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

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National Research Council. "Part I Current Approaches to Risk Assessment: 2 Risk Assessment and its Social and Regulatory Contexts." Science and Judgment in Risk Assessment. Washington, DC: The National Academies Press, 1994. 1. Print.

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2
Risk Assessment and Its Social and Regulatory Contexts

This chapter provides an overview of the origins and uses of quantitative risk assessment and the problems associated with it. Historical perspective is offered to aid understanding of how a method infused with so much uncertainty has still come to be seen by many as useful. Some attention is devoted to the important questions of how risk assessment has been used in decision-making and whether its use has improved decisions. The issues of public acceptance of the method and the degree to which decisions based on it are seen to provide adequate protection of the public health are also addressed. This chapter lists the major criticisms of risk assessment and the ways in which its results have been used, thus providing the justification for the selection of issues discussed in the succeeding chapters.

General Concepts

This section briefly discusses some basic definitions and concepts concerning human-health risk assessment, its content, and its relationships to research and to decision-making. The definitions and concepts were first systematically formulated by a National Research Council committee in a report issued in 1983, Risk Assessment in the Federal Government: Managing the Process. The Red Book had a major influence on the practice of risk assessment and will be discussed extensively in this section of the report.

What is Risk Assessment?

Human-health risk assessment entails the evaluation of scientific information on the hazardous properties of environmental agents and on the extent of

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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)
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