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Environmental and Health Risk Assessment and Management: Principles and Practices (Environmental Pollution) PDF

494 Pages·2005·10.51 MB·English
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Environmental and Health Risk Assessment and Management ENVIRONMENTAL POLLUTION VOLUME9 Editors Brian J. Alloway,Department of Soil Science, The University of Reading, U.K. Jack T. Trevors,Department of Environmental Biology, University of Guelph, Ontario, Canada Editorial Board T. Anderson,The Institute of Environmental and Human Health, Texas Tech University, Lubbock, U.S.A. T.H. Christensen,Department of Environmental Science and Engineering, Danish Technical University, Lyngby, Denmark I. Colbeck,Institute for Environmental Research, Department of Biological Sciences, University of Essex, Colchester, U.K. K.C. Jones,Institute of Environmental and Natural Sciences, Lancaster University, U.K. W. Salomons,GKSS Research Center, Geesthacht, Germany The titles published in this series are listed at the end of this volume. Environmental and Health Risk Assessment and Management Principles and Practices by Paolo F. Ricci University of Queensland (NRCET) Brisbane, Australia and University of San Francisco San Francisco, California, USA Library of Congress Cataloging-in-Publication Data ISBN-10 1-4020-3775-9 (HB) ISBN-13 978-1-4020-3775-7 (HB) ISBN-10 1-4020-3776-7 (e-book) ISBN-13 978-1-4020-3776-4 (e-book) Published by Springer, P.O. Box 17, 3300 AADordrecht, The Netherlands. www.springeronline.com Printed on acid-free paper Copyright to individual chapters remain with the author. Copyright to the work as a whole remains with Springer. All Rights Reserved © 2006 Springer No part of this work may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording or otherwise, without written permission from the Publisher, with the exception of any material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Printed in the Netherlands. CONTENTS Preface xvii CHAPTER 1. LEGAL PRINCIPLES, UNCERTAINTY, AND VARIABILITY IN RISK ASSESSMENT AND MANAGEMENT 1 1.1. INTRODUCTION 3 1.1.1. Precautionary Acts as an Answer to the Principal Question 1.2. THE PRECAUTIONARY PRINCIPLE 5 1.3. VARIANTS OF THE PRECAUTIONARY PRINCIPLE: US law 7 1.3.1. Implications of Different Approaches to Precaution 10 1.3.2.De Minimis Risk, Significant Risk, and other Principles of Precaution 13 1.3.3. Disseminationof Information about Risk Assessment and Management 15 1.4. DIFFICULTIESWITH PRINCIPLESOF PRECAUTION 16 1.5. ELEMENTSOF RISK ASSESSMENT AND MANAGEMENT 18 1.6. UNCERTAINTY AND VARIABILITY 20 1.7. SCIENCE AND LAW: From scientific evidence to causation 23 1.7.1. Scientific Evidence: What can be legally admissible? 25 1.7.2. Scientific Evidence in Legal Causation 1.8. PROBABILITIES TO EXPRESSUNCERTAINTY AND VARIABILITY 30 1.8.1. Three Views about Probability 32 1.9. PRACTICAL ANALYSISOFUNCERTAINTY AND VARIABILITY 34 1.9.1. Bayesian Analysis 35 vi Environmental and Health Risk Assessment and Management 1.10. RISK ASSESSMENT AND RISK MANAGEMENT 36 1.11. CONCLUSION 37 CHAPTER 2. SUSTAINABILITY AND MAKING DECISIONSUNDER UNCERTAINTY 39 2.1.SUSTAINABILITY AND RISK MANAGEMENT 2.1.1. Indicators and Indices 43 2.2. VERIFICATION, VALIDATION, AND CONFIRMATION 46 2.3. LEGAL BALANCING OF RISKS, ECONOMIC COSTS, AND BENEFITS 48 2.4. CRITERIA FOR MAKING CHOICES IN RISK MANAGEMENT 52 2.5. A PARADIGM FOR DECISION-MAKING: The single decision-maker 57 2.6. PRACTICAL PROBABILISTIC REASONING: An elaboration .58 2.6.1. Comment 65 2.7.SCALESOF MEASUREMENT AND IMPLICATIONS FOR RISK ANALYSIS 2.8CONCLUSION 68 QUESTIONS 68 CHAPTER 3. RISK, COST, AND BENEFIT