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Delaney Clause: Press Release 1/12/95

The U.S. Environmental Protection Agency is proposing to revoke the food additive regulations (maximum allowable residue level), and therefore likely reduce some uses, for four pesticides in certain processed foods. The Agency's action is one of a series of actions resulting from the l992 U.S. Ninth Circuit Court of Appeals decision, which strictly interprets the Delaney clause. The Delaney clause of the Federal Food, Drug, and Cosmetic Act (FFDCA) provides that no additive may be approved for use in processed food if it is found to induce cancer in man or animals. The pesticides in today's proposed action were found to be carcinogenic in laboratory animals.

EPA will work with the manufacturers, the agricultural community, and the United States Department of Agriculture to help identify safe substitutes for these pesticides.

The food additive regulations subject to revocation are:

1. acephate in food handling establishments (food processing, food manufacturing and food service such as restaurants);
2. triademefon in milled fractions of barley (except flour) and wheat (except flour);
3. iprodione in dried ginseng and raisins; and
4. imazalil in citrus oil.

Lynn Goldman, EPA's Assistant Administrator for Prevention, Pesticides and Toxic Substances, said, "Although these four pesticides posed only a negligible dietary risk, the court decision requires that we propose this action. We do not believe that most approved uses of these pesticides will be affected."

Acephate is an insecticide used on cotton, soybeans, vegetables and peanuts. Triademefon is a fungicide used on grains, fruit trees, grapes and vegetables. Iprodione is a fungicide used on almonds, a variety of fruits and vegetables, and peanuts. Imazalil is a fungicide used on barley, bananas, citrus and wheat.

Today's proposed revocations do not address the associated raw food tolerances (allowable pesticide residues) or registrations for pesticides and uses at issue.

EPA regulates pesticide residues in food under FFDCA and in l988 adopted a policy interpreting the Delaney clause as subject to an exception for carcinogenic pesticides which pose only a negligible risk. The Agency's policy was challenged in court by the Natural Resources Defense Council and others who were seeking a "zero risk" interpretation of the Delaney clause. The Court concluded that the Delaney clause is not subject to the Agency's negligible or de minimis interpretation (Les vs Reilly). The court's decision applies to all pesticides which cause cancer in test animals and concentrate during processing.

Public comments may be submitted for 90 days after publication of today's notice in the Federal Register. Submit comments to: Public Response Section, Field Operations Division (7506C), Office of Pesticide Programs, U.S. EPA, 40l M St. S.W., Washington, D.C. 20460.