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PR DELANEY CLAUSE

Release Date: 02/28/96
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PR DELANEY CLAUSE

FOR RELEASE: TUESDAY, FEBRUARY 27, 1996 ACTING UNDER PROVISIONS OF THE COURT REGARDING THE DELANEY CLAUSE, EPA PROPOSES TO REVOKE NINE PESTICIDE TOLERANCES

The U.S. Environmental Protection Agency is proposing to revoke nine raw or fresh food tolerances (maximum allowable residue levels) for five pesticides. Today's action is another in a series of Delaney related actions resulting from a l992 U.S. Ninth Circuit Court of Appeals Decision.

EPA has concluded that revoking these nine tolerances would have little impact on the price or availability of food to the consumer.

Lynn Goldman, EPA Assistant Administrator for Prevention, Pesticides and Toxic Substances, said, "The strict application of the Delaney clause requires us to propose these revocations because of technical legal requirements for processed foods. The proposed revocations announced today should not cause consumers to avoid particular foods.

"This Administration remains committed to comprehensive reform of our pesticide food safety laws, to establish a consistent, healthbased standard for all pesticide residues in food," Goldman said. "A standard is needed that will protect everyone, especially children, while allowing EPA to use current science in making its pesticide decisions. Until such reforms are enacted, however, EPA must comply with the Delaney clause as it stands."

The nine tolerances being proposed for revocation are: dicofol on apples, grapes and plums; mancozeb on oats and wheat; propargite on apples and figs; simazine on sugarcane; and triadimefon on wheat. Once a pesticide tolerance is revoked, the affected crop can no longer be legally treated with that pesticide.

The Delaney clause of the Federal Food, Drug and Cosmetic Act (FFDCA) prohibits the approval of food or feed tolerances for pesticide residues in processed food or animal feed if the pesticide is found to induce cancer in man or animals, regardless of the level of risk. Tolerances in processed food or feed are required when the pesticide used on the raw food or feed concentrates in ready-to-eat food or feed in levels higher than the raw food or feed tolerance, or when the pesticide is used directly in processing.

Studies indicate that all pesticides covered in today's announcement cause cancer in laboratory animals. In the past, EPA regarded pesticide residues that posed no significant risk as acceptable under the Delaney clause. But the court decision,(Les vs Reilly), required a strict literal interpretation of the Delaney clause. EPA is required to revoke tolerances which violate the Delaney clause, no matter how small the risk.

While today's actions are based on legal grounds, EPA is 

continuing to evaluate all of the pesticides involved as part of its ongoing reregistration program. If, as part of this evaluation, EPA finds that any tolerances pose unreasonable risk, the Agency will take appropriate regulatory action to ensure protection of public health.

EPA is today revoking these nine tolerances on raw foods because it is otherwise impossible to guarantee that processed foods will be in compliance with the Delaney clause. While the overall economic impact on growers will be minor, some commodities and some growing regions may be more adversely affected than others.

Also today, EPA has concluded that it is not necessary to revoke 31 raw food tolerances because processed food tolerances are not needed to prevent the adulteration of processed food and therefore neither the Delaney clause nor EPA's coordination policy applies.

The following raw or feed tolerances will be retained: acephate on cottonseed, benomyl on citrus and rice, captan on grapes and tomatoes, carbaryl on pineapples, dicofol on tomatoes, diflubenzuron on soybeans, dimethipin on cottonseed, ethylene oxide on whole spices (direct treatment), iprodione on peanuts and rice and lindane on tomatoes. Also proposed for retention are mancozeb on barley, grapes and rye, maneb on grapes, methomyl on wheat, norflurazon on grapes, oxyfluorfen on cottonseed, peppermint, spearmint and soybeans, PCNB on tomatoes, permethrin on tomatoes, propargite on grapes and plums, thiodicarb on cottonseed and soybeans, and triadimefon on grapes and pineapple.

In a settlement agreement approved by the court in February l995, EPA agreed to make decisions by April, l997 concerning whether 81 raw food or animal feed tolerances should be revoked because use might lead to illegal residues in processed food or animal feed. Today's announcement covers EPA's decisions on 4l of those raw food or animal feed tolerances. (A tolerance for alachlor on sunflower seed was orginally included in the group of 41 tolerances, but registration for this use was voluntarily cancelled and the tolerance revoked.) EPA expects to issue proposed decisions on the remaining 40 by April l997.

Comments on today's proposed actions are due within 90 days after publication of the decisions in the Federal Register. The comments should be addressed to: Public Response Section, Field Operations Division, Office of Pesticide Programs, U.S. EPA, 40l M St. S.W., Washington, D.C. 20460.

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