The Delaney Clause Effects on Pesticide Policy

Donna U. Vogt
Analyst in Life Sciences
Science Policy Research Division
Updated July 13, 1995
95-514 SPR

SUMMARY

Pesticide residues in processed foods are regulated under Section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA) which pertains to "food additives." Section 409 specifically addresses cancer-causing (carcinogens) pesticide residues in processed foods with its Delaney Clause. This Clause has a fixed risk standard, "zero cancer risk," for food additive pesticide residue tolerances. Such a risk standard does not allow an assessment of any possible agricultural benefits from the use of pesticides. Several groups, including the pesticide and food industries, want Congress to replace the Delaney Clause with a "negligible risk" standard. The pesticide industry claims that a single "negligible risk" standard would set one risk standard for all foods and would allow newer, safer pesticides to be marketed even with some evidence of carcinogenicity. However, Delaney Clause supporters argue that Delaney reduces risks associated with carcinogenic pesticide chemicals and no carcinogenic substances should be added voluntarily to food; there are enough natural carcinogenic toxins already in the food supply. The Senate is currently considering the Comprehensive Regulatory Reform Act of 1995 (S. 343) which would replace the Delaney Clause provisions governing pesticide residues in foods (food additives), color additives, and animal drugs with a negligible risk standard. This version states:" No agency shall prohibit or refuse to approve a substance or product on the basis of safety where the substance or product presents a negligible or insignificant foreseeable risk to human health resulting from its intended use." Critics, particularly the Administration, say this revision of the risk standard is untested and lacks the directive of being health-based.

ISSUES

What is the Delaney Clause?

The Delaney Clause is contained in the section on food additives (Section 409) of the Federal Food Drug and Cosmetic Act of 1958.(1) The Delaney Clause states that no additive will "be deemed safe if it is found to induce cancer when ingested by man or animal," and directs FDA not to approve such food additives. Its language has been interpreted to mean a "zero risk" standard for any cancer-causing food additive, including residues from pesticides found in processed foods.

How did it end up in law?

In the 1950s, James J. Delaney, a Democratic Congressman from Long Island City in Queens, New York, chaired a House Select Committee to Investigate the Use of Chemicals in Food Products. After several oversight hearings, Mr. Delaney became convinced that too many chemicals, including pesticide chemicals, were being found in foods. His amendment prohibits any carcinogenic additive from being added to processed foods and was adopted as part of the Food Additive Amendments in 1958. This amendment established the basis on which the Government would evaluate safety of substances added to foods. The language of the section states that additives must be "safe." Over time, in the legislative history of the FFDCA, the term "safe" was defined as a "reasonable certainty that no harm would result from the proposed use of the additive." The Delaney Clause added the provision that no additive to processed food could be carcinogenic. Opponents argued at the time that the health end-point of cancer should not be singled out in a statute, for most causes of cancers were unknown. Some opponents argued that other disease conditions besides cancer were equally deserving of preventive measures.

How does the Delaney Clause affect the setting of pesticide residue tolerances?

Pesticides are regulated in the food supply through the establishment of maximum permissible levels of residues in or on foods called tolerances. Without a tolerance, or an exemption from a tolerance, a food containing a pesticide residue exceeding the tolerance is deemed "adulterated." The responsibility for setting legal limits or tolerances for pesticide residues lies with the EPA. The Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) enforce tolerances set by EPA.

The FFDCA governs the setting of tolerances differently for raw foods and processed foods. Tolerances for residues on raw foods are authorized to be established under section 408 of FFDCA; tolerances for residues in processed foods are established under section 409. Section 409 lays out requirements for the use of all additives in foods, including pesticide residues that could concentrate from levels in raw products in their processed form, or that are added during processing. Section 409 also contains the Delaney Clause.

The criteria used to approve the tolerances for raw foods are set out in section 408. EPA sets tolerances for all types of pesticide/food combinations, even for carcinogenic pesticides. If the cancer risk is outweighed by several factors including "the necessity for the production of an adequate, wholesome, and economical food supply," EPA will set a carcinogenic pesticide residue/raw food tolerance.

This risk-benefit balancing in section 408 is different from the "risk-only" criterion in section 409. The Delaney Clause does not allow consideration of benefits of product use nor whether the cancer risk is "negligible" (extremely small). Over time, science has developed methods to detect smaller residue levels. When FDA monitors processed foods with sophisticated equipment, they can find residue levels in parts per trillion. These foods are considered adulterated under the law, if the levels are greater than allowed in the raw food. A finding of adulteration is based on FDA determining that the residue in the processed food exceeds a tolerance or there is no tolerance for the specific pesticide/commodity combination.

Why does the Delaney Clause cause problems for food safety?

Delaney's standard of absolute zero or "no cancer-causing food additives" does not allow for the characterization of relative risk in various foods, even if the risk of the residue is extremely small. The Delaney Clause's concept of zero risk inhibits the flexibility of a regulatory agency to make tolerance decisions based on the latest risk models because it means that even the most trivial risk cannot be allowed.

