1947, section 136bb(1)). Since 1996, EPA has been required to apply a safety-only standard when examining the potential dietary risks that may be posed by residues of a pesticide that might be found in food (US Congress 1947, section 136bb(2)). Registration is conditioned on the submission and review of test data regarding the health and ecological effects of the pesticidal substance.

Section 408 of the Federal Food, Drug, and Cosmetic Act

Any substance deemed to be a pesticide under FIFRA is automatically subject to regulation under FFDCA section 408 if used on a food or feed crop or if residues of it are otherwise expected to occur on food or feed (US Congress 1958). EPA's jurisdiction under FFDCA applies even if the pesticide has been exempted from regulation under FIFRA. Section 408 provides authority for EPA to issue regulations that permit pesticide residues in or on food. Maximum permissible residue levels for pesticides are referred to as tolerances and are set by rule for raw agricultural commodities and for processed food and animal feed under the same “reasonable certainty of no harm” standard that FDA applies to food additives under section 409 of FFDCA. Section 408 also authorizes EPA to issue exemptions from the requirement of a tolerance where a pesticide poses no toxicological concerns and/or dietary exposure is negligible. By definition, a pesticide cannot be a food additive.

Additional data related to dietary exposure must be submitted to EPA to support issuance of a tolerance in conjunction with the registration of a food-use pesticide. As with unapproved food additives, in the absence of a duly promulgated tolerance or exemption, or if a residue level exceeds the tolerance, the food is deemed to be adulterated and subject to enforcement action under section 402 of the FFDCA (US Congress 1958, section 342(a)). Although EPA is responsible for setting pesticide tolerances, foods are subject to inspection and enforcement action by FDA.

4.2 EVALUATION OF THE ENVIRONMENTAL PROTECTION AGENCY'S REGULATION OF PESTICIDAL SUBSTANCES IN PLANTS UNDER THE 1994 PROPOSED RULE

In 1994, after a long review of regulatory options and having gained valuable experience in the evaluation of proposals for field tests of several transgenic pest-protected plants, EPA announced its intention to regulate the pesticidal substances produced in such plants, but not the plants themselves, under the provisions of FIFRA and FFDCA (EPA 1994a, c). The committee found that



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