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

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. "Part II Strategies for Improving Risk Assessment: 6 Default Options." Science and Judgment in Risk Assessment. Washington, DC: The National Academies Press, 1994.

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Page 105

Alternatives to Default Options

FINDING: EPA's practice appears to be to allow departure from a default option in a specific case when it ascertains that there is a consensus among knowledgeable scientists that the available scientific evidence justifies departure from the default option. EPA, though, has not articulated criteria for allowing departures.

RECOMMENDATION: The agency should consider attempting to give greater formality to its criteria for a departure, to give greater guidance to the public and to lessen the possibility of ad hoc, undocumented departures from default options that would undercut the scientific credibility of the agency's risk assessments. At the same time, the agency should be aware of the undesirability of having its guidelines evolve into inflexible rules.

Process For Departures

FINDING: EPA has relied on its Science Advisory Board and other expert bodies to determine when a consensus among knowledgeable scientists exists.

RECOMMENDATION: EPA should continue to use the Science Advisory Board and other expert bodies. In particular, the agency should continue to make the greatest possible use of peer review, workshops, and other devices to ensure broad peer and scientific participation to guarantee that its risk-assessment decisions will have access to the best science available through a process that allows full public discussion and peer participation by the scientific community,

Missing Defaults

FINDING: EPA has not stated all the default options in each step in the risk-assessment process, nor the steps used when there is no default. Chapters 7 and 10 elaborate on this matter and identify several possible "missing defaults."

RECOMMENDATION: EPA should explicitly identify each generic default option in the risk-assessment process.

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105
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)