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Issues in Risk Assessment (1993)
Commission on Life Sciences (CLS)

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. "Appendix C Workshop Introduction ." Issues in Risk Assessment. Washington, DC: The National Academies Press, 1993.

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Issues in Risk Assessment

Appendix C
Workshop Introduction

One of the principal objectives of the Committee on Risk Assessment Methodology (CRAM) is to determine how risk assessment can be applied to ecological end points. The major environmental problems of the 1990s include such diverse stresses as contamination with toxic substances, overharvesting, habitat destruction, and climate change. Characteristic spatial scales for different types of stresses range from the local to the global. Yet, because priorities must be set at both the national and the local levels, consistent methods are needed for quantifying magnitudes of risks, comparing risks, and making risk-benefit tradeoffs.

A committee was established to plan a workshop on ecological risk assessment. A meeting was held in July 1990 to identify workshop objectives and develop a program. The planning committee agreed that the workshop should survey existing approaches to ecological risk assessment through discussion of specific case studies representative of the major types of environmental stresses, evaluate the applicability of the 1983 four-part risk assessment scheme to environmental assessment and regulation, and identify technical approaches and uncertainties that are common to many environmental problems.

The program began with the three keynote speakers: Terry Yosie, vice-president of the American Petroleum Institute, Mike Slimak, the deputy director of the Office of Ecological Processes and Effects Research, U.S. Environmental Protection Agency, and Warner North, a member of the committee that produced the NRC's 1983 report on human health risk assessment.

