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2. The Current System: Theory and Practice
Pages 23-44

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From page 23...
... Act. Tolerances authorize and place legal limits on the presence of pesticide residues in or on raw agricultural commodities and, in appropriate cases, processed foods.
From page 24...
... Label specifications are generally designed to avoid adverse effects on the environment or on adjacent or future crops, to ensure efficacy, and to minimize applicator exposure. TOLERANCE SETTING UNDER THE FDC ACT Pesticides that are to be registered for use on food crops must have been granted tolerances covering expected residues of the pesticide in raw and processed foods.
From page 25...
... By necessary implication, however, pesticide residues in processed foods remain food additives and thus subject to the premarket approval requirement of section 409.7 The FDA has primary responsibility for implementing section 409, but the EPA has
From page 26...
... Unsafe food additives, as well as the foodstuffs containing them, are adulterated and subject to the same enforcement procedures and penalties applicable to raw agricultural commodities. If Congress had stopped here, pesticide residues in raw commodities and those in processed foods would be subject to different standards, but the distinction would be clear.
From page 27...
... To expose them, the committee first summarizes the procedural and analytical steps the EPA follows in setting tolerances under sections 408 and 409 and describes the universe of tolerances promulgated to date. Then the committee examines more fully the significance of discovering that pesticide residues concentrate in processed food.
From page 28...
... that may in some cases be rea~izecl. A section 409 tolerance must reflect the possible residue levels in processed foods derived from that raw commodity.
From page 29...
... Key elements of the data package include a description of the chemistry of the pesticide itself; identity and quantity of residues expected to be present in food; analytical procedures used in obtaining the residue data, which must be complete enough to permit replication by a competent analyst; residues in animal feed derived from crop by-products or from forages and resulting residues, if any, in meat, milk, poultry, fish, and eggs; and toxicity tests on the parent compound and any major impurities, degradation products, or metabolites. The gathering and interpretation of residue chemistry data are some of the most difficult technical challenges that the registrant and the EPA face.
From page 30...
... It is unclear to the committee how significant this difference is in actual practice. It seems likely, though, that there are more oncogenic pesticides than carcinogenic ones; chronic feeding studies will sometimes reveal oncogenicity even when a pesticide's capacity to cause malignant tumors is uncertain.
From page 31...
... TOLERANCE SETTING FOR NON-ONCOGENIC PESTICIDES UNDER SECTION 408 The core of the typical tolerance-setting process under section 408 is the effort by the EPA to compare the quantity of residues to which humans might be exposed through consumption of pesticide-treated food with the level it judges, based on the available toxicological data, as safe. If the EPA finds that the pesticide (or its expected impurities, metabolites, and degradation products)
From page 32...
... pesticide residues are present at the full tolerance level in every food consumed. Together these assumptions generally exaggerate estimates of dietary exposure to residues.
From page 33...
... To compensate for such gaps in knowledge, the EPA and other agencies that use quantitative risk assessment typically adopt conservative assumptions that are designed to avoid understating the potential human risk. For example, results from the most sensitive animal species are used in extrapolating from high doses to low doses, mathematical models are selected that are thought to avoid understating
From page 34...
... Decisions to approve tolerances carrying an upper-bound risk between 1 in 1 million and 1 in 10,000 are generally, but not always, made after taking steps to reduce dietary exposure and confirming that risks from other routes of exposure are also small. In reaching decisions on dietary risks that fall between 1 x 10-4 and 1 x 10-6, the EPA enlarges its inquiry.
From page 35...
... In these cases, a food additive tolerance is not required; the raw agricultural commodity tolerance suffices. If the oncogenic pesticide concentrates in the processed food, the EPA automatically denies a tolerance without further analysis.
From page 36...
... The agency also requests a wider range of data in their registration standards program. The toxicity and residue chemistry data generated by these programs in the future will substantially enlarge the number of pesticides that, under current law and policy, seem to require section 409 tolerances and thus could be affected by the Delaney Clause.
From page 37...
... Residue chemistry data, required to elicit information to assess dietary exposure to pesticide residues in raw and processed foods, will reveal many concentrating residues for which no 409 tolerances are now approved. THE DELANEY CLAUSE CLOSER EXAMINATION The foregoing discussion explains the role that the Delaney Clause plays in pesticide tolerance setting and suggests why the provision will loom larger in future EPA decisions.
From page 38...
... Increased and more sensitive chronic toxicity testing and advances in analytical methods identified many more natural and man-made carcinogens in human food. Many of these were residual reactants, trace constituents of direct food additives, or components of packaging materials that migrated into food in minute amounts.
From page 39...
... Two of thesethe constituents policy and the de minimis interpretation deserve discussion here. The constituents policy rests on an interpretation of the phrase "no additive shall be deemed to be safe if it is found to induce cancer...." The FDA now interprets the term "additive" to refer to the added substance as a whole and not to each of its individual constituents.
From page 40...
... One is exemplified by the dichotomous risk standards in sections 408 and 409. From the outset of its deliberations, the committee has been unable to identify any sound scientific or policy reason for regulating pesticides present in or on raw commodities differently than those present on processed foods.
From page 41...
... If older pesticides are judged to not pose a public health problem, then contemporary requirements restricting new, less oncogenic pesticides may be overly protective and may impede introduction of useful new pesticides. The Issue of Concentration in Processed Foods Another major problem derives from the current law's emphasis on whether a pesticide residue concentrates in processed food.
From page 42...
... The criteria that the EPA uses to define processed foods and feeds are in a nonregulatory companion to 40 CFR 158, Subpart K, entitled "Pesticide Assessment Guidelines Subdivision 0: Residue Chemistry." These criteria are guidelines, not regulations. Yet, they represent the EPA's current thinking on processed versus raw foods and feeds.
From page 43...
... The agency's inability under current law and policy to register a new, weakly oncogenic substitute chemical when residues concentrate in processed food exaggerates the perceived benefits of the older products. Registrations and tolerances may be denied even though EPA scientists are convinced that the new chemical would pose less risk and provide essentially equal food-production benefits.
From page 44...
... 44 REGULATING PESTICIDES IN FOOD 19. In August 1986 the FDA applied the de minimis interpretation to approve two color additives, D&C Orange No.


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