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APPEND`xB Bibliography A. GUIDELINES AND POLICY FOR RISE ASSESSMENT Albert, R. E., R. Train, and E. Anderson. Rationale Developed by EPA for the Assessment of Carcinogenic Risks. Journal of the NC Vol. 58, No. 5, May 1977, pp. 1537-1541. Calkins, D. R., R. L. Dixon, C. R. Gerber, D. Zarin, and G. S. Omenn. Identification, Characterization and Control of Potential Buman Carcinogens: A Framework for Federal Decision~Making. Journal of the NCI Vol. 64, No. 1, January 1980, pp. 169-176. Consumer Product Safety Commission. Interm Policy and Procedure for Classifying, Evaluating, and Regulating Carcinogens in Consumer Products. Federal Register Vol. 43, No. 114, June 13, 1978, pp. 25658-25665. Department of Labor, Occupational Safety and Health Administration. Identif icatzon, Class if ication, and Regulation of Potential Occupational Carcinogens. Federal Register Book 2 of 2, Vol. 45, No. 15, January 22, 1980, pp. 5001-5296. Environmental Protection Agency. Health Risk and Economic Impact Assessments of Suspected Carcinogens: Interim Procedures and Guidelines. Federal Register Vol. 41, No. 102, May 25, 1976, pp. 21402-2140 5. Environmental Protection Agency. Mutagenicity Risk Assessments; Proposed Guidelines. Federal Resister Vol. 45, No. 221, November 13, 1980, pp. 74984-74988. Food and Drug Administration. Chemical Compounds in Food Producing Animals: Criteria and Procedures for Evaluating Assays for Carcinogenic Residues. Federal Register Vol. 44, No. 5S, May 20, 1979, pp. 17070-17114 . 181

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182 International Agency for Research on Cancer. General Principles for Evaluating the Carcinogenic Risk of Chemicals. In Evaluation of the Carcinogenic Risk of Chemicals to Humans. lARC, Lyon, France, Vols. 1-29, . . 1972-1982. }nteragency Regulatory Liaison Group. Work Group on Risk Assessment. Scientif Tic Bases for dentin ication of Potential Carcinogens and Estimation of Risks. Journal of Me NCI Vol. 63, No. 1, July 1979, 25 pp. and Abstract. March of Dimes Birth Defects Foundation. Guidelines for Studies of Human _ ~ _ Reproductive Hazards: Proceedings of Conference. Washington, r>.c., January 26-27, 1981, 163 pp. National Academy of Sciences. Committee for a Study on Saccharin and Food Safety Policy. Food Safetv Policv: Scientific and Social Considerations. NAS-NRC, March 1979. National Academy of Sciences. Comma ttee on the Biological Effects of Tonizing Radiations. The Effects on Populations of Exposure to Low Levels of Ionizing Radiation. NASNan, 1980, 638 pp. National Cancer Advisory Board. General Criteria for Assessing the Evidence of Carcinogenecit:? of Chemical Substances. Report of the Subcommittee on Environmental Carcinogenes~s, NCAB. Journal of the NC Vol. 58, No. 2, February }977, pp. 461-465. State of California, Health and Welfare Agency. Carcinoma gen Identification Policy: A Statement of Science as a Basis of Police: Section 2: Methods for Estimating Cancer Risks from Exposure to Carcinogens. October 1982. U.S. Regulatory Council. Statement on Regulation of Chemical Carcinogens: Policy and Request for Public Comments. Federal Register Part ~V, Vol. 44, No. 202, October 17, 1979, pp. 60038-60049. 13. SUGGESTIONS FOR PROCEDURAL REFORM Albert, R. A. Toward a More Uniform Federal Strategy for the Assessment Ad Regulation of Carcinogens. Report to the Office of Technology Assessment, 1980. American Industrial Health Council. AIEC Proposal for a Science Panel (mimed), March 12, 1981, 9 pp. and Appendix, ATHC Recommended Framework for identifying Carcinogens and Regulating Them in Manufacturing Situations, October 11, 1979, 11 pp.

