Document dYeV0NpbywJM52VMxqGomez26

'0 jo-. Organization Resources Counselor^ Inc May 19, 1978 Dr. Eula Bingham Assistant Secretary of Labor Occupational Safety and Health Administration U.S. Department of Labor 200 Constitution Avenue, NW. Washington, D. C. 20210 Re: Proposed "Identification, Classification and Regulation of Toxic Substances Posing a Potential Occupational Carcinogenic Risk" Dear Dr. Bingham: We appreciate your response of May 11, 1978 to our March 31 letter on the requirements of Executive Order 22044, "Improving Government Regulations'1 as they relate to the proposed regulations of toxic substances posing a potential occupational carcinogenic risk. We do not, however, agree with your conclusions of this issue as to the applicability of the Executive Order. For the reasons stated in our letter of March 31 and the follow-up letter of April 28, our view remains that the proposal does meet the "* Executive Order 12044. We urge you to reconsider nd proceed with the preparation of such analysis. J. W. Miller WWA:shb AP00047888 RECEIVED MW V a ld/tJ u. X BARR U.S. DEPARTMENT OF LABOR Occupational Safety and Health Administration WASHINGTON, D-C. 20U0 ,-rfjan^. MAY 5 197b TO ALL PARTICIPANTS IN THE OSHA "CANCER POLICY" HEARING . The enclosed material is sent to you to help you be prepared for the scheduled hearing beginning May 16. Please note the "Prehearing Guidelines" because some of the procedures are newly adopted for this hearing.. Due to the number of partici pants in this hearing and its length some new procedures were necessary. Also enclosed is a listing of the groups mentioned in the Prehearing Guidelines and a tentative order of testimony. The order of testimony is tentative and there may be changes made during the course of the hearing but we hope to be able to adhere to the prepared schedule. If you have any questions about the hearing please contact Tom Hall or Kevin Conlon at 202-523-3024. Sincerely, 'fbm IrjztJL@ Tom Hall Hearing Management Officer AP00047889 U.S. DEPARTMENT OF LABOR Oma of ADfcUNisn-mvx Law Jvdo** Suit* 700- nil 20th Street, N .W. Washington, D.C. 20036 TO ALL PARTICIPANTS IN THE OSHA "CANCER POLICY" HEARING RE: PREHEARING GUIDELINES Your participation in the "Cancer Policy" hearing is both welcome and appreciated. As you may know, several hundred persons have indicated a desire to participate in this proceeding. In the interest of allowing the fullest public participation without unduly protracting this pro ceeding, the following prehearing rules are issued. The hearing will begin at 9:30 a.m. on May 16 and at 9:45 a.m. on subsequent days, unless special circumstances require a change; any such change will be announced during the course of the hearing. A lunch break will be taken at a convenient point in the testimony. The hearing day will end when the scheduled testimony and questions for that day are finished. TESTIMONY AND EVIDENCE In the interest of due process, fairness, and the develop ment of a complete record, OSHA has required that any participant who requests more than 15 minutes for his presen tation, or who will submit documentary evidence for the hearing, submit by February 28 the written testimony and documentary evidence he intends to present at the hearing. This material has been placed in the OSHA Docket Office, Room S6212, U.S. Department of Labor, 3rd Street and Constitution Avenue, N.W. , Washington, D.C. 20210, where it is available for inspection and duplication. This will afford all participants full op portunity to review the evidence and to formulate any questions they wish to ask at the hearing. Submission of testimony and other evidence in written form will assist in expediting the hearing process. In the absence of special circumstances, participants who have filed notices of intention to appear but who have not substantially complied with the requirements for the submission of written testimony and documentary evidence, will be allowed a maximum time of 15 minutes for their presen tations at the hearing. Since written evidence will be received as part of the record of this proceeding (and, of course, is entitled to the same weight as evidence presented orally) the presentation of a witness at the hearing must summarize the written submission in 15 minutes or less. Alternatively, a participant may elect not to make an oral presentation but simply to offer his written data as submitted and to make himself available for questions. It is recognized that many of the participants have busy schedules and that many are attending from distant locations at considerable expense. AP00047890 QUESTIONING A scheduled has been established which is intended to pro vide a reasonable opportunity for questioning, without unduly protracting the proceeding or inconveniencing the participants. In light of the number of participants in the proceeding it will not be possible to allow unlimited questioning. By the close of each hearing day, each participant who intends to question a witness scheduled to appear the next hearing day must so indicate his intention on a sign-up sheet provided by OSHA. The amount of time requested for questioning must also be indicated. Where the time available for questioning appears to be inadequate to accommodate all of those who wish to question a particular witness, time limitations and a rotation of questioners will be utilized. The time limitations will vary according to the importance of the issues, the amount of time for which a witness has been scheduled and the number of participants who wish to question the witness. The rotation of questioners will be done in as fair a way as possible. Therefore each participant has been assigned by OSHA to a group for the sole purpose of organizing the rotation for questioning. Attache hereto are those assignments. Questions from a participant in a group are not viewed as being on behalf of others in the group. Rather, the grouping of participants is merely a mechanism to provide everyone with a reasonable opportunity to ask questions of other participants. The questioning will be done in rounds. Each group will hav one questioner per round. Thus, the questioning of the first witness will begin with a designated participant from group 1. When the questioner has used the allotted time (for example, 30 minutes), a designated participant from each of the remaining groups would be given an opportunity to ask questions for up to the allotted time. After all groups have completed the first round of questioning, the second round of questioning will begin with another participant from group 1 for an allotted time (for example 15 or 30 minutes). Another participant from each of the other groups would be given an opportunity to ask questions of that witness. Subsequent rounds of brief duration will be permitted where necessary and to the extent that time permits. AP00047891 At the conclusion of the scheduled time for each witness, any participant who indicated a desire to ask questions of a particular witness and believes that he or she did not have sufficient time to ask questions on important issues and that other questioners did not deal with the issue, may, within 3 work days submit written questions on such issues to the Administrative Law Judge, to OSHA, and to the witness. The witness may, if he or she chooses, respond to these questions in writing. In appropriate circumstances, OSHA or the Administrative Law Judge may request that the witness return at a later date to respond to such questions or to submit written responses. Where the participant who submits written questions as described above has already asked questions of that witness, he or she must also demonstrate why such questions could not have been asked in the allotted time. In this regard, it is suggested that questioners commence their questioning with the most crucial issues and ask their most important questions first. In the event that a group is unable to agree on who will question for a particular round, the Administrative Law Judge will determine who will do so. Questions should be as brief as possible, may not be repetitive and must be designed to clarify testimony or elicit relevant information within the witness's area of competence or expertise. "Questions" which are really testimony will not be permitted. POST HEARING COMMENTS A 15 day period after the close of the hearing will be designated for the receipt of any additional information or evidence requested from participants during the proceeding. Participants will also be afforded 35 additional days to submit written comments, summations, or briefs during an additional interval which will be designated for this purpose. At the close of the posthearing comment period the entire record of this rulemaking proceeding will be certified by the Administrative Law Judge and forwarded to the Assistant Secretary of Labor for Occupational Safety and Health for final action. The foregoing rules are deemed consistent with orderly and fair procedures. Exceptions to the above will be allowed in appropriate circumstances, as determined by the Administrative Law Judge AP00047892 GROUP I Adhesive and Sealant Council, Inc. American Coke and Coal Chemicals Institute American Foundrymen's Society American Industrial Health Council American Industrial Hygiene Association American Iron and Steel Institute American Iron Ore Association American Occupational Medical Association American Paper Institute American Petroleum Institute American Textile Manufacturers Institute Asbestos Information Association Boating Industry Association Chamber of Commerce of US Chemical Specialities Manufacturers Association Cleaning and Laundry Association Executives Diesel Automobile Association Drycleaning Inaustry Council Dry Color Manufacturers Association Dyes Environmental and Toxicology Organization Fluor Engineers and Constructors, Inc. AP00047893 