National Academy of Sciences | 150 Year Anniversary

Questions? Call 800-624-6242

| Items in cart [0]

The National Academies Press

PAPERBACK
price:$49.00
add to cart

Rights & Permissions

topleft topright

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

Citation Manager

. "CASE STUDY 2: ECOLOGICAL RISK ASSESSMENT FOR TERRESTRIAL WILDLIFE EXPOSED TO AGRICULTURAL CHEMICALS." Issues in Risk Assessment. Washington, DC: The National Academies Press, 1993.

Please select a format:

BibTeX EndNote RefMan


Page
295
bottomleft bottomright

The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy.


Issues in Risk Assessment

use and release rates rather than on monitoring or modeling studies. Risk characterization was only qualitative; it did not address such issues as the number and distribution of species that were vulnerable, or the degree of damage to the shellfish industry. Risk management actions were based on the demonstrable existence of hazard, on societal concern for the vulnerable species, and on the ready availability of alternative antifouling agents.

Some workshop participants were critical of the risk assessment approach adopted by Congress and state regulatory agencies. No attempt was made to plan and execute a formal risk assessment. Risk identification was based primarily on data on nonnative species. The Eastern oyster and blue crab, the species putatively at greatest risk, have been found to be less sensitive. Regulatory responses were based on findings of high environmental concentrations of TBT in yacht harbors and marinas, rather than in ecologically important regions such as breeding grounds. The central issue is whether a safe loading capacity (environmental concentration) of TBT for nontarget organisms can be defined, given substantially reduced rates of input. Recent information on fate and persistence, chronic toxicity, and dose-response relationships could support a more quantitative risk assessment with the possibility of more or less stringent restrictions.

CASE STUDY 2:Ecological Risk Assessment for Terrestrial Wildlife Exposed to Agricultural Chemicals

R. J. Kendall, Clemson University

The science of ecological risk assessment for exposure of terrestrial wildlife to agricultural chemicals has advanced rapidly during the 1980s. EPA requires detailed assessments of the toxicity and environmental fate of chemicals proposed for agricultural use (EPA, 1982; Fite et al., 1988). Performance of an ecological risk assessment requires data from several disciplines: analytical toxicology, environmental chemistry, biochemical toxicology, ecotoxicology, and wildlife ecology.

Addressing the ecological risks associated with the use of an agricultural chemical involves a complex array of laboratory and field studies—in essence, a research program. This paper provides examples of

Page
295
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)

Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 295
Issues in Risk Assessment use and release rates rather than on monitoring or modeling studies. Risk characterization was only qualitative; it did not address such issues as the number and distribution of species that were vulnerable, or the degree of damage to the shellfish industry. Risk management actions were based on the demonstrable existence of hazard, on societal concern for the vulnerable species, and on the ready availability of alternative antifouling agents. Some workshop participants were critical of the risk assessment approach adopted by Congress and state regulatory agencies. No attempt was made to plan and execute a formal risk assessment. Risk identification was based primarily on data on nonnative species. The Eastern oyster and blue crab, the species putatively at greatest risk, have been found to be less sensitive. Regulatory responses were based on findings of high environmental concentrations of TBT in yacht harbors and marinas, rather than in ecologically important regions such as breeding grounds. The central issue is whether a safe loading capacity (environmental concentration) of TBT for nontarget organisms can be defined, given substantially reduced rates of input. Recent information on fate and persistence, chronic toxicity, and dose-response relationships could support a more quantitative risk assessment with the possibility of more or less stringent restrictions. CASE STUDY 2:Ecological Risk Assessment for Terrestrial Wildlife Exposed to Agricultural Chemicals R. J. Kendall, Clemson University The science of ecological risk assessment for exposure of terrestrial wildlife to agricultural chemicals has advanced rapidly during the 1980s. EPA requires detailed assessments of the toxicity and environmental fate of chemicals proposed for agricultural use (EPA, 1982; Fite et al., 1988). Performance of an ecological risk assessment requires data from several disciplines: analytical toxicology, environmental chemistry, biochemical toxicology, ecotoxicology, and wildlife ecology. Addressing the ecological risks associated with the use of an agricultural chemical involves a complex array of laboratory and field studies—in essence, a research program. This paper provides examples of

OCR for page 296
Issues in Risk Assessment integrated field and laboratory research programs, such as The Institute for Wildlife and Environmental Toxicology (TIWET) at Clemson University. Preliminary toxicological and biochemical evaluations include measurements of acute toxicity (LC50 and LD50), toxicokinetics, and observations of wildlife in areas of field trials. Assessment of reproductive toxicity includes studies with various birds and other wildlife, particularly European starlings that nest at high densities in established nest boxes; these studies include measurements of embryo and nestling survival, postfledgling survival, behavior, diet, and residue chemistry (Kendall et al., 1989). Nonlethal assessment methods include measurement of plasma cholinesterase activity associated with organophosphate pesticide exposures (Hooper et al., 1989). A wide variety of birds, mammals, and invertebrates have been used in these studies. End points evaluated in wildlife toxicological studies include mortality, reproductive success, physiological and biochemical changes, enzyme impacts, immunological impairment, hormonal changes, mutagenesis and carcinogenesis, behavioral changes, and residues of parent compounds and metabolites (Kendall, 1992). The paper includes a case history of a comparative evaluation of Carbofuran and Terbufos as granular insecticides for control of corn rootworms. Carbofuran has been responsible for many incidents of wildlife poisoning and is recognized as being very hazardous to wildlife. In contrast, although Terbufos is highly toxic to wildlife in laboratory studies, exposure of wildlife under field conditions appears generally to be relatively low, and widespread mortality is not evident. Field studies of Terbufos conducted by TIWET might be the only ones conducted to date that satisfy EPA's requirements for a Level 2 field study, a more quantitative assessment of the magnitude of the effects of a pesticide than the qualitative Level 1 studies. (Level 2 studies are performed when toxicity tests and use patterns suggest a detailed study is warranted.) Data generated in those studies support an ecological risk assessment for Terbufos that is reported in the paper. However, the research program on Terbufos represents many years of effort with integration of laboratory and field research to achieve a full-scale level 2 study in just one geographic area on one crop. Ecological modeling techniques will be needed to generalize the results to other chemicals or to other situations.