Risk Assessment in the Federal Government Managing the Process Working Papers (1983) / Chapter Skim
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An Anatomy of Risk Assessment: Scientific and Extra-Scientific Components in the Assessment of Scientific Data on Cancer Risks
An Anatomy of Risk Assessment: Scientific and Extra-Scientific Components in the Assessment of Scientific Data on Cancer Risks
Pages 83-102
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From page 83... ...
The paper covers three areas: · the inherent structure of risk assessment · the relationship of scientific judgment and "value" judgment in risk assessment · some implications for the organization and management of risk assessment APPROACH Regulation -- and the rule of law more generally -- demands s implification. lathe regulation of potential public health risks often demands simple categorical findings ~ for example, whether a particular chemical is carcinogenic or not)
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From page 84... ...
, which are listed in ache attachment . The components fal ~ into three analytically distinct activities O hazard identification, dose-response assessment, and exposure assessments Hazard identification involves the qualitative determination of whether a particular agent causes a particular adverse effect in humans.
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From page 85... ...
In truth, however, an analyst's discretionary judgments unavoidably enter an assessment at many points, whether or not they are explicitly presented and subjected to scrutiny. In fact 20 of the components normal ly require discretionary choices (whether implici t or explicit ~ for every quantitative risk assessment that involves both animal and human effects studies.
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From page 86... ...
I f only animal data are available and a quint itative assessment is performed, 15 mandatory choices remain. For the hazard identification phase alone, 10 mandatory components present themselves (7 for bioassay data, 3 for human effects data)
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From page 87... ...
seem relati~rely clearly to apply to the unitary risk assessment -- that is, they apply to multiple data types for a particular substance, but not across subs lances. Example: Component 16 weighs physiological extenuations for a particular chemical risk.
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From page 88... ...
Component 7 requires decisions in assessing animal data in the case that the route of exposure in the study data is different from that o ~ regulatory concern. Some rules of thumb may be desirable (eggs, don't rely too much on studies involving derreal exposures for assessing airborne human exposures)
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From page 89... ...
These findings have implications for the administrative management of risk assessment. Because so many specialized fields may be direct by relevant, it may prove difficult for agencies to engage experts on all the relevant fields in the units that conduct risk assessments, or for groups that review risk assessments to ensure that all relevant disciplines are represented.
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From page 90... ...
SCIENCE ANSI VALUE IN RISK ASSESSMENT [there has been much debate offer whether risk assessment is 'iscientific" or "political" in nature, and, therefore, whether scientists or politically accountable officials should have the final authority in performing assessments. Familiar assertions in the current debate over risk assessment include these: Risk assessment is inherently scientific in nature; it should be done in isolation from political influences, which can only distort true scientific judgments lathe basic problem in risk assessment is that political appointees in the agenc ies conceal their value judgments under the mantle of science.
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From page 91... ...
Since so fence canno t ful ly charac terize care inogenes is, there is no alternative but to apply value judgments in areas of sci~nti fic uncertainty . As in most controversies, there is probably an element of truth in each of these conflicting observations.
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From page 92... ...
A handful of components are seen as pure value judgments. Six components (59 24, 30, 32, 34, 36)
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From page 93... ...
No one doubts that pathology should be left Deco qualified pathologists; however, there is some scientific variation in the way different component pathologic ts characterize the same results -- a difference they perceive as based solely on scientific considerations, not personal values. However, the differences correspond to different levels of conser~ratism about risk, the key value judgment; this forces a choice among different pathologists' findings, and that secondary choice i tsel f may be af fected by value cons iderat ions .
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From page 94... ...
A component is 'iscientific" if, in practice, it mus t be determined by scientists because lay persons cannot be easily trained to understand all the complex factors that must be considered In making a final choice O (For example, lawyers cannot be expected to learn to read bioassay tissue slides co -- petently and must, for this reason, defer to pathologists. ~ The general ques tion in the s tudy pert armed by the Cocci ttee on the Institutional Means for Assessment of Risks to Public Health may be viewed as, ''What elements in a risk assessment should be left to the scientists to decide?
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From page 95... ...
t' For all the components seen as reflecting "value judgment," the underlying question appears to be how conservative a judgment to make in the face or scientific uncertainty. The choice for these components in essentially a matter of determining whether to employ principles of risk-averseness, which would lead to the use of worstcase assumptions, or whether principles of risk-tolerance should be emp toyed .
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From page 96... ...
2. Risk assessments should routinely be reviewed by some body of scientific experts, which should ascertain 'whether the assumptions made are con~ is tent with current science O 30 Ultimate responsibility for all assumptions made should be borne by policy officials in order to ensure that any value judgments applied are subject to democratic processes.
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From page 97... ...
Tactic holds when two or three interspecies conversion factors are possible, the calculation should be done two or three ways, and each value carried forward -- presumably in tabular form -- for the decision-maker to choose among on policy grounds O The P Tactic is useful where there are only a few sources of uncertainty in a risk assessment.
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From page 98... ...
* A mandatory consideration if bioassay results are present.
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From page 99... ...
* A mandatory consideration if bioassay results are present.
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From page 100... ...
General 21) Mat relative weights should be given to available human, bioassay, and other test indicators in concluding whether a chemical is a carcinogen?
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From page 101... ...
Express ion of Overall Resul ts 34) What are the statistical uncertainties in the assessment, and how should the range of uncertainty be presented?
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