Raquel Collison

Environmental Regulations 440

10-19-13

The Delaney Clause – What has been accomplished?

The regulation of toxic substances has long been a concern for various federal

departments that set standards for economics, sustenance, radioactive substances, and

work place environments. The importance that human and environmental health is

protected with the upmost tolerance and respect for the masses has resulted in what is

considered tolerable risk, which is typically grounded upon health – based standards.

Thus, various regulatory options have been available to the various federal departments

in order to combat the harmful effects of toxic substance abuse and / or neglect, such as

setting feasibility statutes (which considers reducing toxic health risks to what is

“practicable”), risk – benefit statues (can we put a price on environmental or human

decline?), and lastly by setting pure health – based standards such as the Delaney Clause.

First issued in 1958 as part of the Food Additives Amendment to the 1954 Federal

Food, Drug, and Cosmetic Act (FFDCA), the Delaney Clause stated that no additives

could be added to processed food that was found to cause cancer in animals or their

offspring as to form a zero – risk approach. At the time, technology was only so advanced

that contaminants could only be measured in parts per thousand; today we can measure in

parts per trillion, and therefore zero – residue would be nearly impossible to avoid.

Therefore, the National Research Council (NRC) added more specifications

relative to pesticide residues in order to improve the EPA’s process of setting tolerances

in 1985. The new ideas were as follows:

I. Regulate pesticides on all foods by the same standards.

II. Set a “negligible risk,” which states that the EPA will dismiss one out of one million

cancer cases.

III. All additive registration and tolerances must comply with the law, including the

Delaney Clause.

IV. Improve tools for risk – benefit assessment (Holloway & Rowell, n.d.).

As with the new specifications set forth by the NRC, there were discrepancies.

Negligible risk was often argued against the Delaney Clause, and in 1996 the Food

Quality Protection Act (FQPA) exempted the zero – risk standard (“Delaney Clause,”

n.d.). Instead, the other aforementioned tolerances were enacted on stronger levels as to

promote certainty that the foods people were eating were still safe pertaining to levels

based upon sound science (“Food Quality Protection Act,” n.d.).

Although the Delaney Clause was soon considered obsolete, the 1996 FQPA set

tougher standards to protect children from the harmful effects of pesticides, such as a new

10x safety factor, and stronger regulations based upon foods that children more

commonly ate. Because of the sad and uninformed past, multitudes of kids have gotten

sick and have died due to the misuse and misunderstanding of toxic substances

(“Children are at greater Risk,” 2012). Before the introduction of the Delaney Clause,

there were little to no standards set for additive use on foods, therefore tolerances in

regards to children’s health were easily unjustified. Eventually, increased childhood

diagnosed cases of asthma, learning disabilities, and exposure rates, just to name a few,

were being researched as to detect the first cause of possible toxin – induced illness based

upon nonexistent standards. Some illnesses progressed into cancer, birth defects,

reproductive problems, and immune deficiency as one ages, and therefore the FQPA

established a basis for a healthier tomorrow.

Although the FQPA protected children as one of its main goals, it replaced the

Delaney Clause – a zero tolerance policy – with a basis for negligible risk. Despite the

initial concern in regards to what would be deemed “acceptable,” the FQPA considered

the use of pesticides, whilst the Delaney Clause only affected the use of food additives

(with some exceptions) – therefore the new provision focused on a much wider basis for

possible carcinogen influence (The Food Quality Protection Act,” 2013). Other

discrepancies with the previous standards are as follows:

For one, the Delaney Clause caused for what was deemed “insufficient” use of the

EPA’s resources. Due to the zero risk standards set forth by the clause, even the most

insignificant use of additives would be banned if they might be considered a carcinogen,

despite their possible overwhelming help to agriculture. The creation of safer pesticides

would then be avoided because even they would still amount to some form of

carcinogens under Delaney’s zero – risk standards (“The Delaney Clause,” 2011).

Now, tolerances would be set by the FQPA, which state “there is reasonable

certainty that no harm will result from the aggregate exposure to the pesticide chemical

residue” - this standard was then applied to both raw and processed foods. Now, if the use

of a certain pesticide has been removed from the former prohibited list due to a

reasonable risk factor, supermarket consumers would be aware of its use in certain foods

through proper labeling regulations (“The Nation’s New Pesticide Law,” 1996). This

newfound tolerance would also apply to substances that:

I. Contain health benefits that outweigh the risks.

II. Are “necessary to avoid significant disruption in domestic production of an adequate,

wholesome, and economical food supply.”

It is also noted that the source(s) of cancer cannot be easily defined, and so the

exempt Delaney Clause resembled various faucets of biological processes perhaps

unrelated to additives in food, not to mention the disregard that higher doses equated to

bigger risk (representing “everything in moderation”). Within the FQPA, there is

negligible risk associated with pesticide use and the cause of cancer (as well as other

induced illnesses, of which were not supported by the prior cause), however the sources

are still difficult to distinguish (Vogt, 1995). Although with the prolonged efforts of

scientific study, more progress is being made in order to determine exactly the case of

increased cancer cases in the United States, and therefore affect the FQPA and its related

tolerances with new published studies.

In conclusion, the replacement of the Delaney Clause with the Food Quality

Protection Act ensured that human health and safety would grow with technology to

foster further generations unaffected by the illnesses caused by the improper use of toxic

substances. With the use of stronger technology – based regulations, the FQPA has been

able to set up negligible risk that considers not only food additives, but more detailed lists

of agricultural pesticide use as well. The new laws that focus on children’s developing

systems and food choices, in particular, have strove to diminish cancer, as well as other

diseases, to improve quality of life with a set of universal standards backed up by great

improvements in technology and scientific research.

References:

(2012, May 09). “Children are at greater Risk from Pesticide Exposure.” The United

States Environmental Protection Agency. Retrieved from

http://www.epa.gov/pesticides/factsheets/kidpesticide.htm

(n.d.). “Delaney Clause.” The Agricultural Encyclopedia. Retrieved from

http://www2.ca.uky.edu/agripedia/GLOSSARY/delaney.htm

(2011). “The Delaney Clause.” The Center on Congress at Indiana University.

Retrieved from http://congress.indiana.edu/delaney-clause

(n.d.). “Food Quality Protection Act.” Cornell University. Retrieved from

http://pmep.cce.cornell.edu/fqpa/

(2013). “The Food Quality Protection Act of 1996.” Washington State University.

Retrieved from http://postharvest.tfrec.wsu.edu/pages/PC98A

Holloway, R.L. & Rowell, M. (n.d.). “The Delaney Clause.” The Texas Agricultural

Service. Retrieved from http://ipm.ncsu.edu/safety/factsheets/delaney.pdf

(1996, Aug 31). “The Nation’s New Pesticide Law.” The Environmental Working Group.

Retrieved from http://www.ewg.org/research/nations-new-pesticide-law

Vogt, D.U. (1995, July 13). “The Delaney Clause Effects on Pesticide Policy.” CRS

Report for Congress. Retrieved by

http://www.cnie.org/NLE/CRSreports/Pesticides/pest-1.cfm