The Delaney Clause: new interpretations - new meaning to a portion of the Federal Food, Drug and Cosmetic Act applying to processed food and indirectly to raw foods that have a processed form

Food Review, April-June, 1991 by Philip Szmedra, Walter Ferguson

The Delaney Clause: New Interpretations

Responding to concern over food safety and questions about chemical residues in the food supply, the Environmental Protection Agency (EPA) has changed the method by which it will consider granting registrations to new pesticides, and reviewing both new and old uses of established pesticide products.

In order to be more consistent in the manner in which pesticide products are registered for sale and use, the EPA is attempting to reconcile the often conflicting stipulations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) with the Delaney Clause portion of the Federal Food, Drug, and Cosmetic Act (FFDCA).

Under FIFRA, EPA registers pesticide products and their uses after determining that the pesticides will cause no unreasonable adverse effects to man or the environment. Under the FFDCA, the Delaney Clause applies to processed food and indirectly to raw foods that have a processed form. The Delaney Clause ensures that none of the additives in processed foods are carcinogenic (interpreted to be tumor causing). For FFDCA purposes, pesticides are considered food additives. The Delaney Clause applies only to pesticides that concentrate in food processing. Therefore, if a carcinogenic pesticide concentrates in processed food and is detectable (Delaney Clause), the pesticide could not be issued a registration under FIFRA.

Under EPA's new policy, the agency applies a uniform set of criteria to all FIFRA registration, tolerance, and food additive regulation decisions. EPA shifts from zero tolerance for carcinogenic pesticides under the Delaney Clause to negligible risk (generally defined as one additional incidence of cancer per 1 million people over a 70-year life span). If the residues of a pesticide on a particular food pose no carcinogenic risk or only a negligible risk, the pesticide's use on that food is approved under both acts provided they meet the other requirements of FIFRA and the FFDCA.

Tolerance Setting

Methods Studied

In 1985, the National Academy of Sciences (NAS) was provided a grant to study EPA's methods for setting pesticide tolerance levels and to examine the current and likely effects of the Delaney Clause on the tolerance-setting process.

The NAS study determined that about 55 percent of total dietary carcinogenic risk arises from pesticide residues on specific crops that have raw and processed food forms. Of this 55 percent, 20 percent stems from the consumption of the processed form of these crops, and 35 percent derives from the consumption of the raw form. However, 45 percent of estimated dietary carcinogenic risk arises from foods considered by EPA to have no processed forms, such as all red meat, milk, and poultry products as well as fruits and vegetables which have no processed form.

These foods without any processed form are not under the Delaney Clause. Therefore, strict application of the Delaney Clause would eliminate only about 55 percent of the estimated dietary carcinogenic risk from consumption of pesticide residues in foods. The remaining 45 percent would be beyond the scope of the Delaney Clause. By applying the new negligible risk approach in pesticide registration decisions rather than the zero risk Delaney Clause method, NAS estimated that total dietary risk from the carcinogenic pesticides included in their study would be reduced by 98 percent.

There is at least "limited evidence" of carcinogenicity (virtually all from animal studies) for 66 or more of the approximately 350 pesticides already approved for food use. EPA expects this number to become somewhat larger as it receives and evaluates more studies on pesticides used in food production.

Economic Implications

EPA's new interpretation of the Delaney Clause could have considerable economic implications for growers and consumers. By shifting from zero tolerance to negligible risk, many new pesticide products would potentially be able to be registered and subsequently marketed. At the same time, older product registrations not able to meet the negligible-risk standard would be canceled.

The new interpretation also could allow some of the "old" materials to remain, which, from an economic standpoint, would be significant. For instance, older pesticide products are generally much less expensive than newly patented products and farmers are comfortable with using products that are familiar to them. In addition, maintaining a large complement of diversified pesticide products helps prevent the buildup of resistance by pests to any single pesticide product or pest control method.

To register a pesticide use, pesticide manufacturers must provide the EPA with information describing the acute and chronic effects of human exposure and toxicity, as well as environmental fate studies. Exposure means the level to which people are subjected to the pesticide products' residues in air, water, and food. Toxicity information details the health effects of a given level of exposure. An assessment of the level of risk associated with a particular pesticide is the combined effects of exposure and toxicity.