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CHEMICAL MANUFACTURERS ASSOCIATION April 13, 1981 TO: Vinyl Chloride Program Panel Dear Panel Members: Enclosed is the final revision of the Vinyl Chloride Annual Report to the Special Programs Advisory Group (SPAG). This report is scheduled for presentation to SPAG on April 21, 1981. Sincerely, CRS:cr Enclosure Carol R. Stack, Ph.D. Administrator Vinyl Chloride Program 9 CMA 007983 Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872, 2501 M street. NW Washington DC 20037 Telephone 202/887-1100 Telex 89617 (CMA WSH) Vinyl Chloride - SPAG Review 1.0 Charters a. Panel Charter The Program Panel will be concerned with vinyl chloride monomer and polyvinyl chloride resin. The Panel will develop a program that examines the possible health effects of vinyl chloride through toxicological research and human (epidemiological) studies. The testing program will include appropriate monitoring to ensure adherence to sound scien tific practice and compliance with prevailing regulations. The Program Panel will review and evaluate the results of all studies. Consistent with CMA practices and policies, the Program Panel wil represent the interests of the Chemical Manufac turers Association (CMA) before Federal agencies in all matters relating to safety and health issues arising out of the production, reaction, release, packaging, storage, handling or use of vinyl chloride. The Program Panel will also be responsible for certain administrative matters, including the election of officers, deciding the basis for sharing the cost of the program among the participating companies, designation of appropriate task and/or working groups, and liaison with interested non-participating parties. The Program Panel will function as a special committee under CMA's bylaws, and as such will be subject to the Special Programs Guidelines. b. Research Coordinators Charter The Vinyl Chloride Research Coordinators, operating within the Charter of the Vinyl Chloride Program Panel, will provide interpretation of available data on the toxicology of vinyl chloride. The coordinators will advise the Panel on appropriate studies, both in the areas of toxicological research and human studies, required to expand the data base. The Group will provide the necessary protocol design or pro tocol review and will conduct or make provision for appro priate monitoring and auditing of all research programs. 2.0 Uses Manufacture of polyvinyl chloride and copolymers; organic synthesis; adhesives for plastics. CMA 007984 3.0 Background and Objectives a. Introduction CMA has had a long-standing interest in vinyl chloride monomer. In the early 1960s, the then Manufacturing Chemists Association arranged for a study at the University of Michigan on acroosteolysis (softening of finger tip bones) in VCM/PVC workers. The findings were published by the American Medical Association in the January 1971 issue of "Archives of Environmental Health". In 1971, at the recommendation of MCA's Occupational Health Committee, U.S. VCM/PVC producers were approached with the proposal that they might wish to support a research program to answer questions on vinyl chloride carcinogenesis raised by Dr. Viola's studies at the Regina Elena Institute for Cancer Research in Italy. A conference of interested member companies was held in November 1971; twenty producers were represented. An ad hoc planning group for vinyl chloride research (precursor to the present Vinyl Chloride Research Coordinators) was formed at the conference to provide review of research proposals and funding require ments. By early 1972, it was established that seventeen companies would support a vinyl chloride research program. The group of sponsoring companies, known then as the "Technical Task Group on Vinyl Chloride" was the first Vinyl Chloride Program Panel. The objective of the Task Group (Panel) was to expand the toxicology data base, thereby lending support to certain health and safety issues surrounding exposure to vinyl chloride monomer in the workplace. b. Research Programs i. IBT Study A research contract was negotiated with Industrial Bio-Test Laboratories in February 1973 to conduct a chronic vinyl chloride inhalation study in rats, mice and hamsters. IBT submitted interim reports to CMA during the course of the two-year study but issued no final report. Subsequent audits by both CMA and third parties found irreparable deficiencies in the study. CMA entered into negotiations for settlement with IBT last year and an agreement was reached. Companies participating in the research program will be refunded on the same pro-rated basis as they contributed to the program. ii. Dow Studies In 1974, the Program Panel agreed to fund a tera tology study in mice, rats and rabbits to be conducted at Dow Chemical Research Laboratories. Results were published in a March 1977 issue of "Toxicology and Applied Pharmacology". The data indicated that vinyl chloride did 2 CMA 007985 not"cause significant embryonal or fetal toxicity and was not teratogenic in any of the species at the concentrations tested '{up to 2500 ppm). A contract was executed with