© 1997 by CRC Press, Inc. Fundamentals of Risk Analysis and Risk Management Edited by Vlasta Molak President GAIA UNLIMITED, Inc. Cincinnati, Ohio LEWIS PUBLISHERS Boca Raton New York London Tokyo L1130_FM.fm Page iii Thursday, August 12, 2004 9:23 PM © 1997 by CRC Press, Inc. Publisher: Joel Stein Project Editor: Carole Sweatman Marketing Manager: Greg Daurelle Direct Marketing Manager: Arline Massey Cover Design: Denise Craig PrePress: Carlos Esser Manufacturing: Sheri Schwartz Library of Congress Cataloging-in-Publication Data Molak, Vlasta. Fundamentals of risk analysis and risk management / Vlasta Molak. p. cm. Includes bibliographical references and index. ISBN 1-56670-130-9 (alk. paper) 1. Technology—Risk assessment. I. Title. T174.5.M64 1996 363.1—dc20 96-19681 CIP This book contains information obtained from authentic and highly regarded sources. Reprinted mate- rial is quoted with permission, and sources are indicated. A wide variety of references is listed. Reasonable efforts have been made to publish reliable data and information, but the authors, editor, and the publisher cannot assume responsibility for the validity of all materials or for the consequences of their use. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage or re- trieval system, without prior permission in writing from the publisher. All rights reserved. Authorization to photocopy items for internal or personal use, or the personal or in- ternal use of specific clients, may be granted by CRC Press, Inc., provided that $.50 per page photocopied is paid directly to Copyright Clearance Center, 27 Congress Street, Salem, MA 01970 USA. The fee code for users of the Transactional Reporting Service is ISBN 1-56670-130-9/97/$0.00+$.50. The fee is subject to change without notice. For organizations that have been granted a photocopy license by the CCC, a sep- arate system of payment has been arranged. CRC Press, Inc.’s consent does not extend to copying for general distribution, for promotion, for creat- ing new works, or for resale. Specific permission must be obtained from CRC Press for such copying. Direct all inquiries to CRC Press, Inc., 2000 Corporate Blvd., N.W., Boca Raton, Florida 33431. © 1997 by CRC Press, Inc. Lewis Publishers is an imprint of CRC Press No claim to original U.S. Government works International Standard Book Number 1-56670-130-9 Library of Congress Card Number 96-19681 Printed in the United States of America 1 2 3 4 5 6 7 8 9 0 Printed on acid-free paper L1130_FM.fm Page iv Thursday, August 12, 2004 9:23 PM © 1997 by CRC Press, Inc. Foreword My Uncle Steve, who worked on one of the government’s first computers, had his own mathematical system wherein he calculated the probability of a horse winning a race. Sometimes Uncle Steve won money on the horses. Sometimes he lost money on the horses. All of his winning and losing was done very scientifically: studying The Daily Racing Digest, calculating the odds according to such dependent variables (such as the track records of the stable, the trainer, the jockey, the horse, and the length of the race), and assigning proper weight to intervening variables (such as the condition of the track and weather at the time of the race). He did well. My Aunt Betty, who also did well at the track, used the time-honored “Hunch System of Equine Competition,” also known as intuition. “I’ve just got a feeling that this horse is due,” she would say to me during our frequent summer visits to Thistledown. All this risk taking with money, whether through science or intuition, can be best summed by the immortal tout who once said: “Ya places yer bets and ya takes yer chances.” And then there was Betty and Steve’s younger brother, Frank, (my father) who never bet on the horses because he believed all horse races were fixed. Risk analysis and risk management are, for most people, much more lofty and consequential than the outcome of a horse race. Nevertheless, Uncle Steve and Aunt Betty’s track assessment styles came to my mind when a nuclear scientist testifying before our Ohio Senate Energy