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183 American Industrial Health Council. Comparative Analysis of ~ ~ 6521 tWamo, er Bill, and Sci ence Pane 1 . . ~ ~ , Proposal, March 3 , 19 8 0 . American Industrial Health Council. Critical Evaluation of Proposals by the AIEC to Strengthen the Sc i entif ic Base for Regulatory Decisions; Report of the Scientif ic Workshop (mimed), August 19 82 , 6 pp . American Industrial }lealth Council. Proposals For Improving the Science Base for Chronic Health Hazard Decisior - Maki no, December 2, 1981, 29 pp. and Appendi xes . Banks, R. The Science Court Proposal in Retrospect: A Literature Rev' ew and Case Study. Critical Reviews in Environmental Control Vol. 10, August 198G, pp. 95-131. . Barr, J. T., D. B. Hughes, and }I. C. Barnard. The Use of Risk Assess...ent in Regulatory Decision Making: Time for a Review. Regulatorv Toxicology and Pharmacology Vol. I, 1981, pp. 264-276. Bazelon, D. L. Risk and Responsibility. Science Vol. 205, July 20, 1979, pp. 277-280. Boffey, P. M. Science Court: Bigh Officials Back Test of Controversial Concept. Science Vol. 194, October 8, 1916, pp. 167-169. Deisler, P. F., Jr. Dealing with Industrial Health Risks: A Step~Wise, GoalOriented Concept. In the Technologicq~, Bohenemser and Rasperson, eds. Westview Press, 1981. Food Safety Council. Social and Economic Committee. A New Approach: Principles and Processes for Making Food Safetv Decisions. FSC, 1981, 103 pp. plus Appendixes. Food Safety Council. A Proposed Food Safetv Evaluation Process: Final Report of Board of Trustees. FSC, June 1982, 142 pp. General Accounting Office. In Risk Improving the Scientif ic and Technical Information Available to the EPA in Its Decision-makinq Process. Report CED-79-115, September 1979, 60 pp. Gori, G. B. Regulation of Cancer-Causing Substances: Utopia or Reality. Chemical and Engineering News September 6, 1982, pp. 25-32. Gori, G. B. The Regulation of Carcinogenic Hazards. Science Vol. 208, April 18, 1980, pp. 256-261. Hid. 638 (Wampler Ball). National Science Council Act of 1981. Introduced January 8, 1981. H.~. 6159 (Ritter Bill). Risk Analysis Research and Demonstration Act of 1982. Introduced April 26, 1982.

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184 Eantrowitz, A. Controlling Technology Democratically. American Scientist Vol. 63, 197S, pp. 505-509. Rantrowitz, A. Proposal for an Institution For Scientific Judgment. Science Vol. 156, May 12, 1967, pp. 763-764. Markey, B. T. Testimony to the Subcommittee on Science Research and Technology, 1979. In R'sk/Benefit Analysis in the Leg illative Process. U . S. . Government Printing Office, Washington, D.C., 1979. Martin, J. Procedures for Decision Making Onder Conditions of Scientific Uncertainty: The Science Court Proposal. Harvard Journal of Legislation Vol. 16, Spring 1979, pp. 443-511. National Academy of Sciences. Committee on Environmental Decision Making. Decision Making in the Environmental Protection Agency. ~ C, 1977, 250 pp. National Academ:? Of Sciences. Committee on Food Protection, Food and Nutrition Board. Risk Assessment/Safetv Evaluation of Food Chemicals. ~S-N=, 1980, 36 pp. National Academy of Sciences. Committee on Prototype Explicit Analyses for Pesticides. Regulating Pesticides. NAS-N~C, 1980, 237 pp. National Academy of Sciences. Committee on Toxicology. Principles and Procedures for Evaluating the Toxicitv of Bousehold Substances. NAS-NRC, 1977, 130 pp. National Academy of Sciences. Environmental Studies Board/Committee on Toxicology. Principles for Evaluating Chemicals In the Environment. NAS-NRC, 1975. R;3m~' S. Regulation of Technical Activities: A New Approach. Science Vol. 213, Aug. 21, 1981, pp. 837-842. Rowe, W. D. Regulation of Toxic Chemicals within ache Lime ts of Knowledge. Report submitted to Me Office of Technology Assessment, 1980. S. 1442 (=tch Bill). Food Safety Amendments of 1981. Introduced June 25, 1981. Squire, R. A. Ranking Animal Carcinogens: A Proposed Regulatory Approach. Science Vol. 214, 1981, pp. 877-880. Toxic Substances Strategy of Committee. Report to the President: Toxic Chemical s and Public Protection. EMS. Government Printing Office, Washington, D.C., 1980. . S. Bouse of Representatives. Omnibus Budget Reconciliation Act of 1981: Conference Report. Report 97-208, July 1981, pp. 383-384, 881-883 .