In addition, the Delaney Clause creates a false expectation that a processed food will not have any cancer-causing substances in it. There are, however, many natural carcinogenic elements in foods to which humans are exposed. These natural toxins, such as fungi or aflatoxin, may be thousands of times more concentrated and potent than the residues from synthetic pesticides. And many foods contain these carcinogenic toxins naturally. So when toxins are natural, the FDA cannot assume the responsibility of ensuring that foods will contain no cancer-causing substances.

What is the Delaney paradox for pesticide policy?

Since the Delaney Clause sets a standard only for carcinogenic residues that concentrate in processed foods, the same pesticide chemical must meet inconsistent requirements (zero-risk versus risk-benefit) depending on whether it is found in/on a processed or raw food. Such inconsistency is often referred to as the "Delaney Paradox." The zero-risk criteria ignores an axiom of modern toxicology---the dose makes the poison. By setting such a stringent requirement, Delaney ignores the relationship between the dose of a toxic substance, and its risk to human beings, and allows no discrimination among carcinogens that pose only small, trivial risks.

In fact, the Delaney Clause has set up several paradoxes. First, the application of the Delaney Clause criteria limited the introduction of lower-risk pesticides that could replace older and potentially more hazardous compounds that had not been brought fully into compliance under a reregistration program. Second, the Delaney Clause singled out one health end point--cancer(2), not substances causing birth defects, or nerve damage or immune system failures. EPA does consider other acute and/or chronic health effects. EPA's preoccupation with cancer because of Delaney's emphasis on it has meant that the pesticide tolerance setting process is more cumbersome and complicated. EPA established separate procedures for setting tolerances for carcinogenic and non-carcinogenic pesticides.

What is negligible risk? How does it relate to the Delaney Clause and pesticide policies?

Because of the contradiction in the statute, EPA asked the National Research Council (NRC) of the National Academy of Sciences (NAS) to review options that it should consider in EPA's regulation of pesticide residues. In 1987, the NRC published a report entitled, "Regulating Pesticides in Foods: The Delaney Paradox." This report recommended that all pesticide residues in food, whether marketed in raw or processed form, or governed by old or new tolerances, should be regulated on the basis of consistent standards. One option explored showed what would happen if "all tolerances would be revoked for a pesticide on a crop when the combined estimated cancer risk from the residues of that pesticide on both the raw and processed forms of a crop did not exceed 1 in 1 million or 1 x 10-6." The NRC called this case of one in one million, a "negligible risk." The NRC found that this negligible risk standard for carcinogens in food, applied consistently to all pesticides and to all forms of food, could dramatically reduce total dietary exposure to carcinogenic pesticides with modest reduction of agricultural benefits. The committee found that the use of a negligible risk standard could lead to the elimination of 98 percent of the existing dietary risk from exposure to 28 pesticides.

In 1988, EPA decided it would accept the NRC recommendation and use a de minimis (insignificant) criteria, which they equated with "negligible risk," to set tolerances for carcinogenic pesticide residues. In the Federal Register notice EPA defined negligible risk to be one chance in a million (1 x 10-6) that an individual will experience cancer from daily exposure (over a 70-year lifetime) to a carcinogenic pesticide. The quantitative standard for tolerances after meeting this "negligible risk" standard would be set as a range in the law to allow the decision on risk to be left to the judgement of EPA based on the quality of the data provided by the pesticide sponsor and the certainty of the risk assessment.

What happened in the courts on Delaney?

After EPA decided to use a de minimis (insignificant) criteria to set pesticide residue tolerances, several environmental and consumer groups objected. They asked the courts to review EPA's 1988 order to use the negligible risk interpretation to permit four pesticide residues as food additives, although the residues were found to be carcinogenic in animals. These groups alleged that EPA had violated the provisions of the Delaney Clause. On July 8, 1992, the U.S. Court of Appeals for the Ninth Circuit agreed and decided in their favor in Les vs. Reilly.(3) The court ruled that the Delaney Clause's history and purpose reflected that Congress intended to prohibit the use of any food additive that is a carcinogen, regardless of the degree of risk involved. Therefore, the court found that EPA's de minimis interpretation of the language of section 409 was unlawful. The court stated that EPA has no authority to approve a section 409 tolerance for a food additive that has been found to induce cancer in appropriate tests.

To comply with the court's decision, on June 30, 1994, EPA revoked the food additive tolerances directly cited in the litigation. Subsequently EPA agreed, on October 12, 1994, to a consent agreement with several environmental groups in a pending case, California vs. Browner, to review about 10 percent of the uses of 37 already marketed pesticides and some uses of 40 other pesticides. This action may threaten some uses of about 10 percent of currently registered pesticides.

Where is the political pressure for changing Delaney?

Many interest groups (the pesticide industry, the food industry, consumer groups and environmental groups) want the pesticide tolerance system changed. Some groups want tolerances set based on cost-benefilt analysis; others want the tolerance criteria to be based exclusively on health considerations without benefits to the production of a "safe, wholesome, and economical" food supply. Still others want the EPA to consider the recommendations laid out in a second NRC report in June 1993, "Pesticides in the Diets of Infants and Children."(4) This report claimed that children's exposure to pesticides is greater than adults because children consume more of some foods (apple sauce) that may have proportionately higher levels of residues than other foods. The report also called upon EPA to modify its tolerance setting process so it is based more on health considerations than on agricultural practices. The report implied that the current tolerances were set too high and that EPA should provide greater protection to infants and children.

