Risk Assessment in the Federal Government: Managing the Process -- Copyright -- Acknowledgments -- Preface -- Contents -- Risk Assessment in the Federal Government: Managing the Process -- Summary -- SETTING -- STUDY OBJECTIVES AND SCOPE -- THE NATURE OF RISK ASSESSMENT -- UNIFORM GUIDELINES FOR RISK ASSESSMENT -- INSTITUTIONAL ARRANGEMENTS FOR RISK ASSESSMENT -- CONCLUSIONS AND MAJOR RECOMMENDATIONS -- Introduction -- DIFFICULTIES IN DECISION-MAKING -- Inherent Limitations -- Uncertainty -- Limited Analytic Resources -- Complexity -- External Pressures -- Public Concern with Health Protection -- Visible Economic Interests -- Congressional Action -- PROPOSED REFORMS -- THE STUDY -- REFERENCES -- I The Nature of Risk Assessment -- TERMINOLOGY -- Risk Assessment and Risk Management -- Steps in Risk Assessment -- Scientific Basis for Risk Assessment -- Step 1. Hazard Identification -- Epidemiologic Data -- Animal-Bioassay Data -- Short-Term Studies -- Comparisons of Molecular Structure -- Step 2. Dose-Response Assessment -- Low-Dose Extrapolation -- Animal-to-Human Dose Extrapolation -- Step 3. Exposure Assessment -- Step 4. Risk Characterization -- SCIENTIFIC AND POLICY JUDGMENTS IN RISK ASSESSMENT -- Components of Risk Assessment -- The Interplay of Science and Policy in Risk Assessment -- Hazard Identification -- Dose-Response Assessment -- Exposure Assessment -- Risk Characterization -- Basis for Selecting Inference Options -- RISK ASSESSMENT IN PRACTICE -- Risk Assessment and Regulatory Decision-Making -- The Agencies That Regulate -- Organizational Arrangements -- Regulatory Statutes -- CONCLUSIONS -- REFERENCES -- II Inference Guidelines for Risk Assessment -- INTRODUCTION AND DEFINITIONS -- HISTORY OF THE USE OF GUIDELINES SAFETY EVALUATION GUIDELINES FOR EFFECTS OTHER THAN CANCER -- Guidelines for Carcinogenic Risk.

International Agency for Research on Cancer (IARC) -- Food and Drug Administration -- Environmental Protection Agency -- Occupational Safety and Health Administration -- Consumer Product Safety Commission -- Interagency Regulatory Liaison Group -- VARIATION IN THE FORM OF GUIDELINES -- Comprehensiveness -- Extent of Detail -- Flexibility -- Degree To Which Guidelines May Be Binding on An Agency and A Regulated Party -- ARGUMENTS FOR AND AGAINST THE USE OF GUIDELINES -- Advantages of Guideline Use -- Separation of Risk Assessment from Risk Management -- Quality Control -- Consistency -- Predictability -- Evolutionary Improvement of the Risk Assessment Process -- Public Understanding -- Administrative Efficiency -- Disadvantages of Guideline Use -- Oversimplification -- Mixing of Scientific Knowledge and Risk Assessment Policy -- Misallocation of Agency Resources to Development and Amendment of Guidelines -- Freezing of Science -- CONCLUSIONS -- REFERENCES -- III Organizational Arrangements for Risk Assessment -- TYPES OF ORGANIZATIONAL ARRANGEMENTS -- Integration -- Intra-Agency Separation -- Extra-Agency Separation -- Use of Scientific Review Panels -- REVIEW OF AGENCY PROCEDURES FOR RISK ASSESSMENT -- OSHA's Directorate of Health Standards Programs (DHSP) -- Agenda and Procedures -- Methods and Use of Guidelines -- Peer Review -- FDA's Bureau Of Foods -- Agenda and Procedures -- Methods and Use of Guidelines -- Peer Review -- EPA's Carcinogen Assessment Group -- Agenda and Procedures -- Methods and Use of Guidelines -- Peer Review -- NIOSH-OSHA -- Agenda and Procedures -- Methods and Use of Guidelines -- Peer Review -- Committees of the National Research Council -- Agenda and Procedures -- Methods and Use of Guidelines -- Peer Review -- FDA's Drug Evaluation Panels -- NRC Review -- FDA-Directed Drug Panels.

National Toxicology Program Panel on Formaldehyde -- EPA's Use of Scientific Review Panels -- EPA's Scientific Advisory Panel (SAP) -- EPA's Subcommittee on Airborne Carcinogens -- PROPOSED CHANGES IN ORGANIZATIONAL ARRANGEMENTS FOR RISK ASSESSMENT -- Description of Proposals -- Science Court -- OSTP Proposal -- H.R. 638 and the AIHC Proposal -- Single-Agency Proposals -- Criticisms of Proposals for Separation and Centralization -- CONCLUSIONS -- Value of Institutional Separation -- Value of Centralization -- Use of Scientific Review Panels -- Other Observations -- REFERENCES -- IV Recommendations -- IMPROVING RISK ASSESSMENT THROUGH PROCEDURAL CHANGES -- Recommendation 1 -- Recommendation 2 -- Content and Form -- Actions Covered -- Recommendation 3 -- Panel Form -- Panel Composition and Selection -- Panel Functions -- Panel Agenda -- Timing of Review -- Weight of Panel Evaluation -- Federal Advisory Committee Act -- Recommendation 4 -- Actions Covered -- Placement and Procedures -- IMPROVING RISK ASSESSMENT THROUGH UNIFORM INFERENCE GUIDELINES -- Recommendation 5 -- Recommendation 6 -- Distinguishing Science from Policy -- Comprehensive and Detailed Nature -- Flexibility -- Presenting the Results of the Assessment -- Recommendation 7 -- The Board and Its Role -- Agency Adoption -- Uniformity -- Periodic Review -- Recommendation 8 -- Recommendation 9 -- A CENTRAL BOARD ON RISK ASSESSMENT METHODS -- Recommendation 10 -- Board Functions -- Organizational Placement -- Qualifications of Members -- Sunset Review -- Appendix A Background Information on Committee Members -- Appendix B Bibliography -- A. GUIDELINES AND POLICY FOR RISK ASSESSMENT -- B. SUGGESTIONS FOR PROCEDURAL REFORM -- C. SCIENTIFIC AND POLICY BASIS OF RISK ASSESSMENT -- D. BIBLIOGRAPHIES -- Appendix C Working Papers.