and Environment committee claimed a planned multistate radioactive waste dump would be of little risk to Ohio. I thought of Uncle Steve and how he would have demanded the track record of the industry of contain- ment of nuclear waste in the past. I thought of Aunt Betty and what her instincts would have told her about whether it was the right time to bet on a long shot named Glows in the Dark. I thought of my father and his wariness about the fix being in. Thus I came to vote against Senate Bill 19. Informed opinions by the highly educated and much lettered are available to support nearly every point of view. Human decision-making is a terribly complicated matter. We all want to make the best decision. We would hope that the best decision is made on the basis of the best available information. Often it is. Sometimes it is not. In the chain reaction of real world decision-making, science collides with economics, which collide with politics, and the decision rests with that body of knowledge, which is (accidentally) left standing. Vlasta Molak has gathered together the works of some of the most impressive authors of papers on risk analysis and risk management in the world. Her writings and her compilation of the work of so many leading scientists in one complete volume is a public service, in that it enables both novice and expert to ponder the many and diverse factors that are at work in assessing, analyzing, and managing risk. This book will be useful to both legislators (local, state, and federal) and their staff to help devise better laws to protect the public, encourage responsible business development, and increase profits – rather than using risk analysis to promote status quo or reduce environmental safeguards. Several chapters that deal with economics and risk analysis have convinced me that being PRO-working average person and PRO-environmental protection is NOT L1130_FM.fm Page v Thursday, August 12, 2004 9:23 PM © 1997 by CRC Press, Inc. being ANTI-business. On the contrary, responsible and effective business organiza- tions profit from a loyal, well-trained work force and reasonable, smart environmen- tal regulations that encourage efficiency and nonpollution. Numerous studies, cited in this book, demonstrate that application of most enlighted environmental man- agement increases profits (since pollution is equivalent to wasted resources) and thus fiscal conservatism and emphasis on private property rights also mean increased environmental protection. Only in an unenlightened society are envi- ronmental safeguards mistakenly considered as opposed to business interests and free markets. Better business with cleaner environment is the paradigm for the 21st century. The old paradigm “business vs. environment” needs to be retired. Funda- mentals of Risk Analysis and Risk Management will help raise this awareness and finally bury the old nonproductive paradigm, which has been one of the major sources of controversy in our legislative process. I would recommend this book to my colleagues, who are often involved in designing very complex environmental and occupational protection laws, as a ref- erence and as a useful book to increase their analytical skills in dealing with the complexity of legislation, regulations, risk-benefit analysis, and risk management. Also, the wealth of references provided in this book can help us better understand how our laws affect our environmental and occupational safety and health, and ultimately our quality of life. Senator Dennis Kucinich Ohio State Senator L1130_FM.fm Page vi Thursday, August 12, 2004 9:23 PM © 1997 by CRC Press, Inc. Preface The idea for this book started as a consequence of my directing and teaching a one-day course on “Fundamentals of Risk Analysis” at the annual meetings of the Society for Risk Analysis (1991, 1992, and 1994). Also, teaching a course at the United Nations Division for Sustainable Development, New York, on “Use of Risk Analysis in Sustainable Development”, and teaching a course on “Environmental Risk Assessment and Management” at the