You are here:
POTENTIAL IMPACTS OF GENOMICS ON EPA REGULATORY AND RISK ASSESSMENT APPLICATIONS
Citation:
Gallagher, K AND W H. Benson. POTENTIAL IMPACTS OF GENOMICS ON EPA REGULATORY AND RISK ASSESSMENT APPLICATIONS. Presented at EPA Science Forum, Washington, DC, June 01 - 03, 2004.
Impact/Purpose:
Conference abstract
Description:
Gallagher, Kathryn and William Benson. In press. Potential Impacts of Genomics on EPA Regulatory and Risk Assessment (Abstract). To be presented at the EPA Science Forum: Healthy Communities and Ecosystems, 1-3 June 2004, Washington, DC. 1 p. (ERL,GB R991).
Advances in genomics will have significant implications for risk assessment practice and regulatory decision making. The Agency's Interim Policy on Genomics (2002) states 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. Genomics information will be considered for assessment purposes on a case-by-case basis only. The Agency's internal Genomics Action Plan (2002) notes that genomics information may lead to the development of predictive biomarkers of effect, enabling the identification of potentially susceptible populations, and will enhance the understanding of the molecular mechanisms of toxicity, which may reduce uncertainty of assumptions and extrapolations used in the risk assessment process.
The Genomics Task Force white paper presents 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 Task Force also outlined ongoing Agency research and research needs for each of these four areas.
Three categories of overarching challenges associated with genomics were identified: research, technical development, and capacity. The research challenges are: (1) linking genomics information to adverse outcomes, and (2) interpreting genomics information for risk and hazard assessment. The technical challenge is the need to develop a framework for analysis and acceptance criteria for genomics information for scientific and regulatory purposes (including data quality standards based on genomic assay performance). Two capacity/human capital challenges are: (1) applying strategic hiring practices to recruit individuals who possess "genomics core competencies," and (2) training EPA risk assessors and managers to interpret and understand genomics data in the context of a risk assessment. Recommendations for addressing these challenges are made by the task force.
The Agency needs to be proactive in identifying, developing, and standardizing applicable genomics approaches. Additionally, many scientific, policy, ethical, and legal concerns will need to be addressed. It is essential for the Agency to continue to collaborate with other federal agencies, academia, the regulated community, and other stakeholders in order to benefit from ongoing advances in genomics in the wider scientific and regulatory communities.
Will be poster session.