Delaney Clause in the United States

Delaney Clause in Environmental Law

A provision in the Federal Food, Drug, and Cosmetic Act (FFDCA) that prohibits unsafe additives in processed food and bans additives that have been shown to cause cancer (carcinogens) in animals or humans. This ban against carcinogens has created a conflict for the Environmental Protection Agency (EPA) in administering this and the second statute that regulates pesticides, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Generally, when the EPA decides whether to allow a substance to be marketed, it must weigh the benefits of its use against the risks. Thus, when the EPA registers a pesticide, it completes a risk benefit analysis and establishes tolerances for pesticide residue on raw agricultural products. But any residue from a pesticide considered carcinogenic is prohibited by the Delaney Clause. It is possible, then, for a farmer to use a registered pesticide according to directions, to achieve an EPA approved level of residue, and still not be allowed to sell or process his crop if the pesticide is considered cancercausing no matter how small the risk. (Pesticides are considered additives in processed food.)

Pesticides are toxic by design, created to kill weeds, insects, rodents, fungi, and other organisms harmful to agriculture. But the goal in pesticide development is to make products that aid agriculture without posing unacceptable risks to humans. Because the sophistication of measurement and growing accuracy of projections have exposed potential risks far more clearly than in the past, it is increasingly difficult to find benign substances. Today, pesticides are found in drinking water sources and in meat, vegetables, and fruits even when no pesticides were applied to them directly. Determining the extent of people’s exposure to them is a difficult task. As new pesticides are developed, safety standards are becoming more stringent, but older, more dangerous pesticides remain on the market. Some people fear that they will be the only ones available if new pesticides cannot be registered due to ultimate prohibitions on residues in food.

Because of the problems it creates, the EPA tried to modify the Delaney Clause in 1988 by issuing interpretive regulations that would allow four registered pesticides to be used even though they had been shown to cause cancer. The EPA argued that they would pose only a minimal [see de minimis] risk. In the case of Les v. Reilly, the court found the EPA’s regulations contrary to law: the EPA has no authority to allow cancer causing substances in processed foods, regardless of the degree of danger.

The EPA is currently working with the Food and Drug Administration and the Board on Agriculture of the National Research Council to refine methods of setting tolerances for pesticides in food. Many solutions have been proposed that would address the conflict created by the Delaney Clause, but only a revision of the statute by Congress will be effective. When the congressional debate occurs, social pressures for safe food, particularly for children, will have to be weighed against the benefits of pesticides to agriculture.
Based on “Environment and the Law. A Dictionary”.