2- Health Industry Manufacturers Association International Fabrlcare Institute Manufacturers Association of Hartford County Manufacturing Chemists Association Motor Vehicle Manufacturers Association Motor Vehicle Manufacturers Association National Agricultural Chemicals Association National Association of Chemical Distributers National Association of Engine ana Boat Manufacturers National Association 'of Printing Ink Manufacturers National Constructors Association National Cotton Batting Institute National Cotton Council of America National Cottonseed Products Association National Electrical Manufacturers Association Neigborhood Cleaners Association Polyurethane Manufacturers Association Refractories Institute Rubber Manufacturers Association Harvey M. Sheloon, Attorney Society of American Wood Preserves, Inc. Society of Plastics Engineers AP00047894 -3Society of the Plastics Industry, Inc. Synthetic Organic Chemical Manufacturers Association Textile Fibers and By-Products Association West Gulf Maritime Association Western Wood Products Association AP00047895 GROUP 2 Air Products and Chemicals A1 coa Allegheny - Ludlum Steel Corp. Allied Chemical American Color and Chemical Corp* American Cyanamid Co. Apollo Colors Inc. Armstrong Cork Co. Balchem Corp Bethlehem Steel Corp. BF Goodrich Company Bristol - Hyers Company Brush Wellman, Inc. Burlington Industries, Inc. Cher.etron Pigments, Allegheny Ludlum Industries Chicago Molded Products Co. Danna Molded Products Oetrex Chemical Industries, Inc. Diamond Shamrock Dolomite Brick Corp of America Oow Chemical U.S.A. E. 1. du Pont Ethyl Corp. Exxon Corp. Exxon Nuclear Company Fike Chemicals, Inc. AP00047896 2- FMC Corp. General Electric Georgia Pacific Corp. Goodyear Tire and Rubber Company Grace Chemicals Division Hercules, Inc. Highland Plastics H. Kohnstamm & Co., Inc. Hoekstra Uniform Rental Service Hooker Chemicals and Plastics Corp. Hughson Chemicals, Lord Corp. Industrial Health Engineering Association, Inc. Inland Steel Inmont Corp. Johns - Manville Jones 4 Laugh!in Steel Corp. Kaiser Steel Kawecki Berylco Industries Koppers Company Major Laundry Rental Service, Inc. Malllnckrodt, Inc. AP00047897 Monsanto Company Muskegon Chemical Co.* National Steel Carp. Northern Petrochemical P/A Industries, Inc. Phillips Petroleum Company PPG Industries Plastics Engineering Company Raybestos Manhattan Republic Steel Reserve Mining Co. Reynolds Aluminum Company Shell Oil Company Standard Oil Company of California Stauffer Chemical Company Styrex Industries Sun Chemical Company Tenneco Chemicals Union Carbide Corp. -3- AP00047898 Uniroyal Chemical Uni royal Inc. United States Steel Corp. United Technologies Upjohn Company US. Borax Vineland Chemical Co. Virginia Chemicals Vulcan Materials Company Witco Chemical -4- AP00047899 GROUP 3 AFL-CIO Amalgamated Clothing and Textile Workers Unions IUD - AFL-CIO International Brotherhood`of Teamsters International Chemical Workers Union OCAW United Electrical Radio and Machine Workers of America United Steelworkers of America United Steelworkers of America, AFA-CIO United Steelworkers of America - (DuPont Comm) United Steelworkers of America - Local Unions (7) United Steelworkers of America - Local Unions (11) United Steelworkers of America - (15 Locals) United Steelworkers of America (Local 2609) United Steelworkers of America (Local 2610) AP00047900 GROUP 4 Environmental Defense fund National Resources Defense Council Public Citizen Urban Environmental Conference, Inc* AP00047901 'GROUP 5 All Federal Governmental Agencies. Witnesses asked by OSHA to testify. AP00047902 GROUP 6 Association of American Cancer Institutes Cap ital Legal Foundation Carnegie - Mellon Institute Chemical Industry Institute of Toxicology Harry B. Demapoulos, MO., (private) Department of Health, State of Connecticut A Healthy, Holistic Awareness Association Industrial Health Foundation Thomas H. Jukes National Legal Center for the Public Interest Bill Pegram Glenn E. Schweitzer Society of Toxicology State of North Carolina Department of Labor AP00047903 U.S. DEPARTMENT OF LABOR Occupicioaal Safety aad Health Administration WASHINGTON, D.C 2A210 f*sf\ Informal Public Hearing on Proposed Standard on the Identification, Classification and Regulation 9Srrr&.C^ of Toxic Substances Posing a Potential Occupational Carcinogenic Risk TENTATIVE SCHEDULE OF APPEARANCES Commencing at 9:30 a.m. on May 16, 1978 Departmental Auditorium - Constitution Avenue Between 12th and 14th Streets, N.W. Washington, D.C. May 16 - 24 Hew Department of Labor Auditorium New Department of Labor Building 3rd and Constitution Avenue, N.W. Washington, D.C. 20210 May 24 - Until Conclusion Administrative'Law judge: J.F. Greene Hearing Management Officer: J. Thomas Hall Hearing Management Officer: Kevin Conlon Office of the Solicitor: Edward Klein Office of the Solicitor: Edith Nash Office of the Solicitor: Charles Gordon Office of the Secretary: Anson M. Keller Clement Associates-: Consultant to OSHA APPEARANCE WITNESS May 16 Tuesday May 17 * Wednesday Occupational Safety and Health Administration (OSHA) Grover Wrenn, Director, Directorate of Health Standards Programs, Occupational Safety and Health Administration Arthur C. Upton, Director of the National Cancer Institute May 18 Thursday Accompanied by Umberto Saffiotti, National Cancer Institute, and Marvin A. Sneiderman, National Cancer Institute David P. Rail, Director of the National Institute of Environmental Health Sciences * Unless otherwise noted each witness for OSHA appears as an individual and not as a spokesman for his or her agency. AP00047904 May 19 Friday Donald Kennedy, U.S. Commissioner of Food and Drugs, Food and Drug Administration. May 22 Monday Richard R. Bates, Associate Commissioner for Science Food and Drag Administration and Harold L. Stewart, Scientist Emeritus, National Institute of Health May 23 Tuesday Marvin A. Sneiderman, Associate Director, Field Studies and Statistics Programs, Division of Cancer Cause and Prevention National Cancer Institute and Robert N. Hoover, Head of the Environmental Studies Section of the Environmental Epidemiology Branch, National Cancer Institute May 24 Wednesday ' Umberto Saffiotti, Chief, Experimental Pathology Branch, Carcinogenesis Research Program, Division of Cancer Cause and Prevention National Cancer Institute and Richard A. Griesemer Associate Director for Carcinogenesis Testing Program, Division of Cancer Cause and Prevention National Cancer Institute May 25 Tbxusday William Lijinsky. Director, Chemical Carcinogenesis Program, Frederick Cancer Research Center May 26 Fridfy Samuel S. Epstein, University of Illinois. Professor of Occupational and Environmental Medicine, School of Public Health May 27 Saturday (Continued if Necessary) AP00047905 Way 30 Tuesday May 31 Wednesday June 1 Thursday 4 June 2 Friday June 5 Monday Joyce McCann University of California Mathew s. Meselson Thomas Dudley Cabot, Professor of the National Sciences, Harvard University John W. Berg Associate Director for Epidemiology and Statistics Colorado Regional Cancer Center David S. Wegmaa, M.D. Associate Professor of Occupational Health/ Harvard School of Public Health Irving Selikoff Mount Sinai School of Medicine William J. Nicholson Associate Professor, Department of Community Medicine, Mount Sinai School of Medicine Renate D. Kimbrough Research Medical Officer, Center for Disease Control, U.S. Public Health Service Lawrence Fishbein Assistant to the Director for Environmental Surveillanc National Center of Toxicological Research Benjamin L. Van Duuren Professor of Environmental Medicine, New York Univeristy Medical Center M. Adrian Gross Associate Director for Pre-clinical Investigations, U.S Food and Drug Administration Benjamin ?. Trump, M.D. Chairman of the Department of Pathology University of Maryland School of Medicine AP00047906 June 5 Monday June 6 Tuesday June 7 Wednesday June 8 Thursday June 9 Friday June 12 Monday June 13 Tuesday Curtis C. Harris Head# Human Tissue Studies Section, Experimental Pathology Branch, National Cancer Institute, David G- Eoel Chief of the viometry Branch and Acting Scientific Director of the National Institute of Environmental Health Sciences, Research Triangle Park David G. Kaufman Associate Professor of Pathology and 'of Biochemistry and Nutrition, North Carolina School of Medicine Bernard Weinstein Professor of Medicine and Director of the Division of Environmental Sciences, college of Physicians and Surgeons of Columbia University Nicholas A. Ashford Senior Research Associate, Center for Policy Latematives, Massachusetts Institute of Technology Richard Peto University Reader in Cancer Studies, Radcliffe Infirmary, Oxford University Industrial Hygienists Panel Charles W. Billings Darrell D. Douglas Bruce J. Held Duncan A. Holaday Robert D. Soule National Institute for Occupational Safety and Health Edward J. Baier, Deputy Director Richard F. Boggs David H. Groth Richard w. Niemeier Robert H. Hill AP00047907 June 13 Tuesday National Institute for Occupational Safety and Health Robert T. Hughes Robert K. Schutz Richard J, Waxweiler Howard A. Walderaan .. June 14, IS, 16, & 19 NO TESTIMONY SCHEDULED June 20, 21, 22 Tuesday, Wednesday, Thursday American Industrial Health Council Paul Oreffica, Pre. Dow Chemical ' Robert E. Olson, Consultant Francis JC Roe, Consultant Richard Wilsonr Consultant David Srusick, Litton Bionetics Ronald W. Hart, Consultant RF Crampton. Consultant Paul Grasso, BP Occup. Health George Claus, Consultant ASM McLean, Consultant Leonard Goldwater, Consultant Johannes Cleznmesen, Consultant Bernard Oser, Consultant Prank C. Lu, Consultant Robert Murray, consultant Ronald A. Lang, Executive Secretary Joseph Nemec Philip Gisser Robert Shriner Robert C. Barnard, Attorney James H. Jandl, Consultant HGS Van Raalte, Toxicologist Shell International T. Colin Campbell, Consultant Slwood P. Blanchard, Fred Eoercer, Alternatives George Dominguez, Economic June 23 Friday BF Goodrich Company William C. Becker, V-? Ext. Affairs Maurice N. Johnson MD, Adm. Environ. Health Robert K. Hinderer, Ph.D., Toxicologist Richard Wilson, Ph.D., Prof. Physics, Harvard Roger W, Strassburg, Ph.D., Dir., Environmental Affairs AP00047908 June 23 Friday Phillips Petroleum Company JV LeBlanc, MD., Med. Dir. W, B. Thomas, Vice President ; Air Products and Chemicals Richard Fleming, Exec. V-p John T. Barr, As*1t Dir. o Research for Plastics Upjohn Company Paul F. Woolrich, Envir. Qual. Program Mgr. jj Gernik, MD., Dir.