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Executive Summary
Pages 1-16

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From page 1...
... Specifically, the EPA asked the board to examine the impact of the Delaney Clause on the tolerance-setting process. Although the Delaney Clause appears on its face to be a minor feature of the complex statutory scheme governing the regulation of pesticides and pesticide residues in food, its potential impact on the EPA's future decision making is great.
From page 2...
... The dichotomous statutory standards applicable to tolerance setting inspired this study. A pesticide regulated on a risk/benefit basis at the time of registration and in the setting of tolerances for residues in or on raw agricultural commodities becomes, solely because it concentrates in processed food, subject to the Delaney Clause's ostensible zero-risk standard.
From page 3...
... For perspective, it is worth noting that an additional dietary oncogenic risk of 1 in 1 million or 1 x 10-6 would raise this background risk of 0.25 to 0.250001. In developing the risk estimates contained in this report, the committee adopted what it understood to be the EPA's current methodology for quantitative risk assessment, recognizing that many key elements of the agency's risk assessment procedures are under review.
From page 4...
... Indeed, the regulation of pesticides involves a consideration of many health and environmental risks, only one of which involves residues of oncogenic pesticides in food. ESTIMATED ONCOGENIC RISK AND ITS DISTRIBUTION IN THE FOOD SUPPLY To characterize the universe of oncogenic pesticides, the committee adopted the list of 53 suspected oncogenic compounds that the EPA transmitted to Congressman Henry Waxman (D-Calif.)
From page 5...
... These figures lead to several observations: · At most, the Delaney Clause could apply to processed-food residues responsible for only one-fifth of the estimated dietary oncogenic risk from pesticides. However, its implementation could eliminate another 35 percent of the estimated risk from residues on the raw forms of these processed foods because it is the EPA's policy to deny section 408 raw food tolerances when section 409 tolerances cannot be established for the processed forms of the same crop.
From page 6...
... Results of the Scenarios Scenario 1 would revoke all tolerances for all oncogenic pesticides and eliminate all estimated dietary oncogenic risk.
From page 7...
... Scenario 3 would reduce total estimated risk from these 28 compounds by 98 percent, while revoking only 32 percent of all tolerances for the 28 oncogenic pesticides. Scenario 4 would eliminate just 35 percent of the estimated dietary oncogenic risk, while revoking the smallest percentage of all tolerances.
From page 8...
... Even a cursory analysis suggests that this and other new regulatory strategies warrant detailed study in terms of their potential to bring about significant reduction in dietary oncogenic risk while preserving beneficial fungicide uses. Cropwide tolerance reductions could reduce the total estimated dietary oncogenic risk from fungicides by up to 50 percent with only modest enforcement effort and minor adjustments in the agricultural sector.
From page 9...
... For many crops, especially fruits and vegetables, there are few equally effective technologic alternatives to chemical pest control. More important, as with synthetic chemical pesticides, R&D efforts in alternative technologies do not appear directed toward the pest problems most likely to be affected by Delaney Clause-driven tolerance revocations; breeding for disease resistance is an important exception.
From page 10...
... The important issue with these crops is whether pesticides currently vital to their production will remain available when the tolerances for oncogenic pesticides on other crops are revoked pursuant to the Delaney Clause. Certain minor crops with processed forms do present potentially significant risk, however.
From page 11...
... The second addresses the possible roles of other than zero oncogenic risk criteria in targeting regulation on pesticide uses that pose potentially significant human health hazards. The third involves the need for and structure of an overall strategy for the EPA as it moves ahead with the task of bringing all existing pesticide registrations and tolerances into compliance with the law, including the Delaney Clause.
From page 12...
... A Nonzero Standard for Oncogenic Risk A negligible risk standardfor carcinogens in food, applied consistently to all pesticides and to all forms offood, could dramatically reduce total dietary exposure to oncogenic pesticides with modest reduction of benefits. The committee believes that the elimination of oncogenic pesticide residues from human food is an appropriate aspiration of regulation.
From page 13...
... The committee's analysis highlights several advantages of a consistently applied negligible-risk standard over even strict adherence to the traditional zero-risk interpretation of the Delaney Clause, which applies a zero-risk standard only to processed foods and their parent raw commodities: · The committee found that, if consistently applied, a negligible-risk standard applied to raw and processed foods (assuming no consideration of benefits) could lead to the elimination of 98 percent of existing dietary risk from exposure to the 28 pesticides comprising the committee's estimate of dietary oncogenic risk.
From page 14...
... . This application of the Delaney Clause has had the effect of preserving the market share for, and continuous dietary exposure to, pesticides that present relatively greater dietary oncogenic risks.
From page 15...
... The recommended strategy would also help preserve the benefits of pesticide uses that pose very low, but possibly not zero, risks. For example, most suspect oncogenic pesticides used on corn, soybeans, and cotton present very low dietary oncogenic risks.
From page 16...
... In developing regulatory decisions, the EPA must take into account trade-offs between oncogenic risks and other sorts of health and environmental hazards among all pesticides registered for a particular use. Nonetheless, this more complicated task would be aided by the analytical tools discussed in this report.


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