Document XExG9nVM1nKEKoGReaBgjRnx

Or^OYflL UNIROYAL,lnc. Oxford Management & Research Center Middlebury, Connecticut 06749 203-573*2000 URL 20198 i TO: R. L. Knapp C, D. McCleary FROM: W. D. Harris, Fh.D, Industrial Toxicologist E-G-l DATE: April 21, 1972 SUBJECT: Vinyl Chloride - MCA Study The committee met at the MCA conference room in Washington on April 20, 1972, I met Dr, William J, Boyne and Mr, Henry Schmidt of Borden and Mr, Arthur C, Siegel of Tenneco at dinner on April 19, We agreed that it would be desirable to run three levels of acetylene based VC in parallel with the ethylene based VC study. We recognized that the cost would be raised substantially. While it would amount to only a few thousand dollars to each of our companies, the cost to the major producers, Goodrich ar.d Dow, would be increased in the order of $10,000-$15,000 each. We could appreciate that these companies might balk. The attached materials were handed out at the meeting, A Shell v.p, called before the meeting to advise that they would not take part in the study. There have also been minor changes in the protocol changing costs slightly. The PPG representative announced an increase in their capacity of 100^000,000 lbs/yr,, thereby increasing their share. Dr, Best will issue a new estimate of each company's share, I presented the Uniroyal, Tenneco and Borden viewpoint that the exposure should be the same for both types erf monomers. The ad hoc planning group had strug gled over this a great deal. They agreed that we were 100% correct technically, but that they simply couldn't sell the increased cost to their managements. All agree that the impurities will not likely influence the toxicology. The four agreed that we simply couldn't have our way so asked that Dr, Johnson obtain from Industrial Bio-Test the cost of running the complete study as well as adding just a high and low level for acetylene based VC. It appears that the additional cost might average $10,000-$20,000 for each of the three companies. It was brought out that a study is being carried out by Dr, Viola and apparently another study is underway in Europe, sponsored by one or a group of companies. Thus far we have been unable to get any information on this study. If the meeting at Leverkeusen materializes, I will keep my ears open for further infor mation. -2- No action is required of Uniroyal at this time. When I receive minutes of the meeting, I will send copies if MCA does not. The proposed schedule of payments to MCA will be as follows: July 1, 1972 = 40% April 1, 1973 = 40% January 1, 1974 = 20% Very truly yours. WDH:ues Attachments cc: E. S. Ebers G. A. Anderson D. E. Dudrow W. D. Harris, Ph.D. Industrial Toxicologist 661 w w m . '- Y Revised Program proposed by the Ad Hoc Planning Group for Vinyl Chloride Research March 22, 1972 Animal Study Inhalation Exposure Levels: (Tentative, subject to specification before start of testing) Set A Control 10,000 ppm VCM-A 10,000 ppm VCM-E 3.000 ppm VCM-E 1.000 ppm VCM-E or Set B Control 5,000 ppm VCM-A 5.000 ppm VCM-E 1.000 ppm VCM-E- 500 ppm VCM-E * Tl_/ v -f- :' h -' pfr *. 1 . Test Animals: Rats, Wistar strain weanlings, equally divided between sexes Mice, strain not hypersusceptible to tumors, wealings, equally divided between sexes 200 animals of each species per test (2,000 total) Exposure Schedule: -" Rats, 7 hours/day, 5 days/week, for 24 months Mice, 7 hours/day, 5 days/week, for 12 months Epidemiology Study - None it- (Deferred for subsequent consideration) ; '' ' ./ v 'J . - VCM-A * Vinyl chloride monomer, acetylene-derived VCM-E Vinyl chloride monomer, ethylene-derived URL 2 0 2 0 0 \ iil Hii *' Vinyl Chloride Monomer - Carcinogenicity Project Contributors Production Capacity VCM & PVC Million lb/vr % Air Products & Chemicals Allied Chemical Borden Chemical Conoco Dow Ethyl Firestone Goodrich Monsanto Olin PPG S Standard Oil (N. J.) Stauffer Tenneco Union Carbide UNIROYAL 160 440 390* 830 1,200 450 240 1,600 150 150 fc Ar\ -0- (150) 150 300 350 285* 8,245 2.0 5.3 4.7 10.1 14.6 5.5 2.9 19.4 1.8 1.8 9.7 TT9' 1.8 1.8 3.6 4.2 3.5 100.0% Proportionate Share of $165,000 $ 3,300 8,745 7,755 16,665 24,090 9,075 4,785 32,010 2,970 2,970 16,005 . 