F and it is soluble in water.

Nitrate compounds

Sources. Many different nitrate compounds are formed during nitrogenous fertilizer production.

Toxicity. Nitrate compounds that are soluble in water release nitrate ions which can cause both human health and environmental effects. Human infants exposed to aqueous solutions of nitrate ion can develop a condition in which the blood’s ability to carry oxygen is reduced. This reduced supply of oxygen can lead to damaged organs and death. Because it is a source of nitrogen, an essential element for aquatic plant growth, nitrate ion may contribute to eutrophication of standing or slow-moving surface water, particularly in nitrogen-limited waters, such as the Chesapeake Bay.

Carcinogenicity. There is currently no evidence to suggest that nitrate compounds are carcinogenic.

Environmental Fate. Nitrogen in nitrate is the form of nitrogen most available to plants. In the environment, nitrate ion is taken up by plants and becomes part of the natural nitrogen cycle. Excess nitrate can stimulate primary production in plants and canproduce changes in the dominant species of plants, leading to cultural eutrophication and ultimately to deterioration of water quality.

Methanol (CAS: 67-56-1)

Sources. Methanol is generated in ammonia production. It is also used as a solvent and for equipment cleaning in pesticide formulations.

Toxicity. Methanol is readily absorbed from the gastrointestinal tract and the respiratory tract and is toxic to humans in moderate to high doses. In the body, methanol is converted into formaldehyde and formic acid. Methanol is excreted as formic acid. Observed toxic effects at high dose levels generally include central nervous system damage and blindness. Long-term



exposure to high levels of methanol via inhalation cause liver and blood damage in animals.

Ecologically, methanol is expected to have low toxicity to aquatic organisms. Concentrations lethal to half the organisms of a test population are expected to exceed one mg methanol per liter water. Methanol is not likely to persist in water or to bioaccumulate in aquatic organisms.

Carcinogenicity. There is currently no evidence to suggest that methanol is carcinogenic.

Environmental Fate. Methanol is highly volatile and flammable. Liquid methanol is likely to evaporate when left exposed. Methanol reacts in air to produce formaldehyde which contributes to the formation of air pollutants. In the atmosphere it can react with other atmospheric chemicals or be washed out by rain. Methanol is readily degraded by microorganisms in soils and surface waters.

Physical Properties. Methanol is a colorless liquid with a characteristic pungent odor. It is miscible with water, and its boiling point is 147°F.

Sulfuric Acid (CAS: 7664-93-9)

Sources. Sulfuric acid is a raw material of most fertilizer products.

Toxicity. Concentrated sulfuric acid is corrosive. In its aerosol form, sulfuric acid has been implicated in causing and exacerbating a variety of respiratory ailments.

Ecologically, accidental releases of solution forms of sulfuric acid may adversely affect aquatic life by inducing a transient lowering of the pH (i.e., increasing the acidity) of surface waters. In addition, sulfuric acid in its aerosol form is also a component of acid rain. Acid rain can cause serious damage to crops and forests.

Carcinogenicity. There is currently no evidence to suggest that sulfuric acid is carcinogenic.

Environmental Fate. Releases of sulfuric acid to surface waters and soils will be neutralized to anextent due to the buffering capacities of both systems. The extent of these reactions will depend on the characteristics of the specific environment.

Physical Properties. Sulfuric acid is an oily, odorless liquid which can be colorless to dark-brown. It is miscible, and its boiling point is 554°F.



Sulfuric acid reacts violently with water with evolution of heat and is corrosive to metals. Pure sulfuric acid is a solid below 51°F.

IV.C. Other Data Sources

The toxic chemical release data obtained fromTRI captures only about 236 of the facilities in the Fertilizer, Pesticide, and Agricultural Chemical Industry. However, it allows for a comparison across years and industry sectors. Reported chemicals are limited to the approximately 600 TRI chemicals. A portionof the emissions fromagricultural chemical facilities, therefore, are not captured by TRI. The EPA Office of Air Quality Planning and Standards has compiled air pollutant emissionfactors for determining the total air emissions of priority pollutants (e.g., total hydrocarbons, SOx, NOx, CO, particulates, etc.) from many chemical manufacturing and formulating sources.

The Aerometric Information Retrieval System (AIRS) contains a wide range of information related to stationary sources of air pollution, including the emissions of a number of air pollutants which may be of concern within a particular industry. With the exception of volatile organic compounds (VOCs), there is little overlap with the TRI chemicals reported above. Table 22 summarizes annual releases (from the industries for which a Sector Notebook Profile was prepared) of carbon monoxide (CO), nitrogen dioxide (NO2), particulate matter of 10 microns or less (PM10), sulfur dioxide (SO2), and volatile organic compounds (VOCs).



Table 22: Air Pollutant Releases by Industry Sector (tons/year)

Industry Sector CO NO2 PM10 PT SO2 VOC Metal Mining 4,951 49,252 21,732 9,478 1,202 119,761

Non-Fuel, Non-Metal Mining 31,008 21,660 44,305 16,433 9,183 138,684

Textiles 8,164 33,053 1,819 38,505 26,326 7,113

Lumber and Wood Products 139,175 45,533 30,818 18,461 95,228 74,028

Wood Furniture and Fixtures 3,659 3,267 2,950 3,042 84,036 5,895

Pulp and Paper 584,817 365,901 37,869 535,712 177,937 107,676

Printing 8,847 3,629 539 1,772 88,788 1,291

Inorganic Chemicals 242,834 93,763 6,984 150,971 52,973 34,885

Plastic Resins and Man-made Fibers 15,022 36,424 2,027 65,875 71,416 7,580

Pharmaceuticals 6,389 17,091 1,623 24,506 31,645 4,733

Organic Chemicals 112,999 177,094 13,245 129,144 162,488 17,765

Agricultural Chemicals 12,906 38,102 4,733 14,426 62,848 8,312

Petroleum Refining 299,546 334,795 25,271 592,117 292,167 36,421

Rubber and Plastic 2,463 10,977 3,391 24,366 110,739 6,302

Stone, Clay, Glass and Concrete 92,463 335,290 58,398 290,017 21,092 198,404

Iron and Steel 982,410 158,020 36,973 241,436 67,682 85,608

Metal Castings 115,269 10,435 14,667 4,881 17,301 21,554

Nonferrous Metals 311,733 31,121 12,545 303,599 7,882 23,811

Fabricated Metal Products 7,135 11,729 2,811 17,535 108,228 5,043

Electronics and Computers 27,702 7,223 1,230 8,568 46,444 3,464

Motor Vehicle Assembly 19,700 31,127 3,900 29,766 125,755 6,212

Aerospace 4,261 5,705 890 757 3,705 10,804

Shipbuilding and Repair 109 866 762 2,862 4,345 707

Ground Transportation 153,631 594,672 2,338 9,555 101,775 5,542

Water Transportation 179 476 676 712 3,514 3,775

Air Transportation 1,244 960 133 147 1,815 144

Fossil Fuel Electric Power 399,585 5,661,468 221,787 13,477,36 7

42,726 719,644

Dry Cleaning 145 781 10 725 7,920 40

Source: United States EPA Office of Air and Radiation, AIRS Database, 1997.



IV.D. Comparison of Toxic Release Inventory Between Selected Industries

The following information is presented as a comparison of pollutant release and transfer data across industrial categories. It is provided to give a general sense as to the relative scale of TRI releases and transfers within each sector profiled under this project. Please note that the following figure and table do notcontainreleases and transfers for industrial categories thatare notincluded in this project, and thus cannot be used to draw conclusions regarding the total release and transfer amounts that are reported to TRI. Similar information is available within the annual TRI Public Data Release Book.

Figure 19 is a graphical representation of a summary of the TRI data for the Fertilizer, Pesticide, and Agricultural Chemical Industryand the other sectors profiled in separate notebooks. The bar graph presents the total TRI releases and total transfers on the vertical axis. Industry sectors are presented in the order of increasing SIC code. The graph is based on the data shown in Table 23 and is meant to facilitate comparisons between the relative amounts of releases and transfers both within and between these sectors. Table 23 also presents the average releases per facility in each industry. The reader should note that differences in the proportion of facilities captured by TRI exist between industry sectors. This can be a factor of poor SIC matching and relative differences in the number of facilities reporting to TRI from the various sectors. In the case of the Fertilizer, Pesticide, and Agricultural Chemical Industry, the 1995 TRI data presented here covers 236 facilities. These facilities listed SIC 2873, 2874, 2875, or 2879 as a primary SIC code.



Figure 19: Summary of 1995 TRI Releases and Transfers by Industry

0

100

200

300

400

500

600

22

24

25

26

11

-26

31

27

11

-27

89

28

12

-28

19

2821

, 28

23,

2824

2833

, 28

34

28

61

-28

69

287

2911

30

32

331

332,

336

333,

334

34

36

371

3731

SIC Range

To

tal

Po

un

ds

(mil

lio

ns)

Total Releases Total Transfers

Source: US EPA 1995 Toxics Release Inventory Database.

SIC Range

Industry Sector SIC Range

Industry Sector SIC Range

Industry Sector

22 Textiles 2833, 2834 Pharmaceuticals 332, 336 Metal Casting

24 Lumber and Wood Products

2861-2869 Organic Chem. Mfg. 333, 334 Nonferrous Metals

25 Furniture and Fixtures 287 Agricultural Chemicals 34 Fabricated Metals

2611-2631 Pulp and Paper 2911 Petroleum Refining 36 Electronic Equip. and Comp.

2711-2789 Printing 30 Rubber and Misc. Plastics 371 Motor Vehicles, Bodies, Parts, and Accessories

2812-2819 Inorganic Chemical Manufacturing

32 Stone, Clay, and Concrete 3731 Shipbuilding

2821, 2823, 2824

Resins and Plastics 331 Iron and Steel



Ave

rage

Rel

ease

s +

T

rans

fers

per

F

acili

ty (

poun

ds)

74,0

00

86,0

00

141,

000

948,

000

169,

000

659,

000

625,

000

886,

000

1,22

9,00

0

375,

000

572,

000

126,

000

121,

000

1,42

9,00

0

168,

000

1,29

7,00

0

162,

000

180,

000

362,

000

151,

000

Tot

al R

elea

ses

+Tra

nsfe

rs

(mil

lion

lbs.

)

24.8

34.1

47.5

289.

1

44.3

438.

5

256.

5

177.

1

946.

8

88.5

103.

0

245.

7

75.7

604.

6

109.

9

365.

7

434.

0

73.1

273.

3

6.5

Tab

le 2

3: 1

995

Tox

ics

Rel

ease

Inv

ento

ry D

ata

for

Sele

cted

Ind

ustr

ies TR

I T

rans

fers

Ave

. Tra

ns.

per

Fac

ility

(p

ound

s)

21,0

00

10,0

00

29,0

00

185,

000

40,0

00

191,

000

469,

000

736,

000

631,

000

48,4

61

162,

000

53,0

00

51,0

00

1,21

5,00

0

113,

000

582,

000

131,

000

169,

000

257,

000

95,0

00

Tot

al

Tra

nsfe

rs

(mil

lion

lbs.

)

7.0

4.1

9.9

56.5

10.4

21.7

192.

4

147.

2

208.

6

11.4

29.2

102.

6

31.8

513.

9

73.9

164

350.

5

68.8

194

4.1

TR

I R

elea

ses Ave

. R

elea

ses

per

F

acili

ty

(pou

nds)

53,0

00

76,0

00

112,

000

763,

000

129,

000

468,

000

156,

000

150,

000

598,

000

326,

788

410,

000

73,0

00

70,0

00

214,

000

55,0

00

715,

000

31,0

00

11,0

00

105,

000

56,0

00

Tot

al

Rel

ease

s (m

illi

on lb

s.)

17.8

30.0

37.6

232.

6

33.9

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Agricultural Chemical Industry Pollution Prevention Opportunities

V. POLLUTION PREVENTION OPPORTUNITIES

The best way to reduce pollution is to prevent it in the first place. Some companies have creatively implemented pollution prevention techniques that improve efficiency and increase profits while at the same time minimizing environmental impacts. This can be done in many ways such as reducing material inputs, re-engineering processes to reuse by-products, improving management practices, and substituting toxic chemicals with those less toxic. Some smaller facilities are able to actually get below regulatory thresholds just by reducing pollutant releases through aggressive pollution prevention policies.

The Pollution Prevention Act of 1990 established a national policy of managing waste through source reduction, which means preventing the generationof waste. The Pollution Prevention Act also established as national policy a hierarchy ofwaste managementoptions for situations in which source reduction cannot be feasiblely implemented. In the waste management hierarchy, if source reduction is not feasible the next alternative is recycling of wastes, followed by energy recovery, and waste treatment as a last alternative.

In order to encourage these approaches, this sectionprovides both general and company-specific descriptions of some pollution prevention advances that have been implemented within the Fertilizer, Pesticide, and Agricultural Chemical Industry. While the list is not exhaustive, it does provide core information that can be used as the starting point for facilities interested in beginning their own pollution prevention projects. This section provides summary information fromactivities thatmaybe, or are being implemented by this sector. When possible, information is provided that gives the context in which the technique can be used effectively. Please note that the activities described in this section do not necessarily apply to all facilities that fall within this sector. Facility-specific conditions must be carefully considered when pollution prevention options are evaluated, and the full impacts of the change must examine how each option affects air, land and water pollutant releases.

The Fertilizer, Pesticide, and Agricultural Chemical Industry uses many pollution prevention (P2), recycle and reuse, and water conservation practices. Wastewaters are primarily generated not by the production or formulating processes themselves but by cleaning operations of the process areas and associated equipment. Because the wastewaters are mostly cleaning rinsates and not waters of reaction, the pollution prevention practices are not process-specific. There are many P2, recycle and reuse, and water conservation practices that are widely accepted and practiced by the Fertilizer, Pesticide, and Agricultural Chemical Industry today.



These pollution prevention, recycle and reuse, and water conservation practices fall into three groups: production practices, housekeeping practices, and practices that use equipment that, bydesign, promote pollutionprevention. Some of these practices and equipment conserve water, others reduce the amountof fertilizer or pesticide product in the wastewater, and still others may prevent the generation of a wastewater altogether (USEPA, 1996). A number of common P2 practices are listed below.

Production practices include:

C triple-rinsing raw material shipping containers directly into the formulation

C scheduling production to minimize cleanouts

C segregating processing/formulating/packaging equipment by: - individual product - solvent-based versus water-based formulations - products that contain similar active ingredients in different concentrations

C storing interior equipment rinse waters for use in formulating the same product

C packaging products directly from formulation vessels

C using raw material drums for packaging final products

C dedicating equipment (possibly only mix tank or agitator) for “hard-to-clean” formulations

Housekeeping practices include:

C performing preventive maintenance on all valves, fittings, and pumps

C placing drip pans under leaky valves and fittings or under any valves or fittings where hoses or lines are routinely connected and disconnected

C cleaning up spills or leaks in outdoor bulk containment areas to prevent contamination of storm water



Equipment that promotes pollution prevention by reducing or eliminating wastewater generation includes:

C low-volume/high-pressure hoses

C spray nozzle attachments for hoses

C squeegees and mops

C low-volume/recirculating floor scrubbing machines

C portable steam cleaners

C drum triple rinsing stations

C roofs over outdoor tank farms (USEPA, 1996)



Table 24: Waste Minimization Methods for the Fertilizer, Pesticide, and Agricultural Chemical Industry

Waste Stream Waste Minimization Methods

Equipment Cleaning Wastes Maximize production runs. Store and reuse cleaning wastes. Use of wiper blades and squeegees. Use of low-volume, high-efficiency cleaning. Use of plastic or foam “pigs.”

Spills and Area Washdowns Use of dedicated vacuum system. Use of dry cleaning methods. Use of recycled water for initial cleanup. Actively involved supervision.

Off-Specification Products Strict quality control and automation. Reformulating off-spec batches.

Containers Return containers to supplier and or reuse as directed. Triple rinse containers. Drums with liners versus plastic drums or bags. Segregating solid waste.

Air Emissions Control bulk storage air emissions. Dedicate dust collection systems. Use automatic enclosed cut-in hoppers. Eliminate emissions of ammonia from reaction of anhydrous ammonia and phosphoric acid.

Miscellaneous Wastewater Streams Pave high spillage areas.

Source: Guides to Pollution Prevention, The Pesticide Formulating Industry, Center for Environmental Research Information, United States EPA, Cincinnati, Ohio, 1990.



V.A. Equipment Cleaning

Shipping Container/Drum Cleaning Operations

Fertilizer and pesticide facilities frequently receive raw materials in containers such as 55-gallon plastic or steel drums or 30-gallon fiber drums. In some cases, the empty drums are returned to the supplier, but usually the facility is responsible for disposal of the drums. The simplest, most cost-effective, and best approach to prevent pollution associated with cleaning drums and shipping containers is to rinse empty drums prior to disposal to capture the raw material residue for direct reuse in future formulations of the same product. In this way, the facility not only eliminates a potential highly contaminated wastewater source, but is also able to recover the product value of the raw material and avoids costs associated with storage of the wastewater (USEPA, 1996). However, pesticide chemicals formulating and packaging facilities and pesticide repackaging and refilling facilities should consult the ListofPollutionPreventionAlternative Practices and ensure compliance with the effluent guidelines and standards found in 40 CFR 455 Subparts C and E before implementing pollution prevention techniques listed in this section.

Rinsing procedures for pesticide drums are provided in40 CFR Part165. The most common method of drum rinsing in the agrichemical industry is triple rinsing. After a drum containing AIs or pesticide products is emptied, it should be triple rinsed with the solvent that will be used in the formulation. This method prevents the creation of a rinsate that cannot be added directly to the formulation (e.g., a facility will not create a water-based rinsate when producing a solvent-based product). Note in some cases the label may specify how to rinse.

Some facilities use a high-pressure, low-volume wash system equipped with a hose and a spray nozzle to triple rinse drums; volumes of five to fifteen gallons of water per drum have been reported. EPA has identified many facilities that reuse these rinsates directly in product formulations. Other facilities treatdrumrinsate and reuse the effluent for further drumor equipment rinsing. If the rinsate cannot be reused directly in product formulations, another effective method to reduce wastewater generation during shipping container/drumcleaning processes is the use ofdrumrinsing stations (USEPA, 1996).

One facility uses a three-cell station for triple-rinsing drums. The water in the first cell is used for the first rinse, the water in the second cell is used for the second rinse, and the water in the third cell is used for the final rinse. The rinse water in the first cell is reused until it is visually too contaminated to effectively clean the drums. At that time, it is removed from the cell (for treatment) and the rinse water fromthe second cell is transferred into the first cell. The rinse water from the third cell is transferred into the second cell, and the third cell is refilled with treated effluent fromtheir treatment system. Each



cell contains approximately100 gallons ofwater;approximately 70 drums can be rinsed before the first cell requires water changing (USEPA, 1996).

Another site uses a unique, closed-loop set-up for emptying and triple rinsing raw material drums. The system was designed by the facility for several purposes: to aid it in emptying and cleaning drums and performing the triple rinse, to eliminate the need for storage of the water (or solvent) for reuse, and to prevent mathematical errors bythe operators during the weighing out of raw materials and water (or solvent). The system consists of two 55-gallon drums, a formulation tank, and connecting hoses. One of the drums is permanently fixed on top of the formulation tank. The formulation tank and drum are situated on a load cell (used for weighing). The second drum, which is full of raw material, is placed on the ground next to the formulation tank. One hose is used to vacuum out the raw material and transfer it to the drum on the formulations tank/load cell. The other hose is equipped with a doughnut-shaped nozzle that provides the triple rinse by spraying the interior of the now empty raw material drum. The rinsate that is created by the triple rinse procedure is automatically removed by the vacuum line and is transferred to the drum on the formulation tank/load cell.

The load cell can be used to weigh the amount of raw material and/or rinsate that is added to the formulation by zeroing out the weight of the tank and drum. This allows the volume of both raw material and rinse water (or solvent) to be factored into the total volume of water (or solvent) required in the formulation. The drum on top of the formulation tank is equipped with a spring-loaded valve that enables the operator to take weight measurements prior to emptying the contents of the drum into the mix tank. This set-up has almost completely eliminated operator math errors and related formulation specification problems.

Bulk Tank and Equipment Cleaning

Pesticide formulating and fertilizer mixing facilities sometimes produce large quantities of formulated pesticide and fertilizer products and receive large quantities of raw materials used to produce those products. Those products and raw materials are stored on site in bulk tanks. The tanks are typically rinsed only when it becomes necessary to use the tank to store a different material. Each time the facility switches the product stored in a bulk tank, the tank is rinsed. Bulk tanks are sometimes also rinsed at the end of a season as a part of general maintenance (USEPA, 1996). Pesticide formulating and fertilizer mixing facilities should consult the List of Pollution Prevention Alternative Practices and ensure compliance with the effluent guidelines and standards found in 40 CFR Part 455 Subparts C and E before implementing pollution prevention techniques involving bulk tank and other equipment cleaning.

Product changeover cleanings can be eliminated or greatly reduced by



dedicating equipment to specific products or groups of products. Although entire lines are not generally dedicated, there are many facilities thatdedicate tanks to formulation mixing only, thereby eliminating one of the most highly contaminated wastewater streams generated at pesticide formulating and packaging facilities. Facilities also dedicate lines to the production of a specific product type, such as water-based versus solvent-based products, thereby reducing the number of cleanings required, and allowing greater reuse of the cleaning water or solvent.

Another effective pollution prevention technique is to schedule production to reduce the number of product changeovers, which reduces the number of equipment interior cleanings required. Facilities may also reduce the number of changeover cleanings required or the quantity of water or solvent used for cleaning by scheduling products in groups. Products may lend themselves to a particular production sequence if they have common active ingredients, assuming the products also have the same solvent base (including water). Where other raw material cross-contamination problems are nota concern, no cleaning would be required between changeover. Facilities that have implemented this technique have conducted testing to ensure that product quality is not adversely affected (USEPA, 1996).

Scheduling production according to packaging type can reduce changeover cleanings of packaging equipment. Packaging lines are often able to handle containers of different sizes; a slight adjustment to one packaging line, such as adding a short length of hose, may prevent the use of an entirely different set of packaging equipment that would also require cleaning. Packaging can also be performed directly out of the formulation vessels to avoid using and subsequently cleaning interim storage tanks and transfer hoses.

Another effective pollution prevention and water conservation technique to minimize the quantity of rinse water generated by equipment interior cleaning is the use of water hoses equipped with hand-control devices (for example, spray-gun nozzles suchas those used on garden hoses). This practice prevents the free flow of water from unattended hoses. Another technique to conserve water is the use of high-pressure, low-volume washers instead of ordinary hoses. One of the facilities visited indicated that, by using high-pressure washers, they reduced typical equipment interior rinse volumes from twenty gallons per rinse to ten gallons per rinse (USEPA, 1996).

Steam cleaning can also be a particularly effective method to clean viscous products that otherwise require considerable volumes of water and/or the addition of a detergent to remove. Many facilities have access to steam from boilers onsite;however, if there is no existing source of steam, steamcleaning equipment can be purchased. Although steam generation can increase energy consumption and add NOx and SOx pollutants to the atmosphere, there are benefits to be gained. Facilities may end up creating a much smaller volume of wastewater and may potentially avoid the need to use detergents or other



cleaning agents that could prevent product recovery. However, steamwould be a poor choice for cleaning applications where volatile organic solvents or inerts are part of the product, as the steamwould accelerate the volatilization of the organic compounds.

Facilities also clean equipment interiors by using squeegees to remove the product from the formulation vessel and by using absorbent “pigs” to clean products out of the transfer lines before equipment rinsing. These techniques minimize the quantity of cleaning water required, although they generate a solid waste streamrequiring disposal. Regardless of whether or not residual product is removed from equipment interiors before rinsing, if certain conditions are met, equipment interior rinsate cantypically be reused as makeup water the next time that a water-based product is being formulated with the same chemical (USEPA, 1996). Pesticide chemicals formulating and packaging facilities and pesticide repackaging and refilling facilities should consult the List of Pollution Prevention Alternative Practices and ensure compliance with the effluent guidelines and standards found in 40 CFR Part 455 Subparts C and E before implementing pollution prevention techniques involving bulk tank and other equipment cleaning.

One facility uses a unique method of cleaning to reduce the volume of water needed to clean equipment interiors. At this facility, the production lines are hooked to dedicated product storage tanks. Prior to rinsing these production lines, the facility uses air to “blow” the residual product in the line back to product storage. Not only will these lines require less water to clean, but the residual product that is blown back to storage is not diluted and should not affect the product specifications in any way.

Another facility drastically reduced dichloromethane usage at several plants by switching to soap and water for cleaning. This change enabled the facility to cut its target chemicals by two-thirds. The facility also reduced the release of carbon tetrachloride, and installed a closed-loop recycling system, to reduce water usage (CMA, 1993).

Aerosol Container Leak Testing

No method of eliminating wastewater from test baths has been identified. However, the volume of water used may be minimized by using a contained (or batch) water bath as opposed to a continuous overflow water bath. A contained water bath is completely emptied and refilled with water when required, based uponvisual inspectionbythe operator. Therefore, the quantity of wastewater generated depends on the frequency of refilling and the volume of the bath (200 gallons is a typical volume of the contained water baths). One facility uses a contained water bath and heats the bath with steamto ensure that the temperature of the cans reaches 130°F. This facility indicated that steam condensation causes some overflow that exits the bath via a standpipe. A continuous overflow bath would probably generate more wastewater per



production unit than a batch water bath (USEPA, 1996).

One facility has installed a diatomaceous earth filter on one DOT test bath. The facility recirculates the bath water through the filter to remove contaminants such as oil and grease and suspended solids. The filtered water is then reused in the bath, thereby extending the usefulness of the bath water. The facility anticipates they will dispose of the filter as nonhazardous waste.

Another facility uses a can-washing step prior to the DOT testbath, presenting an additional source of wastewater. This can washing is performed at the operator’s discretion to reduce the quantity of contaminants entering the bath water. The effectiveness of this step has not been quantitatively determined (USEPA, 1996).

Laboratory Equipment Cleaning

Many pesticide formulating and packaging facilities operate on-site laboratories for conducting quality control tests of raw materials and formulated products. Wastewater is generated from these tests and from cleaning glassware used in the tests. One effective pollution prevention/reuse technique during laboratory equipment cleaning operations is to dedicate laboratory sinks to certain products, and collect any wastewater generated from the testing of those products either for reuse in the same product or for transfer back to the AI manufacturer or product registrant. In the cases where the facility uses solvents in conjunction with the quality control tests performed in the laboratory, the solvent-contaminated water may not be able to be reused in the process (USEPA, 1996).

V.B. Process Changes

Storage Tanks

One method to reduce the amount of wastewater from ammonium nitrate production is to incorporate a wastewater evaporator system which reduces the amount of contaminated cooling water discharge. The wastewater passes through a series of evaporation steps whereby the vapors are used as wash water in the calcium carbonate filters and the concentrated solution is pumped to the neutralizers where it is mixed with the acidic nitrogen-phosphate solution and used to regulate the nitrogen-phosphate nutrient ratio of the fertilizer. Through this modified technology, steam and electric energy consumptionincreases somewhat, but suchincreases are balanced bythe more effective utilization of nitrogen and the reduction of wastewater. More information onthis methodcanbe found in“Waste Water Evaporation Process for Fertilizer Production Technology,” Compendium on Low and Non-waste Technology, United Nations Economic and Social Counsel. (http://es.inel.gov/studies/cs244.html)



Many methods are available for reducing the amount of emissions resulting from fixed roof storage tanks. Some of these methods include use of conservation vents, conversion to floating roof tanks, use of nitrogen blanketing to suppress emissions and reduce material oxidation, use of refrigerated condensers, use of lean-oil or carbon absorbers, or use of vapor equilibration lines. When dealing with volatile materials, employment of one or more of these methods can result in cost savings to the facility by reducing raw material losses and improving compliance with local air quality requirements (USEPA, 1996).

Air Emission Control Systems

Agricultural chemical facilities often produce large quantities of dust which are collected from numerous sources. The chemical composition of the various dust sources can vary widely. Opportunities often exist to reduce waste generation through segregation of these waste dusts and particulates.

At Daly-Herring Co., in Kingston, NC, dust streams from several different production areas were handled by a single baghouse. Since all of the streams were mixed, none of the waste could be recycled to the process that generated them. By installing separate dedicated baghouses for each production line, all of the collected pesticide dust could be recycled. The initial investment for the equipment was $9,600. The payback period was only ten months. Daly-Herring saved over $9,000 per year in disposal costs and $2,000 per year in raw material costs (Hunt, 1989).

At FMC Corp. in Fresno, CA, common dust collectors were used by multiple production systems. Due to the cross contamination of materials, recycling was impossible. To promote recycling, the company compartmentalized the dust collectors with each compartment serving a single source. All collected materials are analyzed for cross contamination and if none exists, they are reused in the succeeding product batch. Other work involved the installation of self-contained dust collectors at each inlet hopper dump station so that captured dust can be returned to the system (USEPA, 1996).

Facilities mayalso use wet scrubbers to control air emissions. Some facilities may only need a wet scrubber on one particular process (i.e., a dedicated scrubber). These facilities have been able to reuse the scrubber blowdown or changed-out scrubber water as make-up water in the formulation of that particular product. Some facilities with nondedicated scrubbers have been



able to use the scrubber blowdownor changed-out scrubber water for floor or equipment exterior cleaning (USEPA, 1996).

Microprill Formation

Microprill formation resulting from partially plugged orifices of melt spray devices can increase fine dust loading and emissions. Certain designs (spinning buckets) and practices (vibration of spray plates) help reduce microprill formation. Reducing the ambient air temperature reduces emissions because the air flow required to cool prills and the formation of fumes are decreased at lower temperatures.

V.C. Good Housekeeping

Floor/Wall/Equipment Exterior Cleaning

During processing, formulating, and packaging operations, the exteriors of equipment may become soiled from drips, spills, and dust (especially equipment located near dry lines). The floors in the area become dirty in the same manner and also from normal traffic. Facility workers clean the equipment exteriors and floors for general housekeeping purposes, and to keep sources of product contamination to a minimum. When water is used, these cleaning procedures become a source of wastewater.

Wastewater can again be minimized through the use of high-pressure, low-volume washers rather than ordinary water hoses. Additionally, some facilities practice steam cleaning rather than water cleaning of equipment exteriors to reduce the amount of wastewater generated (USEPA, 1996).

Instead of hosing down the exterior of a piece of equipment, some facilities wipe equipment exteriors with rags or use a solvent cleaner, such as a commercially available stainless steel cleaner. This practice avoids generating a wastewater stream, but does create a solid waste that, depending on the solvent used, could be considered a hazardous waste. Squeegees are also used to cleanequipment exteriors and floors, and are not disposed of after single uses. It may be possible to dedicate squeegees to a certain line or piece ofequipment, butusing squeegees maystill require using some water (USEPA, 1996).

Some facilities use automated floor scrubbers, which replace the practice of hosing downfloors. Floor scrubbers are mechanical devices that continually recirculate cleaning water to clean flat, smooth surfaces with circulating brushes. During operation, the scrubber collects the cleaning water in a small tank that is easily emptied after the cleaning process, or at a later date. Using a floor scrubbing machine can require as little as five to fifteen gallons of cleaning solution (typically water) per use. A mop and a single bucket of



water can also be used in place ofa hose. Floor mopping can generate as little as ten gallons of water per cleaning depending on the size of the surface to be cleaned (USEPA, 1996).

A number of facilities reuse their floor wash water with and without filtering. One facility has set up its production equipment on a steel-grated platform directly above a collection sump. Following production, the equipment and the floor of the platform, on which the operator stands when formulating product, are rinsed and the water is allowed to flow into the sump. A pump and a filter have been installed in the sump area to enable the operator to transfer this rinsate back into the formulation tank for the next formulation. This sump is also connected to floor trenches in the packaging area for the same product. When the exterior of the packaging equipment and the floors in this area are rinsed, this water is directed to the trenches and eventually ends up in the collection sump for reuse (USEPA, 1996).

Leaks and Spills Clean-Up

Dry products that have leaked or spilled can be vacuumed or swept without generating any wastewater. Liquid leaks and spills can be collected into a trench or sump (for reuse, discharge, or disposal) with a squeegee, leaving only a residue to be mopped up or hosed down if further water cleanup is required. Liquid leaks and spills can also be cleaned up using absorbent material, such as absorbent pads or soda ash. For an acidic product, soda ash or a similar base material will also serve to neutralize the spill. If a residue remains, some water may be used for mopping up or hosing the area down, but methods to reduce floor wash should be implemented whenever possible. Many facilities clean up leaks and spills from water-based products with water and then solvent-based products with absorbent materials. Using an absorbent material may be the best practice for cleaning up small scale solvent-based leaks and spills;however, EPA does recognize that this material then needs to be disposed of (cross-media transfer). Therefore, good housekeeping practices may be even more important in the case of organic solvent-based product spills and leaks because, if not prevented, these spills and leaks may have to be cleaned up with absorbent material and disposed of (USEPA, 1996).

Direct reuse of products which have leaked or spilled is another possible pollution prevention technique. If drip pans or other containers are used to catch leaks and spills, the material (either water-based or solvent-based) can be immediately reused in the product being processed, formulated, or packaged, or stored for use in the next product batch. Collection hoppers or rubs can be installed beneath packaging fillers to capture spills and immediately direct the spills back to the fillers. Leaks or spills around bulk



storage tanks can be contained by dikes, which, in fact, are often required by state regulations (USEPA, 1996).

Precipitation Runoff

Precipitation runoff includes all precipitationthatfalls onfacility surfaces that are believed to be contaminated. Contaminated precipitation runoff can be prevented by bringing all operations indoors, as many facilities have done, or by covering outdoor storage tanks and dikes with roofs, which has also been done at many facilities. The roofs would ideally extend low enough to prevent crosswinds from blowing rain into spill-containment dikes. To prevent rainwater contamination, the drain spouts and gutters should conduct roof runoff to areas away from process operations, and the roofs should be kept in good repair (USEPA, 1996).

If operations remain outdoors, a transfer, or containment pad should be installed with a sump or other means ofcollecting rinse water. The pad should be constructed of asphalt or concrete and maintained with crack sealer and a top coat sealer to control infiltration. The pad should also be large enough to contain wind-blown particulates from dry materials. If pads are cleaned before a rainfall, then uncontaminated precipitation runoff may be directly discharged to surface drains (CFA, 1996). Facilities can also monitor the water in a containment system by periodically testing for a variety of contaminants.

It may be difficult for facilities that do not require large volumes of water to reuse all the precipitationcollected in the containment system. These facilities could keep the containment systemfree of any spilled pesticides through good housekeeping practices so thatprecipitationfalling into the containment system does not become contaminated. Some facilities house their pesticide bulk storage area inside a building or under a covered area to eliminate precipitation from collecting in the containment system, as well as to protect the area from vandalism and severe weather (USEPA, 1996).

Containment Pad in the Loading/Unloading Area

Agrichemical dealers sometimes install loading/containment pads in the operation area to contain and collect any product spills that may occur during pesticide loading operations. The pad is usually installed contiguous to the bulk storage tanks and the repackaging of products into smaller containers. Facilities may also conduct all their portable cleaning operations, such as rinsing minibulk containers, directly on the pad in order to contain and collect the rinsates.

The pad is normally constructed of concrete and is sloped to a sump area. Some facilities divide the sump area into individual collection basins so that the facilities can segregate wastewaters contaminated by different products



and reuse these wastewaters for applications. For instance, facilities in the Midwest frequently have two collection basins; one basin collects wastewaters contaminated with corn herbicides and the other collects wastewaters contaminated with soybean herbicides. As part of this collection system, some facilities install one or more tanks to store wastewater until it can be applied to land, while other facilities use portable minibulk tanks to store the wastewater. When facilities collect wastewaters that must be segregated by different types of products, multiple storage tanks are used to avoid contamination (USEPA, 1996).

V. D. Energy Efficiency

Installation of a Feed-Gas Saturator

A mixture of steamand natural gas with a volumetric ratio of steam to carbon of about 3.5:1 is reacted in the primary reformer of reforming ammonia plants. Most of the steam is generated from heat sources within the plant, but the balance of the steam has to be produced in auxiliary boilers. This retrofit permits the use of low-level heat fromthe flue gases, which would otherwise be lost, to be used insaturating the feed natural gas with water. This generates extra steamwhich replaces some of the steam generated in the boiler (UNEP, 1996).

Modification of Convection Coils

As a resultofother modifications, the temperature profile of the flue gases may change considerably in the cold-leg section of the primary reformer. This change can be compensated for byreplacing the low steamsuperheat coil with a new one with additional rows of tubes and heavier fins on all tubes (UNEP, 1996).

Low-heat Removal of Carbon Dioxide

The traditional systems used for removal of carbon dioxide from the process steamuses hotpotassiumcarbonate whichrequires heatfor regeneration. This heat comes from process heat but needs to be supplemented with external steam. A new low-heat removal system is now available, which uses flashing for part of the regeneration process, and requires less external heat (UNEP, 1996).

Ammonia Synthesis Modifications

Ammonia Converter RetrofitThe vertical quench-type converters are changed from axial flow to radialflow, greatly decreasing the pressure drop across the converter which in turnallows the use of smaller size catalyst with a larger surface area. Thisimproved catalyst yields a higher conversion per pass, generating a lower



recycle volume. The lower recycle volume and the lower pressure drop resultin reduced energy requirements. This modification yields an increase effectivecapacity of the ammonia converter of about 35 percent (UNEP, 1996).

Addition of Process ComputerA dedicated process computer can be installed along with other on-lineanalysis and control systems to monitor and control key variables. With thissystem, continuous set point changes are possible to optimize the operation ofseveral plant areas such as hydrogen/nitrogen ratio, steam/carbon ratio,synthesis loop purge, methane leakage, converter control, and refrigerationpurge (UNEP, 1996).

Hydrogen Recovery from the Purge GasInert gases must be pumped fromthe plant to avoid their buildup in the system.This purge is carried out by removing a side stream of synthesis gas afterrecovering the ammonia. By installing the proper recovery system, thehydrogen in this gas mixture can be recovered decreasing the energyrequirements of the process by about five percent or permitting an increase ofabout five percent in production capacity (UNEP, 1996).


Agricultural Chemical Industry Federal Statutes and Regulations

VI. SUMMARY OF APPLICABLE FEDERAL STATUTES AND REGULATIONS

This section discusses the federal regulations that may apply to this sector.The purpose of this section is to highlight and briefly describe the applicablefederal requirements, and to provide citations for more detailed information.The three following sections are included:

C Section VI.A contains a general overview of major statutesC Section VI.B contains a list of regulations specific to this industryC Section VI.C contains a general discussion on State regulation of

pesticides C Section VI.D contains a list of pending and proposed regulatory

requirements

The descriptions withinSectionVIare intended solelyfor general information. Depending upon the nature or scope of the activities at a particular facility, these summaries may or may not necessarily describe all applicable environmental requirements. Moreover, they do not constitute formal interpretations or clarifications of the statutes and regulations. For further information, readers should consult the Code of Federal Regulations (CFR) and other state or local regulatory agencies. EPA Hotline contacts are also provided for each major statute.

VI.A. General Description of Major Statutes

Federal Insecticide, Fungicide, and Rodenticide Act

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was firstpassed in 1947, and amended numerous times, most recently by the FoodQuality Protection Act (FQPA) of 1996. FIFRA provides EPA with theauthority to oversee, among other things, the registration, distribution, sale anduse of pesticides. The Act applies to all types of pesticides, includinginsecticides, herbicides, fungicides, rodenticides, and antimicrobials. FIFRAcovers both intrastate and interstate commerce.

Establishment RegistrationSection 7 of FIFRA requires that establishments producing pesticides, oractive ingredients used in producing a pesticide subject to FIFRA, registerwith EPA. Registered establishments must report the types and amounts ofpesticides and active ingredients they produce. The Act also provides EPAinspection authority and enforcement authority for facilities/persons that arenot in compliance with FIFRA.

Product RegistrationUnder section 3 of FIFRA, all pesticides (with few exceptions) sold ordistributed in the United States must be registered by EPA. Pesticideregistration is very specific and generally allows use of the product only as



specified on the label. Each registration specifies the use site, i.e., where theproduct may be used, and amount that may be applied. The person who seeksto register the pesticide must file an application for registration. Theapplication process often requires either the citation or submission ofextensive environmental, health, and safety data.

To register a pesticide, the EPA Administrator must make a number offindings, one of which is that the pesticide, when used in accordance withwidespread and commonly recognized practice, will not generally causeunreasonable adverse effects on the environment.

FIFRA defines “unreasonable adverse effects onthe environment” as “(1) anyunreasonable risk to manor the environment, taking into account the economic,social, and environmental costs and benefits of the use of the pesticide, or (2)a humandietary risk fromresidues thatresult froma use of a pesticide in or onany food inconsistent with the standard under section408 of the Federal Food,Drug, and Cosmetic Act (21 U.S.C. 346a).”

Under FIFRA section 6(a)(2), after a pesticide is registered, the registrantmust also notify EPA of any additional facts and information concerningunreasonable adverse environmental effects of the pesticide. Also, if EPAdetermines that additional data are needed to support a registered pesticide,registrants maybe required to provide additional data. If EPA determines thatthe registrant(s) did not comply with their request for more information, theregistration can be suspended under FIFRA section 3(c)(2)(B) and section 4.

Use RestrictionsAs a part of the pesticide registration, EPA must classify the product forgeneral use, restricted use, or general for some uses and restricted for others(Miller, 1993). For pesticides that may cause unreasonable adverse effects onthe environment, including injury to the applicator, EPA may require that thepesticide be applied either by or under the direct supervision of a certifiedapplicator.

ReregistrationDue to concerns that much of the safety data underlying pesticide registrationsbecomes outdated and inadequate, in addition to providing that registrationsbe reviewed every 15 years, FIFRA requires EPA to reregister all pesticidesthat were registered prior to 1984 (section 4). After reviewing existing data,EPA may approve the reregistration, request additional data to support theregistration, cancel, or suspend the pesticide.



Tolerances and ExemptionsA tolerance is the maximum amount of pesticide residue that can be on a rawproduct and still be considered safe. Before EPA can register a pesticide thatis used on raw agricultural products, it must grant a tolerance or exemptionfroma tolerance (40 CFR sections 163.10 through163.12). Under the FederalFood, Drug, and Cosmetic Act(FFDCA), a raw agricultural product is deemedunsafe if it contains a pesticide residue, unless the residue is within the limitsof a tolerance established by EPA or is exempt from the requirement.

Cancellation and SuspensionEPA can cancel a registration if it is determined that the pesticide or itslabeling does not comply with the requirements of FIFRA or causesunreasonable adverse effects on the environment (Haugrud, 1993).

In cases where EPA believes that an “imminent hazard” would exist if apesticide were to continue to be used through the cancellation proceedings,EPA may suspend the pesticide registration through an order and thereby haltthe sale, distribution, and usage of the pesticide. An “imminent hazard” isdefined as an unreasonable adverse effect on the environment or anunreasonable hazard to the survival of a threatened or endangered species thatwould be the likely result of allowing continued use of a pesticide during acancellation process.

When EPA believes an emergency exists that does not permit a hearing to beheld prior to suspending, EPA can issue an emergency order which makes thesuspension immediately effective.

Imports and ExportsUnder FIFRA section 17(a), pesticides not registered in the United States andintended solely for export are not required to be registered provided that theexporter obtains and submits to EPA, prior to export, a statement from theforeign purchaser acknowledging that the purchaser is aware that the productis not registered in the United States and cannot be sold for use there. EPAsends these statements to the government of the importing country. FIFRA setsforth additional requirements thatmustbe metbypesticides intended solelyforexport. The enforcement policy for exports is codified in sections 40 CFRsections 168.65, 168.75, and 168.85.

Under FIFRA section 17(c), imported pesticides and devices must comply with United States pesticide law. Except where exempted by regulation or statute, imported pesticides mustbe registered. FIFRA section 17(c) requires that EPA be notified of the arrival of imported pesticides and devices. This is accomplished through the Notice of Arrival (NOA) (EPA Form 3540-1), which is filled out by the importer prior to importation and submitted to the EPA regional office applicable to the intended port of entry. United States Customs regulations prohibit the importation of pesticides without a completed NOA. The EPA-reviewed and signed form is returned to the importer for



presentation to United States Customs when the shipment arrives in the United States NOA forms can be obtained from contacts in the EPA Regional Offices or www.epa.gov/oppfead1/international/noalist.htm.

Additional information on FIFRA and the regulation of pesticides can be obtained from a variety of sources, including EPA’s Office of Pesticide Programs’ homepage at www.epa.gov/pesticides, EPA’s Office of Compl iance , Agr icu l ture and Ecosys tem Div i s ion a t http://es.epa.gov/oeca/agecodiv.htm, or The National Agriculture Compliance Assistance Center toll-free at 888-663-2155 or http://es.epa.gov/oeca/ag. Other sources include the National Pesticide Telecommunications Network toll-free at 800-858-7378 and the National Antimicrobial Information Network toll-free at 800-447-6349.

Clean Water Act

The primary objective of the Federal Water Pollution Control Act, commonly referred to as the Clean Water Act (CWA), is to restore and maintain the chemical, physical, and biological integrity of the nation's surface waters. Pollutants regulated under the CWA are classified as either “toxic” pollutants; “conventional” pollutants, such as biochemical oxygen demand (BOD), total suspended solids (TSS), fecal coliform, oil and grease, and pH; or “non-conventional” pollutants, including any pollutant not identified as either conventional or priority.

The CWA regulates both direct and “indirect” dischargers (those who discharge to publicly owned treatment works). The National Pollutant Discharge Elimination System (NPDES) permitting program (CWA section 402) controls direct discharges into navigable waters. Direct discharges or “point source” discharges are fromsources suchas pipes and sewers. NPDES permits, issued by either EPA or an authorized state (EPA has authorized 43 states and 1 territory to administer the NPDES program), contain industry-specific, technology-based and water quality-based limits and establish pollutant monitoring and reporting requirements. A facility that proposes to discharge into the nation’s waters must obtain a permit prior to initiating a discharge. A permit applicant must provide quantitative analytical data identifying the types of pollutants present in the facility’s effluent. The permit will then set forth the conditions and effluent limitations under whicha facility may make a discharge.

Water quality-based discharge limits are based on federal or state water quality criteria or standards, that were designed to protect designated uses of surface waters, suchas supporting aquatic life or recreation. These standards, unlike the technology-based standards, generally do not take into account technological feasibility or costs. Water quality criteria and standards vary from state to state, and site to site, depending on the use classification of the receiving body of water. Most states follow EPA guidelines which propose



aquatic life and human health criteria for many of the 126 priority pollutants.

Storm Water DischargesIn 1987 the CWA was amended to require EPA to establish a program toaddress storm water discharges. In response, EPA promulgated NPDESpermitting regulations for stormwater discharges. These regulations requirethat facilities with the following types of storm water discharges, amongothers, apply for an NPDES permit: (1) a discharge associated with industrialactivity; (2) a discharge from a large or medium municipal storm sewersystem; or (3) a discharge which EPA or the state determines to contribute toa violation of a water quality standard or is a significant contributor ofpollutants to waters of the United States.

The term“stormwater discharge associated with industrial activity” means a stormwater discharge fromone of 11 categories of industrial activity defined at 40 CFR section 122.26. Six of the categories are defined by SIC codes while the other five are identified through narrative descriptions of the regulated industrial activity. If the primary SIC code of the facility is one of those identified in the regulations, the facility is subject to the storm water permit application requirements. If any activity at a facility is covered by one of the five narrative categories, storm water discharges from those areas where the activities occur are subject to storm water discharge permit application requirements.

Those facilities/activities that are subject to storm water discharge permit application requirements are identified below. To determine whether a particular facility falls within one of these categories, the regulationshould be consulted.

Category i: Facilities subject to storm water effluent guidelines, new source performance standards, or toxic pollutant effluent standards.

Category ii: Facilities classified as SIC 24-lumber and wood products (except wood kitchen cabinets); SIC 26-paper and allied products (except paperboard containers and products); SIC 28-chemicals and allied products (exceptdrugs and paints); SIC 29-petroleum refining; SIC 311-leather tanning and finishing; SIC 32 (except 323)-stone, clay, glass, and concrete; SIC 33-primary metals; SIC 3441-fabricated structural metal; and SIC 373-ship and boat building and repairing.

Category iii: Facilities classified as SIC 10-metal mining; SIC 12-coal mining; SIC 13-oil and gas extraction; and SIC 14-nonmetallic mineral mining.

Category iv: Hazardous waste treatment, storage, or disposal facilities.

Category v: Landfills, land applicationsites, and opendumps that receive or have received industrial wastes.



Category vi: Facilities classified as SIC 5015-used motor vehicle parts;andSIC 5093-automotive scrap and waste material recycling facilities.

Category vii: Steam electric power generating facilities.

Category viii: Facilities classified as SIC 40-railroad transportation; SIC 41-local passenger transportation; SIC 42-trucking and warehousing (exceptpublic warehousing and storage); SIC 43-U.S. Postal Service; SIC 44-watertransportation; SIC 45-transportation by air; and SIC 5171-petroleum bulkstorage stations and terminals.

Category ix: Sewage treatment works.

Category x: Construction activities except operations that result in thedisturbance of less than five acres of total land area.

Category xi: Facilities classified as SIC 20-food and kindred products; SIC21-tobacco products; SIC 22-textile mill products; SIC 23-apparel relatedproducts;SIC 2434-wood kitchencabinets manufacturing;SIC 25-furniture andfixtures;SIC 265-paperboard containers and boxes; SIC 267-converted paperand paperboard products; SIC 27-printing, publishing, and allied industries;SIC 283-drugs; SIC 285-paints, varnishes, lacquer, enamels, and alliedproducts; SIC 30-rubber and plastics; SIC 31-leather and leather products(except leather and tanning and finishing); SIC 323-glass products; SIC 34-fabricated metal products (except fabricated structural metal); SIC 35-industrial and commercial machinery and computer equipment; SIC 36-electronic and other electrical equipment and components; SIC 37-transportation equipment (except ship and boat building and repairing); SIC38-measuring, analyzing, and controlling instruments; SIC 39-miscellaneousmanufacturing industries; and SIC 4221-4225-public warehousing and storage.

Pretreatment ProgramAnother type of discharge that is regulated by the CWA is one that goes to apubliclyowned treatment works (POTW). The national pretreatment program(CWA section 307(b)) controls the indirect discharge of pollutants to POTWsby “industrial users.” Facilities regulated under section 307(b) must meetcertain pretreatment standards. The goal of the pretreatment program is toprotect municipal wastewater treatment plants from damage that may occurwhenhazardous, toxic, or other wastes are discharged into a sewer systemandto protect the quality of sludge generated by these plants.

EPA has developed technology-based standards for industrial users of POTWs. Different standards apply to existing and new sources within each category. “Categorical” pretreatment standards applicable to an industry on a nationwide basis are developed by EPA. In addition, another kind of pretreatment standard, “local limits,” are developed by the POTW in order to



assist the POTW in achieving the effluent limitations in its NPDES permit.

Regardless of whether a state is authorized to implement either the NPDES or the pretreatment program, if it develops its own program, it may enforce requirements more stringent than federal standards.

Wetlands Wetlands, commonly called swamps, marshes, fens, bogs, vernal pools, playas, and prairie potholes, are a subset of “waters of the United States,” as defined in section 404 of the CWA. The placement of dredge and fill material into wetlands and other water bodies (i.e., waters of the United States) is regulated bythe United States Army Corps ofEngineers (Corps) under 33 CFR Part 328. The Corps regulates wetlands by administering the CWA section 404 permit programfor activities thatimpactwetlands. EPA’s authority under section 404 includes veto power of Corps permits, authority to interpret statutory exemptions and jurisdiction, enforcement actions, and delegating the section 404 program to the states.

EPA’s Office of Water, at (202) 260-5700, will direct callers with questions about the CWA to the appropriate EPA office. EPA also maintains a bibliographic database of Office of Water publications which can be accessed through the Ground Water and Drinking Water Resource Center at (202) 260-7786.

Oil Pollution Prevention Regulation Section 311(b) of the CWA prohibits the discharge of oil, in such quantities as maybe harmful, into the navigable waters of the United States and adjoining shorelines. The EPA Discharge of Oil regulation, 40 CFR Part 110, provides information regarding these discharges. The Oil Pollution Prevention regulation, 40 CFR Part112, under the authority of section 311(j) of the CWA, requires regulated facilities to prepare and implement Spill Prevention Control and Countermeasure (SPCC) plans. The intent of a SPCC plan is to prevent the discharge of oil from onshore and offshore non-transportation-related facilities. In 1990, Congress passed the Oil Pollution Act which amended section 311(j) of the CWA to require facilities that because of their location could reasonably be expected to cause “substantial harm” to the environment by a discharge of oil to develop and implement Facility Response Plans (FRP). The intent of a FRP is to provide for planned responses to discharges of oil.

A facility is SPCC-regulated if the facility, due to its location, could reasonably be expected to discharge oil into or upon the navigable waters of the United States or adjoining shorelines, and the facility meets one of the following criteria regarding oil storage: (1) the capacity of any aboveground storage tank exceeds 660 gallons, or (2) the total aboveground storage capacity exceeds 1,320 gallons, or (3) the underground storage capacity exceeds 42,000 gallons. The 40 CFR section 112.7 contains the format and content



requirements for a SPCC plan. In New Jersey, SPCC plans can be combined with DPCC plans required by the state provided there is anappropriate crossreference index to the requirements of both regulations at the front of the plan.

According to the FRP regulation, a facility can cause “substantial harm” if it meets one of the following criteria: (1) the facility has a total oil storage capacity greater than or equal to 42,000 gallons and transfers oil over water to or from vessels; or (2) the facility has a total oil storage capacity greater than or equal to 1 million gallons and meets any one of the following conditions: (i) does nothave adequate secondary containment, (ii) a discharge could cause “injury” to fish and wildlife and sensitive environments, (iii) shut down a public drinking water intake, or (iv) has had a reportable oil spill greater than or equal to 10,000 gallons in the past 5 years. Appendix F of 40 CFR Part 112 contains the format and content requirements for a FRP. The FRPs that meet EPA’s requirements canbe combined with United States Coast Guard FRPs or other contingency plans, provided there is an appropriate cross-reference index to the requirements of all applicable regulations at the front of the plan.

For additional information regarding SPCC plans, contact EPA’s RCRA, Superfund, and EPCRA Hotline, at (800) 424-9346. Additional documents and resources can be obtained from the hotline’s homepage at www.epa.gov/epaoswer/hotline. The hotline operates weekdays from 9:00 a.m. to 6:00 p.m., EST, excluding federal holidays.

Safe Drinking Water Act

The Safe Drinking Water Act (SDWA) mandates that EPA establish regulations to protect human health from contaminants in drinking water. The law authorizes EPA to develop national drinking water standards and to create a joint federal-state system to ensure compliance with these standards. The SDWA also directs EPA to protect underground sources of drinking water through the control of underground injection of fluid wastes.

EPA has developed primary and secondarydrinking water standards under its SDWA authority. EPA and authorized states enforce the primary drinking water standards that are contaminant-specific concentration limits that apply to certain public drinking water supplies. Primary drinking water standards consist of maximum contaminant level goals (MCLGs), which are non-enforceable health-based goals, and maximum contaminant levels (MCLs), which are enforceable limits set generally as close to MCLGs as possible, considering cost and feasibility of attainment.

The SDWA Underground Injection Control (UIC) program (40 CFR Parts 144-148) is a permit programwhichprotects underground sources of drinking water by regulating five classes of injection wells. The UIC permits include design, operating, inspection, and monitoring requirements. Wells used to



inject hazardous wastes must also comply with RCRA corrective action standards in order to be granted a RCRA permit, and must meet applicable RCRA land disposal restrictions standards. The UIC permit programis often state/tribe-enforced, since EPA has authorized many states/tribes to administer the program. Currently, EPA shares the UIC permit program responsibility in seven states and runs the program in 10 states and on all tribal lands.

The SDWA also provides for a federally-implemented Sole Source Aquifer program, which prohibits federal funds from being expended on projects that may contaminate the sole or principal source of drinking water for a given area, and for a state-implemented Wellhead Protection program, designed to protect drinking water wells and drinking water recharge areas.

The SDWA Amendments of 1996 require states to develop and implement source water assessment programs (SWAPs) to analyze existing and potential threats to the quality of the public drinking water throughout the state. Every state is required to submit a programto EPA and to complete all assessments within 3 ½ years of EPA approval of the program. SWAPs include: (1) delineating the source water protection area; (2) conducting a contaminant source inventory; (3) determining the susceptibility of the public water supply to contamination fromthe inventories sources; and (4) releasing the results of the assessments to the public.

EPA’s Safe Drinking Water Hotline, at (800) 426-4791, answers questions and distributes guidance pertaining to SDWA standards. The Hotline operates from 9:00 a.m. through 5:30 p.m., EST, excluding federal holidays. Visit the website at http://www.epa.gov/ogwdw for additional material.

Resource Conservation and Recovery Act

The Solid Waste Disposal Act (SWDA), as amended by the Resource Conservation and Recovery Act (RCRA) of 1976, addresses solid and hazardous waste management activities. The Act is commonly referred to as RCRA. The Hazardous and Solid Waste Amendments (HSWA) of 1984 strengthened RCRA’s waste management provisions and added Subtitle I, which governs underground storage tanks (USTs).

Regulations promulgated pursuant to Subtitle C of RCRA (40 CFR Parts 260-299) establish a “cradle-to-grave” system governing hazardous waste fromthe point of generation to disposal. RCRA hazardous wastes include the specific materials listed in the regulations (discarded commercial chemical products, designated with the code “P” or “U”; hazardous wastes from specific industries/sources, designated with the code “K”; or hazardous wastes from non-specific sources, designated with the code “F”) or materials which exhibit a hazardous waste characteristic (ignitability, corrosivity, reactivity, or toxicity and designated with the code “D”).



Entities that generate hazardous waste are subject to waste accumulation, manifesting, and recordkeeping standards. A hazardous waste facility may accumulate hazardous waste for up to 90 days (or 180 days depending on the amount generated per month) without a permit or interim status. Generators may also treat hazardous waste in accumulation tanks or containers (in accordance with the requirements of 40 CFR section262.34) without a permit or interim status.

Facilities that treat, store, or dispose of hazardous waste are generally required to obtain a RCRA permit. Subtitle C permits for treatment, storage, or disposal facilities contain general facility standards such as contingency plans, emergency procedures, recordkeeping and reporting requirements, financial assurance mechanisms, and unit-specific standards. RCRA also contains provisions (40 CFR Part 264 Subparts I and S) for conducting corrective actions which govern the cleanup ofreleases ofhazardous waste or constituents from solid waste management units at RCRA treatment, storage, or disposal facilities.

