Risk Assessment in the Federal Government Managing the Process (1983) / Chapter Skim
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4 Recommendations
4 Recommendations
Pages 150-176
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From page 150... ...
Because risk assessment is only one aspect of risk management decision-making, however, even greatly improved assessments will not eliminate dissatisfaction with risk management decisions The Committee believes that the basic problem with risk assessment is not its administrative setting, but rather the sparseness and uncertainty of the scientific knowledge of the health hazards addressed. Reorganization of the risk assessment function will not create the data and underlying knowledge that assessors need to make risk assessments more precise.
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From page 151... ...
IMPROVING RISK ASSESSMENT THROUGH PROCEDURAL CHANGES BECOMME:NDATION 1 Regulatory agencies should take steps to establish and maintain a clear conceptual distinction between assessment of risks and the consideration of risk management alternatives; that is' the scientific findings and policy judgments embodied in risk assessments should be explicitly distinguished from the political, economic, and technical considerations that influence the design and choice of regulatory strategies. Although the Committee concludes that risk assessment cannot be made completely free of policy considerations, it also believes that policy associated with specific risk management decisions should not influence risk assessment unduly.
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From page 152... ...
Moreover, direct communication with the risk assessors is desirable to ensure that the regulatory decision-maker understands the relative quality of the available scientific evidence, the degree of uncertainty implicit in the final risk assessment, and the sensitivity of the results to the assumptions that have been necessary to produce the assessment. Such separation could also impair the risk manager's ability to obtain assessments that are tamely and in a useful form.
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From page 153... ...
. Although agencies commonly perform risk assessments before they take regulatory actions, the written assessments that are prepared vary in coverage, amount of explanatory detail, format, and completeness to an extent that limits their use as instruments of communication.
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From page 154... ...
Second, a written assessment can help to distinguish the factual basis of a risk assessment from inferences drawn where there is a lack of scientific consensus; this distinction will facilitate scientific review of the risk assessment, document the scientific basis of the assessment for outside observers, and acquaint the regulatory decisions maker with the relative completeness of the scientific evidence. Third, it will aid communication among specialists working on different parts of the assessment.
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From page 155... ...
. We suggest that EPA prepare a written assessment for every major and significant action, and we encourage other agencies to devise similar methods of identifying which regulatory actions require written assessments.
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From page 156... ...
Such review should contribute to the important distinction between risk assessment and risk management, because risk management information would be excluded from the review; should improve the scientific quality of the assessments through the process of criticism and response; and should increase the credibility of agency assessments. The practice of preparing written risk assessments will facilitate the review process.
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From page 157... ...
Panel Composition and Selection . Members of a scientific review panel should be selected for their competence in fields relevant to the assessment of risks of the kind being evaluated.
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From page 158... ...
Therefore, the Committee recommends that every action, including a decision not to regulate, that requires a written risk assessment be available for independent scientific review. A scientific review pane1's agenda may also include risk assessments for other decisions of interest to panel members, or its review could be initiated after a request by a third party.
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From page 159... ...
Experience suggests that agencies are less receptive to criticism of the basis of their actions af ter they have announced a proposed course of action. Furthermore, although index pendent review can some times forestall misguided regulatory actions even after they are initiated, prior review of such actions may help to avoid serious damage to agency credibility and unnecessary costs to private interests that would be adversely affected by public proposals for regulatory action.
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From page 160... ...
Consideration should be given to modifying both requirements or exempting such panels from the Act, as Congress did for CPSC's Chronic Hazard Advisory Panels. RECOMMENDATION 4 When two or more agencies share interest in and iurisdiction over a health hazard epae i~ ~ c~nd~e tor cegulation by them in the near term, a joint risk assessment should be Prepared under the auspices of Me National Toxicology Program or another aPuropr~ate organization.
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From page 161... ...
We suggest that the National Toxicology Program be the usual vehicle for coordinating preparation of joint risk assessments. The National Toxicology Program has been in operation for several years and, In the Committee's judgment, has performed capably as coordinator of federal toxicologic research.
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From page 162... ...