ANALYSIS (RCBA) IN RISK ASSESSMENT AND MANAGEMENT 71 3.1. INTRODUCTION 72 3.2. COST-BENEFIT ANALYSIS, CBA 75 3.2.1. Discussion 77 3.2.2. Discounting: Social rate of discount and the interest rate 81 3.2.3. Variability in CBA 82 3.2.4. Supply and Demand Analysis 84 3.2.5. Modeling Supply and Demand Statistically 91 3.3. EVALUATING NON-MARKET PRICED GOODS AND SERVICES 94 3.3.1. Comment 98 3.4. DEATH OR MORBIDITY AVERTED IN RCBA 99 Table of Contents vii 3.5. INTERGENERATIONAL EQUITY 101 3.6.SUBSIDIES 102 3.7. TAXATION 3.8. BUBBLES, TRADEABLE PERMITS, AND BANKING 105 3.9. CONCLUSION 108 QUESTIONS 110 CHAPTER 4. EXPOSURE-RESPONSE MODELS FOR RISK ASSESSMENT 113 4.1. INTRODUCTION 115 4.1.1. Discussion 119 4.1.2. Some Exposure-Response Models and Results for Air Pollution 4.1.3. The APHEA (Air Pollution and Health, a European Approach) 123 4.2. THE MAXIMUM LIKELIHOOD ESTIMATOR (MLE) 124 4.2.1. Likelihood Ratio 125 4.3. BASIC STATISTICAL FORMULAE (Also See Chapter11) 126 4.4. MODELING EMPIRICAL CAUSAL RELATIONS BETWEEN EXPOSURE AND RESPONSE 128 4.5. LOGISTIC REGRESSION: The Dependent Variable is Binary 132 4.5.1. Discussion 135 4.6. POISSON REGRESSION: The Dependent Variable Measures Counts of Rare Events 137 4.7.SURVIVAL ANALYSIS:Successes and Failures Over Time 141 4.7.1. Survival Analysis 141 4.7.2. Discussion of Hazard Functions and Distribution Functions 145 4.7.3. Comment 148 4.8. COX PROPORTIONAL (RELATIVE RISK) HAZARDS MODEL 149 4.9. TIME SERIES ANALYSIS 151 viii Environmental and Health Risk Assessment and Management 4.9.1. Time-Domain Analysis of Time Series, ARIMA 152 4.9.2. The Moving Average, MA, Process 154 4.9.3. The Auto Regressive, AR, Process 154 4.9.4. Simple ARMA Process 154 4.9.5. Discussion 158 4.9.6. Frequency Domain Analysis 159 4.10. MODEL SELECTION: Basic Considerations 4.10.1. Akaike’s Information Criterion, AIC 4.10.2. Cross-Validation 164 4.10.3. Direct or Reverse Regression? 164 4.10.4. Data Mining 165 4.11. CONCLUSION 167 QUESTIONS 168 CHAPTER 5. PROBABILISTIC DOSE-RESPONSE MODELS AND CONCEPTSOF TOXICOLOGY 171 5.1. INTRODUCTION 173 5.1.1. Cancer Risk Assessment 175 5.1.2. Cancer Slope Factors (CSF), Reference Doses (RfD), and Concentrations (RfC) 176 5.2. RISK ASSESSMENT THROUGH DOSE-RESPONSE MODELING 178 5.2.1. Toxicological Dose-Response Models 5.3. MULTISTAGE (MS) DOSE-RESPONSE MODELS: Focus on Cancer 183 5.3.1. A Regulatory Method 184 5.3.2. Discussion 187 5.3.3. Comment 187 5.4. MOOLGAVKAR, VENZON AND KNUDSON (MVK) CANCER MODEL 189 5.5.OTHER DOSE-RESPONSE MODELS 190 Table of Contents ix 5.5.1. The Weibull Model 190 5.5.2. Hartley and Sielken Model 191 5.6. BENCHMARK DOSE AND CONCENTRATION (BMD, BMC) 192 5.6.1. Comment 193 5.6.2. Benchmark Response, BMR 198 5.6.3. Effective Dose 0.01, ED 198 01 5.7. ANIMAL STUDIES IN RISK ASSESSMENT: NOOBSERVED ADVERSE EFFECT LEVELS, HORMESIS, AND OTHER CONCEPTS 201 5.7.1. Lowest Observed Adverse Effect Level (LOAEL), and the No Observed Adverse Effect Level (NOAEL) 5.7.2. Safety and Uncertainty Factors in Risk Assessment 203 5.8 ALLOMETRIC FORMULAE: Converting Dose from Animals to Humans 205 5.8.1. Hormesis 209 5.9. SUMMARY OF TOXICOLOGY IN RISK ASSESSMENT AND MANAGEMENT 5.9.1. Toxicological Concepts 215 5.9.2. Modeling Changes in Concentrations 5.9.3. Discussion 218 5.9.4. Molecular Studies in Epidemiology 219 5.10. MIXTURES OF CHEMICALS 220 5.10.1. Toxicity Equivalency Factor Approach (US EPA, 2004) 222 5.11.CONCLUSION 222 QUESTIONS 223 CHAPTER 6. MONTE CARLO, BOOTSTRAPS AND OTHER METHODS TO QUANTIFY OR PROPAGATE VARIABILITY AND UNCERTAINTY 227 6.1. INTRODUCTION 228 6.2. COMBINATIONS OF DISTRIBUTIONS: Superimposition 231

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