HTML _ 92-800 - The Delaney Clause: The Dilemma of Regulating Health Risk for Pesticide Residues
9-Nov-1992; Donna U. Vogt; 28 p.

Abstract: Under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA), the Environmental Protection Agency (EPA) is responsible for establishing tolerances for pesticide residues in or on foods and feeds. Tolerances are legal limits to the amount of pesticide residues that can be found on a raw agricultural commodity at the farm gate or in a processed food. The FFDCA has two sections, 408 and 409, which set up different and inconsistent criteria for setting tolerances for pesticide residues in foods. Section 408, which applies to raw agricultural commodities, mandates a cost-benefit approach that balances the risks associated with the use of a pesticide against the benefits of using it in the food supply. Section 409, which applies only to processed foods, includes the Delaney Clause that prohibits a food additive, including pesticides, found to induce cancer in humans or animals. The Delaney Clause requires EPA to consider only a pesticide's risk and not to consider any offsetting benefits. It mandates a ¨zero risk¨ standard, implying that no food additive is likely to offer benefits sufficient to outweigh any risk of cancer. In practice, EPA decided to regulate all pesticide residues using criteria known as ¨negligible risk¨ (used synonymously with the term de minimis) and ignore the criteria for setting tolerances in section 409 which requires ¨zero risk.¨ EPA followed this policy in large part because negligible risk allows for residues that have a lifetime cancer risk of one in one million whereas the ¨zero risk¨ criteria creates severe problems from both a scientific and public health standpoint. EPA's negligible risk policy explicitly accepts small health risks in return for certain benefits. However, this policy was challenged in the courts and in July 1992 was overturned. EPA assesses the dietary risk of pesticide residues by comparing the level of residues that are found on raw agricultural commodities and processed foods with health effect data to see if this level is acceptable. These assessments require certain types of data: residue chemistry data, dietary exposure data, and toxicological data. The proposals and debates over food safety in the 102nd Congress focused on four issues. First, several Members felt that there should be no change in the Delaney Clause. Second, all the bills proposed that section 408 be used to set tolerances for all pesticide residues and that ¨negligible risk¨ to be used as the standard for acceptable risk. However, negligible risk was defined differently under the various proposals. A third approach would have changed the manner in which risk is used for establishing tolerances. Under this approach, EPA would use data on the actual residues left on food to assess risks rather than estimating the risks from laboratory tests. A fourth approach would promote a recent EPA initiative known as the Safer Pesticide Policy. [read report]

Topics: Pesticides

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