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ACTIVITIES TO DEVELOP AN INTERIM GUIDANCE FOR MICROARRAY-BASED ASSAYS FOR REGULATORY AND RISK ASSESSMENT APPLICATIONS AT EPA
Citation:
GALLAGHER, K., W. H. BENSON, AND T. MCCLINTOCK. ACTIVITIES TO DEVELOP AN INTERIM GUIDANCE FOR MICROARRAY-BASED ASSAYS FOR REGULATORY AND RISK ASSESSMENT APPLICATIONS AT EPA. Presented at EPA Science Forum, Washington, DC, May 16 - 18, 2006.
Description:
Abstract for presentation. Advances in genomics will have significant implications for risk assessment policies and regulatory decision making. In 2002, EPA issued its lnterim Policy on Genomics which stated that such data may be considered in the decision making process, but that these data alone were insufficient as a basis for decisions. Following release of the lnterim Policy, the Science Policy Council (SPC) created a cross-Agency Genomics Task Force and charged it with examining the broader implications genomics is likely to have on EPA programs and policies. The Task Force developed a Genomics White Paper entitled Potential Implications of Genomics for Regulatory and Risk Assessment Applications at EPA" (USEPA, 2004), which identified four areas likely to be influenced by the genomics information: 1) prioritization of contaminants and contaminated sites, 2) monitoring, 3) reporting provisions; and 4) risk assessment. The critical need to establish a framework for analysis and acceptance criteria for genomics information for scientific and regulatory purposes was identified. The Task Force recommended that the Agency charge a workgroup to establish such a framework and in doing so consider the performance of assays across genomic platforms (e.g., reproducibility, sensitivity, pathway analysis tools) and the criteria for accepting genomics data for use in a risk assessment (e.g., assay validity, biologically meaningful response). As a result, in 2004, the Genomics Technical Framework and Training Workgroup was formed. The Genomics Technical Workgroup considered all of the "omics" technologies and applications and decided that an interim guidance document on the use of data generated by DNA microarray technology would be the most beneficial to the Agency and regulated community at this time and has been developing an lnterim Guidance for Microarray-Based Assays for Regulatory and Risk Assessment Applications at EPA. EPA has been collaborating with FDA in this effort. The document will provide information to the regulated community and other interested parties regarding submitting microarray data to the Agency and guidance for Agency reviewers in evaluating such data and/or information.