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Notice of Availability for the U.S. Environmental Protection Agency's Strategic Plan for Evaluating the Toxicity of Chemicals

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Environmental Protection Agency (EPA).


Notice of document availability.


The U.S. Environmental Protection Agency (EPA) is announcing the availability of the final document The U.S. Environmental Protection Agency's Strategic Plan for Evaluating the Toxicity of Chemicals (EPA 100/K-09/001). The purpose of the Strategic Plan is to serve as a blueprint for EPA in incorporating advances in molecular biology and computational sciences into toxicity testing and risk assessment practices across the Agency. The Strategic Plan is centered on three interrelated components: (1) Toxicity pathways identification and use of this information in screening and prioritization of chemicals for further testing, (2) the use of toxicity pathways information in risk assessment, and (3) the institutional transition necessary to implement such practices across EPA. This Strategic Plan describes an ambitious and substantive improvement in the efficiency and effectiveness of the process by which environmental pollutants are evaluated for toxicity and risk. A workgroup of EPA's Science Policy Council oversaw the development of this document, incorporating input obtained from an external peer review.


The final document is available electronically through the EPA Office of the Science Advisor's Web site at:​osa/​spc/​toxicitytesting/​. A limited number of paper copies will be available from EPA's National Service Center for Environmental Publications (NSCEP), P.O. Box 42419, Cincinnati, OH 45242; telephone 1-800-490-9198 or 513-489-8190; facsimile 301-604-3408; e-mail Please provide your name and mailing addresses and the title and EPA number (as given above) of the requested publication.

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Melissa Kramer, Office of the Science Advisor, Mail Code 8105R, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564-8497; fax number: (202) 564-2070, e-mail:

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EPA recently took the lead in commissioning the National Research Council (NRC) of the National Academies to develop a long-range vision for toxicity testing and risk assessment. Their 2007 report, Toxicity Testing in the 21st Century: A Vision and a Strategy (​catalog.php?​record_​id=​11970), envisions a landmark transformation that focuses on identifying and evaluating “toxicity pathways,” i.e., cellular response pathways responsible for adverse health effects when sufficiently perturbed by environmental agents under realistic exposure conditions.

To build upon the transformative changes advocated in the NRC document, while ensuring an internally coordinated and integrated approach, EPA established a cross-Agency workgroup under the auspices of its internal Science Policy Council. This workgroup produced The U.S. Environmental Protection Agency's Strategic Plan for Evaluating the Toxicity of Chemicals that provides a framework for EPA to comprehensively move forward to incorporate this new scientific paradigm into future toxicity testing and risk assessment practices.

This new paradigm has the potential to address increasingly complex issues that EPA faces in evaluating environmental contaminants for risks to human health and the environment. For example, it is expected to create more efficient and cost-effective means to screen and prioritize for further assessment the tens of thousands of chemicals that are already found in the environment. The new paradigm should facilitate evaluating the susceptibility of different life-stages and genetic variations in the population, understanding the mechanisms by which toxicity occurs, and considering the risks of concurrent, cumulative exposure to multiple and diverse chemicals, while at the same time significantly reducing reliance on animal testing for assessing human risk.

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Dated: February 18, 2009.

Kevin Y. Teichman,

Acting EPA Science Advisor.

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[FR Doc. E9-6683 Filed 3-24-09; 8:45 am]