Introduction to Risk Analysis

A Systematic Approach to Science-Based Decision Making

By: Daniel M. Byrd III, Richard C. Cothern

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Hardcover | 1 August 2000

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433 Pages

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27.05 x 18.77 x 3.33

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Written for safety and loss-control, environmental, and quality managers, this is the first comprehensive, integrated guide to developing a complete environmental risk analysis for regulated substances and processes. Unlike other books, Introduction to Risk Analysis looks at risk from a regulatory perspective, allowing both professionals in regulatory agencies concerned with riskâ"including OSHA, EPA, USDA, DOT, FDA, and state environmental agenciesâ"and professionals in any agency-regulated industry to understand and implement the methods required for proper risk assessment.

The authors examine risk and the structure of analysis. Emphasizing the predictive nature of risk, they discuss the quantitative nature of risk and explore quantitative-analysis topics, including data graphing, logarithmic thinking, risk estimating, and curve fitting.

Chapters include discussions on functions, models, and uncertainties; the regulatory process; risk assessment; exposure; dosimetry; epidemiology; toxicology; risk characterization; comparative risk assessment; ecological risk assessment; risk management; and risk communication. Six in-depth case studies, an annotated bibliography, and more than 50 figures are also included.

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Society & Social Sciences Non-Fiction Engineering & Technology Technology in General Civil Engineering Mechanical Engineering & Materials Production & Industrial Engineering Reliability Engineering Earth Sciences, Geography, Environment, Planning The Environment Environmental Science Business & Management