Although RCRA is a federal statute, many states implement the RCRA program. Currently, EPA has delegated its authority to implement various provisions of RCRA to 47 of the 50 states and two United States territories. Delegation has not been given to Alaska, Hawaii, or Iowa.

Most RCRA requirements are not industry specific but apply to any company that generates, transports, treats, stores, or disposes ofhazardous waste. Here are some important RCRA regulatory requirements:

C Criteria for Classification of SolidWaste DisposalFacilitiesandPractices (40 CFR Part 257) establishes the criteria for determining which solid waste disposal facilities and practices pose a reasonable probability of adverse effects onhealth or the environment. The criteria were adopted to ensure non-municipal, non-hazardous waste disposal units that receive conditionally exempt small quantity generator waste do notpresent risks to humanhealth and environment.

C Criteria for Municipal Solid Waste Landfills (40 CFR Part 258) establishes minimum national criteria for all municipal solid waste landfill units, including those that are used to dispose of sewage sludge.

• Identificationof SolidandHazardous Wastes (40 CFR Part261) establishes the standard to determine whether the material in question is considered a solid waste and, if so, whether it is a hazardous waste or is exempted from regulation.

• Standards for Generators of Hazardous Waste (40 CFR Part 262) establishes the responsibilities of hazardous waste generators including obtaining an EPA ID number, preparing a manifest, ensuring proper packaging



and labeling, meeting standards for waste accumulation units, and recordkeeping and reporting requirements. Generators can accumulate hazardous waste on-site for up to 90 days (or 180 days depending on the amount of waste generated) without obtaining a permit.

• Land Disposal Restrictions (LDRs) (40 CFR Part 268) are regulations prohibiting the disposal of hazardous waste on land without prior treatment. Under the LDRs program, materials must meet treatment standards prior to placement in a RCRA land disposal unit (landfill, land treatment unit, waste pile, or surface impoundment). Generators of waste subject to the LDRs must provide notification of such to the designated TSD facility to ensure proper treatment prior to disposal.

• Used Oil Management Standards (40 CFR Part 279) impose management requirements affecting the storage, transportation, burning, processing, and re-refining of the used oil. For parties that merely generate used oil, regulations establish storage standards. For a party considered a used oil processor, re-refiner, burner, or marketer (one who generates and sells off-specificationused oil directly to a used oil burner), additional tracking and paperwork requirements must be satisfied.

• Tanks and Containers Standards (40 CFR Part 264-265, Subpart CC) contains unit-specific standards for all units used to store, treat, or dispose of hazardous waste. Tanks and containers used to store hazardous waste with a high volatile organic concentration must meet emission standards under RCRA. Regulations require generators to test the waste to determine the concentration of the waste, to satisfy tank and container emissions standards, and to inspect and monitor regulated units. These regulations apply to all facilities who store such waste, including large quantity generators accumulating waste prior to shipment offsite.

• Underground Storage Tanks (USTs) containing petroleum and hazardous substances are regulated under Subtitle I of RCRA. Subtitle I regulations (40 CFR Part 280) contain tank design and release detectionrequirements, as well as financial responsibility and corrective action standards for USTs. The UST programalso includes upgrade requirements for existing tanks that were to be met by December 22, 1998.

• Boilers and Industrial Furnaces (BIFs) that use or burn fuel containing hazardous waste must comply with design and operating standards. BIF regulations (40 CFR Part 266, Subpart H) address unit design, provide performance standards, require emissions monitoring, and, in some cases, restrict the type of waste that may be burned.

EPA's RCRA, Superfund, and EPCRA Hotline, at (800) 424-9346, responds to questions and distributes guidance regarding all RCRA regulations. Additional documents and resources can be obtained from the hotline’s



homepage at http://www.epa.gov/epaoswer/hotline. The RCRA Hotline operates weekdays from 9:00 a.m. to 6:00 p.m., EST, excluding federal holidays.

Comprehensive Environmental Response, Compensation, and Liability Act

The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), a 1980 law commonly knownas Superfund, authorizes EPA to respond to releases, or threatened releases, of hazardous substances that may endanger public health, welfare, or the environment. The CERCLA also enables EPA to force parties responsible for environmental contamination to clean it up or to reimburse the Superfund for response or remediation costs incurred by EPA. The Superfund Amendments and Reauthorization Act (SARA) of 1986 revised various sections of CERCLA, extended the taxing authority for the Superfund, and created a free-standing law, SARA Title III, also known as the Emergency Planning and Community Right-to-Know Act (EPCRA).

The CERCLA hazardous substance release reporting regulations (40 CFR Part 302) direct the person in charge of a facility to report to the National Response Center (NRC) any environmental release of a hazardous substance which equals or exceeds a reportable quantity. Reportable quantities are listed in 40 CFR section302.4. A release report may trigger a response by EPA or by one or more federal or state emergency response authorities.

EPA implements hazardous substance responses according to procedures outlined in the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) (40 CFR Part 300). The NCP includes provisions for cleanups. The National Priorities List (NPL) currently includes approximately 1,300 sites. Both EPA and states can act at other sites; however, EPA provides responsible parties the opportunity to conduct cleanups and encourages community involvement throughout the Superfund response process.

EPA's RCRA, Superfund and EPCRA Hotline, at (800) 424-9346, answers questions and references guidance pertaining to the Superfund program. Documents and resources can be obtained from the hotline’s homepage at http://www.epa.gov/epaoswer/hotline. The Superfund Hotline operates weekdays from 9:00 a.m. to 6:00 p.m., EST, excluding federal holidays.

Emergency Planning and Community Right-To-Know Act

The Superfund Amendments and ReauthorizationAct(SARA) of 1986 created the Emergency Planning and Community Right-to-Know Act (EPCRA, also known as SARA Title III), a statute designed to improve community access to information about chemical hazards and to facilitate the development of chemical emergency response plans by state and local governments. Under EPCRA, states establish State Emergency Response Commissions (SERCs),



responsible for coordinating certain emergency response activities and for appointing Local Emergency Planning Committees (LEPCs). EPCRA and the EPCRA regulations (40 CFR Parts 350-372) establish four types of reporting obligations for facilities which store or manage specified chemicals:

• EPCRA section 302 requires facilities to notify the SERC and LEPC of the presence of any extremely hazardous substance at the facility in anamount in excess of the established threshold planning quantity. The list of extremely hazardous substances and their threshold planning quantities is found at 40 CFR Part 355, Appendices A and B.

• EPCRA section 303 requires that each LEPC develop an emergency plan. The plan must contain (but is not limited to) the identification of facilities within the planning district, likely routes for transporting extremely hazardous substances, a description of the methods and procedures to be followed by facility owners and operators, and the designation of community and facility emergency response coordinators.

• EPCRA section 304 requires the facility to notify the SERC and the LEPC in the event of a release exceeding the reportable quantity of a CERCLA hazardous substance (defined at 40 CFR Part 302) or an EPCRA extremely hazardous substance.

• EPCRA sections 311 and 312 require a facility at which a hazardous chemical, as defined by the Occupational Safety and Health Act, is present in an amount exceeding a specified threshold to submit to the SERC, LEPC and local fire department material safety data sheets (MSDSs) or lists of MSDSs and hazardous chemical inventory forms (also knownas Tier I and II forms). This information helps the local government respond in the event of a spill or release of the chemical.

• EPCRA section313 requires certaincovered facilities, includingSIC codes 20 through 39 and others, which have ten or more employees, and whichmanufacture, process, or use specified chemicals in amounts greater than threshold quantities, to submit an annual toxic chemical release report. This report, commonly known as the Form R, covers releases and transfers of toxic chemicals to various facilities and environmental media. EPA maintains the data reported in a publically accessible database known as the Toxics Release Inventory (TRI).

All information submitted pursuant to EPCRA regulations is publicly accessible, unless protected by a trade secret claim.

EPA's RCRA, Superfund, and EPCRA Hotline, at (800) 535-0202, answers questions and distributes guidance regarding the emergency planning and community right-to-know regulations. Documents and resources can be



o b t a i n e d f r o m t h e h o t l i n e ’ s h o m e p a g e a t http://www.epa.gov/epaoswer/hotline. The EPCRA Hotline operates weekdays from 9:00 a.m. to 6:00 p.m., EST, excluding federal holidays.

Clean Air Act

The Clean Air Act (CAA) and its amendments are designed to “protect and enhance the nation's air resources so as to promote the public health and welfare and the productive capacity of the population.” The CAA consists of sixsections, knownas Titles, whichdirectEPA to establishnational standards for ambient air quality and for EPA and the states to implement, maintain, and enforce these standards through a variety of mechanisms. Under the CAA, many facilities are required to obtain operating permits that consolidate their air emission requirements. State and local governments oversee, manage, and enforce many of the requirements of the CAA. CAA regulations appear at 40 CFR Parts 50-99.

Pursuant to Title I of the CAA, EPA has established national ambient air quality standards (NAAQSs) to limit levels of “criteria pollutants,” including carbonmonoxide, lead, nitrogen dioxide, particulate matter, ozone, and sulfur dioxide. Geographic areas that meet NAAQSs for a given pollutant are designated as attainment areas; those thatdo not meet NAAQSs are designated as non-attainment areas. Under section 110 and other provisions of the CAA, each state must develop a State Implementation Plan (SIP) to identify sources of air pollution and to determine what reductions are required to meet federal air quality standards. Revised NAAQSs for particulates and ozone were finalized in 1997. However, these revised NAAQSs are currently being challenged before the U.S. Supreme Court.

Title I also authorizes EPA to establish New Source Performance Standards (NSPS), which are nationally uniform emission standards for new and modified stationarysources falling within particular industrial categories. The NSPSs are based onthe pollutioncontrol technology available to that category of industrial source (see 40 CFR Part 60).

Under Title I, EPA establishes and enforces National Emission Standards for Hazardous Air Pollutants (NESHAPs), nationally uniformstandards oriented toward controlling specific hazardous air pollutants (HAPs). Section 112(c) of the CAA further directs EPA to develop a list of sources that emit any of 188 HAPs and to develop regulations for these categories of sources. To date EPA has listed 185 source categories and developed a schedule for the establishment of emission standards. The emission standards are being developed for both new and existing sources based on “maximum achievable control technology” (MACT). The MACT is defined as the control technology achieving the maximumdegree ofreductionin the emissionof the HAPs, taking into account cost and other factors.



Title II of the CAA pertains to mobile sources, such as cars, trucks, buses, and planes. Reformulated gasoline, automobile pollution control devices, and vapor recovery nozzles on gas pumps are a few of the mechanisms EPA uses to regulate mobile air emission sources.

Title IV-Aestablishes a sulfur dioxide and nitrogenoxides emissions program designed to reduce the formation of acid rain. Reduction of sulfur dioxide releases will be obtained by granting to certain sources limited emissions allowances that are set below previous levels of sulfur dioxide releases.

Title V of the CAA establishes an operating permit program for all “major sources” (and certain other sources) regulated under the CAA. One purpose of the operating permit is to include in a single document all air emissions requirements that apply to a given facility. States have developed the permit programs in accordance with guidance and regulations from EPA. Once a state program is approved by EPA, permits are issued and monitored by that state.

Title VI of the CAA is intended to protect stratospheric ozone by phasing out the manufacture of ozone-depleting chemicals and restrict their usage and distribution. Production of Class I substances, including 15 kinds of chlorofluorocarbons (CFCs), were phased out (except for essential uses) in 1996. Methyl bromide, a common pesticide, has been identified as a significant stratospheric ozone depleting chemical. The production and importation of methyl bromide, therefore, is currently being phased out in the United States and internationally. As specified in the Federal Register of June 1, 1999 (Volume 64, Number 104) and in 40 CFR Part 82, methyl bromide productionand importation will be reduced from1991 levels by25% in1999, by 50% in 2001, by 70% in 2003, and completely phased out by 2005. Some uses of methyl bromide, such the production, importation, and consumption of methyl bromide to fumigate commodities entering or leaving the United States or any state (or political subdivision thereof) for purposes of compliance with Animal and Plant Health Inspection Service requirements or with any international, federal, state, or local sanitation or food protection standard, will be exempt from this rule. After 2005, exceptions may also be made for critical agricultural uses. The United States EPA and the United Nations Environment Programme have identified alternatives to using methyl bromide in agriculture. Information on the methyl bromide phase-out, including alternatives, can be found at the EPA Methyl Bromide Phase-Out Web Site: (http://www.epa.gov/docs/ozone/mbr/mbrqa.html).

EPA's Clean Air Technology Center, at (919) 541-0800 and at the Center’s homepage at http://www.epa.gov/ttn/catc, provides general assistance and information on CAA standards. The Stratospheric Ozone Information Hotline, at (800) 296-1996 and at http://www.epa.gov/ozone, provides general information about regulations promulgated under Title VI of the CAA; EPA's EPCRA Hotline, at (800) 535-0202 and at



http://www.epa.gov/epaoswer/hotline, answers questions about accidental release prevention under CAA section 112(r); and information on air toxics can be accessed through the Unified Air Toxics website at http://www.epa.gov/ttn/uatw. In addition, the Clean Air Technology Center’s website includes recent CAA rules, EPA guidance documents, and updates of EPA activities.

Toxic Substances Control Act

The Toxic Substances Control Act (TSCA) granted EPA authority to create a regulatoryframeworkto collectdata onchemicals inorder to evaluate, assess, mitigate, and control risks which may be posed by their manufacture, processing, and use. TSCA provides a variety of control methods to prevent chemicals fromposing unreasonable risk. It is important to note that pesticides as defined in FIFRA are not included in the definition of a “chemical substance” when manufactured, processed, or distributed incommerce for use as a pesticide.

TSCA standards may apply at any point during a chemical’s life cycle. Under TSCA section 5, EPA established an inventory of chemical substances. If a chemical substance is not already on the inventory, and has not been excluded by TSCA, a premanufacture notice (PMN) must be submitted to EPA prior to manufacture or import. The PMN must identify the chemical and provide available information on health and environmental effects. If available data are not sufficient to evaluate the chemical’s effects, EPA can impose restrictions pending the development of information on its health and environmental effects. EPA can also restrict significant new uses of chemicals based upon factors such as the projected volume and use of the chemical.

Under TSCA section 6, EPA can ban the manufacture or distribution in commerce, limit the use, require labeling, or place other restrictions on chemicals that pose unreasonable risks. Among the chemicals EPA regulates under section6 authority are asbestos, chlorofluorocarbons (CFCs), lead, and polychlorinated biphenyls (PCBs).

Under TSCA section 8(e), EPA requires the producers and importers (and others) of chemicals to report information on a chemical’s production, use, exposure, and risks. Companies producing and importing chemicals can be required to report unpublished health and safety studies on listed chemicals and to collect and record any allegations of adverse reactions or any information indicating that a substance may pose a substantial risk to humans or the environment.

EPA’s TSCA Assistance Information Service, at 202 554-1404, answers questions and distributes guidance pertaining to Toxic Substances Control Act standards. The Service operates from 8:30 a.m. through 4:30 p.m., EST, excluding federal holidays.



Coastal Zone Management Act

The Coastal Zone Management Act (CZMA) encourages states/tribes to preserve, protect, develop, and where possible, restore or enhance valuable natural coastal resources such as wetlands, floodplains, estuaries, beaches, dunes, barrier islands, and coral reefs, as well as the fish and wildlife using those habitats. It includes areas bordering the Atlantic, Pacific, and Arctic Oceans, GulfofMexico, LongIsland Sound, and GreatLakes. A unique feature of this law is that participation by states/tribes is voluntary.

In the Coastal Zone Management Act Reauthorization Amendments (CZARA) of1990, Congress identified nonpoint source pollution as a major factor in the continuing degradation of coastal waters. Congress also recognized that effective solutions to nonpoint source pollution could be implemented at the state/tribe and local levels. In CZARA, Congress added section 6217 (16 U.S.C. section1455b), which calls upon states/tribes with federally-approved coastal zone management programs to develop and implement coastal nonpoint pollution control programs. The section 6217 programis administered at the federal level jointly by EPA and the National Oceanic and Atmospheric Agency (NOAA).

Section 6217(g) called for EPA, in consultation with other agencies, to develop guidance on “management measures” for sources of nonpoint source pollution in coastal waters. Under section 6217, EPA is responsible for developing technical guidance to assist states/tribes in designing coastal nonpoint pollution control programs. On January 19, 1993, EPA issued its Guidance Specifying Management Measures For Sources of Nonpoint Pollution in Coastal Waters, which addresses five major source categories of nonpoint pollution: (1) urban runoff, (2) agriculture runoff, (3) forestry runoff, (4) marinas and recreational boating, and (5) hydromodification.

Additional information on coastal zone management may be obtained from EPA’s Office of Wetlands, Oceans, and Watersheds at http://www.epa.gov/owow or from the Watershed Information Network at h t t p : / / w w w . e p a . g o v / w i n . T h e N O A A w e b s i t e a t http://www.nos.noaa.gov/ocrm/czm/ also contains additional information on coastal zone management.



VI.B. Industry Specific Requirements

The agricultural chemical industry is affected by several major federal environmental statutes. In addition, the industry is subject to numerous laws and regulations from state and local governments designed to protect health, safety, and the environment. A summary of the major federal regulations affecting the agricultural chemical industry follows.

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

Every regulation promulgated under FIFRA affects the agricultural chemical industry in some way. The FIFRA regulations are found in 40 CFR Parts 152 through 186. Each part and its title are listed below.

Part 152 -

Part 153 -

Part 154 -Part 155 -

Part 156 -

Part 157 -

Part 158 -


Part 163 -

Part 164 -

Part 166 -

Part 167 -

Part 168 -

Part 169 -

Part 170 -

Part 171 -


Part 177 -

Pesticide Registration and Classification Procedures

Registration Policies and Interpretations

Special Review Procedures Registration Standards

Labeling Requirements for Pesticides and Devices

Packaging Requirements for Pesticides and Devices

Data Requirements for Registration

Good Laboratory Practice Standards State Registration of Pesticide Products

Certification of Usefulness of Pesticide Chemicals

Rules of Practice Governing Hearings, Under FIFRA, Arising from Refusals to Register, Cancellations of Registrations, Changes of Classifications, Suspensions of Registrations and Other Hearings Called Pursuant to section 6 of the Act

Exemption of Federal and State Agencies for Use of Pesticides Under Emergency Conditions

Registration of Pesticide and Active Ingredient Producing Establishments, Submission of Pesticide Reports Statements of Enforcement Policies and Interpretations

Books and Records of Pesticide Production and Distribution

Worker Protection Standards

Certification of Pesticide Applicators

Experimental Use Permits Procedures Governing the Rescission of State Primary Enforcement Responsibility for Pesticide Use Violations

Issuance of Food Additive Regulations



Part 178 -

Part 179 -

Part 180 -

Part 185 -

Part 186 -

Objections and Requests for Hearings

Formal Evidentiary Public Hearing

Tolerances and Exemptions from Tolerances for Pesticide Chemicals in or on Raw Agricultural Commodities Tolerances for Pesticides in Food

Pesticides in Animal Feed

Please refer to the general discussion of FIFRA in Section VI.A for additionalrequirements not discussed below.

Product Registration Data RequirementsEPA requires the citation or submission of extensive environmental, health,and/or safety data during the registration application process. The categoriesof data required include the product’s chemistry; environmental fate; residuechemistry, hazards to humans, domestic animals, and nontarget organisms;spray drift characteristics; reentry protection requirements; and performance(40 CFR Part 158). Under the “product chemistry” category, applicants mustsupply technical information describing the product’s active and inertingredients, manufacturingor formulating processes and physical and chemicalcharacteristics. Data from “environmental fate” studies are used to assess theeffects of pesticide residues on the environment, including its toxicity topeople through consumption or exposure to applied areas and its effect onnontarget organisms and their habitat. Residue chemistry information includesthe expected frequency, amounts, and time of application, and test results ofresidue remaining on treated food or feed. Information under “hazards tohumans, domestic animals, and non-target organisms” includes specific testdata assessing acute, subchronic, and chronic toxicity. All studies required tobe submitted must satisfy Good Laboratory Practice (GLP) regulations (40CFR Part 160). Guidelines for studies of product chemistry, residuechemistry, environmental chemistry, hazard evaluation and occupational andresidential exposure can be found in 40 CFR Part 158.

Registration of EstablishmentsAny person producing a pesticide or device, except a custom blender,4 issubject to section 7 and 40 CFR. Part 167; and is required to register hisestablishment with EPA prior to beginning production. Foreign establishmentsalso must register with EPA if they produce a pesticidal product for import to

4 A custom blender means any establishment which provides the service of mixing pesticides to a customer’s specifications, usually a pesticide(s)-fertilizer(s), pesticide-pesticide, or a pesticide animal feed mixture, when: (1) The blend is prepared to the order of the customer and is not held in inventory by the blender; (2) the blend is to be used on the customer’s property (including leased or rented property); (3) the pesticide(s) used in the blend bears end-use labeling directions which do not prohibit use of the product in such a blend; (4) the blend is prepared from registered pesticides; (b) the blend is delivered to the end-user along with a copy of the end-use labeling of each pesticide used in the blend and a statement specifying the composition of mixture; and (6) no other pesticide production activity is performed at the establishment.



the United States. Establishments must be registered with EPA if they intendthat a substance produced will be used as an active ingredient of a pesticideor if they have actual or constructive notice that the substance will be used asan active ingredient. If a pesticide is produced for export, whether registeredor unregistered, or is produced under an experimental use permit, theproducing establishment must be registered.

In order to register an establishment with EPA, contact the EPA Regionaloffice where the establishment is located, or for a foreign establishment, theWashington, DC EPA office. The following information must be submitted onEPA Form 3540-1 when registering an establishment: (1) the name andaddress of the company; (2) the type of ownership; and (3) the name andaddress of eachproducing establishment for whichregistration is sought. Anychanges to the information provided must be submitted to EPA within thirtydays after such changes occur. Upon receiving a complete application, EPAwill assign a registration number for each listed establishment. This numbermust appear on the label.

Establishment Reporting RequirementsUnder section 7(c)and 40 CFR. section 167.85, each registered pesticideproducing establishment must submit an annual production report to EPA byMarch1 ofeachyear. Domestic establishments submit their report to the EPAregional office where the company headquarters is located. Foreignestablishment production reports are submitted to the Washington, DC EPAoffice. Custom blenders are exempt from this requirement.

The report must cover any pesticide, active ingredient, or device produced.The report, to be submitted on specific EPA forms, includes the followinginformation: (1) the name and address of the establishment; (2) the amount ofeach pesticide produced, repackaged, or relabeled in the past year; (3) theamountofeachpesticide sold, distributed, or exported in the past year;and (4)the amountof the pesticide estimated to be produced, repackaged, or relabeledin the current year. Foreign establishments only are required to submit a reporton pesticides imported into the United States.

Maintenance of RecordsAll producers of pesticides, devices, or active ingredients used in producingany pesticide must maintain records concerning the production and shipmentof each pesticide under 40 CFR Part 169. These records are independent ofother required records, including in-plant maintenance, extermination, orsanitation programs. Each establishment must maintain these records for twoyears. In addition, records on disposal methods must be maintained for 20years, as well as authorized human trials. Records containing research datamust be maintained as long as the registration is valid and the producer is inbusiness. All required records must be available if requested by an inspector.



Prior Informed Consent As part of its participation in a voluntary international programknown as the Prior Informed Consent procedure, EPA prepares the following lists of pesticides that are suspended, canceled or severely restricted. These lists were last updated by EPA in August of 1997.

A “Suspended or Canceled” pesticide is defined as a pesticide for which all registered uses have been prohibited by final government action, or for which all requests for registration or equivalent action for all uses have, for health or environmental reasons, not been granted.

C Suspended or Canceled

1. aldrin2. benzene hexachloride [BHC] (voluntary cancellation)3. 2,3,4,5-Bis(2-butylene)tetrahydro-2-furaldehyde [Repellent-11]4. bromoxynil butyrate (voluntary cancellation)5. cadmium compounds (voluntary cancellation)6. calcium arsenate (voluntary cancellation)7. captafol (voluntary cancellation)8. carbon tetrachloride9. chloranil (voluntary cancellation)

10. chlordane 11. chlordimeform (voluntary cancellation)12. chlorinated camphene [Toxaphene] (voluntary cancellation)13. chlorobenzilate (voluntary cancellation)14. chloromethoxypropylmercuric acetate [CPMA]15. copper arsenate (voluntary cancellation)16. cyhexatin (voluntary cancellation)17. DBCP18. decachlorooctahydro-1,3,4-metheno-2H-cyclobuta(cd) pentalen-2

one[chlordecone]19. DDT20. dieldrin21. dinoseb and salts22. Di(phenylmercury)dodecenylsuccinate [PMDS] (voluntary

cancellation)23. EDB24. endrin (voluntary cancellation)25. EPN (voluntary cancellation)26. ethyl hexyleneglycol [6-12] (voluntary cancellation)27. hexachlorobenzene [HCB] (voluntary cancellation)28. lead arsenate (voluntary cancellation)29. leptophos (Never received initial registration)30. mercurous chloride 31. mercuric chloride



32. mevinphos33. mirex (voluntary cancellation)34. monocrotophos (voluntary cancellation)35. nitrofen (TOK) (voluntary cancellation)36. OMPA (octamethylpyrophosphoramide)37. phenylmercury acetate [PMA]38. phenylmercuric oleate [PMO] (voluntary cancellation)39. potassium 2,4,5-trichlorophenate [2,4,5-TCP] 40. pyriminil [Vacor] (voluntary cancellation)41. safrole (voluntary cancellation)42. silvex 43. sodium arsenite44. TDE (voluntary cancellation)45. Terpene polychlorinates [Strobane] (voluntary cancellation)46. thallium sulfate47. 2,4,5-Trichlorophenoxyacetic acid [2,4,5-T]48. vinyl chloride

A “Severely Restricted” pesticide means a pesticide for which virtually all registered uses have been prohibited by final government regulatory action, but for which certain specific registered use or uses remain authorized.

C Severely Restricted

1. arsenic trioxide2. azinphos methyl3. carbofuran (voluntary cancellation)4. daminozide (voluntary cancellation)5. heptachlor6. methyl parathion7. sodium arsenate8. tributyltin compounds

Federal Food, Drug, and Cosmetics Act

Under the Federal Food, Drug, and Cosmetics Act (FFDCA), EPA setstolerances for pesticide residues in food. This authority originally belongedto the Food and Drug Administration (FDA), but was transferred when EPAwas formed in 1970. FDA still has responsibility for enforcing compliancewith the tolerances. An agricultural product is deemed unsafe under theFFDCA if it contains pesticide residues above the tolerance level establishedby EPA or if there is no tolerance, unless it is exempt fromthe requirement fortolerances.

The FFDCA also contains the Delaney Clause that bars the establishment offood additive regulations covering substances that induce cancer inhumans oranimals. Prior to the Food Quality Protection Act of 1996, this provision



applied to certain pesticide residues in processed food. With the 1996 amendments, pesticide residues are now governed bya single safety clause set forth in section 408.

Toxic Substances Control Act (TSCA)

TSCA gives EPA comprehensive authority to regulate any chemical substance whose manufacture, processing, distribution in commerce, use, or disposal may present an unreasonable risk of injury to health or the environment. EPA keeps an inventory of existing chemicals regulated under TSCA (TSCA section 8(b)). Certain chemicals are specifically excluded from the TSCA inventory, such as pesticides, as defined when manufactured, processed, or distributed in commerce for use as a pesticide under FIFRA (40 CFR section 710.2(h)(2)). However, if a chemical has multiple uses, those uses not subject to FIFRA are regulated by TSCA. In addition, certain mixtures of chemicals are exempt from TSCA (40 CFR section 710.2(h)(1)) (Landfair, 1993).

Four sections are of primary importance to the remainder of the agricultural chemical industry. Section5 mandates thatchemical companies submit to EPA pre-manufacture notices thatprovide information on health and environmental effects for each new product and test existing products for these effects (40 CFR Part720). Over 20,000 premanufacture notices have been filed. Section 4 authorizes EPA to require testing of certain substances (40 CFR Part 790). Section 6 gives EPA the authority to prohibit, limit, or ban the manufacture, process, and usage of chemicals (40 CFR Part 750). Among the chemicals EPA regulates under section 6 are asbestos, chlorofluorocarbons (CFCs), and polychlorinated biphenyls (PCBs). For certain chemicals, TSCA section 8 also imposes record-keeping and reporting requirements including substantial risk notification; record-keeping for data relative to adverse reactions; and periodic updates to the TSCA Inventory.

Resource Conservation and Recovery Act (RCRA)

The Resource Conservation and Recovery Act (RCRA) was enacted in 1976 to address problems related to hazardous and solid waste management. RCRA gives EPA the authority to establish a list of solid and hazardous wastes and to establish standards and regulations for the treatment, storage, and disposal of these wastes. Regulations in Subtitle C of RCRA address the identification, generation, transportation, treatment, storage, and disposal of hazardous wastes. These regulations are found in 40 CFR Part 124 and CFR Parts 260-279. Under RCRA, persons who generate waste must determine whether the waste is defined as solid waste or hazardous waste. Solid wastes are considered hazardous wastes if they are listed by EPA as hazardous or if they exhibitcharacteristics ofa hazardous waste: toxicity, ignitability, corrosivity, or reactivity.



Products, intermediates, and off-specification products potentially generated at agricultural chemical facilities that are considered hazardous wastes are listed in 40 CFR Part 261. Some of the handling and treatment requirements for RCRA hazardous waste generators are covered under 40 CFR Part262 and include the following: determining whatconstitutes a RCRA hazardous waste (Subpart A); manifesting (Subpart B); packaging, labeling, and accumulation time limits (Subpart C); and record keeping and reporting (Subpart D).

Many agricultural chemical facilities store some hazardous wastes at the facility beyond the accumulation time limits available to generators (e.g., 90 or 180 days). Such facilities are required to have a RCRA treatment, storage, and disposal facility (TSDF) permit(40 CFR Part 262.34). Some agricultural chemical facilities are considered TSDF facilities and are subject to a number of regulations, including but not limited to those covered under 40 CFR Part 264: contingency plans and emergency procedures (40 CFR Part 264 Subpart D); manifesting, record keeping, and reporting (40 CFR Part 264 Subpart E); use and management of containers (40 CFR Part 264 Subpart I); tank systems (40 CFR Part 264 Subpart J); surface impoundments (40 CFR Part 264 Subpart K); land treatment (40 CFR Part 264 Subpart M); corrective action of hazardous waste releases (40 CFR Part 264 Subpart S); air emissions standards for process vents of processes that process or generate hazardous wastes (40 CFR Part 264 Subpart AA); emissions standards for leaks in hazardous waste handling equipment (40 CFR Part 264 Subpart BB); and emissions standards for containers, tanks, and surface impoundments that contain hazardous wastes (40 CFR Part 264 Subpart CC).

Many agricultural chemical facilities are also subject to the underground storage tank (UST) program (40 CFR Part 280). The UST regulations apply to facilities that store either petroleum products or hazardous substances (except hazardous waste) identified under the Comprehensive Environmental Response, Compensation, and Liability Act. UST regulations address design standards, leak detection, operating practices, response to releases, financial responsibility for releases, and closure standards.

A number of RCRA wastes have been prohibited from land disposal unless treated to meet specific standards under the RCRA Land Disposal Restriction (LDR) program. The wastes covered by the RCRA LDRs are listed in 40 CFR Part 268 Subpart C and include a number of wastes that could potentially be generated at agricultural chemical facilities. Standards for the treatment and storage of restricted wastes are described in Subparts D and E, respectively.

The LDRs also apply to the use of fertilizers containing hazardous wastes. Therefore, fertilizers containing hazardous wastes that do not meet the applicable land disposal treatment standards cannot be spread on the land, with some exceptions. Specific exemptions to the use of certain recycled materials and hazardous wastes in fertilizers have been provided in 40 CFR Part 266, Subpart C - Recycled Materials Used in a Manner Constituting



Disposal. Subpart C states that products containing recyclable materials are not subject to regulation under RCRA if the recyclables are physically inseparable fromthe product or if they meet the standards of40 CFR Part 268, Subpart D “for each recyclable material (i.e., hazardous waste) that they contain.” These standards include limits on heavy metals. Subpart C also states that zinc-containing fertilizers using hazardous waste K061 (emission control dust/sludge fromthe primary production of steel in electric furnaces) which is listed as hazardous due to its hexavalent chromium, lead, and cadmium content, are not subject to the land disposal requirements.

Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) and the Superfund Amendments and Reauthorization Act of 1986 (SARA) provide the basic legal framework for the federal “Superfund” program to clean up abandoned hazardous waste sites (40 CFR Part 300 et seq.). The 1986 SARA legislation extended CERCLA taxes for five years and adopted a new broad-based corporate environmental tax, applicable to the allied chemicals (SIC 28) industry, which includes the agricultural chemical industry. In 1990, Congress passed a simple reauthorization that did not substantially change the law but extended the programauthority until 1994 and the taxing authority until the end of 1995. A comprehensive reauthorizationwas considered in1994, but not passed. Since the expiration of the taxing authority on December 31, 1995, taxes for Superfund have been temporarilysuspended. The taxes can only be reinstated by reauthorization of Superfund or an omnibus reconciliation act which could specifically reauthorize taxing authority. The allied chemical industry paid about $300 million a year in Superfund chemical feedstock taxes. Joint and several liability generally requires Potentially Responsible Parties (PRPs) to perform or pay for their fair share of cleanup costs.

Title III of the 1986 SARA amendments (also knownas Emergency Response and Community Right-to-Know Act, EPCRA) requires all manufacturing facilities, including agricultural chemical facilities, to report annual information about stored toxic substances, as well as release of these substances into the environment, to local and state governments and to the public. This is known as the Toxic Release Inventory (TRI). EPCRA also establishes requirements for federal, state, and local governments regarding emergencyplanning. In 1994, over 300 more chemicals were added to the list of chemicals for which reporting is required.

Clean Air Act (CAA)

The original CAA authorized EPA to set limits on agricultural chemical facility emissions. The new source performance standards (NSPS) for fertilizer manufacturers can be found in 40 CFR Part 60:



Subpart G -

Subpart T -

Subpart U -

Subpart V -

Subpart W -

Subpart X -

Standards of Performance for Nitric Acid Plants (40 CFR section 60.70 - 60.74)

Standards of Performance for the Phosphate Fertilizer Industry: Wet Process Phosphoric Acid Plants (40 CFR section 60.200 - 60.204)

Standards of Performance for the Phosphate Fertilizer Industry: Superphosphoric Acid Plants (40 CFR section 60.210 - 60.214)

Standards of Performance for the Phosphate Fertilizer Industry: Diammonium Phosphate Plants (40 CFR section 60.220 - 60.224)

Standards of Performance for the Phosphate Fertilizer Industry: Triple Superphosphate Plants (40 CFR section 60.230 - 60.234)

Standards of Performance for the Phosphate Fertilizer Industry: Granular Triple Superphosphate Storage Facilities (40 CFR section 60.240 - 60.244)

These standards primarily consist of emission and monitoring standards for nitrogen oxides (Nitric Acid Plants) and fluorides (Phosphatic Fertilizer Industry) .

The Clean Air Act Amendments of 1990 set National Emission Standards for Hazardous Air Pollutants (NESHAP) fromindustrial sources for 41 hazardous air pollutants to be met by 1995 and for 148 other hazardous air pollutants to be reached by 2003. National emission standards for new and existing major sources inphosphoric acid manufacturing, phosphate fertilizers production and pesticide active ingredient production are listed in 40 CFR Parts 9 and 63. 40 CFR Parts 61 and 63 contains several provisions dealing with emissions sources potentially found at an agricultural chemical facility (e.g. equipment leaks, tanks, surface impoundments, separators, and waste treatment operations) may affect the agricultural chemical industry. A number of the chemicals used and produced at agricultural chemical manufacturing and formulating facilities are hazardous air pollutants under CAA.

Under section 112(r) ofCAA, owners and operators ofstationarysources who produce, process, handle, or store substances listed under CAA section 112(r)(3) or any other extremely hazardous substance have a “general duty” to initiate specific activities to prevent and mitigate accidental releases. Since the general duty requirements apply to stationary sources regardless of the quantity of substances managed at the facility, many agricultural chemical manufacturing and formulating facilities are subject. Activities such as identifying hazards which may result from accidental releases using



appropriate hazard assessment techniques; designing, maintaining and operating a safe facility; and minimizing the consequences of accidental releases if they occur are considered essential activities to satisfy the general duty requirements. These statutory requirements have been in affect since the passage of the Clean Air Act in 1990. Although there is no list of “extremely hazardous substances,” EPA’s Chemical Emergency Preparedness and Prevention Office provides some guidance at its website: http://www.epa.gov/swercepp.html.

Also under section 112(r), EPA was required to develop a list of at least 100 substances that, in the event ofan accidental release, could cause death, injury, or serious adverse effects to human health or the environment. The list promulgated by EPA is contained in 40 CFR section 68.130 and includes acutely toxic chemicals, flammable gases and volatile flammable liquids. Under section 112(r)(7), facilities handling more than a threshold quantity (ranging from 500 to 20,000 pounds) of these substances are subject to chemical accident prevention provisions including the development and implementation of a risk management program (40 CFR sections 68.150-68.220). The requirements in 40 CFR Part 68 begin to go into effect in June 1999. Many of the chemicals on the 112(r) list are commonly handled by agricultural chemical manufacturers and formulators in quantities greater than the threshold values. Ammonia held by farmers for use as an agricultural nutrient is exempt from the chemical accident prevention provisions.

Standards in 40 CFR Part 61 Subpart R - National Emission Standards for Radon Emissions from Phosphogypsum Stacks (40 CFR sections 61.200 -61.210) deal specifically with the phosphatic fertilizer industry. The standards require monitoring and reporting of radon-222 emissions from the stacks and sets limits on the amounts of radon-222 that can be emitted into the air. EPA has also set standards for the maximum concentration of radium-226 allowed in phosphogypsum removed from stacks for use in agriculture.

Clean Water Act (CWA)

The Clean Water Act, first passed in 1972 and amended in 1977 and 1987, gives EPA the authority to regulate effluents from sewage treatment works, chemical plants, and other industrial sources into waters. The act sets standards for treatment of wastes for both direct and indirect (to a Publicly Owned Treatment Works (POTW)) discharges. EPA has set effluent guidelines for both the fertilizer manufacturing and formulating, and pesticide formulating, packaging and repackaging point source categories. The implementation of the guidelines is left primarily to the states who issue National Pollutant Discharge Elimination System (NPDES) permits for each facility (EPA has authorized 43 states to operate the NPDES program).

Effluent guidelines specific to the fertilizer manufacturing and formulating point source category are contained in 40 CFR Part 418 and are divided into



product specific effluent guidelines as follows:

Subpart A -

Subpart B -

Subpart C -

Subpart D -

Subpart E -

Subpart F -

Subpart G -

Phosphates (40 CFR section 418.10 - 418.17)

Ammonia (40 CFR section 418.20 - 418.27)

Urea (40 CFR section 418.30 - 418.36)

Ammonium Nitrate (40 CFR section 418.40 - 418.46)

Nitric Acid (40 CFR section 418.50 - 418.56)

Ammonium Sulfate (40 CFR section 418.60 - 418.67)

Mixed and Blend Fertilizer Production (40 CFR section 418.70 - 418.77)

In 1997, revised effluent guidelines were finalized for the Pesticide Formulating, Packaging and Repackaging Subcategory. These regulations replace the effluent guidelines established in 1978 for the Pesticide Formulating and Packaging Subcategory. The revised guidelines are contained in 40 CFR Part 455 and are divided into the following subcategories:

Subpart C - Pesticide Chemicals Formulating and Packaging Subcategory

Subpart E - Repackaging of Agricultural Pesticides Performed at Refilling Establishments

Each Subpart consists ofeffluent standards representing the amount of effluent reductionpossible by using either best practicable control technologies (BPT), bestconventional pollutiontechnologies (BCT), or best available technologies (BAT). The states and EPA give effect to these standards through NPDES permits that they issue to direct dischargers. BCT standards limit the discharge of conventional pollutants, while BPT and BAT standards represent successive levels of control of priority pollutants and non-conventional pollutants.

For Subcategory C, EPA established effluent limitations and pretreatment standards which allow each facility a choice of meeting a zero discharge limitation or to comply with a pollution prevention alternative that authorizes the discharge ofsome pesticide active ingredients (AIs) and priority pollutants after various pollution prevention practices are followed and treatment is conducted as needed. For Subcategory E, EPA has established a zero discharge limitation and pretreatment standard.

The Storm Water Rule (40 CFR section 122.26) requires fertilizer manufacturingand formulating and pesticide formulating facilities discharging storm water associated with industrial activities (40 CFR section 122.26 (b)(14)(ii)) to apply for NPDES permits for those discharges.



Under 40 CFR 503 Subpart B - Land Application, EPA regulates the land application of sewerage treatment sludge, which includes fertilizers derived from sewerage treatment sludge. Subpart B regulations include specific limitations on heavy metal content, as well as general operational and management standards.

VI.C. State Regulation of Pesticides

All states have their own pesticide laws and many states have their own pesticide registration requirements. States have primary use enforcement authority if EPA has determined that the state has adequate pesticide use laws and has adopted adequate procedures to enforce those laws. The EPA may enter into a cooperative agreement with a state to carry out enforcement of state laws and train and certify applicators. The FIFRA allows states to administer their own EPA-approved applicator certifications program. Also, each state is allowed to regulate the sale and use of pesticides as long as the regulations are at leastas stringent as EPA’s and the regulations do not conflict or differ from EPA’s labeling and packaging restrictions.

States typicallyrequire that fertilizer products be registered with the state and that claims made on fertilizer labels can be substantiated. States also regulate the efficacy of fertilizers through labeling requirements. State fertilizer labeling requirements typically require that the label indicate the product name, the brand and grade, the percentage ofeachnutrient (nitrogen, available phosphate, potassium, etc.), and the name and address of the registrant. Some states also require thatthe label indicate materials fromwhichthe nutrients are derived.

Additional information on specific state requirements can be obtained from the Association of American Pesticide Control Officials, Inc. (AAPCO) at: http://aapco.ceris.purdue.edu/index.html. This website contains a list of state pesticide control officials that includes contact information.



VI.D. Pending and Proposed Regulatory Requirements

FIFRA

Registration • In order to reduce the potential for groundwater contamination from

certain pesticides, EPA proposed the Ground Water Pesticide Management Plan Rule in June of 1996 (61 FR 33259). EPA is proposing to restrict the use of certain pesticides by providing states and tribes with the flexibility to protect the ground water in the most appropriate way for local conditions, through the development and use of Pesticide Management Plans (PMPs). When finalized, the regulations will likely give states and tribes the authority to develop management plans that specify risk reduction measures for the following four pesticides: atrazine, alachlor, simazine, and metolachlor. Without EPA-approved plans, use of these chemicals would be prohibited. A final rule is expected to be published in late 2000. (Contact: Arty Williams, United States EPA Office of Prevention, Pesticides and Toxic Substances, 703-305-5239)

• In response to the Food Quality Protection Act of 1996, EPA is planning to propose revisions to antimicrobial registration and classification procedures (40 CFR Part 152) that will reduce to the extent possible the review time for antimicrobial pesticides. Revisions to labeling requirements (40 CFR Part 156) and data requirements for antimicrobial registration (40 CFR Part 158) are also being proposed. The revisions are expected to be released in early 2001. This regulation would also implement some general provisions of FIFRA that pertain to all pesticides, including labeling requirements and notification procedures. (Contact: Jean Frane, United States EPA Office of Prevention, Pesticides, and Toxic Substances, 703-305-5944 and Paul Parsons, United States EPA Office of Prevention, Pesticides, and Toxic Substances, 703-308-9073)

• In order to evaluate the registrability of pesticide products, EPA is expected to propose revisions to the data requirements for FIFRA registration (40 CFR Part 158). These revisions would clarify all data requirements to reflect current practice and are expected to be published in 2001. (Contact: Jean Frane, United States EPA Office of Prevention, Pesticides, and Toxic Substances, 703-305-5944)

Use Restrictions • In May of 1991, EPA proposed amendments to the existing Restricted

Use Classification (RUC) regulations (40 CFR Part 152, Subpart I) to add criteria pertaining to the groundwater contamination potential of pesticides (56 FR 22076). The criteria would be used to determine



which pesticides should be considered for restricted use classifications to protect groundwater. A policy statement is expected to be issued in late 2000. (Contact: Joseph Hogue, United States EPA Office of Prevention, Pesticides, and Toxic Substances, 703-308-9072)

Tolerances and Exemptions • EPA expects to reassess pesticide tolerances and exemptions for raw

and processed foods established prior to August3, 1996 (40 CFR Part 180, 40 CFR Part 185, 40 CFR Part 186), to determine whether they meet the standard of the Federal Food, Drug and Cosmetic Act (FFDCA). FFDCA section 408 (q), as amended by the Food Quality Protection Act, requires that EPA conduct this reassessment on a phased 10-year schedule. For the current phased schedule, EPA is required to complete reassessments as follows: 33% by August 3, 1999, 66% by August 3, 2002, and 100% by August 3, 2006. Based on its reassessment, EPA will likely propose a series of regulatory actions to modify or revoke tolerances. (Contacts: Robert McNally, United States EPA, Office of Prevention, Pesticides and Toxic Substances, 703-308-8085 and Joseph Nevola, United States EPA Office ofPreventionPesticides and Toxic Substances, 703-308-8037)

• Regulations specifying policies and procedures under which the EPA can establish food tolerances associated with the use of pesticides under emergency exemptions (40 CFR Part 176) are expected to be finalized in late 2000. The EPA issues emergency exemptions for temporary use of pesticides where emergency conditions exist. Under FFDCA, as amended by the Food Quality Protection Act, EPA must establish time-limited tolerances for suchpesticides if the use is likely to result in residues in food. (Contact: Joseph Hogue, United States EPA Office ofPrevention, Pesticides, and Toxic Substances, 703-308-9072)

• EPA proposed a rule to adjust and update the fee structure and fee amounts for tolerance actions, which are required under FFDCA (40 CFR section 180.33). The rule is expected to finalized in late 2000. (Contact: Carol Peterson, United States EPA, Office of Prevention, Pesticides, and Toxic Substances, 703-305-6598)

• Revisions to regulations onemergencyexemptions under section 18 of FIFRA, are expected to be issued in late 2001 (40 CFR Part 166). EPA is considering revisions in four areas: 1) Options for increased authority for states to administer certain aspects of the exemption process, and/or increased use by the EPA of multi-year exemptions;2) the use ofemergencyexemptions to address pesticide resistance;3) the



possibility of granting exemptions based upon reduced risk considerations; and 4) definitions of emergency situation and significant economic loss, which would affect whether or not an exemption may be granted. (Contact: Joseph Hogue, United States EPA Office ofPrevention, Pesticides, and Toxic Substances, 703-308-9072)

Pesticide Storage and Disposal • In 1994, EPA proposed a rule, authorized under section 19 of FIFRA,

to establish standards for pesticide containers and secondary containment relating to the distribution and sale of pesticides (59 FR 6712). Standards are expected to be developed for the removal of pesticides from containers, rinsing containers, container design, container labeling, container refilling, the containment of stationary bulk containers and for the containment of pesticide dispensing areas (40 CFR Part 165, 40 CFR Part 156). A final rule is expected to be published in late 2000. (Contact: Nancy Fitz, United States EPA, Office ofPrevention, Pesticides and Toxic Substances, 703-305-7385)

Exports • The RotterdamAgreement, signed in1998, requires that certain banned

or severely restricted hazardous chemicals are subject to intensive information exchange procedures, and if an importing country decides against import, exporting countries are obligated to prohibit export to that country. Twenty-four pesticides are currently covered by the treaty. As a result of the United States signing of this treaty, EPA has drafted legislation that allows it in the future to propose revisions to its pesticide export policy. (Contact: Cathleen Barnes, United States EPA Office of Prevention, Pesticides and Toxic Substances, 703-305-7101)

Worker Protection • EPA has proposed a change to the Worker Protection Standards (WPS)

of FIFRA (40 CFR Part 170). Specifically, the glove requirements may be modified to allow glove liners to be worn inside chemically resistant gloves. The proposed rule will be finalized in 2001. (Contact: Kevin Keaney, United States EPA Office of Prevention, Pesticides and Toxic Substances, 703-305-5557)


Agricultural Chemical Industry Compliance and Enforcement History

VII. COMPLIANCE AND ENFORCEMENT HISTORY

Background

Until recently, EPA has focused muchof its attentiononmeasuring compliance with specific environmental statutes. This approach allows the Agency to track compliance with the Federal Insecticide, Fungicide, and Rodenticide Act, the Clean Air Act, the Resource Conservation and Recovery Act, the Clean Water Act, and other environmental statutes. Within the last several years, the Agency has begun to supplement single-media compliance indicators with facility-specific, multimedia indicators of compliance. In doing so, EPA is in a better position to track compliance with all statutes at the facility level, and within specific industrial sectors.

A major step inbuilding the capacity to compile multimedia data for industrial sectors was the creation of EPA's Integrated Data for Enforcement Analysis (IDEA) system. IDEA has the capacity to “read into” the Agency's single-media databases, extract compliance records, and match the records to individual facilities. The IDEA system can match Air, Water, Waste, Toxics/Pesticides/EPCRA, TRI, and Enforcement Docketrecords for a given facility, and generate a list of historical permit, inspection, and enforcement activity. IDEA also has the capability to analyze data by geographic area and corporate holder. As the capacity to generate multimedia compliance data improves, EPA will make available more in-depth compliance and enforcement information. Additionally, sector-specific measures of success for compliance assistance efforts are under development.

Compliance and Enforcement Profile Description

Using inspection, violation and enforcement data from the IDEA system, this section provides information regarding the historical compliance and enforcement activity of this sector. In order to mirror the facility universe reported in the Toxic Chemical Profile, the data reported within this section consists of records only fromthe TRI reporting universe. With this decision, the selectioncriteria are consistent across sectors with certainexceptions. For the sectors that do not normally report to the TRI program, data have been provided from EPA’s Facility Indexing System (FINDS) which tracks facilities in all media databases. Please note, in this section, EPA does not attempt to define the actual number of facilities that fall within each sector. Instead, the section portrays the records of a subset of facilities within the sector that are well defined within EPA databases.

As a check on the relative size of the full sector universe, most notebooks contain an estimated number of facilities within the sector according to the Bureau of Census (See Section II). With sectors dominated by small businesses, such as metal finishers and printers, the reporting universe within



the EPA databases may be small in comparison to Census data. However, the group selected for inclusion in this data analysis section should be consistent with this sector’s general make-up.

Following this introduction is a list defining each data column presented within this section. These values represent a retrospective summary of inspections and enforcement actions, and reflect solely EPA, state, and local compliance assurance activities that have been entered into EPA databases. To identify any changes in trends, the EPA ran two data queries, one for the past five calendar years (April 1, 1992 to March 31, 1997) and the other for the most recent twelve-month period (April 1, 1996 to March 31, 1997). The five-year analysis gives an average level of activity for that period for comparison to the more recent activity.

Because most inspections focus on single-media requirements, the data queries presented in this section are taken from single media databases. These databases do not provide data on whether inspections are state/local or EPAled. However, the table breaking downthe universe ofviolations does give the reader a crude measurement of the EPA’s and states’ efforts withineach media program. The presented data illustrate the variations across EPA regions for certain sectors.5 This variation may be attributable to state/local data entry variations, specific geographic concentrations, proximity to population centers, sensitive ecosystems, highly toxic chemicals used in production, or historical noncompliance. Hence, the exhibited data do not rank regional performance or necessarily reflect which regions may have the most compliance problems.

Compliance and Enforcement Data Definitions

General Definitions

Facility Indexing System (FINDS) -- assigns a common facility number to EPA single-media permit records. The FINDS identification number allows EPA to compile and review all permit, compliance, enforcement, and pollutant release data for any given regulated facility.

Integrated Data for Enforcement Analysis (IDEA) -- is a data integration system that can retrieve information from the major EPA program office databases. IDEA uses the FINDS identification number to link separate data records fromEPA’s databases. This allows retrieval of records from across

5 EPA Regions include the following states: I (CT, MA, ME, RI, NH, VT); II (NJ, NY, PR, VI); III (DC, DE, MD, PA, VA, WV); IV (AL, FL, GA, KY, MS, NC, SC, TN); V (IL, IN, MI, MN, OH, WI); VI (AR, LA, NM, OK, TX); VII (IA, KS, MO, NE); VIII (CO, MT, ND, SD, UT, WY); IX (AZ, CA, HI, NV, Pacific Trust Territories); X (AK, ID, OR, WA).


---


media or statutes for anygivenfacility, thus creating a “master list” of records for that facility. Some of the data systems accessible through IDEA are: AFS (Air Facility Indexing and Retrieval System, Office of Air and Radiation), PCS (Permit Compliance System, Office of Water), RCRIS (Resource Conservation and Recovery Information System, Office of Solid Waste), NCDB (National Compliance Data Base, Office ofPrevention, Pesticides, and Toxic Substances), CERCLIS (Comprehensive Environmental and Liability InformationSystem, Superfund), and TRIS (Toxic Release InventorySystem). IDEA also contains information from outside sources such as Dun and Bradstreet and the Occupational Safety and Health Administration (OSHA). Most data queries displayed in notebook sections IV and VII were conducted using IDEA.

Data Table Column Heading Definitions

Facilities in Search -- are based on the universe of TRI reporters within the listed SIC code range. For industries not covered under TRI reporting requirements (metal mining, nonmetallic mineral mining, electric power generation, ground transportation, water transportation, and dry cleaning), or industries in which only a very small fraction of facilities report to TRI (e.g., printing), the notebook uses the FINDS universe for executing data queries. The SIC code range selected for each search is defined by each notebook's selected SIC code coverage described in section II.

Facilities Inspected indicates the level of EPA and state agency inspections for the facilities in this data search. These values show what percentage of the facility universe is inspected in a one-year or five-year period.

Numberof Inspections -- measures the total number of inspections conducted in this sector. An inspection event is counted each time it is entered into a single media database.

Average Time Between Inspections -- provides an average length of time, expressed in months, between compliance inspections at a facility within the defined universe.

Facilities with One or More Enforcement Actions -- expresses the number of facilities that were the subject of at least one enforcement action within the defined time period. This category is broken down further into federal and state actions. Data are obtained for administrative, civil/judicial, and criminal enforcement actions. Administrative actions include Notices of Violation (NOVs). A facility with multiple enforcement actions is only counted once in this column, e.g., a facility with 3 enforcement actions counts as 1 facility.


--

--

--


Total Enforcement Actions describes the total number of enforcement actions identified for an industrial sector across all environmental statutes. A facility with multiple enforcement actions is counted multiple times, e.g., a facility with 3 enforcement actions counts as 3.

State LeadActions -- shows what percentage of the total enforcement actions are taken by state and local environmental agencies. Varying levels of usage by states of EPA data systems may limit the volume of actions recorded as state enforcement activity. Some states extensively report enforcement activities into EPA data systems, while other states may use their own data systems.

Federal Lead Actions shows what percentage of the total enforcement actions are taken by the United States Environmental Protection Agency. This value includes referrals fromstate agencies. Many of these actions result from coordinated or joint state/federal efforts.

Enforcement to Inspection Rate is a ratio of enforcement actions to inspections, and is presented for comparative purposes only. This ratio is a rough indicator of the relationship between inspections and enforcement. It relates the number of enforcement actions and the number of inspections that occurred within the one-year or five-year period. This ratio includes the inspections and enforcement actions reported under the Clean Water Act (CWA), the Clean Air Act (CAA) and the Resource Conservation and Recovery Act (RCRA). Inspections and actions from the TSCA/FIFRA/ EPCRA database are not factored into this ratio because most of the actions taken under these programs are not the result of facility inspections. Also, this ratio does not account for enforcement actions arising from non-inspection compliance monitoring activities (e.g., self-reported water discharges) that can result in enforcement action within the CAA, CWA, and RCRA.

Facilities with One or More Violations Identified -- indicates the percentage of inspected facilities having a violation identified in one of the following data categories: In Violation or Significant Violation Status (CAA); Reportable Noncompliance, Current Year Noncompliance, Significant Noncompliance (CWA); Noncompliance and Significant Noncompliance (FIFRA, TSCA, and EPCRA); Unresolved Violation and Unresolved High Priority Violation (RCRA). The values presented for this column reflect the extent ofnoncompliance within the measured time frame, butdo notdistinguish between the severity of the noncompliance. Violation status may be a precursor to an enforcement action, but does not necessarily indicate that an enforcement action will occur.

Media Breakdownof Enforcement Actions andInspections -- four columns identify the proportion of total inspections and enforcement actions within



EPA Air, Water, Waste, and TSCA/FIFRA/EPCRA databases. Each column is a percentage of either the “Total Inspections,” or the “Total Actions” column.

VII.A. Fertilizer, Pesticide, and Agricultural Chemical Industry Compliance History

Table 25 provides an overview of the reported compliance and enforcement data for the Fertilizer, Pesticide, and Agricultural Chemical Industryover five years fromApril 1992 to April 1997. These data are also broken out by EPA Regions thereby permitting geographical comparisons. A few points evident from the data are listed below.

C About 75 percent of agricultural chemical facility inspections and 73 percent of enforcement actions occurred inEPA Regions IV, V, VI, and VII.

C Region IX had the highest ratio of enforcement actions to inspections (0.13) and the longest average time between inspections (21 months). This indicates that fewer inspections were conducted in relation to the number of facilities in the Region, but that these inspections were more likely to result in an enforcement action than inspections conducted in other Regions.

C With the exception of Region I, in which no inspections or enforcement actions were carried out in between 1992 and 1997, Region VIII had the lowest enforcement to inspection rate (0.03).


-- --


Table 25: Five-Year Enforcement and Compliance Summary for the Fertilizer, Pesticide, and Agricultural Chemical Industry

A B C D E F G H I J

Region Facilities in Search

Facilities Inspected

Number of Inspections

Average Months Between

Inspections

Facilities with 1 or More

Enforcement Actions

Total Enforcement

Actions

Percent State Lead

Actions

Percent Federal

Lead Actions

Enforcement to Inspection

Rate

I 3 0 0 0 0 0% 0%

II 11 8 50 13 3 4 75% 25% 0.08

III 18 16 123 9 2 10 80% 20% 0.08

IV 77 44 449 10 15 41 83% 17% 0.09

V 35 23 128 16 4 7 57% 43% 0.05

VI 34 21 167 12 5 9 56% 44% 0.05

VII 43 31 225 11 8 17 71% 29% 0.08

VIII 9 5 33 16 1 1 100% 0% 0.03

IX 25 10 72 21 5 9 78% 22% 0.13

X 8 6 46 10 4 4 25% 75% 0.09

TOTAL 263 164 1,293 12 47 102 74% 26% 0.08 Source: Data obtained from EPA’s Integrated Data for Enforcement Analysis (IDEA) system in 1997.



