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* * Manufacturing Chemists Association Minutes of Meeting VINYL CHLORIDE RESEARCH COC '<T>INATORS MCA Conference Room November 28, 1973 MEMBERS PRESENT; T. R. Torkelson, Chairman T. R. Aalto for Marvin Rosen z. G . Bell, Jr. V7. D. Harris Richard Henderson for M. R. Gascue C. A . Johnson M. N. Johnson, K.D. H. L. Kusnetz for R. L. Haycock A . B. Lindquist K . E. Rinehart 03SIERVERS PRESENT: D. P . Duffield, M.D. Per ry Gehring MCA STAFF PRESENT: A . C. Cla rk K . D. J ohnson The Dow Chemical Company Tenneco Chem;icals. Inc. PPG Industri ss, In:C . UNI ROYAL, Ir. c, Clin Corpora tion The Goodyear Tire . Rubber Company The b. F. Go dorich Company Shell Cberaic a 1 Core. pany Stauffer Che rical Company Ethy'' Corner ? t ' OP ICI Mond Div i ion The mow Cher, ica 1 C c.T.pany 1. Bis Ch1oromethvl P t.h e s Possible V i n v 1 CbIcride Inuuritv The question has been ra ised as to th. e pos s ibility tha t P is-CME might cons titu te one of the ur i d e r. t i fied pea >; s sometimes found i n vi r,y 1 chloride gas chr or; a uograph L. TCi c in gs. Although the re i n o reason to e u spect chat such cor. tarn inaticn r.iight be respons ible for the tumors found in VCM -ex posed rats, since the se tumors are no t of t!he variety rt /- ?i V*J 'W II \-i t \'e*' ul'j i ,L v CMA 101014 caused by Bis-CME exposures, the subject hypothesis does remain a theoretical possibility, and manufacturers with such unidentified but detectable impurities in their VCM may find it desirable to ascertain the identity or non identity of such peaks with Bis-CME 2. Report on "Meat Wrappers" Asthma Syndrome Copies of the paper by Sokol, Aelonv and Beall (JAMA 226, 639-641 - 1973) were distributed to those present. An earlier report by Bobby F. Kraft (now with NICSH) on this topic was .mentioned, and the Secretary was asked to procure and distribute copies. It was the consensus of the Research Coordinators that the syndrome here reported v,7as not related to vinyl chloride monomer, but that, by focusing public attention upon vinyl chloride, it did create possible problems for the industry. 3 - International Labour Office News Release A News Release from the Washington office of the ILO announcing an ILO occupational health meeting in Geneva, November 19-28, contained a statement to the effect that vinyl chloride exposures produce emphysema. The Secretary announced that the Washington office of the ILO was unable to provide documentation for this allegation, but had of fered to seek such frc.m their consultants. He was asked to procure and distribute the draft report of the Geneva meeting when it becomes available. 4. Status Report on Industrial BIO-TEST Program Information received by telephone from Mr. Goode indicated that the exposures -were continuing cn schedule, with no obvious abnormalities in animal behavior or weight gain, or no gross lesions evident. The next quarterly progress report is expected to be received in late December. y; if *v r iAl cMA 101015 1, -3- 5. Status Report on TCA Program Dr. Guffey has submitted a telephone report indicating that they now have relevant records in hand of about 2,000 employees, and have identified an equal number for whom records are being screened by plant personnel. Their ef forts to secure follow-ups on terminated employees through retail credit records have been encouraging. Although there has been some slippage with respect to initial target schedules, they are still confident that the study can be completed by March 1974. The question was brought up as to whether we should invite Japanese manufacturers of VCM to submit available epidemiological data from their experience. It was the consensus cf the group that we should not initiate contacts before the American data has been evaluated, at which time the question could again be considered. TCA is agreeable to scheduling an oral summary project report in mid- cr late-February, preparatory to the drafting of the final written report, and if desired, presentation of a paper at Florence. 6. American__Data Presentation at the International Cancer Concress in Florence The Research Coordinators delegated to the chairman the responsibility for arranging with the Congress ad ministrators for an opportunity to present the available data from the American studies at the Congress, with the option of appointing a small task group to assist him. He is also to discuss this matter with representatives of the European Group to coordinate the two presentations.7 7. Dietarv Feecir.c studies The Secretary presented a sue.dene at the U. S. Department cf Agrr encapsulation of vegetable oils as a y of the v/crh being Iture on the microairy cattle feed If ^ : ny !