Page
281
Front Matter (R1-R18)
Executive Summary (1-2)
USE OF THE MAXIMUM TOLERATED DOSE IN ANIMAL BIOASSAYS FOR CARCINOGENICITY (3-8)
THE TWO-STAGE MODEL OF CARCINOGENESIS (9-9)
A PARADIGM FOR ECOLOGIC RISK ASSESSMENT (10-12)
Issues In Risk Assessment Use Of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity (13-14)
BACKGROUND (15-17)
SCOPE OF REPORT (18-20)
DEFINITIONS AND BACKGROUND (21-23)
CORRELATIONS (24-32)
RELATIONSHIP BETWEEN TOXICITY AND CARCINOGENICITY OBSERVED AT MTD (33-42)
QUALITATIVE INFORMATION (43-48)
QUANTITATIVE INFORMATION (49-52)
OPTION 1 (53-53)
OPTION 2 (54-54)
OPTION 3 (55-56)
Option 4A (57-58)
Option 4B (59-60)
5 Conclusions and Recommendations (61-66)
REFERENCES (67-78)
BACKGROUND (79-79)
DEFINING AND DETERMINING THE MTD (80-90)
Appendix B Organizing Subcommittee (91-92)
Appendix C Federal Liaison Group (93-94)
Appendix D Workshop Program (95-96)
Appendix E Workshop Attendees (97-110)
1. INTRODUCTION (111-112)
2.1 Measures of Carcinogenic Potency (113-115)
2.2 Carcinogenic Potency Database (CPDB) (116-116)
2.3 Variation in Carcinogen Potency (117-118)
2.4 Classification of Carcinogens (119-120)
3.1 Empirical Correlations (121-124)
3.2 Range of Possible TD50 Values (125-125)
3.3 Analytical Correlations (126-127)
3.4 Model Dependency (128-129)
3.5 Genotoxic vs. Nongenotoxic Carcinogens (130-130)
4.1 Predictions Based on the MDT (131-131)
4.2 Predictions Based on Mutagenicity and Acute Toxicity (132-134)
5.1 Correlation Between Upper Bounds On the Low Dose Slope and MTD (135-135)
5.2 Correlation Between q1* and the TD50 (136-138)
5.3. Preliminary Estimate of Risk (139-139)
6. INTERSPECIES EXTRAPOLATION (140-140)
6.1 Extrapolation from Rats to Mice (141-143)
6.2 Extrapolation from Rodents to Humans (144-145)
7. CONCLUSIONS (146-148)
8. ACKNOWLEDGEMENTS (149-149)
9. REFERENCES (150-159)
ANNEX A: MAXIMUM LIKELIHOOD METHODS FOR FITTING THE WEIBULL MODEL (160-161)
ANNEX B. SHRINKAGE ESTIMATORS OF THE DISTRIBUTION OF CARCINOGENIC POTENCY (162-163)
ANNEX C: ADJUSTMENT OF POTENCY VALUES FOR LESS THAN LIFETIME EXPOSURE (164-165)
ANNEX D: CORRELATION BETWEEN TD50 AND MTD (166-168)
ANNEX E: CORRELATION BETWEEN TD50S FOR RATS AND MICE (169-172)
Appendix G Informal Search for ''Supercarcinogens" (173-174)
CRITERIA AND CANDIDATE CHEMICALS (175-176)
DATA (177-180)
RESULTS (181-181)
DISCUSSION (182-184)
Issues in Risk Assessment The Two-Stage Model Of Carcinogenesis (185-186)
INTRODUCTION (187-187)
BIOLOGIC CONSIDERATIONS (188-189)
THE TWO-STAGE MODEL (190-195)
APPLICATIONS OF THE TWO-STAGE MODEL TO ANIMAL DATA (196-211)
Data Needs (212-212)
Criteria for Adoption (213-213)
Prospects (214-214)
CONCLUSIONS AND RECOMMENDATIONS (215-216)
REFERENCES (217-222)
BIOLOGICAL FACTORS IN TWO-STAGE MODELS (223-225)
TWO-STAGE MODEL OF CLONAL EXPANSION (226-227)
APPLICATION OF THE TWO-STAGE MODEL TO ANIMAL DATA (228-232)
Appendix B Workshop Program (233-234)
Appendix C Workshop Federal Liaison Group (235-236)
TOPIC GROUP MEMBERS (237-238)
Appendix E Workshop Organizing Task Group (239-240)
Isuees In Risk Assessment A Paradigm for Ecological Risk Assessment (241-242)
1 Introduction (243-246)
2 Scope of Ecological Risk Assessment (247-248)
COMPONENTS OF THE 1983 FRAMEWORK (249-250)
CONSISTENCY OF CASE STUDIES WITH THE 1983 FRAMEWORK (251-253)
INTEGRATION OF ECOLOGICAL RISK INTO THE 1983 FRAMEWORK (254-254)
DEFINITION OF FRAMEWORK COMPONENTS FOR ECOLOGICAL RISK ASSESSMENT (255-258)
EXTRAPOLATION ACROSS SCALES (259-260)
QUANTIFICATION OF UNCERTAINTY (261-261)
VALIDATION OF PREDICTIVE TOOLS (262-262)
VALUATION (263-264)
5 Conclusions (265-266)
6 Recommendations (267-268)
REFERENCES (269-272)
Appendix A Workshop Participants (273-278)
Appendix B Workshop Organizing Subcommittee and Federal Liaison Group (279-280)
Appendix C Workshop Introduction (281-282)
TERRY F. YOSIE BUILDING ECOLOGICAL RISK ASSESSMENT AS A POLICY TOOL (283-285)
D. WARNER NORTH: RELATIONSHIP OF WORKSHOP TO NRC'S 1983 RED BOOK REPORT (286-288)
MICHAEL SLIMAK: U.S. ENVIRONMENTAL PROTECTION AGENCY ACTIVITIES IN ECOLOGICAL RISK ASSESSMENT (289-292)
CASE STUDY 1: TRIBUTYLTIN RISK MANAGEMENT IN THE UNITED STATES (293-293)
Discussion (294-294)
CASE STUDY 2: ECOLOGICAL RISK ASSESSMENT FOR TERRESTRIAL WILDLIFE EXPOSED TO AGRICULTURAL CHEMICALS (295-296)
CASE STUDY 3A: MODELS OF TOXIC CHEMICALS IN THE GREAT LAKES: STRUCTURE, APPLICATIONS, AND UNCERTAINTY ANALYSIS (297-298)
CASE STUDY 3B: ECOLOGICAL RISK ASSESSMENT OF TCDD AND TCDF (299-299)
Discussion (300-300)
CASE STUDY 4: RISK ASSESSMENT METHODS IN ANIMAL POPULATIONS: THE NORTHERN SPOTTED OWL AS AN EXAMPLE (301-301)
Discussion (302-302)
CASE STUDY 5: ECOLOGICAL BENEFITS AND RISKS ASSOCIATED WITH THE INTRODUCTION OF EXOTIC SPECIES FOR BIOLOGICAL CONTROL OF A... (303-303)
Discussion (304-304)
CASE STUDY 1: UNCERTAINTY AND RISK IN AN EXPLOITED ECOSYSTEM: A CASE STUDY OF GEORGES BANK (305-306)
Discussion (307-308)
Generic Issues (309-309)
Analysis of Case Studies (310-310)
DOSE-RESPONSE ASSESSMENT (311-311)
Selection of End Points (312-312)
Consideration of Nonlinearities And Discontinuities (313-313)
Understanding the Stressor (314-314)
Additions to the 1983 Paradigm Needed for Ecological Risk Assessment (315-315)
Modeling Needs for Stress-Response Relationships (316-316)
Methods of Measuring Stressors for Ecological Exposure Assessment (317-317)
Definition of Risk Characterization (318-318)
Components of Risk Characterization (319-319)
Organization and Presentation (320-320)
Differences from and Similarities To the 1983 Report (321-321)
Application to the Case Studies (322-323)
Agricultural Chemicals (324-324)
Northern Spotted Owl (325-325)
General Discussion: Models and Risk Assessment (326-326)
Uncertainties Identified In the Case Studies (327-327)
Implications of Uncertainty for Ecological Risk Assessment (328-328)
VALUATION (329-330)
Risk Assessment Has Many Uses (331-332)
Different Risk Assessment Methods Are Suited to Different Risk Assessment Needs (333-333)
Risk Assessors and Risk Managers Need to Communicate (334-334)
Credibility is Crucial (335-336)
Appendix G Contemplations on Ecological Risk Assessment (337-342)
Appendix H Workshop Summary (343-346)
Appendix I References for Appendixes (347-350)
Appendix J Workshop Program (351-356)

