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Appendix N-2: Making Full Use of Scientific Information in Risk Assessment
Pages 629-640

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From page 629...
... Neither we nor others on the CAPRA Committee have asserted that these EPA risk assessment procedures are inappropriate. Rather CAPRA has sought to strengthen EPA's risk assessment process through further refinements.
From page 630...
... It is assumed in Appendix N-1 that the fundamental output of a risk assessment is a single estimate of risk: one number. We take a very different view, that risk assessment is a process for summarizing the available scientific information in both qualitative and quantitative form, for risk managers and for interested members of the public.
From page 631...
... The approach we are advocating contrasts sharply with the approach advocated by Dr. Finkel, which introduces into the risk assessment process an additional standard: whether the alternative based on the scientific information yields a plausible, conservative estimate of risk.
From page 632...
... These guidelines are based on general scientific knowledge and applied to assure consistency in the development of multiple risk assessments. It is our understanding that EPA has selected default options that are scientifically plausible and conservative in the sense that they are intended to avoid underestimating health risks.
From page 633...
... We view the extent of conservatism in risk assessment guidelines as a policy issue to be determined by EPA, most appropriately through notice and comment rulemaking in the same manner as when EPA risk assessment guidelines were adopted in 1986. The proposal in Appendix N-1 does not give precise guidance for establishing default options or for departing from these defaults.
From page 634...
... Scientists should not attempt to resolve risk management disputes by influencing the choice of default options or the criteria for departure from default options. The Use of an Iterative Approach, in which Specific Science Displaces Default Options and Provides a Means to Improve Risk Assessments and Reduce Uncertainty in Risks The CAPRA report advocates the conduct of iterative risk assessments matched to decision-making needs.
From page 635...
... We oppose this aspect of his proposal, especially for the upper tiers of risk assessment. The goal for risk assessment should be to inform decision makers and the public, not to give them a number.)
From page 636...
... Within the risk management context if not within risk assessment, it may be useful to characterize the judgment of knowledgeable scientists in terms of a subjective probability. Suppose there is a consensus among scientists that the probability is p that the risk is at or near zero.
From page 637...
... · Scientific information, to the extent it is available, should be used as much as feasible in the risk assessment process. · When differences of scientific opinion exist on the use or interpretation of scientific information or hypotheses, these should be clearly documented in the risk assessment process and the impact on risk characterization identified.
From page 638...
... A recent OTA report, Researching Health Risks (OTA, 1993) , addressed the issue of conducting targeted research of this kind both as related to specific chemicals but also as a means of improving risk assessment methodology.
From page 639...
... 639 ._ cn C.)
From page 640...
... 1986. Guidelines for carcinogen risk assessment.


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