VII.B. Comparison of Enforcement Activity Between Selected Industries

Tables 26 and 27 allow the compliance history of the agricultural chemical sector to be compared to the other industries covered by the industry sector notebooks. Comparisons between Tables 26 and 27 permit the identification of trends in compliance and enforcement records of the various industries by comparing data covering five years (April 1992 to April 1997) to that of the last year for which data were available (April 1996 to April 1997). Some points evident from the data are listed below.

C The agricultural chemical sector was inspected more frequently than most of the sectors shown (12 months on average between inspections).

C Between 1992 and 1997, the industry had a higher enforcement to inspectionrate thanmostsectors (0.08);however, in 1997 the ratio decreased to 0.05 which is lower than most sectors.

C The agricultural chemical sector had one of the highestpercentages of facilities inspected with one or more violations (97 percent) in 1997, but one of the lowest percentages of facilities with one or more enforcement actions (5 percent).

Tables 28 and 29 provide a more in-depth comparison between the Fertilizer, Pesticide, and Agricultural Chemical Industry and other sectors by breaking out the compliance and enforcement data by environmental statute. As in the previous Tables (Tables 26 and 27), the data cover the years 1992 to 1997 (Table 28) and 1997 (Table 29) to facilitate the identificationofrecent trends. A few points evident from the data are listed below.

C The percent of inspections carried out under each environmental statute has changed only slightly between the average of the years 1992 to 1997 and that of the past year. The Clean Air Act accounted for the most inspections (43 percent) during this period. This increased to almost half of all agricultural chemical facility inspections (49 percent) in 1997.

C The percent of enforcement actions taken under each environmental statute changed significantly from the 1992 to 1997 period to the past year. Enforcement actions taken under the Clean Air Act increased from 39 percent to 55 percent and enforcement actions takenunder RCRA increased from30 percent to 36 percent. At the same time, the enforcement actions taken under the Clean Water Act went from 20 percent in 1992 to 1995 to no actions in 1997.



Tab

le 2

6: F

ive-

Yea

r E

nfor

cem

ent a

nd C

ompl

ianc

e Su

mm

ary

for

Sele

cted

Ind

ustr

ies

J

Enf

orce

men

t to

Insp

ecti

on

Rat

e

0.07

0.04

0.05

0.05

0.06

0.10

0.04

0.10

0.06

0.08

0.09

0.10

0.11

0.08

0.25

0.06

0.08

0.07

0.08

0.11

0.08

0.06

0.07

0.13

0.06

0.09

0.10

0.06

I

Per

cent

F

eder

al

Lea

d A

ctio

ns

47%

11%

21%

23%

10%

30%

19%

20%

12%

26%

24%

20%

35%

26%

32%

18%

25%

29%

29%

22%

25%

20%

18%

16%

16%

39%

12%

24%

H

Per

cent

St

ate

Lea

d A

ctio

ns

53%

89%

79%

77%

90%

70%

81%

80%

88%

74%

76%

80%

65%

74%

68%

82%

75%

71%

71%

78%

75%

80%

82%

84%

84%

61%

88%

76%

G

Tot

al

Enf

orce

men

t A

ctio

ns 11

1

132

309

622 83

265 91

478

428

235

219

122

468

102

763

276

277

305

191

174

600

251

413 32

774 70

97

789

F

Fac

iliti

es w

ith

1 or

Mor

e E

nfor

cem

ent

Act

ions

63

88

149

385 53

134 65

150

238 89

93

35

153 47

124

178 97

121

113 68

365

150

253 20

375 36

48

403

E

Ave

rage

M

onth

s B

etw

een

Insp

ecti

ons 46

52

46

25

15

15

13 6 46 9 8 8 6 12 3 25

11 5 16 7 22

17

13 9 36

38

27

14

D

Num

ber

of

Insp

ecti

ons

1,60

0

3,74

8

6,07

1

12,8

26

1,46

5

2,76

7

2,37

9

4,63

0

7,69

1

3,08

7

2,43

0

1,20

1

4,29

4

1,29

3

3,08

1

4,38

3

3,47

4

4,47

6

2,53

5

1,64

0

7,91

4

4,50

0

5,91

2

243

12,9

04

816

973

14,2

10

C

Fac

iliti

es

Insp

ecte

d

378

741

1,90

2

2,80

3

267

473

386

430

2,09

2

286

263

129

355

164

148

981

388

275

424

161

1,85

8

863

927 37

3,26

3

192

231

2,16

6

B

Fac

iliti

es

in S

earc

h

1,23

2

3,25

6

4,67

6

5,25

6

355

712

499

484

5,86

2

441

329

164

425

263

156

1,81

8

615

349

669

203

2,90

6

1,25

0

1,26

0 44

7,78

6

514

444

3,27

0

A

Indu

stry

Sec

tor

Met

al M

inin

g

Coa

l M

inin

g

Oil

and

Gas

Ext

ract

ion

Non

-Met

alli

c M

iner

al M

inin

g

Tex

tile

s

Lum

ber

and

Woo

d

Fur

nitu

re

Pul

p an

d P

aper

Pri

ntin

g

Inor

gani

c C

hem

ical

s

Res

ins

and

Man

mad

e F

iber

s

Pha

rmac

euti

cals

Org

anic

Che

mic

als

Agr

icul

tura

l Che

mic

als

Pet

role

um R

efin

ing

Rub

ber

and

Pla

stic

Sto

ne,

Cla

y, G

lass

and

C

oncr

ete

Iron

and

Ste

el

Met

al C

asti

ngs

Non

ferr

ous

Met

als

Fab

rica

ted

Met

al P

rodu

cts

Ele

ctro

nics

Aut

omob

ile

Ass

embl

y

Shi

pbui

ldin

g an

d R

epai

r

Gro

und

Tra

nspo

rtat

ion

Wat

er T

rans

port

atio

n

Air

Tra

nspo

rtat

ion

Fos

sil

Fue

l E

lect

ric

Pow

er



Tab

le 2

7: O

ne-Y

ear

Enf

orce

men

t and

Com

plia

nce

Sum

mar

y fo

r Se

lect

ed I

ndus

trie

s H

Enf

orce

men

t to

Insp

ectio

n R

ate 0.

05

0.03

0.03

0.04

0.04

0.10

0.02

0.09

0.04

0.06

0.09

0.07

0.07

0.05

0.23

0.05

0.04

0.04

0.06

0.09

0.06

0.06

0.04

0.08

0.04

0.08

0.08

G

Tot

al

Enf

orce

men

t A

ctio

ns 10

22

34

91

12

52

11

74

53

31

36

14

56

11

132 41

27

34

26

28

83

43

47 4

103 11

12

F

Fac

iliti

es w

ith

1 or

mor

e E

nfor

cem

ent A

ctio

ns

Per

cent

* 6%

6%

3%

5%

6%

16%

4%

14%

3%

10%

15%

10%

16%

5%

44%

7%

7%

11%

10%

16%

7%

6%

7%

14%

5%

12%

8%

Num

ber

9 20

26

73

10

44 9 43

28

19

26 8 42 5 58

33

19

22

24

17

63

27

35 3 85

10 8

E

Fac

iliti

es w

ith

1 or

Mor

e V

iola

tion

s Per

cent

*

72%

25%

15%

26%

56%

69%

54%

78%

65%

78%

88%

105%

94%

97%

98%

83%

59%

88%

103%

91%

94%

96%

85%

86%

43%

63%

72%

Num

ber 10

2 90

127

384 96

192

136

248

577

155

152 84

243

102

129

389

151

174

240 98

796

402

431 19

681 53

69

D

Num

ber

of

Insp

ecti

ons 21

1

765

1,17

3

2,45

1

295

507

459

788

1,36

3

548

419

209

837

206

565

791

678

866

433

310

1,37

7

780

1,05

8 51

2,49

9

141

151

C

Fac

iliti

es

Insp

ecte

d

142

362

874

1,48

1

172

279

254

317

892

200

173 80

259

105

132

466

255

197

234

108

849

420

507 22

1,58

5 84

96

B

Fac

iliti

es

in S

earc

h

1,23

2

3,25

6

4,67

6

5,25

6

355

712

499

484

5,86

2

441

329

164

425

263

156

1,81

8

615

349

669

203

2,90

6

1,25

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VII.C. Review of Major Legal Actions

Major Cases/Supplemental Environmental Projects

This section provides summary information about major cases that have affected this sector, and a listofSupplemental Environmental Projects (SEPs).

VII.C.1. Review of Major Cases

As indicated in EPA’s Enforcement Accomplishments Report, FY1995 and FY1996 publications, about 17 significant enforcement actions were resolved between 1995 and 1996 for the Fertilizer, Pesticide, and Agricultural Chemical Industry.

American Cyanamid Company On June 28, 1995, Region II issued an administrative complaint against AmericanCyanamid Companyfor violations at its Lederle Laboratories facility located in Pearl River, New York. The complaint proposed assessment of a $272,424 fine for the company’s failure to submit timely TRI Form Rs for 1,1,1-trichloroethane, naphthalene, phosphoric acid, toluene, manganese compounds and zinc compounds for the reporting years 1990, 1991, 1992, and 1993.

Precision Generators, Inc. The Regional Administrator signed a consent order in the Precision Generators, Inc., a FIFRA case, in which the respondent agreed to pay the proposed penalty of $4,000. The administrative complaint cited the respondent’s sale and misbranding of its unregistered pesticide product ethylene fluid used to accelerate the ripening of fruits and vegetables. Such a product is a “plant regulator” falling within the definition of “pesticide” in FIFRA.

E.C. Geiger, Inc. On August 18, 1995, the Regional Administrator signed a consent agreement and consent order finalizing settlement of the administrative proceeding against E.C. Geiger, Inc. of Harleysville, Pennsylvania, for violations of sections 12(a)(1)(A) and (B) of FIFRA, 7 U.S.C. section 136j(a)(1)(A) and (B). The complaint alleged that during 1992, Geiger sold or distributed an unregistered and misbranded pesticide product, a rooting hormone called “Indole-3-butyric Acid-Horticultural Grade.” For these violations the complaint sought a $14,000 penalty. Geiger has agreed to pay a penalty of $8,900.

Rhone-Poulenc, Inc. Region III reached a settlement with Rhone-Poulenc, Inc., in a Part II administrative action brought for violations of RCRA boiler and industrial furnace (BIF) regulations at Rhone-Poulenc’s Institute, West Virginia plant. The settlement calls for Rhone-Poulenc to pay a penalty of over $244,000 and to undertake numerous compliance tasks.

IMC-Agrico Company On November 8, 1994, the Regional Administrator ratified a consent decree betweenthe United States and IMC-Agrico Company



concerning IMC’s violations of section 301(a) of the CWA. IMC owns and operates phosphate rock mines and associated processing facilities inFlorida and Louisiana. Eight of its mineral extraction operations located throughout Florida and its Port Sutton Phosphate Terminal located in Tampa, Florida, were the subject of this referral. The action arose out of IMC’s violation of its permit effluent limits for a variety of parameters including dissolved oxygen, suspended solids, ammonia, and phosphorous, as well as nonreporting and stormwater violations at the various facilities-over 1,500 permit violations total. The case was initiated following review of the facility discharge monitoring reports and EPA and state inspections of the sites. The consent decree settlement involved an up-front payment of $835,000 and a $265,000 Supplemental Environmental Project (SEP). The pollution prevention SEP involved converting IMC’s scrubber discharge and intake water systems into a closed loop system, greatly reducing pollution loading at the Port Sutton facility, by April 1995.

J.T. Eaton & Company, Inc. J.T. Eaton & Company, Inc. distributed and sold at least 13 unregistered pesticides (mostly rodenticides). These unregistered pesticides resulted from varying the form of the rodent bait and the packaging of several of Eaton’s registered products (e.g., registered as a bulk product) but sold in ready-to-use place packs. The company also distributed and sold a misbranded pesticide product and made inaccurate claims in advertising for another product. A stop sale, use, or removal order and an administrative complaint were issued simultaneously on March 23, 1995. The penalty assessed in the complaint was $67,500. The complaint was settled on August 25, 1995, for $40,000.

Citizens Elevator Co., Inc. Citizens Elevator Co. repackaged and distributed and sold the pesticide “Preview” in five gallon buckets, many bearing pie filling labels, to at least 24 customers, constituting the distribution and sale of an unregistered pesticide. The complaint, issued June 30, 1994, assessed a penalty of $108,000. In supplemental environmental projects for the prevention of spills of pesticides and fertilizers and the safer, more efficient storage and application of pesticides and fertilizer. The respondent spent $184,771. A consent agreement signed June 30, 1995, settled the case for $8,400.

NitrogenProducts, Inc. On September 25, 1995, a joint stipulation and order of dismissal was filed in the United States District Court for the Eastern District of Arkansas. Nitrogen Products, Inc. (NPI), agreed to pay a civil penalty of $243,600 to the United States for violations of the Clean Air Act, and Subparts A and R of 40 CFR Part 61. The foreign parent corporation, Internationale Nederlanden Bank, N.V., acquired the facility through



foreclosure and expended over $2 million to cover the phosphogypsum stack and regrade.

Micro Chemical, Inc. The illegal transportation of hazardous waste by a Louisiana pesticide formulation company, Micro Chemical, Inc., to an unpermitted disposal facility inviolationofRCRA resulted ina $500,000 fine, five years of probation, and compliance with corrective action measures contained in a corrective action administrative order on consent. In March 1990, Micro Chemical transported 100 cubic yards of hazardous waste from its facility to a field in Baskin, Louisiana-a location that did not have a RCRA permit. After its discovery, it was removed under the Louisiana Department of Agriculture’s guidance. Micro Chemical has taken measures to stabilize and prevent the spread of pesticide contamination from the Micro Chemical facility site, as required by a RCRA 3008(h) corrective action administrative order on consent. The order will result in the removal of all contaminated soil at the site, and the remediation of all off-site contamination that has migrated into a drainage basin located adjacent to the site.

Chempace Corporation OnSeptember 26, 1996, RegionVPTES filed a civil administrative complaint against Chempace corporation of Toledo, Ohio alleging 99 counts for the distribution or sale of unregistered and misbranded pesticides, and pesticide productionin unregistered establishments. The total proposed penalty in the complaint is $200,000. The case is significant in that Chempace had, previous to the complaint, canceled all of the company’s pesticide productregistrations pursuant to section 4 of FIFRA, as well as their establishment registration pursuant to section 7. However, the company continued to produce and sell those canceled pesticides in a facility that was not registered.

Northrup King Co. On September 30, 1996, as a result of a FIFRA inspection conducted byRegionVonMarch27-28, 1996, Region V issued a FIFRA civil complaint to Northrup King Co. of Golden Valley, Minnesota. The pesticide involved in the case is a genetically engineered corn seed that protects against the corn borer. Because this case is the first FIFRA complaint involving a genetically engineered pesticide, the case is nationally significant. The complaint alleged 21 counts of sale and distribution of an unregistered pesticide, 21 counts for failure to file a Notice of Arrival for pesticide imports, and 8 counts of pesticide production in unregistered establishments, for a total proposed penalty of $206,500. A consent agreement and consent order was filed simultaneously with, and in resolution of the complaint. The respondent agreed to pay $165,200, which is the largest penalty collected by Region V under FIFRA.

Micro Chemical. Micro Chemical is a pesticide formulating, mixing, and packaging facility 3,000 feetup gradient of the Winnsboro’s groundwater well complex. In March 1990, a release from the facility was reported by a citizen. Investigations revealed that the company had attempted to dump 100 cubic yards of pesticide contaminated soil offsite. People living near the dump site



became ill from the fumes and the state ordered the soil to be returned to Micro Chemical. Ultimately a criminal case was initiated for the midnight dumping. Other storage violations detected were the subject of an administrative complaint issued in September 1992. A RCRA 3008(h) order on consent was entered into on September 1994 to remediate the site. In resolving the September 1992 complaint, a final order was issued on March 28, 1996. Micro Chemical agreed to pay a penalty of $25,000 and agreed to fund a SEP valued at $25,000. The SEP established collection events for household waste and waste pesticides in the Franklin Parish area. During FY96, the SEP enabled about 100 tons of waste to be collected and properly disposed.

Terra Industries, Inc. At the request of the Chemical Emergency Prevention and Preparedness Office (CEPPO), and in accordance with section 112(r) of the CAA, EPA released the results of its investigation into the cause of an explosion of the ammonium nitrate plant at this nitrogen fertilizer manufacturing facility. The report released in January 1996 identifies numerous unsafe operating procedures at the plant as contributing factors to the explosion, and recommends certain standard operating procedures which would help prevent similar occurrences at ammonium nitrate production facilities.

The Terra explosion occurred on December 13, 1994, killing four individuals and injuring 18 others. It also resulted in the release of approximately 5,700 tons of anhydrous ammonia to the air and approximately 25,000 gallons of nitric acid to the ground and required evacuation over a two-state area of over 2,500 persons from their homes.

In a subsequent action, an administrative civil complaint alleging violations of EPCRA sections 213 and 313, and section 8(a) of TSCA, was filed citing that Terra International failed to submit Toxic Release Inventory (TRI) information to EPA in a timely manner, and data submitted to EPA by Terra failed to include releases of more than 17 million pounds of toxic chemicals to the environment on-site.

Pfizer/AgrEvo Reporting of unreasonable adverse effects information is required under FIFRA section 6(a)(2), and failure to submit such reports has resulted in a $192,000 settlement involving AgrEvo Environmental Health, Inc. and Pfizer, Inc. The case arose in early 1994 after an individual reported disabling neurological symptoms and chemical sensitivity after using RID products to kill lice. The ensuing EPA investigation revealed numerous additional unreported incidents involving RID which is manufactured by AgrEvo and distributed by Pfizer. EPA amended the complaint charging 24 counts against each company. FIFRA 6(a)(2) requires pesticide registrants to submit to EPA any additional information (beyond that submitted in the pesticide registration process) that they have regarding unreasonable adverse effects of their pesticides onhumanhealth or the environment. The information is used by the Agency in the determination of risks associated with pesticides.



Rohm and Haas Company This complaint cited Rohm and Haas for 66 violations under FIFRA section 12(a)(1)(c), for the distribution or sale of a registered pesticide the composition of which differed from the composition as described in its registration under FIFRA section 3. EPA registers pesticides based upon the accurate assessment of components used in the manufacture of the product. Use of an unapproved formula can lead to production of a pesticide for whichno assessment of risk has been determined or result in unknown synergistic effects. Following settlement negotiations, and in accordance with the FIFRA Enforcement Response Policy, the original penalty of $330,000 was reduced to $118,800, based on a 20% reduction to the gravity level, a 40% reduction for immediate self-disclosure, mitigation, and corrective actions, and a 15% reduction for good attitude, cooperation, and efforts to comply with FIFRA.

VII.C.2. Supplementary Environmental Projects (SEPs)

SEPs are compliance agreements that reduce a facility’s non-compliance penalty in return for an environmental project that exceeds the value of the reduction. Often, these projects fund pollution prevention activities that can reduce the future pollutant loadings of a facility. Information on SEP cases can be accessed via the Internet at http://es.epa.gov/oeca/sep.


Agricultural Chemical Industry Activities and Initiatives

VIII. COMPLIANCE ASSURANCE ACTIVITIES AND INITIATIVES

This section highlights the activities undertaken by this industry sector and public agencies to voluntarily improve the sector’s environmental performance. These activities include those initiated independently by industrial trade associations. In this section, the notebook also contains a listing and description of national and regional trade associations.

VIII.A. Sector-Related Environmental Programs and Activities

National Agricultural Compliance Assistance Center (Ag Center)

EPA's Office of Compliance, with the support from the United States Department of Agriculture (USDA), developed EPA’s National Agriculture Compliance Assistance Center (Ag Center). The Ag Center offers comprehensive, easy-to-understand information about approaches to compliance that are both environmentally protective and agriculturallysound.

The Ag Center focuses on providing information about EPA’s own requirements. In doing so, the center relies heavily on existing sources of agricultural informationand established distribution channels. Educational and technical informationon agricultural production is provided bythe USDAand other agencies, but assistance in complying with environmental requirements has not traditionally been as readily available. The Ag Center is currently working with USDA and other federal and state agencies to provide the agricultural community, including regional and state regulatoryagencies, with a definitive source for federal environmental compliance information. The Ag Center offers information on a variety of topics, including the following:

• Pesticides • Animal waste management • Emergency planning and response • Groundwater and surface water • Tanks / containment • Solid / hazardous waste

Through a toll-free telephone number and a website that is regularly updated and expanded, the Ag Center offers a variety of resources including:

• current news, compliance policies and guidelines, pollution prevention information, sources of additional information and expertise, and summaries of regulatory initiatives and requirements

• user-friendly materials that consolidate informationabout compliance requirements, pollutionprevention, and technical assistance resources for use by regional and state assistance and educational programs, trade associations, businesses, citizens, and local governments



• agriculture-related information on reducing pollution and using the latest pollution prevention methods and technologies

• information on ways to reduce the costs of meeting environmental requirements, including identification of barriers to compliance

The Ag Center's toll-free number is 1-888-663-2155 and the website address is: http://es.epa.gov/oeca/ag/

National Pesticide Information Retrieval System (NPIRS)

Purdue University has developed a collection of databases through their Center for Environmental and Regulatory Information Systems, one of which is the National Pesticide Information Retrieval System. NPIRS is a collection of six databases related to pesticides, including product registration document information, data submitter information, residue tolerances, fact sheets, material safety data sheets, and the daily federal register. Full search access to the NPIRS databases is by annual subscription.

Association of American Plant Food Control Officials (AAPFCO) Label Recommendations

The AAPFCO is considering a set of recommendations issued by a task force of fertilizer producers and state officials. These recommendations call for labeling and standards for non-nutrient constituents in fertilizer and directions that will allow users to apply fertilizers at a rate that will not exceed these standards. One proposed addition to labels is to list all raw materials, including recycled wastes; however, the concentration of these materials will not be required (ARA, 1997).

Agricultural Research Institute

ARI was founded in 1951 as a part of the National Academy of Sciences, then incorporated separately in 1973. ARI analyzes agricultural problems and promotes research by its members to solve them. ARI publishes annual meeting minutes, a directory, books, pamphlets, and newsletters.

National Association of State Departments of Agriculture (NASDA)

NASDA was founded in 1916 by directors ofstate and territorial departments ofagriculture to coordinate policies, procedures, laws, and activities between the states and federal agencies and Congress. NASDA conducts research, holds a trade show, and distributes several bulletins, newsletters, and directories.

ChemAlliance

EPA’s Office of Compliance developed ChemAlliance, a new Compliance Assistance Center for the chemical industry. Among its features is an exciting “expert help,” which offers an interactive guide to finding compliance



resources specific to a user’s needs. Take a “virtual plant tour” to find out which regulations apply to your company’s operations by clicking on a detailed chemical plant illustration. ChemAlliance can be reached at 1-800-672-6048; its web site is located at . http://www.chemalliance.org,

VIII.B. EPA Voluntary Programs

Pesticide Environmental Stewardship Program (PESP)

The Pesticide Environmental Stewardship Program(PESP) is a broad effort by EPA, USDA, and the FDA to reduce pesticide use and risk in both agriculture and nonagricultural settings. In September 1993, the three agencies announced a federal commitment to two major goals: 1) developing specific use/risk reduction strategies thatinclude reliance on biological pesticides and other approaches to pestcontrol that are thought to be safer than traditional chemical methods, and 2) by the year 2000, having 75 percent of United States agricultural acreage adopt integrated pest management programs.

A key part of the PESP is the public/private partnership which began when EPA, USDA, and FDA announced the partnership and more than 20 private organizations signed on as charter members. All organizations with a commitment to pesticide use/risk reduction are eligible to join the PESP, either as Partners or Supporters. The PESP program has 35 partners. Together, these partners represent at least 45,000 pesticide users. The program has a goal of adding 35 new partners per year.

33/50 Program

The 33/50 Program is a ground breaking program that has focused on reducing pollution fromseventeen high-priority chemicals through voluntary partnerships with industry. The program’s name stems from its goals: a 33% reduction in toxic releases by 1992, and a 50% reduction by 1995, against a baseline of 1.5 billion pounds of releases and transfers in 1988. The results have been impressive: 1,300 companies have joined the 33/50 Program (representing over 6,000 facilities) and have reached the national targets a year ahead of schedule. The 33% goal was reached in 1991, and the 50% goal -- a reduction of 745 million pounds of toxic wastes -- was reached in 1994. The 33/50 Program can provide case studies on many of the corporate accomplishments in reducing waste (Contact 33/50 ProgramDirector David Sarokin -- 202-260-6396).

Table 30 lists those companies participating in the 33/50 program that reported the SIC codes 2873, 2874, 2875, and 2879 to TRI. Some of the companies shown also listed facilities that are notproducing agricultural chemicals. The number of facilities within each company that are participating in the 33/50 program and that report SIC codes 2873, 2874, 2875, and 2879 is shown. Where available and quantifiable against 1988 releases and transfers, each company’s 33/50 goals for 1995 and the actual total releases and transfers and percent reduction between 1988 and 1995 are presented. Eleven of the seventeen target chemicals were reported to TRI by agricultural chemical facilities in 1995.



Table 30 shows that 24 companies comprised of 78 facilities reporting SIC 287 participated in the 33/50 program. For those companies shown with more than one agricultural chemical facility, all facilities may not have participated in 33/50. The 33/50 goals shown for companies with multiple facilities, however, were company-wide, potentially aggregating more than one facility and facilities not carrying out agricultural chemical operations. In addition to company-wide goals, individual facilities within a company may have had their own 33/50 goals or may have been specifically listed as not participating in the 33/50 program. Since the actual percent reductions shownin the lastcolumn applyto onlythe companies’ agricultural chemical facilities, direct comparisons to those company goals incorporating non-agricultural chemical facilities or excluding certainfacilities maynotbe possible. For information on specific facilities participating in 33/50, contact David Sarokin (202-260-6907) at the 33/50 Program Office.


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Table 30: Fertilizer, Pesticide, and Agricultural Chemical Industry Participation in the 33/50 Program

Parent Company (Headquarters Location)

Company-Owned Facilities Reporting

33/50 Chemicals

Company- Wide % Reduction Goal1

(1988 to 1995)

1988 TRI Releases and Transfers of 33/50 Chemicals

(pounds)2

1995 TRI Releases and Transfers of 33/50 Chemicals

(pounds)2

% of Change per Facility (1988-1995)

AMERICAN HOME PRODUCTS CORP. MADISON, NJ

2 49 47,950 73,876 -54

ARCADIAN CORP. MEMPHIS, TN

6 0 4,340 10,127 -133

BAY ZINC CO. INC. MOXEE CITY, WA

1 50 77,250 252 100

CHEM-TECH LTD. DES MOINES, IA

1 90 800 0 100

CHEVRON CORP. SAN FRANCISCO, CA

3 50 8,746 0 100

CONAGRA INC. OMAHA, NE

6 8 17,086 5,238 69

E.I. DU PONT DE NEMOURS & CO WILMINGTON, DE

2 50 144,412 440,370 -205

ELF AQUITAINE INC. NEW YORK, NY

1 49 3,068 0 100

FIRST MISSISSIPPI CORP. JACKSON, MS

7 0 701,144 214,334 69

FMC CORPORATION CHICAGO, IL

5 50 6,190 2,339 62

GLAXO WELLCOME INC. RESEARCH TRIANGLE PARK, NC

1 37 1,125 0 100

GOWAN COMPANY YUMA, AZ

1 0 0 2,207

IMC FERTILIZER GROUP INC. NORTHBROOK, IL

7 0 56,350 51,548 9

ISK AMERICAS INC. ATLANTA, GA

2 50 884,412 726,713 18

LAROCHE HOLDINGS INC. ATLANTA, GA

1 0 17,590 0 100

MALLINCKRODT GROUP INC. SAINT LOUIS, MO

1 44 0 0

MILES INC. PITTSBURGH, PA

1 38 39,822 6,650 83

MONSANTO COMPANY SAINT LOUIS, MO

1 23 0 1,260

RHONE-POULENC INC. MONMOUTH JUNCTION, NJ

21 50 3,128,263 1,392,117 55

SC JOHNSON & SON INC. RACINE, WI

1 50 19,086 20,096 -5

SANDOZ CORPORATION NEW YORK, NY

3 50 207,086 87,000 58

TALLEY INDUSTRIES PHOENIX, AZ

1 0 8,243 2,289 72

UNIVERSAL COOPERATIVES INC. MINNEAPOLIS, MN

1 70 17,750 1,265 93

UNOCAL CORPORATION LOS ANGELES, CA

2 50 0 9

Total 78 5,390,713 3,037,690 44

Source: United States EPA 33/50 Program Office, 1997. 1 Company-Wide Reduction Goals aggregate all company-owned facilities which may include facilities not producing agricultural chemicals. 2 Releases and Transfers are from facilities only. 1995 33/50 TRI data were not available at time of publication. * = Reduction goal not quantifiable against 1988 TRI data. ** = Use reduction goal only. *** = No numeric reduction goal.



Project XL

Project XL was initiated in March 1995 as a part of President Clinton’s Reinventing Environmental Regulation initiative. The projects seek to achieve cost effective environmental benefits byproviding participants regulatoryflexibility onthe condition that they produce greater environmental benefits. EPA and programparticipants will negotiate and sign a Final Project Agreement, detailing specific environmental objectives that the regulated entity shall satisfy. EPA will provide regulatory flexibility as an incentive for the participants’ superior environmental performance. Participants are encouraged to seek stakeholder support from local governments, businesses, and environmental groups.

There have been at least two Project XL proposals relating to fertilizer production, however both of these have been either rejected or withdrawn. PCS Nitrogen(formerlyArcadianFertilizer) had proposed to reuse stockpiled phosphogypsumas an ingredient in a soil enhancer. Another proposal by Dow Chemical Company in Louisiana was to trade off equipment leak reductions for relief from some emissions control, monitoring, reporting and record-keeping requirements.

EPA hopes to implement fifty pilot projects in four categories, including industrial facilities, communities, and government facilities regulated byEPA. Applications will be accepted on a rolling basis. For additional information regarding XL projects, including application procedures and criteria, see the May 23, 1995 Federal Register Notice. (Contact: Fax-on-Demand Hotline 202-260-8590, Web: http://www.epa.gov/ProjectXL, or Christopher Knopes at EPA’s Office of Policy, Planning and Evaluation 202-260-9298)

Climate Wise Program

EPA’s ENERGYSTAR Buildings Program is a voluntary, profit-based program designed to improve the energy-efficiency in commercial and industrial buildings. Expanding the successful GreenLights Program, ENERGY STAR Buildings was launched in 1995. This programrelies ona 5-stage strategy designed to maximize energy savings thereby lowering energy bills, improving occupant comfort, and preventing pollution -- all at the same time. If implemented in every commercial and industrial building in the United States, ENERGY STAR Buildings could cut the nation’s energy bill by up to $25 billion and prevent up to 35% of carbon dioxide emissions. (This is equivalent to taking 60 million cars of the road). ENERGY STAR Buildings participants include corporations; small and medium sized businesses; local, federal and state governments; non-profit groups; schools; universities; and health care facilities. EPA provides technical and non-technical support including software, workshops, manuals, communication tools, and an information hotline. EPA’s Office of Air and Radiation manages the operation of the ENERGY STAR Buildings Program. (Contact: Green Light/Energy Star Hotline at 1-888-STAR-YES or Maria Tikoff Vargas, EPA Program



Director at 202-233-9178 or visit the ENERGY STAR Buildings Program website at http://www.epa.gov/appdstar/buildings/)

Green Lights Program

EPA’s Green Lights program was initiated in 1991 and has the goal of preventing pollution by encouraging United States institutions to use energy-efficient lighting technologies. The program saves money for businesses and organizations and creates a cleaner environment by reducing pollutants released into the atmosphere. The program has over 2,345 participants which include major corporations, small and medium sized businesses, federal, state and local governments, non-profit groups, schools, universities, and health care facilities. Each participant is required to survey their facilities and upgrade lighting wherever it is profitable. As of March 1997, participants had lowered their electric bills by $289 million annually. EPA provides technical assistance to the participants through a decision support software package, workshops and manuals, and an information hotline. EPA’s Office of Air and Radiation is responsible for operating the Green Lights Program. (Contact: Green Light/Energy Star Hotline at 1-888-STARYES or Maria Tikoff Vargar, EPA Program Director, at 202-233-9178)

WasteWi$e Program

The WasteWi$e Program was started in 1994 by EPA’s Office of Solid Waste and Emergency Response. The program is aimed at reducing municipal solid wastes by promoting waste prevention, recycling collection and the manufacturing and purchase of recycled products. As of 1997, the program had about 500 companies as members, one third of whom are Fortune 1000 corporations. Members agree to identify and implement actions to reduce their solid wastes setting waste reduction goals and providing EPA with yearly progress reports. To member companies, EPA, in turn, provides technical assistance, publications, networking opportunities, and national and regional recognition. (Contact: WasteWi$e Hotline at 1-800-372-9473 or Joanne Oxley, EPA Program Manager, 703-308-0199)

NICE3

The United States Department of Energy is administering a grant program called The National Industrial Competitiveness through Energy, Environment, and Economics (NICE3). By providing grants of up to 45 percent of the total project cost, the program encourages industry to reduce industrial waste at its source and become more energy-efficient and cost-competitive through waste minimizationefforts. Grants are used by industry to design, test, and demonstrate new processes and/or equipment with the potential to reduce pollution and increase energy efficiency. The program is open to all industries; however, priority is given to proposals from participants in the forest products, chemicals, petroleum refining, steel, aluminum, metal casting and glass manufacturing sectors. (Contact: http//www.oit.doe.gov/access/ nice3, Chris Sifri, DOE, 303-275-4723 or Eric Hass, DOE, 303-275-4728)



Design for the Environment (DfE)

DfE is working with several industries to identify cost-effective pollution prevention strategies that reduce risks to workers and the environment. DfE helps businesses compare and evaluate the performance, cost, pollutionpreventionbenefits, and human health and environmental risks associated with existing and alternative technologies. The goal of these projects is to encourage businesses to consider and use cleaner products, processes, and technologies. For more information about the DfE Program, call (202) 260-1678. To obtain copies of DfE materials or for general information about DfE, contact EPA’s Pollution Prevention Information Clearinghouse at (202) 260-1023 or visit the DfE Website at http://es.inel.gov/dfe.

VIII.C. Trade Association/Industry Sponsored Activity

VIII.C.1. State Advisory Groups

Association of American Pesticide Control Officials (AAPCO)P.O. Box 1249 Members: 55Hardwick, VT 05843 Staff: 1Phone: 802-472-6956Fax: 802-472-6957E-mail: [email protected]

Formed in 1947, the Association of American Pesticide Control Officials(AAPCO) consists of state and federal pesticide regulatory officials. Allfederal and provincial Canadian officials, officials of all North Americancountries involved with the regulation of pesticides may be members ofAAPCO as well. AAPCO holds meetings twice a year and publishes anannual handbookthat contains uniform policies and model pesticide legislationthat the association has adopted.

AAPCO aims to promote uniformand effective state legislation and pesticideregulatory programs. Its other objectives are to develop inspectionprocedures, to promote labeling and safe use of pesticides, to provideopportunities for members to exchange information, and to work with industryto promote the usefulness and effectiveness of pesticide products.

State FIFRA Issues Research and Evaluation Group (SFIREG)P.O. Box 1249 Members: Hardwick, VT 05843 10 state representativesPhone: 802-472-6956Fax: 802-472-6957E-mail: [email protected]

The State FIFRA Issues Research and Evaluation Group evolved in 1978 out



of a cooperative agreement between the EPA’s Office of Pesticide Programs (OPP) and the Association of American Pesticide Control Officials (AAPCO). SFIREG is an independent but related body of AAPCO that provides state comments to the Office of Pesticide Programs on issues relating to the manufacture, use and disposal of pesticides. Its membership is comprised of ten state representatives, who represent and are selected by the states in each of the ten EPA Regions.



VIII.C.2. Trade Associations

Association of American Plant Food Control Officials (AAPFCO) University of Kentucky Members: 200 Division of Regulatory Services 103 Regional Services Building Lexington, KY 40546-0275 Phone: 606-257-2668

606-257-2970 Fax: 606-257-7351

The AAPFCO is an organization of state fertilizer control officials from the United States and Canada who are involved in the administration of fertilizer regulations and laws. The AAPFCO’s purpose is to achieve uniformity throughout their membership with regards to promoting effective legislation, adequate sampling, accurate labeling, and safe use of fertilizers, as well as to study and discuss relevant issues.

Agricultural Retailers Association (ARA) 11701 Borman Dr., Ste. 110 Members:1,100

Staff: 17St. Louis, MO 63146 Phone: 800-844-4900 Fax: 314-567-6808

The Agricultural Retailers Association was founded in 1954 and is made up ofdealers, manufacturers, and suppliers of fluid fertilizers and agrichemicals, as well as equipment manufacturers, retail affiliations, and state association affiliates. ARA was formerly known as the National Nitrogen Solutions Association. Their publications include Agricultural Retailers Association-Membership Directory and Buyer’s Guide (annual), Connections, a bimonthly newsletter, and the Fluid Fertilizer Manual.

Fertilizer Industry Round Table (FIRT) 5234 Glen Arm Rd. Nonmembership Glen Arm, MD 21057 Phone: 410-592-6271 Fax: 410-592-5796

The Fertilizer Industry Round Table was founded in 1951. Participants include production, technical, and researchpersonnel in the fertilizer industry. FIRT acts as a forum for discussion of technical and production problems. They hold an annual meeting and publish the proceedings.



The Fertilizer Institute (TFI)501 2nd St., NEWashington, DC 20002Phone: 202-675-8250 Fax: 202-544-8123

Members: 300 Staff: 22

The Fertilizer Institute was founded in 1970 and now has 48 affiliated groups.Members include producers, manufacturers, retailers, trading firms, andequipment manufacturers. TFI represents members in various legislative,educational, and technical areas, and provides information and public relationsprograms. Publications include: Directory of Fertilizer References, annual;Fertilizer Facts and Figures, annual; Fertilizer Institute--Action Letter,monthly; Fertilizer Record, periodic.

Chemical Manufacturers Association (CMA)1300 Wilson Blvd. Members: 185Arlington, VA 22209 Staff: 280Phone: 703-741-5000Fax: 703-741-6000

The Chemical Manufacturers Association was founded in 1872 and now hasa budget of $36 million. CMA conducts advocacy and administers researchareas of broad import to chemical manufacturing, such as pollution preventionand other special research programs. CMA also conducts committee studies,operates the Chemical Emergency Center (CHEMTREC) for guidance toemergency service on handling emergencies involving chemicals and theChemical Reference Center which offers health and safety information aboutchemicals to the public. Publications include semi-monthly newsletters,ChemEcology and CMA News, and the CMA Directory and User’s Guide.

Chemical Specialties Manufacturers Association (CSMA)1913 Eye St., NW Members: 425Washington, DC 20006 Staff: 31Phone: 202-872-8110Fax: 202-872-8114

The Chemical Specialties Manufacturers Associationwas founded in 1914 andis made up of manufacturers, marketers, formulators, and suppliers ofhousehold, industrial, and personal care chemical specialty products such aspesticides, cleaning products, disinfectants, sanitizers, and polishes. CSMAserves as a liaison to federal and state agencies and public representatives,provides information and sponsors seminars on governmental activities andscientific developments.



American Crop Protection Association (ACPA)1156 15th St., NW, Ste. 400 Members: 82Washington, DC 20005 Staff: 29Phone: 202-296-1585Fax: 202-463-0474

The AmericanCrop Protection Association was founded in 1933 and now has a budget of $7 million. Members include companies involved in producing or formulating agricultural chemical products including agricultural fumigants, agricultural scalicides, chemical plant sprays and dusts, defoliants, soil disinfectants, weed killers, and others. It is comprised of legislative, regulatoryand science departments and publishes a periodic bulletin, manuals, Growing Possibilities, quarterly, and This Week and Next, weekly.

Western Crop Protection Association (WCPA) 3835 N. Freeway Blvd. Ste. 140 Members: 170

Staff: 6Sacramento, CA 95834 Phone: 916-568-3660 Fax: 916-565-0113

The WCPA is a regional organization of manufacturers, formulators, distributors, and dealers of basic pesticide chemicals and suppliers of solvents, diluents, emulsifiers, and containers. They are affiliated with the American Crop Protection Association. They publish several bulletins and periodicals.

National Pest Control Association (NPCA) 8100 Oak St. Members: 2,300

Staff: 21Dunn Loring, VA 22027 Phone: 703-573-8330 Fax: 703-573-4116

The National Pest Control Association was founded in 1933 and now has a budget of $2.8 million. Members include companies engaged in control of insects, rodents, birds, and other pests. NPCA provides advisory services on control procedures, new products, and safety and business administration practices. NPCA sponsors research at several universities, furnishes, technical information and advice to standards and code writing groups, and maintains anextensive libraryonpests. NPCA publishes many titles including manuals, newsletters, membership guides, technical releases, and reports.

International Fertilizer Development Center (IFDC) PO Box 2040 Muscle Shoals,



AL 35662 NonmembershipPhone: 205-381-6600 Staff: 180Fax: 205-381-7408

The International Fertilizer Development Center was founded in 1974 andincludes participants such as scientists, engineers, economists and specialistsin market research and development and communications. IFDC uses a $13.5million budget to try to alleviate world hunger by increasing agriculturalproduction in the tropics and subtropics through development of improvedfertilizers. IFDC sponsors and conducts studies in fertilizer efficiencies andoffers courses on fertilizer production, environmental issues, and cropsustainability. They maintain greenhouses and laboratories, and publishseveral periodicals and manuals.

United Products Formulators and Distributors Association(UPFDA) 1 Executive Concourse No. 103 Members: 102Duluth, GA 30136 Staff: 1Phone: 404-623-8721Fax: 404-623-1714

The United Products Formulators and Distributors Association was foundedin 1968 and is made up of companies engaged in formulating and distributingpesticide products. The UPFDA works to solve problems of membercompanies and promote sound and beneficial legislationand to cooperate withallied industries.

North American Horticultural Supply Association (NAHSA)1790 Arch St. Members: 135Philadelphia, PA 19103 Staff: 3Phone: 215-564-3484Fax: 215-564-2175

The North American Horticultural Supply Association was founded in 1988and represents horticultural supplies suchas greenhouse building materials andsupplies, pesticides, and fertilizers. The NAHSA works to strengthen andenhance the relationship betweenmanufacturers and distributors and promotesdistribution in the market. They publish a quarterly newsletter, NAHSANews,and an annual Industry Calendar.

American Agricultural Economics Association (AAEA)1110 Buckeye Ave. Members: 4,500Ames, IA 50010-8063 Staff: 6Phone: 515-233-3202Fax: 515-233-3101



The American Agricultural Economics Association, founded in 1910, is aprofessional society of state, federal, and industrial agricultural economists,teachers, and extension workers. The AAEA works to further knowledge ofagricultural economics through scientific research, instruction, publications,meetings, and other activities. They publish a bimonthly newsletter, a semi-bimonthly American Journal of Agricultural Economics, a quarterly magazineChoices, and a biennial Handbook Directory.

Institute for Agriculture and Trade Policy (IATP)1313 5th St., SE, No. 303Minneapolis, MN 55414Phone: 612-379-5980Fax: 612-379-5982

The IATP was founded in 1986 and has an annual budget of $1.15 million.They maintain a speakers bureau and conduct research programs on tradeagriculture, global institutions, North-South relations, and the Third World.They publish several periodical bulletins.

California Fertilizers Association (CFA)1700 I St., Ste. 130Sacramento, CA 95814Phone: 916-441-1584Fax: 916-441-2569

The CFA represents fertilizer manufacturers, distributors, wholesalers, andretail dealers that sell products within California. They maintain a legislativehotline and publish studies and handbooks on issues pertaining to fertilizers.



American Society of Agronomy (ASA)677 S. Segoe Rd. Members: 12,500Madison, WI 53711 Staff: 30Phone: 608-273-8080Fax: (608) 273-2021

The ASA was founded in 1907 and presently operates on a budget of 2.5 million dollars per year. ASA is a professional society of plant breeders, soil scientists, chemists, educators, technicians, and other concerned with crop production and soil management. ASA sponsors fellowship programs and provides placement service. ASA publishes annual, bimonthly, and monthly periodicals as well as special publications.

Potash and Phosphate Institute (PPI) 655 Engineering Drive No. 110 Members: 14

Staff: 30Norcross, GA 30092 Phone: 770-447-0335 Fax: 770-448-0439

PPI supports scientific research in the areas of soil fertility, soil testing, plant analysis, and tissue testing. PPI participates in farmers meetings, workshops, and training courses and publish a quarterly magazine, Better Crops with Plant Food.


Agricultural Chemical Industry Contacts and References

IX. CONTACTS/ACKNOWLEDGMENTS/RESOURCE MATERIALSFor further information on selected topics within the Fertilizer, Pesticide, and Agricultural ChemicalIndustry, a list of contacts and publications are provided below.Contacts6

Name Organization Telephone Subject

Michelle C. Yaras

EPA, Office of Enforcement and Compliance Assurance (OECA), Agriculture and Ecosystems Division, Agriculture Branch

202 564-4153 Notebook Contact

Arty Williams EPA, Office of Prevention, Pesticides and Toxic Substances (OPPT)

703 305-5239 Ground Water Pesticide Management Plan Rule

Jean Frane EPA, OPPT 703 305-5944 Food Quality Protection Act

Paul Parsons EPA, OPPT 703 308-9073 FIFRA Data Requirements

David Stangel EPA, OECA 202 564-4162 Stored or Suspended Pesticides; Good Laboratory Practice Standards; Pesticide Management and Disposal

Joseph Hogue EPA, OPPT 703 308-9072 FIFRA Restricted Use Classifications

Robert McNally EPA, OPPT 703 308-8085 FIFRA Pesticide Tolerances

Joseph Nevola EPA, OPPT 703 308-8037 FIFRA Pesticide Tolerances

Ellen Kramer EPA, OPPT 703 305-6475 FIFRA Pesticide Tolerances

Carol Peterson EPA, OPPT 703 305-6598 FIFRA Tolerance Fee Structure

Robert A. Forrest EPA, OPPT 703 308-9376 FIFRA Exemptions

Nancy Fitz EPA, OPPT 703 305-7385 FIFRA Pesticide Management and Disposal

Cathleen Barnes EPA, OPPT 703 305-7101 FIFRA Prior Informed Consent

John MacDonald EPA, OPPT 703 305-7370 Certification and Training

Kevin Keaney EPA, OPPT 703 305-5557 FIFRA Worker Protection Standards

6 Many of the contacts listed above have provided valuable information and comments during the development of this document. EPA appreciates this support and acknowledges that the individuals listed do not necessarily endorse all statements made within this notebook.



The following people received a draft copy of this Sector Notebook and may have provided comments.

Name Organization Telephone

Paul Bangser EPA, Office of General Counsel, Water Division 202 260-7630

Philip J. Ross EPA, Office of General Counsel, Pesticides and Toxic Substances Division

202 260-0779

Don Olson, Chief EPA, Industrial Branch, OECA, Office of Regulatory Enforcement, Water Enforcement Division

202 564-5558

Jon Jacobs EPA, OECA, Office of Regulatory Enforcement, Case Development, Policy and Enforcement Branch -Eastern Regions, Toxics and Pesticides Enforcement Division

202 564-4037

Jerry Stubbs EPA, Case Development, Policy and Enforcement Branch-Western Regions, Toxics and Pesticides Enforcement Division, Office of Regulatory Enforcement

202 564-4178

Anne E. Lindsay, Director

EPA, Field and External Affairs Division Office of Pesticide Programs

703 305-5265

Marcia E. Mulkey, Director

EPA, Office of Pesticide Programs 703 305-7090

Artie Williams, Chief

EPA, Environmental Field Branch, Field and External Affairs Division, Office of Pesticide Programs

703 305-5239

Seth Heminway EPA, OC Sector Notebook Coordinator 202 564-7017

Sam Silverman EPA, Enforcement Coordinator Region 1

617 565-3443

Laura Livingston EPA, Enforcement Coordinator Region 2

212 637-4059

Samantha Fairchild EPA, Enforcement Coordinator Region 3

215 814-5710

Sherri Fields EPA, Enforcement Coordinator Region 4

404 562-9684

Tinka Hyde EPA, EPA, Enforcement Coordinator Region 5

312 886-9296

Robert Lawrence EPA, Enforcement Coordinator Region 6

214 665-6580

Diane Callier EPA, Enforcement Coordinator Region 7

913 551-7459

Mike Gaydosh EPA, Enforcement Coordinator Region 8

303 312-6773

Jo-Ann Semones EPA, Enforcement Coordinator Region 9

415 744-1547

Ron Kreizenbeck EPA, Enforcement Coordinator Region 10

206 553-1265

Edward M. White Assistant Pesticide Administrator, Indiana State Chemist Office, Purdue University

765 494-1587



Dale Dubberly, Chief Bureau of Compliance Monitoring Florida Department of Agriculture & Consumer Services

850 488-8731

Robin Rosenbaum Pesticide Registration Manager, Pesticide & Plant Pest Management Division, Michigan Department of Agriculture

517 335-6542

Buzz Vance Nebraska Department of Agriculture 402 471-6853

Donnie Dippel Assistant Commissioner, Pesticide Programs, Texas Department of Agriculture

512 463-7476

Paul Kindinger Agricultural Retailers Association (ARA) 314 567-6655

Joel Padmore Association of American Plant Food Control Officials (AAPFCO), Food & Drug Protection Division North Carolina Department of Agriculture

919 733-7366

Renee Pinel California Fertilizers Association 916 441-1584

Mark Muller Institute for Agriculture and Trade Policy 612 870-3420

Rick Kirchhoff National Association of State Departments of Agriculture (NASDA)

202 296-9680

Robert Rosenberg National Pest Control Association 703 573-8330

Robert E. Roberts Executive Director Environmental Council of States (ECOS)

202 624-3660

Diane Bateman The Fertilizer Institute (TFI) 202 675-8250

Jay Vroom American Crop Protection Association 202 296-1585



Section II: Introduction to the Fertilizer, Pesticide, and Agricultural Chemical Industry

1992 Census of Manufacturers Industry Series: Agricultural Chemicals, United States Department of Commerce, Bureau of Census, Economics and Statistics Administration, Washington, DC, May 1995.

1987 Standard Industrial Classification Manual, Office of Management and Budget, 1987.

Aspelin, Arnold, Pesticide Industry Sales and Usage, 1994 and 1995 Market Estimates, Office of Prevention, Pesticides and Toxic Substances, USEPA, August 1997.

“Facts and Figures for the Chemical Industry,” Chemical and Engineering News, June 23, 1998.

Hodge, Charles A. and Popovici, Neculai N., ed., Pollution Control in Fertilizer Production, Marcel Dekker, Inc., 1994.

Hoffmeister, George. “Fertilizers”, Kirk-Othmer Encyclopedia of Chemical Technology, 4 th ed. New York: John Wiley & Sons. 1993.

Kent, James A., ed., Riegel’s Handbook of Industrial Chemistry, Ninth edition, Van Nostrand Reinhold, New York, 1992.

Ollinger, Michael, and Fernandez-Cornejo, Jorge. Regulation, Innovation, and Market Structure in the United States Pesticide Industry, Economic Research Service, USDA, June 1995.

Andrilenas, Paul, and Vroomen, Harry. United States Department of Agriculture, Seven Farm Input Industries, Fertilizer, Economic Research Service, U.S.D.A., September 1990.

Dun & Bradstreet’s Million Dollar Directory, 1997.

United Nations Environment Programme and United Nations Industrial Development Organization, Mineral Fertilizer Production and the Environment, UNEP, Paris, 1996.

United States Environmental Protection Agency, Enforcement, Planning, Targeting & Data Division,, FIFRA, section 7 Data System, United States EPA. 1996.

United States Environmental Protection Agency, Development Document for Best Available Technology, Pretreatment Technology, and New Source Performance Technology for the Pesticide Formulating, Packaging, and Repackaging Industry- Final, EPA, Office ofWater, Washington, DC, September 1996.

United States Environmental Protection Agency, Biopesticides Web Site, Office of Pesticide Programs, <http://www.epa.gov/oppbppd1/biopesticides/>, August 1999.

United States Environmental Protection Agency,Compilation of Air Pollutant Emission Factors (AP42), Fifth edition, EPA, Office of Air Quality Planning and Standards, Research Triangle Park, NC, July 1993.



United States Environmental Protection Agency, Guides to Pollution Prevention, The Pesticide Formulating Industry, EPA, Center for Environmental Research Information, Cincinnati, February 1990.

United States Industry & Trade Outlook ‘98, United States Department of Commerce, International Trade Administration, Washington, DC, 1998.

United States International Trade Commission, Industry & Trade Summary, Pesticide Products and Formulations, USITC Publication 2750, Office of Industries, March 1994.

Section III: Industrial Process Description

Air and Waste Management Association, Buonicore, Anthony J. and Davis, Wayne T., ed., Air Pollution Engineering Manual, Van Nostrand Reinhold, New York, 1992.

Cremlyn, R., Pesticides, John Wiley & Sons, New York, 1978.

Hargett, Norman and Pay, Ralph, “Retail Marketing of Fertilizers in the United States” Presented at the Fertilizer Industry Round Table, Atlanta, Georgia, 1980.

Hoffmeister, George. “Fertilizers”, Kirk-Othmer Encyclopedia of Chemical Technology, 4th ed. Volume 10, New York: John Wiley & Sons. 1993.

Kroschwitz, Jacqueline, and Howe-Grant, Mary (eds.). “Ammonia”, Kirk-Othmer Encyclopedia of Chemical Technology, 4th ed. Volume 2, New York: John Wiley & Sons. 1992.

Hodge, Charles A. and Popovici, Neculai N., ed., Pollution Control in Fertilizer Production, Marcel Dekker, Inc., 1994.

Kent, James A., ed., Riegel’s Handbook of Industrial Chemistry, Ninth edition, Van Nostrand Reinhold, New York, 1992.

Korcak, R.F. “Utilization of Coal Combustion By-Products in Agriculture and Horticulture,” Agricultural Utilization of Urban and Industrial By-Products, American Society of Agronomy, Madison, WI, 1995.

Lewis, Richard J., Sr., ed., Hawley’s Condensed Chemical Dictionary, Twelfth edition, Van Nostrand Reinhold, New York, 1993.

Manual on Fertilizer Statistics, Food and Agriculture Organization of the United Nations, Rome, 1991.

Miller, W.P. “Environmental Considerations in Land Application of By-Product Gypsum,” Agricultural Utilization of Urban and Industrial By-Products, American Society of Agronomy, Madison, WI, 1995.



Nielson, Francis T., Manual of Fertilizer Processing, Marcel Dekker, Inc., New York, 1987.

The Fertilizer Institute (TFI), comments submitted by Jim Skillen on a draft of this Sector Notebook, September 1999.

United Nations Environment Programme, Mineral Fertilizer Production and the Environment, Technical Report N.26, United Nations Industrial Development Organization, 1996.

United States Environmental ProtectionAgency, Compilation of Air Pollutant Emission Factors (AP42), Fifth edition, EPA, Office of Air Quality Planning and Standards, Research Triangle Park, NC, July 1993a.


United States Environmental Protection Agency, Development Document for Effluent Limitations Guidelines and New Source Performance Standards for the Basic Fertilizer Chemicals Segment of the Fertilizer Manufacturing Point Source Category, EPA, Office of Air and Water Programs, Washington, DC, March 1974.

United States Environmental Protection Agency, Guides to Pollution Prevention, The Pesticide Formulating Industry, Risk Reduction Engineering Laboratory and Center for Environmental Research Information, Office of Research and Development, February 1990.

United States Environmental Protection Agency, Pesticide Industry Sales and Usage, 1994 and 1995 Market Estimates, Office of Prevention, Pesticides and Toxic Substances, August 1997.

United States Environmental Protection Agency, Report to Congress for Cement Kiln Dust. Volume II: Methods and Findings. Springfield, VA: United States Department of Commerce, December 1993b.

United States Environmental Protection Agency, 1996 Toxics Release Inventory Database.

Water Environment Federation, Pretreatment of Industrial Wastes, Manual of Practice FD-3, Alexandria, VA, 1994.

Section IV: Chemical Release and Transfer Profile



United States EPA Office of Air and Radiation, AIRS Database, 1997.

United States Environmental ProtectionAgency, 1995 Toxics Release Inventory Public Data Release, United States EPA Office of Pollution Prevention and Toxics, April 1997. (EPA 745-R-97-005)



Section V: Pollution Prevention Opportunities

California Fertilizer Association, Dry and Liquid Fertilizer Handling Guidelines for Retail Fertilizer Facilities, CFA, http://www.calfertilizer.org/fertguide.html, November 1996.

Hunt, Gary, et. al., eds. Case Summaries of Waste Reduction by Industries in the Southeast. Waste Reduction Resource Center for the Southeast, North Carolina department of Natural Resources and Community Development, Raleigh, NC, July 1989.

Preventing Pollution in the Chemical Industry, Five Years of Progress, Chemical Manufacturers Association, 1993.

United Nations Environment Programme, Mineral Fertilizer Production and the Environment, Technical Report N.26, United Nations Industrial Development Organization, 1996.


United States Environmental Protection Agency, Guides to Pollution Prevention, The Pesticide Formulating Industry, EPA, Center for Environmental Research Information, Cincinnati, February 1990.

Section VI: Summary of Applicable Federal Statutes and Regulations

Haugrud, K. Jack. “Agriculture,” Chapter 8 in Sustainable Environmental Law, Integrating Natural Resource and Pollution Abatement Law from Resources to Recovery, Environmental Law Institute, St. Paul, 1993.

Landfair, Stanley W. “Toxic Substances Control Act,” Chapter 11 in Environmental Law Handbook, 12th ed., Government Institutes, Inc., Rockville, MD, 1993.

Miller, Marshall E. “Federal Regulation of Pesticides,” Chapter 13 in Environmental Law Handbook, 12th ed., Government Institutes, Inc., Rockville, MD, 1993.

Section VII: Compliance and Enforcement History

United States Environmental Protection Agency, Data obtained from EPA’s Integrated Data for Enforcement Analysis (IDEA) system in 1997.

Section VIII: Compliance Activities and Initiatives

Agricultural Retailers Association, Retailer Facts by FAX, ARA Weekly, November 7, 1997.



Center for Environmental and Regulatory Information Services. <http://www.ceris.purdue.edu>

Jaszczak, Sandra, ed. Gale Encyclopedia of Associations. 31sted., International ThomsonPublishing Co., 1996.

United States Environmental Protection Agency, 33/50 Program Office, 1997.


Safe Drinking Water Act http://en.wikipedia.org/wiki/Safe_Drinking_Water_Act

The Safe Drinking Water Act (SDWA) is the principal federal law in the United States that ensures safe drinking water for the public.[1] Pursuant to the act, the Environmental Protection Agency (EPA) is required to set standards for drinking water quality and oversee all states, localities, and water suppliers who implement these standards.

