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PAPERBACK price:$49.00 add to cart Rights & Permissions Free PDF Access Sign in to download PDF book and chapters Free Resources PDF SUMMARY Display this book on your site! Related Titles Twenty-Third Symposium on Naval Hydrodynamics A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? Report of a Study Other Related Titles Issues in Risk Assessment (1993) Commission on Life Sciences (CLS) Citation Manager Export the bibliographic data for this book in your chosen format Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Citation Manager . "REFERENCES." Issues in Risk Assessment. Washington, DC: The National Academies Press, 1993. Please select a format: Page 217   E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore 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. References Anderson, E.L. and the Carcinogen Assessment Group of the U.S. Environmental Protection Agency. 1983. Quantitative approaches in use to assess cancer risk. Risk Anal. 3:277-295. Armitage, P., and R. Doll. 1957. A two-stage theory of carcinogenesis in relation to the age distribution of human cancer. Br. J. Cancer 11:161-169. Balmain, A., and K. Brown. 1988. Oncogene activation in chemical carcinogenesis. Adv. Cancer Res. 51:147-182. Barbacid, M. 1987. ras genes. Ann. Rev. Biochem. 56:779-827. Cavender, F.L., B.T. Cook, N.P. Page, V.J. Cogliano, and A.M. Koppibar. 1986. Carcinogenicity Assessment of Chlordane and Heptachlor/heptachlor Epoxide. EPA 600/6-87/004. U.S. Environmental Protection Agency, Research Triangle Park, N.C. Clement Associates, Inc. 1988. Comparative Potency Approach for Estimating the Cancer Risk Associated with Exposure to Mixtures of Polycyclic Aromatic Hydrocarbons. Interim Final Report. Contract #68-02-4403, prepared for the U.S. Environmental Protection Agency, Research Triangle Park, N.C. Cohen, S.M., and L.B. Ellwein. 1990. Proliferative and genotoxic cellular effects in 2-acetylaminofluorene bladder and liver carcinogenesis: Biological modeling of the EDO1 study. Toxicol. Appl. Pharmacol. 104:79-93. Cohen, S.M., and L.B. Ellwein. 1991. Genetic errors, cell prolifera Page 217 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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Issues in Risk Assessment References Anderson, E.L. and the Carcinogen Assessment Group of the U.S. Environmental Protection Agency. 1983. Quantitative approaches in use to assess cancer risk. Risk Anal. 3:277-295. Armitage, P., and R. Doll. 1957. A two-stage theory of carcinogenesis in relation to the age distribution of human cancer. Br. J. Cancer 11:161-169. Balmain, A., and K. Brown. 1988. Oncogene activation in chemical carcinogenesis. Adv. Cancer Res. 51:147-182. Barbacid, M. 1987. ras genes. Ann. Rev. Biochem. 56:779-827. Cavender, F.L., B.T. Cook, N.P. Page, V.J. Cogliano, and A.M. Koppibar. 1986. Carcinogenicity Assessment of Chlordane and Heptachlor/heptachlor Epoxide. EPA 600/6-87/004. U.S. Environmental Protection Agency, Research Triangle Park, N.C. Clement Associates, Inc. 1988. Comparative Potency Approach for Estimating the Cancer Risk Associated with Exposure to Mixtures of Polycyclic Aromatic Hydrocarbons. Interim Final Report. Contract #68-02-4403, prepared for the U.S. Environmental Protection Agency, Research Triangle Park, N.C. Cohen, S.M., and L.B. Ellwein. 1990. Proliferative and genotoxic cellular effects in 2-acetylaminofluorene bladder and liver carcinogenesis: Biological modeling of the EDO1 study. Toxicol. Appl. Pharmacol. 104:79-93. Cohen, S.M., and L.B. Ellwein. 1991. Genetic errors, cell prolifera