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185 U.S. House of Representatives. Committee on Agriculture. The National Science Council Act, June 1981. l U. S. . Bouse of Representat Ives. Committee on Science and Technology. Risk Analysis Research and Demonstration Act of 1982. Report No. 97-62S, June 24, 1982. Wessel, M. R. Science and Conscience. Columbia Univer- sity Press, 1980, 140 pp. C . SCIENTIFIC AND POLICY BASI S OF RISK ASSESSMENT Ames, B. N. Identifying Environmental Chemicals Causing Mutations and Cancer. Science Vol. 204, May 22, 1979, pp. 587-593. Anderson, E. L. Quantitative Methods in Use in the United States to Assess Cancer Risk. Paper presented at the Workshop on Quantitative Estimation of Risk to Human Health from Chemicals, Rome, Italy, July 12, 1982. Anderson, E. L. Uses of Quantitative Risk Assessment by EPA tmimeo). Prepublication draft, 18 pp. Ashford, N. A., E. M. Bolt, D. Hattis, 3. I. Natz, G. R. Beaton, and W. C. Priest. Evaluating Chemical Regulations: Trade-off Analysis and Impact Assessment for Environmental Decision-Making {m~meo). MIT Center for Policy Alternatives, 1979. Baram, M. S. Cost-Benef~t Analysis: An Inadequate Basis for Health, Safety, and Environmental Regulatory Deciszonmaking. Ecology Law Quarterlv Vol. 8, No. 3, 1980, pp. 473-531. Campbell, G., D. Cohan, and D. W. North. The Application ~$ Decision Analysis to Toxic Subs Methodologv and Two Case Studies. Decision Focus Incorporated, 1981. Prepareo f or EPA by Cornfield, J. Carcinogenic Risk Assessment. Science Vol. 198, November 18, 1977, pp. 693-699. Crandall, R. W., and L. B. Lave, eds. The Scientific Basis of Health and Saf eta Requlatzon. Brooking s Institution, 1981, 309 pp. Crouch, 13., and R. Wilson. Interspecies Comparison of Carcinogenic Potency. Journal of Toxicology and Environmental Health Vol. 5 t 1979 r pp. 10951118r plus Append ixes . Crouch' E. ~ and R. Wilson. Regulation of Carcinogens. Basic Analysis Vol. 1J 1981, pp. 47-57; discussion pp. 59-66.

