Regens J L, Dietz T M, Rycroft R W
Public Adm Rev. 1983 Mar-Apr;43(2):137-45.
This article examines the extent to which differences exist in the relative degree of discretion permitted by the statutory mandates under which health risk assessments are conducted as a basis for regulatory action. Attention is focused on the Environmental Protection Agency and the Food and Drug Administration, because they are the lead federal regulatory agencies on most environmental health matters. The statutes are found to define risk, consider effects, identify target populations, and use benefit-cost analysis in a flexible way. But the burden of proof of risk typically is assigned in a more direct and stringent fashion. Overall, however, agencies are found to have substantial discretion in the manner in which risk assessments are incorporated into the policy process. A number of examples of efforts to reduce this flexibility are outlined and their implications for the future of the analysis of risks are delineated.
本文探讨了在作为监管行动依据而进行健康风险评估时，法定要求所允许的相对自由裁量程度存在何种差异。重点关注环境保护局和食品药品管理局，因为它们是联邦层面在大多数环境卫生事务上的主要监管机构。研究发现，这些法规以灵活的方式界定风险、考虑影响、确定目标人群并运用效益成本分析。但通常以更直接和严格的方式分配风险举证责任。然而总体而言，各机构在将风险评估纳入政策过程的方式上具有很大的自由裁量权。文中概述了一些旨在减少这种灵活性的举措示例，并阐述了它们对未来风险分析的影响。