-Occup. Health ES Feenstra, DVM, Res, Mgr. Path Toxicology R. A. Dor.ia, Ph.D., Dir., Fine Chemical Production D--E. Gregg, Ph.D., International-Administrative J. C. Griffin, Ph.D., Dir*, Pharmaceutical .... Manufacturing R. L. Johnston, DVM, Supportive Research, Agric. Res. & Devel. W. H. Nay, Vice President, Engineering M. D. Welch, Attorney PPG Industries Zeb G. Bell, Mgr. Toxicology June 26 & 27 Monday & Tuesday American Petroleum Institute Dr. Hardin 3. Jones Arthur Furst Dr. Peter Goldman Irving I. Kessler, MD Howard I. Miabach, MD Rulon W. Rawson, MD David Scho Eenfeld, MD John Thrope, MD Melvin First, ScD Richard Zeckhauser, Ph.D Daniel B. Rathbun, Vice President June 28 . Wednesday American Iron and Steel Institute Robert Snyder, Ph.D., Consultant Anthony J. Triolo, Ph.D., Consultant Carl Ackerman, Engineer John D. Sealer, MD., Med.. Dir. Bethlehem Steel William L. Gadd, Mgr. Ind. Hyg, National Steel Robert J. Halen, MD., J-L Steel William C. Jones, Mgr. Environ Health - USS AP00047909 June 28 Wednesday American Iron and Steel Institute . AE Moffit, Dir - Toxicology Bethlehem Steel John H. Stenmark, V-P Ind. Rel. AISI Lindsley D. Van Der Verr, Mgr. Cost Planning USS Peter C. Wright/ Ph.D./ Biostatistician Neil J. King, Attorney Arthur B. Spitzer, Attorney Robert P. Stranahan, Jr., Attorney Manufacturing Chemists Association M.W. Johnson, MD, B> T. Goodrich D.E. Ellison, Virginia Chemicals Thomas J. McDonagh, MD, Exxon Chemical J.M. Pardee, Eastman-Kodak P.W. Simmons, Dow Chemical John H. Pickering Andrew T. W. Macdonald Edmund B. Grost June 29 Thursday Johns-Manville Corporation Paul Kotin, M.D. Dr. Gerald R. Chase ' June 30 Friday Dow Chemical U.S.A. Dr. Etcyl Blair, Dir. of Health S Environmental Researcl Dr. Perry Gehring, Dir. of Toxicology Research Dr. Ralph Langner, Dir. of Industrial Hygiene Richard Olson, Mgr.-Industrial Hygiene Cheryl Schultz, Industrial Eygiene Roger Daniel, Environmental Health Services Dr. Robert Bumb, Manufacturing Mgr. - Styrene Plastics J. S. Hanson, Attorney FMC Corp Dr. Sherman K. Reed, V-? Chem. Tech. Dr. Harold K. Latourette, Environ. Mgr. Dr. Martin J'. Fletcher, Mgr. Toxicology i Society of Toxicology Harold M. Peck, M.D., President July 5 Wednesday E. I. duPont de Nemours Co. Dr. Bruce Karrh, Medical Director John A. zapp, Toxicologist AP000479f 0 Ju.lv 5 Wednesday July 6 Thursday July 7 Friday E. I. auPont de Nemours Co. Ben C. Rusche, Dir. Health Safety Russel S. Pease, oecup. Environ. Control Charles F. Reinhardt, Haskell Lab. Ned K. Walters, Mgr. Safety William E. Fayerveather, Biostatistician Robert R. Bonczek, Attorney Taylor W. Hanavan, Attorney B. Anne Gwynn, Attorney John F. Dickey, Attorney Fike Chemicals, Inc. Elmer A. Fike A Healthy, Holistic Awareness Association Josephine A. Trevathan, Esq., President Reserve Mining Co. Matthew R. Banovetz, Executive Vice President Edward T. Fride, Attorney George w. Wright, M.D., Consultant Ian T. T. Higgins, M.D., Consultant William E. Smith, M.D., Consultant Donald D. Haase, M.D., Occupational Medical Consultant Dr. Lawrence J. partridge, Jr., Consultant Raymond L. Erickson, Attorney National Agricultural Chemicals Association Dr. Stan D. vessleinoritch Dr. william E. Butler Dr. Mitchell R. Zavon Dr. John L. Emerson Dr. Michael A. Gallo Dr. TH KaJcuk Dr. Jerry M. Smith Charles A. O'Connor, III, Attorney New York University Medical School Harry B. Demapoulos, M.D., (private) Shell Oil Comoany RE Coe - Mgr." OSH-Affairs RE Joyner, Med. Dir. EL Kusnetz - Mgr. Ind. Hyg. ML Sagenkahn - Mgr. Business MB Slomka - Toxicologist HR Sommer - Toxicologist Res. AP0004791f July 7 Friday July 10 Monday Shell Oil Company FB Thomas - Toxicologist CE Kline - Pres. CH. Kline Company GL Innes - V-? CH Kline Company DE Stevenson - Dir./ Toxicology Lab. B. F. Aurelius, Attorney Exxon Corp. Robert A. Scale, Dir. Toxicology Jeremiah Lynch, Ind. Hyg. N. J. Roberts, M.D., Medical Director Goodyear Tire and Rubber Company Waveland D. Davis - Mgr. Safety Compliance William 3. Birsch - Mgr. Chem. Engineering Dr. Lawrence K. Hunt - Health Safety Section Head HR Wickenden - Mgr. Planning Dale R. Martin, Attorney Monsanto Company John W. Hanley, Pres. Monte C. Throdahl, Group Vice President Environmental Policy Staff Alexander Munn, M.D., Dir., Medicine & Environmental Health Polyurethane Manufacturers Association Jack E. Peterson, Ph.D., Peterson Assoc. Kurt C. Frisch, Ph.D. Alphonso Chapanis, Ph.D. Arrid A. Sather, Michael, Bert & Friedrich George Kilbride, Mandrels, Inc. Jay Meili, MoIdea Dimensions, Inc. William G. Stahr, Whittaker Coatings Gene A. Huber, SWECO Inc. Thomas M. Houghton, CONAP, Inc. American Federation of Labor and Industrial Organizations A. F. Grospiron George J. R. Taylor Margaret Seminario Steven Wodka Michael Wright Congress of AP00047912 July 10 Monday July 11 Tuesday July 12 Wednesday Industrial Union Department of the afl-CIO Sheldon W. Samuels Oil, Chemical and Atomic Workers Steven Wodka Jimmie Truite Noel King United Steelworkers of America Melena Burkinan Elmer Chatak Mary-Win O'brien Michael J. Wright Adolph E. Schwartz Public Citizen Sidney M. Wolfe/ M.D./ Health Research Group American Occupational Medical Association Robert E. Eckardt, M.D., ph.D. Bruce E. Douglass, M.D. Association of American Cancer Institutes Henery C. Pitotf M.D., Ph.D. Edwin A. Mirand, Secretary-Treasurer Urban Environment Conference Inc. George Coling National Resources Defense Council Marcia J. Cleveland/ Attorney Motor Vehicle Manufacturers Association Thomas H. Hanna/ V-P Timothy Mather, Mgr. Personnel Thomas J. Slavin, Ind. Syg. V. Marie Slywynsky, Attorney Anthony P. Massaro, Inc. Hyg. AMC Daryl N. James, Inc. Jyg. Chrysler Lawrence Roslinski, Toxicologist/ FMC Gene Kortsha, Hyg. GM Gerald A. Sattelmeier, Industrial Hygiene Department Refractories Institute J. William Widing, Pres. John . Kem, V-P John P. Holt, V-P AP00047913 Refractories Institute David A. Knowlton, Dir. Safety and Health Otto L. Forchheimer, Tech. Dir. Lawrence J. Partridge, Proj. Dir. AD Little AM Carto, Exec. V-P Standard Oil Company of California ED Kane, V-p Tech. Chemical Industry Institute of Toxicology Leon Golberg, Pres. Bristol - Myers Company Dr. Paul MedfordNewberne, Consultant Dr. Adrianne Zllefson Rogers, Consultant William K. Hoskins, Member-Legal Staff Society of the Plastics Industry, lac. Ralph L. Harding, Pres. Stanford H. Shaw, Chinn Lawerence, Hadley EL Bixby, Goodall Rubber Len Bothe , Bird & Son Bill Hammond, GAT Carp. Larry S.Weaver, Plasticware Cup Co. Clayton T. Lyons, Master Container Robert Wood, Mobil ChemicalPaul Rothchild, Owens - Illinois Inc. Charles Earrison, Hedwin Corp. Paul Trow, Rexel Division Harley Henry, Styrex Industries Robert Cook, Plastics Industries Michael Roby, Rubbermaid Inc. Thomas Van Acker, Monsanto Lloyd Dixon, Dexter corp. Everrett Oftedahl, Expanda - Foam, Inc. Luther Dickens, Radva Plastics Corp. Dana Kelley, Dres. International Fred Ford, Duval Corp. John W. Morse, Engineering Plastics Rodger Glander, Glastic Corp. Ken Zseler, Budd Co. James Smith, Rostor.e Corp. S. D. Edmisten, Fibercast Co. M. L. Christensen, Atlas Plastics CO. Chester McCloskey, Norac Co. AP00047914 July 13 Thursday July 14 Friday Society of the Plastics Industry, Inc. Douglas I. Hanson, Hanson Pattern & Mold Lloyd Gottesman, Tenneco Chemicals Robert Hay, Firestone Foam Products Ernest McClelland, Plast-O-Meric, Inc. Society of the Plastics Industry, Inc. Al. Haas, Eastman Chemical Dr. Kenneth L. Burgess, Dow Chemical H. Donald Penney, Borg-Waraer Chemical D. C. Neuchterlein, Dow Chemical James V. Hardman, Hardman Inc. Jim Hornberg, Hysol Corp. Chester McClosky, Norac Co. Daniel Bidding, Dana Molded products Paul Thomas, Chicago Molded Jerry Formo, Plastics, Inc. Richard McKibben, Modem Plastics Adolphe J. de Matteo, Thieley Plastics William F. Mericle,Cincinnati Milacron Inc. James McWilliam, Zvanhoe Tool & Die Harry B. Ussery, Southeatern-Kusan, Inc. Fritz Backscheider, Recto Molded products Robert A. Hoffer, Hoffer Plastics Bryon Anderson, Northern Petrochemical Norbert Finke General Molded Ken Dahl, JS Plastics Paul Tiez, Tiez-Bauer Plastics Lawerenee R. Bauer, Reed Prentice Division Robert Poet, Vistron Corp. Gerald Kessler, Kessler Products Co. Gordon J. Naff, Highland Plastics Onion Carbide Corp. Jackson B. Browning, Dir. Health & Safety Thomas W. Carmody, Dir. Occp. Health Carl U. Demahl, MD, Medical Director Carrol S. Weil, Toxicologist John W. Whittlesey, Attorney Stauffer chemical Company Wayne C. Jaeschke, Dir. - Environ. Services Ralph I. Freudenthal, Dir. Toxicology John T. Ronan, III, Attorney Carnegie - Mellon Institute Raymond S. E. Yang, Toxicology AP00047915 July 17 Monday Industrial Health Engineering Associates, IncKnowlton J. Caplan - (private) National Constructors Association Delano F. English V- Sherwood Kelly . ' James E. Pakenham Richard 3. Peterson " Kawecki Berylco Industries Tyson W. Coughlin, Attorney Economic Analysis Division, SPA Bill Pegram West Gulf Maritime Assoc. Hal Draper, Safety Director National Steel Corp. William M. SHith, Dir. - Environ. Control William L. Gadd, Dir. - Ind. Hyg. r. E. L. Tertick - Medical Director Carl H. Hellerstedt, Jr., Attorney Roger M. Golden, Attorney Health -Industry Manufacturers Association G. Briggs