Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007) / Chapter Skim
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Appendix B: OMB Proposed Risk Assessment Bulletin
Appendix B: OMB Proposed Risk Assessment Bulletin
Pages 121-148
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Appendix B OMB Proposed Risk Assessment Bulletin
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in 1983: Risk This proposed bulletin is being released for peer review and public comment. It should not be construed to represent the official policy of the U.S.
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For example, in 1993 the Carnegie Commission on Science, Technology, and Government issued "Risk and the Environment: Improving Regulatory Decision-making."1 In 1994, the NAS issued "Science and Judgment in Risk Assessment" to review and evaluate the risk assessment methods of EPA.2 In 1995, the Harvard Center for Risk Analysis issued "Reform of Risk Regulation: Achieving More Protection at Less Cost."3 In 1997, the Presidential/Congressional Commission on Risk Assessment and Risk Management issued "Risk Assessment and Risk Management in Regulatory DecisionMaking."4 A series of NAS reports over the past 10 years have made useful recommendations on specific aspects and applications of risk assessment.5 The findings in these reports informed the development of this Bulletin. OMB, in collaboration with OSTP, has a strong interest in the technical quality of agency risk assessments because these assessments play an important role in the development of public policies at the national, international, state and local levels.
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7 National Research Council Understanding Risk: Informing Decisions in a Democratic Society, Washington DC: National Academy Press, 1996; Risk Commission Report, Volume 2, 1997; National Research Council, Improving Risk Communication, Washington DC: National Academy Press, 1989. This proposed bulletin is being released for peer review and public comment.
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In 1987 and again in 1990, the Environmental Protection Agency (EPA) prepared a comparative assessment of environmental hazards – both risks to human health and the environment – to inform the Agency's priority setting.10 This work demonstrated that the environmental risks of greatest concern to the public often were not ranked as the greatest risks by agency managers and scientists.
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For example, the Surgeon General's Report on Smoking and Health has, over the years, contained a wide variety of health risk estimates. These estimates have been adopted in programs and documents disseminated by local and state governments, Federal agencies, private companies, and the public at large.
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17 Monson, R, Occupational Epidemiology, Second Edition, CRC Press, Boca Raton, Florida, 1990. 18 Rodricks, JV, Calculated Risks: The Toxicity and Human Health Risks of Chemicals in Our Environment, Cambridge, University Press, New York, NY, 1992.
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This proposed bulletin is being released for peer review and public comment. It should not be construed to represent the official policy of the U.S.
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This proposed bulletin is released for peer review and public comment. It should not be construed to represent the official policy of the U.S.
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Alternatively, the federal government's assessment of risk can directly or indirectly influence the regulatory actions of state and local agencies or international bodies. Examples of "influential risk assessments" include, but are not limited to, assessments that determine the level of risk regarding health (such as reference doses, reference concentrations, and minimal risk levels)
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This Bulletin also shall not apply to risk assessments performed with respect to inspections relating to health, safety, or environment. This Bulletin also does not apply to any risk assessment performed with respect to an individual product label, or any risk characterization appearing on any such label, if the individual product label is required by law to be approved by a Federal agency prior to use.
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This proposed bulletin is being released for peer review and public comment. It should not be construed to represent the official policy of the U.S.
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For example, a risk assessment informing a general regulatory decision as to whether exposure to a chemical should be reduced would not be constrained to a one-disease process (e.g., cancer) when valid and relevant information about other disease processes (e.g., neurological effects or reproductive effects)
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, Washington DC: National Academy Press, 1994. 27 See Carnegie Commission on Science, Technology and Government, Risk and the Environment: Improving Regulatory Decision Making, New York, NY, June 1993, at 87 ("Regulatory agencies should report a range of risk estimates when assessing risk and communicating it to the public.
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2 at 20, 1997. This proposed bulletin is released for peer review and public comment.
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Standards Related to Regulatory Analysis When a risk assessment is being produced to support or aid decision making related to regulatory analysis, there are additional standards that should be met. Risk assessors should consult OMB Circular A-4, which addresses requirements designed to improve the quality of regulatory impact analyses.
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A "central estimate" of risk is the mean or average of the distribution; or a number which contains multiple estimates of risk based on different assumptions, weighted by their relative plausibility; or any estimate judged to be most representative of the distribution.32 The central estimate should neither understate nor overstate the risk, but rather, should provide the risk manager and the public with the expected risk.33 Section V: Special Standards for Influential Risk Assessments In addition to the standards presented in section IV, all influential risk assessments should meet certain additional standards. When it is not appropriate for an influential risk assessment to adhere to one or more of the standards in this section of the Bulletin, the risk assessment should contain a rationale explaining why the standard(s)
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Presenting the range of plausible risk estimates, along with a central estimate, conveys a more objective characterization of the magnitude of the risks. Influential risk assessments should characterize uncertainty by highlighting central estimates as well high-end and low-end estimates of risk.
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131-134. This proposed bulletin is released for peer review and public comment.
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41 Burmaster, DE, PD Anderson, Principles of Good Practice for the Use of Monte Carlo Techniques in Human Health and Ecological Risk Analysis, Risk Analysis, vol.
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8. Standard for Discussing Scientific Limitations Influential risk assessments should, to the extent possible, provide a discussion regarding the nature, difficulty, feasibility, cost and time associated with undertaking research to resolve a report's key scientific limitations and uncertainties.
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Each agency should, taking into account the resources available, priorities, and the importance of the document, consider revising its influential risk assessments as relevant and scientifically plausible information becomes available. Each agency should (1)
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OIRA and OSTP shall foster learning about risk assessment practices across agencies. Section X: Effective Date The requirements of this Bulletin apply to: (1)
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; 2. "influential risk assessment" means a risk assessment the agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions; 3.
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estimates of population risk when estimates of individual risk are developed; and e. whenever possible, a range of plausible risk estimates, including central or expected estimates, when a quantitative characterization of risk is made available.
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All influential agency risk assessments shall: 1. Be "capable of being substantially reproduced" as defined in the OMB Information Quality Guidelines.
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OIRA, in consultation with OSTP, shall be responsible for overseeing agency implementation of this Bulletin. OIRA and OSTP shall foster better understanding about risk assessment practices and assess progress in implementing this Bulletin.
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