Genetic Susceptibility and Environmental Regulation

描述(由申请人提供)：这项拟议研究计划的目标是评估将遗传易感性数据应用于环境监管的法律、伦理和政策影响。近年来产生的大量数据表明，每个人对环境毒物的易感性有很大不同。虽然一些研究探讨了遗传研究对环境易感性的法律和伦理影响，或在风险评估中使用这种数据，但很少有工作研究遗传易感性数据如何--在某些情况下必须--在美国现有的环境法框架内适用。存在大量的法规、法规、指导性文件、司法裁决和其他法律材料，它们将在很大程度上管理如何将遗传易感性数据纳入环境监管决定。尽管这些不同的法律材料大多是在没有具体承认遗传易感性差异的情况下编写的，但它们仍然为纳入关于遗传易感性的新数据提供了相关的法律框架。例如，根据《清洁空气法》颁布的国家环境空气质量标准必须设定在保护最易受影响的人群的水平，并且有大量相关的规则制定先例、司法裁决和立法历史，这些将决定遗传信息在这种法定条款下的适当作用。该项目将评估遗传易感性数据如何能够或在某些情况下必须纳入现有的管理框架和先例。它将确定现有法律规定下遗传易感性数据应用方面的法律、伦理和科学问题和挑战，并建议将基因组信息纳入环境监管决策的标准和指南。它还将评估现有法律框架的潜在改进和替代办法，以更好地容纳遗传信息，包括更多地依赖个性化自助或有针对性的措施，如增加检测、警告和避免措施。该项目将由三名主要研究人员组成，他们在环境管理以及与遗传学有关的法律和伦理问题方面都有丰富的经验和背景。

DESCRIPTION (provided by applicant): The objective of this proposed research program is to evaluate the legal, ethical and policy implications of the application of genetic susceptibility data to environmental regulation. An enormous amount of data has been generated in recent years showing that individuals differ substantially in their susceptibility to environmental toxicants. While some research has addressed the legal and ethical implications of genetic research on environmental susceptibility or the use of such data in risk assessment, little if any work has examined how genetic susceptibility data could, and in some cases must, be applied within the existing environmental law framework in the United States. An extensive body of statutes, regulations, guidance documents, judicial decisions, and other legal materials exist that will largely govern how genetic susceptibility data will be incorporated into environmental regulatory decisions. Although most of these various legal materials were developed without specific recognition of the differences in genetic susceptibility, they nevertheless provide the relevant legal framework for the incorporation of new data on genetic susceptibility. For example, national ambient air quality standards promulgated under the Clean Air Act must be set at a level which protects the most susceptible subpopulations, and there is a large body of relevant rulemaking precedents, judicial decisions, and legislative history that will determine the appropriate role of genetic information under such a statutory provision. This project will evaluate how genetic susceptibility data can or in some cases must be incorporated under the existing regulatory framework and precedents. It will identify legal, ethical and scientific issues and challenges in the application of genetic susceptibility data under existing legal provisions, and recommend criteria and guidelines for incorporating genomic information into environmental regulatory decision making. It will also evaluate potential improvements and alternatives to the existing legal framework to better accommodate genetic information, including greater reliance on individualized self-help or targeted measures, such as increased testing, warning and avoidance measures. This project will be undertaken by a consortium of three principal researchers with extensive experience and backgrounds in both environmental regulation and legal and ethical issues relating to genetics.