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186 Cramp, R. S. Art Improved Procedure for Low~Dose Carcinogenic Risk Assessment from Animal Data. Journal of Environmental Pathology and Toxicology Vol. 5, No. 4, 1983. Crud, R. S. Dose-Response Problems in Carcinogenesis. Biometrics Vol. 35, March 1979, pp. 157-167. Cramp, R. S., D. Hoel, C. Langley, and R. Peto. Funded mental Carcinogenic Processes and Their Implications for Low Dose Risk Assessment. Cancer Research Vol 36, September 1979, pp. 2973-2979. Cramp, R. S. The Scientific Basis for Health Risk Assessment. Presentation at the seminar sponsored by George Washington University Graduate Program In Science, Technology, and Public Policy and by the EPA, Washington, D.C., March 3, 1982. Devoret, R. Bacterial Tests for Potential Carcinogens. Scientific American Vol. 241, No. 2, August 1979, pp. 40-49 . Doll, R., and R. Peto. The Causes of Cancer: Quantita- tive Estimates of Avoidable Risks of Cancer in the United States Today. Journal of the NCI Vol. 66. No. 6, June 1981, pp. 1191-1308. Doniger, D., R. L`roff, and N. Dean. An Analysis of Past Federal Efforts to Control Toxic Substances. Report to CE:Q by the Environmental Law Institute, July 20, 1978, 71 pp. Dower, R. C., and D. Maldonado. An Overview: Assessing the Benef ~ ts of Environmental Bealth and Safety Regulations. U. S . Regulatory Council, 1981, 34 pp . Gelpe, M. R., and A. D. Tariock. The Uses of Scientific Information in Environmental Decisiormaking. Southern California Law Review Vol. 48, 1974, pp. 371-427. Greenwood, T. Assessment of Me Role of Science and Technologv in St~ndard-Setting by Two Federal Regulatow Agencies. Report to OSLO, March 1, 1981, 308 pp. Greenwood, T. Knowledge and Descretzon in Regulation (forthcoming) . Fischhoff , B., S. Lichtenstein' P. Slovic, S. L. Derby, and R. L. Reeney. Acceptable Risk. Cambridge University Press, 1981, 185 pp. Flamm, W. G. O.S. Approaches to Regulatory Carcinogens and Mutagens in Food (mimed). Address to the National Cancer Institute of Canada and Toxicology Forum Conference, Vancouver, August 13, 1981. Gaylor, D. W. The E:Do1 Study. Statuary and Conclusion. Journal of Environmental Pathology and Toxicology Vol. 3, 1979, pp. 179-183.

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187 Higgins, I. T. T. Importance of Epidemiological Studies Relating to Bazards of Food and Environment. British Medical Bulletin Vol. 31, No. 3, 1975, pp. 230-235. Hoel, D. G., D. W. Gaylor, R. L. Eirschstein, U. Saffiotti, and M. A. Schneiderman. Risks of Irreversible Delayed Toxicity. Toxicology and Environmental Bealth Vol. 7, 1975, pp. 133-151. Howard, R. A., J. E. Matheson, and D. W. North. Decision Anal sis for Environmental Protection Decisions. SRI, y June ~ 977, 67 pp. Estimation of Journal of Larch, N. J. Explicit Criteria and Principles for Identifying Carcinogens: A Focus of Controversy and EPA. Volume lIa, Case Studies, National Academy of Sciences, 1977, pp. 119-206. Lave, L., and T. Romer. A Survey of Safety Levels in Federal Regulation. Nuclear Regulatory Commission Rep. HUREG/CR-2226, June 1981, 46 pp. Leape, J. P. Quantitative Risk Assessment in Regulation of Environmental Carcinogens. Barvard Environmental Law Review Vol. 4, 1980, pp. 86-116. Leventhal, H. Environmental Dec~szo~maK'ng ana one =~= of the Courts. University of Pennsylvania Law Review Vol. 122, January 1974, pp. 509-555. Lowrance, W. W. _ Of Accede Risk: Science and The Determination of Safetv. William Raufmann, Inc., Los Altos, Calif., 1976, 180 pp. Mantel, N., and M. Schneiderman. Levels, A Hazardous Undertaking. 35, June 197S, pp. 1379-1386. Estimating ~Safe. Cancer Research Vol. McGarity, T. O. Substantive and Procedural Discretion in Administrative Resolution of Science Policy Questions: Regulating Carcinogens in EPA and OSHA. In law Carnal Vol. 67, 1979, pp. 729 - 810. Refill, R. A. CPSC Regulation of Cancer Risks in Consumer Products. Virginia Law Review Vol. 67, 1981, p. 1261. Merrill, R. A. FDA Regulation Environmental Contaminate tion of Food. Virginia Law Review Vol. 66, 198G, p. 1357. Merrill, R. A. Chemicals. Conference bunco, I. C., Regulatory Toxicology Federal Regulation of Canc:er~Causing (mimed). Report to the Administrative of the United States. April 1, 1982. and D. R. Krewski. Risk Assessment and Dec~sionmaking. Food and Cosmetic Vol. 19, 1981, pp. 549-560. -

