Document 4yKRQmRXNJzbmrEG0JKpzvV

i* Chemical Manufacturers Association Record of Meeting VINYL CHLORIDE PROJECT PANEL, RESEARCH COORDINATORS AND AUDIT TASK GROUP May 14, 1980 Washington Hilton Hotel 10:00 a.m. Washington, D.C. Jackson Room MEMBERS PRESENT A. G. Wheeler H. W. Blakeslee F. Kennedy T. R. Torkelson T. J. Benya R. Park M. N. Johnson Z. G. Bell, Jr. V. L. Kirkland J. P. Murphy R, N. Wheeler R. K. Hinderer G. K. Hatfield W. A. Bittenbender D. M. Serrone (for R. W. McBurney) ICI Americas, Inc. Certain-Teed Corporation Continental Oil Company Dow Chemical U.S.A. Ethyl Corporation Firestone Plastics Company BFGoodrich Company PPG Industries, Inc. Shell Oil Company Stauffer Chemical Company Union Carbide Corporation BFGoodrich Company Diamond Shamrock Corporation Borden Chemical Diamond Shamrock Corporation J. T. Seawell a. C. Shah C. R. Stack E. B. Frost CMA Staff CMA Staff CMA Staff CMA Legal Department MEMBERS ABSENT W. M. Smith R. W. Laundrie P. Cohen R. J. Abramowitz R. Brookman W. D. Harris C. P. Wen J. T. Carter J. Lynch J. Gabbett C. A. Johnson R. B. Judge S. K. Law G. Roush, Jr. P, M. Reed Air Products and Chemicals, Inc. General Tire and Rubber Company Great American Chemical Corporat Hooker Chemicals and Plastics Pantasote, Inc. UNIROYAL, Inc. Gulf Oil Chemicals, Inc. BP Chemicals, Ltd. Exxon Chemical Company Georgia-Pacific Corporation Goodyear Tire and Rubber Company W. R. Grace and Company Keysor-Century Corporation Monsanto Company Tenneco Chemicals, Inc. CMA 014220 *3 ENT BY INVITATION Dr. Carroll W. M. Busey 2 Firestone Plastics Company Experimental Pathology Labs,Inc. The meeting was called to order by the Panel Chairman, Dr. Ted Torkelson, at 10:05 a.m. 1.0 Review of Dr. Busey's Pathology Report Copies of Dr. William Busey's histopathology report on all re maining brain tissues from mice, hamsters, and rats exposed to vinyl chloride in the flawed Industrial Bio-Test (IBT) research project were distributed to those present. Dr. Busey made an oral presentation of his findings to the group. No gross or microscopic alterations were seen in any of the brains examined from the mice and hamsters, however, the number of brains available for examination represented a small percentage (3 - 14%) of the groups exposed at any given dose level. The yield of rat brains was slightly better but did not exceed 23% for any one exposure group. Histopathological examination of the rat brains revealed olfactory -- neuroblastomas in seven animals (five males and two females) ex- posed to vinyl chloride at the highest dose level. This type of tumor is the same as that diagnosed by Maltoni as a "neuroblastoma" and is characterized histologically by pseudo-rosette formation and a high incidence of mitotic figures. In addition, a single glio blastoma multiforme was detected in one male rat exposed at 200 ppm, and a single astrocytoma was found in the brain of a female rat exposed to the same concentration. Dr. Busey concluded that a causal relationship existed between vinyl chloride exposure and the development of olfactory neuroblastomas, as these tumors rarely occur spontaneously in the rat. No sig nificance could be attached to the single occurrences of the other tumor types found. 2.0 Review of Dr. West's IBT Audit Report Dr. Bob West's report was distributed to the group and his observa tions on the IBT study were discussed. Dr. West's audit focused on the recording and monitoring of exposure concentrations, body weight data, mortality logs, hand written observations and correspondence The report indicated that the study was conducted using poor labor; tory techniques. Perhaps the most disturbing finding was substantial CMA 014221 evidence of animal replacement well into the course of the research. Df. West concluded that the results could only be viewed in qualitative terms and no quantitative analysis of the data is possible. 0 panel Action on Audit Reports 3.1 A motion was made to accept Dr. Busey's report as written. The motion was passed unanimously. 3.2 A motion was made to accept Dr. West's report with the words "confidential and privileged" removed from each page. The motion passed unanimously. 3.3 The Panel moved and agreed to send the reports to: A) Mr. Frank Rover, Chief, Chemical Hazards Identification Branch, CPA, with a cover letter saying that this is th additional meterial referred to in our letter of March 19. The research is a confirmation of Maltoni's findings and does not merit further study; the Panel will direct its resources at other work. CMA will be negotiating a settlement with IBT along the same lines as that being pursued for trichloroethylene. B) Six Federal Agencies: EFA(0fice of Douglas Costle), FDA, NCI, NIOSH, OSHA, and CPSC. This package will include the 23-month status report summary prepared by IBT and Dr. Busey's earlier pathology audit (submitted to CMA January 9, 1979), as well as the two most recent reports of Drs. Busey and West. The cover letter will contain similar information as that stated in A above. Dr. Zeb Bell, Dr. Ted Torkelson, and CMA staff will prepare the cover letters. Panel approval of the letters is not needed. 3.4 Appreciation of the Panel was expressed to both Drs. Busey and West for-the expeditious and thorough manner in which they conducted their work. A $500 cost overrun on Dr. west's contract was unanimously approved. 0 The Panel was reminded that CMA has no TSCA 3(e) reporting obligatio however, submission of the two audit reports to Mr. Rover will, in all likelihood, place them in the 8(e) office and files of EPA. 0 The Busey and West reports will be sent to IBT and a meeting arrange in the near future. CMA will ask for cost reimbursement of the enti contract. CMA 014222 4 Mr. Edward Frost, the CMA General Counsel, related the case pending in Louisiana against Union Carbide in which a cancer patient exposed to acrylonitrile is claiming that he would not have exposed himsei: to this chemical if he had known of the carcinogenic properties of vinyl chloride. Acrylonitrile and vinyl chloride share a common broad-based chemical structure. The accusation is being made that CMA suppressed vinyl chloride information in the early 1970's. Liskow and Lewis are handling the case for Union Carbide; CMA has no defense funds at present. Mr. Frost will write letters to Counsels of par ticipating companies to make some financial arrangements. Epidemiology Study - Environmental' Health Associates (EHA) A copy of Mr. Joe Seawell's letter to Mr. Richard Davis of EHA was distributed to those present. The letter outlined Panel action on a proposal received from EHA on January 15. In order to expedite preparatory work and plans for the evaluation of the current data base, a five-year update of the cohort, and a brain case control study, it was suggested that a meeting be arranged at EHA. Those participating would include CMA staff, EHA staff, Project Panel representatives, and individuals involved with the original study done by Equitable Environmental Health. A motion was made to this effect and passed unanimously. Dr. Torkelson spoke briefly on the possible reason for OSHA's concern over vinyl chloride at this time. It was speculated that rulemaking on polyvinyl chloride is possible. Dr. stack mentioned that the two University of Louisville annual reports were submitted to OSHA in response to their request (Federal Register, December '79) for information on vinyl chloride and polyvinyl chloride. The reports were also sent to five other Federal agencies at this time. The meeting was adjourned at 12:00 noon. Project Administrator Vinyl Chloride CRS :md Enclosures: Revised final reports from Drs. Busey and West Record Subject to Approval May 21, 1980 CM* 014223