Commission on Risk Assessment

and Risk Management





Risk Assessment and Risk Management
in Regulatory Decision-Making




DRAFT REPORT

FOR

PUBLIC REVIEW AND COMMENT









June 13, 1996




  • Commission Members and Staff

  • Table of Contents

  • PDF Version of Report

















    • COMMISSION ON RISK ASSESSMENT AND RISK MANAGEMENT



    Gilbert S. Omenn (Chairman), Dean, School of Public Health and Community Medicine, University of Washington, Seattle, WA

    Alan C. Kessler (Vice-Chairman), Partner, Buchanan Ingersoll, Philadelphia, PA

    Norman T. Anderson, Director of Research, American Lung Association of Maine, Augusta, ME

    Peter Y. Chiu, Senior Physician, Kaiser Permanente, Milpitas, CA

    John Doull, Professor, Department of Pharmacology, Toxicology and Therapeutics, Kansas University Medical Center, Kansas City, KS

    Bernard Goldstein, Director, Environmental and Occupational Health Sciences Institute and Chairman, Department of Environmental and Community Medicine, UMDNJ-Robert Wood Johnson Medical School, Piscataway, NJ

    Joshua Lederberg, President Emeritus, Rockefeller University, New York, NY

    Sheila McGuire, President, Iowa Health Research Institute, Boone, IA

    David Rall, Former Director, National Institute of Environmental Health Sciences, Washington, DC

    Virginia V. Weldon, Senior Vice President for Public Policy, Monsanto Company, St. Louis, MO



    Staff

    Gail Charnley, Executive Director

    Sharon Newsome, Associate Director

    Joanna Foellmer, Program Specialist and Designated Federal Official





    Table of Contents

    Page*
    Executive Summary v
    1.   Introduction 1
    2.   Framework for Risk Management 6
    3.   Uses and Limitations of Risk Assessment in Regulatory Decision-Making 17
          3.1   Toxicity Assessment 19
          3.2   Exposure Assessment 28
          3.3   Uncertainty in Estimating Risk and Risk Reduction 34
          3.4   Chemical Mixtures 37
          3.5   Ecological Risk Assessment 41
          3.6   Radiation Risks and Microbial Risks 45
    4.   Uses and Limitations of Economic Analysis in Regulatory Decision-Making 49
          4.1   Benefit-Cost and Cost-Effectiveness Analysis 50
          4.2   Uncertainty and Inconsistency in Economic Analysis 55
          4.3   Linking Risk Assessment and Economic Analysis 59
    5.   Risk Management and Regulatory Decision-Making 62
          5.1   Risk Characterization: Communicating and Comparing Risks 63
          5.2   Comparative Risk Assessment for Risk Management 71
          5.3   Bright Lines 74
          5.4   Alternatives to Command-and-Control Regulation 77
          5.5   Peer Review 82
          5.6   Judicial Review 85
    6.   Recommendations for Specific Regulatory Agencies and Programs 94
          6.1   Environmental Protection Agency 96
                  6.1.1   Office of Air and Radiation 97
                  6.1.2   Superfund 109
                  6.1.3   Office of Prevention, Pesticides and Toxic Substances 116
                  6.1.4   Office of Water 121
          6.2   Occupational Safety and Health Administration 125
          6.3   Food and Drug Administration 129
          6.4   Department of Agriculture 133
          6.5   Department of Energy 136
          6.6   Department of Defense 139
    References 141
    Appendices
          A.1   Biographies of Commission Members
          A.2   Mandate of the Commission
          A.3   Comments on Science and Judgment in Risk Assessment
          A.4   Individuals Who Presented Testimony at Commission Meetings
          A.5   Abstracts of Reports Prepared at the Invitation of the Commission
          A.6   Federal Agency Risk Assessment and Risk Management Practices




    *Page number in printed report.