Table of Contents:
  • ""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""