Dow in November 1976 to conduct a pharmacokinetic/metabolism study of vinyl chloride in rats. This research was an extension of similar studies being performed at Dow. A summary of the research was submitted to CMA in May 1977. iii. University of Louisville Research Program (Phase VlTT In 1975, the emphasis on research shifted from toxicological investigations to one more directly related to the early diagnosis and clinical management of vinyl chloride injuries resulting from past industrial exposure. Accordingly, the Panel approved support of a grant to the University of Louisville for the development of "Research Techniques and Methods for Detection and Prevention of Carcinogenesis in Industrial Workers". Support of the research continued and two further agreements were signed with the University in 1978 and 1979. Final reports for the* first and second years were received; the third is anticipated shortly. Continued funding of this program by the Panel is not likely. iiii. Epidemiology Studies A contract was awarded to Tabershaw Cooper Associates, Inc. (TCA) in June 1973 to conduct an epidemi ology study of vinyl chloride workers. A final report issued by Equitable Environmental Health Associates (successor to TCA) included 10,173 individuals. Brain tumor incidence was found to be in excess but did not apear to be related to either the duration or intensity of exposure to vinyl chloride. Weak associations between vinyl chloride exposure and malignancies at other sites were noted. EEH suggested that the cohort be studied again five years hence, since observation time would be extended and more deaths available for analysis. 4. Membership See attachments A, B and C. 5. Research Programs a. Completed studies (See attachment D). b. Future studies The Program Panel has considered a proposal from Environmental Health Associates, Inc. (EHA) to update the 1978 EEH epidemiology study (see above). In this study, 3 0079B6 CMA work histories of the 10,173 member cohort will be updated through- December 1979. Twenty companies are supporting this program (re: Vinyl Chloride Program Panel - Phase viii). a budget has. been established and a contract agreement with EHA will be drawn up shortly. Of particular interest in this study is whether or not the brain tumor incidence remains in excess. Also, are the associations seen in the earlier study strengthened or weakened? 6. Advocacy Although there has been limited activity, advocacy has not been emphasized by the Panel. This is partially the result of the extremely close liaison of the members of the Panel with the Vinyl Chloride Health and Safety Committee of the Society of the Plastics Industries, Inc. This arrangement has appeared to work well and at the present time increased advocacy is not anticipated. Several regulatory issues remain, however: 1. EPA is currently considering lowering the air standard for vinyl chloride. The Environmental Defense Fund is involved in these negotiations. 2. The FDA has delayed action on a request for approval of PVC liquor bottles. 3. OSHA appears interested in PVC dust and in vinyl chloride itself. However, no notice has been published and no time table has been established. 7. Key Issues A small number of key issues remain, but it should be emphasized that because of the high visibility of vinyl chloride, these issues can change rapidly and dramatically. 1. Whether single exposures to vinyl chloride are capable of causing cancer is an important ques tion. The study sponsored by CPSC, at Edgewood Arsenal, purports to have shown a positive effect from single exposure. Study conditions and the type of response were questionable, but adverse publicity may result when the report is published. 2. Vinyl chloride has been shown to cause other cancers in animals besides angiosarcoma. Human data is inconsistent; with some studies positive and others not. 3. Scientific quality of the proposed epidemiological study is critical. It is essential that the study be acceptable by current scientific standards. CMA 007987, ~~ Furthermore, it is essential that the study population include all those eligible from the Tabershaw Cooper study, so as to maintain the cohort. This may require liaison with companies who have lost interest in vinyl chloride as a product, but still have former employees that were in the original cohort. 4. The EPA air standard may be an issue, depending upon the pressure placed on that Agency by the Environmental Defense Fund. 5. Transportation accidents are a possibility. This may present an emotionally charged situation for activists. 8. Liaison Liaison has been and continues to be an important activity. The relationship to the SPI has been very effective, primarily because of the significant overlap in committee membership. Liaison with European countries was extremely active and still continues at a lower activity. Several European based companies are represented on the Panel and many Panel members have European affiliates. The four European companies sponsoring Dr. Maltoni's studies have been most helpful. Working primarily through ICI (Dr. David Duffield and later Dr. John Stafford) we have succeeded in transmitting information rapidly between our groups. 