Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007) / Chapter Skim
Currently Skimming:
5 Omissions from the Bulletin
5 Omissions from the Bulletin
Pages 78-87
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
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From page 78... ...
It would be impractical and inappropriate for this committee to attempt to address all risk assessment issues that might be relevant to one or more federal agencies. Guidance on those and other issues, however, is important, and their importance led to the recommendation that OMB encourage federal agencies to develop individual guidelines tailored to their own needs and practices (see Chapter 7)
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From page 79... ...
Despite these introductory statements, the bulletin focuses mainly on biologic systems, with an emphasis on human health risk assessment, and provides little guidance related to physical (engineered) systems.
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From page 80... ...
. Those provisions appear to exempt a broad set of risk assessments, including some Food and Drug Administration (FDA)
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From page 81... ...
As noted in Chapter 2, the recommendations set forth in the various expert studies apply generally to all risk assessments, and the committee finds no basis in the bulletin for blanket exclusion of assessments related to product approvals and registrations from standards designed to improve the quality of agency assessments. Responding to a committee question in that regard, OMB explained that the Information Quality Guidelines (67 Fed.
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From page 82... ...
That omission is particularly striking in view of frequent citations of the 1994 National Research Council (NRC) report Science and Judgment in Risk Assessment, which, as the title indicates, gives special attention to the role of professional judgment in making risk assessment decisions in the absence of relevant experimental or field data -- a circumstance common to many risk assessments.
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From page 83... ...
EPA notes that omission in its comments: "Scientific ‘defaults' or ‘inference guidelines' play an important role for EPA in providing a consistent and peer reviewed means of addressing recurring, fundamental issues of science policy in its risk assessments. The proposed Bulletin does not address this aspect of risk assessment practice" (see Appendix E, p.
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From page 84... ...
If an agency is responsible for determining whether information received from the public and used as part of a risk assessment complies with OMB requirements, additional time and resources would be required. Alternatively, if the submitter is responsible, the agency would know when the information is received whether it meets the standards and thus whether it can be considered without additional analysis and delay.
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From page 85... ...
For the same reasons that federal agencies are responsible for conforming to standards in proposing any risk assessment, it seems incumbent on external submitters to evaluate and document as part of their submission -- that is, to assure the agencies and the public -- that risk assessment information offered for use in decision-making conforms to the same relevant standards. If federal agencies are themselves responsible for the initial evaluation of all public submissions of risk assessment information (as defined in the bulletin)
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From page 86... ...
For example, regarding exposure analysis, residents of a community or workers in an industry can provide information essential for agencies to use in developing exposure scenarios critical to the risk assessment process. Stakeholders from all points on the spectrum of interested parties -- other state and federal agencies, advocacy groups from industry, and affected communities -- can be expected to offer perspectives on the risk assessment policies under discussion.
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From page 87... ...
1997. Risk Assessment and Risk Management in Regula tory Decision-Making, Vol.
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