SDWA applies to every public water system in the United States.[2] There are currently more than 160,000 public water systems providing water to almost all Americans at some time in their lives.

SDWA does not apply to bottled water. Bottled water is regulated by the United States Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.[3]

National Primary Drinking Water Regulations

The SDWA requires EPA to establish National Primary Drinking Water Regulations (NPDWRs) for contaminants that may cause adverse public health effects.[4]

The regulations include both mandatory levels (Maximum Contaminant Levels, or MCLs) and nonenforceable health goals (Maximum Contaminant Level Goals, or MCLGs) for each included contaminant. MCLGs have additional significance because they can be used under the Superfund law as "Applicable or Relevant and Appropriate Requirements" (ARARs) in cleanups of contaminated sites on the National Priorities List (NPL).

The 1986 SDWA amendments [5] required EPA to apply future NPDWRs to both community and non-transient non-community water systems when it evaluated and revised current regulations. The first case in which this was applied was the final rule on July 8, 1987.[6] At that time NPDWRs were promulgated for certain synthetic volatile organic compounds (VOCs) and applied to non-transient non-community water systems as well as community water systems. This rulemaking also clarified that non-transient non-community water systems were not subject to MCLs that were promulgated before July 8, 1987.

Future NPDWR standards will apply to non-transient non-community water systems because of concern for the long-term exposure of a stable population. It is important to note that EPA's decision to apply future NPDWRs to non-transient non-community water systems may have a significant impact on Department of Energy (DOE) facilities that operate their own drinking water systems.

"Lead Free" Plumbing Requirements

Main article: Lead and copper rule

The 1986 amendments require EPA to set standards limiting the concentration of lead in public water systems, and defines "lead free" pipes as:

(1) solders and flux containing not more than 0.2 percent lead; (2) pipes and pipe fittings containing not more than 8.0 percent lead; and (3) plumbing fittings and fixtures as defined in industry-developed voluntary standards (issued no later than August 6, 1997), or standards developed by EPA in lieu of voluntary standards.[7]

EPA issued a lead and copper regulation in 1991.

Airline Water Supplies

In 2004, EPA tested drinking water quality on commercial aircraft and found that 15 percent of tested aircraft water systems tested positive for total coliform bacteria. In April 2008 EPA published a proposed regulation for aircraft public water systems. The proposal would require air carriers operating in the U.S. to conduct coliform sampling, management practices, corrective action, public notification, operator training, and reporting and recordkeeping.[8]

Related Programs

Underground Injection Control Program

The 1974 act authorized EPA to regulate injection wells in order to protect underground sources of drinking water.[9]

Whistleblower protection

The SDWA includes a whistleblower protection.[10] Employees in the US who believe they were fired or suffered another adverse action related to enforcement of this law have 30 days to file a written complaint with the Occupational Safety and Health Administration.

1996 SDWA Amendments

In 1996, Congress amended the Safe Drinking Water Act to emphasize sound science and risk-based standard setting, small water supply system flexibility and technical assistance, community-empowered source water assessment and protection, public right-to-know, and water system infrastructure assistance through a multi-billion-dollar state revolving loan fund. They were signed into law by President Bill Clinton on August 6, 1996.[11]

Main Points of the 1996 Amendments

1. Consumer Confidence Reports: All community water systems must prepare and distribute annual reports about the water they provide, including information on detected contaminants, possible health effects, and the water's source.

2. Cost-Benefit Analysis: US EPA must conduct a thorough cost-benefit analysis for every new standard to determine whether the benefits of a drinking water standard justify the costs.

3. Drinking Water State Revolving Fund: States can use this fund to help water systems make infrastructure or management improvements or to help systems assess and protect their source water.

4. Microbial Contaminants and Disinfection Byproducts: EPA is required to strengthen protection for microbial contaminants, including Cryptosporidium, while strengthening control over the byproducts of chemical disinfection. The Stage 1 Disinfectants and Disinfection Byproducts Rule and the Interim Enhanced Surface Water Treatment Rule together address these risks.

5. Operator Certification: Water system operators must be certified to ensure that systems are operated safely. EPA issued guidelines in February 1999 specifying minimum standards for the certification and recertification of the operators of community and non-transient, noncommunity water systems. These guidelines apply to state Operator Certification Programs. All States are currently implementing EPA-approved operator certification programs.

6. Public Information and Consultation: SDWA emphasizes that consumers have a right to know what is in their drinking water, where it comes from, how it is treated, and how to help protect it. EPA distributes public information materials (through its Drinking Water Hotline, Safewater web site, and Resource Center) and holds public meetings, working with states, tribes, water systems, and environmental and civic groups, to encourage public involvement.

7. Small Water Systems: Small water systems are given special consideration and resources under SDWA, to make sure they have the managerial, financial, and technical ability to comply with drinking water standards.

White House Budget Office Thwarts EPA Warning on Asbestos-Laced Insulation http://www.commondreams.org/headlines02/1229-01.htm Published on Sunday, December 29, 2002 by the St Louis Post-Dispatch by Andrew Schneider WASHINGTON — The Environmental Protection Agency wa s on the verge of warning millions of Americans that their attics and walls m ight contain asbestos-contaminated insulation. But, at the last minute, the White Hous e intervened, and the warning has never been issued.

The agency's refusal to share its knowledge of what is believed to be a widespread health risk has been criticized by a former EPA administra tor under two Republican presidents, a Democratic U.S. senator and physicians and scientis ts who have treated victims of the contamination.

The announcement to warn the public was expected in April. It was to accompany a declaration by the EPA of a publ ic health emergency in Libby, Mont. In that town near the Can adian border, ore from a vermiculite mine was contaminated with a n extremely lethal asbestos fiber called tremolite that has kil led or sickened thousands of miners and their families.

Ore from the Libby mine was shipped across the nati on and around the world, ending up in insulation called Zo nolite that was used in millions of homes, businesses and schools a cross America.

A public health emergency declaration had never bee n issued by any agency. It would have authorized the removal of the disease-causing insulation from homes in Libby and also pro vided long-term medical care for those made sick. Additionally , it would have triggered notification of property owners elsewhere who might be exposed to the contaminated insulation.

Zonolite insulation was sold throughout North Ameri ca from the 1940s through the 1990s. Almost all of the vermicul ite used in the insulation came from the Libby mine, last owned by W.R. Grace & Co.

In a meeting in mid-March, EPA Administrator Christ ie Todd Whitman and Marianne Horinko, head of the Superfund program, met with Paul Peronard, the EPA coordinator of the Libby cleanup and his team of health specialists. Whitman and Hor inko asked tough questions, and apparently got the answers the y needed. They agreed they had to move ahead on a declaration , said a participant in the meeting.

By early April, the declaration was ready to go. Ne ws releases had been written and rewritten. Lists of governors to call and politicia ns to notify had been compiled. Internal e-mail shows that discussions had even been held on w hether Whitman would go to Libby

When the government comes across this kind of information and doesn't tell people about it, I just think it's wrong, unconscionable, not to do that. Your first obligation is to tell the people living in these homes of the possible danger. Former EPA administrator William Ruckelshaus, who worked for Presidents Richard Nixon and Ronald Reagan

for the announcement.

But the declaration was never made.

Derailed by White House

Interviews and documents show that just days before the EPA was set to make the declaration, the plan was thwarted by the White Hou se Office of Management and Budget, which had been told of the proposal months earlier.

Both the budget office and the EPA acknowledge that the White House agency was actively involved, but neither agency would discuss how or why.

The EPA's chief spokesman Joe Martyak said, "Contac t OMB for the details."

Budget office spokesperson Amy Call said, "These qu estions will have to be addressed to the EPA."

Call said the budget office provided wording for th e EPA to use, but she declined to say why the White House opposed the declaration and the public notification.

"These are part of our internal discussions with EP A, and we don't discuss predecisional deliberations," Call said.

Both agencies refused Freedom of Information Act re quests for documents to and from the White House Office of Management and Budget.

The budget office was created in 1970 to evaluate a ll budget, policy, legislative, regulatory, procurement and management issues on behalf of the president.

Office interfered before

Former EPA administrato r William Ruckelshaus, who worked for Presidents Ri chard Nixon and Ronald Reagan, called the decision not to notif y homeowners of the dangers posed by Zonolite insulation "the wrong thing to do."

"When the government comes across this kind of info rmation and doesn't tell people about it, I just think it's wrong, unconscionable, not to do that," he said. "Your first obligation is to tell the people living in these ho mes of the possible danger.

They need the information so they can decide what a ctions are best for their family. What right does the government have to conceal these dan gers? It just doesn't make sense."

But, he added, pressure on the EPA from the budget office or the White House is not unprecedented.

Ruckelshaus, who became the EPA's first administrat or when the agency was created by Nixon in 1970, said he never was called by the pres ident directly to discuss agency decisions. He said the same held true when he was c alled back to lead the EPA by Reagan after Anne Gorsuch Burford's scandal-plagued tenure .

Calls from a White House staff member or the Office of Management and Budget were

another matter.

"The pressure could come from industry pressuring O MB or if someone could find a friendly ear in the White House to get them to inte rvene," Ruck elshaus said. "These issues like asbestos are so technical, often so convoluted , that industry's best chance to stop us or modify what we wanted to do would come from OMB. "

The question about what to do about Zonolite insula tion was not the only asbestos- related issue in which the White House intervened.

In January, in an internal EPA report on problems w ith the agency's much-criticized response to the terrorist attacks in New York City, a section on "lessons learned" said there was a need to release public health and emerg ency information without having it reviewed and delayed by the White House.

"We cannot delay releasing important public health information," said the report. "The political consequences of delaying information are greater than the benefit of centralized information management."

It was the White House budget office's Office of In formation and Regulatory Affairs that derailed the Libby declaration. The regulatory affa irs office is headed by John Graham, who formerly ran the Harvard Center for Risk Analys is.

His appointment last year was denounced by environm ental, health and public advocacy groups, who claimed his ties to industry were too s trong. Graham passes judgment over all major national health, safety and environmental standards.

Sen. Dick Durbin, D-Ill., urged colleagues to vote against Graham's appointment, saying Graham would have to recuse himself from reviewing many rules because affected industries donated to the Harvard University Center .

Thirty physicians, 10 of them from Harvard, accordi ng to The Washington Post, wrote the committee asking that Graham not be confirmed becau se of "a persistent pattern of conflict of interest, of obscuring and minimizing d angers to human health with questionable cost-benefit analyses, and of hostilit y to governmental regulation in general."

Repeated requests for interviews with Graham or any one else involved in the White House budget office decision were denied.

"It was like a gut shot"

Whitman, Horinko and some members of their top staf f were said to have been outraged at the White House intervention.

"It was like a gut shot," said one of those senior staffers involved in the decision. "It wasn't that they ordered us not to make the declara tion, they just really, really strongly suggested against it. Really strongly. There was no choice left."

She and other staff members said Whitman was person ally interested in Libby and the national problems spawned by its asbestos-tainted o re. The EPA's inspector general had reported that the agency hadn't taken action more t han two decades earlier when it had proof that the people of Libby and those using asbe stos-tainted Zonolite products were in

danger.

Whitman went to Libby in early September 2001 and p romised the people it would never happen again.

"We want everyone who comes in contact with vermicu lite — from homeowners to handymen — to have the information to protect thems elves and their families," Whitman promised.

Suits, bankruptcies grow

Political pragmatists in the agency knew the admini stration was angered that a flood of lawsuits had caused more than a dozen major corpora tions — including W.R. Grace — to file for bankruptcy protection. The suits sought bi llions of dollars on behalf of people injured or killed from exposure to asbestos in thei r products or workplaces.

Republicans on Capitol Hill crafted legislation — e xpected to be introduced next month — to stem the flow of these suits.

Nevertheless, Whitman told her people to move forwa rd with the emergency declaration. Those in the EPA who respect their boss fear that W hitman may quit.

She has taken heat for other White House decisions such as a controversial decision on levels of arsenic in drinking water, easing regulat ions to allow 50-year-old power plants to operate without implementing modern pollution contr ols and a dozen other actions which environmentalists say favor industry over health.

Newspapers in her home state of New Jersey ran fron t page stories this month saying Whitman had told Bush she wanted to leave the agenc y.

Spokesman Martyak said his boss is staying on the j ob.

EPA was poised to act

In October, the EPA complied with a Freedom of Info rmation Act request and gave the Post-Dispatch access to thousands of documents — in nine large file boxes. There were hundreds of e-mails, scores of "action memos" descr ibing the declaration and piles of "communication strategies" for how the announcement would be made.

The documents illustrated the internal and external battle over getting the declaration and announcement released.

One of the most contentious concerns was the antici pated national backlash from the Libby declaration. EPA officials knew that if the a gency announced that the insulation in Montana was so dangerous that an emergency had to b e declared, people elsewhere whose homes contained the same contaminated Zonolit e would want answers or perhaps demand to have their homes cleaned.

The language of the declaration was molded to stres s how unique Libby was and to play down the national problem.

But many in the agency's headquarters and regional offices didn't buy it.

In a Feb. 22 memo, the EPA's Office of Pollution Pr evention and Toxics said "the national ramifications are enormous" and estimated that if o nly 1 million homes have Zonolite "(are) we not put in a position to remove their (in sulation) at a national cost of over $10 billion?"

The memo also questioned the agency's claim that th e age of Libby's homes and severe winter conditions in Montana required a higher leve l of maintenance, which in turn meant increased disturbance of the insulation in the home s there.

It's "a shallow argument," the memo said. "There ar e older homes which exist in harsh or harsher conditions across the country. Residents in Maine and Michigan might find this argument flawed."

No one knows precisely how many dwellings are insul ated with Zonolite. Memos from the EPA and the Agency for Toxic Substances and Disease Registry repeatedly cite an estimate of between 15 million and 35 million homes .

A government analysis of shipping records from W.R. Grace show that at least 15.6 billion pounds of vermiculite ore was shipped from Libby to 750 plants and factories throughout North America.

Between a third and half of that ore was popped int o insulation and usually sold in 3-foot-high kraft paper bags.

Government extrapolations and interviews with forme r W.R. Grace Zonolite salesmen indicate that Illinois may have as many as 800,000 homes with Zonolite, Michigan as many as 700,000. Missouri is likely to have Zonolite in 380,000 homes.

With four processing plants in St. Louis, it is est imated that more than 60,000 homes, offices and schools were insulated with Zonolite in the St. Louis area alone.

Eventually, the internal documents show, acceptance grew that the agency should declare a public health emergency.

In a confidential memo dated March 28, an EPA offic ial said the declaration was tentatively set for April 5.

But the declaration never came.

Instead, Superfund boss Horinko on May 9 quietly or dered that asbestos be removed from contaminated homes in Libby. There was no national warning of potential dangers from Zonolite. And there was no promise of long- term medical care for Libby's ill and dying. The presence of the White House budget office is noted throughout the documents. The press announcement of the watered- down decision was rewritten five times the day befo re it was released to accommodate budget office wording chang es that played down the dangers.

Dangers of Zonolite

The asbestos in Zonolite, like all asbestos product s, is believed to be either a minimal risk or no risk if it is not disturbed. The asbestos fib ers must be airborne to be inhaled. The fibers then become trapped in the lungs, where they may cause asbestosis, lung cancer and mesothelioma, a fast-moving cancer of the lung' s lining.

The EPA's files are filled with studies documenting the toxicity of tremolite, how even minor disruptions of the material by moving boxes, sweeping the floor or doing repairs in attics can generate asbestos fibers.

This also has been confirmed by simulations W.R. Gr ace ran in Weedsport, N.Y., in July 1977; by 1997 studies by the Canadian Department of National Defense; and by the U.S. Public Health Service, which reported in 2000, that "even minimal handling by workers or residents poses a substantial health risk."

Last December, a study by Christopher Weis, the EPA 's senior toxicologist supporting the Libby project, reported that "the concentrations of asbestos fibers that occur in air following disturbance of (insulation) may reach lev els of potential human health concerns."

Most of those who have studied the needle- sharp tremolite fibers in the Libby ore consider them far more dangerous than other asbestos fibers.

In October, the EPA team leading the cleanup of low er Manhattan after the attacks of Sept. 11 went to Libby to meet with Peronard and his crew . The EPA had reversed an early decision and announced that it would be cleaning as bestos from city apartments.

Libby has been a laboratory for doing just that.

Peronard told the visitors from New York just how d angerous tremolite is. He talked about the hands-on research in Libby of Dr. Alan Whitehou se, a pulmonologist who had worked for NASA and the Air Force on earlier projects befo re moving to Spokane, Wash.

"Whitehouse's research on the people here gave us o ur first solid lead of how bad this tremolite is," Peronard said.

Whitehouse has not only treated 500 people from Lib by who are sick and dying from exposure to tremolite. The chest specialist also ha s almost 300 patients from Washington shipyards and the Hanford, Wash., nuclear facility who are suffering health effects from exposure to the more prevalent chrysotile asbestos.

Comparing the two groups, Whitehouse has demonstrat ed that the tremolite from Libby is 10 times as carcinogenic as chrysotile and probably 100 times more likely to produce mesothelioma than chrysotile.

W.R. Grace has maintained that its insulation is sa fe. On April 3 of this year, the company wrote a letter to Whitman again insisting its produ ct was safe and that no public health declaration or nationwide warning was warranted.

Dr. Brad Black, who runs the asbestos clinic in Lib by and acts as health officer for Montana's Lincoln County, says "people have a right to be warned of the potential danger they may face if they disturb that stuff."

Martyak, chief EPA spokesman, argues that the agenc y has informed the public of the potential dangers. "It's on our Web site," he said.

Sen. Patty Murray, D-Wash., is sponsoring legislati on to ban asbestos in the Unit ed States. She said the Web site warning is a joke.

"EPA's answer that people have been warned because it's on their Web site is ridiculous," she said. "If you have a computer, and you just hap pened to think about what's in your attic, and you happen to be on EPA's Web page, then you get to know. This is not the way the safety of the public is handled.

"We, the government, the EPA, the administration ha ve a responsibility to at least let people know the information so they can protect the mselves if they go into those attics," she said.

What you should know about asbestos dangers

Zonolite insulation has been produced and sold for home and business use for more than half a century. The featherweight, silverish-brown pieces of popcornlike vermiculite are usually the size of a nickel or dime, but some firm s have sold pea-size vermiculite.

Here's what government experts say you should do:

If you're a homeowner: Stay away from Zonolite insu lation, and leave it alone.

Asbestos is dangerous only when the mater ial is disturbed and the fibers become airborne and can be drawn into the lungs.

If you must work in the attic: "If you're a do-it-y ourselfer or someone who's in attics every day — like electricians, telephone people, cable in stallers, the heating and cooling people — get and wear the proper respirator and change you r clothes before you go home," says Paul Peronard of the Environmental Protection Agenc y.

If you don't know whether you have Zonolite but thi nk you might: Do not let children play in the area. Do not sweep the Zonolite or use a nor mal vacuum cleaner. This will just recirculate the dangerous fibers, which could linge r in the air for days. There are vacuum cleaners on the market that come with highly sensit ive HEPA filters that will capture the fibers.

If you want to find out about the material in your attic: There are asbestos testing laboratories in or near most communities. If you want Zonolite removed: For do-it-yourselfers , the EPA and many state and local health departments can tell you the safest way to g et rid of the insulation.

Professional cleanup help is available, but hiring a professional asbestos remover can be costly. To avoid potential conflicts of interest, h ave the insulation tested by one firm and removed by another. State and local agencies have t he names and numbers of people trained, equipped and licensed to do this work.

Carefully check out the credentials of those you hi re. An untrained or sloppy crew can spread asbestos throughout your house or office.

For more information:

U.S. EPA — National Asbestos Hot Line: 1-800-368-58 88 U.S. EPA Region 7 (Missouri): 1-800-223-0425 U.S. EPA Region 5 (Illinois): 1-800-621-8431 EPA Web site: www.epa.gov (search for vermiculite) Missouri — Office of Environmental Health and Air P ollution Control: 1-800-392-7245

St. Louis County Health Department, Air Pollution C ontrol: 314-615-8923 or 8924 St. Louis, Division of Air Pollution Control: 314-6 13-7300 Illinois: The health departments in Madison, St. Cl air, Monroe and Clinton counties say they refer all calls involving asbestos to the Illi nois Department of Public Health: 1-217-782-5830

Copyright 2002 St Louis Post-Dispatch

U.S. Food and Drug Administration FDA Consumer magazine July-August 2002 Table of Contents

Bottled Water: Better Than the Tap? By Anne Christiansen Bullers

It's a rare day that Kelly Harrison, a mother of fi ve from Tulsa, Okla., doesn't find herself chauffeuring kids to some kind of sports practice or school activity. As she checks to see that each chi ld is seat-belted into the family's minivan, Harrison also makes sure they 've got the essentials: the right sports equipment, the right clothes, and what she considers to be the right drink--bottled water.

When she was growing up, Harrison, 34, might have g rabbed a soft drink or juice on her way out the door. But for her kids, Harrison insists on what she thinks is a healthier choice--water. She s ays her children's young bodies need water as they play in the Oklahom a sun. Bottled water also contains no caffeine, no calories and no sugar . Plus, bottled water comes in convenient bottles, easy to tote from home to wherever the busy family goes. [ See what Americans are drinking in 2002. ]

"I really think this is best for a lot of different reasons," says Harrison, who often tucks a bottle for herself into the baske t in her minivan that contains other on-the-go mom necessities, such as a paperback book and her cell phone.

Once, most Americans got their water only from the tap. Now, like Harrison, they're often buying their water in a bot tle. At work, after a workout, or just about any time, Americans are drin king bottled water in record numbers--a whopping 5 billion gallons in 200 1, according to the International Bottled Water Association (IBWA), an industry trade group. That's about the same amount of water that falls fr om the American Falls at Niagara Falls in two hours.

Explosive growth in the industry for more than a de cade has placed bottled water in nearly every supermarket, convenie nce store and vending machine from coast to coast, where dozens o f brands compete for consumers' dollars. In four years, industry exp erts anticipate that bottled water will be second only to soda pop as Am erica's beverage of choice.

Water, of course, is essential to human health. Dri nking enough water to replace whatever is lost through bodily functions i s important. But surveys indicate that most of us might not be drink ing enough. Is bottled water part of the answer? To decide, consumers need to arm themselves with knowledge about what they're buying before the y grab the next bottle of Dasani, Evian or Perrier off the shelf. " It really pays to do your homework," says Stew Thornley, a water quality heal th educator with the Minnesota Department of Health.

Different Varieties

Bottled water may seem like a relatively new idea-- one born during the heightened awareness of fitness and potential water pollution during the last two or three decades. However, water has been bottled and sold far from its source for thousands of years. In Europe, water from mineral springs was often thought to have curative and some times religious powers. Pioneers trekking west across the United St ates during the 19th century also typically considered drinkable (potabl e) water a staple to be purchased in anticipation of the long trip across t he arid West.

Today, of course, there are dozens of brands of bot tled water and many different kinds, including flavored or fizzy, to ch oose from.

Federal Regulations

The Food and Drug Administration regulates bottled water products that are in interstate commerce under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Under the FD&C Act, manufacturers are responsible f or producing safe, wholesome and truthfully labeled food products, inc luding bottled water products. It is a violation of the law to introduce into interstate commerce adulterated or misbranded products that violate the various provisions of the FD&C Act.

The FDA also has established regulations specifical ly for bottled water, including standard of identity regulations, which d efine different types of bottled water, and standard of quality regulations, which set maximum levels of contaminants (chemical, physical, microbi al and radiological) allowed in bottled water.

From a regulatory standpoint, the FDA describes bot tled water as water that is intended for human consumption and that is sealed in bottles or other containers with no added ingredients, except that it may contain a safe and suitable antimicrobial agent. Fluoride may also be added within the limits set by the FDA.

High Standards

Is the extra expense of bottled water worth it? One thing consumers can depend on is that the FDA sets regulations specific ally for bottled water to ensure that the bottled water they buy is safe, according to Henry Kim, Ph.D., a supervisory chemist at the FDA's Center fo r Food Safety and Applied Nutrition, Office of Plant and Dairy Foods and Beverages. Kim, whose office oversees the agency's regulatory progr am for bottled water, says that major changes have been made since 1974, when the Safe Drinking Water Act (SDWA) first gave regulatory ove rsight of public drinking water (tap water) to the U.S. Environmenta l Protection Agency (EPA). Each time the EPA establishes a standard for a chemical or microbial contaminant, the FDA either adopts it for bottled water or makes a finding that the standard is not necessary for bottled water in order to protect the public health.

"Generally, over the years, the FDA has adopted EPA standards for tap water as standards for bottled water," Kim says. As a result, standards for contaminants in tap water and bottled water are very similar.

However, in some instances, standards for bottled w ater are different than for tap water. Kim cites lead as an example. B ecause lead can leach from pipes as water travels from water utilities to home faucets, the EPA set an action level of 15 parts per billion (ppb) i n tap water. This means that when lead levels are above 15 ppb in tap water that reaches home faucets, water utilities must treat the water to re duce the lead levels to below 15 ppb. In bottled water, where lead pipes ar e not used, the lead limit is set at 5 ppb. Based on FDA survey informat ion, bottlers can readily produce bottled water products with lead le vels below 5 ppb. This action was consistent with the FDA's goal of reduci ng consumers' exposure to lead in drinking water to the extent pr acticable.

Production of bottled water also must follow the cu rrent good manufacturing practices (CGMP) regulations set up a nd enforced by the FDA. Water must be sampled, analyzed and found to b e safe and sanitary. These regulations also require proper pla nt and equipment design, bottling procedures and recordkeeping.

The FDA also oversees inspections of the bottling p lants. Kim says, "Because the FDA's experience over the years has sh own that bottled water poses no significant public health risk, we c onsider bottled water not to be a high risk food." Nevertheless, the FDA inspects bottled water plants under its general food safety program and al so contracts with the states to perform some bottled water plant inspecti ons. In addition, some states require bottled water firms to be licensed a nnually.

Members of the IBWA also agree to adhere to the ass ociation's Model Code, a set of standards that is more stringent than federal regulations in some areas. Bottling plants that adopt the IBWA Model Code agree to one unannounced annual inspection by an independent firm.

The FDA also classifies some bottled water according to its origin.

• Artesian well water. Water from a well that taps an aquifer--layers of porous rock, sand and earth that contain water--which is under

pressure from surrounding upper layers of rock or c lay. When tapped, the pressure in the aquifer, commonly calle d artesian pressure, pushes the water above the level of the a quifer, sometimes to the surface. Other means may be used t o help bring the water to the surface. According to the EPA, water from artesian aquifers often is more pure because the confining layers of rock and clay impede the movement of contamination. However, despite the cla ims of some bottlers, there is no guarantee that artesian water s are any cleaner than ground water from an unconfined aquifer, the E PA says.

• Mineral water. Water from an underground source tha t contains at least 250 parts per million total dissolved solids. Minerals and trace elements must come from the source of the und erground water. They cannot be added later.

• Spring water. Derived from an underground formation from which water flows naturally to the earth's surface. Sprin g water must be collected only at the spring or through a borehole tapping the underground formation feeding the spring. If some e xternal force is used to collect the water through a borehole, th e water must have the same composition and quality as the water that naturally flows to the surface.

• Well water. Water from a hole bored or drilled into the ground, which taps into an aquifer.

Bottled water may be used as an ingredient in bever ages, such as diluted juices or flavored bottled waters. However, beverag es labeled as

containing "sparkling water," "seltzer water," "sod a water," "tonic water," or "club soda" are not included as bottled water un der the FDA's regulations, because these beverages have historica lly been considered soft drinks.

Some bottled water also comes from municipal source s--in other words--the tap. Municipal water is usually treated before it is bottled.

Examples of water treatments include:

• Distillation. In this process, water is turned into a vapor. Since minerals are too heavy to vaporize, they are left b ehind, and the vapors are condensed into water again.

• Reverse osmosis. Water is forced through membranes to remove minerals in the water.

• Absolute 1 micron filtration. Water flows through f ilters that remove particles larger than one micron in size, su ch as Cryptosporidium, a parasitic protozoan.

• Ozonation. Bottlers of all types of waters typicall y use ozone gas, an antimicrobial agent, to disinfect the water inst ead of chlorine, since chlorine can leave residual taste and odor to the water.

Bottled water that has been treated by distillation , reverse osmosis, or other suitable process and that meets the definitio n of "purified water" in the U.S. Pharmacopeia can be labeled as "purified water."

Bottled vs. Tap

Whether bottled water is better than tap water, and justifies its expense, remains under debate. Stephen Kay, vice president o f the IBWA, says member bottlers are selling the quality, consistenc y and safety that bottled water promises, and providing a service for those whose municipal systems do not provide good quality drink ing water.

"Bottled water is produced and regulated exclusivel y for human consumption," Kay says. "Some people in their munic ipal markets have the luxury of good water. Others do not."

Thornley, of the Minnesota Department of Health, ag rees that consumers can depend on bottled water's safety and quality. B ut he says consumers should feel the same way about the quality of their tap water. Tap water may sometimes look or taste differently, he says, b ut that doesn't mean it's unsafe. In fact, the most dangerous contaminan ts are those that consumers cannot see, smell or taste, he says. But consumers don't need to worry about their presence, he adds. Munici pal water systems serving 25 people or more are subject to the federa l Safe Drinking Water

Act. As such, the water constantly and thoroughly t ested for harmful substances, he says. If there is a problem, consume rs will be warned through the media or other outlets.

"In lieu of being told otherwise, consumers should feel confident of the safety of their water," Thornley says.

Dr. Robert Ophaug, a professor of oral health at th e University of Minnesota School of Dentistry, notes that tap water has another advantage many people don't think about: It typical ly contains fluoride. Many communities have elected to add fluoride to dr inking water to promote strong teeth and prevent tooth decay in res idents, though some groups continue to oppose this practice and believe it's detrimental to health.

Ophaug says bottled water often does not have fluor ide added to it. Or, if it has been purified through reverse osmosis or dis tillation, the fluoride may have been removed. People who drink mostly bott led water, especially those who have children, need to be awar e of this, he says. They may need to use supplemental fluoride that is available by prescription from dentists or doctors. The suppleme nts are usually recommended for children ages 7 to 16. Fluoride sup plements cost around $15 for a three-month supply.

"At the least, inform the children's dentist or doc tor that you are relying on bottled water," Ophaug says.

The IBWA says there are more than 20 brands of bott led water with added fluoride available to consumers today. When f luoride is added to bottled water, the FDA requires that the term "fluo ridated," "fluoride added," or "with added fluoride" be used on the lab el. Consumers interested in how much fluoride bottled water conta ins can usually find out by contacting individual companies directly.

Surging Sales

Consumers don't appear ready to give up their bottl ed water any time soon. Younger, health-oriented people are driving t he market's growth, according to industry officials. "They've grown up with bottled water, and it doesn't seem like such a stretch to them to buy water," says Kay.

Jeremy Buccellato, 31, of Ramsey, Minn., says he's heard the arguments that tap water is just as good if not better than b ottled water. A glass from his own tap, however, provides water that's discolo red, chlorinated, and tastes like "pool water." Buccellato says the extra money he spends on bottles of Dasani water is worth it.

"It tastes better and looks better, plus it's easy to take with me," says Buccellato. "What's not to like?"

Harrison agrees that there's nothing like a refresh ing cool bottle of water to beat the heat during an Oklahoma summer.

"It's a product that fits our needs and our lifesty le," she says.

Anne Christiansen Bullers is a free-lance writer in Prairie Village, Kan.

To Filter or Not to Filter?

Consumers can buy purified water. They also have th e option of doing it at home.

Numerous companies sell filtration systems. Some at tach to the faucet and filter the water as it comes through the tap. O thers are containers that filter the water in them. Among the best-known manufacturers are PUR and Brita.

Water purified with these products typically costs less than buying bottled water. According to Brita, its high-end fau cet filter system provides water for 18 cents a gallon, a considerabl e saving from $1 or more typically charged for an 8- to 12-ounce bottle of water.

John B. Ferguson, communications manager/executive editor with the Water Quality Association, says that consumers can feel confident about the water quality provided by brand name home-filtr ation systems.

Stew Thornley of the Minnesota Department of Health agrees that home filtration systems can improve the taste or appeara nce of tap water at a minimal cost. However, Thornley points out that con sumers need to be careful about maintaining these filters. Typically, specific instructions are included with the purchase of the product. Without proper maintenance, he says, it's possible bacteria or other contaminan ts can build up in the products.

--A.C.B.

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Fluoride

Adverse Health Effects

The International Academy of Oral Medicine and Toxicology has classified Fluoride as an unapproved dental medicament due to its high toxicity.

Fluoride was found to be an equivocal carcinogen by the National Cancer Institute Toxicological Program.1

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A Chronology of Fluoridation By Val Valerian

Material Added on November 3, 1997 (c) 1996,1997 Leading Edge Research Group. All Rights Reserved. P.O. Box 7530, Yelm, Washington 98597 http://www.trufax.org Email: [email protected]

"Fluoridation is not a Communist Plot; it is an attempt by industry to camouflage their deadliest pollutant, with government officials and Madison Avenue advertisers beating the drums. The fluoridation empire is like a castle built on quicksand." Gladys Caldwell, author, "Fluoridation and Truth Decay", 1974. -------------------------------------------------------------------------------- 1855 Smelters in Freiburg, Germany first paid damages to neighbors injured by fluoride emissions. (See 1893) 1893 The smelters in Freiburg, Germany paid out 80,000 marks in damages for fluorine contamination injuries and 644,000 marks for permanent relief. (See 1855, 1900, 1907). 1900 The existence of the smelting industry in Germany and Great Britain is threatened by successful lawsuits for fluorine damage and by budensome laws and regulations. 1907 The smelters in Freiburg, Germany (see 1893) are identified as the cause of cripplied cattle in the area since 1877, and fluorides are identified as the culprit. 1916 The first evidence of brown mottling of teeth is reported in the United States, and would be eventually found to be caused by fluorides in water. 1922 Aluminum production (along with production of toxic by-product sodium fluoride) increases. Aluminum cookware is mass introduced in the US, beginning the gradual accumulation of aluminum in the brains of Americans. Additional aluminum is injected into society in "antacids" and toothpaste tubes, which aggrevate the action of toxic fluorides.

1928 The equivalent of the U.S. Public Health Service is under the jurisdiction of Treasury Secretary Andrew W. Mellon, a founder and major stockholder of ALCOA aluminum, a major producer of toxic fluoride wastes. Mellon would step down from control of the Public Health in 1931. 1928 Edward L.Bernays, nephew to Sigmund Freud, writes the book Propaganda, in which he explains the structure of the mechanism which controls the public mind, and how it is manipulated by those who wish to create public acceptance for a particular idea or commodity. Says Bernays, "those who manipulate this unseen mechanism of society constitute an invisible government which is the true ruling power of our country. Our minds are molded, our tastes are formed, largely by men we have never heard of." Bernays represents another connection to Germany and would be essential in the fluoride campaign in the United States. Wrote Bernay's, "if you can influence group leaders, either with or without their conscious cooperation, you automatically influence the group which they sway." (See Bernay's, 1947, and the fluoride campaign). 1930 Kettering Laboratory is founded from gifts from Ethyl Corporation, General Electric and DuPont (all who have interlocking relationships with I.G. Farben in Germany) to "investigate chemical hazards in American industrial operations" under contract, with provision that research "shall not be released to the public without the consent of the contracting company." During the mid-20th century, Kettering dominated the medical literature on the toxicology of fluorides, but information was not released into the public domain. 1931 A considerable portion of Kettering Laboratory's facilities are dedicated to the study of fluorides. Under contract, the studies are not releasable to the public. (See also 1939, Mellon Institute) 1931 Three independent groups of scientists determine that fluoride in the water is the cause of dental mottling. Research teams from ALCOA Aluminum (who have fluorides as a hazardous by-product of aluminum manufacture) and the University of Arizona. Also shown by North African investigators and others. Dr. Gerald Cox of the Mellon Institute, owners of ALCOA, would later solve the expensive disposal problem with toxic fluorides by convincing others that it could be dumped in the public water supply as a "preventative" for tooth decay. 1931 Under an agreement with I.G. Farben, ALCOA accepts a restriction on the production of magnesium in the U.S, hampering the war effort, while Germany itself stepped up production. Most of the U.S. production was shipped out of the country to Germany. 1931 Public Health Service dentist H. Trendley Dean is dispatched by ALCOA founder Andrew Mellon to certain remote towns in the Western U.S. where water wells have a naturally high concentration of calcium fluorides. Dean's mission would be to find out how much fluoride people could physically tolerate before obvious visible damage to

their teeth. Dean publishes a purposely skewed and deceptive study which purports to show that at 1ppm, flourides result in the "reduction of tooth decay". (See Gerald Cox, 1939) 1931 The Mellon Institute is ALCOA's Pittsburgh research lab. 1931 From 1931 to 1939, the U.S. Public Health Service seeks to remove fluorides from water supplies because of endemic mottled teeth. ALCOA's fluoride proposals have not been bought into by the public or government yet. 1931 I.G. Farben and Alcoa Aluminum sign Alted Agreement pooling patents, which would continue through 1939 and beyond. I.G. Farben complex begins large contributions to fund Nazi cause. 1933 A study is published in which it is shown that fluorides inhibit the action relative to lipase on ethyl acetate in vivo 50 percent at a concentration of one part in 15 million. (McClure, F.J., "A Review of Fluorine and its physiological effects", Physiological Review, 13: 295-297, July 1933). 1933 According to a study by Freni in 1994 (71), in 1933 and again in 1984 that fluorides produce cumulative generational effects on biological organisms. 1937 U.S. Public Health Service publishes material indicating that fluoride concentrations in many U.S. cities varied between 0.6 ppm to 8.0 ppm. A concentration of 0.9 ppm means that over 10% of children have mottled teeth and tooth deformities. 1937 A clinical hygienic study by K. Roholm in 1937, Fluoride Intoxication, published by H.K. Lewis, London. Roholm is convinced that fluorides cross the placental barrier into the fetus. (70). This realization is echoed in 1951 by an M.D. and chemist from the University of Oregon Medical School. 1938 Dr. Wallace Armstrong and P.J.Brekhus at the University of Minnesota Department of Biochemistry publish a study in which they claim that the enamel of sound teeth had a significantly greater fluoride content than the enamel of teeth with cavities. Armstrong was to admit that these results were false. In a followup study in 1963, Dr. Armstrong found no difference in the fluoride contents of the enamal of sound or decayed teeth. 1938 The University of Mexico Bulletin, August 1, 1938, in an article entitled "Menace of Fluorine to Health", states "Solutions of sodium fluoride with a fluoride content as low as one part in 15 million may inhibit the action of the lipase (pancreatic juice) as much as 50 percent." 1939 The ALCOA company, the world's largest producer of sodium fluoride,transfers it technology under the Alted Agreement to Germany. Dow Chemical follows suit. 1939 ALCOA-sponsored bochemist Gerald J. Cox fluoridates rats in his lab and

mysteriously concludes that "fluoride reduces cavities". He makes a public proposal that the U.S. should fluoridate its water supplies. Cox begins to tour the United States, stumping for fluoridation. 1939 Scientists at I.G. Farben prepare the first sample of fluorinated nerve gas Sarin. 1939 On September 29, 1939, Mellon Institute scientist Gerald J. Cox plays a major role in the promotion of fluoridation by saying "the present trend toward removal of fluorides from food and water may need reversal. Water engineers had been recommending a maximum allowable fluoride contaminant level of 0.1 part per million (ppm), maintaining a tenfold margin of safety. (When fluorides were eventually added to water through corporate pressure, that safety factor would be thrown out and the level raised tenfold beyond the engineering recommendations in 1939, when fluoride was properly recognized as a toxic contaminant. Note: Mellon Institute was founded by Andrew and Richard Mellon, former owners of ALCOA Aluminum, plagued by disposal problems of toxic fluoride by products. ALCOA also had a relationship with I.G. Farben in Germany) 1939 U.S. Public Health Service regulations state "the presence of fluorides in excess of 1 ppm shall constitute rejection of the water supply." (Yet, when water fluoridation is instituted, levels are set at a minumum of 1 ppm) 1939 Volume 9 Report to the House Un-American Activities Committee delves deeply into the alleged use of fluoridation to keep the American people docile, so they would accept the changing of their system of government to a socialist state. 1940 "Fluoride inhibits neuromuscular activity". Ref: Russo, G. Att.Acad. Sci. Nat.., 1940. 1940 Soviet concentration camps maintained by fluoride administration to inmates to decrease resistance to authority and induce physical deteriorization. 1942 "Fluorine may cause anoxia in the newborn and shorten the period of their survival" Ref: Himwich, H.E., et al., American Journal of Physiology, 1942. 1942 Germany becomes worlds largest producer of aluminum (and Sodium Fluoride). Fluoride is used in the concentration camps to render the prisoners docile and inhibit the questioning of authority. 1943 Researchers from the US Public Health Service examine the health of residents of Bartlett, Texas to see if the 8ppm fluoride in the drinking water was affecting their health. It was checked again in 1953. They find that the death rate in Bartlett was three times higher than a neighboring town which contained 0.4 ppm fluoride. 1943 A special New York State Health Department Committee is appointed to study the advisability of adding fluoride to Newburg's drinking water, chaired by Dr. Hodge, then chief of fluoride toxicity studies for the Manhattan Project.

1943 The Journal of the American Medical Association on September 18, 1943, contains an article, "Chronic Fluorine Intoxication", which states, "fluorides are general protoplasmic poisons, changing the permeability of the cell membrane by inhibiting certain enzymes. The exact mechanism of such actions, it was said, are obscure. The sources of fluorine intoxication are drinking water containing 1ppm or more of fluorine, fluorine compounds used as insecticidal sprays for fruits and vegatables (cryolite and barium fluorosilicate) and the mining and conversion of phosphate rock to superphosphate, which is used as a fertilizer. That process alone releases approximately 25,000 tons of pure fluorine into the atmosphere annually. Other sources of fluorine intoxication is from the fluorides used in the smelting of many metals, such as steel and aluminum, and in the production of glass, enamel and brick." 1943 Environmental pollution by toxic metals, including fluorides, affects forests, livestock, and urban residents, but coverage remains on local levels. 1944 "Even at 1ppm, fluoride in drinking water poisons cattle, horses and sheep" (Moules, G.R., Water Pollution Research and Summary of Current Literature, 1944. 1944 The city manger of Grand Rapids, Michigan announces that the Michigan State Department of Health is planning a long range experiment with fluoridated water and that Grand Rapids was selected as the location for the experiment. The city commission approves a motion to fluoridate on July 31, and decides it is to begin in January 1945, despite the warning issued three months earlier, ironically, by the American Dental Association. Grand Rapids becomes the first city in the United States to conduct this experiment. It was to serve as the test city to be compared against un-fluoridated Muskegon for a period of ten years relative to tooth decay, "at which time it would be determined whether or not fluoride was "safe and effectiv." Dr. H. Trendley Dean was put in charge of the project. The experiment was terminated early, after the control city was fluoridated, ruining the validity of the experiment, with the pronouncement that fluorides in public water supplies was "safe".See 1945. 1944 The Pentagon Scientific Research and Development Group further pursued the project to fluoridate the drinking water of Newburg, New York. Members included Henry L. Barnett, a captain in the Manhattan Project medical section, John W. Fertig, SRDG, Dr. Hodge, and David Ast, chief dental officer of the New York State Health Department, who was placed in charge of the Newburg Project. The group sought information on cumulative effects, which was also a goal of the Manhattan Project. (See below) 1944 Through 1948. Previously classified documents from Manhattan Project which indicate the government knew the physiological and psycho-behavioral effects of fluorides, as a result of studies connected with determining the effect of uranium hexafluoride processing on workers, as well as studies in defense of litigation against the project by tree growers who experienced fluoride damage from airborne pollutants connected with the project. Ref: Declassified documents from the National Archives published in 1997.

1944 An April 29, 1944 Manhattan Project memo, released in 1997, states "Clinical evidence suggests that uranium hexafluoride may have a rather marked central nervous system effect, with mental confusion, drowsiness and lassitude as the conspicuous features... it seems that the fluoride component is the causative factor....since work with these compounds is essential, it will be necessary to know in advance what mental effects may occur after exposure, if workmen are to be properly protected. This is important not only to protect a given individual, but also to prevent a confused workman from injuring others by improperly performing his duties". Ref: Previously classified SECRET Manhattan Project Memo, 29 April 1944, declassified and released from the National Archives. 1944 Oscar Ewing is put on the payroll of the Aluminum Company of America ALCOA), as an attorney, at an annual salary of $750,000. In 1947, Ewing was made Federal Security Agency Administrator, with the announcement that he was taking a big cut in salary. The US Public Health Service, then a division of the FSA, comes under the command of Ewing, and he begins to vigorously promote fluoridation nationwide. Ref: May 25-27 Hearings before the Committee on Interstate and Foreign Commerce. A by-product of aluminum manufacture is toxic sodium fluoride. Ewings public relations strategist for the fluoride campaign was the nephew of Sigmund Freud, Edward L. Bernays. Bernays conducts a public relations campaign to promote fluorine ingestion by applying Freudian theory to induce public acceptance. It was one of Bernays most successful campaigns. 1944 The October 1944 issue of the Journal of the American Dental Association cautions that "knowledge of the subject does not warrant the introduction of fluorine in community water supplies generally. Sodium fluoride is a highly toxic substance, and while its applications in safe concentrations, and under strict control by competent personnel, may prove to be useful therepeutically, under other circumstances it may definitely be harmful. To be effective, fluorine must be ingested into the system during the years of tooth development, and we do not yet know enough about the chemistry involved to anticipate what other conditions may be produced in the structure of the bone and other tissues of the body generally. We do know that the use of drinking water containing as little as 1.2 to 3.0 ppm of fluorine will cause such developmental disturbances in bones as osteosclerosis, spondylosis, and osteopetrosis, as well as goiter, and we cannot run the risk of producing such serious systemic disturbances in applying what is at present a doubtful procedure intended to prevent development of dental disfigurements among children ... because of our anxiety to find some therapeutic procedure that will promote mass prevention of caries, the seeming potentialities of fluorine appear speculatively attractive, but, in the light of our present knowledge or lack of knowledge of the chemistry of the subject, the potentialities for harm far outweigh those for good." 1945 An FDA Chief inspector discovers that fluorides are being added to beer by the Commonwealth Brewing Company of Massachusetts (the same state where they did experimental fluoride treatments on institutionalized children). The owner of the brewery

was arrested and subjected to a Federal jury trial for poisoning the beer. The indictment charged that the beer contained "an added poison or deleterious poison, fluoride, which was unsafe within the meaning of the statute (Section 301a of the Food, Drug and Cosmetic Act), since it was a substance not required in the production of the beer, it could have been avoided by good manufacturing practice." The fact was established that the fluoride was added in the concentration of 0.5 ppm. The jury was instructed that fluoride was established to be harmful and poisonous, and that it was unimportant to show how much beer it would take to demonstrate harmful effects. Beer was classified as a food and fluoride as a poison in 1945. The Commonwealth Brewery Company was slapped with a $10,000 fine, and Kaufmann, the owner, was given a 6 month suspended jail sentence and a three year probation period. 1945 Newburgh, New York has their water supply fluoridated in May 1945. Subsequent exams of the children by x-ray reveal that almost 14% have cortical defects in bone, compared to the nearby unfluoridated town of Kingston, where 7.5% have bone defects. The data is suppressed. In tandum, Project F (connected with the Manhattan Project) conducted their own studies of Newburg residents, focusing on the amounts of fluoride Newburg residents retained in the tissues and blood - key information sought by the bomb program, according to previously classified documents released in 1997. See 1956. 1945 The newspaper Philadelphia Record, 18 October 1945, reveals an article entitled "First Bomb Suit for Ruined Peaches filed by Salem County Growers for $400,000" details suits against chemical manufacturers connected with the Manhattan Atomic Bomb Project for hydrogen fluoride damage to peach groves. Companies involved were DuPont de Nemours (which has been interacting with I.G. Farben in Nazi Germany), the Sun Oil Company and the General Chemical Company. 1945 The government does a public test case of fluoridation, comparing fluoridated Grand Rapids with unfluoridated Muskegon, Michigan. The study is to last ten years. After one year, it becomes obvious to the government that fluorides do not conform to their public propaganda, and the study is terminated. The city of Muskegon is then fluoridated in 1947 to conceal the difference in effect. Other experiments are performed covertly on population areas, without the knowledge of the subjects. 1945 Covert experiments with fluorides are conducted in Massachusetts and in Connecticut between 1945 and 1946 on indigent, mentally retarded children at state-run schools. According to 1954 testimony of Florence Birmingham, a trustee of the Wrentham State School in Massachusetts, her schools administration learned only by accident that fluorides were being put in the drinking water. 1945 A study reveals that fluoride's affinity for magnesium and manganese ions enables it to deplete their availability for vital enzyme functions. (Borei, H., "Inhibition of Cellular Oxidation by Fluoride", Arkiv.Kemi,Mineral,Geol., 20A, No. 8, 1945). 1946 A letter from the U.S. Engineer Office, Manhattan District, Oak Ridge, Tennessee, to Colonel Warren, Manhattan Project, 1 May 1946, regarding a trip to the DuPont plant,

discusses the fluoride damage to the environment. The letter also states "Would there be any use in making attempts to counteract the local fear of fluoride on the part of residents of Salem and Gloucester counties through lectures on fluoride toxicology and perhaps the usefulness of fluoride in tooth health?" Letter signed by Harold C. Hodge, who was also involved in the Newburgh, New York experiments. Ref: Previously classified SECRET Manhattan Project Letter, 1 May 1946, declassified and released from the National Archives in 1997. 1946 An issue of Medical Biochemistry contains a research study by Everetts which indicates that blood clotting may be affected by fluorides. 1946 Reports from the House Committee on Un-American Activities in the Armed Forces for 1946 and 1947 reveal the dociling effect of fluorides in the water supplies at military bases on American troops. 1946 Water fluoridation proponents claim no benefits for people over 9 years of age, promising the magic effect of fluorides occurred prior to eruption of teeth. Despite this claim, all U.S. military reservations, populated by adults, were heavily fluoridated. 1946 Six more U.S. cities "allowed" to fluoridate their water supplies. 1947 ALCOA lawyer Oscar Ewing is appointed head of the Federal Security Agency, later HEW, a position that places him in charge of the Public Health Service. Under Ewing, a national fluoridation campaign rapidly materializes, spearheaded by the Public Health Service. Over the next three years, 87 additonal cities were fluoridated, including the control city of Muskegon in the original Michigan experiment, thus wiping out the most scientifically objective test of safety and "benefit" before the test was half over. Ewing's public relations strategist for the fluoride campaign was Edward L. Bernays, Sigmund Freuds nephew, who pioneered Freudian theory toward advertising and government propaganda. (See Bernay's, 1928 and his book Propaganda). Because of Bernay's people would be induced to forget that fluorides were toxic poisons. Opponents to the fluoride program were painted as "deranged". In 1996 they would be painted as "civil rights activists". 1947 Forrestal appointed Secretary of Defense. Asked to resign in 1949 after noting forces planning the war in Korea. See 1949. Later murdered. Forrestal was very much opposed to the use of fluorides on military bases to keep the troops docile. (York Daily Times, Letters to the Editor from former FBI agent Wesley C. Trollope, Omaha, Neb., March 17, 1967). 1948 Study done in England where bone defects in three groups of school boys were studied. Two groups were from districts where the water supply was practically free of fluorine. The third group was from the town of Launton, where the natural water supply contains 1ppm of fluorine (the same as the level deemed "safe" by the U.S. Public Health Service). X-ray examination revealed that 20 percent of the first two groups had mild non-specific spinal irregularities. In the third group, the one consuming 1ppm fluoride in

their water, 64% were found to have spinal defects, and lesions were more severe. 1948 A censored version of the Manhattan Project fluoride safety study is published in the August 1948 Journal of the American Dental Association. Comparison with the previously classified version in 1997 indicates that the U.S. Atomic Energy Commission did censor damaging information on fluorides. Ref: Fluorides, Teeth and the Atomic Bomb, 1997. 1948 John McCone becomes Secretary of Defense of the United States. McCone gives contracts to Standard Oil and Kaiser Aluminum, in which he already has financial interests. Aluminum manufacture by-products, fluorides, would be added to the population water supplies to induce submission by damaging the brain and stem resistence to domination by global socialism. 1950 The 24th edition of the U.S. Dispensatory (pp 1456-1457)defines fluorides as "violent poisons to all living tissue because of their precipitation of calcium. They cause fall of blood pressure, respiratory failure, and general paralysis. Continous ingestion of non-fatal doses causes permanent inhibition of growth ... the use of fluoride-containing dentifrices and internal medicants is not justified." In subsequent editions, the editors removed this entire portion. Why? Science and biology doesn't change. Political agendas do. 1950 The publication Science features research by C.W. Sheppard which indicates that fluorides "lower hemoglobin and may cause irreversible loss of potassium from the red cells." 1950 Alcoa Aluminum's Vancouver, Washington plant is found guilty of dumping 7,000 pounds of toxic fluorides each month into the Columbia River. According to the December 15, 1952 Seattle Times, "the fluoride contaminated the grass and forage and resulted in injury and death to cattle." See 1957 (Alcoa). 1950 The U.S. Public Health Service officially publicly endorses the concept of the addition of fluorides to public water supplies. 1950 The Seventh Annual Report of the Sugar Research Foundation recognizes sugar as the major cause of tooth decay. The SRF furnishes grants to the Harvard Department of Nutrition to "solve the tooth decay problem without restricting sugar consumption". The result of these grants was the advocating of water fluoridation. 1950 From 1950 to 1951, ALCOA advertises sodium fluoride for addition to water supplies. 1950 The Seventh Annual Report of the Sugar Research Foundation (130 corporations) expresses its "aim in dental research" : to discover means of controlling tooth decay by methods other than restricting sugar intake. Two institutions most aggressive in promotion of water fluoridation, the Dental Schools of Harvard and the University of

Rochester, receive large grants for fluoride research from the sugar industry. 1950 Soviets add fluorides to water in prison system to maintain subservience in the inmate population, affect the central nervous system and produce compliance with authority. Fluorides shipped from the US via Alaska, starting in the 1940's, to the Soviets for use in their Gulag prison system. The U.S. continues to promote addition of fluorides to public water supplies. 1950 In the Journal of the American Dental Association, Vol 40:440, April 1950, was a study by G.J. Cox and H.C. Hodge, "Toxicity of Fluorides in Relation to Their Use in Dentistry", which says, "Some of the basic and necessary metabolic processes in the cell are stopped by concentrations of fluorides such as are found in acute poisoning. These changes are comparable to those seen in high-grade anoxia and are the basis for describing fluorides as general protoplasmic poisons." Study also quoted in JADA Nov 1962, pp.687-688. 1951 The February 10, 1951 issue of JAMA Medical Literature reports the following symptoms of chronic fluoride poisoning, stating "Chronic intoxications resulting from prolonged intake of smaller amounts of fluorides include dental fluorosis. Fluoride also tends to accumulate in bones, leading to hypercalcification and brittleness. Ligaments and tendons also become calcified. Serious symptoms may ensue, such as loss of mobility of joints, easy fractures and pressure on the spinal chord. Other effects include baldness in young men, accompanied by increased fluoride concentrations in hair and nails, anemia and decreased blood clotting power due to the binding of calcium. Dysmenorrhea, alterations in growth and weight, lowered birth rate, high incidence of fractyre, thyroid alterations and liver damage have been observed in regions of endemic fluorosis." 1951 The U.S. Public Health Service, with the cooperation of the American Dental Association, holds a meeting of state dental directors at which the methods for promotion of fluoridation were outlined. Thus the USPHS formed an alliance with medical trade unions and industry to promote the addition of toxic fluorides to the public water supplies. A concentration of 1.2 ppm was suggested, and state dental directors were instructed to lie to the public about the toxic effects of sodium fluoride, deliberately misinform the public by relating the presence of "high-fluoride areas" to "less cancer and less polio" - an entire public relations campaign meant to convince the public to allow themselves to be medicated - just like the inmates in Soviet and German prisons and camps. Their technique was not to refute the thing but to show that the opposite was true, even if the opposite was not true. Ref: Proceedings of the 1951 meeting in Washington D.C. 1952 After Dr. A.L. Miller, former Nebrasks Health Commissioner, became a Congressman, and found he had been bamboozled by the former highly paid attorney for Alcoa Aluminum, Oscar Ewing (who later founded Triangle Research Park) into helping fluoridate the water of Washington, D.C., Miller revealed at a Congressional Hearing, reported in the March 24, 1952 Congressional Record, how he had been misled. He wondered aloud about how Mr. Ewing became Federal Security Administrator and

whether Alcoa "might not have a deep interest in getting rid of the waste products from the manufacture of aluminum products". Miller asked Dr. John D. Porterfield of the U.S. Department of Agriculture if studies had been done to see what fluorides might do to pregnant women. Porterfield replied, "They have different objectives in mind, sir. There is more money available for matters that have economic value than there is for health." 1952 The American Dental Association publishes an issue of its Journal instructing its dentists not to discuss their personal opinions about fluoride. 1952 From 1952 to 1956, the cities on the "fluoridation list" began to fluoridate their water supplies. As the process of water fluoridation continued, the cancer death rate of the fluoridated cities began to far exceed the rate of the unfluoridated cities. 1952 San Francisco begins to fluoridate its public water supplies. 1952 Pittsburgh, Pennsylvania begins to fluoridate its water supplies. On Oct 15, 1967, the Pittsburg Press would report that 98% of the school children 13-15 years of age had crooked teeth in Pittsburgh. 1952 During February through April 1952, dental officers from England visit the United States, including the National Institute of Dental Health in Bethesda, Maryland, and the ADA headquarters in Chicago. Host of the visit are Surgeon General Scheele and Assistant Surgeon General Knutson. All four members of the British committee are "convinced", and return to England. 1952 U.S. "Public Health" officials Dr. Dean, Dr. Arnold and McClure concentrate their efforts to introduce fluoridation into Australia and New Zealand. 1952 Congressional representative from Nebraska, Dr. A.L.Miller, who was also the Chairman of the Special Committee on Chemicals and Foods, comments on the fact that within 3 months the USPHS, who did not endorse fluoridation of public water supplies, suddenly reversed course and promoted it very heavily. Dr. Miller said he could not find any public evidence that the AMA, the ADA and other health agencies had done any work at all on researching the safety, but were in fact just endorsing each other's opinions in support of the program. Miller noted that all scientific experts in biochemistry had advised the "go-slow" sign relative to fluoridation of public water. Dr. Miller expressed the fact that he wondered whether of not ALCOA and its subsidiary companies might not have a deep interest in getting rid of waste products from the making of aluminum. Dr. Miller also stated that it was interesting to note that Oscar Ewing, who headed up the Federal Security Administration (at the time the parent organization for the U.S. Public Health Service) was connected with the legal firm of Hubbard, Hill and Ewin, who also represent ALCOA. [Later, dentists who opposed administration of toxic fluorides to patients were censured or lost their membership to the ADA (beginning around 1960); scientists who came out with evidence of fluorides dangerous nature were personality and publically denegrated by the ADA and USPHS, and the research (often far better and more rigourous) was portrayed by the ADA and USPHS as being faulty or irrelevant;

those who opposed fluoride could not get or keep USPHS grants; public health officials who disagreed lost their jobs. Meanwhile, the ADA, USPHS and fluoride producing industry continued in the conspiracy to defraud the public by claiming fluoridation was "absolutely safe". It is estimated that since the time fluorides have been added to the food, water and air in the early 20th century, over 130 million Americans have suffered chronic fluoride poisoning, accelerated aging and degenerative disease - all due to fluoride products which they are encouraged to consume. It continues, despite the evidence, because fluorides also are behavior modifiers for the population - chemical mind control with built-in money-making degenerative capabilities.] 1952 82nd Congress, 2nd Session, Hearings of the Select Committee to Investigate Use of Chemicals in Food and Cosmetics. Dr. Miller "The US Dental Assn made some examination and recommended to the farmers that fluorine not be added to the water of pregnant sows because it did something to the pigs that were unborn" Dr. Porterfield "There is more money available for matters that have economic value than there is for health." 1953 Dr. Max Ginns of Worchester, Massachusetts, circulates a petition against water fluoridation, signed by 119 dentists and 59 medical doctors who oppose the use of fluorides. Ginns was dropped from the state dental society in 1961 because of this effort. 1953 It is learned by Miss Florence Birmingham, who testified before the Committee on Interstate and Foreign Commerce hearings on the fluoridation of water, that the state of Massachusetts has been doing fluoride experiments at state institutions for the feebleminded, including Wrentham, Fernald and Belchertown on the orders of the state health department. All of this a clear violation of the Nuremberg Pact. 1953 The May 14, 1953 issue of the AMA publication Todays Health contains an editorial in which it is stated, "Because the matter of water fluoridation is so exclusively a dental project, no experimental work has been carried out on this by medical professions. It is our understanding that this matter has been gone into extensively by the American Dental Association..." 1954 Charles E. Perkins, the scientist sent by the U.S. to Germany after World War II to supervise the breakup of I.G. Farben, states, "the real purpose behind water fluoridation is to reduce the resistence of the masses to domination and control, and loss of liberty." 1954 Denver begins fluoridation of its public water supplies. 1954 A study is published which links fluorides and the development of cancer in animals. Ref: A Taylor, "Sodium Fluoride in the Drinking Water of Mice",Dental Digest, Vol 60, pp170-172. 1954 C.E.Perkins, I.G.Farben chemist, admits fluoride is to reduce resistance in people to authority.