Management & Management Techniques Management Decision Making Business Strategy

List of Figures and Tables	p. xvii
Preface	p. xxiii
About the Authors	p. xxv
Risk Analysis	p. 1
Probability of Future Loss	p. 1
Risk Defined	p. 1
Predictive Nature of Risk	p. 2
Universality of Risk	p. 3
Structure of Risk Analysis	p. 4
Risk Assessment	p. 4
Risk Management	p. 5
Risk Communication	p. 6
Risk Policy	p. 7
Risk Characteristics	p. 8
Precision and Accuracy	p. 8
Safe vs. Risk Free	p. 9
Risk Perception	p. 9
Risk Exposure	p. 10
Communication Problems	p. 12
Units	p. 12
Life Tables	p. 15
Cohort Life Table	p. 16
Current Life Table	p. 17
Life Expectancy	p. 18
Uncertainty	p. 19
Probability Axioms	p. 19
Contrasting Views of Uncertainty as Probability	p. 22
Validation	p. 23
Gold Standards	p. 24
Reproducibility	p. 24
The Meaning of Uncertainty	p. 26
Uncertainty vs. Variability	p. 27
Consequences of Uncertainty	p. 29
Models	p. 29
Uses of Mathematical Models	p. 31
Simulation Models	p. 31
Model Validity	p. 32
Regulations and Regulatory Models	p. 33
Politics of Regulation	p. 33
Responding to Technological Change	p. 34
Process of Risk Analysis	p. 35
The Rest of the Book	p. 36
References	p. 38
Functions, Models, and Uncertainties	p. 41
Qualitative Approaches to Risk	p. 41
Quantitative Approaches to Risk	p. 44
Graphs and Mathematical Models	p. 50
Growth Rate, Doubling Time, and Logarithms	p. 58
Statistics about Pedestrians	p. 60
Probability Distributions	p. 66
Tolerance-Distribution Models	p. 74
Mechanistic Models	p. 83
Uncertainty	p. 87
Subjective Judgment	p. 87
Linguistic Imprecision	p. 88
Statistical Variation	p. 88
Sampling	p. 89
Inherent Randomness	p. 90
Model Uncertainty	p. 90
Causality	p. 90
Lack of Data and Information	p. 91
Problem Formulation	p. 92
Making Estimates	p. 92
Bladder Cancer from Saccharin	p. 93
Penetration of a Liquid Natural Gas (LNG) Facility by a Meteorite	p. 94
References	p. 95
Chapter Appendix	p. 96
Regulation	p. 97
The Regulatory Process	p. 97
Why Have Regulatory Agencies?	p. 100
Food Safety: An Example	p. 101
Ethical Systems and Values	p. 104
The Legislative Component	p. 106
The Administrative Component	p. 107
The Judicial Component	p. 109
Additional Information about Federal Regulation	p. 110
References	p. 112
Exposure Assessment	p. 113
Exposure	p. 113
Planning an Exposure Assessment	p. 120
Purpose of the Exposure Assessment	p. 121
Using Exposure Assessments in Risk Assessment	p. 121
Using Exposure Assessments for Status and Trends	p. 122
Using Exposure Assessments in Epidemiologic Studies	p. 123
Scope of the Assessment	p. 123
Level of Detail of the Assessment	p. 124
Determining the Approach for the Exposure Assessment	p. 124
Establishing the Exposure Assessment Plan	p. 125
Planning an Exposure Assessment as Part of a Risk Assessment	p. 125
Limited vs. Repeated Exposures	p. 126
Dose-Rate Effects	p. 126
Reversibility of Toxicological Processes	p. 126
Composition of the Exposed Population	p. 127
Establishing the Sampling Strategy	p. 127
Data Quality Objectives	p. 127
Sampling Plan	p. 128
Quality Assurance Samples	p. 130
Background Level	p. 130
Quality Assurance and Quality Control	p. 130
Quality Assurance and Quality Control for Previously Generated Data	p. 130
Selection and Validation of Analytical Methods	p. 131
Sources of Exposure	p. 131
Fate and Transport Models	p. 131
Exposure Models	p. 147
Physical Transport in Surface Waters	p. 151
Groundwater	p. 151
Atmosphere	p. 152
Intake Calculations	p. 152
Inhalation	p. 152
Water Ingestion	p. 153
Soil Ingestion	p. 154
Dermal Absorption	p. 155
Dermal Absorption from Water	p. 155
Dermal Exposures from Soil	p. 156
Some Standard Values for Soil Dermal Exposure	p. 157
Example Calculation	p. 157
Food Absorption	p. 157
Example of Food Absorption	p. 158
Multimedia-Multipathway Exposures and Models	p. 159
Most Important Design Elements in Multimedia-Multipathway Studies	p. 162
National Human Exposure Assessment Survey	p. 162
Potential Problems in Multimedia-Multipathway Studies	p. 165
Sources of Additional Information	p. 168
References	p. 168
Risk Assessment: Dosimetry	p. 173
Dose (and some terminology)	p. 173
Dosimetric Measurements	p. 179
Dosimetric Routes	p. 180
Absorption, Distribution, Metabolism, and Elimination	p. 182
Pharmacokinetics	p. 184
Physiological Pharmacokinetics	p. 190
Sources of Additional Information about Dosimetry	p. 193
References	p. 194
Epidemiology	p. 197
Introduction to Epidemiology	p. 197
Epidemiological Methods	p. 204
Distributions in Epidemiology	p. 206
Epidemiological Surveys	p. 206
Case Reports, Case Series, and Cross-Sectional Studies	p. 207
Case-Control Studies	p. 208
Cohort Studies	p. 208
Deficiencies of Observational Studies	p. 209
Controlled Studies	p. 209
Hazard and Causation	p. 211
Epidemiology in Transition	p. 216
The Impact of Information Technology	p. 217
The Effect of Specialization	p. 217
The Perspective of Risk	p. 217
Cancer Epidemiology	p. 218
Exposure-Response Relationships in Epidemiology	p. 224
Meta-analysis	p. 227
The Public Health Paradigm	p. 231
