Tabla de Contenidos:
  • ISSUES IN RISK ASSESSMENT
  • Copyright
  • Preface
  • Contents
  • Executive Summary
  • USE OF THE MAXIMUM TOLERATED DOSE IN ANIMAL BIOASSAYS FOR CARCINOGENICITY
  • THE TWO-STAGE MODEL OF CARCINOGENESIS
  • A PARADIGM FOR ECOLOGIC RISK ASSESSMENT
  • Issues In Risk Assessment Use Of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity
  • 1 Introduction
  • BACKGROUND
  • SCOPE OF REPORT
  • 2 Correlations Between Carcinogenic Potency and Other Measures of Toxicity
  • DEFINITIONS AND BACKGROUND
  • CORRELATIONS
  • RELATIONSHIP BETWEEN TOXICITY AND CARCINOGENICITY OBSERVED AT MTD
  • 3 Advantages and Disadvantages of Bioassays that Use the MTD
  • QUALITATIVE INFORMATION
  • QUANTITATIVE INFORMATION
  • 4 Options Considered
  • OPTION 1
  • OPTION 2
  • OPTION 3
  • OPTION 4
  • Option 4A
  • Option 4B
  • 5 Conclusions and Recommendations
  • REFERENCES
  • Appendix A Workshop Summary Maximum Tolerated Dose: Implications For Risk Assessment
  • INTRODUTION
  • BACKGROUND
  • DEFINING AND DETERMINING THE MTD
  • Appendix B Organizing Subcommittee
  • Appendix C Federal Liaison Group
  • Appendix D Workshop Program
  • Appendix E Workshop Attendees
  • Appendix F Correlation Between Carcinogenic Potency and the Maximum Tolerated Dose: Implications for Risk Assessment
  • 1. INTRODUCTION
  • 2. CARCINOGENIC POTENCY
  • 2.1 Measures of Carcinogenic Potency
  • 2.2 Carcinogenic Potency Database (CPDB)
  • 2.3 Variation in Carcinogen Potency
  • 2.4 Classification of Carcinogens
  • 3. CORRELATION BETWEEN TD50 AND THE MTD
  • 3.1 Empirical Correlations
  • 3.2 Range of Possible TD50 Values
  • 3.3 Analytical Correlations
  • 3.4 Model Dependency
  • 3.5 Genotoxic vs. Nongenotoxic Carcinogens
  • 4. PREDICTION OF THE TD50
  • 4.1 Predictions Based on the MDT
  • 4.2 Predictions Based on Mutagenicity and Acute Toxicity
  • 5. LOW DOSE RISK ASSESSMENT.
  • 5.1 Correlation Between Upper Bounds On the Low Dose Slope and MTD
  • 5.2 Correlation Between q1* and the TD50
  • 5.3. Preliminary Estimate of Risk
  • 6. INTERSPECIES EXTRAPOLATION
  • 6.1 Extrapolation from Rats to Mice
  • 6.2 Extrapolation from Rodents to Humans
  • 7. CONCLUSIONS
  • 8. ACKNOWLEDGEMENTS
  • 9. REFERENCES
  • ANNEX A: MAXIMUM LIKELIHOOD METHODS FOR FITTING THE WEIBULL MODEL
  • ANNEX B. SHRINKAGE ESTIMATORS OF THE DISTRIBUTION OF CARCINOGENIC POTENCY
  • ANNEX C: ADJUSTMENT OF POTENCY VALUES FOR LESS THAN LIFETIME EXPOSURE
  • ANNEX D: CORRELATION BETWEEN TD50 AND MTD
  • ANNEX E: CORRELATION BETWEEN TD50S FOR RATS AND MICE
  • Appendix G Informal Search for ''Supercarcinogens
  • CRITERIA AND CANDIDATE CHEMICALS
  • DATA
  • RESULTS
  • DISCUSSION
  • Issues in Risk Assessment The Two-Stage Model Of Carcinogenesis
  • The Two-Stage Model of Carcinogenesis
  • INTRODUCTION
  • BIOLOGIC CONSIDERATIONS
  • THE TWO-STAGE MODEL
  • APPLICATIONS OF THE TWO-STAGE MODEL TO ANIMAL DATA
  • DISCUSSION
  • Data Needs
  • Criteria for Adoption
  • Prospects
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
  • Appendix A Workshop Summary
  • TWO-STAGE MODEL OF CARCINOGENESIS
  • BIOLOGICAL FACTORS IN TWO-STAGE MODELS
  • TWO-STAGE MODEL OF CLONAL EXPANSION
  • APPLICATION OF THE TWO-STAGE MODEL TO ANIMAL DATA
  • Appendix B Workshop Program
  • Appendix C Workshop Federal Liaison Group
  • Appendix D Workshop Attendees
  • TOPIC GROUP MEMBERS
  • Appendix E Workshop Organizing Task Group
  • Isuees In Risk Assessment A Paradigm for Ecological Risk Assessment
  • 1 Introduction
  • 2 Scope of Ecological Risk Assessment
  • 3 Revision of 1983 Framework To Incorporate Ecological Risk Assessment
  • COMPONENTS OF THE 1983 FRAMEWORK
  • CONSISTENCY OF CASE STUDIES WITH THE 1983 FRAMEWORK
  • INTEGRATION OF ECOLOGICAL RISK INTO THE 1983 FRAMEWORK.
