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

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NATIONAL ACADEMY PRESS · 2101 Constitution Ave., N.W. · Washington, D.C. 20418

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

The project was supported by the U.S. Environmental Protection Agency under contract CR818293-01-0.

Library of Congress Cataloging-in-Publication Data

Science and judgment in risk assessment / Committee on Risk Assessment
of Hazardous Air Pollutants, Board on Environmental Studies and
Toxicology, Commission on Life Sciences., National Research Council.
p. cm
Includes bibliographal references and index.
ISBN 0-309-04894-X
1. Air—Pollution—Toxicology—United States—Statistical methods.
2. Health risk assessment—Statistical methods. I. National
Research Council (U.S.). Committee on Risk Assessment of Hazardous
Air Pollutants.
RA576.S365 1994
363.73'92'0973—dc20
94-17475
CIP

Copyright 1994 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

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II
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)