Issues in risk assessment
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Issues in risk assessment
National Academy Press, 1993
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注記
Includes bibliographical references
内容説明・目次
内容説明
The scientific basis, inference assumptions, regulatory uses, and research needs in risk assessment are considered in this two-part volume.
The first part, Use of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity, focuses on whether the maximum tolerated dose should continue to be used in carcinogenesis bioassays. The committee considers several options for modifying current bioassay procedures.
The second part, Two-Stage Models of Carcinogenesis, stems from efforts to identify improved means of cancer risk assessment that have resulted in the development of a mathematical dose-response model based on a paradigm for the biologic phenomena thought to be associated with carcinogenesis.
Table of Contents
Front Matter
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
BACKGROUND
SCOPE OF REPORT
DEFINITIONS AND BACKGROUND
CORRELATIONS
RELATIONSHIP BETWEEN TOXICITY AND CARCINOGENICITY OBSERVED AT MTD
QUALITATIVE INFORMATION
QUANTITATIVE INFORMATION
OPTION 1
OPTION 2
OPTION 3
Option 4A
Option 4B
5 Conclusions and Recommendations
REFERENCES
BACKGROUND
DEFINING AND DETERMINING THE MTD
Appendix B Organizing Subcommittee
Appendix C Federal Liaison Group
Appendix D Workshop Program
Appendix E Workshop Attendees
1. INTRODUCTION
2.1 Measures of Carcinogenic Potency
2.2 Carcinogenic Potency Database (CPDB)
2.3 Variation in Carcinogen Potency
2.4 Classification of Carcinogens
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
4.1 Predictions Based on the MDT
4.2 Predictions Based on Mutagenicity and Acute Toxicity
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
INTRODUCTION
BIOLOGIC CONSIDERATIONS
THE TWO-STAGE MODEL
APPLICATIONS OF THE TWO-STAGE MODEL TO ANIMAL DATA
Data Needs
Criteria for Adoption
Prospects
CONCLUSIONS AND RECOMMENDATIONS
REFERENCES
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
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
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
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
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
CASE STUDY 1: TRIBUTYLTIN RISK MANAGEMENT IN THE UNITED STATES
Discussion
CASE STUDY 2: ECOLOGICAL RISK ASSESSMENT FOR TERRESTRIAL WILDLIFE
EXPOSED TO AGRICULTURAL CHEMICALS
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
Generic Issues
Analysis of Case Studies
DOSE-RESPONSE ASSESSMENT
Selection of End Points
Consideration of Nonlinearities And Discontinuities
Understanding the Stressor
Additions to the 1983 Paradigm Needed for Ecological Risk
Assessment
Modeling Needs for Stress-Response Relationships
Methods of Measuring Stressors for Ecological Exposure Assessment
Definition of Risk Characterization
Components of Risk Characterization
Organization and Presentation
Differences from and Similarities To the 1983 Report
Application to the Case Studies
Agricultural Chemicals
Northern Spotted Owl
General Discussion: Models and Risk Assessment
Uncertainties Identified In the Case Studies
Implications of Uncertainty for Ecological Risk Assessment
VALUATION
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
目次
- 1 Front Matter
- 2 Executive Summary
- 3 USE OF THE MAXIMUM TOLERATED DOSE IN ANIMAL BIOASSAYS FOR CARCINOGENICITY
- 4 THE TWO-STAGE MODEL OF CARCINOGENESIS
- 5 A PARADIGM FOR ECOLOGIC RISK ASSESSMENT
- 6 Issues In Risk Assessment Use Of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity
- 7 BACKGROUND
- 8 SCOPE OF REPORT
- 9 DEFINITIONS AND BACKGROUND
- 10 CORRELATIONS
- 11 RELATIONSHIP BETWEEN TOXICITY AND CARCINOGENICITY OBSERVED AT MTD
- 12 QUALITATIVE INFORMATION
- 13 QUANTITATIVE INFORMATION
- 14 OPTION 1
- 15 OPTION 2
- 16 OPTION 3
- 17 Option 4A
- 18 Option 4B
- 19 5 Conclusions and Recommendations
- 20 REFERENCES
- 21 BACKGROUND
- 22 DEFINING AND DETERMINING THE MTD
- 23 Appendix B Organizing Subcommittee
- 24 Appendix C Federal Liaison Group
- 25 Appendix D Workshop Program
- 26 Appendix E Workshop Attendees
- 27 1. INTRODUCTION
- 28 2.1 Measures of Carcinogenic Potency
- 29 2.2 Carcinogenic Potency Database (CPDB)
- 30 2.3 Variation in Carcinogen Potency
- 31 2.4 Classification of Carcinogens
- 32 3.1 Empirical Correlations
- 33 3.2 Range of Possible TD50 Values
- 34 3.3 Analytical Correlations
- 35 3.4 Model Dependency
- 36 3.5 Genotoxic vs. Nongenotoxic Carcinogens
