Tolerance Revocation Policy 6/95

Tolerance Revocation Policy 6/95

Tolerance Revocation Policy 6/95

For Release: Friday, June 9, 1995

EPA Adopts Policies Governing Tolerance Revocation Actions Under Delaney Clause

The U.S. Environmental Protection Agency is adopting policies for determining which pesticide residues are covered by the Delaney clause which prohibits establishment of tolerances for residues of carcinogens in processed food and animal feed. These policies will define when concentration of pesticide residues occur in processed food and whether a particular processed food is considered "ready to eat." The modifications are a response to a l992 Delaney clause-related petition of the National Food Processors Association (NFPA) and others which challenged some of the Agency's policies regarding pesticide residues in food. EPA was required by a court-approved settlement agreement to respond to the NFPA petition by today. Today's new policies are consistent with the laws governing pesticide residues in food and will serve to clarify EPA's decision-making criteria for industry and the general public.

The NFPA petition asked EPA to address an additional issue, the so-called coordination policy by which EPA decides how tolerances for fresh fruit and vegetables (section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA)) are affected by revoking tolerances for processed foods (section 409 of FFDCA). The EPA has asked the parties to the settlement to approve a modification of the settlement agreement to postpone issuance of the coordination policy, and any subsequent revocations of section 408 tolerances (raw food) for about six months. This additional time will allow EPA to work out enforcement and other issues with the Food and Drug Administration and the U.S. Department of Agriculture which may be affected by the action taken today.

The NFPA petition followed closely a decision by the Ninth Circuit Court of Appeals (July, l992, Les vs Reilly), which held EPA to a literal interpretation of the Delaney clause and rejected the Agency's negligible risk policy to address pesticides which may be affected by the Delaney clause. The court said that the Delaney clause prohibits the establishment of a tolerance or legal residue level in processed foods for pesticides that induce cancer in humans or animals, even if the risks are negligible.

The action taken today does not immediately impact any specific pesticides or crops. However, EPA will be using these policies as it makes decisions to establish or reassess individual pesticide tolerances. In particular, the Agency will be using these and possibly other policies to guide its decisions as it implements the February l995 court-approved settlement agreement between the Agency and the Natural Resources Defense Council and others concerning pesticides that may be affected by the Delaney clause. This agreement set timetables for decisions on whether or not to revoke certain tolerances of approximately 37 pesticides. As the Agency makes these decisions, EPA will carefully consider any information relevant to the application of these policies to individual pesticides and crops.

Pesticides are regulated by EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The regulation of allowable residue levels in food is under FFDCA. The Agency sets tolerances for pesticide residues remaining on raw food under section 408 of FFDCA. In some circumstances, pesticides also need tolerances under section 409 of FFDCA. Section 409 contains the Delaney clause which prohibits the establishment of tolerances for residues of carcinogens in processed food and animal feed. Tolerances for processed food are necessary to prevent food from being deemed adulterated when the concentration of the pesticide residue in a processed food, when ready to eat, is greater than the tolerance prescribed for the raw agricultural commodity, or if the processed food itself is treated or comes into contact with a pesticide.

The NFPA petition asked EPA to establish policies for three specific areas of the tolerance-setting program: when concentration of pesticide residues occur in processed food; when a food is ready to eat; and how to coordinate regulatory action between the two sections of FFDCA, 408 (governing tolerances on raw food) and 409 (governing tolerances on processed food).

EPA will pursue a steady implementation of the Court's interpretation of the Delaney clause on a specific timetable as outlined in the agreement with NRDC, including revocation of existing tolerances that violate the Delaney clause and denial of tolerances for new uses that would be in violation of Delaney.

CONCENTRATION POLICY

In the past, EPA has found that a food additive tolerance (section 409) is necessary whenever a pesticide concentrates in the processed food (i.e., the levels in parts per million are greater in the processed food than in the raw food). NFPA raised a number of concerns with the Agency's traditional approach to determining whether concentration occurs. EPA has concluded that modifications can be made to its policy to ensure better predictions of concentration. Information from processing studies will remain the most important information in determining whether concentration occurs. However, departing from past practice, EPA will also take into account information concerning mixing and blending of crops information pertaining to average residues.

READY TO EAT POLICY

As mentioned above, under FFDCA a tolerance for pesticide residues in processed food is only needed under the FFDCA when residues in ready-to-eat processed food exceed the raw food tolerance. The NFPA petition argues that EPA has issued food additive tolerances for foods that were not ready to eat. EPA has concluded that its past interpretation of ready to eat has sometimes been too rigidly applied and modifications can be made so that food should be considered "ready to eat" if it can be consumed "as is" without further preparation. For example, potato chips are ready to eat and mint oil is not ready to eat. In light of these more consistent interpretations, in some cases EPA may revoke the processed food tolerances (section 409) for those foods and feeds that are considered not ready to eat and put in place different regulations so that residues in such foods can be legally distributed and their residues appropriately monitored. Similarly, EPA intends to apply the "ready to eat" policy to animal feeds.

COORDINATION POLICY

The Agency is not today responding to the coordination policy issue. Under this policy, if a processed food tolerance cannot be established or maintained, then the Agency would also deny or revoke the raw food tolerance and deny or cancel the registration of the pesticide. For example, if a carcinogenic pesticide, legally used on apples under the risk/benefit provisions of FIFRA, would concentrate in apple juice (thus requiring a food additive tolerance under section 409), under the Delaney clause EPA would be required to revoke the food additive tolerance and would revoke the corresponding raw food tolerance as well. The reason for this approach to coordination has been simple: farmers who properly treat their crops with approved pesticides should be able to confidently market their products without risk of condemnation and seizure by the Food and Drug Administration, which monitors food.

NFPA asked EPA to reverse this policy, arguing that growers and food processors could assure that residues in processed foods would not exceed residues in raw commodities.

ECONOMIC IMPACT ASSESSMENT

Under the new policies announced today, a number of pesticide uses are likely to continue to need section 409 tolerances. Thus, the Delaney clause may result in some pesticide uses being barred. Prior to these policy modifications, EPA had prepared a worst-case economic impact assessment that assumed all potentially-affected pesticide uses would be barred. The worst-case assessment estimated impacts of up to $500 million on agricultural producers and processors.

Given the changes announced today, EPA believes that this worst-case economic assessment overestimates potential impacts because the universe of potentially affected tolerances will be changed. The Agency will be better able to judge impacts as it applies these revised policies to the decisions on food additive tolerances now scheduled for later this summer. EPA expects to factor the results of these decisions made today into the decisions on the coordination policy.

EPA's response is expected to be published in the Federal Register within the next 10 days. Reporters can obtain a copy by calling Al Heier at EPA's Press Office (202-260-4374). Others can obtain copies by calling the Office of Pesticide Communications: 703-305-5017.

U.S. EPA Press Releases

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