  • DEFINITION OF FRAMEWORK COMPONENTS FOR ECOLOGICAL RISK ASSESSMENT
  • 4 Key Scientific Problems Limiting Application of Ecological Risk Assessment
  • EXTRAPOLATION ACROSS SCALES
  • QUANTIFICATION OF UNCERTAINTY
  • VALIDATION OF PREDICTIVE TOOLS
  • VALUATION
  • 5 Conclusions
  • 6 Recommendations
  • REFERENCES
  • Appendix A Workshop Participants
  • Appendix B Workshop Organizing Subcommittee and Federal Liaison Group
  • Appendix C Workshop Introduction
  • Appendix D Opening Plenary Presentations
  • TERRY F. YOSIE BUILDING ECOLOGICAL RISK ASSESSMENT AS A POLICY TOOL
  • D. WARNER NORTH: RELATIONSHIP OF WORKSHOP TO NRC'S 1983 RED BOOK REPORT
  • MICHAEL SLIMAK: U.S. ENVIRONMENTAL PROTECTION AGENCY ACTIVITIES IN ECOLOGICAL RISK ASSESSMENT
  • Appendix E Case Studies and Commentaries
  • CASE STUDY 1: TRIBUTYLTIN RISK MANAGEMENT IN THE UNITED STATES
  • Discussion
  • CASE STUDY 2: ECOLOGICAL RISK ASSESSMENT FOR TERRESTRIAL WILDLIFE EXPOSED TO AGRICULTURAL CHEMICALS
  • Discussion
  • CASE STUDY 3A: MODELS OF TOXIC CHEMICALS IN THE GREAT LAKES: STRUCTURE, APPLICATIONS, AND UNCERTAINTY ANALYSIS
  • CASE STUDY 3B: ECOLOGICAL RISK ASSESSMENT OF TCDD AND TCDF
  • Discussion
  • CASE STUDY 4: RISK ASSESSMENT METHODS IN ANIMAL POPULATIONS: THE NORTHERN SPOTTED OWL AS AN EXAMPLE
  • Discussion
  • CASE STUDY 5: ECOLOGICAL BENEFITS AND RISKS ASSOCIATED WITH THE INTRODUCTION OF EXOTIC SPECIES FOR BIOLOGICAL CONTROL OF A...
  • Discussion
  • CASE STUDY 1: UNCERTAINTY AND RISK IN AN EXPLOITED ECOSYSTEM: A CASE STUDY OF GEORGES BANK
  • Discussion
  • Appendix F Breakout Sessions
  • HAZARD IDENTIFICATION
  • Generic Issues
  • Analysis of Case Studies
  • DOSE-RESPONSE ASSESSMENT
  • Aspects of An Adequate Stress-Response Analysis for Ecological Risk Assessment
  • Selection of End Points
  • Consideration of Nonlinearities And Discontinuities
  • Expression of Uncertainty.
  • Understanding the Stressor
  • Understanding the Response
  • Other Considerations
  • Additions to the 1983 Paradigm Needed for Ecological Risk Assessment
  • Application of Stress-Response Analysis In Case Studies
  • Modeling Needs for Stress-Response Relationships
  • EXPOSURE ASSESSMENT
  • Methods of Measuring Stressors for Ecological Exposure Assessment
  • Test of the Definition
  • RISK CHARACTERIZATION
  • Definition of Risk Characterization
  • Components of Risk Characterization
  • Organization and Presentation
  • Differences from and Similarities To the 1983 Report
  • Application to the Case Studies
  • MODELING
  • Use of Models in the Case Studies
  • Tributyltin
  • Agricultural Chemicals
  • Polychlorinated Biphenyls and 2,3,7,8-Tetrachlorodibenzo-p-Dioxin
  • Species Introductions
  • Northern Spotted Owl
  • Georges Bank Fishery
  • General Discussion: Models and Risk Assessment
  • UNCERTAINTY
  • Uncertainties Identified In the Case Studies
  • Implications of Uncertainty for Ecological Risk Assessment
  • Recommendations for Dealing With Uncertainty
  • VALUATION
  • RISK ASSESSMENT AND THE REGULATORY PROCESS
  • Risk Assessment Has Many Uses
  • Different Risk Assessment Methods Are Suited to Different Risk Assessment Needs
  • Risk Assessors and Risk Managers Need to Communicate
  • Credibility is Crucial
  • Appendix G Contemplations on Ecological Risk Assessment
  • Appendix H Workshop Summary
  • Appendix I References for Appendixes
  • Appendix J Workshop Program.