Rosenthal I, Jayjock M A, Keener R L, Plamondon J E
Safety Health and Environmental Affairs Department, Rohm and Haas Company, Bristol, PA.
Qual Assur. 1991 Oct;1(1):10-30.
The Toxic Substances Control Act (TSCA) authorizes the EPA to take appropriate actions to ensure that new and existing chemicals do not pose "unreasonable risk" to health or the environment. Section 2(b)(3) of the Act directs the Agency to accomplish this objective in a manner that does "not impede unduly or create unnecessary economic barriers to technological innovation." In recent years, critics have felt that the EPA has failed to achieve these primary goals of TSCA. This paper considers some of the reasons for this criticism and advocates an alternate approach of exposure limits and operationally sufficient controls to assist in achieving these goals. An illustration of how this alternate approach might work under practical conditions is presented, using as an example a new chemical substance from the class of acrylate monomers. These concepts and risk assessments provide data for a better design of future studies according to good laboratory practice and quality assurance.
《有毒物质控制法》（TSCA）授权美国环境保护局（EPA）采取适当行动，以确保新的和现有的化学物质不会对健康或环境构成“不合理风险”。该法案第2(b)(3)条指示该机构以“不会过度阻碍或对技术创新造成不必要经济障碍”的方式实现这一目标。近年来，批评者认为EPA未能实现TSCA的这些主要目标。本文探讨了产生这种批评的一些原因，并倡导采用暴露限值和操作上足够的控制措施的替代方法，以协助实现这些目标。文中以丙烯酸酯单体类中的一种新化学物质为例，展示了这种替代方法在实际条件下可能如何发挥作用。这些概念和风险评估为根据良好实验室规范和质量保证更好地设计未来研究提供了数据。