3ra,045 2,970 2,970 5,940 6,930 5,775 (1) (1) (2) (3) (1) $165,000 Includes Monochem capacity (1) Exceeds stipulated limit (2) No limit stipulated (3) Commitment still pending URL 20201 4/14/72 Technical Task Group on Toxicology of Vinyl Chloride Monomer /Carcinogenicity/ Designations by companies: Air Products & Chemicals Allied Chemical Borden Chemical Conoco Dow Ethyl Firestone Goodrich Monsanto Olin PPG Standard Oil (N. J.) Stauffer Tenneco Union Carbide UNIROYAL W. Mayo Smith W. A. Knapp Henry L. Schmidt, Jr. Flynt Kennedy T. R. Torkelson (U.Z. ^JUJr W. W. Madden Civ*** CdhjU* .M?--N. Johnson-, M.D. Mac Roy Gasque, M.D. Zeb G. Bell, Jr. - URL 2 0 2 0 2 a 70 ^ g to N. V. Hendricks A. B. Lindquist Marvin Rosen R. N. Wheeler, Jr. Walter D. Harris 4/14/72 Manufacturing Chemists Association MINUTES OF MEETING Ad Hoc Planning Group for Vinyl Chloride Research Washington Hilton Hotel Washington, D. C. March 22, 1972 MEMBERS PRESENT; R. N. Wheeler, Jr., Chairman N. V. Hendricks K. S. Lane, M.D. M. N. Johnson, M.D. R. L. Maycock (for N. G. White) W. E. McCormick T. R. Torkelson K. D. Johnson, Secretary GUEST PRESENT: Z G. Bell MEMBERS ABSENT: M. V. Anthony B. M. G. Zwicker Union Carbide Corporation Standard Oil Company (N. J.) Union Carbide Corporation Monsanto Company Shell Chemical Company B. F. Goodrich Chemical Co. The Dow Chemical Company MCA Staff PPG Industries Stauffer Chemical Company B. F. Goodrich Chemical Co. URL 2 0 2 0 3 1.0 Minutes of the Meeting of December 14, 1971 There being no corrections offered to the subject minutes, they were approved as distributed. 2.0 Report of Current Status of Responses to Requests for Support of Research Program Copies of the summary reproduced in the Appendix to these minutes were distributed-to those in attendance. The total (qualified) commitment of funds is now $165,000. 3.0 Proposed Program Revisions Dr. Torkelson reported that, on the basis of informal discussions with Industrial Bio-Test, he believed that the 2- - URL 2 0 2 0 4 modification of the initially proposed program, as shown below, could be completed for approximately $150,000: Exposure Levels - Highest Level 200 rats + 200 mice -- ethylene derived VCM 200 rats + 200 mice -- acetylene derived VCM Intermediate Level 200 rats + 200 mice -- ethylene derived VCM only Lowest Level 200 rats + 200 mice -- ethylene derived VCM only Control 200 rats + 200 mice. Exposure Schedule - i,-. , 7 hours per day (or maximum attainable in one shift operation) 5 days per week. The Planning Group agreed to recommend this program to the industry and to defer a decision on exposure levels until input had been obtained on current results from European on-going studies. 4.0 Proposed Project Budget The Planning Group recommended a minumum budget as follows: Industrial Bio-Test Services Vinyl Chloride Monomer Supply Contingency Funds $150,000 5,000 10,000 $165,000 The Secretary was asked to seek written confirmation from Industrial Bio-Test of the cost estimate given by them to Dr. Torkelson for the performance of the reduced scope test programs Support for this budget level is potentially available, in returns already received. Should added support develop, it was recommended that the Board authorization and member support be so stated that some of the widened support might be used to increase available contingency funds, rather than be limited to reducing individual contributions toward a fixed budget. -3- URL 2 0 2 0 5 5.0 Consultation with Current Research The Secretary reported t^at Dr. Knoepfel of Solvay American was now in Europe and would be back in the U. S. the first of next week. Upon his return he would be prepared to discuss the current status of European vinyl chloride monomer research. If initial telephone contacts indicate the usefulness of so doing, Dr. K. S. Lane, Mr. N. V. Hendricks, and Dr. K. D. Johnson were asked to arrange for a conference with Dr. Knoepfel at the earliest opportunity. The value of having Dr. Dinman, who is now in Switzerland on sabbatical leave, visit the European research institutions was discussed at some length. It was agreed that a decision be deferred on this point, but that the project budget be set up to permit the proposed project to finance such a trip from contingency funds if this should prove advantageous. .? .....ilr.