Environ Health Perspect. 1986 Aug;67:201-82. doi: 10.1289/ehp.67-1474412.
In order to articulate a view of chemical carcinogenesis that scientists generally hold in common today and to draw upon this understanding to compose guiding principles that can be used as a bases for the efforts of the regulatory agencies to establish guidelines for assessing carcinogenic risk to meet the specific requirements of the legislative acts they are charged to implement, the Office of Science and Technology Policy, Executive Office, the White House drew on the expertise of a number of regulatory agencies to elucidate present scientific views in critical areas of the major disciplines important to the process of risk assessment. The document is composed of two major sections, Principles and the State-of-the-Science. The latter consists of subsections on the mechanisms of carcinogenesis, short-term and long-term testing, and epidemiology, which are important components in the risk assessment step of hazard identification. These subsections are followed by one on exposure assessment, and a final section which includes analyses of dose-response (hazard) assessment and risk characterization. The principles are derived from considerations in each of the subsections. Because of present gaps in understanding, the principles contain judgmental (science policy) decisions on major unresolved issues as well as statements of what is generally accepted as fact. These judgments are basically assumptions which are responsible for much of the uncertainty in the process of risk assessment. There was an attempt to clearly distinguish policy and fact. The subsections of the State-of-the-Science portion provide the underlying support to the principles articulated, and to read the "Principles" section without a full appreciation of the State-of-the-Science section is to invite oversimplification and misinterpretation. Finally, suggestions are made for future research efforts which will improve the process of risk assessment.
为了阐明当今科学家普遍持有的化学致癌作用观点，并基于这一理解制定指导原则，作为监管机构努力制定评估致癌风险指南的依据，以满足他们负责实施的立法行为的具体要求，白宫行政办公室科学与技术政策办公室借鉴了多个监管机构的专业知识，以阐明对风险评估过程至关重要的主要学科关键领域的当前科学观点。该文件由两个主要部分组成，即“原则”和“科学现状”。后者包括关于致癌作用机制、短期和长期测试以及流行病学的子部分，这些是危害识别风险评估步骤中的重要组成部分。这些子部分之后是关于暴露评估的部分，以及最后一部分，其中包括剂量反应（危害）评估和风险特征分析。这些原则源自每个子部分的考虑因素。由于目前在理解上存在差距，这些原则包含了对重大未解决问题的判断性（科学政策）决策以及被普遍接受为事实的陈述。这些判断基本上是假设，它们是风险评估过程中许多不确定性的原因。人们试图明确区分政策和事实。“科学现状”部分的子部分为所阐述的原则提供了基础支持，若不充分理解“科学现状”部分就阅读“原则”部分，容易导致过度简化和误解。最后，针对未来研究工作提出了建议，这些研究将改进风险评估过程。