University of São Paulo and University of Mato Grosso, Cuiába, Brazil, made me aware of the need for a reference that I could give to students to get a comprehensive overview of the field and lead them to valuable references if they wanted to increase their knowledge in specific aspects of risk analysis. Moreover, my position as Secretary of the Society for Risk Analysis (from 1989–1994) convinced me that there is a great need for integrating the rapidly expanding field of risk analysis and risk management, and for providing a common language for all the practitioners and members of this varied interdisciplinary pro- fessional group. The last few years have witnessed the concepts of risk analysis and risk man- agement permeating public discussion, often confusing decision makers and the public. When Lewis Publishers called me in 1995, after having seen the title of the course I taught at the SRA Annual Meeting in December 1994, and asked me to write a book on the subject of risk analysis and risk managment, I decided that the need for such a book was overwhelming, and that providing such a book would be a worthwhile project. Since no single person could accomplish such a monumental task of integrating the diverse fields of risk analysis and risk management, I asked my colleagues to help me write the chapters for which they were recognized experts in their particular practice of risk analysis and risk management. Most of them graciously agreed, or gave up under my incessant prodding. Some of them cancelled at the last moment, but I was fortunate to find new authors who were not intimidated by the task. With the miracle of Internet, I was able to bring in several authors from different parts of the world to help expand our understanding of how risk analysis is practiced around the world. After almost two years of work, we have completed the task of producing this book of 26 chapters, in which we cover the fundamentals of what is known as risk analysis and risk management in the contemporary western world. Most chapters also provide a summary, questions and answers to be used as tools in teaching courses in risk analysis. The glossary should also be helpful both to students and practitioners of risk analysis. Finally, the index should make it easier to focus on a particular area of the reader’s interest. The addresses of co-authors are given as an easy access for those readers and students of risk analysis who may have some questions. The E-mail addresses of some of the authors should be particularly useful for further communication. I want to thank all of the 20 co-authors who have graciously accepted the task of making their chapters understandable to an educated general reader, while at the same time providing references and in-depth discussion for those who want more detailed understanding. My work and discussions with them were very enlightening and fun. They have done an excellent job in educating me of the aspects of risk L1130_FM.fm Page vii Thursday, August 12, 2004 9:23 PM © 1997 by CRC Press, Inc. analysis of which I was not aware, and helping to deepen my understanding of different applications of risk analysis. Also, I want to thank Brian Lewis, who asked me to do this book before selling his company, Lewis Publishers, to CRC Press. My thanks go to the professionals at CRC Press, who have been very helpful in explain- ing the “nuts and bolts” of publishing and have been encouraging in finishing this work. Finally, I want to thank my daughter, Yelena, and Ohio State Senator, Dennis Kucinich for their review of some of my chapters and useful discussions and sug- gestions. They brought to my attention broader implications of the topics in this book of real life and political functioning in which risk analysis and risk management have become household words, frequently used without ever being properly defined and understood. Any mistakes found in this book are mine and unintentional, and I would appreciate if the reader brings them to my attention. We hope that this book will be a useful guide to all who want