9. Controversial Issues None. 10. Financial Status (See attachments E, F and G) 11. Critical Dates June 1981 - start of vinyl chloride epidemiology study update (Environmental Health Associates, Inc.). Spring 1983 - epidemiology study completed. May 15, 1981 - final report on University of Louisville study expected. 12. Future Needs None. 5 CMA 007988 13. Summary. The Pxinel has undertaken several animal studies to expand the- toxicological data base on vinyl chloride monomer. These phases of the program were completed and it is not anticipated that the Panel will sponsor further research in this area. The University of Louisville Program is winding down and continued funding of this research is unlikely. At the moment, the Panel's attention is focused on human studies and the use of epidemiological research to clarify the relationship between the etiology of certain diseases and vinyl chloride exposure. The Panel's pursuit of an advocacy program has been limited. Members of the Program Panel have maintained a close liaison with the VC Health and Safety Committee of the Society of the Plastics Industries, Inc. (SPI), the lead organization in the vinyl chloride advocacy area. Several regulatory issues do remain and the Panel will continue to maintain interest through its association with SPI, t 6 CMA 0079 s ATTACHMENT A * VINYL CHLORIDE PROGRAM PANEL PHASE VIII W. Mayo Smith AIR PRODUCTS AND CHEMICALS, INC . P.O. Box 538 Allentown, Pa. 18105 215-481-7215 Dr. Eugene N. Skiest BORDEN, INC. 990 Kingsmill Parkway Columbus, Ohio 43229 614-225-4958 M. N. Johnson, M.D. BFGOODRICH COMPANY 500 S. Main Street Akron, Ohio 44318 216-374-3298 Dr. A. C. Johnson THE GOODYEAR TIRE St RUBBER COMPANY 1144 East Market Street Akron, Ohio 44316 216-796-7676 H. w. Blakeslee Environmental Engineer CERTAINTEED CORP. 1400 Union Meeting Rd. Blue Bell, Pa. 19422 215-542-0500 ext. 4403 Dr. C. P. Wen GULF SCIENCE & TECHNOLOGY P.O. Box 2100 Houston, Texas 77001 713-754-1832 Flynt Kennedy CONOCO, INC. P.O. Box 1267 Ponca City, Oklahoma 74601 405-767-4411 John R. Semancik DIAMOND SHAMROCK PLASTICS, 1100 Superior Avenue Cleveland, Ohio 44114 216-694-5000 CORP. T. R. Torkelson DOW CHEMICAL U.S.A. 1803 Building Midland, Michigan 48640 517-636-5197 Theodore J. Benya ETHYL CORPORATION 451 Florida Street Baton Rouge, La. 70801 504-388-7856 Robert W. Laundrie GENERAL TIRE AND RUBBER COMPANY 1 General Street Akron, Ohio 44329 216-798-2992 Harold F. Dubec, Jr. HOOKER CHEMICALS & PLASTICS CORP. P.O. Box 456 Burlington, N.J. 08016 609-499-2300 ext. 226 W. R. Gaffey MONSANTO COMPANY 800 N. Lindbergh Blvd. St. Louis, Missouri 63166 314-694-8811 Zeb G. Bell, Jr. PPG INDUSTRIES One Gateway Center Pittsburgh, Pa. 15222 412-434-2585 V. L. Kirkland SHELL CHEMICAL COMPANY One Shell Plaza P.O. Box 4320 Houston, Texas 77090 P. E. Roggi STAUFFER CHEMICAL COMPANY Westport, Connecticut 06881 203-222-4414 CMrt 0 0 7 9 9 0 Vinyl Chloride Program Panel Phase VIII (Cont.) Donald H. Hunter TENNECO CHEMICALS, INC. P.0. Box 365 Piscataway, New Jersey 08854 201-981-5221 R. N. Wheeler, Jr. UNION CARBIDE CORPORATION Building 3005, Room 350 P.O. Box 8361 South Charleston, W. Va. 25303 304-747-2164 Walter D. Harris, Ph.D, UNIROYAL, INC. World Headquarters Middlebury, Connecticut 06749 203-573-2139 CMA 007991 ATTACHMENT B VINYL CHLORIDE PROGRAM PANEL - PHASE VII Dr. W. M. Smith Group R & D, Coordinator AIR PRODUCTS & CHEMICALS, INC. Allentown, Pa. 18103 215-481-7215 Mr. Russell Park FIRESTONE PLASTICS COMPANY Research Division P.O. Box 699 Pottstown, Pa. 19464 215- 326-2000 ext. 402 Mr. Allan G. Wheeler Supervisor Industrial Toxicology ICI AMERICAS, INC. Safety & Environmental Affairs Wilmington, De. 19897 302-575-4533 Mr. H. William Blakeslee Environmental Engineer CERTAIN-TEED CORPORATION Pipe & Plastics Group P. 0. Box 1100 Blue Bell, Pa. 19422 215- 542-0500 ext. 4402 Dr. Flynt Kennedy CONTINENTAL OIL COMPANY 1000 South Pine P.O. Box 1267 Ponca City, Oklahoma 74601 405-767-4411 Dr. R. W. McBurney Vice President and Corporate Medical Director DIAMOND SHAMROCK CORPORATION 1100 Superior Avenue Cleveland, Ohio 44114 216- 694-5252 Mr. Robert W. Laundrie THE GENERAL TIRE & RUBBER COMPANY P.O. BOX 951 Akron, Ohio 44329 216- 798-2990 Dr. M. N. Johnson Director Environmental Health THE BFGOODRICH COMPANY Chemical Division B 0020 Building 5-H 500 S. Main Street Akron, Ohio 44318 216-379-3299 or 3298 Dr. Paul Cohen Vice President GREAT AMERICAN CHEMICAL CORP. 650 Water Street Fitchburg, Ma. 01420 617-343-6973 Mr. R. J. Abramowitz Technical Director HOOKER CHEMICALS & PLASTICS P.O. BOX 456 Burlington, N.J. 08016 609-499-2300 ext. 216 Dr. T. R. Torkelson Health & Environmental Science DOW CHEMICAL U.S.A. 1803 Building Midland, Michigan 48640 517-636-5197 Dr. Robert Brookman Vice President Research and Development PANTASOTE, INC. 26 Jefferson Street Passaic, N.J. 07055 201-777-8500 CMA 007992 Vinyl Chloride Program Panel - Phase VII (Cont.) Dr. T. J. Benya Toxicology & Industrial Hygiene Department ETHYL CORPORATION 451 Florida Avenue Baton Rouge, La. 70801 504-388-7856 or 7858 Dr. Vance L. Kirkland