- 37 4.1 Predictions Based on the MDT
- 38 4.2 Predictions Based on Mutagenicity and Acute Toxicity
- 39 5.1 Correlation Between Upper Bounds On the Low Dose Slope and MTD
- 40 5.2 Correlation Between q1* and the TD50
- 41 5.3. Preliminary Estimate of Risk
- 42 6. INTERSPECIES EXTRAPOLATION
- 43 6.1 Extrapolation from Rats to Mice
- 44 6.2 Extrapolation from Rodents to Humans
- 45 7. CONCLUSIONS
- 46 8. ACKNOWLEDGEMENTS
- 47 9. REFERENCES
- 48 ANNEX A: MAXIMUM LIKELIHOOD METHODS FOR FITTING THE WEIBULL MODEL
- 49 ANNEX B. SHRINKAGE ESTIMATORS OF THE DISTRIBUTION OF CARCINOGENIC POTENCY
- 50 ANNEX C: ADJUSTMENT OF POTENCY VALUES FOR LESS THAN LIFETIME EXPOSURE
- 51 ANNEX D: CORRELATION BETWEEN TD50 AND MTD
- 52 ANNEX E: CORRELATION BETWEEN TD50S FOR RATS AND MICE
- 53 Appendix G Informal Search for "Supercarcinogens"
- 54 CRITERIA AND CANDIDATE CHEMICALS
- 55 DATA
- 56 RESULTS
- 57 DISCUSSION
- 58 Issues in Risk Assessment The Two-Stage Model Of Carcinogenesis
- 59 INTRODUCTION
- 60 BIOLOGIC CONSIDERATIONS
- 61 THE TWO-STAGE MODEL
- 62 APPLICATIONS OF THE TWO-STAGE MODEL TO ANIMAL DATA
- 63 Data Needs
- 64 Criteria for Adoption
- 65 Prospects
- 66 CONCLUSIONS AND RECOMMENDATIONS
- 67 REFERENCES
- 68 BIOLOGICAL FACTORS IN TWO-STAGE MODELS
- 69 TWO-STAGE MODEL OF CLONAL EXPANSION
- 70 APPLICATION OF THE TWO-STAGE MODEL TO ANIMAL DATA
- 71 Appendix B Workshop Program
- 72 Appendix C Workshop Federal Liaison Group
- 73 TOPIC GROUP MEMBERS
- 74 Appendix E Workshop Organizing Task Group
- 75 Isuees In Risk Assessment A Paradigm for Ecological Risk Assessment
- 76 1 Introduction
- 77 2 Scope of Ecological Risk Assessment
- 78 COMPONENTS OF THE 1983 FRAMEWORK
- 79 CONSISTENCY OF CASE STUDIES WITH THE 1983 FRAMEWORK
- 80 INTEGRATION OF ECOLOGICAL RISK INTO THE 1983 FRAMEWORK
- 81 DEFINITION OF FRAMEWORK COMPONENTS FOR ECOLOGICAL RISK ASSESSMENT
- 82 EXTRAPOLATION ACROSS SCALES
- 83 QUANTIFICATION OF UNCERTAINTY
- 84 VALIDATION OF PREDICTIVE TOOLS
- 85 VALUATION
- 86 5 Conclusions
- 87 6 Recommendations
- 88 REFERENCES
- 89 Appendix A Workshop Participants
- 90 Appendix B Workshop Organizing Subcommittee and Federal Liaison Group
- 91 Appendix C Workshop Introduction
- 92 TERRY F. YOSIE BUILDING ECOLOGICAL RISK ASSESSMENT AS A POLICY TOOL
- 93 D. WARNER NORTH: RELATIONSHIP OF WORKSHOP TO NRC'S 1983 RED BOOK REPORT
- 94 MICHAEL SLIMAK: U.S. ENVIRONMENTAL PROTECTION AGENCY ACTIVITIES IN ECOLOGICAL RISK ASSESSMENT
- 95 CASE STUDY 1: TRIBUTYLTIN RISK MANAGEMENT IN THE UNITED STATES
- 96 Discussion
- 97 CASE STUDY 2: ECOLOGICAL RISK ASSESSMENT FOR TERRESTRIAL WILDLIFE EXPOSED TO AGRICULTURAL CHEMICALS
- 98 CASE STUDY 3A: MODELS OF TOXIC CHEMICALS IN THE GREAT LAKES: STRUCTURE, APPLICATIONS, AND UNCERTAINTY ANALYSIS
- 99 CASE STUDY 3B: ECOLOGICAL RISK ASSESSMENT OF TCDD AND TCDF
- 100 Discussion
- 101 CASE STUDY 4: RISK ASSESSMENT METHODS IN ANIMAL POPULATIONS: THE NORTHERN SPOTTED OWL AS AN EXAMPLE
- 102 Discussion
- 103 CASE STUDY 5: ECOLOGICAL BENEFITS AND RISKS ASSOCIATED WITH THE INTRODUCTION OF EXOTIC SPECIES FOR BIOLOGICAL CONTROL OF A..
- 104 Discussion
- 105 CASE STUDY 1: UNCERTAINTY AND RISK IN AN EXPLOITED ECOSYSTEM: A CASE STUDY OF GEORGES BANK
- 106 Discussion
- 107 Generic Issues
- 108 Analysis of Case Studies
- 109 DOSE-RESPONSE ASSESSMENT
- 110 Selection of End Points
- 111 Consideration of Nonlinearities And Discontinuities
- 112 Understanding the Stressor
- 113 Additions to the 1983 Paradigm Needed for Ecological Risk Assessment
- 114 Modeling Needs for Stress-Response Relationships
- 115 Methods of Measuring Stressors for Ecological Exposure Assessment
- 116 Definition of Risk Characterization
- 117 Components of Risk Characterization
- 118 Organization and Presentation
- 119 Differences from and Similarities To the 1983 Report
- 120 Application to the Case Studies
- 121 Agricultural Chemicals
- 122 Northern Spotted Owl
- 123 General Discussion: Models and Risk Assessment
- 124 Uncertainties Identified In the Case Studies
- 125 Implications of Uncertainty for Ecological Risk Assessment
- 126 VALUATION
- 127 Risk Assessment Has Many Uses
- 128 Different Risk Assessment Methods Are Suited to Different Risk Assessment Needs
- 129 Risk Assessors and Risk Managers Need to Communicate
- 130 Credibility is Crucial
- 131 Appendix G Contemplations on Ecological Risk Assessment
- 132 Appendix H Workshop Summary
- 133 Appendix I References for Appendixes
- 134 Appendix J Workshop Program
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