Phillips, Fh. D. American Cyanamid Co. C. Boyd Shaffer, Dir. - Toxicology Nolan B. Sommer, Senior Vice President American Coke and Coal Chemicals Institute Lucian M. Ferguson, Exec. V-P American Paper Institute Julian M. Kien, Director, Employee Relations United Technologies W. F. Patton - Supr. Health & Safety Engineering J. A. Martin - Dir. - Ind. Hyg. Western Wood Products Association K. L. Patrick Ethyl Corp. Gary Ter. Haar AP00047916 July 17 Monday July 18 Tuesday Armstrong Cork Co. L. J. Bibri, V-P National Association of Chemical James K. Coyne, Gor. Rel. Vernon Lowe, Exc. Sec. Pliilip B. Bowman, Attorney Distributers Allegheny - Ludlum Steel Corp. W. R. Deem, V-P Manufacturing A. S. Odasso, Director, Environmental Control Glenn E. Schweitzer National Association of Printing Ink Manufacturers james E. Renson, Exec. Dir. Highland Plastics Gordon J. Naff Hooker Chemicals and Plastics Corp.. John Janous, lad. Hyg. Paul Nees, Toxicologist Fred Olotka, Mgr. Safety and Health Neil WOodworth, Supr-Environ Services Robert Luss, Attorney Muskegon Chemical Co. John R. Yost. Dana Molded Products Daniel ?. Hidding Environmental Defense Pund Leslie Dach Raybestos - Manhattan Hilton C. Lewinsohn, Corp. Med. Dir. Jones E. Laughlin Steel Corp. Dr. R. J. Salen, Med. Dir. J. H. Kirkwood, Vice President, Robert C. Gombar, Attorney Industrial Relations Diesel Automobile Association Robert A. Gibbons, President - Chicago Molded Products Co. Paul M. Thomas, Executive Vice President AP00047917 Ju.lv 18 Tuesday Juiv 19 Wednesday Uniroyal Inc. Walter D. Harris, Ph.D., Ind. Toxicologist American Iron Ora Association RM Neil, Chemical Safety Commission Mallinckrodt, Inc. Noble Robinson, Dir.-Env. Affairs Roger-A. Keller, Attorney Witco Chemical George F'. Polzer, Exec. V-P Kaiser Steel J. S. Hazen, Dir. - Labor Rel. E. H. Given, Mgr - Medical- Services D.A. Kandel, Industrial Hygiene Administrator Plastics Engineering Company Ralph T. Brot2, President Tenneco Chemcials Dr. Roy T. Gottesman Exxon Nuclear Company Warren S. Nechadom, Mgr. Licensing Roy Nilson, Manager, Licensing Hercules, Inc. Emil..Christafano, Ind. Hyg. Crane Packing Company Harvey M. Sheldon, Attorney National Cottonseed Products Assoc. Garlon A. Harper, Dir. - Res. and Educ. Fred E. Husbands, Executive Vice President National Cotton Batting Institute Dr. P. J. Wakelyn, Mgr. Evniron. Safety Arthur Grehan, Executive Secretary Balchem Carp. Herbert 0. Weiss, Pres. Ursula T. Berube, Administrative Assistant AP00047918 July 3.9 Wednesday Reynolds Aluminum Company . E. Claiborne Irby, MD., Med. Dir. Harry L. Skalsky, Ph.D., Toxicology MCV Joseph F, Borzelleca, Ph.D., Toxicology MCV John R. Amos, Attorney National Association of Manufacturers Richard Gallagher Randolph M. Hale W. Scott Railton William Blasier Robert R. Siegel Edward Singer Grace Chemicals Division Peter M. Matonis, Ph.D. Dir-Envircn. Affairs P/A Industries, Inc. Robert G. Hauser, Pres. American Color and Chemical Corp. Garrett A. Sullivan, Pres. Dolomite Brick Corp of America OL Forchheimer, V-? Eric Charlton, Executive Vice President Asbestos Information association Harrison B. Rhodes, Dr. Eng. R. H. Mereness, Executive Director Diamond Shamrock Donald W. Hillman, MD., Med. Dir. Society of American Wood Preserves, Inc. George R. Eliades, Pres. Dyes Environmental and Toxicology Organization Samuel N. Boyd, El DuPont Chmn. Rd-DETO * Koppers Company Alonzo W.. Lawrence, Ph.D., V-F Occup. Health Sun Chemical Company Dr. Hugh M. Smith - Mgr. R & D Michael Lewis - Dir. Engineering AP00047919 V Julv 19 Wednesday Julv 20 Thursday Rubber Manufacturers Association Frank T. Ryan, Dir, Environ. Health Affairs Hughson Chemicals, Lord Corp. John J. Szwarc, Safety Engineer i Dry Color Manufacturers Association George Koehler, Mgr. Safety American Cyanamid John Dickenson, Pub. Affairs, Harshaw Chemical Company J. Lawrence Robinson, Executive Director Society of Plastics Engineers Lawrence J. Broutman, Ph.D., Pres. Joseph E. Hadley, Jr., Attorney National. Legal Center for the Public Interest Miro M. Todoovich - Chmn. Academic Council Alexander Von Graevenitz George E. Moore Barth X. de Rosa Capital Legal Foundation James R. Richards, Legal Dir. ' General Electric Thomas R. Casey MD, Med. Director Jerome T. Coe, Environ. Qual. Task Force Adhesive and Sealant Council, Inc. Julie Rapp, Exec. Sec. Georgia Pacific Corp. TM Hahn, Pres. Textile Fibers and By-Products Association Dr. P J Wakelyn Don A. Bryant, President Alcoa Bertram D. Dinman, Med. Director Fluor Engineers and Constructors, Inc. James E. Owens, Dir., Quality. Assurance, Marvin Marcus j AP00047920 July 20 Thursday July 21 Friday Vineland Chemical Co. Arthur Schwerdtle E. George Fazianos, Attorney * Chemical Specialties Manufacturers Association Dan R. Harlow, JD, Ph.D., Dir. Scientific Affairs Dept, of Health, State of Connecticut Douglas S. Lloyd, MD, MFH, Commissioner National Electrical Manufacturers Association Bernard H. Falk, Pres. Dale R. Schmidt, Coordinator of Government Activities American Textile Manufacturers Institute Joseph L. Lanier, Chmn Health & Safety Raymond P. Boylston, Dir., Safety and H'ealth Division Neigborhood Cleaners Association William Seitz, Exec. Dir. International Fabricare Institute William E. Fisher, Adm. Research UC - Berkley Thomas H. Jukes (private) Vulcan Materials Company Thomas A. Robinson, Ph.D., Dir. - Environ Affairs Organization Resources Counselors, Inc. 3. K. Kwon D. R. Mattheis Major Laundry Rental Service, Inc. Sol Schwartz, Owner Northern Petrochemical B. J. Anderson, V-P Drycleaning Industry Council Philip W. Croen, Chmn Cleaning and Laundry Association Executives Philip W. Croen, Pres. Hoekstra Univorm Rental Service Herman C. Hoekstra, Owner AP00047921 July 21 Friday Department of Defense George- Marienthal, Dept. Ass. Sect. Energy, Environ, Safety Styrex Industries Harley D. Henry, Pres. ; Manufacturers Association of Hartford County Richard C. Noyes, Pres. Chemetron Pigments, ALlegany Ludlum Industries Blaine C. Mays, Consultant Gov; Affairs Robert R. Mueller, Prod. Mgr. Rene A. Willis, Gov. Affairs- Bethlehem Steel Corp. AE Moffitl, Dir.- Environ. Toxicology Carl Ackerman, Staff Engineer David M. Anderson, Manager of Environmental Quality Control Inmost Corp. Alfred S. Kidwall, Dir. Gov. Affairs Virginia Chemicals Donald S. Ellison, Mgr. Gov. Relations Uniroyal Chemical Edward J. SowinsJci, Industrial Toxicologist United States Steel corp. W. C. Janes, Mgr. Environ Health Dr. Merle Bundy, Med. Director Dr. D. J. Smith - Ass11 Med. Dir. L. D. Van Der Veer, Mgr. - Cost Planning W. L. White, Attorney J. L. Boucher, Attorney Inland steel Richard G. Phelps, Mgr. - Primary Tech. James J. Romanek, Attorney Boating Industry Association National Association of Engine and 3oat Manufacturers Clifton Peter Rose, Attorney American Foundxymen's Society Gary E. Mosher, Industrial Hygienist AP00047922 July 21 Friday jul- 24 iy July 25 Tuesday b r ti w \ \ 1 \ % American Foundrymen's Society H* Kohnstamm & Co., Inc. Paul L. Kohnstamm, Chairman & Chief Executive Officer Apollo Colors Inc. Wafren Norton Industrial Health Foundation, Inc. Paul Gross, M.D. Chamber of Coimerce of the United States Christine M. Waisanea National Cotton C&jnsil of ftnerica Earl W. Sears O.S. Borax aixi Chemical Corp. E. Steinberg Council on Wage and Price Stability Roy A. Niereriberg Brush Wellman f Inc. John M. Newman, Jr. American Industrial Hygiene Association Paul F. wcolrich Synthetic organic Chemical Manufacturers Association Ronald A. Lang Allied Chemical John T. Estes AP00047923 / 3. NIOSH believes that scientifically sound change and the standard should deal with protection to repairmen. \ NIOSH favors quantitative fit for respirators. No smoking should be permitted where carcinogens may be released into the work place air. NIOSH favors extending medical exam in certain way. OSHA submitted 32 questions to NIOSH some of which are answered in Appendix C. NlOSH's answers cover:-- ........ . 1. Animal studies are appropriate to identify potential human carcinogens. Species should be those consistently positive when tested with human carcinogens. Rodents fit this criteria. NIOSH rejects the criticism of mice as test animals. AP00047924 -3- 2. Don't know how valid 1-5% estimate for occupa tional cancers. The dose relationship shown by carcinogens lead to expectation of fewer cases at low doses. OSHA is directed by its statute to determine socially acceptable value of risk and the establishment of absolute risk, not relative risk. 3(a). OSHA sets out tables showing agents identified as occupational hazards by epidemiology and confirmed and suspect carcinogens by target organ (6 paces). (b). Mo one study can provide all needed health in formation. Epidemiological studies have potential to determining effect of long-term low level exposure, but * difficult to determine past exposure and dose-response. Animal data present problem of extrapolation. Both studies should be used. (c). Epidemiology uncovered smoking risk, benzene and arsenic. More weight m.ust be given to positive epidemiological studies than negative. (d). Efforts should be made to identify high risk individuals in epidemiological studies. 4. Animal data can be relied on in the absence of human data. Inhalation and percentaneous routes of exposure are satisfactory. Oral route also satisfactory. Inhalation preferred route; topical applications also give useful information. Injection site sarcomas by themselves probably do not indicate carcinogenicity. Support MTD. 5. Present information is not sufficient for develop ment of a consistent basis for decisions on additive and synergistic effects. 