1954 In 1954, the Christian Science Monitor surveyed all 81 Nobel Prize winners in the fields of chemistry, medicine and physiology on their opinion regarding water fluoridation. Seventy-nine percent failed to endorse water fluoridation, which the promoters claim is endorsed by all "reputable" scientists. 1955 An Oregon Federal Court tries the case of Martin v. Reynolds Metals, in which the Martin farm had been contaminated by fluorides from the aluminum plant. ALCOA and six other metals and chemical companies join Reynolds as "friends of the court" to get the decision reversed when the court finds in favor of the Martins. The Reynolds attorney contends "if allowed to stand, the verdict would become a ruling case, making every aluminum and chemical plant liable to damage claims from fluoride and heavy metal pollution simply by operating. Despite all this, the Martins won, and Reynolds finally made the case moot by buying the Martin's ranch for a large sum. 1955 Dr. Heinrich Hornung, a German health officer and one of Europes most dedicated advocates of water fluoridation, comes to the U.S. in an attempt to refute evidence of fluoride toxicity. 1955 From 1955 to 1957, K.K. Paluev, a brilliant General Electric Company research and development engineer, was the first to point out that the statistics relative to the studies done in Grand Rapids, Michigan; Newburgh, New York and other cities touted as "reducing decay by 65%" those promoting fluoridation show a delay in eruption of teeth, due to the fluoridation, and that the claimed "65 percent reduction in tooth decay" were obtained partially by tabulating unerupted teeth as "sound" teeth. According to a statistical analysis later in 1959, paid for by the University of Melbourne, every fluoridation experiment done, as far as statistics are concerned, abound in contridictions, discrepancies, and omissions of pertinent data, and lack of adequate controls. (Fluoridation Errors And Omissions in Experimental Trials, by Philip R.N. Sutton, D.D.Sc., L.D.S. (Senior Research Fellow, Department of Oral Medicine and Surgery, Dental School, University of Melbourne, in collaboration with Sir Arthut B.P. Amies, Dean of the Dental School, University of Melbourne, Australia). In other words, every experimental trial in the world claimed to justify the belief that fluorides prevent dental caries is fraudulent, and can be proved fraudulent. For extreme detail on this matter, consult "The Greatest Fraud: Fluoridation", by Philip R. Sutton, 1996, Kurunda Pty, Ltd, P.O. Box 22, Lorne, Australia 3232. ISBN 0-949491-12-8. 1955 Fluoride toothpaste is marketed with the warning that "fluoridated toothpaste should not be used where the water supply is fluoridated." A later decision stipulated that "children under 6 should not use Crest". Both warnings were instituted by the Public Health Service, but in 1958 both regulations were abandoned, even though no research was available to show that the fluoride overdose hazard no longer existed. 1955 Dr. William Wolf, a clinical professor at New York University School of Dentistry, observes four cases of poisoning from drinking fluoridated water. After verifying the diagnosis, he warns colleagues. The Dean of the University then informs him that his teaching services will no longer be required. Wolf informs the Dean that he will go public

with this, and the Dean dropps the matter. 1956 Maurice Natenburg, medical writer and managing editor of Regent House, publishes a pamphlet entitled The Fluoride Curtain, in which he states "The AMA endorsed fluoridation just after their successful fight against an Ewing-sponsored bill to introduce socialized medicine in the United States. The AMA made a special assessment on its members, spending some $3 million in the battle to defeat the bill. After the battle was over, the AMA suddenly saw the 'merits' of water fluoridation." See 1961 AMA disapproval of fluoridation. 1956 March 1956 issue of the Journal of the American Dental Association, H.C. Hodge remarks, "skeletal deposition of fluoride is a continuing process in which a considerable portion of the ingested fluoride, perhaps 25 to 50%, is deposited in the skeleton." 1956 The final report of the Newburg, New York demonstration project is published in the Journal of the American Dental Association, concluding that "small concentrations" of fluoride were safe for U.S. citizens. The biological "proof", based on work performed at the University of Rochester Atomic Energy Project, was delivered by Dr. Hodge. 1956 Ionel Rapaport, French endocrinologist at the Psychiatric Institute of the University of Wisconsin, ascertains the birthplace of all mongoloid children in Wisconsin, North Dakota, South Dakota and Illinois, and grouped them together according to the published fluoride content of the municipal drinking water. Tabulating the 687 urban cases, he finds a two-fold statistically significant greater prevalence or risk of mongoloid births in communities with 1 ppm or more in the water. Using Van Valens formula reveals a combined statistical probability of less that 1 in 125,000 that the correlations from all four states are due to chance. The incidence of the birth defect increases as the fluoride content of the water increases. This is the only study of its kind to include maternal data. See 1959, second study on Down's Syndrome and fluoridated areas). [Bulletin of the Academy of National Medicine, Paris, Vol 140, pp.529-531]. 1956 American Psychoanalytical Association study on sleep disturbances was convened, showing how the profession responded to various neurological disturbances emerging in society. Since the connection between changes in brain chemistry and external substances had been replaced by psychology, it made it extremely difficult (according to Gershwind in 1982) to accept that there are instances in which difficulties in emotional adjustment are the primary result of alterations in the brain. 1957 The American Medical Association announces "no evidence has been found since the 1951 statement to prove fluoridated water at the recommended concentration of fluoride is harmful to the general health.". See JAMA Medical Literature, 1951. 1957 Feltman and Kosel find that 34 of 38 leading Vitamin and mineral supplements have as much as 286 micrograms of fluoride in them. [Feltman R., et al, "Fluoride in Pharmaceutical Preparations", NorthWest Medicine, Vol 55, pp.663-1664, June 1956.]

1957 The FDA tolerance for insect sprays on 60 fruits and vegetables allows 7 ppm fluorides. DeEds writes, " it is a well-established fact that chronic intoxication may manifest itself in man as recognized abnormalities only after constant, or frequent exposure to fluorides. " [ Official FDA Tolerances for Residues of Pesticide Chemicals, National Agricultural Chemicals Assn News and Pesticide Review, Vol 15, pp.5-14, May 1957 ]. 1957 Controversial statement from Oliver Kenneth Goff, June 22, 1957, a member of the Communist Party and the Young Communist League from May 2, 1936 to October 9, 1939, reveals he testified before the House Un-American Activities Committee in 1939, as to the implementation of the fluoridation of American public water supplies in the same way they used it as a brain tranquillizer at Soviet prison camps. Goff reflected that the Party leaders felt that it would bring about lethargy in the U.S, and keep the public docile during a steady encroachment of Communism. Also discussed, says Goff, was keeping a store of deadly fluoride near the water supplies where during a time of revolt it could be dumped wholesale into the water supply and either kill off the populace, or threaten them with liquidation, so that they would surrender to obtain fresh water. (See Ref#64,65). Sworn statement in Arapahoe Country, Colorado, notarized. (Ref: Fluoridation, by Isabel Jansen, R.N, 1990, ISBN 0-932298-73-7, page 128, Tri-State Press, Antigo, Wisconsin 54409) 1957 An experiment is done at the Montreal Neurological Institute by William Scoville and Brenda Miller removed the hippocampus from a man suffering from epilepsy in an attempt to stop the attacks. (See 1994 scientific report on the effect of sodium fluoride on the brain and behavior, and the hippocampus). The subject in this historical case, H.M., lost the ability to remember recent events. Almost 28 years after the operation, for H.M. a typical day's activities included doing crossword puzzles and watching television, although he does not remember where he lives, who cares for him, or what he ate at his last meal. (Neurobiology, 1994) 1957 In a 1957 AMA report it was stated " It is too early to know what the effects of artificial fluoridation will be. What is reported as a reduction in dental decay may in fact be a delay in recognition of decay, and reasons given for believing that artificially fluoridated water will have the same effects as water with natural fluoride are not valid." 1957 The September 1957 issue of Northwest Medicine featured an article by Thomas E. Douglas, M.D., entitled "Fluoride Dentifrice and Stomatitis", where Dr. Douglas explains his puzzlement over the increasing frequency of patients with oral lesions. He discovered that all patients with lesions used fluoridated toothpaste. 1957 Alcoa Aluminum Company announces the sale of sodium fluoride (rat poison) directly to municipalities for fluoridation of drinking water. When it became obvious that phosphate fertilizer companies could sell toxic fluorides cheaper, Alcoa was priced out of the fluoride dumping market. 1957 Records for New Britain, Connecticut (where the use of industrial fluorides had

been in use for 6 years) showed that some of the children's teeth had been damaged beyond repair where the water is fluoridated, even when the percentage of industrial fluorine is kept at or below 1 ppm, mottling is produced in 10-15% of the children examined. Mottled teeth are teeth showing symptoms of fluorosis, and the enamel of mottled teeth is brittle and subject to mechanical injury which is difficult or impossible to repair. 1958 In April 1958, the Association of American Physicians and Surgeons, with more than 15,000 members, most of whom are also members of the American Medical Association, pass a resolution in opposition to fluoridation, which states "The Association condemns the addition of any substance to the public water supply for the purpose of affecting the bodily or mental function of the consumer." 1958 Dr. F.J. Stare of Harvard University gives a speech in Needham, Massachusetts, promoting "fluoride as a nutrient", citing the research done by Maurer and Day. Dr. Fred Exner takes him to task, pointing out that the study by Maurer and Day was called "The Non-Essentiality of Fluoride in Nutrition", and that animals fed a fluoride-poor diet could produce no symptoms of "fluoride deficiency". Journal of Nutrition, 62, 561-573,1957. Dr. Stares' fraudulent claims are still be quoted as 'facts", although he recanted his claim that "fluorides will benefit or cure bone disease" in the April 6, 1972 Boston Herald Traveler. 1958 Fluoridation is introduced experimentally in the West German town of Kassel by special dispensation of the Minister of Health. The fluoridation plant would be taken out of service in April 1, 1971 as a result of legal and health considerations. 1958 Renowned geneticist H.J. Muller reveals that fluorides produce primary damage by injuring the genetic material of the cells they enter. [Muller, Symposium on Emphysema and Chronic Bronchitis: "Do Air Pollutants Act as Mutagens?", Aspen, Colorado, June 13-15, 1958] 1958 In October 1958, Dr. J.F. Montague, a medical doctor, published material reflecting his growing concern over fluoridation in the Journal of the International College of Surgeons connecting the presence of fluorine in the human body to cancer. Also in 1958, an interesting piece of work was done by Dr. James Kerwin, a dentist, in which it was shown that the simultaneous presence of fluorine and strontium 90 in the human body may result in a greater accumulation of both substances in which compounds like strontium fluoride are formed. Because of the low solubility of these substances, the body has a very hard time getting rid of them. His report was published in Dental Digest in February 1959. 1958 The World Health Organzation (WHO) establishes an Expert Committee in Geneva to study fluoridation. At least 5 out of 7 members of the commitee had promoted fluoridation in their respective countries. [The deck was already stacked]. Two well-known American proponents were Dr. J.W. Knutson and Professor H.C. Hodge. Hodge had some of his research financed by the Atomic Energy Commission, which was

confronted with serious fluoride disposal problems from uranium processing. Another member promoting fluoridation, Professor Yngve Ericsson from Sweden, a prominent advocate of fluoridation in Europe, was the recipient of a U.S. Public Health Service grant and received royalties from Sweden's toothpaste industry. Research documenting poisoning from fluoridated water was rejected. See 1969, WHO Endorsement of fluorides] 1959 Rapaport does a second study on fluoridation and birth defects in Illinois from 1950 to 1956. The study is reported in 1959. The data indicated a highly significant association between the frequency of Down's Syndrome and the fluoride content of the mother's drinking water. 1959 In the report of the proceedings of the 3rd Medical-Dental Conference on the Evaluation of Fluoridation, held on March 7, 1959 in New York City, the committee concluded that "It is apparent that the practice of fluoridation is not the simple is not the simple, trustworthy procedure that the promoting authorities have given the profession and the public to believe. Added to the lack of control of fluorides at the consumers tap are these major uncertainties: the gross variation in individual water consumption, the varied intake of fluorides in food and the fluoride intake from atmospheric and occupational exposure. These unpredictable issues make meaningless any talk about "controlled individual fluorine intake." Most, if not all of this research has been buried by the authorities, who maintain glibly that "fluoride compounds are safe in the water supply". Willfull criminal negligence and conspiracy. 1959 Fluorides were used as an enzyme inhibitor in a study by J.D. Ebert that was published in 1959 on the metabolic pathways by which organs in an embryo are formed. In low concentrations, he found that sodium fluoride blocked almost completely the regions destined to form muscle, primarily affecting the heart muscle. In higher concentrations, it caused the entire embryo to disintegrate in a clear-cut pattern, starting with the heart-forming region. 1959 As early as 1959, the knowledge existed that the presence of fluoride in human bodies hastens the absorption of radioactive substances present in the environment. In a report to the Atomic Energy Commission's Division of Biology and Medicine entitled "The Metabolism of Alkaline Earth Metals by Bone" by F.W. Lengemann, professor of chemistry at the University of Tennessee on March 23, 1959, it was scientifically shown that the presence of fluorine and other environmental substances such as lead and cyanide in the human body increased the ratio of strontium 90 to calcium in bone - caused the body to absorb radioactives. 1959 In 1959, the Ontario Minister of Health, Dr. Dymond, announced that no further fluoridation would be permitted there, because "no one knows for sure what the effect is to persons given fluoride throughout a lifetime." 1959 In research conducted on the incidence of Mongolism in cities in Wisconsin, Illinois and the Dakotas published in 1959 in the official publication of the French Academy of

Medicine, it was found that as the percentage of fluorides in the water rose, there was a parallel rise in the incidence of Mongoloid births the age of the mothers giving birth to Mongoloid babies also declined with rising fluoride levels. It is interesting that in the first three years of fluoridation, New Britain, Connecticut experienced a 150% rise in still births. 1960 In 1960, the American Dental Association issued a pamphlet for public consumption called Fluoridation Facts: Answers to Criticisms of Fluoridation. In defense of the use of toxic fluoride compounds in public water supplies (which is a grievous crime against humanity, since it means mandated involuntary public medication), they used the logic that "people have been known to live to a ripe old age" in areas where the water supply is fluoridated. Unfortunately, they neglected to mention that the addition of fluoride to the water supply correlated directly with the number of still births, mongoloid children, brittle teeth and enlarged dental root structures, adverse spinal conditions, osteomalacia (softening of the bones) and osteoporosis (abnormally porous and spaced structure inside bone) in the medicated population as opposed to control populations that were unmedicated. People die young "at a ripe old age". 1960 A study is done in Japan that involved examination of fluoride deposition in the fetuses of dogs. It was found that the quantity of deposited fluorine was especially large in bones, largest in the cranial bone as well as the lower leg bone. The quantity of fluorine deposition was parallel with the progression of the calcification. They also proved that the deposit of fluorine on teeth and bones starts through the placenta as early as the embryo period, and then takes place through the mothers milk through the infancy period, and through food, as well as directly through the inside of the oral cavity. As fluorine is a known active enzyme poison, it is known to affect cell division (mitotic) in the fetus, resulting in anatomical anomalies (teratism). 1960 The commitee on fluoride meets in Toronto, Ontario, Canada. Dr. G.E. Hall guides the deliberations. His daughter was employed by an aluminum corporation with fluoride pollution problems, he was himself serving as honorary advisory director for a leading fluoridation promotion organization, and his university (University of Western Toronto) was the recipient of grants from the U.S. Public Health Service. (three conflicts of interest). Fluoridation of all public water supplies in Canada was advocated. 1960 In San Francisco on November 29, 1960 a 200-foot portion of a 50-foot wide street collapsed after an almost-new water main burst. After an analysis of the pipe by Griffin-Hasson laboratories in Los Angeles, it was discovered that fluoridation chemicals had corroded the pipe, which showed a fluoride concentration of 22,000 ppm on the pipe. 1961 Sweden's Supreme Court declared fluoridation illegal. 1961 The legal department of the American Medical Association issues a letter stating, "The AMA does not engage in the approval, endorsement, guarantee or acceptance of unfluoridated water or fluoridated water."

1961 In Great Britain, Dr. R.A.Holman of the Royal Institute of Pathology discussed fluoride poisoning in an article in the April 15, 1961 issue of the British Medical Journal. He noted that the long-term effects of sodium fluoride ingestion needed much more investigation, and continued, "Fluoride is a well-known inhibitor of several enzyme systems, and can form spectroscopically recognizable compounds with the enzyme catalase, resulting in its inhibition. Catalase poisoning has been linked with the development of viruses and the causation of a number of diseases, including cancer. Many observers have suggested that the agents (fluorides and other toxic environmental substances) which decrease the catalase the cells may predispose those cells to tumor formation. Voisin has said, "the method most likely to solve the problem of cancer is to ask why the cancer cell is lacking in catalase and try to prevent its impoverishment from taking place. 1962 A study in Portugal revealed that fluoride at 1ppm concentration caused a 25% decrease in activitiy of the enzyme succinic dehydrogenase in liver tissue, both in test tubes and in animal experiments. In vivo, fluoride at 1ppm inhibited liver activity by 6.4 percent. In kidneys this enzyme activity was reduced by 47.8 percent by fluoride at 1ppm in drinking water. The authors concluded, "significant enzyme inhibition due to prolonged fluoride administration demonstrates the impairment of an important step in cellular metabolism". (Sullivan, W.D.,S.J., and Von Knobeledorff, A.J., Broteria Serie de Ciencias Naturais, Lisbon, 21, No.1, 1962). 1962 Dr. John Knutson of the U.S. Public Health Service examines cancer death rates following the fluoridation of the public water supplies of Grand Rapids, Michigan. He found a 22% increase in cancer death rates, contrasted to the unfluoridated control city of Muskegon, itself fluoridated 5 years into the "15 year test" in order to conceal the greater caries prevalence in Grand Rapids. Ref: Fluoride Drinking Waters p.213 (1962). 1962 According to the 1962 Revision of Drinking Water Standads, the safety factor for fluoride in drinking water was listed as "zero". (Water and Its Impurities, Thomas Camp: Reinhold, New York). According to the author, "the threshold for mottled enamel overlaps the recommended concentration for artificial fluoridation". 1962 According to the November 1962 Journal of the American Dental Association, from 10% to 20% of the children in fluoridated Grand Rapids, Michigan, developed mottled or fluorosed teeth. 1962 Noted cancer researcher Dr. Ludwig Gross, whose work on leukemia is invaluable in cancer research and whose findings prompted a governmental crash program, was put on report after writing: "The plain fact is that fluoride is an insidious poison - harmful, toxic, and cumulative in its effects, even when ingested in minimal amount, will remain unchanged no matter how many times it will be repeated in print that 'fluoridation of the water supply is safe'". This 'defection' was pointed out to Dr. Gross' superiors in the US Public Health Service. However, a Veterans Administration official replied on September 24, 1962: "Dr. Gross is free to offer his opinion in any relation he may desire, but he does not speak for the Veterans Administration on the subject of fluoridation. This agency is

not opposed to the fluoridation of public water supplies." 1963 American Academy of Sciences study shows low fluoride levels increase tumors. 1963 A study is published which links fluorides and development of cancer in animals. Ref: Irwin Herskowitz and Isabel Norton "Increased Incidence of Melanotic Tumors...Following Treatment with Sodium Fluoride", Genetics, Vol 48, pp307-310. 1963 J.R. Shapiro, M.D., National Institute of Arthritis and Metabolic Diseases, in the October 31, 1963 issue of the New England Journal of Medicine, observed that the concept of extending low-dose fluoride "currently employed in preventing dental caries in children 'to include adults in the hope of preventing future osteoporosis' is largely unsupported by available data". See 1971. 1964 The Ministry of the Interior of Denmark issues a public announcement "fluoridation of public water supplies as well as of all consumables is prohibited". Denmark bans fluoride supplements in January 1964. 1964 As of April 1964, accounts in local newspapers showed that 200 cities had discontinued fluoridatio after they found that fluoridation did cause harmful effects to humans, animals and fish; that it did corrode plumbing; and that the cost was more than stated by proponents. 1964 A report in the British Dental Journal carried in the Philadelphia Bulletin on November 8, 1964, stated that a four-year experiment involving 1,000 English children had been abandoned because no significant differences were found in terms of caries between fluoride toothpastes and non-fluoridated ones. The British test was an independent trial by university professors, and all statistics were treated by independent statisticians. In contrast, in the United States, those experimental trials which used statistics featured statistical work done by the toothpaste manufacturers or by firms which were paid by the manufacturers, or by dental organizations. Such experiments are invalid. 1964 Scientific information is published on the Paradoxical Effect of the biological effect of chemical toxins, in an article by Shatz et al. That is the response increases with time and then diminishes with even higher doses. In other words there is not a linear relationship between dose and effect. This means that there is no threshold below which fluorides and radiation, for example, are harmless. This also applies to the electromagnetic effects on human biology. [Shatz, A., et al, "The Occurrence and Importance of Paradoxical Concentration Effects on Biological Systems", Compost Science, Vol 5, p.22-30, Spring 1964; Shatz, A., "Low Level Fluoridation and Low-Level Radiation - Two Case Histories of Misconduct of Science", by A. Schatz, Ph.D, Philadelphia, 1996] 1965 The November 1965 issue of the Journal of the American Dental Association, contains a section listing the names of individuals who oppose fluoridation, along with

denigrating information, charging that people are distributing leaflets misrepresenting sodium fluoride as rat poison ... which of course it is. 1965 The President's Science Advisory Commitee designates fluoride as "a highest priority pollutant". See 1967. 1965 A study is published which links fluorides to cancer in animals. Ref: A. Taylor and N.C.Taylor, "Effect of Fluoride on Tumor Growth", Proceedings of the Society of Experimental Biology and Medicine, Vol 65, pp252-255. 1965 Researchers at the University of Texas, Drs.Alfred and Nell Taylor, find that fluoride in the drinking water at levels between 0.5 and 1.0 ppm increased tumor growth rate in cancer-prone mice by 15-25%, inhibiting the efforts of the immune system to attack tumors. 1965 When asked about the advisability of adding sodium fluoride to table salt, the FDA on July 12, 1965 answered, "We would consider the addition of sodium fluoride to table salt as a violation of the Federal Food, Drug and Cosmetic Act." 1966 The National Health Federation publishes a book entitled Fluoridation, in which it is reported "the effect on fluorides on trout was toxic. In water samples with fluoride levels between 0.5 and 4.6 ppm from airborn fumes, trout eggs were worthless...there were malformations ... loss of adult fish was very great." Based on August 25, 1961 case in which the Meader Hatchery near Pocatello, Idaho, obtained a judgment in the U.S. Court of Appeals against the Simplot Company, which was releasing airborn fluorides, polluting fish production. 1966 A study at Texas A&M University demonstrates that fluoride causes genetic damage to onions and tomatos. 1966 Scientific report reveals that "at concentrations too low to cause visible tissue injury, fluorides induce significant mitotic and meiotic chromosome alterations in tomato plants." [Mohamed, A.H.,et al, "Cytological Effects of Hydrogen Fluoride on Tomato Chromosomes" Canadian Journal of Genetic Cytology, Vol 8, p.575-583,1966] 1966 The International Society for Research on Nutrition, Vital Substances and the Diseases of Civilization (founded by Dr. Albert Schweitzer in 1954) approves a strong resolution (No.39) advising local and state governments against fluoridation. The resolution stated, among other things, that "fluoride is an enzyme poison which can cause irreversable and unpredictable diseases." The action is supported by more than 98 percent of the Society's 400-member Scientific Counsil, of which more than half hold appointments in major world academic institutions in over 75 countries. [ Fluoridation and Truth Decay, 1974, Caldwell, p.285 ]. After Schweitzers death, Linus Pauling attempts to get the Society to reverse its position on fluorides, but the Society responded by reaffirming its antifluoridation position in two succeeding years. Despite this effort by hundreds of world scientists not beholding to the USPHS for grant money, the U.S.

Public Health Service continued its fluoridation propaganda on American citizens. 1966 In May 1966, the Los Angeles Water and Power Department took it upon itself to call a meeting in an effort to get Los Angeles water fluoridated. The effort ended when legal counsel informed the water department that they had no jurisdiction over fluoridation. Word of the meeting brought throngs of people protesting the addition of toxic fluorides to the water supply. After the meetings ended, the City Council then called for a fluoridation hearing to begin on July 21, 1966 at which councilman Tom Bradley (later mayor of Los Angeles) was to introduce the fluoridation resolution. Dr. Louis Bullock, president of the Los Angeles branch of the American Cancer Society touted the new cancer drug 5-Fluoracil as "one of the most effective drugs used to treat and control cancer", stating that they 'safely' gave cancer patients 150 to 500 mg of fluoride a day", and that "it strengthened the bones". [Yet, the 1965 Modern Drig Encyclopedia and Therapeutic Index Pharmaceuticals, Biologicals and Allergens contains a three-column listing of disasterous effects from 5-Fluoracil, one of them being "fatalities may be encountered occasionally in patients in relatively good condition". In March 31, 1972, the Los Angeles Herald Examiner headlined a story "Scientist Hots Cancer Drug 'Overkill' ", which stated that 5-Fluoracil as a cancer treatment represents a case of classic overkill which does more harm than the cancer itself." In other words, Bullock was either naive or he lied at the July 21, 1966 meeting ]. See 1969 LA Times. 1966 In February 1966, Dr. Robert Felix, former Director of the National Institute of Mental Health, addresses a fluoridation conference of 500 national leaders. He doesn't speak of the dental health of children, but instead about the "mental health of opponents of fluoridation". In his speech, "The Care and Handling of Extremists", Dr. Felix offered the "fact" that "all opponents of fluoridation are mentally deranged, one way or another". He instructed proponents of fluoridation on "how to recognize and cope with the various categories of opponents". The Proceedings of this mad Symposium can be found in the February 10th and 14th, 1966 issue of the Congressional Record. Dr. Arthur Fleming, former Secretary of Health, Education and Welfare, was at the meeting. He suggested that "we need a 365-day-a-year educational program for schools", and suggested that "students might go home and talk fluoridation up at the dinner table". Programs in schools were then implemented where children were used as shills and messengers of propaganda for fluoridation. Several superintendents of schools in the Los Angeles area indicated that they would not take part in such a program. 1966 Testimony presented by John J. Miller, Ph.D, Chicago, Illinois at fluoridation hearings in San Jose, California on March 11, 1966, included the following statement: "Fluoride acts to tie up magnesium - forming magnesium fluoride - an insoluble compound which thus prevents the essential enzyme from using magnesium. As a result, mental processes are seriously interfered with, and nerve reactions throughout the body depressed ... this sort of toxicity is shown by research to play a role in epileptic seizures and other convulsions." [Ref: Fluoridation and Truth Decay, 1974, p.93] 1966 On April 22, 1966, Dr. F.J. McClure of the National Institute of Dental Research stated that according to their studies, "neither fluoridated toothpaste not topical

application with stannous fluoride is found to be of benefit in reducing the incidence of children's cavities". 1966 The Federal Drug Administration bans fluoride pills for pregnant women in October 1966, according to Drug News Weekly. The FDA ban was accompanied by the statement that "fluorides use did not impart stronger teeth or prevent tooth decay in the newborn" and that "there is scientific debate as to whether fluorides might aggrevate mental retardation and Mongolism in the offspring". Prior to this ban, millions of fluoride supplement tablets were used by pregnant women on recommendation of the Public Health Service and promoters of fluoridation. 1967 Fluoride pills are generally available free to children from dentists. See 1971. 1967 The U.S. Surgeon General, testifying before the Senate Subcommittee on Air Pollution and Water Pollution, declares that an investigation of environmental fluoride was urgent "to determine whether health is indeed threatened and what control measures may be necessary." 1967 An FDA statement dated June 19, 1967, informed that "the treatment of community water supplies is not subject to regulations under laws administered by the Food and Drug Administration, nor by any other Federal Agency. It is strictly a matter for decision by the community officials or under local ordinances." 1967 The July 1967 Annals of Allergy reported dermatitis and gastro-intestinal conditions from fluoridated toothpaste; and headaches, fever, and blood in stools from Tri-Vi-Flor given to children. 1968 In the January 1968 issue of the Journal of the Louisiana State Medical Society, Dr. C.C. Bass writes, "I now believe that continued ingestion of fluoride actually increases the activity of the already existing periodontoclasia." 1968 Emmanuel Landau, Ph.D., Statistical Advisor for the Center of Air Pollution Control, admits that fluoride pollution poses a potential danger to humans, saying "anything we don't know about constitutes a potential hazard. We know almost nothing about fluoride polluton. There is a great need for more research." [Note: Here we see the repeated lie that "little is known about fluoride pollution", despite the fact that there are probably more studies and more articles written on fluoride toxicity than on any other poison.] 1968 A study at the University of Missouri shows that fluoride causes genetic damage to tomatoes. 1968 The U.S. Department of Health Educationa and Welfare, in a May 31, 1968 letter to Congressman William C. Kramer, states, "The 1ppm fluoride in drinking water poses no safety problem if it is the only source of fluorides". However, American and Canadian research alone shows that water fluoridation accounts for only part of the daily fluoride

consumption. 1968 In the October 1968 issue of the Journal of the Indiana Dental Association, Dr. J.C. Muhler, who holds patents on the fluoride topical paste used in school "brush-ins", reported 11 cases of gum damage. 1968 Scientists at the University of Holland, Drs. Mukherjee and Sobels, find that fluorides increase the frequency of genetic damage in sperm cells of lab animals exposed to X-rays. Fluorides inhibited the repair of DNA damaged by radiation. 1968 For one year, the CIA begins chemical warfare experiments relative to the poisoning of water systems by injecting a chemical substance into the water supply of the FDA building in Washington. 1968 The Journal of the American Dental Association, Vol. VI, boasted: "Puerto Rico - First to Enact Fluoridation Law". Some cities in Puerto Rico were fluoridated in 1954, before any data were in on the so-called "10 year experiment" in the continental United States. A report of the condition of the teeth of children in PR was made by Dr. U.L. Monteleone of Allentown, Pennsylvania, who visited PR. According to Dr. Monteleone in May 1969, the children in PR had rampant dental decay, rampant malocclusion and rampant fluorosis. Monteleone was suspended for making the report. The June 1968 issue of the American Journal of Clinical Nutrition reported similar findings on the children in fluoridated Puerto Rico: "Dental caries are common ... dental fluorosis was particularly prevalent among school and adolescent boys in the 10-14 year old age group." 1968 Thomas R. Camp, Minority Report, Legislative Study Commission, 1968: "In view of the facts, it is recommended that legislation be passed in Massachusetts prohibiting the sale of fluorides for human ingestion whether in the drinking water, food or tablets." 1969 In the May 3, 1969 issue of the Washington Post, Nobel Laureate Dr. Joshua Lederberg, Genetics Department, Stanford University School of Medicine, says he would question those who claim fluoridation is "absolutely safe". 1969 The February 4, 1969 Los Angeles Times publishes a news story entitled "Expert estimates $12 billion in 30 years will be saved if water is fluoridated", authored by the Times Medical writer, Harry Nelson, quoting Dr. William Burton, Chief, Division of Health, State Department of Public Health. The material was a total fabrication. 1969 The World Health Organization endorses fluoridation of water supplies on July 23, 1969, despite cautions from G.Penso of the Italian delegation, who warned about "possible genetic damage to future generations". During the final hours of the session, when only 45 of the 1,000 delegates from 131 countries were still present, all bills that had not been accepted, including the one on fluorides, were collected and voted upon (no quorum, just like the Federal Reserve Bill in 1913), including the statement on fluoridation. The resolution urged member states to "examine the possibility of introducing fluoridation" wherew "fluoride intake is below optimum levels". [WHO

Chronicles, Vol 23, p.512, 1969] 1969 The July 7, 1969 issue of the Columbus Citizen-Journal, Ohio, contained an article entitled "The Costs of Fluoridating Water", in which the following facts were published follow a one year review of world literature on fluoridation completed in June 1969: Fluoride increases the incidence of mongolism, depresses the growth rate of human cells in culture, causes dermatitis, affects thyroid function, alters the concentration of metabolites in blood and urine, inhibits many important enzymes, affects reproduction, may incorporate itself into naturally occurring compounds to form others, is capable of producing cancer and giving rise to deformed babies, reduces fertility in female rats by more than 60 percent, and mimics the effects of some hormones - disturbing the hormonal balance." 1969 By 1969, the fluoridated cities had an average cancer death rate of 225 per 100,000 people, while non-fluoridated cities had an average cancer death rate of 195 per 100,000. The data indicates a fluoride-linked increase of cancer of 10% in only 13-17 years. These figures were checked and confirmed in 1979 by the United States National Cancer Institute. The increase in cancer death observed in fluoridated cities occurred primarily in people ages 45 and over; this fact is explainable because both the immune system and the normal DNA repair process (the two major defense systems against cancer) decline with age. 1970 In the October 1, 1970 Los Angeles Times, it was reported that the California State Board of health threatened to revoke the water license in San Gabriel if they continued to dispense water with 2ppm fluoride. 1970 A study at the University of Missouri demonstrates that fluoride causes genetic damage to corn and fruit flies. 1970 A spokesman for Reynolds Aluminum Company is quoted in the April 1970 Environmental Handbook Prepared for the First National Environmental Teach-In as stating that "it is cheaper to pay fines for polluting the environment than to control fluorides" (pay for the destruction of fluoride hazardous wastes). 1970 Dr. John D. Erickson of the CDC examined the cancer death rates of all U.S. cities with a population of 250,000 or more, and found that people in fluoridated areas experienced an age-sex-race corrected cancer death rate which was 4% higher than that of people in unfluoridated areas. The study was published in the New England Journal of Medicine, Vol 298, pp 1112-1116, 1978, eight years later. 1970 Psychologist James V. McConnel writes in Psychology Today that, " the day has come when we can combine sensory deprivation with drugs, hypnosis and astute manipulation of reward and punishment to gain almost complete control over individual behavior...we should reshape society so that we all would be trained from birth... no one owns his own personality."

1970 The U.S. Department of Agriculture Research Service releases Handbook No. 380, which summarizes some of the devastating effects of fluoride pollution: "A literature review was presented to indicate that fluoride was one of the industrial poisons that lowered the immunobiological response of man, pigeons, rabbits and other animals against certain diseases, such as typhoid fever, anthrax, tuberculosis and Staphylococcus aureus (p.52: Ref: Fridlyland, I.G.,1959, The Effect of Industrial Poisons on the Immunological State of the Organism, Gigiena i Sanitariya 24 (8): 55-61 (p.56). 1970 The 1970 World Health Organization book Flurodes and Human Health contained an article written by Dr. P. Venkateswarlu entitled "Effects on Body Fluids and Soft Tissues", which stated "Recently, the development of fairly dependable micromethods for fluoride determination and the availabilty of radiofluoride have given impetus to the study of fluoride metabolism in the soft tissues and body fluids." 1971 A study at Texas A&M University demonstrates that fluoride causes genetic damage to fruit flies. The study is repeated in 1973. 1971 An article in the scientific journal Nature revealed a study done by D.B. Ferguson of the University of Manchester Medical School which showed that the activity of the human serum enzyme alkaline phosphatase is measureably reduced by either dietary fluoride or fluoridated drinking water. According the Dr. Ferguson, "It can no longer be said that low levels of fluoride do not affect in vivo enzyme activity in man." (Nature, Vol. 231, pp.159-160, June 2, 1971). 1971 The November 12, 1971 Framingham, Massachusetts News Local carried an announcement from the board of health. Fluoridation was stopped in order to cure a green hair problem which had cropped up, due to the fluoridation chemicals leaching out copper from the pipes. It would be necessary to add another toxic chemical, sodium hydroxide, to counteract the problem. 1971 In the AMA's Drug Evaluation News, physicians are advised not to give children fluoride and vitamin pills together. [Note: Children do not retain as much fluoride when they are also given essential nutrients such as calcium, which acts as an antidote to fluorides. It leads one to wonder why the AMA would want children to accumulate more fluorides.] 1971 The August 22, 1971 National Enquirer reviews British claims on how the new drug fenfluramine (Fen-Phen) burns up fat and is appropriate for obese people. [In 1997, 26 years later, it is revealed that fenfluramine damages the heart and brain, which might indicate that the original "safety" studies were faked]. Dr. John Sedgewick, one of Britain's leading authorities on obesity pushes the drug in 1971. The article stated that the fenfluramine pill contains fluoride, and is an amphetamine type of drug which Dr. Sedgewicj intended to request the FDA to approve for sale in the U.S. Whereas Dr. Sedgewick claims that fluoride acts like a sedative, "it is also likely that it causes lack of appetite." Research performed on farm animals shows that when cows eat fluoride-poisoned forage from industrial sources, nature protects them by curbing their appetite,

causing loss of weight. According to an article in the April 15, 1973 Los Angeles Times, fenfluramine caused side effects of drowsiness and stomach/bowel complaints in patients. 1971 A study conducted by Dr.S.H. Cohn and his associates at the Medical Research Center, Brookhaven National Laboratory, Upton, Long Island (reported in the January 1971 American Journal of Clinical Nutrition, concluded that fluorides cannot be considered an effective treatment for osteoporosis. 1971 Germany bans water fluoridation. 1971 The January 15, 1971 issue of the Journal of the American Veterinary Association states "air pollution damage to agricultural production in the United States in 1967 was estimated at $500 million, and that fluoride damage to livestock and vegetation comprised a substantial part of this damage." 1971 An 11-member board of the American Academy of Allergies amazingly declares "no evidence of allergy or intolerance to fluorides as used in the fluoridation of communal water supplies." The statement was requested from the AAA by the U.S. Public Health Service, who was attempting to neutralize reports of fluoride poisoning. None of the scientists at the AAA ever carried out any research on fluorides. After the "statement" the U.S. Public Health Service "awards grants" to four of the scientists on the AAA board amounting to $780,621. Other members of the board had been previous recipients of such grants for research on various phases of allergy. In 1976, the British Royal College of Physicians would refer to the AAA statement (bribed statement) in order to deny reports of fluoride poisoning in England. [ Fluoride, Walbott, 1978, pp.287-288]. 1971 In 1971 alone, fluoridated toothpastes added 116,000 pounds of fluoride to the environment. 1971 The Swedish Parliament repeals the country's fluoridation law on Nov 18, 1971, and in doing so stated "valid evidence to support the claims widely quoted by fluoridation proponenys simply does not exist". The American news media maintained silence in not reporting this notable event. [Fluoridation and Truth Decay, Caldwell, 1974, p.287 ] See 1961. 1972 Sweden bans water fluoridation. 1972 A scientific study published in the AMA publication Archives of Environmental Health (July 1972) showed "dangerous levels of lead (above 5 percent) in the outer coatings of tubes of Crest, Fresh Breath, Macleans, Craig Martin and Worthmore toothpastes". The article also stated that "potentially hazardous amounts of lead in the toothpaste itself were found in Crest, Fresh Breath and Worthmore toothpastes". As expected, toothpaste makers denied these findings, but presented no documentation to justify their denial. These disclosures are additional reasons for attaching little scientific

merit to an ADA endorsement, including its endorsement of fluoridation. 1972 Consumer advocate Ralph Nader wrote to chairman Miles Kirkpatrick of the Federal Trade Commission that studies in the United States and England have shown that toothpastes with fluorides leave a brown stain on teeth four times as often as toothpaste without fluoride. In answer to Nader's question of the efficacy of these fluoridated toothpastes, a spokesman for the FDA answered that his department disallowed any claims a toothpaste "helps harden and strengthen the structure of tooth enamel on contact." 1972 On February 22, 1972, opponents of water fluoridation in Massachusetts appeared before the Legislative Social Service Committee to speak in favor of a bill asking for an impartial study commission to evaluate the dental and medical effects of fluoridation in communities fluoridated for 10 or more years. However, not suprisingly, dentists and public health officials fought desperately to prevent this bill from appearing before the legislature. 1972 In the Australian Medical Journal, an article by Dr.Stephen Boyd, of the Urban Biology Group, Australian National University, states, "it is important to appreciate that the first symptoms of exposure to many toxic chemicals (see fluorides) are not physiological, but psychological, and include such European Research, Vol 3, No.2, pp99-104, 1981. 1972 The February 24, 1972 issue of the Washington Post featured an article by Jay Mathews, who reported that "Mongolism, thought by doctors to occur in 1 out of 600 births, is today the most common cause of severe mental retardation." 1972 On May 17, 1972, a letter from the National Institute of Dental Research Director Dr. Samuel Kreshover stated, "Official approval of water fluoridation continues and special health studies beyond those that have already been completed are not contemplated." 1972 A letter from the Environmental Protection Agency, dated March 31, 1972, announced, "The EPA, in addition to its pollution abatement activities, supports and promotes the fluoridation of public water supplies through its water supply program ... this practice has been and is being thoroughly researched and safety is our prime consideration." 1972 The prestigious journal Science, July 14, 1972, requested doctors "Perform Tests and/or Examinations on People Who Have Shown Sensitivity to Fluorides from Fluoridation", and to send the results to a Fact Finding Committee in Milwaukee, Wisconsin, chaired by Dr.R.J.H. Mick in Laurel Springs, New Jersey. The project consisted of a double-blind study using the provocative sub-lingual testings with varying dilutions of a fluoride solution up to a concentration of 1 ppm. The project, held at the Red Carpet Inn in Milwaukee on August 5 and 6, 1972, was a 'continuing study to determine the immediate side effects of individuals extremely sensitive to fluorides'. A

number of individuals developed immediate symptoms of headache, burning in the throat, dizziness, nausea and vomiting to test solutions whose concentration were much less than 1 ppm, whereas the placebo (unfluoridated tap water) elicited no reactions. 1973 Russian Research Institute of Industrial Health and Occupational Diseases discovers fluorides cause genetic damage in rats. 1973 A study at the Central Laboratory for Mutagen Testing in West Germany shows that fluorides cause genetic damage to fruit flies. 1973 Netherlands bans water fluoridation on June 22, 1973. Holland's Supreme Court ruled that "In its judgment, the High Court considered the fluoridating of a public water supply to be a medical measure and outside the purpose of the Dutch waterworks law which obligates a water board to ensure a supply of wholesome drinking water without the addition of any medical substance." 1973 A study at Texas A&M University shows that fluorides cause genetic damage to barley. 1974 Columbia University College of Physicians and Surgeons discovers fluoride causes genetic damage, in rodents, sheep and cows. 1974 The Safe Water Drinking Act is passed. Environmental Protection Agency (EPA) sets maximum contamination levels (MCL) for various water pollutants, including sodium fluoride. The EPA sets the fluoride contamination level at an unbelievable 1.4 ppm for "warmer climates" and up to 2.4 ppm for "colder climates". Furthermore, the American Dental Association begins pressuring the EPA to raise the MCL for fluoride in public water to 8 ppm, when it is fully known that systemic damage occurs below 1 pmm. The former US Surgeon General C. Everett Koop is among those who join the drive to increase the MCL for fluoride, even doing television ads proclaiming that fluoridation was "absolutely safe". Shown slides of severe fluorosis damage to a childs teeth at 4ppm, ADA spokesperson Lisa Watson maintains that it does "not involve health effects but is only a cosmetic problem". The National Drinking Water Advisory Council refuses to recommend raising the fluoride MCL, and came close to recommending its lowering, but the EPA farmed out research work to ICAIR Life Systems, which issues a fraudulent report (confirmed by ICAIR employee Dr. John Beaver) that is woven into the US EPA report on fluoride, resulting in the EPA recommendation of MCL for sodium fluoride in public water to be 4 ppm. 1974 Mass fluoride spill in public water system in North Carolina. 1975 Dr. John Yiamouyiannis publishes a preliminary survey which shows that people in fluoridated areas have a higher cancer death rate than those in non-fluoridated areas. The National Cancer Institute attempts to refute the studies. Later in 1975, Yiamouyiannis joins with Dr. Dean Burk, chief chemist of the National Cancer Institute (1939-1974) in performing other studies which are then included in the Congressional Record by

Congressman Delaney, who was the original author of the Delaney Amendment, which prohibited the addition of cancer-causing substances to food used for human consumption. Both reports confirmed the existence of a link between fluoridation and cancer. (Note: Obviously Dr. Burk felt free to agree with scientific truth only after his tenure at NCI ended, since his job depended on towing the party line). 1976 Dr. D.W.Allman and co-workers from Indiana University School of Medicine feed animals 1part-per-million (ppm) fluoride and notice the urinary levels and tissue levels of a substance called cyclic AMP (adenosine monophosphate) increased by more than 100%. They also found that in the presence of aluminum in a concentration as small as 20 parts per billion, fluoride is able to cause an even larger increase in cyclic AMP levels. Cyclic AMP inhibits the migration rate of white blood cells, as well as the ability of the white blood cell to destroy pathogenic organisms. Ref: Journal of Dental Research, Vol 55, Sup B, p523, 1976, "Effect of Inorganic Fluoride Salts on Urine and Tissue Cyclic AMP Concentration in Vivo". (Note: It is no small accident that toothpaste tubes containing fluoride are often made of aluminum, nor is it an accident that aluminum cookware and fluoride use were injected into the population virtually simultaneously.) 1976 A research dentist at Case Western Reserve University School of Medicine, Dr. J. Gabrovsek, recognizes the significance of the effects of fluoride-induced increases in cyclic AMP levels, and the effect this might have on the immune system. (See 1980). 1977 Fluoride Symposium of the 143rd Annual Meeting of the American Association for the Advancement of Science reports that 0.5mg fluoride supplement tablets were causing dental fluorosis in children. 1977 The Congressional Subcommitee on Intergovernmental Relations convenes two (2) full Congressional Hearings on the subject of fluorides. During the hearing, it was proven that (1) The "scientific efforts" of those promoting fluoridation were fraudulent, and (2) That other existing studies proved beyond a doubt that approximately 10,000 excess cancer deaths per year could be attributed to fluoridation in the United States. 1977 Mass fluoride spill in Marin County California. Ref: San Rafael Ind Journal 11/25 1977 Congressional representative L.H. Fountain, chairman of the 1977 Sub-Committee Hearings on Fluoride, states that "the carcinogenic nature of fluoride remains unanswered" and orders the U.S. Public Health Service (USPHS - who is in on the fluoride conspiracy anyway) "to conduct animal studies to see if fluoride causes cancer". Dr. Herman Kraybill, from the National Cancer Institute (who in 1972 had been chosen by NCI to write a memo saying that fluorides do not cause cancer) was placed in charge of these studies. Kraybill boldly states, "this will be the final study to confirm negativity of fluoride ions in carcinogenesis." He cites 13 studies having nothing to do with the subject of fluorides and cancer in order to support his claim that "no link between fluorides and cancer existed." (NCI Director Dr. Arthur Upton later admitted the 13 studies had nothing to do with the subject of the study). (See 1982, 1985,1988) Congressman Fountain showed that Dr. Hoover and other National Cancer Institute

officials had purposely withheld information and had purposely sent fraudulent data to professors at Oxford, who published data as their own, defending the use of fluorides. 1977 In 1977, Congressional Hearings were held in which Dr.Yiamouyiannis and Dr.Burk were able to show that the increase in deaths were due to water fluoridation. At the conclusion of the hearings, Representative Fountain and his committee instructed the United States Public Health Service (well known by now for questionable and dangerous medical advisory practices which benefit the medical and pharmaceutical industries) to conduct animal studies to "determine whether or not fluoride causes cancer". As a result, the USPHS retained Battelle Memorial Institute (also well known for NWO technical activities and is considered by many to be part of the cancer cover-up) to perform a study on mice and rats - unfortunately, rodent physiology differs considerably from humans, making the transfer of data between species relatively meaningless.(See1989,Battelle Study). 1978 Pomeranian Medical Academy in Poland discovers that fluorides cause genetic damage in human blood cells. 1978 Consumer Reports publishes a two part article in July and August 1978 which includes the claim "the simple truth is that there is no ‘scientific controversy over the safety of fluoridation." Later in 1990, the Technical Director for Consumer Reports disputes the claim, saying "the proponents of fluoridation insist that there are no grounds for controversy at all, and with that I totally disagree. The point is that this is a legitimate scientific controversy." The technical director in 1990 is Dr.Edward Groth III. 1978 Mass fluoride poisoning in Michigan. Ref: USPHS/CDC, EPI 78-24-2 pp12. 1978 Physicians Desk Reference states "a daily fluoride intake of .5 mg from birth to age three years is recommended." 1978 The German magazine Stern reports on the Turkish village of Kizilcaoern, where the drinking water contains 5ppm fluorides. All of the children have brown teeth. Women produce dead babies after only four months of pregnancy. All the inhabitants suffer from tremendous premature aging. The same fluoride-related brittle-bone disorders have been observed among people drinking water with as little as 0.7 ppm fluoride. 1978 A court case was won in Pennsylvania that proved fluoridation was harmful and resulted in a ban. It received great publicity, much to the concern of the American Dental Association and the industry. (See 1979) 1979 General research seems to begin in an attempt to understand how fluorides in the body disrupt collagen synthesis. 1979 In order to counteract the tide of truth on fluorides, the American Dental Association (ADA) issues a "white paper" on fluoridation characterizing opponents of putting fluorides in the public water supply as "uninformed, self-styled experts whose

qualifications for speaking out on such a scientific issue as fluoridation were practically nonexistent or whose motivation was self-serving." (Highly ironic, since this is instead the position of the ADA and the medical industrial complex in the first place). In addition, the ADA paper maintained "the lifelong benefits of fluoridation" and encouraged responses to opponents to begin with, "there is no evidence...", "investigators have observed...". The ADA recommended that "the advice of behavioral scientists should be sought with regard to rebuttals". This ADA paper resulted in collusion between the ADA,CDC,EPA,NCHS,NIDR, state dental societies and directors to "identify those communities where the timing is favorable". A planning commitee was formed to plan a symposium for the future. (See 1983). 1979 The January 20th edition of the New York Times carried a story in which a child was killed because of a lethal dose of fluoride at a city dental clinic. The parents were awarded $750,000. 1979 In the U.S., the National Institute of Dental Research publishes altered research claiming fluorides do not cause genetic damage in mice. The fraud is discovered. 1979 Dr.W.L. Gabler and Dr.P.A.Long at the University of Oregon Health Sciences Center find that as little as 0.2 ppm fluoride in the body (the "safe" level for public water supplies is 1.0 ppm, 8 times higher) stimulates superoxide production in resting white blood cells, seriously depressing the ability of white blood cells to destroy pathogenic agents. Superoxide in the bloodstream also gives rise to tissue damage and acceleration of the aging process. Ref: "Fluoride Inhibition of Polymorphonuclear Leukocytes", Journal of Dental Research, Vol 48, No.9, p1933-1939, 1979. 1979 Mass fluoride spill into the Annapolis, Maryland public water system, which resulted in a concentration up to 50 parts per million, boosting the heart attack rate five times and acutely affecting 10,000 people. 1979 In a book released in 1979 entitled "Continuing Evaluation of the Use of Fluorides", a chapter was written by Dr. Hodge, who was instrumental in the Newburg experiments running parallel to the Manhattan Project work on fluorides. With regard to the "safe" dosage, Hodge wrote: "The most important and widely disregarded fact about dental fluorosis is that no safe established daily intake exists,, i.e., the maximal amount in mg fluoride which consumed daily does not produce cosmetically damaging white areas or brown stain in some areas has not been fixed." Hodge also corrected his previously published figures for crippling skeletal fluorosis he made in the 1950's where he had neglected to convert pounds to kilograms. As a result, most reviews which contain the "crippling daily dose of fluoride", including the U.S. Department of Health and Human Services 1991 document Review of Fluoride: Benefits and Risks, as well as the current RDA and new Dietary Reference Intakes published by the Institute of Medicine in 1997, use 20-80 mg/day figures. At currently reported intake levels 5mg per day will cause crippling deformities of the spine and major joints. 1979 John Curnette and co-workers from Tufts University find that when blood cells are

exposed to fluoride at a concentration that simultated vigourous superoxide production by the cells, phagocytosis was virtually abolished. 1979 Research at the University of Oregon Health Sciences Center by Drs. Gabler and Leong find that as little as 0.2 ppm stimulated superoxide production in resting white blood cells, the same concentration would affect active white blood cells if they were at the same time challenged by a foreign body. 1979 On November 11th, up to 50ppm fluoride was dumped into the Annapolis Maryland water supply, resulting in the poisoning of 50,000 people. Many died of heart failure during the week following the spill. 1979 A child in Melbourne, Australia dies after eating six fluoride tablets. (11/3/79) 1980 Dr. J. Gabrovsek, a research dentist (See 1976) publishes a paper which states, "Because of the inhibitory effects of sodium fluoride on phagocytosis and leukocytosis (migration of white blood cells), which are basic defense systems, I have doubts about the absolute safety of water fluoridation on a long-term basis." 1980 Mass fluoride poisoning in New Mexico Elementary School. Ref: Pediatrics v65. 1981 Drs. Susheela and Sharma and co-workers from the India Institute of Medical Sciences find that fluoride exposure disrupts the synthesis of collagen in the body and leads to the breakdown of collagen in bone, tendon, muscle, skin cartilage,lung, kidney and trachea. It appears that fluoride disruption of collagen synthesis in cells responsible for laying down collagen leads these cells to try and compensate for their inability to put out intact collagen by producing larger quantities of imperfect collagen and/or non-collagenous protein. Ref: "Fluoride poisoning and the Effects of Collagen Biosynthesis of Osseous and Non-osseous Tissue", Toxicological European Research, Vol 3, No.2, pp99-104, 1981. 1981 Institute of Botany in Baku, USSR, does three studies which indicate fluoride causes genetic damage in rats. 1981 Research is done at the Department of Toxicology at the Central University of Venezuela by Dr. A Iares showing fluoride added to drinking water of rats caused birth defects. Repeated in 1982 in China, with same results. 1981 Dr.John Emsley and co-workers at King's College in London find that fluoridereacts strongly with the bonds which maintain the normal shapes of proteins in the body. The work is subsequently confirmed by Dr. Steven Edwards and co-workers from the University of California in San Diego, and by Drs. Froede and Wilson from the University of Colorado at Boulder. By distorting the configuration of the body's own protein, the immune system attacks its own protein , resulting in an autoimmune or allergic response. Fluroides contribute to the development of an Acquired Immune Deficiency Syndrome,which is covered up by the media and medical community, which

maintains a public focus on a viral cause for the problem, promoting the harmless HIV virus as the "cause" for "AIDS", covering up the pharmo-chemical sensitization of the population which has complex legal ramifications. 1981 Research at the Kanagawa Dental University in Japan by Dr. K. Ishida indicates that as little as 1ppm fluoride in the body interferes with collagen metabolism and leads to collagen breakdown, causing osteoporosis, bone cancer, brittle bones and teeth, an loss of connective tissue which hold organs in place. 1981 Dr.Robert Clark from the Boston University Medical Center shows that fluorides (as in fluoridated water supplies, toothpaste,etc) stimulate granule formation and oxygen consumption in white blood cells when they were not challenged with a foreign agent, but inhibited these processes when the white blood cell needed them to fight off foreign agents. Ref: "Neutrophil Iodination Reaction Induced by Fluoride: Implications for Degranulation and Metabolic Activation" Blood, Vol 57, pp913-921, 1981. 1981 Mass fluoride spills in Jonesboro, Maine (Oct) and Potsdam, New York (Aug). 1981 Dr. Martin Drozdz at the Institute of Bioanalytical and Environmental Studies in Katowice, Poland found that rats fed 1ppm fluoride in their water had increased levels of hydroxyproline and hydroxylysine levels in the blood and urine, as well as a decrease in skin and lung collagen levels. Ref: Drozdz et al., "Studies on the Influence of Fluoride Compounds upon Connective Tissue Metabolism in Growing Rats", published in Toxilogical European Research, Vol 3, No.5, pp.237,239-241, 1981. 1982 A study at the University of Missouri concludes that fluoride causes genetic damage in mice. 1982 The U.S. Public Health Service conducts its first group of studies on animal cancer and fluorides, mandated by the 1977 Congressional Hearings. The study lasts until 1984, and then is scrapped because of flaws in design and progress. (See 1985, Batelle Memorial Instutite). 1982 A study at the Institute of Botany in Baku, USSR, demonstrates that fluorides cause genetic damage in onions. Repeated in 1983. 1982 Peter Wilkinson at the University of Glascow testifies before the Scottish High Court in Edinburgh in a legal case entitled "Inhibition of the Immune System with Low levels of Fluoride" which revealed that fluoride decreases the migration rate of human white blood cells. At a concentration of .2ppm (which is .8ppm below the "approved" level of 1 ppm), relative white cell migration rate is reduced 8%. A concentration of 1ppm would produce a physiological decline of around 10%. Fluoride added to water supplies, tooth paste, school dental washes, supplement pills and dentists visits are increased and promoted, contributing to a further co-factor in the decline of the immune capability of the population. Fluoride confuses the human immune system and causes it to attack the body's own tissues, cumulatively resulting in accelerated aging.

