Table of Contents
Volume 2
The Presidential/Congressional Commission on Risk Assessment and Risk Management
Preface
Executive Summary
i
1. Introduction
1
2. The Framework for Environmental Health Risk Management
7
Defining Problems and Putting Them in Context
8
Analyzing Risks
19
Examining Options
23
Making Decisions
27
Taking Action
29
Evaluating Results
31
Implementing the Framework
34
3. Risk Management and Regulatory Decision-Making
39
Communicating and Comparing Risks
39
Identifying Risk Communication Needs
39
Communicating About Risk by Comparing Different Kinds of Risk
41
Need for a Common Metric
43
Comparative Risk Analysis for Risk Management Priority Setting
46
Risk-Based Priorities and Resource Allocation
46
Strategies for Managing Risk
49
Risk Management Options: Alternatives to Command and Control
49
Bright Lines for Risk Management
54
Judicial Review of Regulatory Decisions to Manage Risk
56
Premature Interruption of the Administrative Process
56
The Nature and Extent of Judicial Review
57
Standard for Judicial Review
58
Consensual Approaches as Alternatives to Increased Judicial Review
60
4. Uses and Limitations of Risk Assessment for Risk Management Decision-Making
63
Toxicity Assessment
63
Using Rodent Tests to Predict Human Cancer Risk
64
Evaluating Chemical Mixtures
67
Accounting for Differences in Susceptibility
71
Exposure Assessment
72
Design of Exposure Assessments to Meet Risk Management Goals
73
Using Realistic Exposure Scenarios
73
Identifying Highly Exposed Populations
75
Ecological Risk Assessment
77
Framework for Evaluating Ecological Risk
77
Environmental Hazards Other Than Chemicals
81
Risks from Radiation Hazards
82
Risks from Microorganisms
84
Risk Characterization
85
Effective Risk Characterization to Support Decision-Making
85
Characterizing the Uncertainty Associated with Risk Estimates
88
Value of Obtaining Additional Information
91
5. Uses and Limitations of Economic Analysis in Regulatory Decision-Making
93
Benefit-Cost Analysis and Cost-Effectiveness Analysis
93
Useful Roles in Regulatory Decision-Making
93
Distributions of Costs and Benefits
96
Uncertainty and Inconsistency in Economic Analysis
97
Characterizing the Uncertainty Associated with Cost and Benefit Estimates
97
Inconsistencies in Monetary Valuation of Benefits
98
Linking Risk Assessment and Economic Analysis
99
6. The Role of Peer Review in Regulatory Decision-Making
103
Improving the Quality of Regulatory Decisions
103
The Conduct and Effectiveness of Peer Review
104
Evaluating the Use of Peer Review and of Scientific and Economic Analyses
in Regulatory Decision-Making
105
7. Recommendations for Specific Regulatory Agencies and Programs
107
Consistency Among Agencies
107
Environmental Protection Agency
108
Office of Air and Radiation
108
Superfund
120
Office of Prevention, Pesticides and Toxic Substances
124
Office of Water
128
Occupational Safety and Health Administration and National Institute for Occupational
Safety and Health
131
Food and Drug Administration
136
Department of Agriculture
139
Department of Energy
142
Department of Defense
144
References
147
Glossary
153
Appendix A1 -- Biographies of Commission Members
159
Appendix A2 -- Mandate of the Commission
163
Appendix A3 -- Comments on
Science and Judgment in Risk Assessment
165
Appendix A4 -- Individuals Who Presented Testimony at Commission Meetings
173
Appendix A5 -- Individuals and Organizations Who Provided Comments on the Commissions
June 1996 Draft Report
177
Appendix A6 -- Differences Between the Draft and Final Reports
183
Appendix A7 -- Abstracts of Reports Prepared at the Invitation of the Commission
199
List of Figures and Tables
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