Document NERayKzmrO6KgD1pgMwqx0b3D

MANUFACTURING C. .-v..oo ASSOCIATION 1S2S CONNECTICUT AVENUE. N. W. WASHINGTON. 0. C. 2000* (2021 4J.12* ^RECEIVED NOV 2 91?71 R.N. WHEELER November 19, 1971 To: Participant* in the November 16, 1971 Vinyl Chloride Conference Subject: Report on Proceeding! of the Conference Held at the Hotel Washington, Washington, D. C. Attendance: Anthony, M. V. Bell, Z. G. Cassidy, L. E. Duffield, D. P. Fedoruk, J. C. Fritz, R. J. Gabbett, J. F. Hendricks, N. V. Johnson, M. N. Johnson, K. D. Knapp, W. A. Knoepfel, R. W. Lefevre, M. J. Lindquist, A. B. McCormick, w. B. Madden, W. w. Mudd, J. R. Pitts, S. F. Siegel, A. C. Sheth, K. K. Smith, W. M. Torkelson, T. R. Weekers, Pierre Wheeler, R. N. White, N. O. Zwicker, B.M.G. Stauffer Chemical Company PPG Industries, Inc. Canadian Industries, Ltd. ICI Ltd. Allied Chemical Company Esso Chemical Company Pantasote Company of New York Standard Oil Company (N.J.) Monsanto Company Manufacturing Chemists Association Allied Chemical Company Solvay American Solvay at Cie Stauffer Chemical Company The B. F. Goodrich Company Firestone Plastics General Tire & Rubber Company Continental Oil Company Tenneco Chemicals, Inc. Allied Chemical Company Air Products and Chemicals, Inc. The Dow Chemical Company Solvay at Cie union Carbide Corporation Shell Chemical Company The B. F. Goodrich Company Our present awareness of the alleged carcinogenicity of vinyl chloride monomer has resulted from studies begun in an effort t elucidate the mechanisms of pathenogenesis of the acroosteolysis seen in some vinyl chloride workers. As most of the companies represented at this meeting were participants in, or otherwise UCC 000449 -2- ~* concerned with, the Case Registry project at the University of Michigan, Dr. K. D. Johnson (MCA staff representative) led off the meeting with a brief report of the status of the project. He requested an indication of the interest of the project spon sors in an extension of the program beyond the exhaustion of currently committed funds, and pointed out that there is now on deposit with MCA to the credit of the individual project sponsors, adequate funds for the maintenance of the Registry for several more years. Upon a showing of interest by the delegates present. Dr. Johnson agreed to send copies to each sponsor of the University of Michigan proposal for a project extension, together with a report of his remaining credit and anticipated cost for the indicated contract extension. He extended to any companies, not now a project sponsor, that have employees at risk and that may wish to become a party to the study, an invitation to request more detailed information on programs and costa from him at MCA. (Note: subsequent to the Conference, MCA received a University of Michigan proposal estimating a cost of $4,000 per year for the maintenance of the Registry and its records.) Mr. N. V. Hendricks summarized the recent events and publi cations which had alerted the industry to the reported tumerogenic properties of vinyl chloride, and called upon Mr. McCormick to report on the studies of this problem that had been made by MCA's Occupational Health Committee. Mr. McCormick reviewed the literature reports, and summarized the information that had been received from Dr. P. L. Viola, the principal investigator in the reported studies, during a visit t the u. S. by Dr. viola under the sponsorship of a group of inter ested companies. On the basis of these data, a suggested research protocol has been developed, and cost estimates secured from a number of competent consulting laboratories for the performanc of the specified tests. Dr. Marcel Lefevre traced the experience of Solvay at Cie with industrial hygiene problems associated with vinyl chlorid synthesis and polymerization, and defined the relationship of his company to Dr. Viola's studies, both past and current. He revealed that additional exposure studies, at seven concentration levels, are now underway with a "composite*' source of vinyl chi ride, 50% acetylene derived and 50% from ethylene dichlorid . It appeared that any U. S. research should seek answers t three questions! (1) Are the tumerogenic properties of the vinyl chloride used in his studies by Dr. Viola related to vinyl chloride, per se, or to impurities present? UCC 000450 ( (2) if impurities are implicated,'are the significant con taminants uniquely related to one or another of the commercial vinyl chloride synthesis methods? (3) if the pertinent carcinogen can be identified, can a "no-effects" level be demonstrated? Inasmuch as the material used by Dr. Viola was of undocumented composition, and variously noted to contain from 1 to 3 percent im purities, and whereas American commercial practice now may specify total organic impurities to as low as 100 ppm (99.99% assay), some hope, but not great confidence, was expressed that it could be shown that Dr. Viola's results were attributable to the. impurities in his sample. Mr. Knoepfel volunteered to attempt to identify the production lots from which Dr. Viola had secured his samples, and to secure available analytical data on such lots. The qualitative list of the