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

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

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Issues in Risk Assessment

The group noted that the degree of uncertainty that is acceptable in a study depends on the costs associated with the outcome of the risk assessment, the magnitude of expected effects, and the availability of alternatives to the hazardous agent being addressed. In the TBT study, although there were many uncertainties, once the risk to oysters was established, uncertainties about effects on other organisms were unimportant. The availability of alternatives to TBT as an antifouling agent further reduced the importance of the uncertainties.

Recommendations for Dealing With Uncertainty
  • A discussion of uncertainty should be included in any ecological risk assessment. Uncertainties could be discussed in the methods section of a report, and the consequences of uncertainties described in the discussion section. End point selection is an important component of ecological risk assessment. Uncertainties about the selection of end points need to be addressed.

  • Where possible, sensitivity analysis, Monte Carlo parameter uncertainty analysis, or another approach to quantifying uncertainty should be used. Reducible uncertainties (related to ignorance and sample size) and irreducible (stochastic) uncertainties should be clearly distinguished. Quantitative risk estimates, if presented, should be expressed in terms of distributions rather than as point estimates (especially worst-case scenarios). Power analysis or a discussion of sample size should be included in all studies involving collection of data and testing of hypotheses.

  • A continuing program of monitoring and experimental testing is needed to improve the accuracy and credibility of the process of ecological risk assessment. There are few standards for judging the accuracy of assessments, and continuing checks need to be made to increase confidence in the process.

VALUATION

W. Desvousges and R. Johnson

The discussion leaders began by summarizing their view of the role

Page
329
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 329
Issues in Risk Assessment The group noted that the degree of uncertainty that is acceptable in a study depends on the costs associated with the outcome of the risk assessment, the magnitude of expected effects, and the availability of alternatives to the hazardous agent being addressed. In the TBT study, although there were many uncertainties, once the risk to oysters was established, uncertainties about effects on other organisms were unimportant. The availability of alternatives to TBT as an antifouling agent further reduced the importance of the uncertainties. Recommendations for Dealing With Uncertainty A discussion of uncertainty should be included in any ecological risk assessment. Uncertainties could be discussed in the methods section of a report, and the consequences of uncertainties described in the discussion section. End point selection is an important component of ecological risk assessment. Uncertainties about the selection of end points need to be addressed. Where possible, sensitivity analysis, Monte Carlo parameter uncertainty analysis, or another approach to quantifying uncertainty should be used. Reducible uncertainties (related to ignorance and sample size) and irreducible (stochastic) uncertainties should be clearly distinguished. Quantitative risk estimates, if presented, should be expressed in terms of distributions rather than as point estimates (especially worst-case scenarios). Power analysis or a discussion of sample size should be included in all studies involving collection of data and testing of hypotheses. A continuing program of monitoring and experimental testing is needed to improve the accuracy and credibility of the process of ecological risk assessment. There are few standards for judging the accuracy of assessments, and continuing checks need to be made to increase confidence in the process. VALUATION W. Desvousges and R. Johnson The discussion leaders began by summarizing their view of the role

OCR for page 330
Issues in Risk Assessment of valuation in ecological risk assessment. Managing ecological risks requires a consistent means of comparing alternatives. Monetary values are an appropriate basis for such comparisons. Economic concerns influence several components of the risk assessment process, including hazard identification (which end points are worthy of societal concern?) and risk characterization (what are the economic implications of uncertainty?). Cost-benefit analyses are frequently a key aspect of risk management decisions. The discussion leaders presented some methods for valuing ecological resources based on two assumptions of classical welfare economics—that societal values are sums of individual values and that people know and can express their willingness to pay (or accept compensation) for various risk policies. They then discussed some aspects of risk that influence individual decisions about willingness to pay or accept compensation: Amount, content, frame, and source of information; Decision heuristics; Cause of damage; Responsibility; Degree of suffering; Immediacy or delay of effects; Morbidity or mortality. They then discussed specific issues related to determining willingness to pay for preserving ecological resources. For recreational-use values (such as fishing, hunting, and birdwatching), techniques for valuation are reasonably well established. Current research in valuation focuses on nonrecreational values. There are two principal types of such values: ecological services (sometimes called services of nature) and existence value. Ecological services are services provided by ecosystems that otherwise would have to be provided by technology. The role of wetlands in pollution abatement and flood control is a good example of an ecological service. Existence values, more vaguely defined and more controversial, are defined by people's willingness to pay for the existence of particular populations or ecosystems, even if they never expect to use or see them. The discussion leaders presented a tutorial on methods used to elicit existence values with questionnaires. There was much heated discussion.