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 Commission’s
      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