Epidemiological Uncertainties	p. 232
Sources of Additional Information about Epidemiology	p. 233
References	p. 235
Toxicology	p. 237
Toxicology	p. 237
Weight of the Evidence in Toxicology	p. 250
Exposure-Response Relationships in Toxicology	p. 251
The Toxicology of Carcinogens	p. 256
Safety Assessment	p. 261
Additional Information about Toxicology	p. 266
References	p. 268
Risk Characterization	p. 271
Bringing Potency and Exposure Estimates Together	p. 271
Exposure-Response Modeling Errors--Trichloroethylene	p. 272
Combining Estimated Error Ranges--Radon from Drinking Water	p. 279
Combining Error Ranges--Monte Carlo Analysis of Trichloroethylene	p. 283
Conclusions	p. 288
References	p. 288
Comparative Risk Analysis	p. 291
Introduction	p. 291
Comparative Environmental Risk Assessments	p. 292
General Comparative Risk Assessments	p. 292
Generation of Electric Power	p. 294
U.S. Environmental Protection Agency's Unfinished Business Report	p. 297
Reducing Risk--Report of EPA's Science Advisory Board	p. 299
Disinfection of Drinking Water	p. 300
Hazard Ranking System	p. 301
Problems with Comparative Environmental Risk Assessments	p. 302
Discussion	p. 304
Change the Philosophical Approach?	p. 304
Who Needs to See the "Big Picture"?	p. 306
Observations	p. 307
Summary	p. 308
Conclusions	p. 309
References	p. 309
Ecological Risk Analysis	p. 311
Introduction	p. 311
Laws Requiring Ecological Risk Assessment	p. 311
What Is Ecological Risk Assessment?	p. 313
Ecological Characteristics	p. 314
Ecological Stressors	p. 314
Screening and Testing of Chemicals	p. 315
The Ecological Risk Analysis Process	p. 318
Problem Formulation	p. 322
Analysis	p. 323
Risk Estimation	p. 326
References	p. 327
Risk Management: Values and Decisions	p. 329
Introduction	p. 329
What Do Values and Ethics Have to Do With Risk Management?	p. 329
Values	p. 330
Introduction	p. 330
Values in Toxicology	p. 331
Values in Environmental Risk Decision Making	p. 332
Some Conceptual Decision Models	p. 334
Ideal Model	p. 335
The National Academy of Sciences' "Red Book" Model	p. 335
Cost-Benefit Analysis and Risk-Risk Balancing	p. 336
A Framework Model	p. 337
A Channel Model	p. 338
An Overlay Model	p. 340
Continuous Model	p. 340
The National Academy of Sciences "Orange Book" Model	p. 342
Other National Academy of Sciences Reports about Risk Management	p. 342
The Presidential Risk Assessment and Risk Management Commission Model	p. 342
Unreasonable Risk	p. 344
Risk Magnitude Models	p. 344
Making Regulatory Decisions	p. 345
Costs	p. 351
Conclusions	p. 351
References	p. 353
Risk Communication	p. 357
Introduction to Risk Communication	p. 357
Risk Perception	p. 360
Fulton's List	p. 362
The Seven Cardinal Rules of Risk Communication	p. 363
Other Approaches to Risk Communication	p. 364
Public Interactions	p. 365
Risk Communication Plans	p. 369
Some General Tips	p. 370
Constraints on Risk Communication	p. 371
Communications Media	p. 372
Some Common Traps	p. 372
Summary of Risk Communications	p. 373
References	p. 373
Case Studies	p. 375
Introduction	p. 375
Ecological Risk Assessment--Acidic Deposition	p. 375
Arsenic and Cancer	p. 375
Electromagnetic Fields	p. 376
Environmental Tobacco Smoke	p. 376
Indoor Air	p. 376
Radon	p. 376
Case Study: Ecological Risk Assessment--Acidic Deposition	p. 377
Introduction	p. 377
Problem Formulation	p. 379
Analysis	p. 379
Risk Characterization	p. 381
References	p. 382
Case Study: Arsenic	p. 382
Introduction	p. 382
Occurrence and Exposure	p. 383
Non-Cancer Health Effects	p. 384
Cancer	p. 385
Modes of Action (Mechanisms)	p. 385
Nutrition	p. 385
Exposure-Response Curve	p. 386
Conclusions	p. 386
Drinking Water Standard for Arsenic	p. 387
Conclusion	p. 388
References	p. 388
Case Study: Electromagnetic Fields	p. 388
General	p. 389
Risk Analysis	p. 389
Conclusion	p. 389
References	p. 390
Case Study: Environmental Tobacco Smoke	p. 391
Introduction	p. 391
Background	p. 392
Exposure	p. 392
Hazard Assessment--Lung Cancer	p. 395
Population Risk Estimates--Lung Cancer	p. 396
Conclusions	p. 397
References	p. 397
Case Study: Indoor Air	p. 398
Introduction	p. 398
Common Symptoms and Responses	p. 399
Possible Sources of Agents that May Cause Disease	p. 400
Diagnosing Problem Buildings	p. 401
Why Are Indoor Air Quality Problems Not Better Understood and Generally Not Addressed?	p. 402
What Can We Do?	p. 403
Conclusion	p. 404
References	p. 404
Case Study: Radon	p. 405
Introduction	p. 405
Why Is Radon Important?	p. 405
Exposure: Mainly from Soils and Drinking Water	p. 407
Epidemiological studies	p. 408
Animal and Cellular Studies	p. 409
Quantitative Risk Assessment	p. 409
Public Reaction Is Widespread Apathy	p. 410
Comparison between Risk Estimates for Exposure to Radon and Other Environmental Contaminants	p. 410
References	p. 411
Appendix	p. 412
Index	p. 415
Table of Contents provided by Syndetics. All Rights Reserved.

Introduction to Risk Analysis

A Systematic Approach to Science-Based Decision Making

At a Glance

Hardcover

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