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

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. "Appendix B: EPA Memorandum from Henry Habicht." Science and Judgment in Risk Assessment. Washington, DC: The National Academies Press, 1994.

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Page 374

The assumptions made in answering these postulated questions should not be confused with the assumptions made in developing a baseline estimate of exposure or with the adjustments in parameter values made in performing a sensitivity analysis. The answers to these postulated questions do not give information about how likely the combination of values might be in the actual population or about how many (if any) persons might be subjected to the calculated exposure or risk in the real world.

A calculation of risk based on specific hypothetical or actual combinations of factors postulated within the exposure assessment can also be useful as a risk descriptor. It is often valuable to ask and answer specific questions of the "what if" nature to add perspective to the risk assessment.

The only information the answers to these questions convey is that if conditions A, B, and C are assumed, then the resulting exposure or risk will be X, Y, or Z, respectively. The values for X, Y, and Z are usually fairly straightforward to calculate and can be expresses as point estimates or ranges. Each assessment may have none, one, or several of these types of descriptors. The answers do not directly give information about how likely that combination of values might be in the actual population, so there are some limits to the applicability of these descriptors.

References

1. National Research Council. Risk Assessment in the Federal Government: Managing the Process. 1983.

2. U.S. EPA. Risk Assessment and Management: Framework for Decision Making. 1984.

3. U.S. EPA. Risk Assessment Guidelines. 51 Federal Register 33992-34054. September 24, 1986.

4. Presentation of Risk Assessment of Carcinogens; Ad Hoc Study Group on Risk Assessment Presentation. American Industrial Health Council. 1989.

Page
374
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)