\ ; `5 A t V L i- L. l \i CMA101016 supplement, and suggested that vapor-phase equilibration of the USDA product with vinyl chloride monomer might yield a material suitable for incorporation of the monomer in rat diets. He was ashed to try to procure a sample of the gelat.in-glutara ldehyde process material for possible evaluation in the laboratories of our members. Dr. Gehring of The Dow Chemical Company indicated that he believed that the monomer could be fed as an addition to the drinking water, and that Dow was performing feasibility studies. Interest in ar, eventual feeding study remains strongfurther action will be influenced by FDA eerier, or; the ill petition referred tc in the next item of these .minutes. Dr. Rinehart was named chairman cf a task group to develop a proposed prorocol and cost estimates for a twoyear feeding study. 8. SPI Petitier, on vinvl Chloride Bottles Copies of the report in the October 22 issue of "Food Chemical News" on the SPI petition opposing the proposed ban on the use of PVC bottles for the packaging of alcoholic beverages, were distributed to those present. The thrust of that petition is that PVC can now be produced that is essentially free from monomer, and that the use of such PVC produces bottles from which no detectable rono.m (with ana lyrical procedures sensitive to not more than 5 ppb in the liquor) migrates into the bottle contents. 0) O The Research Coordinators, after review and discussion of the SPI data, agreed that, on :hs casis of io cm residue" of 7C.M in the bottle cost en ts, :r.e SPv posincn t r. a t 4- V Gerties o; VCM vers rv t oer d?i -rn. fu- v s v; G i, 1 ~ - * a r. d ' :e is no : resent or 11' :h e r ;o oo ir.t; J. Lt h D A* CMA 101017 -5 9. Studies of VCM Metabolism Dr. Gehring presented a proposal for studies on the metabolism of vinyl chloride monomer, and distributed sum maries of preliminary work completed at Dow. They have demonstrated a dose-related depression in the non-protein bound sulfhydryl of livers of rats exposed to VCM vapors of from 50 to 5,000 ppm. Various metabolic pathways for vinyl chloride that would be consistent with, this observation have been oostulated. as study ir. their laboratories cost-reimbursable basis. T studies v.'ith the basic work a view to eventual confirms man . m e' :o co .i--^ ^ for the project sponsors on a is would include CllT tracer being done in rams, and 'with ion in cogs and perhaps in Dr. Duffield mentioned that seme *o reliminary work] 4 in Europe has indicated that most of the small doses of C labeled VCM administered to rats by intubation is excreted unchanged in the urine. 10. Teratooenic Studies Dr. Duffield presented a brief report of an ICI study in which female rats v;ere exposed to VCM vapors (at levels of 10,000 and 6,000 ppm, five hours per day, five days per week) from the tvelth day after mating to parturition, with an apparent .marked decrease in the num ber of live births compared to the control group. He could not comment on the statistical significance of these results, or speculate as to mechanisms leading to this lowered fertility. He promised to seek mere information for us cn these points. ^ v g * "n r" i_ p c r's c''o 0 ^ g c 's ^ c c r c -- - ~^ on a number of solvents, including several ohlorir.aued solver us. Exposures were at levels of 2=i rimes the 00"; only chloroform was effective in reducing live births, destroying all embryos at an exposure level of 300 ppm. t $ k--s l " v t L* i M' /*. C/WA 101018 He proposed that Dow perform similar studies on VCK, and estimated that they could do so at a cost of about $18,000. 11 Progress Report on European Studies Dr. Duffield summarized present observations on the European studies. These now cover almost eighteen months of post-exposure history following the one year of vapor exposures. Groups of approximately 70 animals were exposed to 10,000, 6,000, 2,500, 500, 250, and 50 ppm of the monomer. The incidence of tumors in each group, anc rhe Exposure Level 2500 ppm 10,0 0 0 6,0 0 0 2300 500 250 50 0 Vinyl Z^cTiba 1 Gland 13 5 Carcinomas_____ __ Liver Carcin omas Angio- 6 11 sa rcom a s_______________ __________ Kidney Carcin omas Nephro- 33 bla stoma s___________ __ ____ _ Scattered Tumors 52 (no jcattern) ___ _______ ______ Survivors 00 2 2 0 00 0 9 7 2 00 0 6 3 5 00 0 3 2 1 00 0 oils 12____ g The relatively low incidence of 1 