to improve their knowledge in confronting dangers of living, and particularly to those who make decisions that affect public safety and the general safety of this planet. The increased awareness and application of risk analysis and risk management can improve our understanding of the dangers that we face on our life journey and help us make better choices. Vlasta Molak L1130_FM.fm Page viii Thursday, August 12, 2004 9:23 PM © 1997 by CRC Press, Inc. The Editor Dr. Vlasta Molak is the International Coordinator and former Secretary of the Society for Risk Analysis (SRA). In 1989 she convened an international com- munication network to promote uses of risk analysis in solving some of the environmental problems result- ing from misuse of technology. On her several trips to Eastern Europe and the former Soviet Union, Dr. Molak initiated activities to start chapters of the SRA in Prague (Republic of Czech), Zagreb (Croatia), Osijek (Croatia), Warsaw (Poland), Budapest (Hun- gary), Moscow (Russia), and Kharkov (Ukraine) with interested scientists, engineers, and policy makers in those countries. Dr. Molak represented the U.S. at a four-day workshop on “How to improve environmental awareness of local decision makers in Eastern Europe,” sponsored by the European Commission. Dr. Molak taught in a training program in Brazil, which was organized by Taft’s University Environmental Management Pro- gram, at the University of Cuiába and the University of São Paulo. The subject was “Environmental Risk Assessment and Risk Management” for professionals involved in Brazilian environmental management. She also taught a course at the United Nations headquarters (New York) on “The Use of Risk Analysis in Sustainable Development.” Dr. Molak is the founder and president of the Biotechnology Forum, Inc. in Cincinnati and chairs the Subcommittee for Technical Interpretation of the Local Emergency Planning Committee for Hamilton County, Ohio. Under her leadership, the Biotechnology Forum has organized series of lectures and workshops. One of the workshops, “The Alaska Story: In the Context of Oil Spill Problems in the Marine Environments,” with special emphasis on the biological cleanup efforts, resulted in the proceedings edited by Dr. Molak. As a chair of the Subcommittee for Technical Interpretation, Dr. Molak initiated the efforts for hazard analysis in Hamilton County, Ohio and formulated the strategy for hazard analysis. She was a member of the Planning Committee for Comparative Risk Analysis for Hamilton County (Cincinnati, Ohio) and a member of the Quality of Life Committee of the Ohio Comparative Risk Analysis Project. She presently is coordinating the efforts to deal with more complex aspects of chemical safety: process safety in manufac- turing, transportation of hazardous materials, and adverse effects of routine chronic releases of toxic chemicals. Dr. Molak has worked at the U.S. Environmental Protection Agency and the National Institute for Occupational Safety and Health (NIOSH) on developing methodologies for risk analysis of toxic chemicals. These methodologies are used to derive various environmental and occupational criteria. Dr. Molak also worked for a private environmental consulting company and now is the founder and pres- ident of GAIA UNLIMITED, Inc., her own consulting company dealing with environmental and occupational risk assessment, risk management, and general L1130_FM.fm Page ix Thursday, August 12, 2004 9:23 PM © 1997 by CRC Press, Inc. environmental problems including strategies for pollution prevention. She is teach- ing various courses for risk analysis (including courses for local and state govern- ments). She is also developing the AGENDA 21 PROGRAM as a dean at the Athena University, based entirely on the Internet. It is intended to be a fully accredited program promoting ideas and operational skills necessary for sustainable development. Her training is interdisciplinary: she has a B.S. in physical engineer- ing, an M.S. in chemistry, a Ph.D. in biochemistry, and postdoctoral training in molecular