Risk Assessment in the Federal Government Managing the Process (1983) / Chapter Skim
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Introduction
Introduction
Pages 9-16
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From page 9... ...
Some earlier regulatory programs had addressed exposure to toxic chemicals, but they were directed mainly at the risk of poisoning and other acute effects. Much policy-mak~ng related to such effects involved routine, short-term, acute animal studies to establish ~no-observed-effect" doses and then the straightforward calculation of allowable hen exposure based on the application of safety factors to relatively uncomplicated scientific findings.
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From page 10... ...
Many of the fundamental difficulties of regulatory risk assessment result from attempts to bend old laws and policies to fit newly perceived risks. For instance: · A regulatory framework based on she traditional approach involving norobserved-e~fect doses and safety factors is now being applied to health effects for which a no-effect dose cannot be demonstrated, except at zero exposure.
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From page 11... ...
INHERENT LIMITATIONS Uncertaintv The dominant analytic difficulty is pervasive uncertainty. Risk assessment draws extensively on science, and a strong scientific basis has developed for linking exposure to chemicals to chronic health effects.
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From page 12... ...
If an agency is considering new action on many substances at once, its scientific staff is stretched thin. Most agencies do not have the analytic resources to do a thorough risk assessment for priority-setting anc..~st rely on less formal methods to ensure that the highestrisk chemicals are examined first.
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From page 13... ...
Such groups insist that regulatory action need not await conclusive evidence of cause and effect and need not be based exclusively on the most scientifically advanced testing methods. Visible Economic Interests Although it is rarely known which individuals are likely to be saved from adverse health effects through a regulation that reduces exposure to a particular chemical, those who bear the economic costs of such restrictions can identify themselves without any difficulty.
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From page 14... ...
With a scientific base that is still evolving, with large uncertainties to be addressed in each decision, and with the presence of great external pressures, some see a danger that ache scientif ic interpretations i n risk aSses=~'ents will be distorted by policy considerations, and they seek new institutional safeguards against such distortion. Among the institutional reforms suggested, two major _;: an" Who focus of this refit: reorganization Acid ~ =~__ ~ ~ _ ~~ _ to ensure that r isk assessments are protected f ram inappropriate policy influences and development and use of uniform guidelines for carrying out risk assessments.
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From page 15... ...
Various approaches have been suggested, including creation of a single body outside the government for the performance or review of risk assessments, creat~on of a single government unit to conduct risk assessments for the entire government, and creation of separate risk assessment units in particular programs or agencies and systematic review of assessments by independent scientific advisory groups. The STODY This report responds to a congressional request to examine the merits of the two major types of Reform proposal.
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From page 16... ...
Remarks to the Committee on the Institutional Means for Assessment of Risks to Public Health.
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