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

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. "Discussion." Issues in Risk Assessment. Washington, DC: The National Academies Press, 1993.

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Issues in Risk Assessment

with attendant consequences for the overall system structure (Fogarty et al., 1989). Population modeling suggests that the stock-recruitment relationship for haddock might have been changed and that the population cannot now withstand as heavy fishing mortality as it could before the increase in predation pressure.

Risk assessment for exploited systems must take into account uncertainties in population abundance, harvest rates, and system structure. Adoption of risk-averse management strategies would minimize the possibility of stock depletion or undesirable alterations in the structure of the system.

Discussion

(Led by R. M. Peterman, Simon Fraser University, and J. L. Ludke, National Fisheries Research Center-Leetown)

Discussion focused on the idea of statistical power—the probability that an experiment (or set of observations) will correctly reject a null hypothesis that is false, i.e., the probability that an experiment will detect effects that actually exist. In fisheries cases, the high degree of variability in population parameters means that most studies have very low power to detect changes, unless the studies are continued for many years or involve frequent measurements (Peterman and Bradford, 1987). Published papers in fisheries biology (and in other disciplines related to risk assessment) rarely report statistical power and hence can misleadingly report negative findings. The case study recommended adopting a conservative null hypothesis to allow for the low power of the observational studies. Other approaches are to improve the design of studies (e.g., by more frequent sampling), to incorporate uncertainties into formal decision analysis, and to reverse the burden of proof (to put the burden of documenting whether detrimental effects are occurring on exploiters of the resource, rather than in the management agency). If "proof" of safety is required, a formal statement of the power of studies should be provided for a size of effect deemed relevant.

The Georges Bank fishery is only one of a long series of cases in which overexploitation has occurred despite a nominal system of scien-

Page
307
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 307
Issues in Risk Assessment with attendant consequences for the overall system structure (Fogarty et al., 1989). Population modeling suggests that the stock-recruitment relationship for haddock might have been changed and that the population cannot now withstand as heavy fishing mortality as it could before the increase in predation pressure. Risk assessment for exploited systems must take into account uncertainties in population abundance, harvest rates, and system structure. Adoption of risk-averse management strategies would minimize the possibility of stock depletion or undesirable alterations in the structure of the system. Discussion (Led by R. M. Peterman, Simon Fraser University, and J. L. Ludke, National Fisheries Research Center-Leetown) Discussion focused on the idea of statistical power—the probability that an experiment (or set of observations) will correctly reject a null hypothesis that is false, i.e., the probability that an experiment will detect effects that actually exist. In fisheries cases, the high degree of variability in population parameters means that most studies have very low power to detect changes, unless the studies are continued for many years or involve frequent measurements (Peterman and Bradford, 1987). Published papers in fisheries biology (and in other disciplines related to risk assessment) rarely report statistical power and hence can misleadingly report negative findings. The case study recommended adopting a conservative null hypothesis to allow for the low power of the observational studies. Other approaches are to improve the design of studies (e.g., by more frequent sampling), to incorporate uncertainties into formal decision analysis, and to reverse the burden of proof (to put the burden of documenting whether detrimental effects are occurring on exploiters of the resource, rather than in the management agency). If "proof" of safety is required, a formal statement of the power of studies should be provided for a size of effect deemed relevant. The Georges Bank fishery is only one of a long series of cases in which overexploitation has occurred despite a nominal system of scien-

OCR for page 308
Issues in Risk Assessment tific stock assessment and fishery management. Discussants generally felt that overexploitation was due to failures of management, rather than to deficiencies in assessment or failure to communicate results to managers. The assessment of the risk to fish populations associated with exploitation in the Georges Bank case study is implicitly consistent with the 1983 health risk assessment framework, although the explicit steps differ. The case study illustrates the 1983 risk assessment paradigm within the larger context of problem-solving. However, the dose-response and exposure steps might be only loosely analogous. Differing circumstances of function, scale, and certitude could require variation in the method of risk assessment. The numerous sources of uncertainty in assessing risk associated with exploitation of fish populations vary and increase in magnitude with increase in scale. Regulation of harvest of geographically confined populations can be achieved with greater confidence than can regulation of wide-ranging populations such as Chesapeake Bay striped bass and Lake Michigan lake trout. Sources of uncertainty include variation in recruitment, measurement (which requires many assumptions), and management and institutional characteristics. Management techniques for reducing risks associated with overexploitation of populations are fairly blunt instruments, and strong actions are usually taken only after the fact. Rarely, if ever, are risk reduction measures considered until an actual impact is noticed or a potential threat emerges. Subtle and cumulative factors that are unknown or are measured imprecisely—e.g., chronic or episodic changes in predation, migration, and disease—are some of the issues with information gaps that contribute to uncertainties in ecological risk assessment. The Georges Bank case study describes multispecies interactions and consequences of selective harvesting practices within the fish community, but falls short of a systematic understanding of cause and effect with regard to changes in multispecies abundance.