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Issues in Risk Assessment tion, and carcinogenesis. Cancer Res. 51:6493-6505. Cohen, S.M., D.T. Purtilo, and L.B. Ellwein. 1991. Pivotal role of increased cell proliferation in human carcinogenesis. Mod. Pathol. 4:371-382. Ellwein, L.B., and S.M. Cohen. 1988. A cellular dynamics model of experimental bladder cancer: Analysis of the effect of sodium saccharin in the rat. Risk Anal. 8:215-221. EPA (U.S. Environmental Protection Agency). 1980. Ambient Water Quality Criteria for Polynuclear Aromatic Hydrocarbons. EPA 440/5-80-069. Environmental Criteria and Assessment Office, Cincinnati, Ohio, and the Office of Water Regulations and Standards, Washington, D.C. Available as NTIS 81-117806. Gaillie, B.L., J.A. Squire, A. Goddard, J.M. Dunn, M. Canton, D. Hinton, X. Zhu, and R.A. Phillips. 1990. A biology of disease: Mechanisms of oncogenesis in retinoblastoma. Lab. Invest. 62:394-408. Goyette, M.C., K. Cho, C.L. Fasching, D.B. Levy, K.W. Kinzler, C. Paraskeva, B. Vogelstein, and E.J. Stanbridge. 1992. Progression of colorectal cancer is associated with multiple tumor-suppressor gene defects but inhibition of tumorigenicity is accomplished by correction of any single defect via chromosome transfer. Mol. Cell Biol. 12:1387-1395. Greenfield, R.E., L.B. Ellwein, and S.M. Cohen. 1984. A general probabilistic model of carcinogenesis: Analysis of experimental urinary bladder cancer. Carcinogenesis 5(4):437-445. Hollstein, M., D. Sidransky, B. Vogelstein, and C.C. Harris. 1991. p53 mutations in human cancers. Science 253:49-53. IRDC (International Research and Development Corporation). 1973. Chlordae: Eighteen-month oral carcinogenesis: Analysis of experimental urinary bladder cancer. Report to Velsicol Corporation. Kopp, A., and C.J. Portier. 1989. A note on approximating the cumulative distribution function of the time to tumor onset in multistage models. Biometr. 45:1259-1263. Luebeck, E.G., S.H. Moolgavkar, A. Buchman, and M. Schwarz. 1991. Effects of polychlorinated biphenyls in rat liver: Quantitative analysis of enzyme-altered foci. Toxicol. Appl. Pharmacol. 111:469-484.

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Issues in Risk Assessment Mantel, N., and W.R. Bryan. 1961. "Safety" testing of carcinogenic agents. J. Natl. Cancer Inst. 27:455-470. Moolgavkar, S.H. 1988. Biologically motivated two-stage model for cancer risk assessment. Toxicol. Lett. 43(1-3):139-150. Moolgavkar, S.H., and D.J. Venzon. 1979. Two-event models for carcinogenesis: Incidence curves for childhood and adult tumors. Math. Biosci. 47:55-77. Moolgavkar, S.H., and A.G. Knudson. 1981. Mutation and cancer: A model for human carcinogenesis. J. Natl. Cancer Inst. 66(6):1037-1052. Moolgavkar, S.H., and G. Luebeck. 1990. Two-event model for carcinogenesis: Biological, mathematical, and statistical considerations. Risk Anal. 10:323-341. Moolgavkar, S.H., A. Dewanji, and D.J. Venson. 1988. A stochastic two-stage model for cancer risk assessment. I. The hazard function and the probability of tumor. Risk. Anal. 8:383-392. Moolgavkar, S.H., E.G. Luebeck, M. de Gunst, R.E. Port, and M. Schwarz. 1990a. Quantitative analysis of enzyme-altered foci in rat hepatocarcinogenesis experiments I: Single agent regimen. Carcinogenesis 11:1271-1278. Moolgavkar, S.H., F.T. Cross, G. Luebeck, and G.E. Dagle. 1990b. A two-mutation model for radon-induced lung tumors in rats. Radiat. Res. 121:28-37. NRC (National Research Council). 1983. Risk Assessment in the Federal Government. Washington, D.C.: National Academy Press. 191 pp. Nebert, D.W. 1989. The Ah locus: Genetic differences in toxicity, cancer, mutation, and birth defects. Crit. Rev. Toxicol. 20:153-174. Nebert, D.W. 1991a. Polymorphism of human CYP2D genes involved in drug metabolism: Possible relationship to interindividual cancer risk. Cancer Cells 3:93-96. Nebert, D.W. 1991b. Identification of genetic differences in drug metabolism: Prediction of individual risk of toxicity or cancer. Hepatol. 14:398-401. Nebert, D.W., D.D. Petersen, and A. Puga. 1991. Human Ah locus polymorphism and cancer: Inducibility of CYPIAI and other genes