ver, hicr.ey, and -"ether" tumors in the 10,000 ppm group is presumed to be due to che high early morcality from Zverbal land tumors. The cor.rrol urn virv1 a c e t a r. e ex -- croc. Another greup of animals, scarred in January 1975, was exposed to rhe vapors for four months only; otherwise the conditions v;ere comoarable no those in the main fc \ l C La i \r fc k 'C cw^ 1 -7- experiment. This experiment was dene to better simulate the fraction of a workers life in v.'hich industrial exposures are likely. At this time, one Zymbal gland tumor has been observed'in the 10,000 ppm group. Among other experiments nov: under way are groups of 120 rats per group, being exposed to concentrations of 200, 150, and 100 ppm in an effort to better define the no-response level. These were started in June 1973 and so far no tumors have been observed. A group of 60 rats is being exposed to 30,000 pp~ ir. an erfert to cup. _i came . i c _ a ' s w cm. x c -- noi s - - - ' -- _ = ^ been seen. Exposures began in June. At the same time, V.'istar strain rams, and somewhat later, Swiss mice and banisters were starred cm a series of exposures ranging from. 10,000 ppm anc below. No rumors have been observed to date. 12 IBT Patnoloc :o Dr. M . icon The European Group has indicated that late January or early February would be an acceptable time for an 1ST project pathologist to visit Dr. Maltoni. It was the consensus of the Research Coordinators that Dr. Callandra would be the best man for such a visit. Dr. Torkslson was delegated the responsibility for making informal contacts with Dr. Callandra to see if he would be available for such a visit. The Secretary was asked to determine from MCA ' s counsel whether we were free to make a full disclosure to Dr. Callandra of the European data. 13. Studies for Possible Future Succort Among the proposals given serious discussion by uhe Research Coordinators, the following were identified as the most pressing: (1) VCM Metabolic Scudies -- S5C,C10 (2) Teraoogenic Scudies -- $20,0CC ag M f fp f u . U i, ig n f, "j*p, A 5 i-- i m 5 i 3^ h. CMA 101020 8- - Dow is to submit proposals on conducting these studies at cost. The Research Coordinators recommend that the TTGVCR oe asked to request approval by the Management Group of $80,000, including contingency funds, for these studies to be begun as soon as possible. (3) Prospective Epidemiology -- $100,000 per year, indefinitely (4) Three Generation Reproduction Studies (5) Mutagenicity Studies. The Secretary was asked to prepare a letter to the TTGVCR soliciting oheir suppers, in. principle, fer the sup port of items (1) and (2above, and alerting them to the probable need for the eventual support of the remaining projects. 14. Review of Comoarv Policies on vgy Customer fnfcr~aticri No action was taken on this agenda item. 15. Wo rk d1a c e Surveilie nee Recommendat ions The Research Coordinators recommended that the TTGVCR survey present practices on work area monitoring and analysis, and to collect information on methods and equipment. Personal monitors are of particular interest to the gxoup. 16. Liaison with NIQSH Concern was expressed that our contacts with Dr. Stokincer and others at NIOSH had not proved to be .more effective in maintaining an cn-ccing e;-:chence of infernatien . The Secretary was asked to inquire cf .'''.DR officers what should be cone at this time to i~ zrove the situation.. 17 . Pr era rati _c n__ for -est-uercre os ?ublic In format ion .^lfog_ran_s The Research Coordinators recommended that MCA and Ck V [ ; pm ; y E 3 krU1- t VTt LS 0*- C Xh t _ E Ma 101021 V -9- the project sponsors give' active consideration to potential public relations problems, and to have prepared a non technical information presentation when industry and Viola data become public at the time of the International Cancer Congress in October. They urged that MCA have a white paper ready for public release, and that the individual companies be prepared to discuss these findings -with their unions, their governments, their customers, and the public press. Future Feetim Schedules : t wss s'j crcs - od -- v c V " "h0 - vi 12. VC R r'.G s V ir, Ch i ce co on Tuesday, February 19, to receive oral progress reports from I5T and TCA project personnel and to consider the reco~~endatiers of the Research Coordinators recorded in these minutes. Respectfully submitted. Vinyl Chloride Research Coordinators KD J:mb Minutes Subject to Approval December 21, 1973 cc: C. P. Duffie Id, M.D. Cf^\ ; r c';r^ p w-1 \i P i: iU1 L. t \i t E a--; OWlM01022