Genetic Susceptibility and Environmental Regulation

描述（由申请人提供）：这个拟议的研究项目的目的是评估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，个体对环境毒物的易感性存在很大差异。虽然有些研究处理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，但几乎没有工作审查遗传易感性数据如何能够，在某些情况下必须在美国现有的环境法框架内应用。现有大量的法规、规章、指导性文件、司法决定和其他法律材料将在很大程度上指导如何将遗传易感性数据纳入环境管理决定。虽然这些不同的法律材料大多数是在没有具体认识到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有关的法律框架。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亚群体的水平上，而且有大量相关的规则制定先例、司法判决和立法历史将决定遗传信息在这种法定规定下的适当作用。该项目将评估如何能够或在某些情况下必须将遗传易感性数据纳入现有的管理框架和先例。它将确定在现有法律规定下应用遗传易感性数据的法律、伦理和科学问题和挑战，并建议将基因组信息纳入环境管理决策的标准和准则。它还将评估现有法律框架的潜在改进和替代方案，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，例如增加检测、警告和避免措施。该项目将由三名主要研究人员组成的联盟进行，他们在环境法规以及与遗传学有关的法律和伦理问题方面具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.