1982 In Science magazine, Vol 217 p26-32, Dr. Dennis Leverett of the University of Rochester states, "if there are increasing concentrations of fluoride in the food chain, particularly food for infants, then we should expect fluorosis to be increasing in the population as well. The widespread use of fluorides might have created a situation in which we are approaching a critical mass of fluoride in the environment. There needs to extensive research done." Later in 1983 he would contradict himself at the University of Michigan symposium. 1983 Zhang and Zhang publish a study which shows that fluorides cause birth defects in fish. 1983 Researchers at Loma Linda University in California, led by Dr.John Farley, show that treatment of bone cells with less than 1ppm fluoride increased collagen formation by 50%, leading to formation of irregular bone. (But also leads to collagen breakdown. See 1981, Ishida). 1983 Research is done at the Kunming Institute of Zoology in China which indicates that fluoride causes genetic damage in deer and in human blood cells. 1983 Physicians Desk Reference states "the recommended fluoride dosage for children between birth and two and a half years old is 0.25 mg. (Compare with 1978,1992) 1983 U.S. Environmental Protection Agency deputy assistant administrator Rebecca Hammer points out that fluoride-polluting industries can get paid for using public drinking waters as a sewer for their toxic waste products when she says "this agency regards the use of fluosilic acid as a source of fluorides for water fluoridation an ideal environmental solution to a long standing problem of contamination of the water and air from fertilizer manufacturing." 1983 A symposium takes place at the University of Michigan after years of planning between the US Dept of Health and Human Services, the USPHS Michigan state health plans, the Kellogg Foundation, CDC,Medical Products Labs and others to "discuss the status of organized opposition to fluoridation, to analyze probable motives influencing the anti-fluoride movement, to develop political and legal strategies for the defense and promotion of fluoridation, and to access the need for a national fluoridation strategy." Dr. Dennis Leverett of the University of Rochester reported that his commitee felt that fluoridation was a "political issue and not a scientific situation". See 1982,1988. The Symposium was a taxpayer-supported event. Also attending were members of the ADA National Fluoridation Advisory Committee, John Small (the government's pro-fluoride czar), the American Association of Dental Schools, members from the Illinois and Ohio State Departments of Health, and the Chief Dental Officer of the Department of Health and Human Services. The proceedings were published in a 129-page book titled "Fluoridation: Litigation and Changing Public Policy." (See ADA Nat'l Fluorodation Commitee address in 1988). Dr. William T. Jarvis, a member of the board of the American Council of Science and Health ( a front group for the junk food industry),

speaks on "The Psychology of Anti-fluoridation", noting that debates on flouride always "seems to result in people becoming anti-fluoridationist." Dr. Stephen Corbin of the USPHS suggested that a mandatory State Fluoridation Law be developed, and a Dr. Easley suggested processes be initiated to deny those seeking relief through the courts their right to due process. Dr. D. Scott of Blue Cross/Blue Shield suggested that the cost of litigation defending fluoridation should be borne by taxpayers! Ms. Colleen Wulf of the Ohio Deparment of Health reported that her committee suggested formation of a non-profit organization which would coordinate with with CDC and ADA, and pointed out that CDC has already drafted promotional materials for fluoride, and that the ADA and the USPHS had already formed the Ad Hoc Commitee to Plan for the Legal Defense of Community Water Fluoridation. She suggests the name of the new group might be something like "Coalition for Improved Dental Health, or something similar". NOT ONE SCIENTIST ATTENDED the University of Michigan Symposium: ten who attended were dental hygenists, two were dentists, five had degrees in Public Relations, Education, Psychology, or Public Health, one had no degree at all and a introduction was written by psychiatrist Stephen Barrett, who ironically would maintain a website in 1997 on "medical quackery". 1983 Dr.John R. Farley and co-workers from Loma Linda University show that treatment of bone cells with less than 1ppm fluoride increases collagen formation by 50 percent (unstable collagen. See 1981 Susheela). Ref: "Fluoride Directly Stimulates Proliferation and Alkaline Phosphatase Activity of Bone Forming Cells", Science, Volume 222, pp330-332, 1983. 1984 Research work at Nippon Dental University in Japan prove that fluorides cause genetic damage in hamster cells, human embryo and blood cells. Research also indicated that fluoride was also capable of transforming normal cells into cancer cells. The level of fluoride that could do this were the same level that the National Cancer Institute suggested should be used to determine whether or not fluoridation of public water supplies causes cancer.Ref: Dr. Takeki Tsutsui, NDU. Cancer Research, Vol 44,pp938-941, 1984, "Sodium Fluoride Induced Morphological and Neoplastic Transformation, Chromosome Aberrations and Unscheduled DNA Synthesis..." Also supported in Carcinogenesis, Vol 9, pp2279-2284, 1988; Cell Biology Toxicology, Volume 4, pp311-324, 1988; Genetics, Vol 48, pp307-310, 1963. 1984 The 1984 issue of Clinical Toxicology of Commercial Products indicates that 1/10 oz of fluoride in the human body is lethal for a 100 pound adult human. Fluoride toothpaste contains up to 1mg/gram of fluoride. A whole tube contains about 199 mg of fluoride - enough to kill a 25-pound child. Toothbrushing causes ingestion of 0.25 mg/day. 1985 Research is conducted by the Edinburgh Medical Research Council in England which indicates that fluoride causes genetic damage in human blood cells. 1985 Based on a report on fluorides altered by Surgeon General Koop, the EPA recommends a raising of the amound of fluorides allowed in drinking water from 2 ppm

to 4 ppm. 1985 Study by the World Congress of Biological Psychiatry finds that in a study of 321 violent individuals, most of them white and middle class, 95% of them showed evidence of brain dysfunction and neurological disabilities. The age of the individuals and symptoms coincide with degeneration caused by vaccination programs. Ref: Vaccination, Social Violence and Criminality. 1985 The U.S. Public Health Service contracts a second set of studies on animal cancer and fluoride, mandated by the 1977 Congressional Hearings. The USPHS contracts Batelle Memorial Institute in Ohio, which conducts a study lasting until 1987. The results are released in 1988. (See 1988). 1985 Dental hygenists, psychiatrists, public relations experts, education specialists and psychologists (no scientists) form "The American Oral Health Institute" and release a book "Abuse of the Scientific Literature in an Antifluoridation Pamphlet", in which they attack scientific data relative to fluoride and those who oppose its use in the public water supply. An examination of the book, ironically, revealed "abuse of scientific literature" on the part of the authors, who demonstrated their lack of scientific expertise and themselves were guilty of deception and misrepresentation of scientific fact. 1985 Research at the University of Oregon by Gabler demonstrate that low levels of fluorides in the body delayed white cell response to foreign agents. 1985 The work of Takuya Saito in Japan demonstrates that even micromolecular amounts of fluoride, below 1ppm, may seriously depress the ability of white blood cells to destroy pathogenic agents in the body. 1986 Research is conducted at the University of Sussex in England which indicates that fluoride causes genetic damage in mouse lymphoma (white) cells. 1986 Study by Kay, A.R., et al, is published in the Journal of Neuroscience, Vol 6, pp.2915-2920,1986, "Fluoride in cerebrospinal fluid of patients with fluorosis", in which it was shown that intracellular fluorides can alter the kinetic properties of calcium currents in hippocampal neurons, which can affect behavior. 1986 The Rocky Mountain Poison Control Center reports 87 cases of fluoride poisoning . Two cases involved fluoride treatment by a dentist. One 13 month old child died. Twenty five suffered gastrointestinal symptoms. Sodium fluoride is the most frequent single cause of acute poisoning in children. 1987 Paterson Institute for Cancer Research in England demonstrates that fluoride causes genetic damage to human cells. 1987 In the United States, research is conducted at the National Institute of Environmental Health which indicates that fluoride causes genetic damage to mouse

lymphoma cells. 1987 Research is conducted at Imperial Chemical Industries (ICI) in England which indicates that fluorides cause genetic damage in human blood cells. 1987 A study is done at the Institute of Pitaniia in the USSR which indicates that fluoride causes genetic damage in rat bone marrow cells. 1988 Dr. Joel Boriskin, chairman of the ADA National Fluoridation Advisory Committee, gives an address before the Calgary Health Department, in which he claimed, "1500 mg of fluoride per day (a lethal dose) is prescribed to older people than have progressive hearing loss." Ref: Journal of the American Dental Association, May 1990. 1988 Affidavit sworn by Dr. Robert J.H.Mick (formerly a Lt. Colonel in the Dental Corps, U.S. Army Reserves, who states that he was "...threatened by General Gorby in Germany with a possible court-martial and other penalties in 1954 if I did not discontinue my activities opposing fluoridation and the fluoridation of military posts." 1988 Battelle Memorial Institute releases its studies on fluorides and animal cancer for the USPHS which, ironically, report highly specific fluoride-related cancers. The data is turned over to the National Toxicology Program (NTP), who gives the data to the Experimental Pathology Labs, who reclassify and delete items damaging to the pro-fluoridation faction. The altered data is then submitted to the "pathology working group" on December 6, 1989, after a year of reworking. All this with the full knowledge of EPA and USPHS. (See 1990). 1988 Dr. Joel Boriskin, chairman of the ADA national fluoridation advisory committee, in an address before the Calgary Health Department, claims that "1500 mg of fluoride per day is prescribed to older people that have progressive hearing loss". (Note: 1500 mg/day is a lethal dose). 1988 Researchers at the Argonne National Laboratory discover that fluoride promotes and enhances the carcinogenicity of other cancer-causing chemicals in the food and environment. Interestingly, this work confirmed studies sponsored by the United States National Cancer Institute conducted back in 1963 by Herskowitz and Norton at Saint Louis University. More than 30 years ago, these scientists showed that low levels of fluoride increased the incidence of melanotic tumors in living organisms from 12 to 100% - often these tumors were induced by fluoride over a period of days. These studies were further amplified by work done by the Taylor's at the University of Texas which found that 1 ppm fluoride in drinking water increased tumor growth rate in mice by 25%. 1989 On March 30, 1989, the California Department of Health Services reported that Niagara brand bottled water was found to contain 450ppm fluoride. The state health director, Kenneth Kizer, warned residents that consumption could be fatal. 1989 In New South Wales, Australia, a law is passed prohibiting town councils from

stopping the fluoridation of their water supplies without the permission of the health department. 1989 In 1989 Dr.Yiamouyiannis used the Freedom of Information Act to obtain carcinogenicity studies conducted by Proctor and Gamble (one of the makers of fluoridated toothpaste) that were submitted to (and covered up by) the United States Public Health Service. These studies showed dose dependent cell abnormalities caused by fluoride. These results were reported in the February 22, 1990 issue of the Medical Tribune. Additional studies by Proctor and Gamble scientists confirmed the link between oral precancerous growth and fluoride, as well as an increase in osteomas (bone tumors) and osteosarcomas (bone cancer). In fact, the National Cancer Institute found in 1991 that the incidence of bone cancer was 50% higher in men ages 0-19 years of age exposed to fluoridated water compared to those who were not. 1989 A study by Hildebolt, et al. on 6,000 school children contradicts any alleged benefit from the use of fluorides. 1989 Research studies are conducted at Nippon University in Japan which shows that fluorides causes genetic damage to human cell cultures. 1989 Fluoride concentrations of 0.3 - 0.5 ppm, half that used for fluoridation, put into the Columbia River in Washington by an aluminum plant, have a very pronounced effect on the migration time and survival of adult salmon. [Damkaer, D.M, and Dey, D.B., "Evidence for Fluoride Effects on Salmon Passage at John Day Dam, Columbia River, 1982-1986", North American Journal of Fisheries Management, Vol 9, 1989, pp.154-162]. 1989 On February 23, 1989, Battelle released the results of its study of fluorides on mice. A most curious result of the study, from the USPHS point of view, was that fluoride induced the occurrence of an extremely rare form of liver cancer, called hepatocholangio carcinoma, in fluoride-treated male and female mice. Two months later in April of 1989, Battelle released the results of its study of fluorides and rats. The study showed a dose-dependent relationship between the incidence of oral cancerous tumors and fluorides. It is interesting to note that mice and rats yielded different The results with fluoride - different types of cancer. As a response to the Battelle study, the National Cancer Institute from examined the incidence of oral cancer in fluoridated and non-fluoridated countries over the period from 1973 to 1987. The National Cancer Institute study found that as exposure to fluoridation increases, so does the incidence of oral cancer; sometimes as much as a 50% increase in oral cancer rates occur in fluoridated areas - this translates to 8,000 new cases of oral and pharyngeal cancer per year, needless pain and suffering and a financial windfall to the medical and pharmaceutical factions that concern themselves with treatment. 1989 The 12 year study the National Cancer Institute was ordered to do in 1977 is finally compete. It finds evidence that fluorides cause cancer in male rats. Directed to examine cancer trends in the U.S. population, the NCI finds nationwide evidence of "a rising rate

in bone and joint cancer of all ages combined, due mainly to trends under the age of 20 (cultural programing on what to eat and drink and how to live), was seen in the fluoridated countries but not the unfluoridated countries. 1990 The National Toxicology Program issues a Press Release with data confirming findings of a link between fluoride and osteosarcomas as well as higher rates of oral cancer in rats. (January 1990) 1990 The American Dental Association issues a Press Release which states "water fluoridation remains the safest, most effective, and most economical public health measure to reduce tooth decay." 1990 The National Toxicology Program in February 1990 releases its pathological data tables with a cover letter which, in a turnabout, claims "there has not been any evidence that shows a relationship between fluoridation and cancer or any other diseases in humans", and "water fluoridation has proven highly effective in improving the nation's dental health by markedly reducing tooth decay". The NTP final report, issued in March, omitted all studies which showed genetic damage from fluorides, and important studies showing that fluorides induce tumors and cancers were ignored. Kraybill, head of the NTP study, becomes a consultant to the American Council of Science and Health (ACSH), who threatens to sue the EPA if it "tries to undermine public confidence in fluoride." 1990 The American Dental Associations ADA News reports that Proctor and Gamble (who make fluoride-based toothpaste) has "unpublished findings" which "refute the carcinogenicity of fluoride". Proctor and Gamble in March 1990 publish their paper on fluoride and bone cancer (rats) and leave out their data on mice. The rat studies confirm an earlier study that proved that fluorides in food resulted in precancerous growth in the mouth. In contradiction to their own results, P&G declares that fluoride "does not cause precancerous or cancerous changes. 1990 A study by Dr.John Yiamouyiannis on 39,000 school children contradicts any alleged benefits from the use of sodium fluorides. 1990 Two scientific studies reveal that "experience with other developmental neurotoxicants will be comparable across species, especially humans and rats." Neurotoxicology and Teratology, Vol 12, pp.261-267, Stanton et al, pp.285-292, Francis et al, 1990, "Workshop on the qualitative and quantitative comparability of human and animal developmental neurotoxicity", "Comparability measures of developmental neurotoxicity in humans and laboratory animals." 1990 Dr. John Colquhoun in New Zealand is forced into early requirement in New Zealand after he conducts a study on 60,000 school children and finds no difference in tooth decay between fluoridated and unfluoridated areas. He additionally finds that a substantial number of children in fluoridated areas suffered from dental fluorosis. He makes the study public.

1990 The September 14th issue of Newsweek reports that the study performed by Battelle Memorial Institute under Congressional mandate to look into fluorides and animal cancer (that found a connection) was refused for publication by the Journal of the National Cancer Instiute. 1991 The Environmental Protection Agency (EPA) again engages ICAIR Life Systems to perform a "literature search on fluorides". A researcher for ICAIR, Dr. John Beaver, admits that he was instructed to select only certain reports and ignore others. The final series of reports was sent to EPA, who forwards them to the Subcommittee on Risk Assessment of Ingested Fluoride of the National Academy of Sciences as an "independent" report. Five out of eight members of the Subcommitee are historically pro-fluoridation. 1991 National Cancer Institute finds that the incidence of bone cancer was about 50% higher in men up to 19 years old exposed to fluoridated water, composed to those not exposed. 1991 A report surfaces that fluoride-containing pesticides on fruit increase human fluoride intake. Some juices contain 6.8 ppm fluoride. [Stannard, J.G., et al, "Fluoride levels and fluoride contamination of fruit juices", Journal of Clinical Pediatric Dentistry, Vol 16 No 1, 1991, pp.38-40 ; "Assessing Fluoride Concentration of Juices and Juice-Flavored Drinks", Journal of the American Dental Association, JADA Preview, 1996, Kiritsy et al.] 1991 An examination of the effect of fluorides by Freni (see 1994) is performed in a complicated study comparing the total fertility rate in countries whose water supplies had at least 3 ppm fluoride. He found a negative total fertility rate (TFR) association that fit with similar toxicology data for animals. Freni hypothesized that fluorides lowers protein synthesis in osteoblasts and that fluorides inhibit the adenylyl cyclase system in human spermatozoa. (See 1994, Narayana and Chinoy). 1992 Chinese research at the Department of Pathology, Guiyang Medical College, finds cellular abnormalies in fetal brain tissue exposed to fluorides. 1992 Canadian Dental Association Proposed Fluoride Guidelines states "Fluoride supplements should not be recommended for children less than three years old." 1992 Government figures reveal that over 144 million Americans are medicated with fluoridated water in the United States. (For inplications, see Neurotoxicity of Sodium Fluoride in Rats, fluoride effect on the hippocampus in the brain, which governs ability to respond to new situations, behavior and decision-making. 1992 Michael Perrone, a legislative assistant in New Jersey, contacts the FDA requesting all information regarding the safety and effectiveness of fluoride tablets and drops. After 6 months of stalling, the FDA admitted they had no data to show that fluoride tablets or

drops were either safe or effective. They informed Perrone that they will "probably have to pull the tablets and drops off the market." 1992 Another scientific study reveals that fluorides suppress the immune system. [Gibson, S., "Effects of Fluoride on the Immune System", Complimentary Medical Research, Vol 6, No.3, October 1992, pp.111-113.] 1992 Scientific report reveals the connection between fluorides and non-ulcer dyspepsia (epigastric pain after eating). [ Gupta, I.P., et al, "Fluoride as a Possible Etiological Factor in Non-Ulcer Dyspepsia", Journal of Gastroenterology and Hepatology, Vol 7, 1992, pp.355-356 ; also, Susheela, A.K., "Fluoride Ingestion and Its Correlation with Gastrointestinal Discomfort", Fluoride, Vol 25 No.1, 1992,pp.5-22] Note: Since fluorides are cumulative in the body, the general level in the population where large gastric problems arise may be occurring. Thus, the large marketing effort for "acid controllers" in the 1990's, which may also be covering up the prevalence of heliobacter pylori infection as well as approaching fluoride toxicity in the population. 1992 A scientific study reveals that fluorides in the water supply to 1 ppm is associated with an increase in the hip fracture rate of women, and that fluoride accumulates with age, and may reach toxic levels in a person's lifetime. [ Danielson, C., et al, "Hip Fractures and Fluoridation in Utah's Elderly Population", Journal of the American Medical Association, Vol 286, No.6, August 1992, pp.746-748] 1992 The EPA is ordered to reinstate a senior scientist, William Marcus, and pay him $50,000 for emotional distress, after firing him because he publically questioned and opposed EPA policy on the use of fluorides in water supplies. 1993 In July 1993, fluoridated water kills three people on dialysis. Chicago Tribune, "Fluoride Blamed in Dialysis Deaths", July 31, 1993. 1993 Another study demonstrates that fluoride is genotoxic (indicating chromosome damage), including those at concentraions of 1.0 - 5.0 ppm. [Ziegler et al, Experimental Carcinogenesis and Mutagenesis Branch, National Institute for Envrionmental Health Sciences, "Genetic Toxicity of Fluoride", Environmental and Molecular Mutagenesis, Vol 21, 1993, p.309-318. 1993 Associated Press releases article on August 18, 1993 claiming "no health risk for fluoridated water", as stated by the National Research Council and Dr.Bernard M. Wagner from the New York University School of Medicine. A statement that "132 million Americans drink water with .7ppm fluoride". 1993 Because of pressure from New Jersey legislative aide Michael Perrone, the Food and Drug Administration is forced to admit they have no studies which show fluoride tablets or drops were either safe or effective, and that the sale of fluoride drops was illegal.

1993 In July 1993, a scientific study of the effect of fluoride on rats links behavior changes and brain damage with aluminum and fluoride. [ Varner, J.A. et al, "Chronic Aluminum Fluoride Administration: II. Selected Histological Observations" Neuroscience Research Communications, Vol 13 No.2, 1993, pp.99-104 ; Chase, M., "Rat Studies Link Brain Cell Damage with Aluminum and Fluoride in Water", Wall Street Journal, October 28, 1992.] 1994 A study by Narayana and Chinoy comments on "the wide prevalence of infertility in fluorosis-affected human populations in India and other parts of the planet. [Narayana and Chinoy, "Effect of Fluoride on Rat Testicular Steroidogenesis", Fluoride, Vol 27, No. 1, pp.7-12, 1994.]They found that fluorides interfere with androgenesis and adversely impair the target organ structures. There was the suggestion that fluorides may alter the configuration of cellular receptors, thereby inhibting the action of testosterone in the same way that hormone-disrupting chemicals (chemicals that mimick estogens) do. 1994 A study on the physiological and behavioral effects of Sodium Fluoride is published on October 12, 1994. The study is done by Mullenix, Denbensten, Schunior and Kernan, from the Toxicology Department, Forsyth Research Institute in Boston, the Department of Radiation Oncology, Harvard Medical School, the Department of Pediatric Dentistry, Eastman Dental Center, and the Veterinary Diagnostic Laboratory at Iowa State University. According to the study, published in Neurotoxicology and Teratology, Vol 17, No. 2, pp. 169-177, 1995, while fluorides have a great number of effects on the body, the effect on the brain and central nervous system structures were examined, and it was found that fluorides affect the hippocampus, which is the central processor which integrates inputs from the environment, memory, and motivational stimuli to produce behavioral decisions and modify memory. Note: Now it can be seen why the Nazis and Soviets used fluorides in the prison camp water supplies to reduce the will to resist and make the prisoners docile and not tend to question authority. It is the primary reason it is added to water supplies, since there is no credible scientific evidence it exists in the water supply for any other purpose. After several years, we have found no credible evidence, only anecdotal reviews by groups with a vested interest in keeping toxic fluorides in use. (See 1957, Montreal Neurological Institute, and the case of H.M). This 1994 study also showed that "effects on behavior relate directly to plasma fluoride levels in the brain, and fluoride accumulation in the brain, establishing that long-term accumulation of fluorides in the brain does occur, even with minimal doses. This 1994 report also stated that "overall, the behavioral changes from fluoride exposures are consistent with interrupted hippocampal development. Although this study was done on rats, according to the report "a generic behavioral disruption is found in this rat study can be indicative of a potential for motor dysfunction, IQ deficits and/or learning disabilities in humans, and that substances that accumulate in brain tissue potentiate concerns about neurotoxic risks. This is the first laboratory study to demonstrate that central nervous system functional output is vulnerable to fluorides that is publically released, although decades of studies have been done, but not released, by the Mellon Institute and various agencies, who keep the results to themselves for the last 50 years. 1994 In November 1994 in Australia, the Victorian Parliament passes an amendment to

the "Fluoridation Act" to change the constitution in order to stop the Supreme Court of Victoria from hearing any public cases or evidence against artificial fluoridation. 1994 Freni, S.C., "Exposure to High Fluoride Concentrations on Drinking Water Associated with Decreased Birth Rates", Journal of Toxicological and Environmental Health, Vol.42, p.109-121, 1994. This is another study which indicates another reason for fluoride administration is population birth control by involuntary chemical medication. 1995 Neurotoxicology and Teratology, Vol 17, No.2,p.169-177, "Neurotoxicity of Sodium Fluoride in Rats", Meullenix, et al, 1995, reveals that fluorides are cumulative in the brain , humans are exposed to plasma fluoride levels as high as those given to rats , fluorides interrupt normal brain development in babies and children , and fluorides affect the hippocampus, the "central processor" in the brain which integrates inputs from the environment, memory, and motivational stimuli to produce behavioral decisions and modify memory. This firmly establishes that mass fluoridation affects the behavior of society, in that it undermines the capacity for people to make decisions and become motivated to act against abnormal environments (such as that present in tyranny). 1995 In Australia, the Tasmanian government passes a bill to prohibit the holding of meetings on the subject of fluoridation. Called the "Consequential Amendments Bill", it is later withdrawn for rewording and reissue at a later date. 1995 A Chinese study on fluorides finds that the IQ of children is lowered in fluoridated areas. Zhang, I.B., et al, "Effect of a High Fluoride Water Supply on Children's Intelligence" [Pending Publication] 1995 On the 50th anniversity of fluoridation in the United States and Canada, a study published by Mullenix et al reveals "the functional output of the central nervous system is vulnerable to fluorides, and that the effects on behavior depend on the age at which exposure takes place and how much fluoride accumulates in brain tissue." Furthermore, "fluorides in drinking water affect the nervous system directly without first causing skeletal deformations from fluorosis". Proponents of fluoridation typically use fluorosis as a measure of effect, when in fact neural effects occur at a very low dosage. 1996 In May 1996, the FDA introduces a new fluoridated drug, this time an "anti- obesity drug, dexfenfluramine, "despite the objection of consumer advocates who content it could cause brain damage." According to the press release on May 1, 1996, the drug "alters the brain chemical serotonin." 1996 The governor of New York signs a bill into law prohibiting communities who do not want water fluoridation from being fluoridated. (June/July 96). 1996 On December 11, 1996, Commander Col. Henry O. Tuell III, wrote to the U.S. Army Medical Command, Fort Sam Houston, Texas, stating, "...recent research and findings regarding efficacy of fluoridation and the adverse health effects could be

serious." The Army post at Fort Detrick, Maryland, remains unfluoridated. 1997 A 1944 World War II Manhattan Project classified report on water fluoridation is found to be missing from the files of the University of Rochester Atomic Energy Project, the U.S. National Arhives, and the Nuclear Repository at the University of Tennessee, Knoxville, by researcher Clifford Honicker, Executive Director of the American Environmental Health Studies Project in Knoxville, Tennessee, which provided key evidence in the public exposure and prosecution of U.S. human radiation experiments.

Fluoride FACTS

Fluoride Is A Carcinogen Fluoride was found to be an equivocal carcinogen by the National Cancer Institute Toxicological Program.1

Further studies by the New Jersey Department of Health have now confirmed a 6.9 fold increase in bone cancer in young males.2

Earlier studies had found a 5% increase in all types of cancers in fluoridated communities.3

Fluoride Increases Hip Fractures

Drinking fluoridated water will double the number of hip fractures for both older men and women.4 5

Extremely low levels of water fluoridation 0.1 ppm still produced statistically significant increased hip fractures. (Bordeaux Study JAMA 1994)

Fluoride Increases Infertility

Infertility in women was found to increase with water fluoridation.

Food and Drug Administration (FDA) scientists reported a close correlation between decreasing total fertility rates in women between ages of 10 and 49, and increasing fluoride levels.

They also reported that a review of all of the animal studies done to date shows that fluoride adversely affects fertility in most animal species.6

Fluoride Increases Fluorosis

Opaque white spots and brown ugly teeth caused by fluoride is called Fluorosis.

Fluorosis currently affects one out of five or more children in this nation although it is rarely seen in California.

California is the least fluoridated state with less than 16% of the population drinking artificially fluoridated water.

Fluoride Does NOT Reduce Tooth Decay

Fluoride is not effective in reducing tooth decay.

No correlation was found between the level of fluoride in water and dental caries.7 8 9 10 11

There appears to be a genetically related increase in tooth decay for Hispanics, Indians, Native Americans and Asians.

Decay is related to the educational and economic level of the parents.12 13 14

Fluoride Is Unapproved By FDA

The FDA considers fluoride an unapproved new drug for which there is no proof of safety or effectiveness.

The FDA does not consider fluoride an essential nutrient.

Fluoride Is Highly Toxic

The International Academy of Oral Medicine and Toxicology has classified Fluoride as an unapproved dental medicament due to its high toxicity.

References

1. Maurer, et. al., Fluoride an equivocal carcinogen J. National Cancer Institute 82, 1118-26, 1990 2. Cohn, Perry D. Ph.D. An Epidemiological Report on Drinking Water Fluoridation and Osteosarcoma in Young Males New Jersey Department of Health, Environmental Health Service, Trenton NJ November 8, 1992 3. Yiamouyiannis, J.A. and Dean Burk, "Fluoridation and Cancer: Age Dependence of Cancer Mortality Related to Artificial Fluoridation," Fluoride, Vol. 10 #3 (102-123) 1977 4. Hip Fracture rates related to Fluoridated water Journal of the American Medical Association 264(4):500-502 1990 5. J. C. Robins and J. L. Ambrus, "Studies on Osteoporosis IX. Effect of Fluoride on Steroid Induced Osteoporosis," Research Communications in Chemical Pathology and Pharmacology, Volume 37, No. 3, pp. 453-461 (1982) 6. Freni SC, Journal of Toxicology and Environmental Health, 42:109-121, 1994 7. Diesendorf M. Tooth Decay not related to fluoride intake from water Nature Vol. 322 10 July 1986 8. Colquhoun J. Tooth Decay related to economics of family American Laboratory 17:98-109 1985 9. Colquhoun J. Community Dentistry and Oral Epidemiology 13:37-41 1985 10. Dr. John Yiamouyiannis statement both in his book (Fluoride the Aging Factor" pub Health Action Press 2nd ed. 1986 )and during debates has not been challenged by the ADA or others. 11. Ziegelbecker D. Fluoride 14; 123-128 1981 12. Steelink and Jones Fluoride in the Municipal Water of Tucson related to diet and ethnic origin International Academy of Oral Medicine and Toxicology March 95 13. Colquhoun J. Fluoride Vol. 23 #3 July 90 14. Colquhoun J. Community Health Studies 11:85-90 1987

Fluoride - exterenal links:

Fluoride: http://emporium.turnpike.net/P/PDHA/fluoride/fluor.htm

http://physchem.ox.ac.uk/MSDS/S/sodium_fluoride

http://www.garynull.com/documents/fluoridation.htm

Nutra Ingredients

September 2, 2002

Brushing beats supplements - Belgium's fluoride ban

(Note: This article was originally available, September 2nd, at

http://www.nutraingredients.com/news/news.asp?id=5259 )

02/09/02 - A ban on the sale of fluoride supplements passed by Belgium on 1 August provoked strong reactions, in particular from anti-fluoride campaigners who viewed

the news as a sign of progress. Belgian health minister at the time Magda Aelvoet said she was now pressing for a Europe-wide ban, hinting that the removal of supplements was just the first step towards removing the chemical from the food

chain.

The supplements have not been re-stocked on pharmacy shelves for nearly three weeks now (they will be phased out gradually - current stocks will not be

replenished), although they are still available with a doctor's prescription. NutraIngredients.com tried to assess the impact of the move for manufacturers of the

supplements, and asked a Belgian health ministry spokesman (who preferred not to be named for this interview) if Belgium's policy would ever have an impact on the

rest of Europe.

The spokesman said that the issue had been given exaggerated coverage in some media, and that in fact, supplement manufacturers and the dental profession were

behind the move.

"We do not think there is an economic impact on the industry. In Belgium at least, Novartis takes care of around 99 per cent of the market. I don't have the figures to hand, but the size is not that significant and fluoride supplements are usually a marginal application for the companies involved.

"The main product available in Belgium is Zymafluor, in tablets, which is produced by Novartis Consumer Health. We have spoken to them and they had no negative reaction to the

move. In fact they had an existing registration for the drug as a medicine, so they are going to

bring it back onto the market," he said.

However he did admit that the ban could be seen in a negative light in some cases. "There could be opposition from the industry because of the image of fluoride - if some uses of fluoride are banned, this could undermine the use of fluoride as a whole."

Belgium's ban is a result of a report carried out by the health ministry's advisory body, the High Council for Health, which claimed to have reviewed all scientific

studies on fluoride supplementation. It concluded that excessive use of fluoride increases the risk of osteoporosis, and could also lead to damage of the nervous system.

This is of course disputed by other experts and individual studies but the health ministry is now planning to present the review, currently being prepared by its advisory body, to the European Commission this month in a bid to make Europe follow its lead.

There is however one major barrier to European legislation, and also Belgium's

current ban - the EU directive on food supplements which was passed this year and must be implemented from July 2003. The directive already includes fluoride, so to

maintain the ban, Belgium must persuade other member nations to support its move. Without Europe's support for the policy, supplement manufacturers would in theory

be able to bring Belgium to the European Court of Justice for blocking free European trade.

"We think we have very strong arguments for the ban," responded the ministry spokesman.

"And it is rather uncertain when the list of supplements (the Directive) will come in. We have asked the council of health to prepare a review of the existing scientific evidence to be presented to the European Commission so we are presenting them with a solid scientific basis for the ban to be brought into Europe."

Given that Ireland and the UK both currently have water fluoridation programmes,

and other countries such as Switzerland, Germany and Austria have fluoridised salt widely available, changing European opinion is going to be a formidable task for Belgium.

"At least we will have the opportunity to discuss it. We are not trying to change everything in Europe. This issue has been around since 1995 when Aelvoet first tried to put it on the European agenda, and it has surfaced again. We are hoping to be able to ban it on a European

level as soon as possible though," said Belgium's spokesman, although he declined to

speculate on the obvious consequences - without this ban on a European level, fluoride supplements could soon be back on sale in the country.

Belgium's scientific review is also likely to witness some opponents. Evidence that

suggests fluoride does not in fact harm health is substantial. A UK study published in 2000 found that there was no clear evidence that water fluoridation was linked to any

health problems. Belgium however looks at the argument from the other side of the coin:

"We base our opposition to fluoride on the fact that there is no positive impact from the supplements - brushing teeth with fluoride toothpaste is sufficient and there is no reason to do

anything else. Fluoride should be applied topically to prevent caries, but should not be swallowed, especially by children who are more vulnerable to it. Although there is natural fluoride in tea and water, for example, we think that there are significant differences between the natural chemical and the synthetic fluoride used in dental products. And we have looked at a general review of the total literature, rather than a single study - we all know studies can

sometimes be biased," responded the health ministry spokesman.

Belgian officials are still prepared to agree that the ban is controversial but suggest that as with any change in opinion to accepted scientific thinking, time will lessen the impact.

Belgium's spokesman also claims that the controversy arose largely through the way the news was presented and not because of the issue.

"The news came out mid-summer, while Magda was still on holiday and before we had

actually officially released it. It was used as a cover story on one magazine (the Belgium-based Humo), and as the minister was away, speculation couldn't be controlled. The reaction was

clearly about the communication of the idea, rather than the decision," said the spokesman.

He explained: "The way it was presented in the press led to much confusion over whether it applied to toothpaste. The position is very clear now, and it is supported by the dentists in Belgium. People should not consume fluoride but instead use it directly on teeth, such as when brushing with fluoride toothpaste. There may be an issue for children under the age of six, who sometimes swallow toothpaste, but we recommend that doses should be as low as possible.

"There has been no decision whatsoever on toothpaste however, despite other interpretations of

our position. But I think we've cleared up the controversy and the debate is finished," he

added.

Belgium's spokesman may be confident that the debate is over, but it is clear that an altogether bigger one is imminent when the European Commission hears Belgium's case. Magda Aelvoet has since resigned from office over a separate issue and it

remains to be seen how far the new health minister plans to take the issue (in the interview with Humo, Aelvoet said that she would ask manufacturers to make toothpaste fluoride-free).

Whatever the outcome, it will take more than one country to change the opinions of

those who believe that fluoride is a beneficial factor, whether in water or in the form of supplements and dental products, but Belgium seems intent on trying.

Dartmouth researcher warns of chemicals added to drinking water Posted 03/15/01

http://www.dartmouth.edu/~news/releases/2001/mar01/flouride.html

In a recent article in the journal NeuroToxicology, a research team led by Roger D. Masters, Dartmouth College Research Professor and Nelson A. Rockefeller Professor of Government Emeritus, reports evidence that public drinking water treated with sodium silicofluoride or fluosilicic acid, known as silicofluorides (SiFs), is linked to higher uptake of lead in children.

Sodium fluoride, first added to public drinking water in 1945, is now used in less than 10% of fluoridation systems nationwide, according to the Center for Disease Control's (CDC) 1992 Fluoridation Census. Instead, SiF's are now used to treat drinking water delivered to 140 million people. While sodium fluoride was tested on animals and approved for human consumption, the same cannot be said for SiFs.

Masters and his collaborator Myron J. Coplan, a consulting chemical engineer, formerly Vice President of Albany International Corporation, led the team that has now studied the blood lead levels in over 400,000 children in three different samples. In each case, they found a significant link between SiF-treated water and elevated blood lead levels.

"We should stop using silicofluorides in our public water supply until we know what they do," said Masters. Officials at the Environmental Protection Agency have told Masters and Coplan that the EPA has no information on health effects of chronic ingestion of SiF-treated water.

In their latest study published in a special December 2000 issue of NeuroToxicology , Masters, Coplan and their team analyzed data on blood levels from more than 150,000 children ages 0 to 6. These tests were part of a sample collected by the New York State Department of Children's Health, mostly from 1994 to 1998 in comparable non-fluoridated and SiF-treated public drinking water in communities with populations of similar size. Socio-economic and demographic risk factors for high blood lead were also considered using information from the 1990 U.S. Census. The researchers found that the greatest likelihood of children having elevated blood lead levels occurs when they are exposed both to known risk factors, such as old house paint and lead in soil or water, and to SiF-treated drinking water.

"Our research needs further laboratory testing," added Masters. "This should have the highest priority because our preliminary findings show correlations between SiF use and more behavior problems due to known effects of lead on brain chemistry." Also requiring

further examination is German research that shows SiFs inhibit cholinesterase, an enzyme that plays an important role in regulating neurotransmitters.

"If SiFs are cholinesterase inhibitors, this means that SiFs have effects like the chemical agents linked to Gulf War Syndrome, chronic fatigue syndrome and other puzzling conditions that plague millions of Americans," said Masters. "We need a better understanding of how SiFs behave chemically and physiologically."

Currently, a bill before the New Hampshire House of Representatives would impose more stringent testing on fluoridating chemicals added to public drinking water. On March 7, 2001, Masters and Coplan testified in favor of the bill, HB 754, The Fluoride Product Quality Control Act, at a public hearing. Masters contends that bill's requirement for testing the silicofluorides is vital but needs to be complemented by further research on neurotoxicity and behavior.

Masters and Coplan note that their recent studies contain the most extensive empirical evidence of the health and behavioral costs of these chemicals. "If further research confirms our findings," Masters added, "this may well be the worst environmental poison since leaded gasoline."

Does fluoride promote dental health, or jeopardize its users?

Local News http://www.columbian.com/article/20080915/NEWS02/809142003

Sunday, September 14 | 10:00 p.m. KATHIE DURBIN, COLUMBIAN STAFF WRITER

For 46 years, residents of Vancouver have been downing a fluoride

compound with every glass of tap water they drink.

In Vancouver, Camas and Battle Ground, people consume fluoride in infant formula, with bourbon, in instant hot chocolate and tea. They also water their lawns with it, wash their clothes with it and flush it

into streams where salmon spawn.

Across the river in Portland, and in the Clark County communities of Washougal, Ridgefield and La Center, the public water supply is

fluoride-free.

Nationally, about 70 percent of Americans drink fluoridated water to prevent cavities and promote dental health.

Why the split? Why have some communities chosen to add minute

amounts of a potent chemical — 1 part per million, or 1 milligram per liter — to their water supplies? Why have others resisted?

On one side of the great fluoride divide is trust. For more than a half-

century, the American Dental Association, the U.S. Public Health Service and the medical establishment have promoted fluoridation of public water supplies as the most efficient and cost-effective way to

reduce tooth decay. The federal Centers for Disease Control and Prevention counts it as one of the century’s most significant advances in public health and credits it with a sharp drop in tooth decay since the 1950s.

Vancouver voters approved fluoridation in 1962, ratifying a city ordinance approved in 1961.

“Fluoride is the first line of access to dental care and optimal dental

health,” Mary Smith, president of the Washington State Dental

Association, told state lawmakers in 2000. The Legislature that year rejected a bill that would have required all public water systems

serving more than 1,000 homes to fluoridate.

The argument on the other side has to do with risk — whether fluoridation of drinking water is the most effective way to prevent

tooth decay, and whether the potential risk of a fluoride overdose is worth the benefits in an era when fluoride is available in many forms

that don’t involve mass medication.

U.S. cities began adding fluoride to their water in the 1950s and 1960s. Back then, that was the only way to deliver its benefits.

A half-century later, fluoride is available in toothpaste, children’s

vitamins and topical rinses applied by dental hygienists, as well as in milk, fruit juices, soft drinks and children’s cereal.

Dr. Alan Melnick, Clark County’s health officer, defends fluoridation of public water as the one way to reduce tooth decay that is available to

all, even children whose families can’t afford to provide them with regular dental care.

“You have public health methods that rely on behavior change and

others that don’t,” Melnick said. “The ones that don’t require behavior changes are the most effective.”

How much risk?

A small but growing number of dentists and scientists, however,

question whether it still makes sense to dose the populace with a

chemical that has been linked in medical studies to brittle bones, bone cancer and damage to the kidneys and central nervous system. Overdosing with fluoride also can cause a condition called dental fluorosis, which results in the yellowing and mottling of tooth enamel.

Fluoridation advocates once thought that ingesting fluoride made teeth stronger. But the scientific consensus today is that its value as a cavity-fighter comes solely from its ability to inhibit the growth of

plaque bacteria on the surface of teeth. Fluoride coats the surfaces of teeth, said dentist Bill Osmunson, a fluoridation foe who practices in Bellevue and Lake Oswego, Ore., but

“it does nothing for the grooves in a tooth. Fluoride is a little like

suntan lotion. Putting it on the surface does a little bit of good.”

Last year, Oregon environmental groups and public health advocates

succeeded in killing a bill in the Oregon Legislature that would have forced all drinking water systems serving more than 10,000 to

fluoridate.

Dr. Alan Bates, an Oregon dentist who is also a Democratic state senator, argued against state-mandated fluoridation.

“What is clear is that water fluoridation is only effective as it passes

over the teeth and is not effective as a result of swallowing and absorption,” Bates said in his testimony. Instead of mandating

fluoridation, he suggested that the state subsidize topical fluoride rinses for all children who don’t have dental coverage.

“This recommendation is important because for low-income families in fluoridated communities, there is no practical alternative to using

fluoridated tap water,” Bates said. “Scientific evidence tells us that any claimed benefits of water fluoridation do not justify the risk.”

Studies raise concern

Fluoride in higher concentrations is a potent poison. In 1952, the Alcoa

aluminum plant in Vancouver was found to have illegally dumped up to 7,000 pounds of fluoride compound wastes into the Columbia River

each month. The chemical contaminated the surrounding grass and forage and resulted in injury and death to cattle, according to a report

in the Seattle Times.

Vancouver uses pure granular sodium fluoride to treat its water

supply. But the fluoride added to most public drinking water supplies, a compound called hydrofluorosilic acid, comes from phosphate fertilizer

plants, where it is stripped from smokestack scrubbers that also capture trace amounts of heavy metals such as lead, arsenic and radium. If it weren’t put into drinking water, it would be treated as toxic waste.

Employees who work with fluoride must wear protective clothing and respirators.

A 1998 study by the International Society for Fluoride Research,

published in the journal Brain Research, found that laboratory rats

given fluoridated drinking water at the same concentrations used in public water systems suffered brain and kidney damage.

In 1999, a union representing 1,500 scientists, lawyers, engineers and

other professional employees of the U.S. Environmental Protection Agency called for an end to fluoridation of drinking water, saying the

practice “borders on a criminal act” on the part of government.

EPA scientists cited scientific literature documenting “the increasingly out-of-control exposures to fluoride,” the lack of benefits from

ingesting fluoride and the potential hazards to human health, including the risk of kidney damage, gene mutations, cancer, reproductive

effects, damage to bones and the nervous system, and dental fluorosis.

In 2006, Harvard researchers published a multiyear study reporting that exposure to fluoride at levels considered optimum by the

American Dental Association increased the risk of bone cancer in boys by more than 500 percent.

Also in 2006, a report from the National Research Council

recommended that the EPA lower its standard for naturally occurring fluoride, which is currently 4 parts per million per liter of water. The

council cited adverse impacts including increased bone fractures and damage to neurological, immune and reproductive systems.

Based on that report, the American Dental Association issued a new

warning against the use of fluoridated water in infant formula, which was echoed by the U.S. Centers for Disease Control.

Melody Scheer, oral health coordinator for Clark County, defends the safety of water fluoridation, but she says the wide availability of fluoride supplements in other forms does pose a risk.

“If a child swallows toothpaste, or takes too many vitamin pills, that is where you can get an overdose,” she said. How effective?

Fluoridation opponents also question whether fluoridation of drinking water has been as effective in preventing cavities as the ADA and public health officials claim.

The 2003 National Survey of Children’s Health, conducted by the U.S.

Department of Health and Human Services, gathered information on dental health and family income in all 50 states.

It found that the best predictor of good dental health was a history of

preventive care in the previous 12 months.

Opponents have used that data to point out that in Washington, where 59 percent of residents drink fluoridated water, 71.5 percent in the

2003 study had very good to excellent teeth. But in Oregon, just 19.4 percent of residents drank fluoridated water, yet 68.4 percent of

children in the study had very good to excellent teeth.

“Oregon has as good or better dental health than Washington,” dentist Osmunson said.

Clark County’s Melnick questions the study’s methodology, noting that parents self-reported their children’s dental health information. “My

goal is to get the right information out there,” he said.

Osmunson was a believer in water fluoridation for 25 years. He even urged local water districts in Idaho to start adding fluoride.

After moving to Oregon, he started looking at the research. “One of

the things that woke me up was the lack of tooth decay in Lake Oswego,” a city that did not fluoridate its water, he said.

Osmunson no longer supports water fluoridation. He doesn’t even

recommend fluoridated toothpaste for his patients. There are too many unanswered questions, he said.

“We know fluoride can cause an increase in fractured bones,” he said. “Can it also cause an increase in fractured teeth, and did fluoride contribute? No one has studied that.”

Dogs, Cats, Osteosarcoma, Dysplasia

and Pet Food Fluoride by George Glasser, NPWA Bulletin

The recent cover-up scandal about osteosarcoma and drinking water fluoridation brought to mind researc h I had done several years ago into canine osteosarcoma which is fairly common among certain breeds of dogs and cats. Because of the association between osteosarcoma and drinking water fluoridation, I contacted people whose dogs developed the cancer to see if they live d in fluoridated areas, but there was not even a cred ible anecdotal connection. It appeared to be a universal problem. I dropped the investigation until the new flap came up about fluoride and osteosarcoma and I decided to take a fresh look at the issue again. Osteosarcoma is the most common bone cancer in humans, cats and dogs. Osteosarcoma mostly occurs in male humans, dogs and cats. In dogs, the disease is more frequently seen in larger breeds such as rottweilers, greyhounds, golden retrievers, etc. Recent studies have also shown that osteosarcoma is also more common in taller people. Osteosarcoma accounts for 85% of all primary bone tumours in dogs, and in the US - 8,000-10,000 dogs per year in U.S develop osteosarcoma http://www.vetmed.lsu.edu/oncology/osteosar.htm . In cats, osteosarcoma accounts for 70% of primary bone tumours.

In humans, about 5 children out of a million develo p osteosarcoma each year. Osteosarcoma accounts for five percent of all primary bone tumors in children . Osteosarcoma is the most common type of bone cancer/tumors seen in humans, dogs and cats. CONNECTING THE DOTS:

If fluoride were possibly a factor - how did the an imals get a sufficient dose in their diet? My research suggested that it was arbitrary and not associated with drinking water fluoridation, if fluoride were a factor. The only other possibility was in their foo d. It took nothing more than an Internet search using "fluoride content + dog food" and there it was: A low-fluoride commercial dog food contains 40 - 60 parts per million of fluoride. A high-fluoride dog food can contain up to 460 parts per million of fluoride (Marks TA, J Toxicol Environ Health. 1984;14(5-6):7 07-14). "A 1971 study at the University of Montana found th e average level of fluoride in leading pet foods to b e 11 to 193 ppm, with the highest found in canned pet fo od. If your dog weighs 100 pounds this translates to a daily consumption of 21 to 368 milligrams of fluori de from commercial food.

The government upper daily limit of 2.5 milligrams of fluoride is said to be safe for children over three years of age. The Montana researchers found that fluoride accumulates in pet's bones. 84 to 1535 milligrams o f fluoride was found in dog's leg bones. 74 to 1,190 milligrams was found in the bones of cats, and it increased with age." http://www.leaflady.org/pethealth.htm . Investigating further, some lower grade dog foods may contain even more - up to 2,000 parts per milli on of fluoride. Interestingly, the only study I could find about do gs, osteosarcoma and fluoride was one where they were investigating fluoridated drinking water - Apparent ly, the researchers, not realising that dogs may alread y be consuming several hundred milligrams of fluoride per day in their food; tens - hundreds of times mor e that the recommended dose for humans of 1.0 milligram per day. While there are fairly strict regulations about how much fluoride can be in the food of farm animals, t he guidelines for pet foods are fluid. I could find no

research for "safe fluoride levels" for cats and do gs. There is no fluoride intake criteria for pet dogs a nd cats - it is all based on ASSUMPTION and not scienc e. The reason that pets and dietary fluoride intake ha ve been totally neglected is that pets do not represen t an agricultural cash commodity.

For instance, daily fluoride intake for breeding fa rm animals and dairy cows are lower than for animals raised for slaughter. The reason for this is high l evels of fluoride can interfere with reproduction, milk production and the general health of the breeding stock/dairy cows.

"Safe levels of fluoride in the diet dry matter for finishing [slaughter] cattle are no more than 100 p pm (0.01 percent) and to more than 40 ppm (0.004 percent) for animals to be kept in the breeding her d." http://muextension.missouri.edu/explore/agguides/an sci/g02081.htm

"Tolerance levels have been identified for domesticated animals, with the lowest values for da iry cattle at 30 mg/kg feed or 2.5 mg/litre drinking-wa ter. . . Symptoms of fluoride toxicity include emaciation, stiffness of joints and abnormal teeth and bones. Other effects include lowered milk production and detrimental effects on the reproductive capacity of animals." http://www.inchem.org/documents/ehc/ehc/ehc227.htm

It seems that pets fall into the lower end of the ' safe limit' priorities along with farm animals bred for slaughter - all regulations for levels of undesirab le constituents of mineral supplements were developed with commercial agricultural ends in mind - profitability and cost saving for the farmer or ran cher. Unfortunately, pets are not considered an agricultu ral commodity and the agricultural standards are simply accepted without reservation by veterinarians for a ll animals. They do not factor in the fact that pets a re pets and their owners are fond of them, and people want to keep them alive and healthy for as long as possible. People's pets are not just nameless cash producing commodities that either go to slaughter o r are put-down when they no longer can produce milk

or offspring. While, volumes of research has been done on pigs, sheep goats, chickens and cattle with regard to adverse health effects from fluoride, there is very little information about pets such as dogs and cats. Consequently, it is safe to assume that many of dog s and cats who appear to be suffering with arthritis, dysplasia, spinal deformities, etc. may have actual ly developed skeletal fluorosis. The veterinarians don 't have a clue that fluorosis might be the problem. It appears that most veterinarians are completely unaware of the fact that there are cat and dog food s contain high fluoride levels and the physical probl ems that it can cause your pet dog or cat. Researchers are looking at many of the health problems as genetic aberrations rather than toxica nt related conditions such as skeletal fluorosis from high levels of fluoride contained in pet foods. While a particular breed may be genetically predisposed to those health problems, the contaminants in the feed may prematurely trigger the events or even make them more pronounced at a young age. The addition of mineral supplements which contain high levels of fluoride is not a conspiracy, but pl ain old ignorance - your pet is simply in the same category as a farm animal bred for slaughter - no o ne has ever adequately investigated the long-term effe cts of fluoride intake on domestic pets or its impact o n specific breeds. While they have known that certain breeds are genetically predisposed to hip dysplasia (osteoarthritis), osteosarcoma, kidney dysfunction, etc., no one has done research to determine if the high levels of fluoride in their feed may exacerbat e or even be the catalyst in triggering these adverse events. Hip dysplasia is actually a form of arthritis of th e hip bones. Most of the dogs and cats that are genetica lly predisposed to dysplasia develop the condition before they are two years old. However, dysplasia m ay

well be misdiagnosed and is actually skeletal fluor osis - but veterinarians have not looked at this possibi lity because they haven't thought outside of the agricultural nutrition box.

The primary source of the fluoride in pet foods is from the added mineral supplements: defluorinated phosphate rock (which still retains some fluoride a nd is found in more expensive pet foods), raw soft phosphate rock, mono and tricalcium phosphate (made from a mixture of phosphoric acid and calcium carbonate). The less expensive the dog food, probably, the higher the fluoride levels because th ey use raw phosphate.

Raw phosphate, mainly because of it's fluoride content (3% -4%) is most physically damaging animal mineral supplement because it is not processed and the least expensive. These facts have been know n since the 1920s in early animal nutritional researc h of fluorine in animal nutrition. Manufacturers are not required to list the fluoride of contaminant levels in pet food. Could it be, that by simply changing the mineral supplements added to dog and cat foods, many of the maladies your pet may suffer from can be virtually eliminated or delayed until much later in life.

Visit this site http://www.dogpack.com/health/healthproblems.htm and do some of your own research by entering "fluoride" or "fluorine*" with the problem into an internet search. From my research, I would suggest purchasing meat from the butcher, andif the animal needs mineral supplements - give them the same quality supplement that you would take yourself. Also see: http://www.npwa.freeserve.co.uk/pollution.htm for more information about phosphate rock. * In animal nutrition, 'fluoride' is more commonly

referred to as 'fluorine'. By George Glasser, Press Officer/Water Quality Advisor National Pure Water Association http://www.npwa.freeserve.co.uk/fluoride.html

Effects of Fluoride on Development of Bone

http://www.fda.gov/cdrh/ost/index.html

Key words: fluoride, bone strength, bone density, radiographic testing, mechanical testing

Various kinds of toxicity have been attributed to ingestion of fluoride, including dental fluorosis; bone fracture; reproductive, renal, gastrointestinal, and immunological toxicities; genotoxicity; and carcinogenicity. In 1990, a study by the PHS National Toxicology Program (NTP) found "equivocal evidence" of carcinogenicity associated with fluoride ingestion, based on a small number of osteosarcomas in male rats. In response to this finding, a subcommittee of the PHS Committee to Coordinate Environmental Health and Related Programs (CCEHRP) conducted a thorough review of the benefits and risks of water fluoridation and other sources of fluoride. The committee issued a report in 1991 recommending further study related to various regulatory requirements for fluoride. Regarding fluoride's effects on bone, CCEHRP recommended research to (1) determine the risk factors associated with the development of fluoride-associated osteosarcoma, and (2) further elucidate the mechanisms of fluoride action on bone at the molecular and physical chemical levels.

A collaborative study between CFSAN and CDRH was undertaken in response to the CCEHRP recommendations. The objective was to determine the levels of fluoride in the plasma, urine, and bone of rats at various stages of development and to characterize the bone strength for those rats. For each category of rat (male/female and pregnant/not pregnant at various stagesneonatal, weanling, and adult), five fluoride levels were studied (0 to 250 ppm in drinking water). CFSAN determined the fluoride content of one femur from each rat and CDRH conducted radiographic and mechanical testing on the contralateral femora to assess the effects of treatment on bone strength. For the radiographic imaging part of the study, computerized tomography testing was performed to measure bone density in the mid-diaphyseal and distal sections of the bone. This enabled scientists to study the effects of treatment on both cortical and trabecular bone. Plain-film radiographs of each bone were also made for a collaborative study with the University of Chicago using fractal analysis to estimate bone strength. Results from these imaging studies will be compared with results from mechanical (bending) tests on the bones to determine (1) the developmental effects of fluoride on bone strength, and (2) the correlation between bone density, fractal dimension and bone strength. DMMS and DECS, divisions within OST, have completed testing, and the data are being analyzed.

This study will provide FDA (and possibly EPA) with additional data to address regulatory concerns identified in the CCEHRP report on the benefits and risks of fluoride. The part of the study examining correlations between mechanical and radiographic test data may be useful to CDRH, CDER, CBER, and perhaps others with respect to evaluating imaging devices used to predict fracture risk, bone substitute materials, drugs used to treat or prevent osteoporosis, and methods for storing bone and bone marrow for transplant. [ProA]

Fluoride and the Phosphate Connection

by George C. Glasser

Cities all over the US purchase hundreds of thousands of gallons of fresh pollution concentrate from Florida - fluorosilicic acid (H2SiF6) - to fluoridate water. Fluorosilicic acid is composed of tetrafluorosiliciate gas and other species of fluorine gases captured in pollution scrubbers and concentrated into a 23% solution during wet process phosphate fertilizer manufacture. Generally, the acid is stored in outdoor cooling ponds before being shipped to US cities to artificially fluoridate drinking water. Fluoridating drinking water with recovered pollution is a cost-effective means of disposing of toxic waste. The fluorosilicic acid would otherwise be classified as a hazardous toxic waste on the Superfund Priorities List of toxic substances that pose the most significant risk to human health and the greatest potential liability for manufacturers. Phosphate fertilizer suppliers have more than $10 billion invested in production and mining facilities in Florida. Phosphate fertilizer production accounts for $800 million in wages per year. Florida's mines produce 30% of the world supply and 75% of the US supply of phosphate fertilizers. Much of the country's supply of fluoro-silicic acid for water fluoridation is also produced in Florida.