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188 National Academy, of Sciences. Committee or Risk and Dec~son~Mak~ng. Risk and Decision Making: Perspectives and Research. NASN=, 1982 68 pp. National Academy of Sciences. Governing Board; Committee on the Assessment of Risks. The Handling of Risk Assessments in Nor Reports (Romeo.). March 1981, 27 pp. Nicholson, W. J., ed. Man~qement oF Assessed Risk for Carcinogens. New York Academy oF Sciences, 1981, 301 pp. Nisbet, I. C. T., and N. J. Karch. Human Reproduction. 1983. Chemical Hazards to Noyes Data, Park Ridge, N.3., Office of Technology Assessment. Assessment of Technologies for Deter nine Cancer Risks from the Environment. Office of Technology Assessment, June 1981, 240 pp. Oak Ridge National Laboratory/Environmental Protection Agency. Assessment of Risks to Eaten Reproduction and to Development or Buman Conceptus from Exposure to Environmental Substances. OP~L/E7S-197, ~ PA/9-82-001, . February 1982, 1S8 pp. Omenn, G. S. Risk Assessment and Environmental Pol~cy- Making: An Overview. Presentation at the seminar sponsored by George Washington University Graduate Program in Science, Technology, and Public Policy and by the EPA, Washington, D.C., January 27, 1982. Rall, I). P. The Role of Laboratory Animal Studies in Est~tir~g Carcinogenic Risks for Man. Address to MARC Symposium, Carcinogenic R~sks~Strategies for Intervention, n Lyon, France, 1977, 12 pp. Riced, P. F., and L. S. Molton. Risk and Benefit in Env~ro~ental Law. Science Vol. 214, December 4, 1981, pp. 1096-1100. Rodricks' J. V.r and R. G. Tardiff. Biological Bases for Risk Assessment. Paper presented at the International Conference on Safety Evaluation and Regulation of Chemicals, Session 2: State of the Art of Safety Evaluation, Boston, Mass., February 24-26, 1982. Rowe, W. D. An Anatomy of Risk. Wiley-Interscience, New York, 1977. Samuel s, S. W. Determination of Cancer Risk in a Democracy. Annals of the New York Academy of Sciences Vol. 271, 1976, pp. 421-430. Thomas, L., S. J. Farber, R. A. Doherty, A. Koppas, and A. A. Upton. Report of the Governor ' s Panel to Review Scientif ic Studies and the Development of Public

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189 Policy on Problems Resulting from Eazardous Wastes (mimer). New York State, October 1980, 33 pp. Van fin, J. Quantitative Risk Assessment. Journal of Occupational Medicine Vol. 22, No. 5, May 1980, pp. 321-326 . Weinberg, A. M. Science and Trans-Science. Minerva No. 1O, }972, pp. 202-222 . Weisburger, a. H., and G. M. Williams. Carcinogen Testing: Current Problems and New Approaches. Science Vol. 214, October 23, 1980 pp. 401-407. D. BIBLIOGRAPHIES Rrewski, D., and C. Brown. Carcinogenic Risk Assessment: A Guide to the Literature. Biometrics Vol. 37, June 198}, pp. 353-366. Tardiff, R. G. Extrapolation: High to Low Doses (mimed). National Academy of Sciences, September 1981, 5 pp. Tardiff, R. G. Extrapolation: High to Low Doses Combined with Laboratory Animals to ~ mans (mimeo). National Academy of Sciences, October 1981, 6 pp. Tardiff, R. G. Extrapolation. Laboratory Animals to Humans (mimeo). National Academ:? Of Sciences, October 1981, 6 pp.

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