One group headed by the National Food Processors Association (NFPA) petitioned EPA to discontinue its policy of linking processed food tolerances with raw food tolerances. Under EPA's "coordination policy," if a processed food tolerance is needed (because the pesticide might possibly be present above the raw product tolerance level) but is prohibited under the Delaney Clause, the corresponding raw food tolerance is not permitted. For example, prohibition of a food additive tolerance on processed tomato puree would also prohibit a tolerance for a pesticide/raw tomato combination, because EPA could not ensure that raw tomatoes bearing pesticide residues will not enter processing channels and result in residue levels that are greater than tolerances in down-stream processed tomatoes. Such a "coordination policy" means that the hegemony of Delaney spreads to other pesticides.

In partial response to this petition, EPA on June 9, 1995, adopted a policy which redefined its "concentration" policy. EPA stated that food should be considered "ready-to-eat" if it is consumed "as is" or is added to other ready-to-eat foods (such as condiments). Raisins, olives, potato chips are ready-to-eat foods; dried hops, mint or citrus oil are not. EPA will now establish maximum residue levels for not-ready-to-eat processed food. These levels will be set at levels that are no higher than levels which could result in the processed food if there were legal pesticide residues on the food. EPA will now use a broader base of information about processing studies to predict concentration of pesticide residues.

Others, such as the National Coalition Against the Misuse of Pesticides (NCAMP), the National Campaign for Pesticide Policy Reform, and the Natural Resources Defense Council (NRDC), resist changing the Delaney Clause. These groups are concerned that this "override" of Delaney is part of a larger movement to apply a cost-benefit standard to many environmental laws. They fear a change in the tolerance setting system would be based on the economic assumptions of cost-benefit analysis and neglect the very real concerns about "health-risks" posed by pesticides. They are also concerned that although science has greatly improved the potential for detecting smaller levels of residues, EPA still does not have the scientific tools to evaluate threshold effect levels for carcinogens. Nor does EPA have exposure assessment models that can evaluate the multiple effects of additive and possible synergistic effects of carcinogenic pesticides. They argue that EPA should reduce the total burden on the human body of multiple exposures to toxic pesticide chemicals. Several of these groups want EPA to give greater emphasis to alternative pesticide management practices.

Critics of Delaney contend that pesticides should be judged on their myriad effects not just on whether they are proven carcinogens that remain on processed foods. The need to focus on cancer risks because of Delaney has meant fewer resources are available to assess other impacts of pesticides, such as the health of farmworkers or pesticide applicators or on the ecosystems in the environment. Supporters of Delaney argue that it is an important statute because it draws attention to health problems that could be caused by chemical additives in foods.

Current Policy Debate

Two major pieces of legislation could have an impact on the pesticide residue tolerance setting system. The Comprehensive Regulatory Reform Act of 1995 (S. 343) would eliminate the concept of "zero risk" from the current tolerance setting system, replacing it with "negligible or insignificant risk." This bill, along with the House-passed Risk Assessment and Cost-Benefit Act of 1995 (H.R. 1022), require that the costs and benefits be considered in decisions about tolerances. If a new tolerance setting system were developed, decisions would be made using evidence showing the benefits of the use of new pesticides for increased crop yields, lower food prices, and reduced health risks of some pesticides compared to the health risks of some residues found in foods or health risks to farm workers. Critics of these proposals, particularly the Clinton Administration, want changes in the risk standard of the statute to reflect a new single health-based standard and incorporate the recommendations of the NRC report to protect the diets of children.

Endnotes

1. The 1938 Federal Food, Drug and Cosmetic Act (FFDCA) ensures that foods are safe, wholesome, and sanitary. Pub. L. No. 85-929, 72 Stat. 1784, 1785 (1958); codified at 21 U.S.C. 348. Identical Delaney language is also included in two other sections of the same law; those governing color additives (Sect. 721(b)(5)(B) 1960); and animal drugs (Sect. 512 (d)(l)(I) 1968).

2. Scientists are just beginning to understand the mechanisms of cancer induction. High rates of cell division are associated with mutations, or damage to the molecular genetic material (DNA) that makes up genes. Cancer often results from multiple mutations. Cells have enzymes that continually repair DNA by clipping out genetic aberrations. Gradually, as the body ages and becomes less proficient in repairing itself, mutations occur which exceed the body's ability to remove the mutated DNA and gives cancer a chance to establish a foothold. Even if a cell's DNA is seriously damaged by a mutagen, cancer will only result if the cell is actively dividing.

3. Les, Kathleen E. v. EPA no. 91-70234, U.S. Court of Appeals for the Ninth Circuit, 968 F.2d 985; 1992 U.S. App. Filed 7/8/92.

4. National Research Council. Commission on Life Seienees. Board on Agriculture and Board on Environmental Studies and Toxicology. Committee on Pesticides in the Diets of Infants and Children. Pesticides in the Diets of Infants and Children. Washington, National Academy Press, 1993.