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Issues in Risk Assessment by combustion products and dioxin. Pharmacogen. 1:68-78. Nebert, D.W., A. Puga, and V. Vasiliou. 1993. Role of the Ah receptor and the dioxin-inducible [Ah] gene battery in toxicity, cancer and in signal transduction. Ann. N.Y. Acad. Sci. (In press) Portier, C.J. 1987. Statistical properties of a two-stage model of carcinogenesis. Environ. Health Perspect. 76:125-131. Portier, C.J., and L. Edler. 1990. Two-stage models of carcinogenesis, classification of agents, and design of experiments. Fund. Appl. Toxicol. 14:444-460. Quinn, D.W. 1989. Calculating the hazard function and probability of tumor for cancer risk assessment when the parameters are time-dependent. Risk Anal. 9:407-413. Takahashi, T., M.M. Nau, I. Chiba, M.J. Birrer, R.K. Rosenberg, M. Vinocour, M. Levitt, H. Pass, A.F. Gazdar, and J.D. Minna. 1989. p53: A frequent target for genetic abnormalities in lung cancer. Science 246:491-494. Tan, W.-Y. 1991. Stochastic Models of Carcinogenesis. New York: Marcel Dekker, Inc. 249 pp. Thorslund, T.W., and G. Charnley. 1988. Quantitative dose-response models for tumor-promoting agents. Pp. 245-256 in Carcinogen Risk Assessment: New Directions in Qualitative and Quantitative Aspects , R.W. Hart and F.D. Hoerger, eds. Banbury Report #31. Cold Spring Harbor Laboratory, Cold Spring Harbor, N.Y. Thorslund, T.W., C.C. Brown, and G. Charnley. 1987. Biologically motivated cancer risk models. Risk Anal. 7:109-119. Thyssen, J., J. Althoff, G. Kimmerle, and U. Mohr. 1981. Inhalation studies with benzo[a]pyrene in Syrian golden hamsters. J. Natl. Cancer Inst. 66:575-577. Williams, G.M., and S. Numoto. 1984. Promotion of mouse liver neoplasms by the oranochlorine pesticides chlordane and heptachlor in comparison to dichlorordiphenyltrichloroethane (DDT). Carcinogenesis 5:1689-1696. Vogelstein, B., E.R. Fearon, S.R. Hamilton, S.E. Kern, A.C. Preisinger, M. Leppert, Y. Nakamura, R. White, A.M.M. Smits, and J.L. Bos. 1988. Genetic alterations during colorectal-tumor development. N.E. J. Med. 319:525-532. Weinberg, R.A. 1988. The genetic origin of human cancer. Cancer

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Issues in Risk Assessment 61:1963-1968. Weinberg, R.A. 1989. Oncogenes, anti-oncogenes and the molecular bases of multistep carcinogenesis. Cancer Res. 49:3713-3721. Williams, G.M., and S. Numoto. 1984. Promotion of mouse liver neoplasms by the organochlorine pesticides chlordane and heptachlor in comparison to dichlorodiphenyltrichloroethane (DDT). Carcinogenesis 5:1689-1696.

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