Calkins D R, Dixon R L, Gerber C R, Zarin D, Omenn G S
J Natl Cancer Inst. 1980 Jan;64(1):169-76.
A two-stage process is proposed for a uniform framework for Federal agency decisions regarding the identification, characterization, and control of potential human carcinogens. Stage I would include the identification, through epidemiologic and/or laboratory studies, of chemicals that represent a potential carcinogenic risk and the characterization of that risk. Stage II would encompass the actual regulatory decision-making process regarding control of potential carcinogens. Stage I relies predominantly on scientific activity and judgment. Centralized management could enhance the efficiency and effectiveness of this process. The new National Toxicology Program may be able to perform this function. Stage II judgments are social and political. Centralization of stage II decision-making is not possible under current law.
针对联邦机构就潜在人类致癌物的识别、特征描述及控制做出决策,提出了一个分两阶段进行的统一框架。第一阶段将包括通过流行病学和/或实验室研究,识别出存在潜在致癌风险的化学物质,并对该风险进行特征描述。第二阶段将涵盖有关控制潜在致癌物的实际监管决策过程。第一阶段主要依赖科学活动和判断。集中管理可以提高这一过程的效率和成效。新的国家毒理学计划或许能够履行这一职能。第二阶段的判断具有社会性和政治性。根据现行法律,第二阶段决策无法实现集中化。