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. ? ?
