Document N2REzeXmBKXL7OgMwd2qBkzDg

MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N. W WASHINGTON, O. C. 20009 (202) 483-6126 November 19, 1971 To: Participants in the November 16, 1971 Vinyl Chloride Conference Subject: Report on Proceedings 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. E. 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. G. Zwicker, B.M.G. Stauffer Chemical Company PPG Industries, Inc. Canadian Industries, Ltd. ICI Ltd. Allied Chemical Company L Esso Chemical Company Pantasote Company of New York Standard Oil Company (N.J.) Monsanto Company Manufacturing Chemists Association Allied Chemical Company Solvay American Solvay et Cie Stauffer Chemical Company $ The B. F. Goodrich Company Firestone Plastics 71 General Tire & Rubber Company Continental Oil Company 'j Tenneco Chemicals, Inc. Allied Chemical Company Air Products and Chemicals, Inc. The Dow Chemical Company Solvay et Cie t> 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 to 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 013743 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 anlextension 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 costs 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 to 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 performance of the specified tests. Dr. Marcel Lefevre traced the experience of Solvay et Cie with industrial hygiene problems associated with vinyl chloride 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 chlor ide, 50% acetylene derived and 50% from ethylene dichloride. It appeared that any U. S. research should seek answers to 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? CMA 013744 1 -4- 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 gjfrpup, without specific ties to any standing MCA tech nical committee, with oversight on behalf of MCA through its staff r epresentarive, 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 S uite 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 Kenneth 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. F,, Goodrich Company 500 S, Mam 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 CMA 013746 -3- (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 that 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 should 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. CMA 013745 -5- The main conference 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 m 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 CMA 013747