U.S. Environmental Protection Agency's activities to prepare for regulatory and risk assessment applications of genomics information. 2007

William H Benson, and Kathryn Gallagher, and J Thomas McClintock
Office of the Science Advisor, U.S. Environmental Protection Agency, Washington, DC 20460, USA.

Genomics is expected to have significant implications for risk assessment and regulatory decision making. Since 2002, the U.S. Environmental Protection Agency (EPA) has undertaken a number of cross-agency activities to further prepare itself to receive, interpret, and apply genomics information for risk assessment and regulatory purposes. These activities include: (1) the issuance of an Interim Genomics Policy on the use of genomics information in risk assessments and decision making, (2) the release of the 2004 Genomics White Paper, which outlines potential applications and implications of genomics for EPA, and (3) the recent release of the external review draft of the Interim Guidance on Microarray-Based Assays, which outlines data submission, quality, analysis, management, and training considerations for such data. This manuscript discusses these activities and more recent follow-up activities with the aim of further communicating these efforts to the broader scientific and stakeholder community.

UI MeSH Term Description Entries
D011640 Public Policy A course or method of action selected, usually by a government, from among alternatives to guide and determine present and future decisions. Social Policy,Affirmative Action,Migration Policy,Population Policy,Social Protection,Action, Affirmative,Migration Policies,Policies, Migration,Policies, Population,Policies, Public,Policies, Social,Policy, Migration,Policy, Population,Policy, Public,Policy, Social,Population Policies,Protection, Social,Public Policies,Social Policies
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D014484 United States Environmental Protection Agency An agency in the Executive Branch of the Federal Government. It was created as an independent regulatory agency responsible for the implementation of federal laws designed to protect the environment. Its mission is to protect human health and the ENVIRONMENT. Environmental Protection Agency (U.S.),Environmental Protection Agency,Environmental Protection Agency, United States,USEPA
D018570 Risk Assessment The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988) Assessment, Risk,Benefit-Risk Assessment,Risk Analysis,Risk-Benefit Assessment,Health Risk Assessment,Risks and Benefits,Analysis, Risk,Assessment, Benefit-Risk,Assessment, Health Risk,Assessment, Risk-Benefit,Benefit Risk Assessment,Benefit-Risk Assessments,Benefits and Risks,Health Risk Assessments,Risk Analyses,Risk Assessment, Health,Risk Assessments,Risk Benefit Assessment,Risk-Benefit Assessments
D023281 Genomics The systematic study of the complete DNA sequences (GENOME) of organisms. Included is construction of complete genetic, physical, and transcript maps, and the analysis of this structural genomic information on a global scale such as in GENOME WIDE ASSOCIATION STUDIES. Functional Genomics,Structural Genomics,Comparative Genomics,Genomics, Comparative,Genomics, Functional,Genomics, Structural

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