Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007) / Chapter Skim
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The bulletin defines risk assessment broadly, states several goals for risk assessment, and proposes general risk assessment and reporting standards and special standards for influential risk assessments. The stated intent of the bulletin is "to enhance the technical quality and objectivity of risk assessments prepared by federal agencies by establishing uniform, minimum standards," and it follows several other influential documents issued by OMB, including the Information Quality Guidelines, the Information Quality Bulletin on Peer Review, and Circular A-4, which pertains primarily to benefit-cost analysis and cost-effectiveness analysis.
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The committee also requested information from the federal agencies on their risk assessment practices and their view of the potential impact of the bulletin on current practices. The committee reviewed both the bulletin and the accompanying supplementary information, and reference to "the bulletin" in this summary includes both the bulletin and the supplementary information.
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Definition of Risk Assessment and the Bulletin's Goals The bulletin defines risk assessment as "a scientific and/or technical document that assembles and synthesizes scientific information to determine whether a potential hazard exists and/or the extent of possible risk to human health, safety or the environment." That definition conflicts with long-established concepts and practices that have defined risk assessment as a process that involves hazard identification, hazard characterization or dose-response assessment, exposure assessment, and risk characterization. The definition in the bulletin is too broad and encompasses not only traditional risk assessments but the components of risk assessment.
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Thus, the goals do not all support the primary purpose of the bulletin -- "to enhance the technical quality and objectivity of risk assessments." Proposed Standards for Risk Assessment The bulletin proposes seven standards for general risk assessment -- one of which refers to risk assessments for regulatory analysis -- and nine special standards for influential risk assessments. The committee found this structure problematic, because one may not know at the outset whether an analysis will constitute an "influential" risk assessment.
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Specifically, OMB has proposed a bulletin addressing risk assessment in the federal government; however, the bulletin focuses mainly on biologic systems, with an emphasis on human health risk assessment. The vast majority of examples it presents (and the authorities cited)
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Thus, OMB has not determined the impact of the bulletin on federal agencies. Impact on Risk Assessment Practices in the Federal Government Although OMB did not construct a baseline reflecting current agency risk assessment practices, the committee concludes on the basis of agency comments and its own knowledge of risk assessment practices that some aspects of the bulletin could be beneficial but that the costs -- in terms of staff resources, timeliness of completing risk assessments, and other factors -- are likely to be substantial.
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Although OMB should determine whether the technical guidance developed by the agencies fully addresses the general principles, the committee recommends that development and peer review of agency technical guidance be left to the agencies. The committee strongly recommends that federal agencies addressing similar hazards or risks work together to develop common technical guidance for risk assessment; that would help to achieve the appropriate consistency among agencies in risk assessment practices.
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The committee agrees that there is room for improvement in risk assessment practices in the federal government and that additional guidance would help "to enhance the technical quality and objectivity of risk assessments prepared by federal agencies." However, the committee concludes that OMB should limit its efforts to stating goals and general principles of risk assessment. The details should be left to the agencies or expert committees appointed by the agencies, wherein lies the depth of expertise to address the issues relevant to their specific types of risk assessments.
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