pp res, rat, resp 03/07/06. chair - steven g. gilbert, phd, dabt co-chair - joel l. mattsson, dvm,...

PP Res, Rat, Resp 03/07/06


Chair - Steven G. Gilbert, PhD, DABTCo-chair - Joel L. Mattsson, DVM, PhD

The Precautionary Principle - Implications and Applications

SOT – ELSI SSMarch 7, 2006


Speakers An Introduction to the Precautionary Principle

Steven G. Gilbert, INND, Seattle, WA

Aspirations and Limitations of the Precautionary PrincipleGary Marchant, Arizona State University College of Law,

Tempe, AZ

Green Chemistry: Developing Sustainable Alternatives to Polluting TechnologiesTerry Collins, Carnegie Mellon University, Pittsburgh, PA

The Hazards of the Precautionary PrincipleJoel Mattsson, Dow AgroSciences, Indianapolis, IN

Discussion


Steven G. Gilbert, PhD, DABTwww.asmalldoseof.org

The Precautionary Principle: Reasonable, Rational, and

Responsible(Evolutionary Not Revolutionary

Approach)


“When an activity raises threats of harm to human health or the environment,

precautionary measures should be take even if some cause and effect relationships are not

fully established scientifically.”

Wingspread Conference, 1998.

Precautionary Principle


• Setting goals (Health indicators)• Taking preventive action in the face of

uncertainty• Shifting the burden of responsibility to the

proponents of an activity (Who benefits?)• Exploring a wide range of alternatives to

possibly harmful actions (Is it necessary?)• Increasing public participation in decision

making (transparency of information & environmental justice)

Central components



ReasonableRationalResponsible


Reasonable

Able to discourse or discuss matters; ready of tongue or speech; sensible; common sense; sound judgment


Reasonable

Able to discourse or discuss matters Comprehensive and inclusive

decision making approach Brings stakeholders together Emphasizes prevention rather than

treatment Encourages sharing of information Considers future generations of

humans and other species


Risk & Precaution


FDA & Precaution


Benefits & Risk


Rational

Having the faculty of reasoning; endowed with reason; coherent; rational


Rational

Having the faculty of reasoning Decisions based on scientific

knowledge and experience We have the knowledge and

experience to prevent harm to future generations

Uncertainty is not a reason to delay action to ensure human and environmental health


Lessons Learned

Thalidomide Ethanol (Alcohol) Methylmercury Lead PBDEs


Thalidomide

Introduced in 1956 as sedative (sleeping pill) and to reduce nausea and vomiting during pregnancy

Withdrawn in 1961

Discovered to be a human teratogen causing absence of limbs or limb malformations in newborns

5000 to 7000 infants effected Resulted in new drug testing rules


What Is This?

CH

H

H

OHC

H

H

(CH3-CH2-OH)

PP Res, Rat, Resp 03/07/06FAS Child


FAS & FAE

Most common preventable cause of adverse CNS development

Fetal Alcohol Syndrome (FAS)4,000-12,000 infants per year in US

Fetal Alcohol Effect (FAE)7,000-36,000 infants per year in US

1 to 3 infants per 1,000 world wide??


Mercury & Toxicology


Fetal Effects of MeHg


The Mercury Cycle


Limit the amount of canned tuna you

eat, based on your bodyweight. Guidelines are: Women of childbearing age should limit the amount

of canned tuna they eat to about one can per week (six ounces.) A

woman who weighs less than 135 pounds should eat less than one

can of tuna per week. Children under six should eat less than one

half a can of tuna (three ounces) per week. Specific weekly limits for

children under six range from one ounce for a twenty pound child,

to three ounces for a child weighing about sixty pounds.

WA State Advisory

http://www.doh.wa.gov/fish/FishAdvMercury.htm


"Lead makes the mind give way."

