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Appendix B: Evolution of Risk Analysis at EPA
Pages 133-138

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From page 133...
... This appendix contains a brief summary of the essential features of the relatively well established approaches to risk assessment at the EPA, and it also provides a look at how the decision needs of the EPA are satisfied by the approaches taken. Information for this appendix derives from a number of EPA guidelines and policy statements, citations to some of the relevant documents of other federal agencies, and reports of the National Academies, most especially the report released in December 2008 called Science and Decisions: Advancing Risk Assessment.
From page 134...
... These concerns prompted a congressionally mandated review by the National Academies, resulting in a report entitled Risk Assessment in the Federal Government: Managing the Process issued by the National Research Council in 1983. That report, which is commonly known as "the Red Book," contained a review and analysis of the scientific and policy controversies that had given rise to it (including allegations that federal risk assessments were often "manipulated" to yield the results desired by decision makers)
From page 135...
... These guidelines would include the scientific basis for risk assessments and would also include the specific inference options that would generically be applied in the conduct of those assessments. It was recognized that the selection of specific inferences from among the options available would involve both scientific and policy choices (the latter different in kind from the policy choices involved in risk management)
From page 136...
... In such circumstances, the agency was encouraged to move from the generic inference to the scientific data available on that specific chemical. These issues of inference options and policy choices within the risk assessment process might have some applicability to the way DHS approaches its mandate for risk assessment (see below)
From page 137...
... RISK ASSESSMENT AND DECISIONS The 2008 NRC report Science and Decisions placed heavy emphasis on the need to ensure that risk analyses2 are undertaken only when the decisions they are intended to support (or the problems they are intended to deal with) have been well defined and understood by both decision makers and risk analysts.
From page 138...
... The model for this development has been based on the concept, first elaborated in the 1983 NRC report, that information arising from research and other sources is not useful without evaluation and synthesis, the latter describing the risk analysis process. Thus, an internal staff, comprised of all the necessary scientific disciplines, is now available to conduct risk analyses on behalf of the agency's decision makers.


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