SHELL OIL COMPANY One Shell Plaza P.O. Box 4320 Houston, Texas 77210 713-241-0044 Mr. John P. Murphy STAUFFER CHEMICAL COMPANY Product Regulations Westport, Connecticut 06880 203-222-3493 Dr. Zeb G. Bell, Jr. Manager Environmental Health and Toxicology Chemicals Division PPG INDUSTRIES, INC. Pittsburgh, Pa. 15222 412-434-2585 Mr. R. N. Wheeler Production Manager UNION CARBIDE CORPORATION Chemicals & Plastics Division P.O. Box 8004 South Charleston, W. Va. 25303 304-747-2164 tCMA 007993 ) ATTACHMENT C VINYL CHLORIDE RESEARCH COORDINATORS Dr. T. R. Torkelson, Chairman Occupational Health Associate DOW CHEMICAL U.S.A. 1603 Building Midland, Michigan 48640 517-636-5197 Dr. W. M. Smith Group R&D Coordinator AIR PRODUCTS & CHEMICALS, P.O. Box 538 Allentown, Pa. 18104 215- 395-7215 INC. Dr. M. N. Johnson Director Environmental Health THE BFGOODRICH COMPANY Cheical Division Medical Center 500 S. Main Street Akron, Ohio 44318 216- 379-3298 or 3299 Dr. Z. G. Bell, Jr. Manager Environmental Health & Toxicology PPG INDUSTRIES One Gateway Center Pittsburgh, Pa. 15222 412-434-2585 Dr. V. L. Kirkland SHELL CHEMICAL COMPANY One Shell Plaza P.O. Box 4320 Houston, Texas 77210 713-241-0044 Mr. R. N. Wheeler Production Manager Chemicals & Plastics Division UNION CARBIDE CORPORATION P.O. Box 8004 S. Charleston, W. Va. 25303 304-747-2164 - Dr. T. J. Benya ETHYL CORPORATION 451 Florida Avenue Baton Rouge, La. 70801 504-388-8011 Dr. W. D. Harris Industrial Toxicolgist UNIROYAL, INC. Oxford Management & Research Center Middlebury, Ct. 06749 203-573-2139 CMA 0 0 7 9 9 5 Report Title and Contract Number Epidemioloqical Study of VC Workers (VC 1.4) Chronic Vanor Inhalation Study with Vinyl Chloride (VC 2.1) VC Pathology Report (VC 2.4) Pathology Report on the Brains from Nice, Hamsters, and Rats Exposed to VC in IBT Study (VC fl.OA) Validation of Strip Charts at IBT (VC 8.OB) Summary of the Studies Conducted on the Pharmacokinetics/Metabolism of VC in Rats (VC 1.1) Effects of Maternally Inhaled Vinyl Chloride on Embryonal fc Petal Development in Mice, Rats and Rabbits (VC 1.2) Research Techniques and Methods for Detect ion and Prevention of Carcino genesis in Industrial Workers (Yr. 1) (VC 6.4) Research Techniques and Methods for Detection and Prevention of Carcino genesis in Industrial Health workers (Yr. 2) (VC 6.5) Research Techniques and Methods for Detect.ion and Prevention of Careino- ndustrla) Workers (VC 6.7) VINYL CHLORIDE Contractor Contract Execution Date TabershawCooper. Assoc. April 25, 75 Industrial RIOTEST Labs., Inc. Exoerimental Pathology Labs Feb. 8, 73 Feb. 2, 78 Experimental Patholoqy Labs April 15, 80 Bob West Assoc. The Dow Chemical Company The Dow Chemical Company April 6, 80 Nov. 2, 76 Auq. 19, 74 University of Louisville Dec. 12, 76 Oniversity of Louisville fin iversity of Louisville Feb. 27, 78 t, March 23, 79 ATTACHMENT D Present Leve1 of Funding $42,500 Comments Released Feb. 23, 7ft 188,450 Terminated 3,687 Released Mav 10, 80 16,460 Released Hay 30, 60 4,000 115,000 Released May 30, 80 Released Seot. 2, 77 224,090 Released Seot. 5, 00 191,771 Released Mav 22, 80 252,820 Released Mav 22, 80 287,784 In Progress 9-22-80 ATTACHMENT E Vinyl Chloride Financial Statement - Phase VIII Period Ending 30 March 1981 Date Phase Began: 1 June 1980 Budget Service/ProgramAuthorized RESEARCH 5-Year Epidemiology Update $ open ADMINISTRATION $ open Direct Charges (3/30/81) Travel Miscellaneous_______ Subtotal Administration $ open TOTAL Phase VIII $ open Amount Committed $ open $ open $ open $ open Unpaid Disbursements Balance Available for Commitment $- 0- 11,817 1,326 159 $ 13,i02 $ 13,302 o 3: > o ovj >>00 Ch VINYL CHLORIDE FINANCIAL STATEMENT Period Ending 30 March 1981 Phase VII - 17 Companies ATTACHMENT F Amount Pledged: Amount Received: Budget Authorized: $325,055 333,488a 325,055 Service/Program Budget Authorized RESEARCH VC 7.0 DP/PREV-UL $ 287,784 ADMINISTRATION $ 37,271 Direct Charges (3/30/81) Travel Miscellaneous Subtotal Administration $ 377571 TOTAL Phase VII $ 325,055 Amount Committed $ 287,784 $ 37,271 $ 37,271' $ 325,055 Unpaid Disbursements Balance Available for Commitment 202,925 $ 84,859 $ -0- $ 22,080 0 493 $ 22,573 $ 225,498 $ 14,698 $ 99,557 $ -0$ -0- aIncludes carryover from Phase VI of $37,271 CMA 0 0 7 9 9 ATTACHMENT G VIMIfl/ CHLORIDE FINANCIAL STATEMENT Period Ending 30 March 1981 Phase 11-31 Companies Onto I'liar.c ncfjim: Amount P lodged: Araonnl lli'cfi wl: IBT Refund Budget Authorized tin i v ice/l'i ogr am__________ February 8, 1972 $ 240,201 / 240,201 110,000b 349 949 ' Uitdgcl Aumint Author i red________Committed lllsbur howent a (Inpnld Halaucc RESEARCH VC 7.0-1RT (te::t ni l Agicement Holding 4 Chnmbers/14 Weeks IlnMing An 1 .iIs/2 Hearn Over mi Consul l i inj - 111 . W. _llnr.oy 1 Sniitolal InUl allRT Kliidy Unpaid Ha I .nice lied I sir United!* Ail i nil bil Subi ol nl vt: U .OA-Aim/iRT/EPl.