6. Mot clear whether cancer caused by first exposure or repeated exposure. Latency is an imprecise term. 7. Short term tests which are being validated should be> used as originally intended as screening device. They cannot ^ be substituted for long term animal studies. AP00047925 48. Discussion of various factors involving extrapola tion: (a) failure of rodent tumors to metastasize not critical. (b) differences in target organ not critical* (c) route of administration important for health purposes. (d) OSHA should also consider physical agents ultraviolet and infra red. AP00047926 R. Fleming R. H. Schenck cc: J. T. Barr 8 May 1978 OSHA Carcinog File Nof^SS-L ExeeutivV Law Attachdd is Appendix C containing NIOSH's responses to OSHA's questions. RHS:rgs ATTACHMENT R. H. Schenck AP00047927 APPENDIX C the following are responses to some of those questions received from OSEA. Responses to sons questions have not been furnished , in this appendix either because they have been discussed in the prepared statement or because of che coaplexlty of the issues and the short amount of tine available to gather and evaluate the data, prepare an appropriate response and meet the April 4, 1978 due date for submissions to the OSHA Docket Office. AP00047928 Questions 1, 2 & 21 The proposal recommends chat animal studies be used to identify potential human carcinogens. This is quite appropriate. In fact, the purpose of the Proposal is to decrease human experimentation, i.e. decrease occupational exposures to carcinogens. Although there might not be 1002 correlation between the effects of chemicals on animals humans, that is not surprising nor should it discourage us from pursuing our goal. It should be noted that of the chemicals and/or classes of chemicals chat have been found to cause cancer in. humans, including: benzidine; 2- napbthylamina; blschloromethylether; ehloromethyl methyl ether; 4- aminodlphenyl; N,N-bis(2-chloroethyl)2-Qaphthylamine; chrysotlle; crocidolite; amosite; compounds; chromium compounds; nickel compounds; arsenic compounds; beryllium compounds; benzene; auramine; diechylstilboestrol; and vinyl chloride, all except possibly benzene have been found to cause tumors in animals (Tomatis, 1976; Nevbeme, 1975; Bayliss and Wagoner, 1977; Infante, et al., 1977; Oswald and Goerttler, 1971) . Thousands of workers have developed cancer as a result of exposures to these agents. They have unwittingly provided scientists with the Information needed to make the correlation between an-tmai and human responses to carcinogens. Another important consideration Is the animal species and strain chat should be used in. the test systems. The degree of correlation between eaca species and humans as well as the relative cost in performing che studies be considered before recommendations can be made. Obviously, chose which have been consistently positive when tested with known human AP00047929 carcinogens are acceptable. Of the human carcinogens mentioned above, almost all have been shown to be positive in rats and several of them are positive in mice. Fortunately, these are the mammalian species which are least co9tly to process, and, therefore, their use can be recommended with very few ot no qualifications. Some scientists believe, however, that Che mouse Is too sensitive to carcinogens, and, therefore, the rat is a better model. Implied in this opinion Is that mice will respond to lover doses of carcinogens than will humans. Since quantitative data on carcinogen exposures to humans is almost non-existent, that comparison is Impossible to make. The fact that the mouse is sligheiy more sensitive to carcinogens than the rat is well-known (Tooatis, 1973), however, the model should be designed to protect humans, not rats. Another argument that has been frequently used to exclude nice is that they have a high frequency of spontaneous tumors which might be induced by hormones and/or viruses, end that tumor promotion, but not induction. Is measured when that model is used. What the proponents of that argument fail to recognize is that whatever variables are present in s mice might also be presene in humans. Human tumors might also be induced by yet unrecognized viruses, and hormones eertainly play a role in human carcinogenesis (Furth, 1975). It is .not unreasonable to expect that the mechanisms of carcinogenesis operative In mice might be identical to those In humans, for example, humans have no zymbal gland. It is certainly possible that many carcinogens in humans are in fact co-carcinogens. There is no method to determine this with any degree of certainty in humans. AP00047930 Question & It has been estimated that occupational cancer represents about one to five percent of the cancer cases reported annually In the United. States. We don't taow how valid the estimates are of the total incidence of occupational cancer. We know that there are a significant number of occupational cancer cases e.g., from 2-naphthylamine, asbestos, arsenic, vinyl chloride and this alone justifies vigorous preventive action* 1 Since numerous studies (vinyl chloride - B(a)F, Kaltoni and Lefemine, 1975; Bingham and ?alk, 1969) etc., have proven chat a dose-response relationship is evident in the area of carcinogenesis just as in other areas of toxicology, it is readily apparent that positive results obtained at high doses indicate that lover risks are to be expected at lower doses. The specific limitations in estimating the lover risk factors are inherent in the specific limitations of the data gathering system. Such factors as animal numbers* number of dose levels, confidence Units' and ocher factors must be considered in properly evaluating the dose-response relationship. In. addition to a socially acceptable value of risk.* the establishment of an absolute value of risk, rather than a relative value of risk (Subcommittee on Environmental Jfutagenesis, 1977) Is mandated by the OSBAct la regard to occupational carcinogenesis. AP00047931 Cjuestioa 5 a. The first direct: connaction between an occupational exposure and risk of a specific cancer was chat of chimney sweeping and cancer of che scrotum pointed out by Pott in 1775. He recognized this association because he saw several affected chimney sweeps but little or none of the disease in persons with other occupations. The disease was exceedingly rare in the general population, and the risk ratio for chimney sweeps was quite high. About 1880 Hirting and Hesse showed that "mountain disease" was a lung.neoplasm. This condition was recognized as an entity in the Middle Ages because of its frequent occurrence among young miners despite Che rarity in the general population. In 1395 the German surgeon, Hehn, published on the hazard of bladder cancer among dye workers. Kahn's association was based not on an exceedingly high risk ratio but rather on the absolute high frequency of the disease among exposed persons. During the past several decades instances of occupational carcinogens have continued to be recognized both on che basis of an extremely high risk ratio and a high Incidence rate among exposed persons. The following tables show various agents which have been Identified as occupational carcinogens on the basis of epidemiologic studies and confirmed and suspected carcinogens by target organ. AP00047932 TABLE 1 Classification of Occupational Carcinogens A. Organic igcnu' \. Aromatic hydrocarbons Agents Coal toot Coal tar Other products of coal combustion Affected ocgan(s) Incubation period (yean) Lung, larynx, skin, scrotum, urinary bladder 9-23 Petroleum Petroleum coke Wax Creosote Anthracene Paraffin Shale Mineral oils Benzene Nasal cavity, larynx, lung, skin, scrotum Bone marrow (leukemia) 12-30 6-14 Risk ratio 2-4 . 2-4 Occupation Gasliousc workers, stokers, and producers; asphalt, coal tar, and pitch workers^ cokeoven workers: mine**;'' still cleaners; chimney sweeps Contact with iubricauf. cooling, paraffin or wt* fbel oils, or eokejruifcsr fillets; retortmen; inak weavers; diesel jet teem 2-3 Explosives, bn i Treei or rubber ** workers: disuSetC uitn; prinurtt * Philip Cole and Marlene Goldman, Chapter 8-0 "Persons at High Risk of Cancer", edited by J. Fraumenic, National Institute AP00047933 A. Gi^mii; agents (continued) 1. Aronimit hydrocatbuus (continued) Avails AurainmC Benzidine ct-napblliylaiUHiC p-naphthylaininc MagenU 4-sminodiphenyl 4-nitrodiphenyl Affected ucg;m(0 Urinary Madder Incubation period (years) 13-30 2. Alkylating agentt Mustard gas Larynx, lung trachea, bronchi 10-25 Oh'Ct([l3(t<IU - Dyxstarfs manufacturers and men; rubber workers (poamten, filtcnncn, laborers); textile dyers*, paint manufacturers 2-36 Mustard gas workers 3. Others Isopropyl oil Vinyl chloride Kasai cavity liver (angiosarcoma), brain 10+ 20-30 21 Producers 200 (liver) Plastic workers 4 (brain) A. Organic agents (continued) 3. Others (continued) Agents Affected orgin(s) Incubation period (years) Bis(chioromeihyi) ether Oiloromcthyi methyl ether Lung (oat eeli carcinoma) 5+ Risk ratio 7-45 Occupation Qiemieal workers B. Inorganic agents 1. Metals Arsenic Skin, lung, liver Chromium Kasai cavity and sinuses, lung, larynx 3-3 Miners; smelters; Insecticide makers and sprayers; tanners; chemical workers; oil refiners; vintners 3-40 Producers, processors, and users; acetylene and aniline workers; bleachers: glass, pottery and linoleum workers; battery makers i AP00047934 B. Inorganic agents (continued) ]. Metals (continued) Agenu Affected organ(s) Incubation period (yean) Risk ratio Occupation Iron oxide Lung, larynx Nickel Kasai sinuses, lung - 3-30 .3-5 Iron ore (hematite) fasten; metal grinders and pcEshers; silver finishers; iron foundry workers 5-10 (lung) Nickel smelten, mixers. 