Phosphate fertilizer manufacturing and mining are not environment friendly operations. Fluorides and radionuclides are the primary toxic pollutants from the manufacture of phosphate fertilizer in Central Florida. People living near the fertilizer plants and mines, experience lung cancer and leukemia rates that are double the state average. Much of West Central Florida has become a toxic waste dump for phosphate fertilizer manufacturers. Federal and state pollution regulations have been modified to accommodate phosphate fertilizer production and use: These regulations have included using recovered pollution for water fluoridation. Radium wastes from filtration systems at phosphate fertilizer facilities are among the most radioactive types of naturally occurring radioactive material (NORM) wastes. The radium wastes are so concentrated, they cannot be disposed of at the one US landfill licensed to accept NORM wastes, so manufacturers dump the radioactive wastes in acidic ponds atop 200-foot-high gypsum stacks. The federal government has no rules for its disposal. During the late 1960s, fluorine emissions were damaging crops, killing fish and causing crippling skeletal fluorosis in livestock. The EPA became concerned and enforced regulations requiring manufacturers to install pollution scrubbers. At that time, the

facilities were dumping the concentrated pollution directly into waterways leading into Tampa Bay. A Phosphate Worse than Death In the late 1960s, EPA chemist Ervin Bellack worked out the ideal solution to a monumental pollution problem. Because recovered phosphate fertilizer manufacturing waste contain about 19% fluorine, Bellack concluded that the concentrated "scrubber liquor" could be a perfect water fluoridation agent. It was a liquid and easily soluble in water, unlike sodium fluoride - a waste product from aluminum manufacturing. It was also inexpensive. Fate also intervened. The aluminum industry, which previously supplied sodium fluoride for water fluoridation, was facing a shortage of fluorspar used in smelting aluminum. Consequently, there was a shortage of sodium fluoride to fluoridate drinking water. For the phosphate fertilizer industry, the shortage of sodium fluoride was the key to turning red ink into black and an environmental liability into a perceived asset. With the help of the EPA, fluorosilicic acid was transformed from a concentrated toxic waste and a liability into a "proven cavity fighter." The EPA and the US Public Health Service waived all testing procedures and - with the help of the American Dental Association (ADA) - encouraged cities to add the radioactive concentrate into America's drinking water as an "improved" form of fluoride. The product is not "fluorine" or "fluoride" as proponents state: It is a pollution concentrate. Fluorine is only one captured pollutant comprising about 19% of the total product. By 1983, the official EPA policy was expressed by EPA Office of Water Deputy Administrator Rebecca Hanmer as follows: "In regard to the use of fluosilicic (fluorosilicic) acid as a source of fluoride for fluoridation, this agency regards such use as an ideal environmental solution to a long-standing problem. By recovering by-product fluosilicic acid from fertilizer manufacturing, water and air pollution are minimized, and water utilities have a low-cost source of fluoride available to them." A Hot New Property In promoting the use of the pollution concentrate as a fluoridation agent, the ADA, Federal agencies and manufacturers failed to mention that it was radioactive. Whenever uranium is found in nature as a component of a mineral, a host of other radionuclides are always found in the mineral in various stages of decay. Uranium and all of its decay-rate products are found in phosphate rock, fluorosilicic acid and phosphate fertilizer. During wet-process manufacturing, trace amounts of radium and uranium are captured in the pollution scrubber. This process was the subject of an article by H.F. Denzinger, H. J. König and G.E. Krüger in the fertilizer industry journal, Phosphorus & Potassium (No. 103, Sept./Oct. 1979) discussed how radionuclides are carried into the fluorosilicic acid.

While the uranium and radium in fluorosilicic acid are known carcinogens, two decay products of uranium are even more carcinogenic: radon-222 and polonium-210. During the acidulation process that creates phosphoric acid, radon gas contained in the phosphate pebble can be released in greater proportions than other decay-rate products (radionuclides) and carried over into the fluorosilicic acid. Polonium may also be captured in greater quantities during scrubbing operations because, like radon, it can readily combine with fluoride. In written communications to the author, EPA Office of Drinking Water official Joseph A. Cotruvo and Public Health Service fluoridation engineer Thomas Reeves have acknowledged the presence of radionuclides in fluorosilicic acid. Radon-222 is not an immediate threat because it stops emitting alpha radiation and decays into lead-214 in 3.86 days. Lead-214 appears to be harmless but it eventually decays into bismuth-214 and then into polonium-214. Unless someone knew to look for specific isotopes, no one would know that a transmutation into the polonium isotope had occurred. Polonium-210, a decay product of bismuth-210, has a half-life of 138 days and gives off intense alpha radiation as it decays into regular lead and becomes stable. Any polonium-210 that might be present in the phosphate concentrate could pose a significant health threat. A very small amount of polonium-210 can be very dangerous, giving off 5,000 times more alpha radiation than the same amount of radium. As little as 0.03 microcuries (6.8 trillionths of a gram) of polonium-210 can be carcinogenic to humans. The lead isotope behaves like calcium in the body. It may be stored in the bones for years before turning into polonium-210 and triggering a carcinogenic release of alpha radiation. Drinking water fluoridated with fluorosilicic acid contains radon at every sequence of its decay to polonium. The fresher the pollution concentrate, the more polonium it will contain. As long as the amount of contaminants added to the drinking water (including radionuclides in fluorosilicic acid) do not exceed the limits set forth in the Safe Drinking Water Act, the EPA has no regulatory problem with the use of any contaminated products for drinking water treatment. Big Risks: No Tests Despite the increased cancer risk from using phosphate waste to fluoridate drinking water, the EPA nor the Centers for Disease Control have never commissioned or required any clinical studies with the pollution concentrate - specifically, the hexafluorsilicate radical whose toxicokinetic properties are different than the lone, fluoride ion. Section 104 (I) (5) of the Comprehensive Environmental Response, Compensation and

Liability Act (CERCLA) directs the Toxic Substances and Disease Registry, the EPA, the Public Health Service and the National Toxicology Program to initiate a program of research on fluoride safety. However, after almost 30 years of using fluorosilicic acid and sodium fluorosilicate to fluoridate the drinking water, not one study has been commissioned. The fluoride ion only hypothetically exists as an entity in an ideal solution of purified water - and tap water is far from pure H2O. All clinical research with animal models is done using 99.97% pure sodium fluoride and double distilled or deionized water. Among the thousands of clinical studies about fluoride, not one has been done with the pollution concentrate or typical tap water containing fluorides. Synergy Soup The fluorosilicic acid is also contaminated with small traces of arsenic, cadmium, mercury, lead, sulfates, iron and phosphorous, not to mention radionuclides. Some contaminants have the potential to react with the hexafluorosilicate radical and may act as complex ionic compounds. The biological fates and toxicokinetic properties of these complex ions are unknown. The reality of artificial water fluoridation is so complex that determining the safety of the practice may be impossible. Tap water is chemically treated with chlorine, soluble silicates, phosphate polymers and many other chemicals. In addition, the source water itself may contain a variety of contaminants. The addition of a fluoridation agent can create synergized toxicants in a water supply that have unique toxico-kinetic properties found only in that particular water supply. Consequently, any maladies resulting from chronic ingestion of the product likely would be dismissed as a local or regional anomaly unrelated to water fluoridation. Technically, artificially fluoridating drinking water is a violation of the Safe Drinking Water Act (SDWA). Under statutes of the SDWA, federal agencies are forbidden from endorsing, supporting, requiring or funding the practice of adding any chemicals to the water supply other than for purposes of water purification. However, the Public Health Service (PHS) applies semantics to circumvent Federal law in order to promote and fund the practice. PHS states that they only recommend levels of fluorides in the drinking water, and it is the sole decision of a state or community to fluoridate drinking water. Federal agencies are forbidden from directly funding or implementing water fluoridation but Federal Block Grants are given to States to use as they see fit. Through second and third parties (such as the American Dental Association, state health departments and state fluoridation coordinators), PHS encourages communities to apply for Federal Block Grant funds to implement fluoridation. The legality of using of Federal Block Grant funds to fund water fluoridation, a practice

prohibited by Federal law, has never been addressed in the courts. Vendors selling the pollution concentrate as a fluoridation agent use a broad disclaimer found on the Material Data Safety Sheet that states: "no responsibility can be assumed by vendor for any damage or injury resulting from abnormal use, from any failure to adhere to recommended practices, or from any hazards inherent to the product." [Emphasis added.] The next time you turn on the tap and water gushes out into a glass, reflect on the following disclaimer from the EPA's 1997 Fluoride: Regulatory Fact Sheet: "In the United States, there are no Federal safety standards which are applicable to additives, including those for use in fluoridating drinking water." George Glasser is a Florida-based writer whose work has appeared in Newlife, Whole Life Times, the Sarasota ECO Report and the Tampa Tribune.

http://www.nontoxic.com/water/fluoridefilters.html

Fluoride in water? call 1 800 968 9355

FLUORIDE ACTION NETWORK http://www.FluorideAction.net

Fluoride disrupts the synthesis of collagen and leads to breakdown in the bone, tendon, skin, cartilage, lungs, trachea, and kidney. Fluoride inhibits the formation of antibodies in the blood, which cause a disruptive effect on various tissues in the body, which then confuses the immune system and causes it to attack its own tissues. Fluoride increases the tumor growth and the general cancer rate. Fluoride has been linked to cancer, low IQ genetic disorders and muscle degeneration. This information has been based on mercola.com research which we trust as a source of information more responsible than government agencies.

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What Is Fluoride?

Fluorine is an element and a gas, never occurring in its free state. In microscopic amounts complexed with other minerals, it is often listed as a trace mineral, a nutrient for human nutrition. This is not the fluoride used for fluoride or fluoridation. Fluoride added to 90% of drinking water is hydrofluoric acid which is a compound of fluorine that is a chemical by product of aluminum, steel, cement, phosphate, and nuclear weapons manufacturing. Such fluoride is manmade. In this form, fluoride has no nutrient value whatsoever. It is one of the most caustic of industrial chemicals. Fluoride is the active toxin in rat poisons and cockroach powder. Hydrofluoric acid is used to refine high octane gasoline, to make fluorocarbons and chlorofluorocarbons for freezers and air conditioners, and to manufacture computer screens, fluorescent light bulbs, semiconductors, plastics, herbicides, -- and toothpaste. It also has the ability to burn flesh to the bone, destroy eyes, and sear lungs so that victims drown in their own body fluid." Once in the body, fluoride is a destroyer of human enzymes. It does this by changing their shapes. Thousands of enzymes are necessary for various essential cell reactions that take place every second we're alive. (Howell) Without enzymes, we'd die instantaneously. Once in the body, fluoride is a destroyer of human enzymes. It does this by changing their shapes. In human biochemistry, thousands of enzymes are necessary for various essential cell reactions.

Fluoride the Aging Factor by John Yiamouyiannis, PhD.

Without enzymes, we'd die instantaneously. Enzymes trigger specific reactions in the body. One way they do this is by having the exact shape necessary, like a key in a lock.

Fluoride Changes The Shape Of The Enzymes So That They No Longer Fit.

Since enzymes are proteins, once they've been changed, they're now foreign-looking. The body now treats them as invaders, even though they're part of that body. This is known as an autoimmune situation - the body attacks itself. Another way to look at it: enzymes are long-chain proteins held in certain shapes. Hydrogen bonds are the velcro strips that hold the enzyme in a certain shape. Fluoride comes along and hydrolyzes the enzyme: cuts the Velcro strips away. The shape collapses. No more enzyme; now just a foreign protein.

Starting Point The most thorough explanation of the origin, action, diseases, and politics of fluoride was presented in a book called

Fluoride the Aging Factor by John Yiamouyiannis, PhD.

This book is the result of 25 years of research and working behind the scenes of the fluoride phenomenon. Dr. Yiamouyiannis was the science director of the National Health Federation. He then went on to head the Safe Water Foundation. No one can comment intelligently about fluoride in the U.S. without dealing with the issues raised in his pivotal book. It is simply a review of the literature on fluoride up to 1994. Dr. Y starts by citing hundreds of international studies of fluoridation that have been conducted all over the world since the 1930s.

Studies looking to find out about fluoride and Studies that were trying to cover up what had already been discovered.

Examples Of The Former:

Taylor Study, University of Austin: fluoride concentration of 1PPM (parts per million) increases tumor growth rate by 25% Fluoride is more poisonous than lead, and just less poisonous than arsenic - Clinical Toxicology of Commercial Products -- 1984 "A seven ounce tube of toothpaste, theoretically at least, contains enough fluoride to kill a small child." -

Procter&Gamble, quoted in Fluoride the Aging Factor p14 Fluoride supplements should not be given to children under three years old - 1992 Canadian Dental Association Proposed Fluoride Guidelines, Dr. Limeback Fluoride Accelerates Your Aging Process.

Austrian researchers proved in the 1970s that as little as 1 ppm fluoride concentration can disrupt DNA repair enzymes by 50%. When DNA can't repair damaged cells, we get old fast.

Fluoride prematurely ages the body, mainly by distortion of enzyme shape. Again, when enzymes get twisted out of shape, they can't do their jobs. This results in collagen breakdown, eczema, tissue damage, skin wrinkling, genetic damage, and immune suppression.

Practically any disease you can name may then be caused. All systems of the body are dependent upon enzymes. When fluoride changes the enzymes, this can damage: immune system digestive system respiratory system blood circulation kidney function liver function brain function thyroid function.

Things wear out too fast - the young body becomes old. The distorted enzymes are proteins, but now they have become foreign protein, which we know is the exact cause of autoimmune diseases, such as lupus, arthritis, asthma, and arteriosclerosis.

Collagen Is The Body's Glue and Fluoride Ruins It.

When collagen breaks down, tissues simply lose their substance, their framework. Fluoride dissolves the body's glue simply by preventing new collagen from being formed.

DR Y gives a masterful explanation of fluoride's disruption of collagen. Not only is the collagen incorrectly formed, it is wrongly mineralized. Some collagen, like bones and teeth, should be mineralized in order to give it hardness. Other collagen structures, like ligaments, tendons and, and muscles, should not be mineralized, in order to keep them flexible and resilient. Fluoride mineralizes the tendons, and muscles and ligaments, making them crackly and painful and inflexible. At the same time fluoride interferes with mineralization of bones and teeth, causing osteoporosis and mottling or dental fluorosis.

So Then Why Are We Fluoridating, For The Last 60 Years?

Unrestricted research into almost any area involving health care is really a tiresome business - it's the same boring story over and over: A Toxin in Search of A Market. First a chemical is created, then an angle is figured out on how to mass market it. Then a disinformation program is put into place to create a permanent smokescreen for the actual scientific data. As we saw with ADD, antibiotics, the history of pharmaceuticals, HRT, heart drugs, chlorination, and now fluoridation - the pattern is consistent. With billions of dollars in play, the chemical industry can afford to choreograph its two most willing marionettes: the media and the medical profession.

Fluoridation. A certified poison, by all the government agencies and scientific agencies cited above.

The rise of the EPA since the 1970s. The increase in environmental consciousness as a political tool for creating the illusion of safety in recent decades. Here's the short version: fluoride is a toxic byproduct in the manufacture of nuclear arms, aluminum, cement, steel, and phosphates. Millions of tons of this poison are produced every year. Imagine the cost of containing and disposing of those mountains of waste every year. It's in the billions. But what if lobbyists from these industries could present "scientific studies" paid for by the industries, and provide for a continual stream of media presentations about the health benefits of fluoride, and create unimaginably lucrative positions for "research" and "education" within the American Dental Association and the AMA, and do all these things in a consistent and unending way, year after year? What are the economic advantages of that? Simple: instead of paying money to dispose of toxic waste, money could now be made by selling fluoride to the water companies of the nation. They'll use the public water supply as a sewer for industrial wastes.

In the face of all the decades of our best research, this arrogant and groundless pronouncement, by the profession to whom we have entrusted our teeth, is saying that our water could have 8 times as much fluoride as it has now, and still be perfectly safe!

The Players: ALCOA Aluminum, mega-giant producer of aluminum, was founded by Andrew Mellon, who was also appointed Secretary of Treasury, since he seemed to know something about money. ALCOA funded a top research facility known as the Mellon Institute. In 1931, a Mellon Institute report by Gerald Cox suggested that 1 PPM fluoride added to drinking water would be good for the teeth. That was it. No studies, no comparisons, no data. All previous research studies had shown that fluoride was toxic.

The US Public Health Service (USPHS) at that time was under the jurisdiction of the Secretary of Treasury - Andrew Mellon, who also owned ALCOA. The USPHS sponsored some research put out by their own Dr. HT Dean, manipulating data so that it "proved" that this same figure of 1 PPM resulted in reduction of tooth decay. So now there were two studies, one by Cox and one by Dean, both funded by agencies controlled by ALCOA, both supporting this arbitrary figure of 1 PPM fluoride that should be added to the water to lower tooth decay.

Next problem: sell it to the American Medical Association and the American Dental Association.

This took years. Even in 1943, an article in JAMA described fluoride as a poison that damaged enzyme systems even at a concentration of 1 PPM.

The article showed concern about 25,000 tons of fluorine released into the atmosphere every year from the phosphate fertilizer industry. (JAMA, Sept 18, 1943).

The following year Journal of the American Dental Association ran another article warning that fluoridated water caused osteoporosis, goiter, and spinal disease. They stated that "the potentialities for harm far outweigh those for good." (JADA, 1 Oct 1944) So how did fluoridation get started then, with all this information - thousands of negative scientific papers and only two favorable studies? ALCOA money, that's how.

In 1944, ALCOA hired an attorney named Oscar Ewing .That same year Ewing was appointed to the Federal Security Administration.

The USPHS was a division of the Federal Security Association. So now ALCOA's lawyer was in a position to control the policies of the Public Health Service.

Fluoride Ruins Your Teeth .

We fluoride water to prevent cavities and build strong teeth.

DR Y gives an exhaustive review of the scientific literature of the past 40 years proving beyond a reasonable doubt that fluoride interferes with tooth formation, causing permanent discoloration and actual crumbling. The process whereby teeth are discolored and crumble from fluoridation is know as dental fluorosis. The US Public Health service has known since the research of its own Dr. HT Dean in 1937 that as fluoride levels rose, so did the percentage of children with dental fluorosis, in a study of 15 major American cities. The same findings were evident in a University of Texas study comparing dental fluorosis in children who lived in fluoridated and un fluoridated areas of Texas. Dr. Segretto found a 35% higher incidence of fluorosis in children who drank water with fluorine concentration of 1-1.4 PPM, compared with those whose water was in the .3 PPM range. This study was written up in the Journal of the American Dental Association.

Yiamouyiannis goes on and on, citing one peer-reviewed study after another, all coming to the same inescapable conclusion:

The More Fluoride In The Water, The More Tooth Malformation And Discoloration.

It's beyond controversy, when you view these studies from all over the world - New Zealand, India, Denmark, England, Ireland, Italy, Illinois - same finding. Even with this consistent finding across the board, the standard level of fluoridation recommended for dental health in the US is 1 part per million. How Is This Possible? A major gain for anti fluoridation happened in the past few years, which most people haven't even noticed.

The FDA required all toothpaste manufacturers to print a warning on the label that if more than a pea-sized amount of toothpaste is swallowed, the local Poison Control Center should be notified.

The American Dental Association and other defenders of fluoride have testified and continue to insist that dental fluorosis is a "cosmetic condition" and is not a health issue! Permanent malformation of the teeth is a little more serious than cosmetic - but even if it weren't, how can a additive whose only alleged purpose is to benefit teeth destroy teeth?? In their current website, the ADA actually challenges this FDA warning on toothpaste labels, saying that it is unnecessarily strict. Paul Connett, PhD explains that spots on the teeth and dental fluorosis are just an indication of damage to other parts of the body: "The teeth are windows to what's happening in the bones." Fluoride And Osteoporosis Bone is collagen. We already saw how fluoride disrupts the formation of enzymes necessary for collagen production. So it's no wonder then that the thin brittle bones characteristic of osteoporosis are the result of fluoridation.

This is no false claim. DR Y cites the 1990 study of 541,000 cases of osteoporosis that found a definite connection between hip fractures in women over 65 and fluoride levels. The study was written up in JAMA. Several other major studies are cited, massive amounts of research, again all reaching the same conclusion - the undeniable correlation of fluoridation with osteoporosis and hip fracture in the elderly.

Bone Is Living Tissue.

It is constantly being replaced with new cells, and having old cells removed. Bone building is a finely balanced, complicated process. Fluoride has been known to disrupt this process since the 1930s. Dr. Alesen, who was the president of the California Medical Association, clearly explains what fluoride does to bone formation. He cites dozens of international scientific studies proving beyond a shadow of a doubt that fluoride has caused thousands of cases of osteoporosis, skeletal thinning, fractures, "rubber bones," anemia, and rickets.

Fluoride also causes osteoporosis by creating a calcium deficiency situation. Fluoride precipitates calcium out of solution, causing low blood calcium, as well as the buildup of calcium stones and crystals in the joints and organs.

Dozens of other studies, like the Riggs study in the 1990 New England Journal of Medicine, showed that fluoride treatment of osteoporosis in the elderly actually increases skeletal fragility, i.e., more fractures. It's the same mechanism at work: incorrect mineralization, as we saw above. Thin old bones lose calcium; young bones age too rapidly by over-mineralization. Using fluoride as a treatment for diseases like osteoporosis has always been a particularly dumb idea, because of side effects known beforehand: general arthritis stomach pain nausea vomiting bone spurs bone inflammation kidney fibrosis dental fluorosis.

Other mineral contaminants like lead and strontium-90 are damaging to human bone just by means of their occupying space where they don't belong. They are inert. The difference with fluoride is that it is biochemically active. With all the diseases caused by fluoride, the common thread is " ¦virtually all these ill effects can be traced to the effect of fluoride on enzymes or proteins, as well as a possible direct effect on the DNA molecule itself." Above we saw how fluoride changes the all-important shape of enzymes, thereby rendering them not only useless, but actually foreign antigens.

Cancer And Fluoride By now we all know how cancer begins with one cell whose inner blueprint - its DNA - has been screwed with. Remember those Velcro hydrogen bonds? Guess what other shape they hold together. The double helix - DNA. This turns out to be the exact mechanism of fluoride as a carcinogen. Austrian and Japanese researchers both found that a concentration of 1 PPM fluoride causes disruption of the body's ability to repair its own DNA. Without this most basic cell function, cancer is promoted, and tumor growth is accelerated. That's standard fluoride level in US city water: one part per million. On p. 65 of his book, Dr. Yiamouyiannis provides an amazing chart of some 19 major scientific studies conducted in universities all over the world, together proving beyond a doubt that fluoride causes genetic damage.

End of story. Except that on p 68, there is another list of world studies proving the same thing with plants and insects - genetic alteration from fluoride. Chief chemist of the National Cancer Institute, Dr. Dean Burk when confronted with mountains of data, stated before Congress: "In point of fact, fluoride causes more human cancer death, and causes it faster than any other chemical." - Congressional Record 21 July 1976 Can That Be Misconstrued? Burk and Yiamouyiannis completed a monumental research project in 1977 in which they compared cancer death rates in 10 fluoridated and 10 non-fluoridated US cities between 1940 and 1970.

The results are on p75 of Fluoride the Aging Factor.

The unmistakable fact is that the graph shows that for the first ten years (1940-1950), when none of the 20 cities fluoridated, the average cancer deaths were virtually identical. But after 1950, there is a major increase in cancer deaths in every single one of the fluoridated cities, while the non fluoridated cities remain clustered together at a much lower level of death. They actually put a number on it: " 30,000 to 50,000 deaths each year from various causes may now be attributable to fluoridation. This total includes 10,000 to 20,000 deaths attributable to fluoride-induced cancer every year." These findings were first confirmed, then denied by the National Cancer Institute (what a surprise). Finally the research was upheld as valid in two separate state courts,

Pennsylvania and Illinois. Ask yourself, why are findings of a scientific study being disputed in court? The usual pattern whenever valid research threatens big money. Another study by the New Jersey Health Dept., cited by Dr. Y, found a 50% increase in bone cancer among young men in fluoridated areas. (Cohn) Dr. William Hirzy, an officer in the EPA explains: "Fluoride is a broad-spectrum mutagen. It can cause genetic damage in both plant and animal cells." Once again, this is just the tip of the iceberg. Hundreds of scientific studies conducted and reported in the most credible universities and agencies throughout the world for the past 25 years have found an unmistakable correlation between fluoridation and cancer deaths. Even the professional opinion makers can't just make all this data vanish. All they can do is what they're trained to do: change the subject. And keep repeating how safe and effective fluoride is. Brain Damage = Low IQ Penetrating observation. The earliest reference to brain disruption from fluoride exposure is found in a recently declassified secret Manhattan Project memo (1944): "Clinical evidence suggests that C616 [uranium hydrofluoride] may have a rather marked central nervous system effect with mental confusion, drowsiness and lassitude¦" How can all these studies be dismissed and ignored? Many of them are from the most prestigious of scientific journals. And the message has been consistent for the past 40 years - fluoride is a poison.

What kind of power can contradict such a cogent, overwhelming body of work?

http://www.chemheritage.org/classroom/chemach/electrochem/heroult-hall.html

Discovered in 1827 by Friedrich Wöhler, aluminum, though the most common metal on earth, is

always found tightly locked in compounds. Efforts to use electrolysis to reduce it failed repeatedly,

and for years it remained an exotic metal used in jewelry and for such special purposes as capping

the Washington Monument.

Paul Héroult. Courtesy Alcoa Inc.

The race for a commercially viable route to aluminum was won in 1886 by two young men working

independently—Paul Héroult (1863–1914) in France and Charles M. Hall (1863–1914) in the United

States. Hall was just six months out of Oberlin College; his sister Julia (1859–1925), who had also

been a chemistry major at Oberlin, was of great assistance to him—helping with experiments, taking

laboratory notes, and giving business advice.

Julia Brainerd Hall, Charles's sister, who made many contributions to the discovery of the electrolytic means of producing aluminum and to the business success of the Pittsburgh Reduction Company and the Aluminum Company of America. Courtesy Alcoa Inc.

The problem many researchers had with extracting aluminum was that electrolysis of an aluminum

salt dissolved in water yields aluminum hydroxide. Both Hall and Héroult avoided this problem by

dissolving aluminum oxide in a new solvent-fused cryolite, Na3AlF6. To scale up the process took Hall

years of development and capital investment. In 1888 he joined with Alfred E. Hunt, an experienced

metallurgist, to form the Pittsburgh Reduction Company. After exhausting the initial investment, the

fledgling company was buoyed by the resources of the Mellon banking interests.

Charles M. Hall at the age of 22. Courtesy Alcoa Inc.

Almost immediately the price of aluminum dropped dramatically. Developments in the early 1880s

had reduced the price of a pound of aluminum from 12 dollars to 4 dollars a pound. The Hall process

reduced it to 2 dollars a pound, and shortly after the company’s move to Niagara Falls—the first

electrochemical company in that location—to 75 cents and then 30 cents. In 1907 the company was

renamed the Aluminum Company of America, and in the 1990s this name was shortened to Alcoa Inc.

top

Sodium Hexafluorosilicate[CASRN 16893-85-9]

and

Fluorosilicic Acid[CASRN 16961-83-4]

Review of Toxicological Literature

October 2001

Sodium Hexafluorosilicate[CASRN 16893-85-9]

and

Fluorosilicic Acid[CASRN 16961-83-4]

Review of Toxicological Literature

Prepared for

Scott Masten, Ph.D.National Institute of Environmental Health Sciences

P.O. Box 12233Research Triangle Park, North Carolina 27709

Contract No. N01-ES-65402

Submitted by

Karen E. Haneke, M.S. (Principal Investigator)Bonnie L. Carson, M.S. (Co-Principal Investigator)

Integrated Laboratory SystemsP.O. Box 13501

Research Triangle Park, North Carolina 27709

October 2001

Toxicological Summary for Sodium Hexafluorosilicate [16893-85-9] and Fluorosilicic Acid [16961-83-4] 10/01

i

Executive Summary

NominationSodium hexafluorosilicate and fluorosilicic acid were nominated for toxicological testing basedon their widespread use in water fluoridation and concerns that if they are not completelydissociated to silica and fluoride in water that persons drinking fluoridated water may be exposedto compounds that have not been thoroughly tested for toxicity.

Nontoxicological DataAnalysis and Physical-Chemical PropertiesAnalytical methods for sodium hexafluorosilicate include the lead chlorofluoride method (fortotal fluorine) and an ion-specific electrode procedure. The percentage of fluorosilicic acidcontent for water supply service application can be determined by the specific-gravity methodand the hydrogen titration method. The American Water Works Association (AWWA) hasspecified that fluorosilicic acid contain 20 to 30% active ingredient, a maximum of 1%hydrofluoric acid, a maximum of 200 mg/kg heavy metals (as lead), and no amounts of solublemineral or organic substance capable of causing health effects. Recently, single-column ionchromatography with conductometric detection and sodium hydroxide-methanol-water eluentwas used for the simultaneous determination of fluorosilicic acid, Ca2+, Mg2+, Al3+, Cl-, and NO3

-

and successfully applied to the analysis of mineral water and composite tablets.

When heated to decomposition, sodium hexafluorosilicate releases toxic fumes of hydrogenfluoride and sodium oxide, while contact with metals releases hydrogen gas. In water, thecompound readily dissociates to sodium ions and hexafluorosilicate ions and then to hydrogengas, fluoride ions, and hydrated silica. At the pH of drinking water (6.5-8.5) and at theconcentration usually used for fluoridation (1 mg fluoride/L), the degree of hydrolysis isessentially 100%. Fluorosilicic acid is a moderately strong acid that can corrode glass andstoneware. Like its salt, its degree of hydrolysis is essentially 100% in drinking water, and whenreacted with steam or water or when heated to decomposition or highly acidified, toxic andcorrosive fumes of fluorides (e.g., hydrogen fluoride and silicon tetrafluoride) are released. Italso reacts with metals, producing hydrogen gas.

Commercial Availability, Production, and UsesSodium hexafluorosilicate is usually commercially available in technical and C.P. grades; it wasformally available in insecticides of up to ~98% purity such as granular baits. A typical productcontains 59.34% fluorine and a maximum of 0.50% each of water moisture, water-insolublematter, and heavy metals (as lead). Fluorosilicic acid is commercially available as aqueoussolutions (up to 70%) in technical and C.P. grades. A typical product contains a maximum of23% of the acid, a minimum of 18.22% fluorine, a maximum of 0.02% heavy metals (as lead),and <1.00% hydrofluoric acid. Many U.S. producers and suppliers are available for bothcompounds (over 20 for each). Bulk producers/suppliers include Lucier Chemical Industries andCreanova Inc.

Sodium hexafluorosilicate is produced by treating fluorosilicic acid with sodium hydroxide,sodium carbonate, or sodium chloride; alkalinity is adjusted to avoid the release of the fluoride.Fluorosilicic acid is mainly produced as a byproduct of the manufacture of phosphate fertilizers


ii

where phosphate rock is treated with sulfuric acid. It can also be made by the reaction of sulfuricacid on barium hexafluorosilicate, apatite, or fluorite (fluorspar).

The latest available figure for U.S. production of sodium hexafluorosilicate is 19,600 metric tons(43.2 million pounds) in 1984. In that same year, 3000 metric tons (6.61 million pounds) wasimported. In 1995, ten phosphate rock processing plants produced 55,900 metric tons (123million pounds) of fluorosilicic acid as a byproduct. In 1999, ten plants again reported on theproduction of fluorosilicic acid as a byproduct from phosphate rock processing; 69,200 metrictons (153 million pounds) was produced. This was an almost 3% increase in output from theprevious year.

The major use of sodium hexafluorosilicate and fluorosilicic acid is as fluoridation agents fordrinking water. Sodium hexafluorosilicate has also been used for caries control as part of asilicophosphate cement, an acidic gel in combination with monocalcium phosphate monohydrate,and a two-solution fluoride mouth rinse. Both chemicals are also used as a chemicalintermediate (raw material) for aluminum trifluoride, cryolite (Na3AlF6), silicon tetrafluoride,and other fluorosilicates and have found applications in commercial laundry.

Other applications for sodium hexafluorosilicate include its use in enamels/enamel frits for chinaand porcelain, in opalescent glass, metallurgy (aluminum and beryllium), glue, ore flotation,leather and wood preservatives, and in insecticides and rodenticides. It has been used in themanufacture of pure silicon, as a gelling agent in the production of molded latex foam, and as afluorinating agent in organic synthesis to convert organodichlorophosphorus compounds to thecorresponding organodifluorophosphorus compound. In veterinary practice, external applicationof sodium hexafluorosilicate combats lice and mosquitoes on cattle, sheep, swine, and poultry,and oral administration combats roundworms and possibly whipworms in swine and preventsdental caries in rats. Apparently, all pesticidal products had their registrations cancelled or theywere discontinued by the early 1990s.

Fluorosilicic acid is used in the tanning of animal hides and skins, in ceramics and glass, intechnical paints, in oil well acidizing, in the manufacture of hydrogen fluoride, for thesterilization of equipment (e.g., in brewing and bottling establishments and for copper and brassvehicles), and in electroplating. It is also employed as an impregnating ingredient to preservewood and harden masonry and for the removal of mold as well as rust and stain in textiles.

Environmental Occurrence and PersistenceFluorosilicic acid (30-35%) can readily be recovered in the hydrogen fluoride process from thesilicon tetrafluoride-containing plant vent gases, as well as from wet-process phosphoric acidplants. In the manufacture of phosphate fertilizer in Central Florida, fluorides and radionuclides(radium and uranium) are released as toxic pollutants. During the acidulation process, radon gascan be released and carried into the fluorosilicic acid, while polonium can be captured during thescrubbing process and combined with fluoride.

For drinking water fluoridation, the maximum use level (MUL) for sodium hexafluorosilicate is2 mg/L; for fluorosilicic acid, the level is 6 mg/L of a 25% fluorosilicic acid solution. Bothvalues correspond to a fluoride concentration of 1.2 mg/L, which is below the U.S.


iii

Environmental Protection Agency’s (EPA’s) Maximum Contaminant Level (MCL) of 4.0 mg/Land the Secondary Maximum Contaminant Level (SMCL) of 2.0 mg/L. The National SanitationFoundation (NSF) has established a Maximum Drinking Water Level of 16 mg/L for silicatesand a Maximum Allowable Level (MAL) of 1.2 mg fluoride/L for its certified products used indrinking water.

Human ExposurePotential exposure to sodium hexafluorosilicate and fluorosilicic acid is via inhalation and eyeand skin contact. Another route for the former compound is ingestion. Although current dataindicate that silicofluorides are used in over 9200 U.S. water treatment systems, serving over 120million individuals, exposure via drinking water is expected to be minimal since both compoundshydrolyze almost completely under these conditions.

In the workplace, exposure to both chemicals is possible during their manufacture,transportation, or use in water treatment. In the National Institute for Occupational Safety andHealth (NIOSH) 1983 National Occupation Exposure Survey (NOES), 79,556 employees werepotentially exposed to sodium hexafluorosilicate, while 10,867 were potentially exposed tofluorosilicic acid.

RegulationsWorkers treating agricultural products with insecticides such as weevil baits and persons usingroach baits and other insecticidal products containing sodium hexafluorosilicate in the home mayhave been exposed by inhalation or the skin, and by hand-to-mouth contact. In the United States,all pesticide uses of sodium hexafluorosilicate have been cancelled. (It is noted that its use as aninsecticide is currently listed in the 2001 Farm Chemicals Handbook, which does not notediscontinuation of the product Safsan.) Both sodium hexafluorosilicate and fluorosilicic acid arelisted in Section 8(b) of the Toxic Substances Control Act (TSCA; chemical inventory section).Both are also exempt from reporting under the Inventory Update Rule (i.e., Partial Updating ofthe TSCA Inventory Data Base Production and Site Reports [40CFR, Section 710(b)]). TheOccupational Safety and Health Administration (OSHA) and American Conference ofGovernmental Industrial Hygienists (ACGIH) have established an eight-hour time-weightedaverage (TWA) of 2.5 mg/m3 fluorides, as fluorine, for work place exposure. NIOSH has alsorecommended an air exposure level to inorganic fluorides of 2.5 mg F/m3 but as a ten-hourTWA.

Toxicological DataHuman DataChronic exposure to sodium hexafluorosilicate dust at levels above the eight-hour TWA canresult in severe calcification of the ribs, pelvis, and spinal column ligaments; effects on theenzyme system; pulmonary fibrosis; stiffness; irritation of the eyes, skin, and mucousmembranes; weight loss; anorexia; anemia; cachexia; wasting; and dental effects. Long-term orrepeated exposure to the skin can result in skin rash. A probable oral lethal dose of 50-500mg/kg, classified as very toxic, has been reported for a 150-pound (70-kg) person receivingbetween 1 teaspoon and 1 ounce of sodium hexafluorosilicate. Cases of sodiumhexafluorosilicate ingestion reported symptoms such as acute respiratory failure, ventricular


iv

tachycardia and fibrillation, hypocalcemia, facial numbness, diarrhea, tachycardia, enlargedliver, and cramps of the palms, feet, and legs.

The symptoms of inhalation of fluorosilicic acid include burning of the eyes and numbnessaround the lips. Symptoms do not necessarily occur immediately; they can appear 24 hours afterexposure. A spill incident of the chemical on an interstate in Florida, covering an area 600 feetlong and 60 feet wide, resulted in the visit of more than 50 people to hospitals. Individualscomplained of skin and respiratory irritation, including burning in the throat, and headaches. Aman riding in a truck with his arm out the window experienced burning on his forearm. Theeffects of long-term exposure to fluorosilicic acid are changes in bone, corrosivity of the mucousmembranes (e.g., ulceration of the nose, throat, and bronchial tubes), coughing, shock,pulmonary edema, fluorosis, coma, and even death. In workers engaged for approximately 30years in the production of phosphate fertilizers, nine out of the 50 observed workers hadincreased bone densities. When swallowed, severe irritation of the lungs, nose, and throat canoccur, as well as severe damage to the throat and stomach. A probable oral lethal dose of 50-5000 mg/kg, classified as very toxic, has been reported for doses between 1 teaspoon and 1ounce for a 150-pound (70-kg) person; a probable oral lethal dose of 5-50 mg/kg, classified asextremely toxic, has been reported for doses between 7 drops and 1 teaspoon for the sameindividual.

Chemical Disposition, Metabolism, and ToxicokineticsIn a female chemical plant worker who ingested sodium hexafluorosilicate in a suicide attempt,fluoride levels in serum and fresh urine were 5.130 and 235.60 mg/dm3, respectively, on day 2 ofhospitalization; treatment with calcium compounds (calcium carbonate and calciumlactogluconate) immediately returned levels to normal. In 50 workers engaged forapproximately 30 years in the production of phosphate fertilizers and exposed to gaseousfluoride (hydrogen fluoride, silicon tetrafluoride, and fluorosilicic acid), urine fluoride excretionranged from 1.0 to 9.6 mg F-/L (controls: 0.3 to 1.2).

In rats fed a diet containing 0.16% sodium hexafluorosilicate supplemented in a corn-soybeanoilmeal-casein ration ad libitum for 22-23 days, the average amounts of fluorine were 94.4 mg infeces and 91.9 mg in urine. The mean amount of fluorine absorbed was 65.1% and that retainedwas 31.0%.

Fluorine concentrations in stomach/rumen contents, urine, and blood serum have beendetermined in domestic animals experiencing sodium hexafluorosilicate poisoning. Significantlyelevated levels were initially found, which decreased with time.

Acute ToxicityIn mice, an oral LD50 of 70 mg/kg (0.37 mmol/kg) for sodium hexafluorosilicate was reported.In rats, oral LD50 values of 125 and 430 mg/kg (0.665 and 2.29 mmol/kg, respectively) werecalculated, while a TDLo of 248 mg/kg (1.32 mmol/kg) was calculated. A subcutaneous LDLo of70 mg/kg (0.37 mmol/kg) was also reported in the animals. In rabbits, the oral LD50 value was125 mg/kg (0.665 mmol/kg). In guinea pigs, an LCLo value of 33 mg/kg (0.18 mmol/kg) forsodium hexafluorosilicate was observed; additionally, an oral LD50 of 200 mg/kg (1.39 mmol/kg)was reported for fluorosilicic acid.


v

Sodium Hexafluorosilicate: Mice orally given sodium hexafluorosilicate (70 mg/kg; 0.37mmol/kg) exhibited toxic effects in the peripheral nerves, sensation, and in behavior. In rats, anoral dose (248 mg/kg; 1.32 mmol/kg) administered intermittently for one month produced toxiceffects in the kidney, ureter, and/or bladder, as well as musculoskeletal and biochemical effects.Using guinea pigs, inhalation experiments (13-55 mg/m3 [1.7-7.2 ppm] sodiumhexafluorosilicate in air for ≥6 hours) resulted in pulmonary irritation; the lowest concentrationthat caused death was 33 mg/m3 (4.3 ppm).

When sodium hexafluorosilicate (500 mg; 2.66 mmol) was applied to the skin of adult rabbits,mild irritation occurred. When applied to the eyes (100 mg; 0.532 mmol), severe irritation wasobserved; following a four-second rinse, the effect was still severe.

Sodium hexafluorosilicate poisoning has been reported in domestic animals (cattle, sheep, ahorse, and a pigeon). Animals exhibited drowsiness, constipation, loss of appetite, paresis of therumen, severe abdominal pain, and diarrhea. Sheep also exhibited grinding of the teeth (anindication of pain) and frothing at the mouth in most cases of lethal poisoning, while the horsealso had bradycardia. In a study in which sheep were orally administered technical sodiumhexafluorosilicate (25, 50, 200, 1500, and 2000 mg/kg; 0.13, 0.27, 1.06, 7.976, and 10.63mmol/kg) via stomach tube, the animals exhibited similar symptoms. Animals died 6 days afteradministration of 200 mg/kg and 2.5 hours after administration of 2000 mg/kg. When a dairyherd of 600 animals was acutely poisoned from railcar contamination of feed, 95% of theanimals had decreased neuromuscular transmission. The poisoning resembled calcium depletion.

Fluorosilicic Acid: In rats orally given fluorosilicic acid (430 mg/kg; 2.98 mmol/kg),somnolence and/or general depressed activity was observed. Other rat studies with fluorosilicicacid (single oral doses of 215, 464, 1000, and 2100 mg/kg [1.49, 3.22, 6.939, and 14.57mmol/kg]) led to its classification as "moderately toxic." Percutaneous administration of thecompound (amounts not provided) in rats, guinea pigs, and pigs resulted in continuouslyspreading necrosis in the deeper regions of injured skin. Hypocellular necrosis, consisting ofsharp leukocyte demarcations, and edema up to the subcutis were also observed. In rabbits, itwas corrosive to the skin (0.5 mL [4 mol] for 1, 24, or 72 hours) and eyes (0.1 mL [0.8 mol]instilled into left eye).

Synergistic/Antagonistic EffectsFluoride, administered in the form of sodium hexafluorosilicate, had a strong affinity for calciumand magnesium. When orally given to sheep via a stomach tube at doses of 25, 50, 200, 1500,and 2000 mg/kg, increased changes in serum calcium and magnesium levels were observed atthe two highest doses within 30 minutes after dose administration. At 200 mg/kg, recovery ofboth levels occurred after five days. With the 1500 mg/kg dose group, changes in phosphorusand sugar levels in whole blood were also significantly increased.

GenotoxicitySodium hexafluorosilicate was negative in the Salmonella/microsome test (concentrations up to3600 g/plate, –S9), the micronucleus test on mouse bone marrow (37.2 mg/kg; 0.198mmol/kg), and in the Bacillus subtilis rec-assay system (0.001-10 M; 188 g/mL-1.9 g/mL).


vi

The compound (0.25 mM; 47 g/mL) did not induce sex-linked recessive lethal mutations inDrosophila.

Other DataWithin one week after beginning work in a foam rubber plant, a 23-year-old man exhibited skinlesions consisting of "diffuse, poorly delineated, erythematous plaques with lichenoid papulesand large pustules" on his arms, wrists, thighs, and trunk. Although scratch and patch tests withsodium hexafluorosilicate (2% aqueous) were negative, tests in rabbits (topical application of a1, 5, 10, and 25% solution) showed the compound to be a pustulogen.

No short-term or subchronic exposure, chronic exposure, cytotoxicity, reproductive toxicity,teratology, carcinogenicity, or initiation/promotion studies were available.

Structure-Activity RelationshipsFor the same fluorine content, sodium fluoride, sodium hexafluorosilicate, cryolite (Na3AlF6),and barium sulfate were observed to have the same extent of chronic fluorine intoxication in rats.Ammonium fluoride, potassium fluoride, barium fluorosilicate, potassium fluorosilicate, andsodium fluorosilicate exhibited the same acute toxicity as sodium fluoride in the animals.

In a comparative study of absorption and excretion of fluorine in rats fed sodium fluoride,calcium fluoride, and sodium hexafluorosilicate, the percent fluorine retained was the same forthe two sodium compounds. Several experiments on growing rats orally given 5, 10, 15, 25, and50 ppm fluorine as sodium fluoride or sodium hexafluorosilicate for 90-100 days found nodifferences in the quantity of fluorine deposited and the contents of ash, calcium, and phosphorusin the incisor teeth, molar teeth, mandibles, and femurs. Furthermore, there were no differencesin the percent of ingested fluorine retained in the body, and a combination of sodium silicate (15ppm silicon) with sodium fluoride (25 ppm fluorine) did not affect the amount of fluorinedeposited. The growth rate was normal in all rats. A separate study using litters of femaleweanling Osborne-Mendel rats that were given 50 ppm fluorine as sodium fluoride orammonium fluorosilicate in drinking water for 99 days observed similar results.

vii

Table of Contents

Executive Summary................................................................................................................... i

1.0 Basis for Nomination..................................................................................................... 1

2.0 Introduction................................................................................................................... 12.1 Chemical Identification and Analysis ............................................................... 1

2.1.1 Sodium Hexafluorosilicate ..................................................................... 12.1.2 Fluorosilicic Acid.................................................................................... 2

2.2 Physical-Chemical Properties ........................................................................... 32.3 Commercial Availability.................................................................................... 4

3.0 Production Processes..................................................................................................... 5

4.0 Production and Import Volumes .................................................................................. 5

5.0 Uses ................................................................................................................................ 6

6.0 Environmental Occurrence and Persistence ................................................................ 6

7.0 Human Exposure........................................................................................................... 7

8.0 Regulatory Status .......................................................................................................... 8

9.0 Toxicological Data......................................................................................................... 99.1 General Toxicology............................................................................................ 9

9.1.1 Human Data ........................................................................................... 99.1.2 Chemical Disposition, Metabolism, and Toxicokinetics ..................... 109.1.3 Acute Exposure .................................................................................... 119.1.4 Short-term and Subchronic Exposure................................................. 149.1.5 Chronic Exposure ................................................................................ 149.1.6 Synergistic/Antagonistic Effects .......................................................... 149.1.7 Cytotoxicity .......................................................................................... 15

9.2 Reproductive and Teratological Effects.......................................................... 159.3 Carcinogenicity ................................................................................................ 159.4 Initiation/Promotion Studies ........................................................................... 159.5 Anticarcinogenicity.......................................................................................... 159.6 Genotoxicity ..................................................................................................... 159.7 Cogenotoxicity ................................................................................................. 159.8 Antigenotoxicity............................................................................................... 159.9 Other Data ....................................................................................................... 15

10.0 Structure-Activity Relationships ................................................................................ 15

viii

11.0 Online Databases and Secondary References ............................................................ 1711.1 Online Databases ............................................................................................. 1711.2 Secondary References...................................................................................... 18

12.0 References.................................................................................................................... 19

13.0 References Considered But Not Cited ........................................................................ 23

Acknowledgements ................................................................................................................. 24

Appendix: Units and Abbreviations...................................................................................... 24

Tables:Table 1 Acute Toxicity Values for Sodium Hexafluorosilicate and

Fluorosilicic Acid ...................................................................................... 11Table 2 Acute Exposure to Sodium Hexafluorosilicate and Fluorosilicic Acid ... 12


1

1.0 Basis for NominationSodium hexafluorosilicate and fluorosilicic acid were nominated for toxicological testing basedon their widespread use in water fluoridation and concerns that if they are not completelydissociated to silica and fluoride in water that persons drinking fluoridated water may be exposedto compounds that have not been thoroughly tested for toxicity.

2.0 Introduction

Sodium Hexafluorosilicate[16893-85-9]

F-Si4+

F-

F-

F-

F-F-

2 Na+

Fluorosilicic Acid[16961-83-4]

F-Si4+

F-

F-

F-

F-F-

2 H+

2.1 Chemical Identification and Analysis2.1.1 Sodium HexafluorosilicateSodium hexafluorosilicate ([Na2SiF6]; mol. wt. = 188.06) is also called:

Destruxol applexDisodium hexafluorosilicatea,b,d

Disodium silicofluorideEns-zem weevil baitENT 1,501Fluorosilicate de sodiumFluosilicate de sodiumOrtho earwig baitOrtho weevil baitProdanProdan (pesticide)PSC Co-Op weevil baitSafsan


2

SaluferSilicate (2-), hexafluoro-, disodium (8CI, 9CI)Silicon sodium fluoridea,b,c

Sodium fluoride silicateSodium fluorosilicatea,b

Sodium fluosilicatea,b,e

Sodium hexafluosilicateSodium silicofluoridea,b

Sodium silicon fluoridea,b

Super prodanUN2674 (DOT)

May be written as the following: awithout any appended formula; bwith Na2SiF6 appended in parentheses, cwith SiNa2F6

appended in parentheses, dwith (2-) appended in parentheses, or ewith ACN (accepted common name) appended in parentheses.

Sources: HSDB (2000b); Registry (2000); RTECS (2000); SANSS (2000)

Other CAS Registry Numbers (CASRNs) that have been used for the compound are 1310-02-7,1344-04-3, 12656-12-1, 39413-34-8, 221174-64-7 (Registry, 2000). CASRNs for the hydratesare 10213-79-3 (pentahydrate), 15630-83-8 (hexahydrate), 27121-04-6 (octahydrate), and 13517-24-3 (nonahydrate). AOAC (Association of Official Analytical Chemists) Method 945.05 hasbeen used to detect fluorine as sodium hexafluorosilicate in pesticide formulations (HSDB,2000b). The chemical composition of sodium hexafluorosilicate used in water supply serviceapplications can be determined by test procedures specified in AWWA (American Water WorksAssociation) B702-99 (AWWA, 1999).

2.1.2 Fluorosilicic AcidFluorosilicic acide ([H2SiF6]; mol. wt. = 144.11) is also called:

Dihydrogen hexafluorosilicatea,c

FKSFluosilicic acida,d (6CI)Hexafluorosilicic acidHexafluorosilicate (2-), dihydrogenHexafluosilicic acidHydrofluorosilicic acida,e

Hydrofluosilicic acida,d

Hydrogen hexafluorosilicatea,b

Hydrogen hexafluorosilicicHydrosilicofluoric acida,e

Sand acida,e

Silicate (2-), hexafluoro-, dihydrogen (8CI, 9CI)Silicic acid (H2SiF6)Silicofluoric acida.e

SilicofluorideSilicon hexafluoride dihydrideUN1778 (DOT)

May be written as the following: awithout any appended formula; bwith H2SiF6 appended in parentheses, cwith (2-) appended inparentheses, dwith ACN (accepted common name) appended in parentheses, or ewith DOT (Department of Transportation)appended in parentheses.

Sources: HSDB (2000a); Registry (2000); RTECS (2000); SANSS (2000)


3

Other CASRNs that have been used for the compound are 1309-45-1 and 12672-67-2 (Registry,2000). Total fluorine in fluorosilicates can be detected by the lead chlorofluoride method. In air,an ion-specific electrode procedure with a range of 0.05 to 475 mg fluoride/m3 has been used(HSDB, 2000a). The percentage of fluorosilicic acid content for water supply serviceapplication can be determined by the specific-gravity method and the hydrogen titration method(specified in AWWA B703-94); the latter is the preferred method, since the former procedureprovides a "very rough estimation." AWWA has specified that fluorosilicic acid must contain 20to 30% active ingredient, a maximum of 1% hydrofluoric acid, a maximum of 200 mg/kg heavymetals (as lead), and no amounts of soluble mineral or organic substance that can cause healtheffects (AWWA, 2000; HSDB, 2000a). Analyses of tap water treated with silicofluorides (e.g.,samples from Seattle, WA, San Francisco, CA, and Ft. Collins, CO) have revealed insignificantlead and arsenic levels (CSDS, 2001). Recently, single-column ion chromatography withconductometric detection and sodium hydroxide-methanol-water eluent was used for thesimultaneous determination of fluorosilicic acid, Ca2+, Mg2+, Al3+, Cl-, and NO3

-; the detectionlimit for the anion of the acid was 1.25 x 106 M. It was successfully applied to the analysis ofmineral water and composite tablets (Xu et al., 2001).

2.2 Physical-Chemical Properties

Property Information Reference(s)Sodium hexafluorosilicatePhysical State white, granular, crystalline, or free-flowing

powder; white hexagonal crystalsOdor odorless

HSDB (2000b)

Boiling Point (oC) decomposes at 500 LCI, Ltd. (2000b)Melting Point (oC) melts at red heat with decompositionSpecific Gravity (g/cm3) 2.7

neutral (solution in cold water)

HSDB (2000b)

pH Value3.0-4.5 (1% solution) LCI, Ltd. (2000b)

Water Solubility soluble in cold water (150 parts) and boilingwater (40 parts)

HSDB (2000b)

mg/L or g/m3 at 17.5 ¡C 6,500 Worthing (1987; cited byShiu et al., 1990)

mg/L or g/m3 at 20 ¡C 72,000 Dean (1985; cited by Shiuet al., 1990)

Insoluble in alcohol (e.g., ethanol) HSDB (2000b)Fluorosilicic acidPhysical State colorless liquid; white crystalsOdor sour, pungentDensity @ 25 ¡C 1.4634 (60.97% solution)

decomposes (60.97% solution)

HSDB (2000a)

Boiling Point (oC)105 (25% solution)

Freezing Point (oC) -15.5 (25% solution)LCI, Ltd. (2000a)

Specific Gravity (g/cm3) 1.234 (25% solution) @ 16 ¡C LCI, Ltd. (2000a)pH Value 1.2 (1% solution) LCI, Ltd. (undated-a)Soluble in alkali; cold and hot water HSDB (2000a)

In alkaline medium, fluorosilicate solutions are readily hydrolyzed; in acidic conditions, silicontetrafluoride and hydrogen fluoride are released. Thermal decomposition of fluorosilicatesreleases gaseous silicon tetrafluoride and forms solid fluoride. When heated to decomposition,


4

sodium hexafluorosilicate releases toxic fumes of hydrogen fluoride and sodium oxide; contactwith metals can release hydrogen gas (HSDB, 2000b; NICNAS, 2001).

Fluorosilicic acid is a moderately strong acid that can corrode glass and stoneware. At about 19˚C, a 60-70% solution solidifies, forming crystalline dihydrate. A 13.3% solution may bedistilled without decomposition. Fluorosilicic acid is deliquescent that is, it absorbs moisturefrom the air and becomes liquid (HSDB, 2000a). It produces toxic and corrosive fumes offluorides (e.g., hydrogen fluoride and silicon tetrafluoride) when reacted with water or steam orwhen the compound is heated to decomposition or highly acidified with sulfuric acid (HSDB,2000a; NICNAS, 2001). It also reacts with many metals, producing hydrogen gas (HSDB,2000a; LCI, Ltd., undated-a).

Aqueous ChemistryIn water, the compound readily dissociates to sodium ions and hexafluorosilicate ions. At the pHof drinking water (6.5-8.5) and at the concentration usually used for fluoridation (1 mgfluoride/L), essentially 100% of sodium hexafluorosilicate dissociates to fluoride ions andhydrated silica (Crosby, 1969; Urbansky and Schock, 2000). In a quasi-constant compositiontitration study using high concentrations of hydrogen ion (H+) and calcium ion (Ca2+), thepromoting effect of Ca2+ on the hydrolysis of sodium hexafluorosilicate was observed to bestronger than the inhibiting effect of H+, thereby causing faster hydrolysis at low pH (Eidelmanand Chow, 1991).

Na2SiF6(aq) + 4 H2O 4 HF(aq) + 2 NaF(aq) + Si(OH)4(aq)

In water, fluorosilicic acid readily hydrolyzes to hydrofluoric acid and various forms ofamorphous and hydrated silica. At the concentration usually used for water fluoridation, 99%hydrolysis occurs and the pH drops to 4.2. As pH increases, hydrolysis increases. At the pH ofdrinking water, the degree of hydrolysis is "essentially 100%" (Crosby, 1969; Urbansky andSchock, 2000).

H2SiF6(aq) + 4 H2O 6 HF(aq) + Si(OH)4(aq)

2.3 Commercial AvailabilitySodium hexafluorosilicate is available as granular bait and in technical and C.P. grades. It isusually commercially available as ~98% pure (HSDB, 2000b). A typical product contains59.34% fluorine and a maximum of 0.50% each of moisture as water, water-insoluble matter,and heavy metals (as lead) (LCI, Ltd., 2000b). Chemical producers include Chemtech ProductsInc. (Alorton, IL), IMC-Agrico Company (Faustina, LA), and Kaiser Aluminum and ChemicalCorporation (Mulberry, FL) (SRI Int., 2000). Lucier Chemical Industries produces and shipssodium hexafluorosilicate in 25-kg bags and 50-pound bags (LCI, Ltd., 2000b). It is supplied byGFS Chemicals Inc. (Powell, OH) and Spectrum Chemical Manufacturing Corporation(Gardena, CA) (Chemcyclopedia Online, 2001). Chem Sources (2001) has identified 24suppliers of the compound; bulk suppliers include Creanova Inc. (Somerset, NJ) and SealChemical Industries (Newport Beach, CA). RIMI Chemicals Company Ltd. formulates thechemical as the product Safsan (Farm Chem. Handbook, 2001).


5

Fluorosilicic acid is commercially available as aqueous solutions of 5, 10, 15, 20, 25, 30, 34, and60-70% in technical and C.P. grades (HSDB, 2000a). A typical product contains a minimum of23% of the acid, a minimum of 18.22% fluorine, a maximum of 0.02% heavy metals (as lead),and <1.00% hydrofluoric acid (LCI, Ltd., 2000a). It is produced by Cargill Fertilizer, Inc.(Riverview, FL), Chemtech Products Inc. (Alorton, IL), Farmland Hydro, L.P. (Bartow, FL),IMC-Agrico Company (Faustina, LA; Nichols, FL; South Pierce, FL; Uncle Sam, LA), PCSPhosphate Company, Inc. (Aurora, NC), Royster-Clark Inc. (Americus, GA; Florence, AL;Hartsville, SC), and U.S. Agri-Chemicals Corporation (Fort Meade, FL) (SRI Int., 2000).Cargill Fertilizer, Inc. produces fluorosilicic acid as a primary nutrient (Farm Chem. Handbook,2001). Another producer, Lucier Chemical Industries (Jacksonville Beach, FL) ships its productin tank cars, tank trucks, and drums (LCI, Ltd., 2000a). Chem Sources (2001) has identified 16suppliers of fluorosilicic acid; bulk suppliers include Creanova Inc. (Somerset, NJ), Fluka(Milwaukee, WI), and Spectrum Laboratory Products, Inc. (Gardena, CA). Under the namehydrofluorosilicic acid [56977-47-0], it is supplied by Alfa Aesar/Johnson Matthey (Ward Hill,MA) and Solvay Fluorides Inc. (St. Louis, MO) (Chemcyclopedia Online, 2001).