-miney vc o. o l) - Alii)/111T -Wen t Sniiloial "Researcli $ 149,000 15.000 7.040 1,010 22.000 2,500 $ T95,95lS (22,417) mi^n" $ 16,460 4,000 SITiT1*!! $ 149,000 15.000 7,040 1,610 22.000 2,500 5 195,956 (22,437) 517375 ir $ 16,460 _4,000_ 5 19 3, 9 7 J $ 130,175 10,000 7,040 1,610 22.UOO ____ 3,600 5 171,513 $175,511 $ 16,460 ____ 4,000_ $ 191,973 ADMINISTRATION , ,, . ,, t Direct Charges (3/30/81) Tr nveI Mi nee 1 l ancon:;_ _____ _______ Suiiioiiii Administration___ TOTAL' I'ilASllit $ 45,916 5 457976" 513HT~ $ 45,976 5 45,976 5139,949 $ 32,930 6,157 ____7 34_ 5 39,021 5133; 7 94" ? 6,155 5-----T7I55 a $ 22,437 was red1sir United to subsequent audits by Drs. Dusey 6 West and to Administration b To be refunded, based on pro-rate share, to participating companies. Aval I al> I c Corami tmcii CMrt 0 0 7 9 9 S CMA 0 0 7 9 9 9 Vt/ru cuMttc l/tL*a suar rk/aso 30 /fatat /ft/ ADDENDUM TO ATTACHMENTS E, F, A G. March 19, 1981 To: Members of the Vinyl Chloride Program Panel Dear Panel Member: The enclosed Annual Report on Vinyl Chloride was prepared by Dr. T. R. Torkelson and myself for presenta tion to the Special Programs Advisory Group (SPAG) on April 21, 1981. Please send your comments to me with a copy to Dr. Torkelson by April 1, 1981. The Panel Chairman and CMA will revise the annual report based on your comments and will send it to SPAG on April 8, 1981. All Panel members will receive a copy of the revised report. If you have any questions on this report, or the functioning of SPAG, please call me at 202/887-1196. Sincerely CRS:md Enclosure Carol R. Stack, Ph.D. Administrator Vinyl Chloride Proaram CMA 008000 Vinyl Chloride - SPAG Review 1.0 Chapter (separate page) 2.0 Uses Manufacture of polyvinyl chloride and copolymers; organic synthesis; adhesives for plastics. 3.0 Background and Objectives a. Introduction CMA has had a long-standing interest in vinyl chloride monomer. In the early 1960s, the then Manufacturing Chemists Association arranged for a study at the University of Michigan on aeroosteolysis (softening of finger tip bones) in VCM/PVC workers. The findings wre published by the American Medical Association in the January 1971 issue of "Archives of Environmental Health". In 1971, at the recommendation of MCA's Occupational Health Committee, U.S. VCM/PVC producers were approached with the proposal that they might wish to support a research!' program to answer questions on vinyl chloride carcinogenesis ~raised by Dr. Viola's studies at the Regina Elena Institute for Cancer Research in Italy. A conference of interested member companies was held in November 1971; twenty producers were represented. An ad hoc planning group for vinyl chloride research (precursor to the present Vinyl Chloride Research Coordinators) was formed at the conference to provide review of research proposals and funding require ments. By early 1972, it was established that seventeen companies would support a vinyl chloride research program. The group of sponsoring companies, known then as the "Technical Task Group on Vinyl Chloride" was the first Vinyl Chloride Program Panel. The objective of the Task Group (Panel) was to expand the toxicology data base, thereby lending support to certain health and safety issues surrounding exposure to vinyl chloride monomer in the workplace. b. Research Programs i. IBT Study A research contract was negotiated with IBT Laboratories in February 1973 to conduct a chronic vinyl chloride inhalation study in rats, mice and hamsters. IBT submitted interim reports to CMA during the course of the two-year study but issued no final report. Subsequent audits by both CMA and third parties found irreparable deficiencies in the study. CMA entered into negotiations for settlement with IBT last year and an agreement was CMA 008001 reached. "Companies participating in the research program will-Be refunded on the same pro-rated basis as they contributed to-the project. ii. Dow Studies In 1974, the Program Panel agreed to fund a tera tology study in mice, rats and rabbits to be conducted at Dow Chemical Research Laboratories. Results were published in a March 1977 issue of "Toxicology and Applied Pharmacology". The data indicated that vinyl chloride did not cause significant embryonal or fetal toxicity and was not teratogenic in any of the species at the concentrations tested (up to 2500 ppm). A contract was executed with Dow in November 1976 to conduct a pharmacokinetic/metabolism study of vinyl chloride in rats. This research was an extension of similar studies being performed at Dow. A summary of the research was submitted to CMA in May 1977. iii. University of Louisville Research Proqram (Phase vnr--------------- --------------------------------------- -- In 1975, the emphasis on research shifted from toxicological investigations to one more directly related to the early diagnosis and clinical management of vinyl chloride injuries resulting from past industrial exposure. Accordingly, the Panel approved support of a grant to the University of Louisville for the development of "Research Techniques and Methods for Detection and Prevention of Carcinogenesis in Industrial Workers". Support of the research continued and two further agreements were signed with the University in 1978 and 1979. Final reports for the first and second years were received; the third is antici pated shortly. Continued funding of this program by the Panel is not likely. iiii. Epidemiology Studies A contract was awarded to Tabershaw Cooper Associates, Inc. (TCA) in June 1973 to conduct an epidemi ology study of vinyl chloride workers. A final report issued by Equitable Environmental Health Associates (successor to TCA) included 10,173 individuals. Brain tumor incidence was found to be in excess but did not apear to be related to either the duration or intensity of exposure to vinyl chloride. Weak associations between vinyl chloride exposure and malignancies at other sites were noted. EEH suggested that the cohort be studied again five years hence, since observation time would be extended and more deaths available for analysis. 