Wagner P M, Nabholz J V, Kent R J
US Environmental Protection Agency, Office of Pollution Prevention and Toxic Health, Washington, DC 20460, USA.
Toxicol Lett. 1995 Sep;79(1-3):67-73. doi: 10.1016/0378-4274(95)03358-r.
Section 5 of the Toxic Substances Control Act (TSCA) does not require any toxicity testing as a prerequisite for submission of a Premanufacturing Notice (PMN) for a new chemical. In order to compensate for the lack of actual test data, a process involving structure-activity relationships (SAR) for assessing hazard potential was constructed. The hazard assessment is then coupled with an estimation of potential exposure to determine potential risk. This process involves the use of multiple interdisciplinary teams that work within a 90-day time frame to complete approximately 2000 risk assessments per year.
《有毒物质控制法》(TSCA)第5节并不要求将任何毒性测试作为提交新化学品生产前通知(PMN)的先决条件。为了弥补实际测试数据的不足,构建了一个涉及结构-活性关系(SAR)以评估潜在危害的流程。然后将危害评估与潜在暴露估计相结合,以确定潜在风险。这个过程需要多个跨学科团队在90天的时间框架内开展工作,每年完成约2000次风险评估。