Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007) / Chapter Skim
Currently Skimming:
3 Risk Assessment Definition and Goals
3 Risk Assessment Definition and Goals
Pages 26-34
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 26... ...
Although the bulletin hints at taking both probability and severity into account, it appears to treat risk primarily as the probability of adverse effect, which is an incomplete conceptualization of risk. DEFINITION OF RISK ASSESSMENT Section I of 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" (OMB 2006a, p.
|
From page 27... ...
That is, the applicability of the bulletin is intrinsically related to the definition of risk assessment because anything defined as a risk assessment will need to comply with the standards as indicated in Section II of the bulletin ("Applicability") , which states that "to the extent appropriate, all agency risk assessments available to the public shall comply with the standards of this Bulletin" (OMB 2006a, p.
|
From page 28... ...
● Some of the documents listed as examples of influential risk assessments in the supplementary information collect and summarize information from a variety of sources and studies and provide it in a format that is useful to both health professionals and the public. Many of the documents contain hazard identification, dose-response assessments, or
|
From page 29... ...
Examples include guidelines for healthcare workers on the handling of hazardous biologic materials, such as body fluids from HIV patients; guidelines for respirator fit testing; National Institutes of Health guidelines for research practices, particularly in relation to new therapies and technologies (for example, those on the use of recombinant-DNA products) ; and health information alerts or warnings, which may result from reports of adverse effects of a therapy or medication.
|
From page 30... ...
. Furthermore, the 1996 NRC report Understanding Risk stated that "what is needed for successful characterization of risk must be considered at the very beginning of the process and must to a great extent drive risk analysis.
|
From page 31... ...
Risk Assessment Definition and Goals 31 TABLE 3-1 Goals for Risk Assessment as Stated in Bulletin and Clarified in Supplementary Information Goal Bulletin Description Supplementary Description 1 "The objectives of an assessment Goal related to problem formulation: shall be a product of an iterative "there will be many choices regarding the dialogue between the assessor(s) and objectives, scope and content of the the agency decision maker(s)
|
From page 32... ...
. Having the scope and content linked to the assessment seems logical, and one would hope that this recommendation is already implicit in most risk assessments.
|
From page 33... ...
Thus, the goals may lead to less expensive and quicker risk assessments, but they do not necessarily lead to higher-quality risk assessments. The dominating theme of the bulletin and the supplementary information is improving the quality of risk assessments undertaken by federal agencies, but the stated goals do not all support this theme.
|
From page 34... ...
2006b. Comments on Proposed Risk Assessment Bulletin.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.