4. Membership CMA 008002 __Panel separate pp. Task Group 5. Research Programs a. Completed studies (Table) b. Future studies The Program Panel has considered a proposal from Environmental Health Associates, Inc. (EHA) to update the 1978 EEH epidemiology study (see above). In this study, work histories of the 10,000 member cohort will be updated through December 1979. Twenty companies are supporting this program (re: Vinyl Chloride Program Panel - Phase VIII). A budget has been established and a contract agreement with EHA will be drawn up shortly. Of particular interest in this study are the number of additional brain tumor cases that may surface. Also, are the associations seen in the earlier study strengthened or weakened? 6. Advocacy Although there has been limited activity, advocacy has not been emphasized by the Panel. This is partially the result of the extremely close liaison of the members of the Panel with the Vinyl Chloride Health and Safety Committee of the Society of the Plastic Industries, Inc. This arrangement has appeared to work well and at the present time increased advocacy is not anticipated. Several regulatory issues remain, however: 1. EPA is currently considering lowering the air standard for vinyl chloride. The Environmental Defense Fund is involved in these negotiations. 2. The FDA has delayed action on a request for approval of PVC liquor bottles. 3. OSHA appears interested in PVC dust and in VC, in itself. However, no notice has been published and no time table has been established. 7. Key Issues A small number of key issues remain, but it should be emphasized that because of the extreme publicity and high visibility of vinyl chloride, these issues can change rapidly and dramatically. 1. Whether single exposures to vinyl chloride are capable of causing cancer is an important ques tion. The study sponsored by CPSC, at Edgewood Arsenal, porports to have shown a positive effect from single exposure. Study conditions and the CMA 008003 type of response were questionable, but adverse publicity may result when the report is published. 2. Vinyl chloride has been shown to cause other cancers in animals. Human data is inconsistent; with some studies positive and others not. 3. Scientific quality of the proposed epidemiological study is critical. It is essential that the study be acceptable by current scientific standards. Furthermore, it is essential that the study population include all those eligible from the Tabershaw Cooper study, so as to maintain the cohort. This may require liaison with companies who have lost interest in vinyl chloride as a product, but still have former employees that were in the original cohort. 4. The EPA air standard may be an issue, depending upon the pressure placed on that Agency by the Environmental Defense Fund. 5. Transportation accidents are a possibility. It may present an emotionally charged situation for activists. 8. Liaison Liaison has been and continues to be an important activity. The relationship to the SPI has been very effective, primarily because of the significant overlap in committee membership. Liaison with European countries was extremely active and still continues at a lower activity. Several European based companies are represented on the Panel and many Panel members have European affiliates. The four European companies sponsoring Dr. Maltoni's studies have been most helpful. Working primarily through ICI (Dr. David Dufflefield and later Dr. John Stafford) we have succeeded in transmitting information rapidly between our groups. 9. Controversial Issues None. 10. Financial Status (See attached financial sheet). CMA 008004 S 0 0 8 0 0 VW3 Report Title and Contract Number Epidemiological Study of VC Workers (VC 1.4) Chronic Vaoor Inhalation Study with Vinyl Chloride (VC 2.1) VC Pathology Report (VC 2.4) Pathology Report on the Brains from Mice, Hamsters, and Rats Exposed to VC in IBT Study (VC 8.0A) Validation of Strip Charts at IBT (VC 8.OB) Summary of the Studies Conducted on the Pharmaeokinetics/Metabolism of VC in Rats (VC 3.1) Effects of Maternally Inhaled Vinyl Chloride on Embryonal & Petal Development in Rice, Rats and Rabbits (VC 3.2) Research Techniques and Hethods for Detection and Prevention of Carcino genesis in Industrial Workers (Yr. 1) (VC 6.4) Research Techniques and Methods for Detection and Prevention of Carcino genesis in Industrial Health Workers (Yr. 2) (VC 6.5) Research Techniques and Methods for Detection and Prevention of Carcinogenesis in Industrial