genetics. Dr. Molak is a Diplomat of the American Board of Toxicology (DABT). L1130_FM.fm Page x Thursday, August 12, 2004 9:23 PM © 1997 by CRC Press, Inc. Contributors Joseph Alvarez, Ph.D. Auxier & Associates Parker, Colorado 80134 E-mail: jalverez@rmii.com Vicki M. Bier, Ph.D. Department of Industrial Engineering Department of Nuclear Engineering and Engineering Physics University of Wisconsin–Madison Madison, Wisconsin 53706 E-mail: bier@ie.wisc.edu William E. Dean, Ph.D. Private Consultant Sacramento, California 95814 E-mail: billdean@calweb.com Paul F. Deisler, Ph.D. Private Consultant Austin, Texas 78703 Jeffrey H. Driver, Ph.D. Technology Sciences Group, Inc. Washington, D.C. 20036 E-mail: TSG@TSGUSA.com Paul K. Freeman, J.D. The ERIC Group, Inc. Englewood, Colorado 80112 B. John Garrick, Ph.D. PLG, Inc. Newport Beach, California 92660 E-mail: garrick@plg.com Herman J. Gibb, Ph.D. National Center for Environmental Assessment U.S. Environmental Protection Agency Washington, D.C. 20460 E-mail: gibb.herman@epamail.epa.gov P. J. (Bert) Hakkinen, Ph.D. Department of Risk, Policy, and Regulatory Sciences The Procter and Gamble Company Ivorydale Technical Center Cincinnati, Ohio 45224 E-mail: hakkinen.pj@pg.com Barbara Harper, Ph.D., DABT Department of Health Risk Pacific Northwest Laboratory Richland, Washington 99352 E-mail: bl_harper@pnl.gov Peter Barton Hutt, LL.M. Covington & Burling Washington, D.C. 20044 Howard Kunreuther, Ph.D. Center for Risk Management and Decision Processing Wharton School University of Pennsylvania Philadelphia, Pennsylvania 19104 E-mail: kunreuther@wharton.upenn.edu Robert T. Lackey, Ph.D. Environmental Research Laboratory U.S. Environmental Protection Agency Corvallis, Oregon 97333 E-mail: lackey.robert@epamail.epa.gov Howard Latin, J.D. John J. Francis Scholar Rutgers University School of Law at Newark Newark, New Jersey 07102 E-mail: latin@andromeda.rutgers.edu Terence L. Lustig, Ph.D. Environmental Management Pty. Ltd. Kensington, NSW, Australia E-mail: TLUSTIG@ZETA.ORG.AU L1130_FM.fm Page xi Thursday, August 12, 2004 9:23 PM © 1997 by CRC Press, Inc. Stuart C. MacDiarmid, Ph.D. Department of Regulatory Authority Ministry of Agriculture Wellington, New Zealand E-mail: macdiarmids@ra.maf.govt.nz Vlasta Molak, Ph.D. GAIA UNLIMITED, Inc. Cincinnati, Ohio 45231 E-mail: vlasta@tso.cin.ix.net Alexander Shlyakhter, Ph.D. Department of Physics Harvard Center for Risk Analysis Harvard University Cambridge, Massachusetts 02138 E-mail: shlyakhter@huhepl.harvard.edu Paul Slovic, Ph.D. Decision Research Eugene, Oregon 97401 E-mail: pslovic@oregon.uoregon.edu James A. Swaney, Ph.D. Department of Economics Wright State University Dayton, Ohio 45435 E-mail: jswaney@desire.wright.edu David Vose, M.Sc. Risk Analysis Services Wincanton, Somerset United Kingdom BA9 9AP E-mail: 100616.320@compuserve.com Gary K. Whitmyre, M.A. Technology Sciences Group, Inc. Washington, D.C. 20036 E-mail: tsg@cais.com Richard Wilson, Ph.D. Department of Physics Harvard Center for Risk Analysis Harvard University Cambridge, Massachusetts 02138 E-mail: wilson@huhepl.harvard.edu Rae Zimmerman, Ph.D. New York University Robert F. Wagner Graduate School of Public Service New York, New York 10003 E-mail: zimmerman@is2.nyu.edu L1130_FM.fm Page xii Thursday, August 12, 2004 9:23 PM [...]... Interests and Treaty-Reserved Rights in Risk Management Barbara L Harper Chapter IV.6 Global Use of Risk Analysis for Sustainable Development Vlasta Molak Conclusion Vlasta Molak Answers to Questions Glossary © 19 97 by CRC Press, Inc L 113 0ChI .1. fm Page 11 Thursday, August 12 , 2004 10 :05 PM Section I Theoretical Background of Risk Analysis © 19 97 by CRC Press, Inc L 113 0ChI .1. fm Page 13 Thursday, August 12 ,... Environmental and Related Programs 19 85 Risk Assessment and Risk Management of Toxic Substances A Report to the Secretary Department of Health and Human Services April 19 85 IRIS 19 95 On-Line Integrated Risk Information System User Support tel 513 /56 9-7 254 Johannsen F.R 19 90 Risk Assessment of Carcinogenic and