Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007) / Chapter Skim
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6 Impact on the Practice of Risk Assessment in the Federal Government
6 Impact on the Practice of Risk Assessment in the Federal Government
Pages 88-104
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From page 88... ...
? On the basis of the committee's general experience, information generated during its review of the bulletin, and the comments received from federal agencies (see Appendix E)
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From page 89... ...
As a starting point, the committee addresses OMB's failure to undertake -- or at least provide to the public -- an evaluation of the likely benefits and costs of implementing the bulletin for agency risk assessment practices and the consequences of that omission for the committee's work. THE ABSENCE OF INFORMATION TO EVALUATE THE IMPACT OF THE BULLETIN ON AGENCY RISK ASSESSMENT PRACTICES OMB, the champion of benefit-cost analysis for decision-making, requires agencies that propose major regulations to provide quantitative, or at least qualitative, information regarding the anticipated consequences of their proposals.
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BENEFITS OMB anticipates that implementation of the bulletin would raise all agency risk assessment practices to consistently higher levels and that that would translate into better information for decision-makers and hence better decisions. The committee accepts (indeed, applauds)
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From page 91... ...
to ask more pertinent questions of risk assessors and to demand compliance with the new standards.3 And availability of the bulletin might diminish delays caused by having to start anew or make major revisions near the end of the process. Therefore, the committee expects that if the proposed bulletin were implemented, at best, some agency risk assessments might be slightly improved from a scientific or technical perspective.
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From page 92... ...
. Many agencies will require more and better data to satisfy the specific risk assessment requirements described in the bulletin.6,7 That in turn will depend in part on future federal budgets for research and datagathering,8 whether that work is undertaken by agency personnel or its implementation of the Information Quality Guidelines…‘in light of our numerous statutes, regulations, guidance and policies'…and [to]
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From page 93... ...
For example, some agencies -- such as the Centers for Disease Control and Prevention and some offices in the Food and Drug Administration and the Environmental Protection Agency (EPA) -- have epidemiologists on staff, but other risk assessing offices that will need fully qualified epidemiologists to meet the standards set forth in the bulletin do not have such experts on board.10 Given the current state of affairs with respect to funding and staffing, the committee finds that implementation of the bulletin, without concentrated attention on data and staffing needs in relation to the baseline, is unlikely to achieve the objective of enhancing the technical quality of risk assessments throughout the federal government.
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From page 94... ...
, requiring a range of plausible risk estimates whenever a quantitative characterization of risk is provided, and Section IV(7c) , requiring "information on the timing of exposure and the onset of the adverse effect(s)
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For example, Section IV(3) states that "when a quantitative characterization of risk is provided, a range of plausible risk estimates shall be provided." How large must the range be?
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From page 96... ...
Moreover, as discussed in Chapter 4, it is not always clear at the outset of a risk assessment whether it would ultimately fall under the general standards, the regulatory standards, or the special standards for influential risk assessments.20 If the risk were considered influential and the most exacting standards were applied only to find little impact, substantial resources would have been used needlessly. Although these new obligations would be imposed, there is no indication that any additional funds are being requested or appropriated.
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NASA-7 (applying the standards for influential risk as
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; p. DOL-6 ("deriving quantitative distributions of model uncertainty and variability…could add significant time…where such analyses are not critical to fully inform regulatory decisionmakers")
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EPA-15 ("this section goes beyond [existing] guidelines by calling for a response to comment package for all influential risk assessments, and also in its call not only to explain the basis for the agency position, but also to explain why other approaches were not taken, and why")
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From page 100... ...
If additional one-way communication is undertaken at the end of an assessment process, to make the results available to a wider (or less knowledgeable) audience, additional resources and time will be necessary to ensure that the materials are prepared in a scientifically sound way.37 Here, as elsewhere in this discussion, committee reserva 35 This concern is greatly increased by public comments requesting that judicial review be considered a component of this process, further converting the scientific process into a legal one.
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From page 101... ...
, risk assessors may be greatly delayed in completing their work. Another example of the burden that would be imposed by the bulletin is the provision that for every risk assessment document (again, defined to include not just complete risk assessments but also individual components)
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From page 102... ...
generally bases its regulatory decisions on a range of central estimates of risk derived from the best supported models and that it is unclear how quantitative uncertainty distributions would be taken into account in OSHA's regulatory framework.
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From page 103... ...
The committee has identified a number of ways in which implementation of the overarching risk assessment principles can improve risk assessment practices but finds that the potential for benefits will vary widely among agencies and that, although salutary in some respects, the proposed bulletin will probably not achieve the objective of raising all agency risk assessment practices to consistently higher levels. In addition, the committee has identified some of the costs associated with the changes that would be brought about -- in staff resources, timeliness of risk assessments, and other factors -- and finds them to be substantial.
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From page 104... ...
1998. Guidelines for Ecological Risk Assessment.
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