Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007) / Chapter Skim
Currently Skimming:
2 Consistency with National Research Council and Other Reports
2 Consistency with National Research Council and Other Reports
Pages 15-25
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From page 15... ...
The content of the bulletin, most especially that pertaining to standards for risk assessment, is discussed in relation to the cited studies, and areas lacking consistency are identified. Consistency with the cited studies is important for ensuring the quality and continuing advance of risk assessment.
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From page 16... ...
The second step, called dose-response assessment, describes the relationship between exposure to the substance or activity and the nature and extent of resulting harm. The third step, usually termed human exposure assessment, describes the nature and extent of human exposure to the substance or activity.
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From page 17... ...
● The Red Book used the term inference options to describe alternative models and assumptions that are needed to complete risk assessments in the absence of complete scientific information or knowledge. Inference guideline was defined as "an explicit statement of a predetermined choice among alternative…options" (NRC 1983, p.4)
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From page 18... ...
: Much attention has been given to quantitative, analytic procedures for describing uncertainty in risk characterizations. Participants in decisions need to consider both the magnitude of uncertainty and its sources and character: whether it is due to inherent randomness or to lack of knowledge; and whether it is recognized and quantifiable, recognized and indeterminate; or perhaps unrecognized.
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From page 19... ...
Perhaps the leading efforts are the PRA standards for nuclear power plants that have been developed by various professional societies. For example, the American National Standards Institute, in conjunction with the American Nuclear Society and the American Society of Mechanical Engineers, has developed risk assessment standards for internal and external initiating events at nuclear power plants (ASME 2002; ANS 2003)
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From page 20... ...
All discuss uncertainties, but two provide only "point" estimates of risk, and the third (on arsenic) provides a relatively limited range of risk estimates based on application of a single dose-response model.
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From page 21... ...
Therefore, there is a danger that in its present form the bulletin may reduce rather than enhance the quality and objectivity of agency risk assessments. The committee's principal concerns are the following: ● The bulletin does not recognize the importance of what several NRC committees have called policy judgments in risk assessment.
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From page 22... ...
Deciding whether it is "sufficiently certain" to replace a default or is to be given more weight, equal weight, or less weight than the default may be seen as requiring a combination of scientific and policy considerations that go beyond risk assessment. With this approach, risk assessors do not discard alternative models and assumptions unless they clearly lack substantial scientific merit; rather, they attempt to judge and describe the relative scientific merits.
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From page 23... ...
● The bulletin says little about the biologic bases of the various models and assumptions that might be used in risk assessments and about how judgments regarding their relative scientific merits are to be encompassed in the expressions of risk and of uncertainty. Perhaps the bulletin intends that such efforts be inherent in the analyses called for, but it could also be read as simply calling for the use of alternative statistical models that have unknown biologic bases.
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From page 24... ...
● The bulletin's inclusion, in its definition of risk assessment, of agency efforts that are directed only to specific steps of the risk assessment process is inconsistent with the definition preferred by the cited studies. Furthermore, OMB redefines risk assessment to include some activities associated with risk management decision-making.
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From page 25... ...
2002. Standard for Prob abilistic Risk Assessment for Nuclear Power Plant Applications.
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