100+ (nasal and roasters; electrolysis sinuses) workers 2. Fibers Asbestos 3. Wood Leather Duals - Lung, pleural and peritoneal mesothelioma * Kasai cavity and sinuses Kasai cavity and sinuses, urinary bladder 4-50 # 1.5-12 . Miners; millers; textile, bmilation, and shipyard workers 30-40 40-50 -- Woodworkers 50 (nasal sinuses) XS gladder) Leather and shoe workers * C. Physical agent* 1. Nonionizing radiation Agents Ultraviolet rays Affected organ(s) Skin . Incubation period (yean) varies with skin pipnent and texture Risk ratio - Occupation Farmers; sailors 2. Ionizing radiation X-rays Uranium Radon Radium Mesothorium Skin, bone marrow Qeukemta) Skta.Iunc. bone. bone marrow (leukemia) ' 3, Other Hypoxia Bone 1 10-2S 10-15 -- 3-9 3-10 Radiologists; medical personnel Radiologists; miners; radium dial painten; radium chemists - Caisson workers i $ s J 1 - i i M AP00047935 i i. nsa. Table 2 Confirmed and suspected occupational carcinogens* by target organ.______ Try*t Organ/Ttuue Bone Brain Gastroenteric Tract Hematopoietic Tissue (leukemia) Kidney Larynx Liver Lung Lymphatic Tissue Kasai Cavity Pancreas Pleural Cavity Prostate Scrotum Skin Urinary Bladder Occupational Carcinogen Confirmed Suspected Beryllium Vinyl Chloride Asbestos Benzene Styrene Butadiene and other Rubber Manufacture Substances Coke Oven Emissions Asbestos, Chromium Vinyl Chloride .* * Arsenic Asbestos Bis (chloromethyl) ether Chloromethyl methyl ether Chromates Coke Oven Emissions Mustard Gas Nickel Soots and Tars Uranium Vinyl Chloride Chromium, Isopropyl Oil, Nickel, Wood Dusts Asbestos Soots and Tars Arsenic Coke Oven Emissions Cutting Oils Soots and Tars 4-Aminobiphcnyl Benzidine B-Naphthylaraine Lead Aldrin Carbon Tetrachloride Chloroform DDT Diddrirr Heptachtor PCB's Trichloroethylene Beryllium Cadmium Chloroprcne* Lead - Arsenic Benzene Benzidine PCB*s Cadmium Qiloropreoc ' Aunmune 4-NitrodiphenyI Magenta *Occupational Diseases - A Guide to their Recognition - U.S. Department of Wnraf-inn and Welfare - NIO$H__ AP00047936 Table 3 Suspected carcinogens based upon structural similarity to vinyl chloride. $uspete4 Carcinogen . - Structure Vinyl Chloride H,C=*CH a Broraopreae H,C =* CHCHjBr Chloroprene H,C~CHCH,a Epibromohydrin HaC--CH--CH,Br : V. Epichlorohydrin Perbromoethyleae Perchlorcethylene Tribromoethylene Trichloroethylene Styrene (Vinyl Benzene) vH,C-CH-CH4a Br,C * CBr, a,c*ca. Br,C=*CH Br a,CCH a H.C^C1 H Vinyl Bromide VtnyHdene Bromide Vmylidene Chloride H,C*=CH Br H,C.CBr Br H,C*CO a- i AP00047937 b. Mo one study approach can provide all or even, most of the needed health information. While epidemiologic studies in the occupational setting have the potential to determine effects of long term low level exposures, the difficulty in making quantitative estimates of present exposures and the even greater problem in determining past exposures makes it hard to obtain accurate dose response data* On Che other hand, while more accurate dose response data can be derived from toxicological studies using experimental animals, one is always faced with the diffi culty of extrapolating results from experimental animals to humans and often with the additional problem of extrapolating from observed higher dose levels to lover dose levels. However, when the two study approaches are utilized In a coordinated way, benefits of each approach can be maintained and many of the individual methodological weaknesses can be overcome. The following cable shows these strengths and weaknesses. AP00047938 I. Table 4* DISCIPLINARY APPROACH* TO HEALTH EFFECTS OF.AIR POLLUTION fMKlUlM 4w0* ______HwiiOj ____ --Vi_--I Epidemiology CtAtmnilici croup* * Toxicology Animal* Biochemical *T*iema caii Natural etpowraa Oh#rrrtion in man No extrapolations Vulnerable croup# Inr.hidnl Long tern. lowlrrrl 3ecU mluia Study many poop!* Quantifying expeoar# difficult Many eo**riate Miunil iM lesponso dsu Afwculloo ** causation Can only make few health BoajorvmcnU Long latent pensdt for dlteaso * problem Easy lo obtain doamponm data Rapid daUa*^uMtlioo Gause-offect moro definite Mcchanum* of response Predict tlispa of tfw response curves Adniaiittr toxie eittttuJi Study teuta and chcoofe effort* RosJtsde models of human dlsoase? Extrapolation Irva tnimali to xa** - Tiftibold of human responic?- ArtificiU <spcnure* I t *Dr. Carl Shy, ''Strengths and Weaknesses of Epidemiological, Clinical and Toxicological Study Approaches,1' Gicmist/Meteorologist Workshop 1975, U.S. Energy Research and Development Administration J 1 ( i AP00047939 The impact of epidemiologic studies in cancer research, such as tha studies on cigarette smoking end lung cancer, prompted a recent Nobel Laureate to proclaim these studies as the major scientific finding of the 20th century. It is doubtful that the impact of smoking on lung cancer incidence would have been known If research had been limited solely to cellular and whole ar^fnai studies. - Although agents contained in cigarette smoke have been shown to induce cancer in laboratory animals, the sum of the carcinogenic effects of the known agents does not equal'that of the cigarette smoke condensate. Particular difficulty has been encountered in inhalation studies of cigarette smoke on laboratory animals because the animals, particularly smaller species such as Che rat, frequently die from the acute toxic effects of the nicotine and carbon monoxide In tobacco smoke. Another problem stems from the fact that the upper respiratory tract of experimental animals, particularly the nose, Is much different from analogous human structures resulting in a more efficient filtration of smoke in the upper respiratory tract of these animals. There is mounting epidemiologic evidence from a series of occupational health studies incriminating benzene as a possible leukemogehlc agent. Thus far, no animal studies have been able to demonstrate this effect. Similarly, the carcinogenic activity of AP00047940 / arsenic has bees demonstrated through, epidemiologic but not by j' toxicologic studies. If reliance were placed solely on. cellular and ii animal tests, then the importance of benzene and arsenic as i, cIarcinoigenic agents would presently be unrecognized. /M . tw According to. Sir Austin Bradford Sill, more weight must be given to positive as opposed to negative studies. Negative epidemiologic Lcudies^ particularly in cancer, cannot be construed as providing firnr evidence of safety. This is because of the problems of latency and the small number of people often observed in epidemiologic carcinogenic studies which often preclude demonstration of statistically significant differences. 1iI ( ; 1 , 1 If the appropriate steps are used in epidemiologic research, then descriptive studies have the potential to identify unusual clusters and high risk Individuals for subsequent study which should then limit the number of negative studies. AP00047941 Question 6 It has been customary to rely upon animal studies in the absence of human evidence for a carcinogenic assessment of chemicals. An examination of the literature and of the experience in this method of approach reveals that flMmat data can be satisfactorily used as a predictor of human response. The development of the vinyl chloride study, the coal tar/coke oven emission studies various other examples illustrate the predictive value of bioassay methods. In addition, the correlation between species .with certain carcinogens such as benzo(a)pyrene, bischloroaethylecher,. amiaodipheayl, benzidine, vinyl chloride, etc., have been in excellent agreement, even though the target tissue may differ among the species tested. In the case of ben2o(a)pyreae, nine species of animals have been tested and all found to respond to this widely tested ubiquitous carcinogen. (Survey of Compounds Which Have Been Tested for Carcinogenic Activity - WCI) . If the responses of animals to known human carcinogens are examined it becomes obvious that all human carcinogenic chemicals, with the possible exception of arsenic and benzene, are.also carcinogenic for animals. The Inhalation and percutaneous routes of exposure are the obvious routes of choice in experimental carcinogenesis studies when considering occupational exposure to chemical carcinogens. These routes are also the AP00047942 choice when considering experimental design of studies to investigateother toxic agents- However, it is well known that clearance from both the upper airways and the deep lung involves the mucociliary escalator in which materials are cleansed from these areas and usually find their way into the alimentary tract, in lieu of expectoration. Therefore, the oral route of administration via either stomach intubation, for purposes of exact quantitation of dose, or through consumption of food or water containing contaminants, is a perfectly adequate routa of administration to test the carcinogeacity of chemicals and complex mixtures found in the occupational environment. Inhalation is usually the preferred route of a adminstradon In animal studies for judging the carcinogenicity of airborne substances. Because of the expense of this type of study and methodologic difficulties, other routes, especially per oral, are used. In. the usual case, this route gives valid, extrapolatable information, but each case has to be considered individually. Similarly, other routes, e.g., topical application, give useful information. Injection site sarcomas by themselves, probably do not indicate carcinogenicity by other exposure routes. They may indicate specific hazards in the event of accidental implantation of the substances. The validity of using the maximum, tolerated dose in rodent bioassays has been discussed and debated for a number of years. It is appropriate Co mention that the National Cancer Institute as veil as ocher agencies such as NIOSH, FDA and EPA continue to consider this as an appropriate approach in experimental bioassays. The reasons for chls choice axe obvious vhen considering economics and the probability of response. AP00047943 Question 10 Present knowledge does not permit development of a consistent and rational basis for decisions on additive and synergistic effects. Complicating this problem is Che question of promoting agents and co-carcinogens, widely and variously used terms without the same meanings to everyone. Additive effects should be assumed when two agents cause cancer at the same site, especially when Che two agents also have chemical similarles, such as PS's or aromatic amines. Synergistic effects should be assumed only when there are data or principles suggesting is the specific case that potentiation is likely. Similarly, co-carcinogenicity and promotion should not be assumed except in a specific case where there are data or principles that apply. In clearcut areas involving -personal, habits .such, aa smoking, counseling of workers should be called for. Other areas of personal habits, such as diet or lifestyle, should not be considered in this proposed standard, at least until the Issues are clearer. AP00047944 Questions 15 & 16 Questions 15 and 16 are closely relaced and will be answered together.