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

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

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Issues in Risk Assessment

Appendix J
Workshop Program

February 26 - March 1, 1991

Airlie Foundation

Warrenton, VA

TUESDAY, FEBRUARY 26, 1991

4:00

WELCOME Bernard Goldstein, Committee Chairman, Robert Wood Johnson Medical School

4:15

DISCUSSION OF PURPOSE Lawrence Barnthouse, Workshop Chairman, Oak Ridge National Laboratory

KEYNOTE SPEECHES

4:30

Broad Policy View, Terry Yosie, American Petroleum Institute

5:00

Relationship of Workshop to NRC's 1983 Risk Assessment Study Warner North, Decision Focus, Inc.

Page
351
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 351
Issues in Risk Assessment Appendix J Workshop Program February 26 - March 1, 1991 Airlie Foundation Warrenton, VA TUESDAY, FEBRUARY 26, 1991 4:00 WELCOME Bernard Goldstein, Committee Chairman, Robert Wood Johnson Medical School 4:15 DISCUSSION OF PURPOSE Lawrence Barnthouse, Workshop Chairman, Oak Ridge National Laboratory KEYNOTE SPEECHES 4:30 Broad Policy View, Terry Yosie, American Petroleum Institute 5:00 Relationship of Workshop to NRC's 1983 Risk Assessment Study Warner North, Decision Focus, Inc.

OCR for page 352
Issues in Risk Assessment 5:30 U.S. EPA Activities in Ecological Risk Assessment Michael Slimak, ORD, U.S. EPA WEDNESDAY, FEBRUARY 27, 1991 CASE STUDIES CHEMICAL STRESSORS 8:30 Tributyl tin Robert Huggett, Virginia Institute of Marine Science 8:55 Discussants: Lawrence Barnthouse, Oak Ridge National Laboratory 9:05 Discussants: Peter Seligman, Naval Ocean Systems Center 9:15 General Discussion 9:30 Agrochemicals Ronald Kendall, Clemson University 9:55 Discussants: Bill Williams, Ecological Planning and Toxicology, Inc. 10:05 Discussants: James Gagne, American Cyanamid Company 10:15 General Discussion 10:30 Break 11:00 PCBs and TCDD Dominic DiToro, Manhattan College 11:25 Discussants: Dennis Paustenbach, McLaren/Hart 11:35 Discussants: Larry Burns, U.S. EPA, Athens, GA 11:45 General Discussion noon Lunch OTHER STRESSORS 1:30 Habitat loss (spotted owl) David Anderson, U.S. Fish & Wildlife Service

OCR for page 353
Issues in Risk Assessment 1:55 Discussants: Orie Loucks, Miami University, OH 2:05 Discussants: Mary Kentula, U.S. EPA, Corvailis, OR 2:15 General Discussion 2:30 Introduction of species Ray Carruthers, USDA, Cornell University 2:55 Discussants: David Policansky, National Research Council 3:05 Discussants: James Carlton, Williams College 3:15 General Discussion 3:30 Break 4:00 Harvesting (George's Bank Fisheries) Andrew Rosenberg, National Marine Fisheries Service 4:25 Discussants: J. Larry Ludke, U.S. Fish and Wildlife Service 4:35 Discussants: Randall Peterman, Simon Fraser University 4:45 General Discussion 5:00 Adjourn THURSDAY, FEBRUARY 28, 1991 BREAKOUT SESSIONS 7:30 Breakfast 8:30 RELEVANCE OF NRC 1983 RED BOOK PARADIGM TO ECOLOGICAL RISK ASSESSMENT   Hazard identification Alan Maki, Exxon Corporation Dorothy Patton, Risk Assessment Forum, U.S. EPA   Dose-response assessment John Bailar, McGill University School of Medicine Judy Meyer, University of Georgia

OCR for page 354
Issues in Risk Assessment   Exposure assessment Brian Leaderer, Yale University School of Medicine Don Porcella, Electric Power Research Institute   Risk characterization William Farland, OHEA, U.S. EPA Glenn Suter, Oak Ridge National Laboratory 10:00 Break 10:30 Reconvene 12:30 Lunch 1:30 ANALYTICAL ISSUES IN ECOLOGICAL RISK ASSESSMENT   Modeling Robert Costanza, University of Maryland David Mauriello, U.S. EPA   Uncertainty Richard Kimerle, Monsanto Company Eric Smith, Virginia Polytechnic Institute and State University   Valuation William Desvousges, Research Triangle Institute F. Reed Johnson, U.S. Naval Academy   Relationship of risk assessment to regulatory process Warner North, Decision Focus, Inc. William Cooper, Michigan State University 3:30 Break 4:00 Reconvene 6:00 Adjourn

OCR for page 355
Issues in Risk Assessment 6:30 Dinner   Speaker Erich W. Bretthauer, Assistant Administrator for Research and Development, U.S. EPA FRIDAY, MARCH 1, 1991 CONCLUDING PLENARY SESSION 7:30 Breakfast RELEVANCE OF NRC 1983 RED BOOK PARADIGM TO ECOLOGICAL RISK ASSESSMENT 8:00 CONTEMPLATIONS ON ECOLOGICAL RISK ASSESSMENT Thomas Lovejoy, Smithsonian Institution 8:30 Hazard identification, Maki and Patton 8:45 Dose-response assessment, Bailar and Meyer 9:00 Exposure assessment, Leaderer and Porcella 9:15 Risk characterization, Farland and Suter 9:30 Discussion, North 10:00 Break ANALYTICAL ISSUES IN ECOLOGICAL RISK ASSESSMENT 10:15 Modeling, Costanza and Mauriello 10:30 Uncertainty, Kimerle and Smith 10:45 Valuation, Desvousges and Johnson

OCR for page 356
Issues in Risk Assessment 11:00 Relationship of risk assessment to regulatory process, North and Cooper 11:15 Discussion, Barnthouse 11:45 Conclusion, Barnthouse noon Lunch/Adjourn