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OCR for page 281
Issues in Risk Assessment Appendix C Workshop Introduction One of the principal objectives of the Committee on Risk Assessment Methodology (CRAM) is to determine how risk assessment can be applied to ecological end points. The major environmental problems of the 1990s include such diverse stresses as contamination with toxic substances, overharvesting, habitat destruction, and climate change. Characteristic spatial scales for different types of stresses range from the local to the global. Yet, because priorities must be set at both the national and the local levels, consistent methods are needed for quantifying magnitudes of risks, comparing risks, and making risk-benefit tradeoffs. A committee was established to plan a workshop on ecological risk assessment. A meeting was held in July 1990 to identify workshop objectives and develop a program. The planning committee agreed that the workshop should survey existing approaches to ecological risk assessment through discussion of specific case studies representative of the major types of environmental stresses, evaluate the applicability of the 1983 four-part risk assessment scheme to environmental assessment and regulation, and identify technical approaches and uncertainties that are common to many environmental problems. The program began with the three keynote speakers: Terry Yosie, vice-president of the American Petroleum Institute, Mike Slimak, the deputy director of the Office of Ecological Processes and Effects Research, U.S. Environmental Protection Agency, and Warner North, a member of the committee that produced the NRC's 1983 report on human health risk assessment.

OCR for page 282
Issues in Risk Assessment Case study presentations followed. Six case study papers were commissioned for the workshop to provide distinct examples of risk assessment problems: assessing the effects of tributyltin on Chesapeake Bay shellfish populations, testing of agricultural chemicals for effects on avian species, predicting the fate and effects of polychlorinated biphenyls (PCBs) and 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in aquatic ecosystems, quantifying the responses of northern spotted owl populations to habitat change, regulating species introductions, and determining the risks associated with overharvesting of the Georges Bank multispecies fishery. Each case study presentation was accompanied by comments from two discussants. The case studies were complemented by eight focused breakout sessions. Four of the breakout sessions were organized around components of the 1983 health risk assessment framework: hazard identification, dose-response assessment, exposure assessment, and risk characterization. Each of these sessions was co-chaired by an ecologist and a health risk assessment expert. The purpose of this format was to encourage interaction between the two disciplines and to investigate the applicability of the general concepts developed in the 1983 report to ecological risk assessment. The remaining four breakout sessions were organized around general risk assessment themes: modeling, uncertainty, valuation, and the role of risk assessment in the regulatory process. Dr. Thomas Lovejoy of the Smithsonian Institution was invited to give a closing presentation summarizing his views, based on attendance at the workshop, on the current status and future prospects of ecological risk assessment. Lovejoy's presentation is included in Appendix E. Participants in the workshop included experts on the specific environmental problems covered in the case studies, representatives of federal and state agencies responsible for performing or evaluating ecological risk assessments, and experts on the technical disciplines (e.g., statistics, ecology, environmental chemistry, and resource economics) that form the scientific basis of ecological risk assessment. The case study papers, summaries of the discussions and plenary presentations, and the workshop findings are presented in this report.