Workers (VC 6.7) VINYL CHLORIDE Contractor Contract Execution Date TabershawCooper. Assoc. April 25, 75 Industrial BIO TEST Labs., Inc. Feb. 8, 73 Experimental Patholoqy Labs Feb. 2, 78 Experimental Pathology Labs April 15, 80 Bob West Assoc. The Dow Chemical Company The Dow Chemical Company April 8, 80 Nov. 2, 76 Auq. 19, 74 University of Louisville Dec. 12, 76 University of Louisville Feb. 27, 78 University of Louisville March 23,,'79 Present Level of Fundinq $42,500 Comments Released Feb. 23, 78 188,450 Terminated 3,687 Released May 30, 80 16,460 Released May 30, 80 4,000 1 15,000 Released Hay 30, 80 Released SeDt. 2, 77 224,090 Released SeDt. 5, 80 191 ,771 Released Mav 22r 80 252,820 Released May 22, 80 287,784 In Progress 9-22-80 Vinyl Chloride Financial Statement Period Ending 31 January 1981 Phase VIII Date Phase Began: 1 June I960 Budget Service/Program_____________ Authorized RESEARCH 5-Year Epidemiology Update $open ADMINISTRATION open Direct Charges (1/31/81) Travel Miscellaneous _______ _ Subtotal Administration ________ $ open TOTAL Phase VIII $ open Amount Unpaid Committed_______Disbursements Balance $ open $ open __________ $ open $ open $- 0 - $ 10,984 1,326 .152 $ 12,462 $ 12,462 Available for C.ommitment VINYL CHLORIDE FINANCIAL STATEMENT Period Ending 31 January 1981 Phase VII - 17 Companies Amount Pledged: Amount Received: Budget Authorized: Service/Program $325,055 333,488a 325,055 Budget Authorized Amount Unpaid Committed Disbursements Balance Available f< Commitment RESEARCH VC 7.0 DP/PREV-UL ADMINISTRATION Direct Charges (1/31/81) Travel Miscellaneous _______ _ Subtotal Administration- TOTAL PHASE VII $ 287,784 $ 37,271 $ 37,271 $ 325,055 $ 287,784 $ 202,925 $ 37,271 $ 22,080 0 493 $ 37,271 $ 22,573 $ 325,055 $ 225,498 $ 84,859 $ -0 - $ 14,698 $ $ 99,557 $ =~0~= -0 - aIncludes carryover from Phase VI of $37,271 CMA 008007 VINYL CHLORIDE FINANCIAL STATEMENT Period Ending 31 January 1981 Phase II - 31 Companies Date Phase Began: Amount Pledged: Amount Received: Budget Authorized: Service/Program Pebruary 8, $ 240,281 240,281 239,949 1972 Budget Authorized Amount Committed Unpaid Available for Disbursements___________Balance___________ Commitment RESEARCH VC 2.0-1BT Restart Agreement Holding 4 Chambers/14 Weeks Holding Animals/2 Years Overrun Consulting-Dr. W. M. Busey I Subtotal Initial IBT Study Unpaid Balance Redistributed* Adjusted Subtotal VC 8.OA-AUD/IBT/EPL-Busey VC 8.OB-AUD/IBT-West Subtotal Research ADMINISTRATION Direct Charges (1/31/61) Travel Miscellaneous Subtotal Administration TOTAL PHASE II 5 149,000 15,000 7,840 1,610 22,000 2,500 F 195,950 (22,437) F 173,511 5 16,460 4,000 $ 193,973 $ 45,976 F 45,976 F 239,949 $ 149,000 15,000 7,840 1,610 22,000 2,500 $ 195,990 (22,437) $ 173,513 $ 16,460 4,000 $ 193,973 $ 45,976 $ 45,976 $ 239,949 $ 130,375 10,000 7,840 1,610 22,000 3,688 $ 173,513 $ 173,513 $ 16,460 4,000 $ 193,973 $ 32,930 6,157 734 $ 39,821 5 233,794 $ 18,625 5,000 -0-0-0- (1,188) F 22,437 (22,437) F -0- $ -0-0- F -0- F 6,155 F 6,155 a $ 22,437 was redistributed to subsequent audits by Drs. Busey *> West and to Administration 8 0 0 8 0 0 VW3 CMA Vinyl Chloride Program Panel CHARTER The Program Panel will be concerned with vinyl chloride monomer and polyvinyl chloride resin. The Panel will develop a program that examines the possible health effects of vinyl chloride through toxicological research and human (epidemiological) studies. The testing program will include appropriate monitoring to ensure adherence to sound scien tific practice and compliance with prevailing rgulations. The Program Panel will review and evaluate the results of all studies. Consistent with CMA practices and policies, the Program Panel wil represent the interests of the Chemical Manufac turers Association (CMA) before Federal agencies in all matters relating to safety and health issues arising out of the production, reaction, release, packaging, storage, handling or use of vinyl chloride. The Program Panel will also be responsible for certain administrative matters, including the election of officers, deciding the basis for sharing the cost of the program among the participating companies, designation of appropriate task and/or working groups, and liaison with interested non-participating parties. - The Program Panel will function as a special committee under CMA's bylaws, and as such will be subject to the Special Program's Guidelines. CMA 008009 VINYL CHLORIDE PROGRAM PANEL PHASE VIII W. Mayo Smith . AIR PRODUCTS AND CHEMICALS, INC . P.O. Box 538 Allentown, Pa. 215-481-7215 18105 Dr. Eugene N. Skiest BORDEN, INC. 990 Kingsmill Parkway Columbus, Ohio 43229 614-225-4958 M. N. Johnson, M.D. BFGOODRICH COMPANY 500 S. Main Street Akron, Ohio 44318 216-374-3298 Dr. A. C. Johnson THE GOODYEAR TIRE & RUBBER COMPANY 1144 East Market Street Akron, Ohio 44316 216-796-7676 H. w. Blakeslee Environmental Engineer CERTAINTEED CORP. 1400 Union Meeting Rd. Blue Bell, Pa. 19422 215- 542-0500 ext. 4403 Dr. C. P. Wen GULF SCIENCE & TECHNOLOGY P.O, Box 2100 Houston, Texas 77001 713-754-1832 Flynt Kennedy CONOCO, INC. P.O. Box 1267 Ponca City, Oklahoma 74601 405-767-4411 John