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美国环境保护局的公差设定程序。

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

作者信息

Trichilo C L, Schmitt R D

机构信息

U.S. Environmental Protection Agency, Residue Chemistry Branch, Washington, DC 20460.

出版信息

J Assoc Off Anal Chem. 1989 May-Jun;72(3):536-8.

PMID:2745386
Abstract

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.

摘要

美国环境保护局(EPA)负责依据《联邦食品、药品和化妆品法案》的授权设定食品中农药残留的耐受量。设定耐受量所需的残留化学数据包括在植物和动物体内的代谢情况、分析方法、残留量以及加工食品中的浓度。耐受量设定程序的一个关键方面是相关基质中残留的特性;如果不知道作为残留出现的化学部分,就不可能开发出合适的方法或生成有意义的残留数据。对于新化学品,EPA会对生成残留数据和执行耐受量所需的分析方法进行单实验室验证。耐受量执行方法需要快速且成本低廉,并使用商用设备和试剂。对于许多较新的农药来说,方法更为复杂,因为这些农药是极性化合物,残留量较低。EPA现在要求那些其方法不符合当今标准的旧农药的注册者必须开发出更好的方法。

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