Bates R R
IARC Sci Publ (1971). 1979(25):93-9.
The four components of the process by which a decision is made about the acceptability of human exposure to a chemical are outlined. The quantity and quality of the data that are required have increased considerably in recent years, and the standards governing the conduct of the studies done to obtain them have become more stringent. Thus, many chemicals now in widespread use were admitted on the basis of evidence that is now considered woefully inadequate; the steps being taken in the US to remedy this situation are described. Since such testing is long and expensive, four regulatory agencies have joined together to develop guidelines that can be used by each. The interpretation of data presents yet another problem. Further, what constitutes adequate evidence for safety is a matter subject to wide ranges of opinion: this is illustrated by the example of cyclamate. The difficulties of extrapolating results to actual situations are outlined; and the limitations of the usefulness of experimental testing are pointed out. Determination of an acceptable ratio between benefits and risks depends on a wide variety of factors, and regulatory decisions in this regard thus depend on several kinds of scientific judgements and on policy decisions based on cultural aspects.
本文概述了对人类接触化学物质的可接受性做出决策的过程中的四个组成部分。近年来，所需数据的数量和质量大幅增加，用于获取这些数据的研究开展标准也变得更加严格。因此，许多目前广泛使用的化学物质当初是基于如今被认为严重不足的证据而被批准使用的；文中描述了美国为纠正这种情况正在采取的措施。由于此类测试耗时且昂贵，四个监管机构联合起来制定了可供各方使用的指导方针。数据的解释又带来了另一个问题。此外，什么构成充分的安全证据是一个存在广泛意见分歧的问题：甜蜜素的例子说明了这一点。文中概述了将结果外推至实际情况的困难；并指出了实验测试有用性的局限性。确定可接受的利益与风险之比取决于多种因素，因此在这方面的监管决策取决于几种科学判断以及基于文化层面的政策决策。