- The problem of additive and synergistic effects is extremely difficult to assess with available scientific methodologies, either toxicology or epidemiology. To date, the scientific community has not adequately dealt with this problem. Toxicology and epidemiology both provide valuable information about carcinogenic risk. The problems of additive (or antagonistic) synergistic effects do not make dose-response data in test animals irrelevant. Epidemiology and toxicology have both strengths and weaknesses. However, by combining two methodologies, in this case toxicology and epidemiology, it is often possible to overcome same of the weaknesses of each individual methodology, yet retaining their strengths. From this point of view, corroborating data on carcinogenic risk from both epidemiology and toxicology provides the most defensible data as to carcinogenic risk. Most toxicology studies assess effects of single exposures. It is virtually Impossible to artificially generate an exact replica of the complex workplace environment in any toxicologic experiment. One of the greatest strengths of the epidemiology approach Is to observe the effects of this complex environment directly in man. However, unless the possible synergistic or additive effect is specifically tested either epidemiologicaily or toxicologlcally, it is impossible to assess the importance of such interactions. In the final analysis, though, health may still be protected even if precise information on interactions is not available. This is because a given compound in a complex mixture may often serve as an index, which when controlled, will also result in decreased exposure to all compounds in the complex mixture. The situation with coke oven emissions is an excellent example In this regard. AP00047945 Question 3-9 jj Latency refers to the long period of cancer Induction* Because of the i uncertainties in identifying the specific tine or event in the genesis of : the cancer and Che uncertainties in /identifying the cancer itself, the term !1 i latency is not precise. It Usually} is taken to he that interval between hjjChe first known exposure to t cancer-causing substance and the first evidence of the consequent cancer, which is often at autopsy. /' / Whether the cancer process is initiated by Che first exposure is not known; it is generally thought chat the process is initiated by the- effect of repeated exposures, but there are rational bases for suggesting that any one of these repeated exposures may have been the initiating event. It Is conceivable that both ideas are correct, for example, it might be that the cancer is initiated by one exposure and is enhanced sufficiently by subsequent exposures to progress to enough overt cases to constitute a statistically significant excess (whether in an epidemiologic survey or an experimental animal investigation). However, this speculation should not obscure the point that latency is an imprecise term referring to the many years required for the development of most cancers to the point they are observed and is defined more precisely in specific investigations or surveys for the purpose of that study. AP00047946 Question 28 According to a report front the D3EW Subcommittee on Environmental Mutagenesis (1977), mutagenesis (short-term or in vitro) testing, in addition to providing valuable information on the risk to future generations, can provide valuable information regarding ocher toxicological manifestations. Examples are cited stating that there is an "apparent relationship between carcinogenicity and mutagenicity" (McCann, ec al., 1975; McCann and Ames, 1976). Eowever, Che predictive value of short-term mutagenicity tests for carcinogenicity is currently under Investigation, involving numerous efforts to assess the use of short-term mutagenicity tests. The Subcommittee Report goes on further to state that the utility of nrutagenicity test procedures for screening of chemicals for somatic effect, for example, carcinogenicity is not predicated on the assumption that the effect is due to mutations in somatic cells; but "the empirical demonstration of a high correlation between mutagenicity and the effect of concern (carcinogenesis) is a sufficient basis for establishing a role for mutagenicity testing as a predictive tool regardless of the mechanism involved." There is widespread belief among investigators in the cancer area that DNA damage is involved In the induction of cancer. This is the basis for the supposition that carcinogens might be detected by the consequences of ENA damage In simple systems (Bridges, 1976). AP00047947 Shore term or in vitro tests chat have had some testing for validation purposes included those referenced by Bridges (1976) . Many other validation tests are ongoing (EeSerres, 1977; Duskal, 1978). Reports axe available' commenting on the stata of the art status of in vitro testing for carcinogenesis (Canto, 1977$ Kouri and Schechtman, 1977; Conservation Foundation, 1977). For scientific purposes, justification of the use of short-term tests for the purpose of screening thousands of chemicals for their suspected carcinogenic activity and for the purpose of prioritizing these chemicals for long-term an-fra*! bioassay, appears to be adequate. However, the original intent for utilization of these tests was only foT these two objectives and not for use as a confirmation*! test for long-term animal bioassay. It is inappropriate at this time to attempt to substitute a short-term test for a long-term animal bioassay for at least two reasons: (1) Validation procedures are not complete and correlations between the test systems have not been adequately performed; and (2) The outcome of the short-term tests as compared to the long-term bioassay are not biological equivalents. In one case the end point Is mutagenesis, in the other case, carcinogenesis. However, one (mutagenesis) may oftan cause the ocher (carcinogenesis). AP00047948 i 'It has also beau observed that a carcinogen does not always produce tumors . i in the same organa in all species. The mouse liver responds more readily j than most other tissues with most of the carcinogens that have been tested, let it is still predictive for cancer at ocher sites in ocher species, including mas (lomatis, 1973; Nevberce, 1975) Another consideration In evaluating a predictive model for human carcinogens is the route of administration. Although the route of administration might not be important in determining whether or not an agent is carcinogenic for research purposes, it is important. from a preventive health standpoint* To properly evaluate carcinogenicity, the suspect agents should be administered to animals by Che same routes as humans are exposed, namely, via the lungs, gastrointestinal tract, dermally and in some cases intramuscularly, intradermally and subcutaneously* The latter conditions would apply, for example, to those agents such as metal fragments thae might become embedded in skin or muscles. In industrial exposures to particulates, oral exposures are frequently as important as pulmonary exposures in as much as the particulates that are trapped in the upper respiratory tract are usually swallowed. Although in the above discussions chemicals have been given primary consideration as carcinogens, some consideration should also be given to physical agents, e.g., ultraviolet and infrared Irradiation and heat. To exclude physical agents from consideration in the regulatory process is unwarranted. To exclude any agent on the basis of its proposed mechanism of action is also unwarranted, since the mechanism is not being regulated, but instead the agent, it is, therefore, recommended that paragraph (1) in section 1990.111 be deleted from the Proposal. AP00047949 Question 31 In Che attempts Co develop models for predicting human carcinogens prolonged debates have centered around the type of lesion in animals chat ; must be Induced before a chemical can be called a carcinogen* Particular attention has been given to the mouse hepatoma (Butler and Nevberne, 1975) . Soma scientists believe that most mouse hepatomas are not cancers because they do not metastasize, and imply that the mouse hepatoma is, therefore, not predictive* This argument is illogical. In the first place, not all hepatocellular carcinomas metastasize in any species studied, yet they are frequently responsible for Che death of the hosts. Of 33 mice chat died subsequent to chronic exposures to 4-dimethylaminoazobenzane, 711 died as a result of hepatocellular carcinoma (vieh ascites and/or anemia) yet pulmonary metastases were infrequently observed (Gellacly, 1975)* ttecascasas are observed in humans in only approximately one-half of patients with hepatocellular carcinomas (Bobbins, 1975). In the second place, even the spontaneous hepatocellular carcinomas in mice seldom metastasize. In fact, very few of any of Che spontaneous neoplasms in mice or rata ever metastasize. In this way, rodents axe more resistant chan humans and possibly are not sensitive enough to the induction of cancer as we know it in humans. The