Tolerance setting process in the U.S. Environmental Protection Agency.

The U.S. Environmental Protection Agency (EPA) is responsible for setting tolerances for pesticide residues in food, under the authority of the Federal Food, Drug, and Cosmetic Act. The residue chemistry data required to set tolerances include metabolism in plants and animals, analytical methods, magnitude of the residue, and concentration in processed foods. A key aspect of tolerance-setting procedures is the identity of the residue in the matrix of concern; without knowledge of the chemical moieties that occur as residues, it is impossible to develop suitable methods or generate meaningful residue data. For new chemicals, EPA carries out a single-laboratory validation of the analytical method needed to generate residue data and to enforce tolerances. Tolerance enforcement methods need to be rapid and inexpensive and to use commercially available equipment and reagents. Methods are more complex for many newer pesticides, which are polar compounds that leave low levels of residue. EPA now requires that the registrants of older pesticides, for which methods are not acceptable by today's standards, must develop better methods.

Regulatory perspective of pesticide analytical enforcement methodology in the United States.

A critical overview is presented of the current regulatory problems encountered by the U.S. Environmental Protection Agency in evaluating the adequacy of pesticide analytical enforcement methodologies submitted in support of proposed pesticide tolerances. One of these problems is the development and validation of appropriate, adequate enforcement analytical methods which account for all free or bound/conjugated residue components of the "total toxic residue" in the commodities of concern. Also included is a detailed discussion of suggested improvements in the development and validation of these enforcement methods, for example, integrating radiolabeled metabolism studies with the subsequent development and validation of proposed analytical enforcement methodologies. New procedures are proposed to facilitate the availability of analytical methods to enforcement agencies and other organizations during the method validation process. Future initiatives to use the collaborative study process in the development and validation of Pesticide Analytical Manual, Volume 2, enforcement methods for contemporary pesticides are also discussed.