title: Policy implications of genetic information on regulation under the Clean Air Act: the case of particulate matter and asthmatics.
abstract: The U.S. Clean Air Act (CAA) explicitly guarantees the protection of sensitive human subpopulations from adverse health effects associated with air pollution exposure. Identified subpopulations, such as asthmatics, may carry multiple genetic susceptibilities to disease onset and progression and thus qualify for special protection under the CAA. Scientific advances accelerated as a result of the groundbreaking Human Genome Project enable the quantification of genetic information that underlies such human variability in susceptibility and the cellular mechanisms of disease. In epidemiology and regulatory toxicology, genetic information can more clearly elucidate human susceptibility essential to risk assessment, such as in support of air quality regulation. In an effort to encourage the incorporation of genomic information in regulation, the U.S. Environmental Protection Agency (EPA) has issued an Interim Policy on Genomics. Additional research strategy and policy documents from the National Academy of Science, the U.S. EPA, and the U.S. Department of Health and Human Services further promote the expansion of asthma genetics research for human health risk assessment. Through a review of these government documents, we find opportunities for the inclusion of genetic information in the regulation of air pollutants. In addition, we identify sources of information in recent scientific research on asthma genetics relevant to regulatory standard setting. We conclude with recommendations on how to integrate these approaches for the improvement of regulatory health science and the prerequisites for inclusion of genetic information in decision making.
authors.affiliation: Center for the Study and Improvement of Regulation, School of Public Health, University of Washington, Seattle, Washington, USA.
authors.forename: C Bradley
authors.initials: CB
authors.lastname: Kramer
authors.forename: Alison C
authors.initials: AC
authors.lastname: Cullen
authors.forename: Elaine M
authors.initials: EM
authors.lastname: Faustman
mesh_terms: D000393:Air Pollutants / Q000009:adverse effects; D000397:Air Pollution / Q000009:adverse effects / Q000331:legislation & jurisprudence* / Q000517:prevention & control*; D001249:Asthma / Q000235:genetics*; D003657:Decision Making; D004391:Dust; D020022:Genetic Predisposition to Disease; D023281:Genomics; D033161:Government Regulation; D006801:Humans; D011640:Public Policy; D018570:Risk Assessment
chemical_list: D000393:Air Pollutants; D004391:Dust