Content: Conceptual basis for risk assessment / Joseph V. Rodricks and Robert G. Tardiff --
Use of toxicity test data in the estimation of risks to human health / Norton Nelson --
Interspecies extrapolation / Daniel B. Menzel and Elaine D. Smolko --
Basic concepts of the dose-response relationship / Robert Snyder --
High- to low-dose extrapolation in animals / Charles C. Brown --
Legal considerations in risk assessment under federal regulatory statutes / Peter Barton Hutt --
Inter-risk comparisons / E.A.C. Crouch and Richard Wilson --
Uncertainty and quantitative assessment in risk management / M. Granger Morgan --
Use of risk assessment and safety evaluation / Virgil O. Wodicka --
The need for risk assessment of chemicals in corporate decision making / Fred Hoerger --
Chemical industry perspectives on regulatory impact analysis / René D. Zentner.
Author(s): Joseph V. Rodricks and Robert G. Tardiff (Eds.)
Series: ACS Symposium Series 239
Publisher: American Chemical Society
Year: 1984
Language: English
Pages: 177
City: Washington, D.C
Title Page......Page 1
Copyright......Page 2
ACS Symposium Series......Page 3
FOREWORD......Page 4
PdftkEmptyString......Page 0
PREFACE......Page 5
1 Conceptual Basis for Risk Assessment......Page 6
Traditional Safety Assessment Schemes......Page 8
Limitations In The Safety Assessment Scheme......Page 9
Newer Concepts Of Assessment......Page 11
Risk Assessment......Page 12
Risk Management......Page 13
Literature Cited......Page 14
2 Use of Toxicity Test Data in the Estimation of Risks to Human Health......Page 16
Literature Cited......Page 25
3 Interspecies Extrapolation......Page 26
Interspecies Differences in Morphology......Page 27
Application of Mathematical Models to Inhalation Toxicology......Page 30
Polymorphic Xenobiotic Compound Metabolism In Animals and Man......Page 33
Conclusion......Page 35
Literature Cited......Page 37
4 Basic Concepts of the Dose-Response Relationship......Page 39
Bioassay Systems......Page 41
Graphical Presentation of the Dose-Response Relationship......Page 43
Conclusion......Page 54
Literature Cited......Page 56
5 High- to Low-Dose Extrapolation in Animals......Page 58
Mathematical Models of Dose-Response......Page 60
Tolerance Distribution Models......Page 61
Models Derived From Mechanistic Assumptions......Page 64
Pharmacokinetic Models......Page 65
Adjustments for Natural Responsiveness......Page 67
Discrimination among dose-response models......Page 70
Summary and Conclusions......Page 77
Literature Cited......Page 78
6 Legal Considerations in Risk Assessment Under Federal Regulatory Statutes......Page 81
Background History......Page 82
Safety/Risk Standards In Federal Health And Safety Statutes......Page 84
Principles Of Statutory Construction......Page 89
Comparison Of Federal Regulatory Statutes......Page 90
Use Of Safety/Risk Assessment In Regulatory Decisions......Page 91
Literature Cited......Page 92
7 Inter-Risk Comparisons......Page 94
System Boundaries......Page 95
Modelling and Uncertainty......Page 97
Everyday Risks of Life......Page 98
Cancer Risks......Page 103
Conclusions......Page 106
Acknowledgments......Page 109
8 Uncertainty and Quantitative Assessment in Risk Management......Page 110
Why is it "Good" to Characterize and Deal With Uncertainty in Risk Assessment and in Other Quantitative Policy Analysis?......Page 113
Sources of Uncertainty in Quantitative Risk Assessment......Page 115
Analytical Strategies and Tools for Dealing with Uncertainty......Page 117
Risk Assessment Tools as a Framework for Discussion Among Contesting Parties......Page 123
Literature Cited......Page 125
9 Use of Risk Assessment and Safety Evaluation......Page 127
Traditional Methods—Safety Factors......Page 128
Problems with safety factors......Page 131
A better way......Page 133
Application to man......Page 134
Summary......Page 139
Literature Cited......Page 140
Chronology of the Growth of Risk Concerns......Page 142
Broad Principles of the Risk Assessment Process in the Corporation......Page 144
Types of Corporate Decisions Based on or Relating to Risk Assessment......Page 145
Data Generation and Risk Assessment Integrated into the Research, Development, and Commercialization Cycle of a Product......Page 148
Risk Assessment on Existing Chemicals — Data Gaps, Exposure Assessment and Priorities......Page 150
Sound Risk Assessment: MuItidisciplinary and Staged......Page 152
Anticipation of Regulatory Decision......Page 153
Perspective for the Future......Page 154
11 Chemical Industry Perspectives on Regulatory Impact Analysis......Page 156
Literature Cited......Page 167
Author Index......Page 169
C......Page 170
D......Page 171
E......Page 172
L......Page 173
R......Page 174
T......Page 176
V......Page 177