Ancient Awareness

GreekDioscerides - 2nd BC


Lead In Homes


Lead Health Effects

Children more vulnerable than adults• Orally consumed lead absorbed in place of calcium

• CHILDREN absorb 30-50% of oral lead

• ADULTS absorb 5-10% of oral lead

• Increased absorption during pregnancy

Childhood effects• Decreased intelligence (lower grades)

• Hyperactivity (higher school dropout rate)

• Growth retardation

• Effects at blood lead levels of >5 µq/dL


Agency Blood Lead Levels

60

40

3025

2015

10

20

10

20

30

40

50

60

Blo

od

Lea

d (

ug

/dl)

CDC1960

CDC1973

CDC1975

CDC1985

WHO1986

EPA1986

CDC1990

CDC2006?

Agency and Year

Acceptable Childhood Blood Lead Levels


Structure of PBDEs

X & Y are number of Bromine atomsCommon Penta, Octa, and Deca

PolyBrominated Diphenyl Ether

O

BrxBry


PBDEs in House Dust (ppb)

From EWG - Toxic Fire Retardants Contaminate American Homes - http://www.ewg.org/reports/inthedust/summary.php


PBDEs in Breast Milk (ppb)

From EWG - Toxic Fire Retardants in Breast Milk from American Mothers - http://www.ewg.org/reports/mothersmilk/es.php


PBDEs In Milk Fat

PBDE in milk fat - Puget Sound mothers

13 13 1326

50 56

117126

156

0

25

50

75

100

125

150

175

1 2 3 4 5 6 7 8 9

Sample Number

pp

b in

Milk

Fat

(adapted from Northwest Environmental Watch, 2004)


Developmental Data

2863 above 1 Million pounds

78.2% no data

21.4% some data

12 or 0.4% good data

www.preventingharm.org


Nearly 12 million children (17%) under age 18 in the US suffer from one or more developmental disabilities

Learning disabilities – 5-10% of kids in public school

ADHD – 3-6% of all school kids, maybe higher

The Consequences


Estimated Costs - National

Best Estimate

Low Estimate High Estimate

Lead Poisoning $43.4 $43.4 $43.4

Asthma $2.0 $0.7 $2.3

Cancer $0.3 $0.2 $0.7

Neurobehavioral Disorders

$9.2 $4.6 $18.4

TOTAL $54.9 $48.8 $64.8

Estimated Costs of Pediatric Disease of Environmental Origin, United States,1997 (billions)

(From “Environmental Pollutants and Disease in American Children,” Landrigan, Schechter, et.al., 2002)


Responsible

Morally accountable for one's actions; capable of rational conduct; answerable


Responsible

Morally accountable for one's actions Ethical responsibility and duty to

prevent harm Responsibility to promote human

and environmental health The proponents of an action are

responsible for demonstrating safety

Duty and responsibility to future generations


Child Health


“Children can develop and mature in an

environment that allows them to reach and maintain their full

potential.”

Vision for Child Health


“Conditions that ensure that all living things have the best opportunity to reach and maintain their full genetic potential.”

S. Gilbert (1999)

Human & Environmental Health


Socially responsible white guys?


"A thing is right when it tends to preserve the integrity, stability, and beauty of the biotic community. It is wrong when it tends otherwise." -

Aldo Leopold, 1949, A Sand County Almanac

The First Bioethicist

---------- 1887 - 1948 ----------

Aldo Leopold


“An ethic, ecologically, is a limitation on freedom of action in the struggle for

existence”Aldo Leopold

Limits on Freedom


“The Commons”

The Tragedy of the CommonsBy Garrett Hardin, Science, 1968


Technical Solutions

“It is our considered professional judgment that

this dilemma has no technical solution.”

The Tragedy of the CommonsBy Garrett Hardin, Science, 1968


Problems – Solutions?

Lead and kids Fetal alcohol syndrome Nuclear disarmament Bioterrorism Ocean Fisheries Persistent chemicals The Commons


The Precautionary Principle is part of the evolution in our

thinking and decision making toward ensuring human and

environmental health.

