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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 . "TOPIC GROUP MEMBERS." Issues in Risk Assessment. Washington, DC: The National Academies Press, 1993. Please select a format: Page 237   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. Appendix D Workshop Attendees Topic Group Members Dr. Richard A. Griesemer, Chair National Institute of Environmental Health Sciences Research Triangle Park, NC Dr. Paul T. Bailey Mobil Oil Corporation Princeton, NJ Dr. Kenny S. Crump Clement Associates, Inc. Ruston, LA Dr. Michael A. Gallo Robert Wood Johnson Medical School University of Medicine and Dentistry of New Jersey Piscataway, NJ Dr. Donald Mattison Graduate School of Public Health University of Pittsburgh Pittsburgh, PA Dr. Franklin E. Mirer Health and Safety Department United Auto Workers Detroit, MI Dr. D. Warner North Decision Focus, Inc. Los Altos, CA NRC Staff Dr. Kathleen R. Stratton Project Director Dr. Richard D. Thomas Principal Staff Scientist Dr. Robert P. Beliles Senior Staff Scientist Ms. Linda V. Leonard Project Assistant Page 237 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 237
Issues in Risk Assessment Appendix D Workshop Attendees Topic Group Members Dr. Richard A. Griesemer, Chair National Institute of Environmental Health Sciences Research Triangle Park, NC Dr. Paul T. Bailey Mobil Oil Corporation Princeton, NJ Dr. Kenny S. Crump Clement Associates, Inc. Ruston, LA Dr. Michael A. Gallo Robert Wood Johnson Medical School University of Medicine and Dentistry of New Jersey Piscataway, NJ Dr. Donald Mattison Graduate School of Public Health University of Pittsburgh Pittsburgh, PA Dr. Franklin E. Mirer Health and Safety Department United Auto Workers Detroit, MI Dr. D. Warner North Decision Focus, Inc. Los Altos, CA NRC Staff Dr. Kathleen R. Stratton Project Director Dr. Richard D. Thomas Principal Staff Scientist Dr. Robert P. Beliles Senior Staff Scientist Ms. Linda V. Leonard Project Assistant

OCR for page 238
Issues in Risk Assessment This page in the original is blank.