reasons for that might also be explained on various factors that modify the ability of tumors to metastasize (Filler, 1975). Thirdly, for predictive purposes there is no reason why the rodent tumors need metastasize. There need only be a correlation between cancer in man and a neoplasm in animals, and this has already been demonstrated many times. AP00047950 April 12, 1978 Page 9 PESTICIDE & TOXIC CHEMICAL NEWS He concluded, "We have repeatedly asserted our recognition of the seriousness of any question regarding possible carcinogenicity, and the necessity for careful con sideration. It would appear, however, that if the results of the single study under question are so Inconclusive as to require such extensive deliberation, even the most extreme estimate of potential hazard to humans under the proposed conditions of use would be extremely minute, if in fact extant." His letter further concluded that If the mouse study had been repeated after early review of the original study, the results would be available about now. EPA COMMENTS ON QSHA CANCER POLICY STRESS AGENCY'S EXPERIENCE WITH FIFRA Citing extensive experience under FIFRA in regulating carcinogens, the Environmental Protection Agency has expressed its approval of the general thrust of the Occupations Safety and Health Administration (OSHA)`s Proposed Regulations for the Identification Classification and Regulation of Toxic Substances Posing a Potential Carcinogenic Risk. However, EPA pointed to what it saw as some serious problems with several aspects of the proposal, particularly OSHA's lack of attention to such factors as exposure level and potency of chemicals and OSHA's decision to require replication of animal tests. EPA's comments on the OSHA proposal were filed after the deadline for comment, however, OSHA has over a month until its May 16 hearing on the proposal to evaluate the EPA statement (See Feb. 16, Page 18). EPA's comments notedthe Agency's belief that OSHA has taken a valuable step forwarc and has established a useful approach to dealing with the "grave problems posed by carcinogenic chemicals." While pointing to general support for the way that OSHA dealt with generic issues in its proposal, EPA pointed out that one area where EPA and OSHA policies may be perceived as differing is in the treatment of factors such as the amount of exposure to a chemical and the potential potency of the chemical as a carcinogen. The agency observed that although OSHA may plan to use estimates of exposure and potency in setting regulation priorities, the proposal does not make clear whether OSHA will do so. EPA explained that its policy, developed largely during its regula tory efforts on pesticides, is to "consider the degree of public exposure and the potency of a potential carcinogen, as well as the reliability of the relevant data, in.determining whether to regulate a substance as well as the degree of regulation required." The agency comment admitted, however, that these differences in ap proach may be due not to disagreement on the underlying issues, but rather to the differences In the missions assigned to EPA and OSHA, adding "for example, it may be that OSHA's classification system is based, in part, on .the assumption that exposure to workers is nearly always significant In Industrial situations." Discussing Its support of the key regulatory concept embodied in the proposed OSHA regulation -- disposition of important generic Issues Ln this general rulemaking rather than in rulemakings Involving individual chemicals or hazards -FPfi alaKnratftH? AP00047951 Page 10 April 12, 1978 PESTICIDE & i'OXIC CHEMICAL NEWS "There can be no question that the strategy of foreclosing repetitive debate about such issues is a sound one that serves the public interests, and the courts have recognized the appropriateness of rulemaking to effectuate that strategy. EPA experience in regulating carcLnogens, particularly under the Federal InsectlcLde, Fungicide and Rodenticide Act (FIFRA) established that immense amounts of time can be consumed in regulatory proceed ings concerning an individual chemical relitlgating these generic issues. The constant repetitionof these extended debates increases the size of the record but does not improve the quality of the deliberations. Fairness and due process are served by ventilation of these Issues once. Repetition serves only to delay regulatory efforts and consume re sources whLch may be urgently needed elsewhere. Of course, it is obvious that some opportunity must always be available to raise genuinely new matters or to present sub stantial new evidence, but EPA agrees that generic issues may otherwise properly be excluded from regulatory proceedings whLch concern individual chemicals if they are confronted Ln a general rulemaking." , Serious Agency concern was expressed about the fact that the proposed regulations provide that animal test results generally cannot be relied upon as a sufficient basis for stringent regulatory action unless replicated or supported by short term studies. EPA added: "Although the proposal allows use of unreplicated animal tests if 'exceptionally well conducted,' we believe that this may be too great a qualification. EPA policy is that an unreplicated test can be an entirely adequate basis for concluding that a chemical must be regulated as a carcinogenic risk. Such tests can often be, extremely persua sive evidence that a hazard exLsts. Moreover, the delay involved in waiting for replication of tests may often be quite substantial, thereby increasing human risk." / EPA also suggested that OSHA should direct additional attention to the matter of setting priorities for controlling hazardous chemicals. The agency said that given the very large number of potentially carcinogenic substances, EPA believes that thought should be given to developing some form of hazard ranking mechanism for the setting of priorities. In addition, EPA observed that the deadline for OSHA action contained in the proposal may be too ambitious, adding, "based on our experience we fear that OSHA may be putting unrealistic demands on itself." EPA said: "Our experience under FIFRA also indicates to us that public input at a very early stage Ln the process, for example, after a tentative classification decision, could be useful and merits consideration. We are con cerned as well, that by basing standards for Category II substances, which have been Identified as possible car cinogens, on noncarclnogenic effects, OSHA introduces an illogical element Into its system," Addressing the amount of discretion OSHA Intends to use in categorizing chemicals, EPA recommended that If the exercise of this discretion Is expected to be very rare, this should be Indicated. } 0 AP00047952 April 12, 19 78 Page II PESTICIDE & TOXIC CHEMICAL NEWS In Its elaboration on its recommendation that OSHA establish a scheme for setting priorities, EPA said: "In the preamble to the Proposal, OSHA acknowledges that NIOSH has supplied It with a large list of potential occupational carcinogens, arti that some systems will have to be developed to prioritize this list, so that the chemicals on it can be processed over a several year period In an orderly manner. However, without modifying the pro cedural scheme in the Proposal to expressly provide for prioritization, OSHA mnsthe risk, of having outside groups dictate how It will attack this list -- and the order in which it will consider other potential occupational carcinogens -- by the simple expedient of filing written petitions. The way the system Is currently set up, the failure to respond to such a petition by setting the regulatory machinery set out In the Proposal in motion could result in litigation, and a court order requiring OSHA to honor its commitment. Respon siveness to petitions from outside groups Is of course a necessary and Important function of government. However, the prerogative to decide when a problem Is going to be looked at must be retained by the regulatory agency. Otherwise It will inevitably find itself expending its limited resources attempting to solve a set of problems which the agency may well find to be less important than other problems that It is aware of." EPA suggested that the only sound solution to this problem Is to create an additional step In the procedural scheme, in which OSHA considers a "candidate" toxic sub stance, and makes a decision concerning when It will commence processing the chemical through the system set up by the proposal. > "RULEMAKING" PROCEDURES MAY REPLACE ADVERSARY PLEADINGS FOR RPAR APPEALS Cross examination would be discouraged and public comment encouraged in procedures the Environmental Protection Agency may propose for handling challenges of Its decisions under the rebuttable presumption against registration (RPAR) process. A new draft of the procedures In EPA's Office of General Counsel provides for doing away for the most part with "trial type" procedures, as well as with the "alternative" procedures spelled out in an earlier draft {See Dec. 21, Page 15). The new draft procedures would rely more on the traditional methods of rulemaking -- scientific experts on the EPA staff proposing and public comment disposing -- rather than on traditional adversary trial procedures. EPA pledges in the draft that "the public will know what (RPAR) decisions are based on and will be able to question them." A second major intent of the draft regulations would be to: "... Establish a mechanism for shortening hearings by making policy decisions, and decisions resting on factual premLses that are not legitimately in dispute, at the beginning of the formal hearing process where they can be relied on n subsequently, rather than at the end of the process after a lot of time and effort have ^ been wasted." A preamble to the new draft outlines the steps for registration and appeal as a five-step process: AP00047953