Conclusion



It is Reasonable, Rational, and Responsible to protect the potential of our children.

We have a duty to the health of the environment and the health of future generations.


A Seat Belt for the Brain

Prevention


The Potential of Children


Additional Information

A Small Dose of Toxicology (www.asmalldoseof.org)

The Science and Environmental Health Network (SEHN) (www.sehn.org)

Late lessons from early warnings: the precautionary principle 1896-2000 – European Environment Agency

Ethical, legal, and social issues: our children's future. Steven G. Gilbert. Neurotoxicology, 26(4), pp 521-530, 2005.


Questions or Comments?

Download Presentation from www.asmalldoseof.org


Authorship Information

For Additional Information ContactSteven G. Gilbert, PhD, DABT

E-mail: [email protected]: www.asmalldoseof.org

This presentation is supplement to “A Small Dose of Toxicology”


Socially Responsible


A Small Dose of Toxicology

See: www.asmalldoseof.org -- smdose


NW Public Health

See: http://healthlinks.washington.edu/nwcphp/nph/

nwph

Public Health and the Precautionary

Principle

By Steven G. Gilbert


Doubt / Uncertainty

"Doubt is our product since it is the best means of competing with the 'body of fact' that exists in the mind of the general public.“

1969 an executive at Brown & Williamson owned by R. J. Reynolds Tobacco Company

(Doubt Is Their Product by David Michaels in Scientific American, June 15, 2005)


• NEW MEXICO CREATES A PRECAUTIONARY PRINCIPLE TASK FORCE

• In New Mexico, the state Environment Department and the state Department of Health have formed a joint task force to study the precautionary principle. The task force will advise the Governor and the Executive Branch on the potential and practice of implementing the principle in New Mexico. Findings and recommendations are due in

• October 2006

New Mexico & Precaution


FDA regulations of Drugs (1938) FDA regulations of Dietary

Supplements (Dietary Supplement Health and Education Act of 1994 (DSHEA))

Ephedra present an unreasonable risk of illness or injury (Dec, 2003)

Safety & Efficacy vs Harm


Lessons Learned

Knowledge to policy

Disease is money

Externalize costs

How to make money from prevention?


• Vision of Child Health

• Knowledge of Reproductive and Developmental Toxicology

• Policy Approach within an ethical framework• Social responsibilities• No technical solutions• Restriction of freedoms• Precautionary Principle

Convergence of Issues


“When an activity raises threats of harm to human health or the environment,

precautionary measures should be take even if some cause and effect relationships are not

fully established scientifically.”

Wingspread Conference, 1998.



• Setting goals (Health indicators)• Taking preventive action in the face of

uncertainty• Shifting the burden of responsibility to the

proponents of an activity (Who benefits?)• Exploring a wide range of alternatives to

possibly harmful actions (Is it necessary?)• Increasing public participation in decision

making (transparency of information & environmental justice)

Central components


• Children have a right to a safe, fair and healthy environment

• Ethical Responsibility to share and use of knowledge

• Duty to promote health and well being of children

• Thoughtful public health advocate

Knowledge - Responsibility


Reasonable

Able to discourse or discuss matters Comprehensive and inclusive

decision making approach Brings stakeholders together Emphasizes prevention rather than

treatment Encourages sharing of information Considers future generations of

humans and other species


Rational

Having the faculty of reasoning Decisions based on scientific

knowledge and experience We have the knowledge and

experience to prevent harm to future generations

Uncertainty is not a reason to delay action to ensure human and environmental health


Responsible

Morally accountable for one's actions Ethical responsibility and duty to

prevent harm Responsibility to promote human

and environmental health The proponents of an action are

responsible for demonstrating safety

pp res, rat, resp 03/07/06. chair - steven g. gilbert, phd, dabt co-chair - joel l. mattsson, dvm,...

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