Non-Carcinogenic Chemicals Critical Reviews in Toxicology 20(5):3 41 366 NAS 19 83 Risk Assessment in the... Criteria and Assessment Office NTIS PB8 912 6585XSP U.S EPA, FEMA, DOT 19 87 Technical Guidance for Hazard Analysis Washington DC: Government Printing Office U.S EPA 19 88a Evaluation of Potential Carcinogenicity of Acrylonitrile Office of Health and Environmental Assessment NTIS PB9 318 1631XSP U.S EPA 19 88b Development of Maximum Contaminant Levels Under the Safe Drinking Water U.S EPA Office for Cooperative Management. .. DC, 19 88 U.S Environmental Protection Agency, Workshop on EPA Guidelines for Human Risk Assessment: Case of Human Evidence, EPA/625/ 3-9 0/ 017 , Risk Assessment Forum, Washington, DC, 19 89 © 19 97 by CRC Press, Inc L 113 0ChI.2.fm Page 31 Wednesday, September 1, 2004 10 :30 PM U.S Environmental Protection Agency, Proposed Guidelines for Carcinogen Risk Assessment, 19 96, Federal Register 6(79) :17 960 18 011 Vine,... II.4 Use of Risk Analysis in Pollution Prevention Vlasta Molak Chapter II.5 Integrated Risk Analysis of Global Climate Change Alexander Shlyakhter and Richard Wilson Chapter II.6 Computer Software Programs, Databases, and the Use of the Internet, World Wide Web, and Other Online Systems P J (Bert) Hakkinen III RISK PERCEPTION, LAW, POLITICS, AND RISK COMMUNICATION Chapter III .1 Risk Perception and Trust... DC: National Academy Press NIOSH 19 90 NIOSH Pocket Guide to Chemical Hazards U.S Department of Health and Human Services OSHA 19 89 Air Contaminants; Final Rule (Codified at 29 CFR 19 10) Federal Register 54:2332–2983 RTECS 19 95 Registry of Toxic Effects of Chemical Substances-On-Line Toxicology Information Program National Library of Medicine tel 3 01/ 49 6 -1 13 Stayner L 19 92 Methodological Issues in Using... decrease the concentrations of pollutant The magnitude of risk can be estimated by comparing the particular exposure to derived criteria or reference doses © 19 97 by CRC Press, Inc L 113 0ChI .1. fm Page 15 Thursday, August 12 , 2004 10 :05 PM 2 TOXICOLOGICAL BASES OF TOXIC SUBSTANCES RISK ANALYSIS Over 11 0,000 chemicals are used in U.S commerce The Registry of Toxic Effects of Chemical Substance (RTECS)... Epidemiology and Cancer Risk Assessment Herman J Gibb Chapter I.3 Uncertainty and Variability of Risk Analysis Richard Wilson and Alexander Shlyakhter Chapter I.4 Monte Carlo Risk Analysis Modeling David Vose Chapter I.5 An Overview of Probabilistic Risk Analysis for Complex Engineered Systems Vicki M Bier Chapter I.6 Ecological Risk Analysis Robert T Lackey Chapter I.7 The Basic Economics of Risk Analysis James... III.7 Science, Regulation, and Toxic Risk Assessment Howard Latin IV RISK MANAGEMENT Chapter IV .1 Risk Management of the Nuclear Power Industry B John Garrick Chapter IV.2 Seismic Risk and Management in California William E Dean Chapter IV.3 Sustainable Management of Natural Disasters in Developing Countries Terrence L Lustig Chapter IV.4 Risk Analysis, International Trade, and Animal Health Stuart C... cause cancer However, the probability of getting cancer at low exposure concentrations may be so low as to be of no practical concern The U.S EPA defines negligible risk for cancer as that smaller than 1: 1,000,000 (U.S EPA 19 80), and for OSHA a risk of less than 1: 1000 is “acceptable” (OSHA 19 89) This is a policy decision and has nothing to do with the science of risk analysis The U.S EPA has used a multistage . Questions Glossary L 113 0_FM.fm Page xvii Thursday, August 12 , 2004 9:23 PM © 19 97 by CRC Press, Inc. Section I Theoretical Background of Risk Analysis L 113 0ChI .1. fm Page 11 Thursday, August 12 , 2004 10 :05 PM © 19 97. as a consequence of my directing and teaching a one-day course on Fundamentals of Risk Analysis at the annual meetings of the Society for Risk Analysis (19 91, 19 92, and 19 94). Also, teaching. Schwartz Library of Congress Cataloging-in-Publication Data Molak, Vlasta. Fundamentals of risk analysis and risk management / Vlasta Molak. p. cm. Includes bibliographical references and index. ISBN 1- 5 667 0 -1 3 0-9