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Science and Judgment in Risk Assessment (1994)
Board on Environmental Studies and Toxicology (BEST)

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. "7 Models, Methods, and Data." Science and Judgment in Risk Assessment. Washington, DC: The National Academies Press, 1994.

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Page 143

Potency Estimates

EPA uses estimates of a chemical's potency, derived from the slope of the dose-response curve, as a single value in the risk-assessment process.

EPA should continue to use potency estimates—i.e., unit cancer risk—to estimate an upper bound on the probability of developing cancer due to lifetime exposure to one unit of a carcinogen. However, uncertainty about the potency estimate should be described as recommended in Chapter 9.

Although EPA routinely cites available human evidence, it does not always rigorously compare the quantitative risk-assessment model based on rodent data with available information on molecular mechanisms of carcinogenesis or with available human evidence from epidemiological studies.

Because the validity of the overall risk-assessment model depends on how well it predicts health effects in the human population, EPA should acquire additional expertise in areas germane to molecular and mechanistic toxicology. In addition, EPA should also acquire additional epidemiological data to assess the validity of its estimates of risk. These data might be acquired in part by formalizing a relationship with the National Institute for Occupational Safety and Health to facilitate access to data from occupational exposures.

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143
Front Matter (R1-R16)
Executive Summary (1-15)
1 Introduction (16-22)
Part I Current Approaches to Risk Assessment: 2 Risk Assessment and its Social and Regulatory Contexts (23-42)
3 Exposure Assessment (43-55)
4 Assessment of Toxicity (56-67)
5 Risk Characterization (68-78)
Part II Strategies for Improving Risk Assessment: 6 Default Options (79-105)
7 Models, Methods, and Data (106-143)
8 Data Needs (144-159)
9 Uncertainty (160-187)
10 Variability (188-223)
11 Aggregation (224-242)
Part III Implementation of Findings: 12 Implementation (243-268)
References (269-286)
Appendix A: Risk Assessment Methodologies: EPA (287-350)
Appendix B: EPA Memorandum from Henry Habicht (351-374)
Appendix C: Calculation and Modeling of Exposure (375-382)
Appendix D: Working Paper for Considering Draft Revisions to the U.S. EPA Guidelines for Cancer Risk Assessment (383-448)
Appendix E: Use of Pharmacokinetics to Extrapolate from Animal Data to Humans (449-452)
Appendix F: Uncertainty Analysis of Health Risk Estimates (453-478)
Appendix G: Improvement in Human Health Risk Assessment Utilizing Site- and Chemical-Specific Information: A Case Study (479-502)
Appendix H-1: Some Definitional Concerns About Variability (503-504)
Appendix H-2: Individual Susceptibility Factors (505-514)
Appendix I: Aggregation (515-536)
Appendix J: A Tiered Modeling Approach for Assessing the Risks Due to Sources of Hazardous Air Pollutants (537-582)
Appendix K: Science Advisory Board Memorandum on the Integrated Risk Information System and EPA Response (583-590)
Appendix L: Development of Data Used in Risk Assessment (591-598)
Appendix M: Charge to the Committee (599-600)
Appendix N-1: The Case for (601-628)
Appendix N-2: Making Full Use of Scientific Information in Risk Assessment (629-640)
Index (641-652)