R. Semancik DIAMOND SHAMROCK PLASTICS, 1100 Superior Avenue Cleveland, Ohio 44114 216- 694-5000 CORP T. R. Torkelson DCW CHEMICAL U.S.A. 1803 Building Midland, Michigan 48640 517-636-5197 Theodore J. Benya ETHYL CORPORATION 451 Florida Street Baton Rouge, La. 70801 504-388-7856 Robert W. Laundrie GENERAL TIRE AND RUBBER COMPANY 1 General Street Akron, Ohio 44329 216-798-2992 Harold F. Dubec, Jr. HOOKER CHEMICALS & PLASTICS CORP. P.O. Box 456 Burlington, N.J. 08016 609-499-2300 ext. 226 W. R. Gaffey MONSANTO COMPANY 800 N. Lindbergh Blvd. St. Louis, Missouri 63166 314-694-8811 Zeb G. Bell, Jr. PPG INDUSTRIES One Gateway Center Pittsburgh, Pa. 15222 412-434-2585 V. L. Kirkland SHELL CHEMICAL COMPANY One Shell Plaza P.O. Box 4320 Houston, Texas 77090 P. E. Roggi STAUFFER CHEMICAL COMPANY Westport, Connecticut 06881 203-222-4414 CMA 008010 Vinyl Chloride Program Panel Phase VIII (Cont.) Donald H. Hunter TENNECO CHEMICALS, INC. P.0. Box 365 Piscataway, New Jersey 08854 201-981-5221 R. N. Wheeler, Jr. UNION CARBIDE CORPORATION Building 3005, Room 350 P.O, Box 8361 South Charleston, W. Va. 25303 304-747-2164 Walter D. Harris, Ph.D. UNIROYAL, INC. World Headquarters Middlebury, Connecticut 06749 203-573-2139 CMA 008011 -t s VINYL CHLORIDE PROGRAM PANEL - PHASE VII Dr. W. M. Smith Group R & D. Coordinator AIR PRODUCTS & CHEMICALS, INC. Allentown, Pa. 18103 215-481-7215 Mr. Russell Park FIRESTONE PLASTICS COMPANY Research Division P.O. Box 699 Pottstown, Pa. 19464 215- 326-2000 ext. 402 Mr. Allan G. Wheeler Supervisor Industrial Toxicology ICI AMERICAS, INC. Safety & Environmental Affairs Wilmington, De. 19897 302-575-4533 Mr. H. william Blakeslee Environmental Engineer CERTAIN-TEED CORPORATION Pipe & Plastics Group P. 0. Box 1100 Blue Bell, Pa. 19422 215- 542-0500 ext. 4402 Dr. Flynt Kennedy CONTINENTAL OIL COMPANY 1000 South Pine P.O. Box 1267 Ponca City, Oklahoma 74601 405-767-4411 Dr. R. W. McBurney Vice President and Corporate Medical Director DIAMOND SHAMROCK CORPORATION 1100 Superior Avenue Cleveland, Ohio 44114 216- 694-5252 Mr. Robert. W. Laundrie THE GENERAL TIRE & RUBBER COMPANY P.O. Box 951 Akron, Ohio 44329 216- 798-2990 Dr. M. N. Johnson Director Environmental Health THE BFGOODRICH COMPANY Chemical Division B 0020 Building 5-H 500 S. Main Street Akron, Ohio 44318 216-379-3299 or 3298 Dr. Paul Cohen Vice President GREAT AMERICAN CHEMICAL CORP. 650 Water Street Fitchburg, Ma. 01420 617-343-6973 Mr. R. J. Abramowitz Technical Director HOOKER CHEMICALS & PLASTICS P.O. Box 456 Burlington, N.J. 08016 609-499-2300 ext. 216 Dr. T. R. Torkelson Health & Environmental Science DOW CHEMICAL U.S.A. 1803 Building Midland, Michigan 48640 517-636-5197 Dr. Robert Brookman Vice President Research and Development PANTASOTE, INC. 26 Jefferson Street Passaic, N.J. 07055 201-777-8500 Dr. T. J. Benya Toxicology & Industrial Hygiene Department ETHYL CORPORATION 451 Florida Avenue Baton Rouge, La. 70801 Dr. Zeb G. Bell, Jr. Manager Environmental Health and Toxicology Chemicals Division PPG INDUSTRIES, INC. CMA 008012 Vinyl Chloride- Program Panel - Phase VII (Cont.) 504-388-7856 ox 7858 Dr. Vance L. Kirkland SHELL OIL COMPANY One Shell Plaza P.O. Box 4320 Houston, Texas 77210 713-241-0044 Mr. John P. Murphy STAUFFER CHEMICAL COMPANY Product Regulations Westport, Connecticut 06880 203-222-3493 One Gateway Center Pittsburgh, Pa. 15222 412-434-2585 Mr. R. N. Wheeler Production Manager UNION CARBIDE CORPORATION Chemicals & Plastics Division P.O. Box 8004 South Charleston, W. Va. 25303 304-747-2164 CMA 008013 IfHti'aliI -Vinyl Chloride Research Coordinators CHARTER The Vinyl Chloride Research Coordinators, operating within the Charter of the Vinyl Chloride Program Panel, will provide interpretation of available data on the toxicology of vinyl chloride. The coordinators will advise the Panel on appropriate studies, both in the areas of toxicological research and human studies, required to expand the data base. TRTG will provide the necessary protocol design or protocol review and will conduct or make provision for appropriate monitoring and auditing of all research programs. CMA 008014 VINYL CHLORIDE RESEARCH COORDINATORS Dr. T. R. Torkelson-, Chairman Occupational Health Associate DOW CHEMICAL U.S.A. 1603 Building Midland, Michigan 48640 517-636-5197 Dr. W. M. Smith Group R&D Coordinator AIR PRODUCTS Si CHEMICALS, P.O. BOX 538 Allentown, Pa. 18104 215- 395-7215 INC. Dr. M. N. Johnson Director Environmental Health THE BFGOODRICH COMPANY Cheical Division Medical Center 500 S. Main Street Akron, Ohio 44318 216- 379-3298 or 3299 Dr. T. J. Benya ETHYL CORPORATION 451 Florida Avenue Baton Rouge, La. 70801 504-388-8011 Dr. Z. G. Bell, Jr. Manager Environmental Health St Toxicology PPG INDUSTRIES One Gateway Center Pittsburgh, Pa. 15222 412-434-2585 Dr. V. L. Kirkland SHELL CHEMICAL COMPANY One Shell Plaza P.O. Box 4320 Houston, Texas 77210 713-241-0044 Mr. R. N. Wheeler Production Manager Chemicals Sc Plastics Division UNION CARBIDE CORPORATION P.O. Box 8004 S. Charleston, W. Va. 25303 304-747-2164 Dr. W. D. Harris Industrial Toxicolgist Oxford Management & Research Center Middlebury, Ct. 06749 203-573-2139 CMA 008015