Environmental Health Sciences, Center for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland 21205, USA.
J Toxicol Environ Health B Crit Rev. 2010 Feb;13(2-4):277-90. doi: 10.1080/10937404.2010.483945.
Europe and the United States further the development of new toxicological tools in different ways. While the replacement of animal tests has been promoted strongly in Europe over the last decades (following the 3Rs principles--reduce, replace, refine), in the United States the vision for a toxicology in the 21st century (Tox-21c), which was prompted by the National Research Council document only 3 years ago, dominates the discussion. In both cases, there is significant political support. However, while in Europe the horizontal animal welfare legislation from 1986 (which urges the use of 3Rs methods wherever possible) currently under revision and cosmetics and chemical legislation are the primary drivers, in the United States it is mainly federal agencies, most prominently the U.S. Environmental Protection Agency (EPA), that made the implementation of the NRC report their toxicity testing strategy only in 2009. This preempts such likely legislative measures as the reauthorization of the Toxic Substances Control Act (TSCA) in the United States. The European implementation is characterized by substantial broad funding programs to develop 3Rs methods and can be termed a "bottom-up" approach; in contrast, the Tox-21 program represents a "top-down" approach, where programmed research is carried out and commissioned. It is postulated that the two approaches are two sides of the same coin, and instruct and complement each other. However, more importantly, if brought together they can result in a Human Toxicology Project and a real revolution in regulatory toxicology.
欧洲和美国以不同的方式推动新毒理学工具的发展。在过去几十年中，欧洲一直在大力推动动物试验的替代（遵循 3R 原则——减少、替代、优化），而在美国，21 世纪毒理学的愿景（Tox-21c）主导着讨论，这一愿景是由美国国家研究委员会在仅仅 3 年前的一份文件所引发的。在这两种情况下，都有重大的政治支持。然而，在欧洲，1986 年出台的横向动物福利立法（敦促尽可能使用 3R 方法）正在修订之中，化妆品和化学立法是主要的推动力；而在美国，主要是联邦机构，尤其是美国环境保护署（EPA），在 2009 年才将 NRC 报告的实施作为其毒性测试策略。这先于美国《有毒物质控制法》（TSCA）的重新授权等可能的立法措施。欧洲的实施特点是有大量广泛的资金计划来开发 3R 方法，可以称之为“自下而上”的方法；相比之下，Tox-21 计划代表了一种“自上而下”的方法，其中进行和委托了有计划的研究。有人假设，这两种方法是同一枚硬币的两面，相互指导和补充。然而，更重要的是，如果将它们结合起来，它们可以促成一个人类毒理学计划和监管毒理学的真正革命。