impurities reported by Dr. Viola as present in his material is appended to this report of proceedings. Mr. McCormick reviewed the test protocol his group had sugges ted, and expressed his view that current plans should contemplate the eventual need of an epidemiological survey of workers with pos sible exposure to potentially carcinogenic concentrations of atmospheric contaminants in vinyl chloride operations. He commented thereby that the $183,000 low bid must be considered as just the start of the anticipated project costs, and than any epidemiology or protocol expansion could substantially increase the funding re quirements. The suggestion that research costs be reduced by limiting the tests with acetylene-derived material to the highest exposure level only, primarily as a "positive control," received general support. The problems of defining routes of funding or concurrence on a specific test protocol led to the decision to appoint a smaller study group to reach agreement on these points and to report the results of their deliberations in the form of a specific research proposal with specific funding requirements and mechanisms. One of the major questions posed to this group was the extent to which tests sh uld be planned on a concurrent basis, to save time, or on a sequential basis, to minimize investment in tests subsequently shown to be unnecessary or non-informative. 000451 -4- / 1 The following individuals were designated to serve on this group. Subsequent consultation with MCA management determined that these individuals could most appropriately operate as a planning group, without specif ic'; ties to any standing MCA tech nical committee, with oversight on behalf of MCA through its staff representative. Dr. K. D. Johnson. When and if they present a research proposal to MCA with a request for MCA administration, the Board will at that time, as a part of any such project author ization, define lines of organizational supervision and reporting for the industry steering committee set up to guide the project. Ad Hoc Planning Group for Vinyl Chloride Research Dr. M. V. Anthony Vice President- Environmental Affairs Stauffer Chemical Company Suite 1208 1612 K Street, N. W. Washington, D. C. 20006 (202) 347-7627 Mr. N. V. Hendricks Assistant Director for Environmental Sciences Standard Oil Company (N.J.) Medical Department 30 Rockefeller Plaza New York, New York 10020 (212) 974-2786 M. N. Johnson, M. D. Assistant Medical Director Monsanto Company 800 N. Lindbergh Boulevard St. Louis, Missouri 63166 (314) 694-2188 Kennetli S. Lane, M. D. Assistant Medical Director Union Carbide Corporation 270 Park Avenue New York, New York 10017 (212) 551-4787 Mr. W. E. McCormick Manager, Department of Environmental Control The B. P. Goodrich Company 500 S. Main Street Akron, Ohio 44318 (216) 379-2562 Dr. T. R. Torkelson Toxicology Specialist The Dow Chemical Company Chemical Biology Research 1803 Building Midland, Michigan 48640 (517) 636-5197 Mr. Norman G. White Manager, Industrial Hygiene Shell Chemical Company Div. of Shell Oil Company 2525 Murworth Houston, Texas 77025 (713) 666-6311 Mr. Benjamin M. G. Zwicker Director, Technical Planning B. F. Goodrich Chemical Company A Div. of The B. F. Goodrich Co. 3135 Euclid Avenue Cleveland, Ohio 44115 (216) 881-8200 Dr. Kenneth D. Johnson Manufacturing Chemists Association 1825 Connecticut Avenue, N. W. Washington, D. C. 20009 (202) 483-6126 x 244 000452 -5- The main conf r nee adjourned at 2:45 P.M., and the Planning Group convened. They agreed that: (1) vinyl chloride manufacturers should be solicited for analytical data on their commercial grade of vinyl chloride, listing identified impurities and their characteristic ranges, methods of analysis, and limits of detection; (2) their interest be determined in contracting for the pro vision of a supply of vinyl chloride of uniform quality over the life of the research project, including their proposed specifications and analytical verification of specification conformance; (3) the Planning Group's proposal should include a recommen dation for funding on a sharing of costs prorated among participating vinyl chloride producers and polymerizers on the basis of total capacity (monomer synthesis plus PVC production, each taken separately, as published in Oil, Paint and Drug Reporter and/or the Stanford Research Institute's Directory of Chemical Producers, is shown in attachment to this report); (4) that discussions with the offering laboratories be con tinued to clarify cost changes associated with suggested protocol modifications, and that Drs. Lane, M. N. Johnson, and Torkelson and Messrs. Hendricks and McCormick review test protocols in the light of new information developed at the conference, and prepare recommendations on a "best value" research protocol; and (5) the next meeting be held in Washington, Tuesday, December 14, at 9:00 A.M. (as the MCA Conference Room is not avail able at that time, MCA will arrange for a meeting room space in a convenient hotel, and will notify members of the Planning Group as soon as space can be confirmed.) Respectfully submitted KDJ/cj Enclosures (3) Staff Representative 000453 Reported Production Capacity Million P unds/Year Comoanv Air Products & Chem. Allied Chem. Corp. American Chem. Corp. Atlantic Tubing & Rubber Borden, Inc. Continental Oil Co. Diamond Shamrock Dow Chemical Ethyl Corp. Firestone T & R General T & R B. P. Goodrich Goodyear T & R Great American Keysor Century xMonochem ---tS 'Monsanto Occidental Petroleum Olin Corp. Pantasote Co. PPG Stauffer -Tenneco Union Carbide UNIROYAL Vinyl Chloride Monomer -- 300 --170 600 1220 --42-0 1000 ... -- .3.0.0 ... ... --. .8.0.0 .2.5.5 -- 5065 Poly vinyl Chloride 170 140 70 100 240 155 .25.0.' 