Fenner-Crisp P A
US Environmental Protection Agency, Washington, D.C., USA.
Exp Toxicol Pathol. 1996 Feb;48(2-3):199-200. doi: 10.1016/S0940-2993(96)80044-3.
The U.S. Environmental Protection Agency serves as the lead agency of the Federal government for the regulation of pesticide use in the United States. Regulatory responsibilities are mandated in the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) and several sections of the Federal Food Drug and Cosmetic Act (FFDCA). In order for a pesticide to be used in the U.S., it must either be granted a full registration under Section 3, or offered special consideration under Section 18 or 24 of FIFRA. Tolerances (maximum allowable residue limits) for pesticides to be used on agricultural commodities meant for human consumption or animal feed are established under Sections 408 and/or 409 of FFDCA. This presentation will describe the underlying conflict between Section 409 of FFDCA and both Section 408 and FIFRA, the recommendations made by the National Academy of Sciences in its 1987 publication Regulating Pesticides in Food--The Delaney Paradox, EPA's attempts to implement these recommendations, the true impact of "Delaney" on the ability of EPA to grant tolerances on raw or processed foods for chemicals determined to meet the "induce cancer" criterion and the status of legislation designed to "fix" Delaney.
美国环境保护局是联邦政府中负责监管美国农药使用的牵头机构。监管职责由《联邦杀虫剂、杀菌剂和灭鼠剂法》（FIFRA）以及《联邦食品、药品和化妆品法》（FFDCA）的多个章节规定。一种农药若要在美国使用，必须要么依据第3条获得全面注册，要么根据FIFRA的第18条或第24条获得特殊考虑。用于供人类食用或动物饲料的农产品上的农药的 Tolerances（最大允许残留限量）是根据FFDCA的第408条和/或第409条确定的。本报告将描述FFDCA第409条与第408条和FIFRA之间的潜在冲突、美国国家科学院在其1987年出版的《食品中农药监管——德莱尼悖论》中提出的建议、美国环境保护局实施这些建议的尝试、“德莱尼条款”对美国环境保护局批准被认定符合“诱发癌症”标准的化学物质在生的或加工食品上的 Tolerances 能力的实际影响，以及旨在“修正”德莱尼条款的立法现状。
