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(PH165) Potential Implications of Genomics for Regulatory and Risk Assessment Applications at EPA.
Benson, W1, Gallagher, K2, Dearfield, K2, 1 U.S. Environmental Protection Agency, Gulf Breeze, FL, USA2 U.S. Environmental Protection Agency, Washington, DC, USA
ABSTRACT- Advances in genomics will have significant implications for risk assessment practice and regulatory decision making. The EPA Interim Policy on Genomics described genomics as the study of all genes of a cell or tissue, at the DNA, mRNA, or protein level. Also, it is noted that while genomics offers the opportunity to understand how an organism responds at the gene-expression level to stressors in the environment, understanding such molecular events with respect to adverse ecological and human health outcomes is far from established. It concludes that while genomics data may be considered in the decision making process at this time, these data alone are insufficient as a basis for decisions. Therefore, EPA currently considers genomics information for assessment purposes on a case-by-case basis only. Following release of the Interim Policy, an EPA Genomics Task Force was formed and developed a document that describes the implications of the use of genomics technologies in Agency practice. Although understanding genomic responses with respect to adverse ecological and/or human health outcomes is far from established, it is important to begin to consider the likely future impacts of genomics technologies on risk assessment and regulatory decision making. Four areas were identified as those very likely to be influenced by genomics: (1) prioritization of contaminants (chemicals and microbes) and contaminated sites; (2) monitoring; (3) reporting provisions; and (4) risk assessment. The document also outlines ongoing Agency research and research needs for each of these four areas. In addition, three categories of overarching challenges associated with genomics were identified: research, technical development, and capacity. It is recognized that the Agency needs to be proactive in identifying, developing, and standardizing applicable genomics approaches.
Key words: Computational models, Genomics, Risk assessment, Regulatory applications
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