Genomics and Environmental Regulation: Science, Ethics, and Law

2 Addressing Genomic Needs at the U.S. Environmental Protection Agency

C H A P T E R 2 Addressing Genomic Needs at the U.S. Environmental Protection Agency KERRY L. DEARFIELD, WILLIAM H. BENSON, KATHRYN GALLAGHER, AND JEREMY D. JOHNSON The data and information emanating from the various genomic technologies (speaking generally here as encompassing all aspects of genomics , proteomics, metabolomics, and systems biology) present many exciting opportunities as well as challenges for the U.S. Environmental Protection Agency (EPA). To deal efficiently and fairly with the information generated by genomic technologies, EPA has initiated many activities . The agency has taken measures to address policy positions; to identify effects on regulatory, research, and risk-assessment activities; and to create working groups to explore many of the needs for EPA to address this information. EPA Interim Policy on Genomics A major consideration EPA had to address was what to do with information being generated by genomic technologies. A large amount of this information is already available, with an increasing amount on the horizon . However, it is not readily usable for EPA purposes, including use in regulations that require the identification of adverse human health or ecological risks. As it stands, much of the genomic information is not correlated with effects the regulatory community historically considers “adverse” (e.g., for human health: cancer, reproductive effects; for ecological health: growth, reproductive effects). This challenge to correlate responses seen in genomic data with adverse effects recognized by the agency must be met for EPA to base regulatory decisions on genomic information alone. Therefore, in June 2002 EPA issued a policy position, called the Interim Policy on Genomics, to help address what to do with available genomic-related information (U.S. Environmental Protection Agency, 2002). This interim policy states that EPA encourages and supports continued genomic research as a powerful tool for understanding the molecular basis of toxicity and for developing biomarkers of exposure, effects, and susceptibility. However (and this is the major statement of the interim policy), genomic data alone are currently insufficient as a basis for risk-assessment and management decisions. The document further states that genomic data may be useful in a weight-of-evidence approach for human health and ecological health risk assessments. Consequently, genomic information will be used in concert with all of the other information EPA considers for a particular assessment or decision. The interim policy will be revisited when EPA can evaluate what genomic data mean relative to adverse effects of concern to EPA. It should be kept in mind, though, that there may be other areas, particularly environmental monitoring , where genomic data can be useful. EPA Actions Associated with the Interim Policy EPA initiated several actions immediately after it issued the interim policy. For example, EPA began to address the ethical aspects, such as privacy and fairness concerns, that are associated with emerging genomic data (Marchant, 2003a, 2003b; Orphanides and Kimber, 2003; Robert and Smith, 2004). One such action was to reorganize agency programs that dealt with genomic issues. EPA has many research activities associated with genomic technologies, in both the human health and ecological arenas. It was clear that these research activities could be better coordinated across the agency and aligned with EPA regulatory responsibilities. EPA analyzed this sit26 E N V I R O N M E N T A L P O L I C Y P E R S P E C T I V E S uation and through a major reorganization initiative created the Computational Toxicology Program (U.S. Environmental Protection Agency, 2003). This program serves to facilitate the introduction of genomics and computational tools into the practical issues facing the agency and to provide leadership in the application of these tools to regulatory decisions at the agency. In response to a charge by EPA senior managers, a Genomics Task Force was formed within the agency to develop a white paper (U.S. Environmental Protection Agency, 2004) on regulatory implications and to highlight additional actions needed. The rest of this chapter will highlight findings from the white paper and subsequent activities. The Genomics Task Force and the White Paper Anticipated regulatory and risk-assessment applications and the implications of genomics for EPA are identified in the white paper. It also includes an overview of current agency science activities that may support these applications (which are not discussed here). The white paper then identifies the science and research needed to advance genomics to support agency activities...