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Proposed EPA/plaintiff agreement for carcinogens in food

EPA has reached a proposed agreement with plaintiffs in a lawsuit concerning pesticides and the Delaney clause. The agreement establishes a schedule for the Agency that will set policy that could lead to cancellation of the uses of 36 pesticides and will lead to further review of at least 49 others.

The state of California, the Natural Resources Defense Council and others sued EPA in l989 over the Agency's application of the Delaney clause of the Federal Food, Drug and Cosmetic Act. In certain circumstances this law prohibits residues of pesticides that "induce cancer" from being present in processed food.

"I am pleased that EPA has reached this proposed agreement, which continues the Clinton Administration's commitment to reduce pesticide use and ensure a safe food supply. The agreement, however, addresses only one complex part of the nation's system for safe pesticide management," said EPA Administrator Carol M. Browner. "The Administration believes the entire food safety program requires overhaul, and we have already begun implementing far-reaching administrative reforms and developed a package to reform current law. All of our actions and decisions are based on quality science designed to better protect the health of the American public.

"Among our initiatives, for example, are new pesticide safety testing procedures designed to be more protective of children, who may be more susceptible to pesticide risks. We are working with farmers to streamline the process for moving safer pesticides onto the market more quickly. And we are working to reduce the total use of pesticides nationally.

"Our actions and initiatives address not just cancer risks, but numerous other health risks, such as reproductive disorders. And our proposal affects not just processed foods, but all foods. This agreement assures that America will continue to enjoy the cheapest, most abundant and safest food supply in the world." The major terms of the agreement are:

• EPA would agree to rule on a l992 petition of the National Food Processors Association (NFPA) within 60 days from the court approval of the settlement agreement. NFPA petitioned EPA among other things to discontinue its policy that links processed food tolerances with raw food tolerances. Under the Agency's "coordination policy," if a processed food tolerance is needed but is prohibited under the Delaney clause, the corresponding raw food tolerance is not permitted. For example, prohibition of a tolerance on processed tomato puree would also prohibit a tolerance on raw tomatoes, because EPA cannot ensure that raw tomatoes bearing pesticide residues will not enter processing channels and result in residues over tolerance in downstream processed tomatoes. The proposed agreement does not dictate the decisions EPA will make on this or other issues raised in the NFPA petition, but does set a deadline for making these decisions.

• EPA would agree to decide within six months of the court's approval of the agreement, whether any of approximately 60 processed food tolerances (409s) (earlier identified by EPA as potentially violating the Delaney clause) violate the Delaney clause. Final decisions on revocations would be required within l8 months thereafter.

• EPA would agree to decide within 24 months of the court's approval of the agreement, which of the approximately 80 raw food tolerances that are associated with existing or needed processed food tolerances that may violate the Delaney clause are subject to revocation under EPA's coordination policy, as defined in EPA's response to the NFPA petition. Final decisions on any proposed raw food tolerance (408) revocations must be issued within five years of the agreement.

• EPA would agree to review within five years any carcinogenicity and processing studies already submitted to the Agency but not yet reviewed to determine if additional processed and raw food tolerances are subject to the Delaney clause and must be revoked. If processing data are lacking, EPA must take steps within one year to obtain such data.

The Delaney clause in section 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA) provides that no processed food tolerance may be approved for any chemical found to induce cancer in man or animals. Pesticides require processed food tolerances only where pesticide residues in the processed food either exceed the residues in the raw food or are added directly to the processed food. In l988 EPA adopted a policy interpreting the Delaney clause as subject to an exception for carcinogenic pesticides which pose only a negligible risk. EPA's action under the Delaney clause and its negligible risk policy was challenged in two similar but separate suits.

In the Les vs. Reilly suit, in July, l992, the plaintiffs successfully obtained a "zero risk" interpretation of the Delaney clause when the United States Court of Appeals for the Ninth Circuit rejected EPA's negligible risk approach to the Delaney clause.

In California vs. Browner, the subject of the proposed agreement released today, the parties sought a court order requiring EPA to revoke raw food tolerances (section 408) associated with processed food tolerances (section 409) which are barred by the Delaney clause.

According to the proposed settlement, 90 food uses of the following 36 carcinogenic pesticides may be phased out within two years:

acephate, alachlor, asulum, atrazine, benomyl, captan, carbaryl chlorothalonil, dichlorvos, dicofol, diflubenzuron, dimethipin dimethoate, ethylene oxide, hexazinone, iprodione, lindane, linuron, mancozeb, maneb, methidathion, methomyl, metiram, metolachlor, norflurazon, oxyfluorfen, PCNB, permethrin, phosmet, propargite, propylene oxide, simazine, tetrachlorvinphos, thiophanate methyl, triadimefon, trifluralin.

The proposed agreement between EPA and the California vs. Browner plaintiffs has been given to the intervenors in the case (American Crop Protection Association and the National Food Processors Association and various grower organizations) for comment and will be submitted to the Court on Dec. 2 for approval.

Obtain copies of the agreement by calling the EPA Communication Branch in the Office of Pesticide Programs, 703-305-5017).

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