Buckholtz N S, Panem S
Neurobehav Toxicol Teratol. 1986 Jan-Feb;8(1):89-96.
A number of policy and scientific issues are associated with the introduction of emerging or non-traditional scientific disciplines into the governmental regulatory apparatus. The present discussion derives from the issue of the extent of toxicological testing required for the evaluation of the health and safety aspects of pesticides and other compounds at the Environmental Protection Agency. The area of neurobehavioral toxicology is used as a case study for the introduction of a new biological endpoint into the regulatory arena. In that context, this paper addresses the following policy/regulatory issues: why expand the endpoints for toxicity testing from those currently in use; what is the current regulatory situation; what are the alternative means by which a new endpoint could be incorporated into the regulatory process; what would be the consequences of requiring examination of new endpoints? In the process of evaluating those issues, scientific issues involved with the selection of test systems are discussed. They include the selection of particular tests, the testing strategy, and the validity, reliability and sensitivity of the tests.
将新兴或非传统科学学科引入政府监管机构涉及诸多政策和科学问题。当前的讨论源于环境保护局对农药及其他化合物的健康与安全方面进行评估所需毒理学测试范围的问题。神经行为毒理学领域被用作一个案例研究，以探讨将一种新的生物学终点引入监管领域的情况。在此背景下，本文探讨以下政策/监管问题：为何要从当前使用的毒性测试终点进行扩展；当前的监管状况如何；将新终点纳入监管过程有哪些替代方法；要求对新终点进行检测会有哪些后果？在评估这些问题的过程中，还讨论了与测试系统选择相关的科学问题。这些问题包括特定测试的选择、测试策略以及测试的有效性、可靠性和敏感性。
