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

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. "CASE STUDY 1: UNCERTAINTY AND RISK IN AN EXPLOITED ECOSYSTEM: A CASE STUDY OF GEORGES BANK." Issues in Risk Assessment. Washington, DC: The National Academies Press, 1993.

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Issues in Risk Assessment

ed by human modification of habitats), deliberate introductions to "improve nature" or for aquaculture or horticulture, and a wide variety of accidental introductions. CBC seems to have a better safety record than other types of introduction. It is not clear whether this is because the activity is basically benign, because the safety precautions work well, or because CBC involves small organisms that pose smaller risks than larger organisms. The worst failures in all categories have occurred in insular environments such as islands and lakes.

The assessment of risks posed by introductions has been addressed separately by scientists in different disciplines (e.g., agriculture, freshwater and marine ecology, and nature conservation). Communication between the disciplines is poor, and several sets of criteria, procedures, and protocols have been developed independently. Whereas the U.S. Department of Agriculture has adopted flow charts as a way to systematize decision-making, other agencies (e.g., the International Council for the Exploration of the Sea) have concluded that too little is known about ecosystem functioning for flow charts to be useful.

Dr. Policansky commented that risk assessment for species introductions is difficult to fit into the four-step Red Book paradigm. Hazard is taken for granted (because it is the introduction of the species itself); dose-response and exposure are yes-no categories, not continuous variables, because the more important point is whether the species is present or not, not how much of the species is present. A more suitable paradigm might be that presented in the 1986 NRC report Ecological Knowledge and Environmental Problem-Solving: Concepts and Case Studies, which placed more emphasis on problem-scoping and problem-solving than on categorical activities.

CASE STUDY 1:Uncertainty and Risk in an Exploited Ecosystem: A Case Study of Georges Bank

M. J. Fogarty, A. A. Rosenberg, and M. P. Sissenwine, National Marine Fisheries Service

This paper addressed the risks of overexploitation of harvested marine

Page
305
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 305
Issues in Risk Assessment ed by human modification of habitats), deliberate introductions to "improve nature" or for aquaculture or horticulture, and a wide variety of accidental introductions. CBC seems to have a better safety record than other types of introduction. It is not clear whether this is because the activity is basically benign, because the safety precautions work well, or because CBC involves small organisms that pose smaller risks than larger organisms. The worst failures in all categories have occurred in insular environments such as islands and lakes. The assessment of risks posed by introductions has been addressed separately by scientists in different disciplines (e.g., agriculture, freshwater and marine ecology, and nature conservation). Communication between the disciplines is poor, and several sets of criteria, procedures, and protocols have been developed independently. Whereas the U.S. Department of Agriculture has adopted flow charts as a way to systematize decision-making, other agencies (e.g., the International Council for the Exploration of the Sea) have concluded that too little is known about ecosystem functioning for flow charts to be useful. Dr. Policansky commented that risk assessment for species introductions is difficult to fit into the four-step Red Book paradigm. Hazard is taken for granted (because it is the introduction of the species itself); dose-response and exposure are yes-no categories, not continuous variables, because the more important point is whether the species is present or not, not how much of the species is present. A more suitable paradigm might be that presented in the 1986 NRC report Ecological Knowledge and Environmental Problem-Solving: Concepts and Case Studies, which placed more emphasis on problem-scoping and problem-solving than on categorical activities. CASE STUDY 1:Uncertainty and Risk in an Exploited Ecosystem: A Case Study of Georges Bank M. J. Fogarty, A. A. Rosenberg, and M. P. Sissenwine, National Marine Fisheries Service This paper addressed the risks of overexploitation of harvested marine

OCR for page 306
Issues in Risk Assessment ecosystems, with specific application to Georges Bank, a highly productive area off the northeastern United States. In this context, risk assessment involves determining the probability that a population will be depleted to an arbitrarily predetermined "small" (e.g., 1% or 5%) size. The "quasi-extinction" level may be defined (Ginzburg et al., 1982) as (1) the population level below which the probability of poor recruitment increases appreciably or (2) the smallest population capable of supporting a viable fishery. The primary determinant of the long-term dynamics of any population is the relationship between the adult population (stock) and recruitment. The null hypothesis is that the relationship is linear, i.e., that recruitment is independent of density (Sissenwine and Shepherd, 1987). Compensatory changes in survival or in reproductive output result in nonlinear stock-recruitment curves. Nonlinearity permits stable equilibrium under harvesting pressure (i.e., under increased mortality rates), up to a critical exploitation level, beyond which the population will decline to quasi-extinction. Stochastic variation in the stock-recruitment relationship or in multispecies interactions can increase risks of adverse effects at moderate exploitation levels. In practice, because of uncertainties resulting from stochastic variations and measurement errors, it is often impossible to reject the null hypothesis of no compensation. Assuming there is no compensation will, in general, result in a conservative assessment of production capacity and its ability to withstand exploitation. Haddock populations on Georges Bank fluctuated about relatively stable levels between 1930 and 1960 when the fraction of the total haddock population killed per year by fisherman (annual fishing mortality rate) varied between 0.3-0.6, but collapsed after the fishing mortality rate increased to 0.8 during the 1960s (Grosslein et al., 1980). The empirical relationship between stock and recruitment was extremely variable with little indication of the form of the underlying curve. Analysis of the population dynamics showed that a density-independent null model could not be rejected and gave a neutral equivalent harvest rate of 0.5, which agrees well with the stable period of the fishery. In contrast, the compensatory model is over optimistic with respect to the long-term harvest rate. The decrease in populations of haddock and other groundfish was accompanied by increases in other species, notably elasmobranchs (rays and sharks). The biomass of predatory species increased dramatically