3.0 Production ProcessesSodium hexafluorosilicate is produced by the neutralization of fluorosilicic acid with sodiumhydroxide, sodium carbonate, or sodium chloride under vigorous agitation. The amount of thealkali is controlled so as not to result in the fluoride (HSDB, 2000b).

Fluorosilicic acid is mainly produced as a byproduct of the manufacture of phosphate fertilizerswhere phosphate rock, containing fluorides and silica or silicates, is treated with sulfuric acid.The gases released, hydrogen fluoride and silicon tetrafluoride, are sprayed with water incondensing towers or drawn into a series of scrubbers and dissolved in water, forming anaqueous solution of fluorosilicic acid (CSDS, 2001; Farm Chem. Handbook, 2001; NICNAS,2001). This is the crude form of fluorosilicic acid; the purified form is obtained by distillation ofthe crude acid or by reacting pure silica with hydrofluoric acid. The compound can also be madeby the reaction of sulfuric acid on barium hexafluorosilicate (HSDB, 2000a). Furthermore,fluorosilicic acid is manufactured by the reaction of apatite and/or fluorite (fluorspar) withsulfuric acid (LCI, Ltd., 2000a). Its production from phosphoric acid producers supplementsfluorspar as a domestic source of fluorine (Miller, 1995, 1999).

4.0 Production and Import VolumesThe latest available figure for U.S. production of sodium hexafluorosilicate is 19,600 metric tons(43.2 million pounds) in 1984. In that same year, 3000 metric tons (6.61 million pounds) wasimported (HSDB, 2000b).

In 1995, ten phosphate rock processing plants produced 55,900 metric tons (123 million pounds)of fluorosilicic acid as a byproduct. Of this amount, 45% was used in water fluoridation, directlyor as the sodium salt, while 34% went toward the production of aluminum trifluoride and 20%went toward other uses (Miller, 1995). In 1999, ten plants again reported on the production offluorosilicic acid as a byproduct from phosphate rock processing; 69,200 metric tons (153million pounds) was produced, and 69,100 metric tons (152 million pounds) was sold or used.This was an almost 3% increase in output from the previous year. The amount used for waterfluoridation was 34, 900 metric tons (51%), while 19,000 metric tons (27%) was used foraluminum trifluoride production, and 15,300 metric tons (22%) was used for other uses such as


6

sodium hexafluorosilicate production (Miller, 1999). The latest figures are definitely an increasecompared to the 1975 and 1976 U.S. production of the acid at 30,000 metric tons (66 millionpounds) from phosphoric acid manufacturing. No import data were found (HSDB, 2000a).

5.0 UsesThe major use of sodium hexafluorosilicate and fluorosilicic acid is as fluoridation agents fordrinking water (HSDB, 2000a,b; Urbansky and Schock, 2000). They have been added to watersince the mid-1940s to prevent tooth decay (Chem. Mark. Rep., 2000). Sodiumhexafluorosilicate has also been used for caries control as part of a silicophosphate cement and asan acidic gel in combination with monocalcium phosphate monohydrate (Jinks et al., 1982 abstr.;Takagi et al., 1992). As part of a two-solution fluoride mouth rinse, it resulted in enhancedremineralization of human enamel lesions and root lesions (Takagi et al., 1997; Chow et al.,2000).

Both chemicals are also used as a chemical intermediate (raw material) for aluminum trifluoride,cryolite (Na3AlF6), silicon tetrafluoride, and other fluorosilicates (HSDB, 2000a,b). In addition,they have found applications in commercial laundry; sodium hexafluorosilicate acts as a laundrysouring agent and the acid acts as a neutralizer for alkalis (LCI, Ltd., 2000a,b).

Other applications for sodium hexafluorosilicate include its use in enamels/enamel frits for chinaand porcelain, in opalescent glass, metallurgy (aluminum and beryllium), glue, ore flotation,leather and wood preservatives, and in insecticides and rodenticides (e.g., moth repellent and forthe control of Noctuid larvae [i.e., cotton leafworms, mole crickets, grasshoppers, locusts, craneflies, earwigs, and sowbugs]) (HSDB, 2000b; LCI, Ltd. 2000b; Farm Chem. Handbook, 2001).It has been used in the manufacture of pure silicon and as a gelling agent in the Dunlop process(production of molded latex foam) (HSDB, 2000b). Recently, it has been used in organicsynthesis as a fluorinating agent to convert organodichlorophosphorus compounds to thecorresponding organodifluorophosphorus compound in low to moderate yields (up to 75%)(Farooq, 1998). In veterinary practice, externally applied sodium hexafluorosilicate has beenused to combat lice and mosquitoes on cattle, sheep, swine, and poultry. It has been given orallyto combat roundworms and possibly whipworms in swine and added to feed (50 ppm) to preventdental caries in rats (HSDB, 2000b). Sodium hexafluorosilicate is listed as an oral care agent onthe International Nomenclature of Cosmetic Ingredients inventory established under a EuropeanCommission Directive (96/335/EC) (INCI, 1998).

Fluorosilicic acid is used in the tanning of animal hides and skins, in ceramics and glass (glassetching), in technical paints, in oil well acidizing, and in the manufacture of hydrogen fluoride.It is also employed as an impregnating ingredient to preserve wood and harden masonry and forthe removal of mold as well as rust and stain in textiles. It has been used for the sterilization ofequipment (e.g., in brewing and bottling establishments and for copper and brass vehicles) aswell as in electroplating (HSDB, 2000a; LCI, Ltd., 2000a). A typical electrolyte contains 95 g/Lfree fluorosilicic acid (King and Ramachandran, 1995). In the electrolytic refining of lead, theelectrolyte contains 33% of the acid (Howe, 1981).

6.0 Environmental Occurrence and PersistenceIn the hydrogen fluoride process, fluorosilicic acid (30-35%) can readily be recovered from thesilicon tetrafluoride-containing plant vent gases, which are absorbed in water. It can also be


7

recovered from wet-process phosphoric acid plants and then processed to form hydrogen fluoride(Smith, 1994; Woytek, 1980). In this process, 45-60% gaseous fluorine compounds arerecoverable. The fluorosilicic acid is usually disposed of by converting it into inert and harmlesswaste products; usually, neutralization with limestone or milk of lime is done to precipitate theacid as a mixture of calcium fluoride and silica. However, small amounts of poisonous fluorinecompounds remain in the effluent (Denzinger et al., 1979).

The manufacture of phosphate fertilizer in Central Florida releases not only fluorides as a toxicpollutant but also radionuclides. Radium wastes come from the filtration systems. Uranium andits decay-rate products are found in the phosphate rock and fertilizer as well as the byproductfluorosilicic acid. During the wet-process procedure, trace amounts of both radium and uraniumare captured in the scrubbers and therefore are in the fluorosilicic acid. During the acidulationprocess yielding phosphoric acid, radon gas in the phosphate pebbles can be released and carriedinto the fluorosilicic acid, while polonium can be captured during the scrubbing process and thencan combine with fluoride (Glasser, undated).

The Centers for Disease Control (CDC) and EPA recommended levels for fluoride in drinkingwater ranges from 0.6-1.2 ppm (CSDS, 2001). For drinking water fluoridation, the maximumuse level (MUL) for sodium hexafluorosilicate is 2 mg/L; for fluorosilicic acid, the level is 6mg/L of a 25% fluorosilicic acid solution. Both values correspond to a fluoride concentration of1.2 mg/L, which is below the U.S. Environmental Protection Agency’s (EPA’s) MaximumContaminant Level (MCL) of 4.0 mg/L and the Secondary Maximum Contaminant Level(SMCL) of 2.0 mg/L. Although EPA has no MCL for silicate in drinking water, the NationalSanitation Foundation (NSF) has established a Maximum Drinking Water Level of 16 mg/L forsilicates. For NSF Certified Products used in drinking water, the Maximum Allowable Level(MAL) for fluoride is 1.2 mg/L; the MUL of the products ranges from 4 to 6.6 mg/L (NSF Int.,2000a). At its plant in Riverview, FL, Cargill Fertilizer, Inc. had an MUL of 8 mg/L sodiumhexafluorosilicate (equivalent to 1.2 mg/L fluoride) for fluoridation (NSF Int., 2001). While themajority of 29 manufacturers of fluorosilicic acid had an MUL of 6 mg/L, a level of 6.6 mg/Lwas measured at the IMC-Agrico Company plant at Uncle Sam, LA. [The Hydrite ChemicalCompany’s MUL was 1.7 mg/L at three plants, while the American Development Corporationhad an MUL of 4 mg/L at two plants] (NSF Int., 2000b).

7.0 Human ExposurePotential exposure to sodium hexafluorosilicate is via inhalation of dusts, ingestion, and eye andskin contact (HSDB, 2000b). The main routes of entry of fluorosilicic acid are inhalation andeye and skin contact (HSDB, 2000a; LCI, Ltd., undated-a).

Exposure to sodium hexafluorosilicate is possible from its use to control crawling insects inhomes and work buildings. The chemical has "high inherent toxicity," and children may ingestthe material from crawling on the floors of treated houses (U.S. EPA, 1999).

In 1992, 5876 U.S. public water suppliers were using fluorosilicic acid and 1635 utilities wereusing its sodium salt for water fluoridation, serving greater than 80 and 36 million persons,respectively (Urbansky and Schock, 2000). Currently, silicofluorides are used in over 9200 U.S.water treatment systems, serving over 120 million individuals (CSDS, 2001). Exposure viadrinking water is, however, expected to be minimal, since at concentrations used in water


8

fluoridation and at the normal pH of drinking water, both compounds hydrolyze almostcompletely (see Section 2.2) (Urbansky and Schock, 2000). At equilibrium, thehexafluorosilicate remaining in drinking water is estimated to be <<1 parts per trillion (Urbanskyand Schock, 2000). In addition, exposure to impurities in the fluoridating agent is judged to beof low health risk when properly treated water is ingested. For example, in fluorosilicic acid,iron and iodine are usually below the levels considered useful as a dietary supplement; thephosphorus level is reported to be insignificant; and silver is usually <4 parts per septillion in thefluoridated water (CSDS, 2001).

In the workplace, exposure to both chemicals is possible during their manufacture,transportation, or use in water treatment (HSDB, 2000a,b). In the NIOSH 1983 NationalOccupational Exposure Survey (NOES) of 8057 facilities, 74 industries, and 60 occupations,79,556 employees were potentially exposed to sodium hexafluorosilicate; the total number offemale employees potentially exposed was 22,185. In the 1983 NOES of 1758 facilities, 19industries, and 15 occupations, 10,867 employees were potentially exposed to fluorosilicic acid;the total number of females potentially exposed was 2068 (RTECS, 2000).

8.0 Regulatory StatusUnder EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), sodiumhexafluorosilicate as a pesticide was subject to registration or re-registration in 1988 (RTECS,2000). In August 1995, the act was amended, eliminating fluorosilicate compounds from theregistration list and their sale for pesticide use (40CFR153, Subpart H) (U.S. EPA, 1995). In theUnited States, all pesticide uses have been cancelled (U.S. EPA, 1999). The registrations ofinsecticide formulations containing 0.18% to 98.5% sodium hexafluorosilicate, some on themarket since the late 1940s, were cancelled in the late 1980s and early 1990s. Target organismsincluded roaches, moths, and weevils. Other cancelled fluorosilicate products were formulatedwith sodium aluminum fluorosilicate or aluminum fluorosilicate (NPIRS¤, 2001). [It is notedthat the use of sodium hexafluorosilicate as an insecticide is currently listed in the 2001 FarmChemicals Handbook (see Section 5.0).] Both sodium hexafluorosilicate and fluorosilicic acidare listed in Section 8(b) of the Toxic Substances Control Act (TSCA; chemical inventorysection). Both are also exempt from reporting under the Inventory Update Rule (i.e., PartialUpdating of the TSCA Inventory Data Base Production and Site Reports [40CFR, Section710(b)]) (TSCAINV, 2000). The Occupational Safety and Health Administration (OSHA) andAmerican Conference of Governmental Industrial Hygienists (ACGIH) have established aneight-hour time-weighted average (TWA) of 2.5 mg/m3 fluorides, as fluorine. OSHA hasestablished this Permissible Exposure Limit (PEL) for the general industry (29CFR1910.1000),construction (29CFR1915.1000), shipyard (29CFR1926.55), and federal contracts (41CFR50-204.50). The ACGIH short-term excursion limit (STEL) recommendation is that excursions inworker exposure levels may exceed three times the threshold limit value (TLV)-TWA for nomore than 30 minutes during a work day and not exceed five times the TLV-TWA, provided thatthe TLV-TWA is not exceeded. ACGIH has listed fluorides, as fluorine, as "A4 notclassifiable as a human carcinogen" (HSDB, 2000b; RTECS, 2000). NIOSH has alsorecommended an air exposure level to inorganic fluorides of 2.5 mg F/m3 but as a ten-hour TWA(RTECS, 2000).


9

9.0 Toxicological Data9.1 General ToxicologyChronic ingestion of excessive amounts of fluoride produces osteosclerosis and mottled toothenamel. Chronic exposure increases osteoblastic activity as well as the density and calcificationof bone (Gilman et al., 1980; cited by HSDB, 2000a).

9.1.1 Human DataSodium HexafluorosilicateChronic exposure to dust at levels above the PEL or TLV can result in severe calcification of therib, pelvis, and spinal column ligaments; effects on the enzyme system; pulmonary fibrosis;stiffness; irritation of the eyes, skin, and mucous membranes; weight loss; anorexia; anemia;cachexia; wasting; and dental effects. Long-term or repeated exposure to the skin can result inskin rash (LCI, Ltd., undated-b). Contact with the molten forms of the chemical may causesevere burns to the skin and eyes (HSDB, 2000b).

The clinical signs and symptoms after ingestion of soluble fluoride salts occur in the followingfive stages: (I) salty or soapy taste, salivation, nausea, abdominal pain, vomiting, (bloody)diarrhea, dehydration, and thirst; (II) muscle weakness, tremors, and in rare instances transientepileptiform convulsions, which may lead to central nervous depression; (III) shockcharacterized by pallor, weak and thready pulse, shortness of breath, weak heart sounds, wet andcold skin, cyanosis, dilated pupils, followed by death in two to four hours; (IV) when death hasnot occurred, paralysis of muscle deglutition, carpopedal spasm, and spasm of extremities; and(V) occasionally localized or generalized urticaria. A probable oral lethal dose of 50-500 mg/kg,classified as very toxic, has been reported for a 150-pound (70-kg) person receiving between 1teaspoon and 1 ounce of the chemical (Gosselin et al., 1976; cited by HSDB, 2000b).

A girl (2.5 years old) who ingested sodium hexafluorosilicate "developed acute respiratoryfailure, a prolonged AT interval, ventricular tachycardia and fibrillation, hypokalemia,hypocalcemia (3 to 4 mg/100 mL), and aspiration pneumonia" (Ellenhorn et al., 1997; cited byHSDB, 2000b). In a suicide attempt, a female chemical plant worker (32 years old) whoingested three teaspoons of sodium hexafluorosilicate immediately began vomiting, and thenexperienced facial numbness, diarrhea, diaphoresis, muscle spasms, weakness, abdominal pain,dyspnea, shallow breathing, and cramps of the palms, feet, and legs. Tachycardia and tachypneawere observed. After 12 hours, generalized weakness and enlargement of the liver continued.Treatment with calcium compounds (calcium carbonate initially; calcium lactogluconate for tendays after life-threatening symptoms had diminished) resulted in recovery within 21 days (Dadejet al., 1987).

Fluorosilicic AcidContact with the molten forms of fluorosilicic acid may cause severe burns to the skin and eyes.It is also extremely corrosive to the respiratory tract (Hawley, 1981; cited by HSDB, 2000a).The symptoms of inhalation include burning of the eyes and numbness around the lips.Symptoms do not necessarily occur immediately; they can appear 24 hours after exposure.


10

On the morning of September 6, 1994, a tanker truck spilling 4500 gallons of fluorosilicic acidon Interstate 4 near Deltona, Florida, covering an area 600 feet long and 60 feet wide, resulted inthe evacuation of approximately 2300 people from their homes into shelters. Later in the day,fumes were detected in the Deltona Woods neighborhood; because the acid could be carried bythe wind, everyone within a mile radius was evacuated, which included 1,750 people in OrangeCounty and 500 people in Deltona. More than 50 people went to hospitals, complaining of skinand respiratory irritation, including burning in the throat, and headaches. An individual riding ina truck with his arm out the window experienced burning on his forearm (Lancaster, 1994).

The effects of long-term exposure to fluorosilicic acid are changes in bone, corrosivity of themucous membranes (e.g., ulceration of the nose, throat, and bronchial tubes), coughing, shock,pulmonary edema, fluorosis, coma, and even death (LCI, Ltd., undated-a). In a study of 50workers engaged for approximately 30 years in the production of phosphate fertilizers, theconcentration of gaseous fluoride (hydrogen fluoride, silicon tetrafluoride, and fluorosilicic acid)ranged from 0.04 to 0.17 mg/m3. Nine workers had increased bone densities (Fabbri et al., 1978;cited by HSDB, 2000a).

When swallowed, severe irritation of the lungs, nose, and throat can occur, as well as severedamage to the throat and stomach (LCI, Ltd., undated-a). A probable oral lethal dose of 50-5000mg/kg, classified as very toxic, has been reported for doses between 1 teaspoon and 1 ounce for a150-pound (70-kg) person; a probable oral lethal dose of 5-50 mg/kg, classified as extremelytoxic, has been reported for doses between 7 drops and 1 teaspoon for the same individual(Gosselin et al., 1984; cited by HSDB, 2000a).

9.1.2 Chemical Disposition, Metabolism, and ToxicokineticsIn a female chemical plant worker who ingested sodium hexafluorosilicate (see Section 9.1.1),fluoride levels in serum and urine (fresh) were 5.130 and 235.60 mg/dm3, respectively, on day 2of hospitalization. Treatment with calcium compounds (calcium carbonate and calciumlactogluconate) immediately returned levels to normal. The following day, the levels dropped to0.399 and 15.39 mg/dm3, respectively; by day 20, the levels were 0.067 and 0.87 mg/dm3,respectively (Dadej et al., 1987).

In 50 workers engaged for approximately 30 years in the production of phosphate fertilizers andexposed to gaseous fluoride (hydrogen fluoride, silicon tetrafluoride, and fluorosilicic acid),urine fluoride excretion ranged from 1.0 to 9.6 mg F-/L (controls: 0.3 to 1.2) (Fabbri et al., 1978;cited by HSDB, 2000a).

In rats fed a diet containing 0.16% sodium hexafluorosilicate supplemented in a corn-soybeanoilmeal-casein ration ad libitum for 22-23 days, the average amounts of fluorine were 94.4 mg infeces and 91.9 mg in urine. The mean amount of fluorine absorbed was 65.1% and that retainedwas 31.0% (Kick et al., 1935).

From 1965 to 1974, 170 cases of suspected fluorosilicate poisoning were reported in domesticanimals. For positive cases, the animals were poisoned from ingestion of bait, which had notbeen disposed of after use. Of these, 27 cases were used in the chemical diagnosis of sodiumhexafluorosilicate poisoning (13 for cattle, 11 for sheep, and 1 each for horse, pigeon, andconcentrate for sheep) (see also Section 9.1.3). In cattle and sheep, measured fluorine


11

concentrations ranged from 120 to 2900 ppm (wet weight) in stomach/rumen contents and up to75 ppm in urine. In blood serum, 8 and 3 ppm fluorine were determined in one animal from thegroups of poisoned cattle and sheep, respectively (Egyed and Shlosberg, 1975).

When sheep were given sodium hexafluorosilicate via stomach tube (25, 50, 200, 1500, and 2000mg/kg; 0.13, 0.27, 1.06, 7.976, and 10.63 mmol/kg), blood serum concentrations and urine levelsof fluoride initially significantly increased and then decreased with time. For example, the low-dose group had blood serum concentrations ranging from 0.1-0.165 ppm fluoride prior totreatment and 4.2 ppm fluoride six hours after dose administration. By day 4, levels dropped to0.38 ppm fluoride. Corresponding urine levels of fluoride were 1.35-6.75, 175, and 25 ppm,respectively (Egyed and Shlosberg, 1975).

9.1.3 Acute ExposureAcute toxicity values for sodium hexafluorosilicate and fluorosilicic acid are presented in Table 1.The details of selected studies discussed in this section are presented in Table 2.

Table 1. Acute Toxicity Values for Sodium Hexafluorosilicate and Fluorosilicic Acid

Route Species (sex and strain) LCLo/LD50/LDLo/TDLo Reference(s)

Sodium hexafluorosilicate

mouse (sex and strain n.p.) LD50 = 70 mg/kg; 0.37 mmol/kg RTECS (1997)

rat (sex and strain n.p.) LD50 = 125 mg/kg; 0.665 mmol/kg HSDB (2000b)

rat (F, Sprague-Dawley albinowhite)

LD50 = 430 mg/kg; 2.29 mmol/kg Rhone-Poulenc Inc. (1971)

rat (sex and strain n.p.) TDLo = 248 mg/kg; 1.32 mmol/kg

oral

rabbit (sex and strain n.p.) LD50 = 125 mg/kg; 0.665 mmol/kg

s.c. rat (sex and strain n.p.) LDLo = 70 mg/kg; 0.37 mmol/kg

RTECS (1997)

inh guinea pig (sex and strain n.p.) LCLo = 33 mg/kg; 0.18 mmol/kg Patty (1963; cited byHSDB, 2000b)

Fluorosilicic acid

oral guinea pig (sex and strain n.p.) LD50 = 200 mg/kg; 1.39 mmol/kg LCI, Ltd. (undated-a)

Abbreviations: F = female(s); inh = inhalation; LCLo = lethal concentration low; LD50 = lethal dose for 50% of testanimals; LDLo = lethal dose low; n.p. = not provided; s.c. = subcutaneous(ly); TDLo = toxic dose low

Sodium HexafluorosilicateMice orally given sodium hexafluorosilicate (70 mg/kg; 0.37 mmol/kg) exhibited toxic effects inthe peripheral nerves, sensation, and in behavior. In rats, an oral dose (248 mg/kg; 1.32mmol/kg) administered intermittently for one month produced toxic effects in the kidney, ureter,and/or bladder, as well as musculoskeletal and biochemical effects (RTECS, 1997). Usingguinea pigs, inhalation experiments (13-55 mg/m3 [1.7-7.2 ppm] sodium hexafluorosilicate in airfor ≥6 hours) resulted in pulmonary irritation; the lowest concentration that caused death was 33mg/m3 (4.3 ppm) (Patty, 1963; cited by HSDB, 2000b).


12

Table 2. Acute Exposure to Sodium Hexafluorosilicate and Fluorosilicic Acid

Species, Strain, andAge, Number, and Sex

of Animals

Chemical Form andPurity

Route, Dose, Duration,and Observation Period

Results/Comments Reference

Sodium hexafluorosilicate

Mouse strain, age,number, and sex n.p.

sodium hexafluoro-silicate, purity n.p.

oral; 70 mg/kg (LD50; 0.37mmol/kg); duration andobservation period n.p.

Toxic effects were observed in the peripheral nerves and sensation(flaccid paralysis without anesthesia, generally neuromuscularblockage) and in behavior (ataxia and muscle contraction orspasticity).

RTECS* (1997)

Rats, strain, age, number,and sex n.p.


oral; 248 mg/kg (1.32mmol/kg) for 30 daysintermittent; observationperiod n.p.

Toxic effects in the kidney, ureter, and/or bladder (other changes inurine composition) were observed. Musculoskeletal (otherchanges) and biochemical (enzyme inhibition, induction, or changesin blood or tissue [phosphatases] levels) effects were seen.

RTECS* (1997)



s.c.; 70 mg/kg (LDLo; 0.37mmol/kg); duration andobservation period n.p.

Fatty liver degeneration and other changes in the liver and toxiceffects in the kidney, ureter, and bladder primarily changes inglomeruli were observed.

RTECS* (1997)

Guinea pigs, strain, age,number, and sex n.p.

sodium silicofluorideas dust, purity n.p.

inhalation; 13-55 mg/m3

(1.2-7.2 ppm) in air for ≥6h; observation period n.p.

Pulmonary irritation was observed. The lowest concentration thatcaused death when inhaled for 6 h was 33 mg/m3.

Patty (1963; citedby HSDB, 2000b)

Sheep, Awassi breed, 1-to 3-yr-old, 5F

technical sodiumhexafluorosilicate,purity n.p.

oral (via stomach tube); 25,50, 200, 1500, and 2000mg/kg (0.13, 0.27, 1.06,7.976, and 10.63 mmol/kg)suspended in water; durationand observation period n.p.

With the 25- and 50-mg/kg doses, animals exhibited grinding ofteeth (an indication of pain), dullness, and mild diarrhea. At 200mg/kg, additional symptoms were experienced and includedstaggering and severe diarrhea. Animals died on day 6. With thetwo higher doses, licking of the lips, kicking of the belly, grindingof the teeth, falling down (after 1.5 h), frothing at the mouth,congested conjunctiva, protrudation of the tongue, forced andlabored breathing, fever, and increased respiration and heart rateswere observed. Animals died 3 h after administration of 1500mg/kg and 2.5 h after administration of 2000 mg/kg.

Post-mortem examination showed serous pericardial fluid (fewmilliliters), a slightly friable liver, mild edema in the lungs, andfroth in the trachea. Hemorrhages occurred on the spleen andmucosal folds of the abomasum, and a gelatinous fluid was presentin the colon.

For the 1500 mg/kg-dose group, the change in GOT went from132% (of pretreatment activity) at 1.5 hours to 230% at 2.5 hours.For LDH, the change was 158% at death. The serum ICDH changeincreased from 168% after one hour to 984% at death.

Egyed andShlosberg (1975)


13

Table 2. Acute Exposure to Sodium Hexafluorosilicate and Fluorosilicic Acid (Continued)

Species, Strain, andAge, Number, and Sex

of Animals

Chemical Form andPurity

Route, Dose, Duration,and Observation Period

Results/Comments Reference

Fluorosilicic acid


fluorosilicic acid,purity n.p.

oral; 430 mg/kg (LD50; 2.98mmol/kg); duration andobservation period n.p.

Somnolence and/or general depressed activity was observed. RTECS* (2000)

Rats, Sprague-Dawleyalbino, age n.p., 5F perdose level

fluorosilicic acid(~23%, neat), purityn.p.

oral (via stomach tube);single doses of 215, 464,1000, and 2100 mg/kg(1.49, 3.22, 6.939, and 14.57mmol/kg) dissolved inwater. Animals wereobserved for 14 days andthen necropsied.

With 464 mg/kg, 3 out of 5 rats died; at ≥1000 mg/kg, 100%mortality was observed. At ≥464 mg/kg, acute depression wasobserved. Necropsy showed that animals in the low-dose groupwere "grossly normal" and that dead rats had massive hemorrhagesin the entire gastrointestinal tract.

Rhone-Poulenc Inc.(1971)

Rats, guinea pigs, andswine tested as a group;no other data wereprovided

fluorosilicic acid,purity n.p.

percutaneous; amounts,duration, and observationperiod n.p.

The intact skin was not affected. When areas were injured beforeapplication of the acid, necrosis, continuously spreading, occurredin the deeper regions. Hypocellular necrosis, consisting of sharpleukocyte demarcations, and edema up to the subcutis wereobserved.

Alhassan and Zink(1982; cited byHSDB, 2000a)

Rabbits, New Zealand,age n.p., 6, sex n.p.


dermal; 0.5 mL (4 mol) tothe intact and abraded skinfor 1, 24, or 72 h

Severe erythema and edema were observed, indicating the materialto be a primary irritant.

Rhone-Poulenc Inc.(1971)

Rabbits, New Zealand,age n.p., 6, sex n.p.


instillation; 0.1 mL (0.8mol) into the left eye. Eyeswere observed at 24, 48, and72 h following treatment.

Severe and permanent corneal opacity with scar tissue occurred. Rhone-Poulenc Inc.(1971)

Abbreviations: GOT = glutamate oxaloacetate transaminase; h = hour(s); ICDH = isocitric dehydrogenase; LDH = lactate dehydrogenase; n.p. = not provided

*RTECS uses codes for Toxic Effects. For some codes, it is unclear whether the effects occur in all organs (e.g., M02 — KIDNEY, URETER, BLADDER[Changes primarily in glomeruli]). In these instances, "and/or" has been used.


14

When sodium hexafluorosilicate (500 mg; 2.66 mmol) was applied to the skin of adult rabbits,mild irritation occurred. When applied to the eyes (100 mg; 0.532 mmol), severe irritation wasobserved; following a four-second rinse, the effect was still severe (RTECS, 1997).

Sodium hexafluorosilicate poisoning in domestic animals from the ingestion of bait which hadnot been disposed of after use (13 cases for cattle, 11 for sheep, and 1 each for horse, pigeon, andconcentrate for sheep) resulted in drowsiness, constipation, loss of appetite, paresis of the rumen,severe abdominal pain, and diarrhea. Sheep also exhibited grinding of the teeth (an indication ofpain) and frothing at the mouth in most cases of lethal poisoning, while the horse also hadbradycardia. In an acute study in which sheep were orally administered technical sodiumhexafluorosilicate (25, 50, 200, 1500, and 2000 mg/kg; 0.13, 0.27, 1.06, 7.976, and 10.63mmol/kg) via stomach tube, the animals exhibited similar symptoms. In addition, with the twohighest doses, falling down (after 1.5 hours), congested conjunctiva, forced and laboredbreathing, fever, and increased respiration and heart rates were observed. Animals died 6 daysafter administration of 200 mg/kg and 2.5 hours after administration of 2000 mg/kg (Egyed andShlosberg, 1975). When a dairy herd of 600 animals was acutely poisoned from railcarcontamination of feed, 95% of the animals had decreased neuromuscular transmission. Thepoisoning, which resembled calcium depletion, was effectively treated with calcium gluconateintravenously (HSDB, 2000b [original source was not cited]).

Fluorosilicic AcidIn rats orally given fluorosilicic acid (430 mg/kg; 2.98 mmol/kg), somnolence and/or generaldepressed activity was observed (RTECS, 2000). Other rat studies with fluorosilicic acid (singleoral doses of 215, 464, 1000, and 2100 mg/kg [1.49, 3.22, 6.939, and 14.57 mmol/kg]) led to itsclassification as "moderately toxic" (Rhone-Poulenc, Inc., 1971). Percutaneous administration ofthe compound (amounts not provided) in rats, guinea pigs, and pigs resulted in continuouslyspreading necrosis in the deeper regions of injured skin. Hypocellular necrosis, consisting ofsharp leukocyte demarcations, and edema up to the subcutis were also observed (Alhassan andZink, 1982; cited by HSDB, 2000a). In rabbits, it was corrosive to the skin (0.5 mL [4 mol] for1, 24, or 72 hours) and eyes (0.1 mL [0.8 mol] instilled into left eye) (Rhone-Poulenc Inc., 1971).

9.1.4 Short-term and Subchronic ExposureNo data were available.

9.1.5 Chronic ExposureNo data were available.

9.1.6 Synergistic/Antagonistic EffectsFluoride, administered in the form of sodium hexafluorosilicate, had a strong affinity for calciumand magnesium. When orally given to sheep via a stomach tube at doses of 25, 50, 200, 1500,and 2000 mg/kg, increased changes in serum calcium and magnesium levels were observed atthe two highest doses within 30 minutes after dose administration. At 200 mg/kg, recovery ofboth levels occurred after five days. With the 1500 mg/kg dose group, changes in phosphorusand sugar levels in whole blood were also significantly increased (16% [of pretreatment levels]at 1.5 hours to 146% at 2.5 hours for phosphorus; 300% to 374%, respectively, for sugar levels)(Egyed and Shlosberg, 1975).


15

9.1.7 CytotoxicityNo data were available.

9.2 Reproductive and Teratological EffectsNo data were available.

9.3 CarcinogenicityNo studies with sodium hexafluorosilicate or fluorosilicic acid were available. IARC (1987)concluded that there was inadequate evidence for carcinogenicity to humans and to animals forinorganic fluorides used in drinking water.

9.4 Initiation/Promotion StudiesNo data were available.

9.5 AnticarcinogenicityNo data were available.

9.6 GenotoxicitySodium hexafluorosilicate was negative in the Salmonella/microsome test (concentrations up to3600 g/plate, –S9) and the micronucleus test on mouse bone marrow (37.2 mg/kg; 0.198mmol/kg) (Gocke et al., 1981). The compound (0.25 mM; 47 g/mL) did not induce sex-linkedrecessive lethal mutations in Drosophila (Gocke et al., 1981; IARC, 1987). In the Bacillussubtilis rec-assay system, sodium hexafluorosilicate (0.001-10 M; 188 g/mL-1.9 g/mL) alsogave negative results (Kada et al., 1980; Kanematsu et al., 1980).

9.7 CogenotoxicityNo data were available.

9.8 AntigenotoxicityNo data were available.

9.9 Other DataWithin one week after beginning work in a foam rubber plant, a 23-year-old man exhibited skinlesions consisting of "diffuse, poorly delineated, erythematous plaques with lichenoid papulesand large pustules" on his arms, wrists, thighs, and trunk. Although scratch and patch tests withsodium hexafluorosilicate (2% aqueous) were negative, animal testing showed the compound tobe a pustulogen. When rabbits received topical application of a 1, 5, 10, and 25% solution ofsodium hexafluorosilicate in petroleum, pustules occurred on normal skin only with the highconcentration, while all concentrations produced pustules on stabbed skin (Dooms-Goossens etal., 1985).

10.0 Structure-Activity RelationshipsAt levels of 14-16 ppm fluorine, sodium fluoride, sodium hexafluorosilicate, and cryolite(Na3AlF6) had the same extent of chronic fluorine intoxication in rats (De Eds and Thomas,1933-1934; cited by McClure, 1950). At 40 and 80 ppm, the chronic toxicity (observations ongrowth rate, fecundity, mortality, tooth development, pathology, and disease) of bariumfluorosilicate and cryolite in rats was "substantially the same as that of sodium fluoride for thesame fluorine content" (Smyth and Smyth, 1932; cited by McClure, 1950). At 14 ppm fluorine,


16

ammonium fluoride, potassium fluoride, barium fluorosilicate, potassium fluorosilicate, andsodium fluorosilicate exhibited the same acute toxicity as sodium fluoride in the animals (Smithand Leverton, 1934; cited by McClure, 1950).

In a comparative study of absorption and excretion of fluorine in rats fed sodium fluoride,calcium fluoride, and sodium hexafluorosilicate, the percent fluorine retained was the same forthe two sodium compounds (Kick et al., 1935 [see Section 9.1.2 for details regarding sodiumhexafluorosilicate]). Several experiments on growing rats orally given 5, 10, 15, 25, and 50 ppmfluorine as sodium fluoride or sodium hexafluorosilicate for 90-100 days found no differences inthe quantity of fluorine deposited and the contents of ash, calcium, and phosphorus in the incisorteeth, molar teeth, mandibles, and femurs. Furthermore, there were no differences in the percentof ingested fluorine retained in the body, and a combination of sodium silicate (15 ppm silicon)with sodium fluoride (25 ppm fluorine) did not affect the amount of fluorine deposited. Thegrowth rate was normal in all rats (McClure, 1950).

In a separate study, litters of female weanling Osborne-Mendel rats were given 50 ppm fluorineas sodium fluoride or ammonium fluorosilicate in drinking water for 99 days. The cariostaticeffect was similar for the two compounds i.e., both inhibited caries to the same extent. Therewere no differences in the amounts of fluorine and ash deposited in the molars, incisors,mandibles, and femurs. There were no differences in growth rate and in the production of incisorstriations (Zipkin and McClure, 1954).


17

11.0 Online Databases and Secondary References11.1 Online Databases

Chemical Information System FilesSANSS (Structure and Nomenclature Search System)TSCAINV (Toxic Substances Control Act Inventory)TSCATS (Toxic Substances Control Act Test Submissions)

National Library of Medicine DatabasesEMIC and EMICBACK (Environmental Mutagen Information Center)

STN International FilesAGRICOLA EMBASE NTISBIOSIS HSDB PROMTCA LIFESCI RegistryCABA MEDLINE RTECSCANCERLIT NIOSHTIC TOXLINE

TOXLINE includes the following subfiles:

Toxicity Bibliography TOXBIBInternational Labor Office CISHazardous Materials Technical Center HMTCEnvironmental Mutagen Information Center File EMICEnvironmental Teratology Information Center File (continued after1989 by DART)

ETIC

Toxicology Document and Data Depository NTISToxicological Research Projects CRISPNIOSHTIC¤ NIOSHPesticides Abstracts PESTABPoisonous Plants Bibliography PPBIBAneuploidy ANEUPLEpidemiology Information System EPIDEMToxic Substances Control Act Test Submissions TSCATSToxicological Aspects of Environmental Health BIOSISInternational Pharmaceutical Abstracts IPAFederal Research in Progress FEDRIPDevelopmental and Reproductive Toxicology DART

In-House DatabasesCPI Electronic Publishing Federal Databases on CDCurrent Contents on Diskette¤

The Merck Index, 1996, on CD-ROM


18

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Gilman, A.G., L.S. Goodman, and A. Gilman, Eds. 1980. Goodman and Gilman’s ThePharmacological Basis of Therapeutics, 6th ed. Macmillan Publishing Company, Inc, New York,NY, p. 1546. Cited by HSDB (2000a).

Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. 1976. Clinical Toxicology ofCommercial Products, 4th ed. Williams and Wilkins, Baltimore, MD, p. II-78. Cited by HSDB(2000b).

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Howe, H.E. 1981. Lead. In: Grayson, M., Ed. Kirk-Othmer Encyclopedia of ChemicalTechnology, 3rd ed. Vol. 14. John Wiley and Sons, Inc., New York, NY, pp. 98-139.

King, M., and V. Ramachandran. 1995. Lead. In: Kroschwitz, J.I., and M. Howe-Grant, Eds.Kirk-Othmer Encyclopedia of Chemical Technology, 4th ed. Vol. 15. John Wiley and Sons,Inc., New York, NY, pp. 69-113.

Patty, F., Ed. 1963. Industrial Hygiene and Toxicology: Volume II: Toxicology, 2nd ed.Interscience Publishers, New York, NY, p. 845. Cited by HSDB (2000b).

Smith, R.A. 1994. Hydrogen. In: Kroschwitz, J.I., and M. Howe-Grant, Eds. Kirk-OthmerEncyclopedia of Chemical Technology, 4th ed. Vol. 11. John Wiley and Sons, Inc., New York,NY, pp. 355-376.

Worthing, C.R., Ed. 1987. The Pesticide Manual (A World Compendium), 8th ed. The BritishCrop Protection Council, Croydon, England. Cited by Shiu et al. (1990).

Woytek, A.J. 1980. Fluorine compounds, inorganic. In: Grayson, M., Ed. Kirk-OthmerEncyclopedia of Chemical Technology, 3rd ed. Vol. 10. John Wiley and Sons, New York, NY,pp. 655-772.


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Egyed, M.N., and A. Shlosberg. 1975. Acute sodium fluorosilicate poisoning in domesticanimals with special reference to sheep. Fluoride 8(3):134-143.

Eidelman, N., and L.C. Chow. 1991. Effect of pH and calcium on hydrolysis of Na2SiF6 andNa2SnF6. A quasi-constant composition titration study. Caries Res. 25(2):101-107.

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22

NPIRS¤ (National Pesticide Information Retrieval System). 2001. NPIRS Product Search;Federal Product Data; Cancelled Products: 58. Purdue Research Foundation, West Lafayette, IN.Internet address: http://www.ceris.purdue.edu/npirs/. Last updated on August 3, 2001. Lastaccessed on August 14, 2001.

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Shiu, W.Y., K.C. Ma, D. Mackay, J.N. Seiber, and R.D. Wauchope. 1990. Solubilities ofpesticide chemicals in water. Part II: Data compilation. Rev. Environ. Contam. Toxicol.116:15-187.

Smith, M.C., and R.M. Leverton. 1934. Comparative toxicity of fluorine compounds. Ind. Eng.Chem. 26:791 ff. Cited by McClure (1950).

Smyth, H.H., and H.F. Smyth, Jr. 1932. Relative toxicity of some fluorine and arsenicalinsecticides. Ind. Eng. Chem. 24:229 ff. Cited by McClure (1950).

SRI Int. 2000. 2000 Directory of Chemical Producers United States. SRI International,Menlo Park, CA, pp. 649 and 890.

Takagi, S., L.C. Chow, and B.A. Sieck. 1992. Depositions of loosely bound and firmly boundfluorides on tooth enamel by an acidic gel containing fluorosilicate and monocalcium phosphatemonohydrate. Caries Res. 26(5):321-327.


23

Takagi, S., L.C. Chow, S. Shih, and B.A. Sieck. 1997. Effect of a two-solution fluoride mouthrinse on deposition of loosely bound fluoride on sound root tissue and remineralization of rootlesions in vitro. Caries Res. 31(3):206-211.

Urbansky, E.T., and M.R. Schock. 2000. Can fluoridation affect water lead levels and leadneurotoxicity? In: American Water Works Association Annual Conference Proceedings,Denver, CO, June 11-15, 2000.

U.S. EPA (Environmental Protection Agency). 1995. Pesticides; Technical Amendments. Fed.Reg. 60(117):32093-32097. Available from the Federal Register Online via GPO Access[wais.access.gpo.gov]. Internet address: http://www.epa.gov/docs/fedrgstr/EPA-PEST/1995/June/Day-19/pr-301.html. Amendments effective on August 18, 1995. Lastaccessed on July 30, 2001.

U.S. EPA (Environmental Protection Agency). 1999. Fluorides. In: Reigart, R., and J. Roberts,Eds. Recognition and Management of Pesticide Poisonings, 5th ed., Office of PesticidePrograms, Washington, DC, pp. 82-85. Available on the Fluoride Action Network (FAN):Fluoride Pesticide Poisonings: Recognition and Management. Internet address:http://www.fluoridealert.org/f-poisonings.htm. Last accessed on July 30, 2001.

Xu, Q., C. Xu, W. Zhang, Y.P. Wang, L.T. Jin, H. Haraguchi, A. Itoh, and K. Tanaka. 2001.Simultaneous determination of silicic acid, Ca, Mg and Al in mineral water and compositetablets by ion chromatography. Chromatographia 53(1-2):81-84.

Zipkin, I., and F.J. McClure. 1954. Cariostatic effect and metabolism of ammonium fluosilicate.Pub. Health Rep. 69:730-733.

13.0 References Considered But Not Cited

Glasser, G. [undated] Sowing the seeds of cancer! National Pure Water Association (npwa):Campaign for Clean Drinking Water web site. Crigglestone, Wakefield, UK. Internet address:http://www.npwa.freeserve.co.uk/cancerseeds.htm. Last accessed on July 30, 2001

Haley, T.J. 1987. Clinical toxicology. In: Haley, T.J, and W.O. Berndt, Eds. Handbook ofToxicology. Hemisphere Publishing Corporation, New York, NY, pp. 592-654.

IPCS (International Programme on Chemical Safety). 1984. Fluorine and fluorides.Environmental Health Criteria 36. World Health Organization (WHO), Geneva, Switzerland,133 pp.

Novikov, S.M., N.I. Levchenko, N.N. Mel’nikova, and T.N. Fursova. 1989. Opredelenieveroyatnostnykh znachen porogovykh urovnei vozdeistviya vrednykh veshchev [Determinationof the probable values of the threshold levels of exposure to harmful substances]. Gig. Sanit.9:46-49.


24

Acknowledgements

Support to the National Toxicology Program for the preparation of Sodium Hexafluorosilicate

[CASRN 16893-85-9] and Fluorosilicic Acid [CASRN 16961-83-4] Review of Toxicological

Literature was provided by Integrated Laboratory Systems, Inc., through NIEHS Contract

Number N01-ES-65402. Contributors included: Karen E. Haneke, M.S. (Principal Investigator);

Bonnie L. Carson, M.S. (Co-Principal Investigator); and Claudine A. Gregorio, M.A.

Appendix: Units and Abbreviations

°C = degrees Celsius

µg/L = microgram(s) per liter

µg/m3 = microgram(s) per cubic meter

µg/mL = microgram(s) per milliliter

µM = micromolar

ACGIH = American Conference of Governmental Industrial Hygienists

AOAC = Association of Official Analytical Chemists

AWWA = American Water Works Association

bw = body weight

C.P. = Commercially Pure

CSDS = Colorado Springs Dental Society

EPA = Environmental Protection Agency

F = female(s)

FIFRA = Federal Insecticide, Fungicide, and Rodenticide Act

g = gram(s)

g/mL = gram(s) per milliliter

h = hour(s)

HSDB = Hazardous Substances Data Bank

IARC = International Agency for Research on Cancer

i.p. = intraperitoneal(ly)

kg = kilogram(s)

L = liter(s)

LC50 = lethal concentration for 50% of test animals

LCLo = lethal concentration low


25

LD50 = lethal dose for 50% of test animals

LDLo = lethal dose low

M = male(s)

MAL = Maximum Allowable Level

MCL = Maximum Contaminant Level

MUL = maximum use level

mg/kg = milligram(s) per kilogram

mg/m3 = milligram(s) per cubic meter

mg/mL = milligram(s) per milliliter

min = minute(s)

mL/kg = milliliter(s) per kilogram

mm = millimeter(s)

mM = millimolar

mmol = millimole(s)

mmol/kg = millimoles per kilogram

mo = month(s)

mol = mole(s)

mol. wt. = molecular weight

NICNAS = National Industrial Chemicals Notification and Assessment Scheme

NIOSH = National Institute for Occupational Safety and Health

NSF = National Sanitation Foundation

NOES = National Occupational Exposure Survey

NOHS = National Occupational Hazard Survey

n.p. = not provided

OSHA = Occupational Safety and Health Administration

PEL = permissible exposure limit

ppb = parts per billion

ppm = parts per million

p.o. = peroral(ly), per os

REL = relative exposure limit

RTECS = Registry of Toxic Effects of Chemical Substances

s.c. = subcutaneous(ly)


26

SMCL = Secondary Maximum Contaminant Level

STEL = short-term exposure limit

TDLo = toxic dose low

TLV = threshold limit value

TSCA = Toxic Substances Control Act

TWA = time-weighted average

wk = week(s)

yr = year(s)

How to Market a Toxic Waste

http://www.garynull.com/documents/Dental/Fluoride/fluoride_index.htm

"We would not purposely add arsenic to the water supply. And we would not purposely add lead. But we do add fluoride. The fact is that fluoride is more toxic than lead and just slightly less toxic than arsenic." (1)

These words of Dr. John Yiamouyiannis may come as a shock to you because, if you're like most Americans, you have positive associations with fluoride. You may envision tooth protection, strong bones, and a government that cares about your dental needs. What you've probably never been told is that the fluoride added to drinking water and toothpaste is a crude industrial waste product of the aluminum and fertilizer industries, and a substance toxic enough to be used as rat poison. How is it that Americans have learned to love an environmental hazard? This phenomenon can be attributed to a carefully planned marketing program begun even before Grand Rapids, Michigan, became the first community to officially fluoridate its drinking water in 1945.(2) As a result of this ongoing campaign, nearly two-thirds of the nation has enthusiastically followed Grand Rapids' example. But this push for fluoridation has less to do with a concern for America's health than with industry's penchant to expand at the expense of our nation's well-being.

The first thing you have to understand about fluoride is that it's the problem child of industry. Its toxicity was recognized at the beginning of the Industrial Revolution, when, in the 1850s iron and copper factories discharged it into the air and poisoned plants, animals, and people.(3)

In the early years of the 20th Century, a young dentist named Frederick McKay settled in Colorado Springs, Colorado. There he discovered that as many as 90% of lifetime residents of the town had grotesque brown stains on their teeth, and that the tooth enamel had an irregular surface texture described as "mottled". Locals referred to the familiar condition as Colorado Brown Stain, but no one had a clue as to its cause. Over the next two decades Dr. McKay, later with the help of dental researcher G. V. Black, proved that the cause was something contaminating the water supply. They also speculated that the affected teeth might be somewhat more resistant to decay. (4)

By the 1920's, rapid industrial growth had exacerbated the problems of industrial pollution, and fluoride was one of the biggest problems. Medical writer Joel Griffiths explains that "it was abundantly clear to both industry and government that spectacular U.S. industrial expansion -- and the economic and military power and vast profits it promised -- would necessitate releasing millions of tons of waste fluoride into the environment."(5) Their biggest fear was that "if serious injury to people were established, lawsuits alone could prove devastating to companies, while public outcry could force

industry-wide government regulations, billions in pollution-control costs, and even mandatory changes in high-fluoride raw materials and profitable technologies."(6)

In 1931, by means of photo-spectrographic analysis of McKay and Black's water samples conducted at the laboratories at the Aluminum Company of America (ALCOA), it was confirmed that the cause of the mottled teeth was fluoride in the water supply. ALCOA took a proprietary interest in this issue, since fluoride is a major waste product of aluminum production. The company wanted to know how much fluoride exposure people could tolerate without getting mottled, discolored teeth. Or, more specifically, how much fluoride could ALCOA release into the nation's earth, water, and air without the public realizing that the company was polluting the environment with a powerful toxin?(7)

That question was to be addressed later that same year, when H. Trendley Dean was sent to study water sources in 345 Texas communities. Dean, a former dental surgeon for the US Public Health Service, was then head of the Dental Hygiene Unit of the National Institute of Health. (Dean's overseer and mentor at the USPHS had been Treasury Secretary Andrew W. Mellon, a founder and major stockholder of ALCOA.) Based on his own research, Dean claimed that "fluoride levels of up to 1.0 ppm in drinking water did not cause mottled enamel; if the fluoride exceeded this level, however, fluorosis would occur."(8)

Now Dean remembered McKay and Black's claims that fluorosis victims mottled, discolored teeth were especially resistant decay. He came up with the notion that fluoride added to the water supply at the magic threshold dosage of 1 ppm would prevent tooth decay, while avoiding damage to bones and teeth.(9) He recommended further studies to determine whether his hypothesis was true.

Griffiths continues: "Back at the Mellon Institute, ALCOA's Pittsburgh industrial research lab, this news was galvanic. There, biochemist Gerald J. Cox immediately fluoridated some lab rats in a study and concluded that fluoride reduced cavities and that: "The case should be regarded as proved." In a historic moment in 1939, the first public proposal that the U.S. should fluoridate its water supplies was made not by a doctor, or dentist, but by Cox, an industry scientist working for a company threatened by fluoride damage claims and burdened by the odious expense of disposing of tons of toxic industrial waste. Cox began touring the country, stumping for fluoridation.(10)

Dean would go on to carve out a nice career for himself as the "father" of public water fluoridation. He became the first dental scientist at the National Institute of Health, advancing to director of the dental research section in 1945. After World War II, he directed epidemiological studies for the Army in Germany. When Congress established the National Institute of Dental Research (NIDR) in 1948, Dean was appointed its director, a position he held until retiring in 1953.(11) In his post at the NIDR, he was to oversee the first clinical trial of fluoridation in an American city, Grand Rapids Michigan.(12)

With those impressive credentials, wouldn't you think a man of science like Dean could be trusted? Think again. The truth is that Dean's great discovery was based on wishful thinking and some very shaky science, as documented by healthy advocate Andreas Schuld(13). Dean's findings did not stand up to scientific scrutiny at all. An independent study of his results revealed that he had engaged in "selective use of data," employing figures from 21 cities that confirmed his findings, and ignoring those from 272 other localities that didn't. (14) In a 1955 court case challenging fluoridation, Dean admitted under oath that his published conclusions were wrong.(15) In hearings conducted by the AMA in 1957, he was forced to admit that dental fluorosis, the first sign of fluoride overdose, could be caused by water fluoridated at 1.0 ppm.(16) But these admissions were not widely publicized, and they were never acknowledged by the USPHS, the American Dental Association, or the other governmental bodies responsible for foisting fluoride on the public. They continued to play the classic denial game: "act like nothing's wrong." And they are still doing it to this very day.

At first, industry could dispose of fluoride legally only in small amounts by selling it to insecticide and rat poison manufacturers. (17) But Dean's "discovery," paved the way for a commercial outlet for the toxin. Griffiths writes that this was not a scientific breakthrough, but rather part of a "public disinformation campaign" by the aluminum industry "to convince the public that fluoride was safe and good," Industry's need prompted Alcoa-funded scientist Gerald J. Cox to announce that "The present trend toward complete removal of fluoride from water may need some reversal."(18) Griffiths writes:

"The big news in Cox's announcement was that this 'apparently worthless by-product' had not only been proved safe (in low doses), but actually beneficial; it might reduce cavities in children. A proposal was in the air to add fluoride to the entire nation's drinking water. While the dose to each individual would be low, 'fluoridation' on a national scale would require the annual addition of hundreds of thousands of tons of fluoride to the country's drinking water.

"Government and industry - especially Alcoa - strongly supported intentional water fluoridation...[it] made possible a master public relations stroke - one that could keep scientists and the public off fluoride's case for years to come. If the leaders of dentistry, medicine, and public health could be persuaded to endorse fluoride in the public's drinking water, proclaiming to the nation that there was a 'wide margin of safety,' how were they going to turn around later and say industry's fluoride pollution was dangerous?

"As for the public, if fluoride could be introduced as a health enhancing substance that should be added to the environment for the children's sake, those opposing it would look like quacks and lunatics....

"Back at the Mellon Institute, Alcoa's Pittsburgh Industrial research lab, this news was galvanic. Alcoa-sponsored biochemist Gerald J. Cox immediately fluoridated some lab rats in a study and concluded that fluoride reduced cavities and that 'The case should be regarded as proved.' In a historic moment in 1939, the first public proposal that the U.S.

should fluoridate its water supplies was made - not by a doctor, or dentist, but by Cox, an industry scientist working for a company threatened by fluoride damage claims."(19)

Once the plan was put into action, industry was buoyant. They had finally found the channel for fluoride that they were looking for, and they were even cheered on by dentists, government agencies, and the public. Chemical Week, a publication for the chemical industry, described the tenor of the times: "All over the country, slide rules are getting warm as waterworks engineers figure the cost of adding fluoride to their water supplies." They are riding a trend urged upon them, by the U.S. Public Health Service, the American Dental Association, the State Dental Health Directors, various state and local health bodies, and vocal women's clubs from coast to coast. It adds up to a nice piece of business on all sides and many firms are cheering the PHS and similar groups as they plump for increasing adoption of fluoridation." (20)

Such overwhelming acceptance allowed government and industry to proceed hastily, albeit irresponsibly. The Grand Rapids experiment was supposed to take 15 years, during which time health benefits and hazards were to be studied. In 1946, however, just one year into the experiment, six more U.S. cities adopted the process. By 1947, 87 more communities were treated; popular demand was the official reason for this unscientific haste.

The general public and its leaders did support the cause, but only after a massive government public relations campaign spearheaded by Edward L. Bernays, a nephew of Sigmund Freud. Bernays, a public relations pioneer who has been called "the original spin doctor,"(21) was a masterful PR strategist. As a result of his influence, Griffiths writes, "Almost overnight...the popular image of fluoride -- which at the time was being widely sold as rat and bug poison -- became that of a beneficial provider of gleaming smiles, absolutely safe, and good for children, bestowed by a benevolent paternal government. Its opponents were permanently engraved on the public mind as crackpots and right-wing loonies."(22)

Griffiths explains that while opposition to fluoridation is usually associated with right-wingers, this picture is not totally accurate. He provides an interesting historical perspective on the anti-fluoridation stance:

"Fluoridation attracted opponents from every point on the continuum of politics and sanity. The prospect of the government mass-medicating the water supplies with a well-known rat poison to prevent a nonlethal disease flipped the switches of delusionals across the country - as well as generating concern among responsible scientists, doctors, and citizens.

"Moreover, by a fortuitous twist of circumstances, fluoride's natural opponents on the left were alienated from the rest of the opposition. Oscar Ewing, a Federal Security Agency administrator, was a Truman "fair dealer" who pushed many progressive programs such as nationalized medicine. Fluoridation was lumped with his proposals. Inevitably, it was attacked by conservatives as a manifestation of "creeping socialism," while the left rallied

to its support. Later during the McCarthy era, the left was further alienated from the opposition when extreme right-wing groups, including the John Birch Society and the Ku Klux Klan, raved that fluoridation was a plot by the Soviet Union and/or communists in the government to poison America's brain cells.

"It was a simple task for promoters, under the guidance of the 'original spin doctor,' to paint all opponents as deranged - and they played this angle to the hilt....

"Actually, many of the strongest opponents originally started out as proponents, but changed their minds after a close look at the evidence. And many opponents came to view fluoridation not as a communist plot, but simply as a capitalist-style con job of epic proportions. Some could be termed early environmentalists, such as the physicians George L. Waldbott and Frederick B. Exner, who first documented government-industry complicity in hiding the hazards of fluoride pollution from the public. Waldbott and Exner risked their careers in a clash with fluoride defenders, only to see their cause buried in toothpaste ads." (23)

By 1950, fluoridation's image was a sterling one, and there was not much science could do at this point. The Public Health Service was fluoridation's main source of funding as well as its promoter, and therefore caught in a fundamental conflict of interest.(24) If fluoridation were found to be unsafe and ineffective, and laws were repealed, the organization feared a loss of face, since scientists, politicians, dental groups, and physicians unanimously supported it.(25) For this reason, studies concerning its effects were not undertaken. The Oakland Tribune noted this when it stated that "public health officials have often suppressed scientific doubts" about fluoridation. (26) Waldbott sums up the situation when he says that from the beginning, the controversy over fluoridating water supplies was "a political, not a scientific health issue."(27)

The marketing of fluoride continues. In a 1983 letter from the Environmental Protection Agency, then Deputy Assistant Administrator for Water, Rebecca Hammer, writes that the EPA "regards [fluoridation] as an ideal environmental solution to a long-standing problem. By recovering by-product fluosilicic acid from fertilizer manufacturing, water and air pollution are minimized and water utilities have a low-cost source of fluoride available to them."(28) More recently, a 1992 policy statement from the Department of Health and Human Services says, "A recent comprehensive PHS review of the benefits and potential health risks of fluoride has concluded that the practice of fluoridating community water supplies is safe and effective."(29)

Today, nearly 250 million people worldwide drink fluoridated water, including about 130 million Americans in 9600 communities. Out of the 50 largest cities in the US, 41 have fluoridated water.(30)

To help celebrate fluoride's widespread use, the media recently reported on the 50th anniversary of fluoridation in Grand Rapids. Newspaper articles titled "Fluoridation: a shining public health success"(31) and "After 50 years, fluoride still works with a smile"(32) painted glowing pictures of the practice. Had investigators looked more

closely, though, they might have learned that children in Muskegon, Michigan, an unfluoridated "control" city, had equal drops in dental decay. They might also have learned of the other studies that dispute the supposed wonders of fluoride.