Research Product

The Environmental Protection Agency (EPA) issued its Interim Policy on Genomics in June 2002. The policy acknowledges that genomics data and analyses will significantly impact many areas of scientific research as well as human health and ecological assessments. Further, the interim policy encourages prudent and beneficial use of genomics information by EPA on a case-by-case basis. EPA hopes that consideration of genomics information will ultimately improve the Agency's risk assessments. However, before this information can be fully used in many Agency applications, there are challenges that need to be addressed. At the request of EPA's Science Policy Council, a Genomics Task Force comprised of Agency staff was formed to examine these potential applications and challenges. The Task Force was specifically charged with examining the broad implications that genomics is likely to have for EPA programs and policies, in an attempt to better understand the appropriate use of these data and the potential consequences of their use, as well as to identify possible infrastructure needs. The group was also charged with developing scenarios to describe various circumstances under which EPA might receive these data. The resulting draft white paper (see box on page 3) presented the implications of using genomics technologies in EPA practice, for the consideration of Agency managers. Recently, this draft white paper was externally peer reviewed, and it is currently being finalized to reflect reviewer comments. Four applications were identified in the draft paper as likely to be influenced by the generation of genomics information within EPA and the submission of such information to EPA. (1) Prioritization of contaminants (chemicals and microbes) and contaminated sites: There are a large number of stressors that EPA must prioritize for further evaluation, such as those for its High Production Volume Challenge Program for industrial chemicals and its Contaminant Candidate List for drinking water pollutants. Genomics may provide a means to develop a more mechanistic, molecular-based approach for prioritization. (2) Monitoring: EPA uses site-specific and media-specific data to make regulatory decisions, monitor compliance, and to determine the state of the environment. Much of these data could be generated by genomics-based techniques, e.g., for microbial source tracking. (3) Reporting provisions: Once the challenge of determining adverse effects using genomics techniques has been met, EPA will need to consider whether these genomic-based data will be subject to Agency reporting provisions for adverse effects. (4) Risk assessment: Genomics technologies and information will ultimately enhance EPA risk assessments, likely by delineating a stressor's mode of action. Although genomics will not fundamentally alter the risk assessment process, it is expected to serve as a new, more powerful tool for evaluating exposure to and effects of environmental stressors. In addition to the four applications of genomics data listed above, the Task Force also identified three overarching challenges to genomics: research, technical development, and capacity. The Agency must meet these critical needs to strengthen its ability to use genomics information in a meaningful way, and to address potential regulatory applications. For research, the critical needs included: (1) linking genomics information to adverse outcomes; and (2) interpreting genomics information for risk and hazard assessment. It is important to note that significant research by EPA and other agencies and researchers will be necessary to fully understand and apply genomics technologies to human health and ecological risk assessments. A critical need for technical development is establishing a framework or criteria for analysis and acceptance of genomics information for scientific and regulatory purposes, including data quality standards based on genomic assay performance. Two critical needs were identified with respect to capacity, including human capital: (1) applying strategic hiring practices to recruit individuals who possess "genomics core competencies" essential for the crucial areas of research, analysis, systems biology, bioinformatics, and risk assessment; and (2) training EPA risk assessors and managers to interpret and understand genomics data in the context of a risk assessment. The Agency recognizes that it must be proactive in identifying, developing, and standardizing applicable genomics approaches. It is essential for EPA to continue to collaborate with other federal agencies, academia, the regulated community, and other stakeholders in this endeavor in order to benefit from ongoing advances in genomics in the wider scientific and regulatory communities.