125 240 75 600 90 70 ..5.0 150 360 150 .1.1.0 150 190 350 135 3970 Total 170 440 240 100 240 755 250 1220 545 240 75 1600 90 70 50 300 150 360 150 110 800 150 445 350 13j> 9035 Percent * of Total 1.9 4.9 2.7 1.1 2.7 8.4 2.8 13.6 6.1 2.7 0.8 17.8 1.0 0.8 0.6 3.3 1.7 4.0 1.7 1.2 8.9 1.7 4.9 3.9 100 *Thia column represents the approximate share of project costs that would be borne by the indicated company if all named companies electedto participate. Since this is not likely, percentage costs prorated among participating companies may be expected to be some what larger than that shown. Ucc OOOlZ, i *- DOCUMENTATION OP THE THRESHOLD LIMIT VALUES FOR -* SUBSTANCES IN WORKROOM AIR - Third Edition 1971 VINYL CHLORIDE *vasaL / a 200 ppm (Approximately ^SflHtag/m3) Vinyl chloride is a flammable gas with anesthetic properties at high concentrations. At anes thetic concentrations (8 to 12%) it has serious effects on cardiac muscle resulting in arrythmias and sensitization in dogs(l,2). There is a wide margin between anesthetic and lethal concentrations (30-4G%)(3). Torkelson, Oyen and Rowe(4) reported that repeated seven-hour exposures for six months at 200 ppm resulted in histologic changes in the central lobular region of the livers of rabbits, but not in rats, guinea pigs and dogs. At 100 ppm there was only slight liver enlarge ment. A subsequent report by Lester, Greenberg and Adams(5) on the effects of repeated ex posure of rats to vinyl chloride assaying 99 + percent purity at 2 and 5% concentration stated that, although liver changes were noted, they were not considered to be of pathological signif icance. In their opinion, a recommended TLV of 500 ppm was satisfactory for worker exposure. An interim report was made by Mutchlcr and Kramer(6) of long industrial health experience with vinyl chloride workers. Beginning in 1950, continuous monitoring was begun at five or six stations and the results compared with breath aiuilyses(7) for vinyl chloride for 50 workers. Between 1950 and 1967 the mean air concentration was 160 ppm, with one maximal peak at 600 ppm of vinyl chloride and with great daily variation from 30 to 170 ppm, on the average. During part of this time vinylidene chloride* was an associated air contaminant estimated at around 5 ppm. Twenty-one clinical parameters were measured for comparison with the environmental data, and relationships were obtained by stepwise multiple linear regression analysis. Of medical examinations numbering 404 on 97 workers, 66 were used for comparison with 650 controls. These examinations with final diagnoses made according to the international classification of diseases, failed to reveal any overt condition attributable to vinyl chloride (or vinylidene chloride) ex posure. No differences of physiologic significance were found in blood pressure, hemoglobin, electrocardiograms, and no body abnormalities (acro-ostcolysis) appeared. No one was clinically 111. Six clinical parameters appeared to be altered, however. Among these, beta lipoprotein, Icterus index, and bromosulfalein retention time may have some physiologic significance. The investigators felt, from a review of the interim findings, that a time-weighted average exposure* concentration at 300 ppm (combined vinyl chloride and 5 ppm vinylidene chloride) could result In some degree of liver dysfunction. The multiphasic screening tests are continuing on all ex posed workers, and analysis of the findings is being made on an individual worker basis. In the meantime, a time-weighted average threshold limit value of 200 ppm vinyl chloride (with a few ppm vinylidene chloride) seems appropriate to prevent adverse systemic effects from longcontinued daily exposure. (* A 90-day animal inhalation exposure to vinylidene chloride at S ppm was without observable effect.) References: 1. Oster, R.H., Carr, C.J., Krantz, J.C., Sauerwald, M.J.: Anestheslol. , 359 (1947). 2. Carr, J., Burgison, R.M., Vitcha, X.F., Krantz, J.C.: J. Pharra. Exptl. Ther. 97, 1 (1949). 3. Mastromatteo, E., Fisher, A.M., Christie, H., Danziger, H.: Am. Ind. Hyg. Assn. J. 21, 394 (1960). 4. Torkelson, T.R., Oyen, F,, Rowe, V.K.: ibid. Sg, 354 (1961). 5. Lester, D., Greenberg, L.A., Adams, W.R.: ibid., 54, 265 (1963). > 6. Mutchler, J.E., Kramer, C.G.: Report on Relation of Exposure to State of Health of bow Chemi cal Workers, Gordon Conf., Tilton, N.U. (August, 1968). 7. Baretta, E.D., Stewart, R.D., Mutchler, J.E.: Am. Ind. Hyg. Assn. J. 30, 537 (1969), (Reprinted from American Conference of Governmental Industrial Hygienists, Cincinnati, Ohio) UCC 000455