Guidelines could help to separate risk assessment from risk management considerations, improve public understanding of the process, foster consistency, and prevent oversights and judgments Mat are inconsistent with current scientific thought. The development and application of guidelines would help to focus discussion by the public and tile scientific community on the generic issues of risk assessment, outside the some tomes charged context of particular regulatory decisions.
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From page 163... ...
Furthermore, uniform federal guidelines could help to harmonize the current development of risk assessment methods by an increasing number of state programs. Uniform guidelines should be prepared for hazard identif ~cation, dose~response assessment, and risk characterization.
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From page 164... ...
The Committee believes that guidelines can lead to risk assessments that clearly delineate the limits of current scientific knowledge and the policy basis for choosing among inference options. Comprehensive and Detailed Nature Comprehensive, detailed guidelines are needed to delineate risk assessment as a process distinct from risk management.
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From page 165... ...
lines, which permit no variation, might preclude the consideration of relevant scientific information peculiar to a particular chemical and thus force assessors to use inference options that are not appropriate in a given case. Also, rigid guidelines might mandate the continued use of concepts that become obsolete with new scientif ic developments.
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From page 166... ...
For these, the choice among inference options can have substantial policy ramifications. Thus, we recommend a
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From page 167... ...
When the board finds no general scientific agreement on the available inference options, ~ t should recommend against the use of options that are scientifically unsupportable and comment on the relative strength of the scientific support For the options that remain.* Agency Adootion The Committee envisions that the second step in the establishment of guidelines w'11 be in the hands of the *
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From page 168... ...
We thus see advantage in coordination of the agencies' adoption of guidelines by a single, central authority such as the Office of Science and Technology Policy, or by a mechanism designated by Congress. The Committee believes that adopting the guidelines as established procedures, rather than as formal regu~ations, would have several important advantages: it would allow guidelines to be adopted and amended more easily; it would bind the agencies to adhere to the guidelines until they were reviewed and revised (thus fostering predictability and consistency -- any agency's failure to comply with its own guidelines could be noted by index pendent scientific review panels and could be cited as grounds for interested parties' legal appeal of an associated regulatory decision)
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From page 169... ...
Such review should follow the same procedures recommended for the initial guidelines, including ultimate agency adoption af ter public comment. RECOMMENDATION 8 l The Committee recommends that guidelines initially be developed, adopted, and applied for assessment of cancer risks.
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From page 170... ...
Bowever, the other health effects that result from exposure to hazardous substances are equally amenable to prevention by regulatory action. Guidelines are desirable for these types of effects, which include mutagenicity, reproductive and teratogenic effects, neurotoxicity, and behavioral changes.
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From page 171... ...
are used by programs in the agencies with various degrees of sophistication and validation. Each agency or each prom gram in an agency should develop mediumrspecific guidelines to stimulate evolutionary improvement, increase consistency and predictability, and isolate the choice among inference options from inappropriate risk management considerations.
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From page 172... ...
Board Functions We foresee four major functions for the Board. The first two, scientific review and development of recommended guidelines, would pursue the process described above for ache initial generation of inference guidelines (Rec~en~ cation 7)
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From page 173... ...
The policy difficulties in regulating chronic health hazards can be resolved only if uncertainty in the scientific basis of assessments i s reduced. Board activities could take such forms as advising funding agencies on research priorities, c~mmiss~oning survey papers to synthesize recent scientific findings, and sponsoring conferences or special publications on particularly apt scientific questions or on matters that are important to risk assessment, but have been neglected by the scientif ic commune ty.
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From page 174... ...
co~ission on risk assessment methods could attract eminent scientists to service and could be designed to balance viewpoints, but would lack permanence and policy experience. Professional societies constitute another class of possible candidates, but they generally have limited familiarity with policy studies.
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From page 175... ...
Qualifications of Sobers We recommend that the Board consist of scientists with training and experience in the various disciplines involved in the process of risk assessment, including biostatistics, toxicology, epidemiology, environmental engineering, and clinical medicine. Other relevant fields -- such as law, ethics, and the social sciences-should be included to ensure due apprec cation of the policy context of Board activities.
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