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

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.