-.i No decision was reached on the value of an effort to solicit input to, and support for, the project from Japanese manufacturers of vinyl chloride monomers and/or polyvinyl chloride. 6.0 Communications with the Industry MCA was asked to address a new mailing to companies that have already offered support for the program. Such a letter should detail: 1. Names of companies that have offered support, however qualified. 2. Production capacity data available to MCA, the source of that data, and the pro rata share of that company, calculated on the base of the total production capacity of the companies listed in (1). 3. The dollar value of the support requested of the company. 4. A description of the proposed new research program protocol. 5. An authorization form that will permit the MCA, with the concurrence of the sponsors advisory group, discretionary authority to expend any added funds available URL 2 0 2 0 6 -4- frora subsequent contributions of new sponsors, should such funds be necessary to defray costs in excess of present budget estimates for services within the scope of the proposed study. 6. A schedule for the first meeting of the sponsors advisory group by the middle of April. 7. The proposed membership of the ad hoc task group to serve as project coordinators. These are: Dr. Z. G. Bell Dr. Walter Harris W. E. McCormick -Tin- --BnnarWJ.6. ' Dr. T. R. Torkelson R. N. Wheeler, Jr. PPG Industries Uniroyal B. F. Goodrich Chemical Co. Ethyl Corporation The Dow Chemical Company Union Carbide Corporation MCA was askearto send a separate communication to vinyl chloride monomer and/or polyvinyl chloride companies that had not yet volunteered support for the project, describing the new scope and its reduced cost and stressing the importance of this project to the industry. It is to be made clear that their support may be used to broaden the scope and depth of the work, increasing its value to all concerned. Their support is not sought merely to lessen the burden on those who have already committed themselves. 7.0 Future Meetings The Planning Group adjourned sine die, subject to call of the chair in the event that such a meeting would be required before the function of that Group is assumed by a Board-designated Ad Hoc Task Group to coordinate a funded program. Respectfully submitted. Secretary Minutes Subject to Approval April 18, 1972 KDJsmkb Proposed Research Program on the Carcinogenic Potential of Vinyl Chloride Status as of March 22, 1972 Support Committed or Probable Support Declined or Improbable No Response Air Products Allied Chemical Borden Conoco Dow Ethyl Firestone Goodrich ICI America Monsanto Olin PPG Shell Standard Oil (N. Stauffer Union Carbide UNIROYAL J.) Ashland CIL Diamond Shamrock Du Pont FMC General Tire & Rubber Goodyear Tire & Rubber Great Lakes Chemical Gulf-Canada Gulf Oil Phillips Petroleum P&G Rohm and Haas Standard Oil (Calif.) Standard Oil (Ind.) Sun Oil Virginia Chemicals Vulcan Materials Hooker Kerr-McGee Marbon Pantasote Tenneco American Chemical* Atlantic Tubing & Rubber* Great American Chemical* Keysor-Century* URL 20207 Solvay American* *Non-members of MCA MCA 3/22/72 iv' URL 2 0 2 0 8 Proposed Research Program on the Carcinogenic Potential of Vinyl Chloride Comments Received as of March 22, 1972 Borden (By phone) Alarmed about any possibility of less than equal consideration of acetylene-derived monomer. Agree to deferring full-scale epidemiologic study for later consideration. Dow - See attached. Ethvl - See attached. Goodrich "It may be necessary to reduce the scope of the pro posed protocol and budget, in order to get adequate funding.... We would also hope that interaction with others in Europe and Japan would be helpful in finalizing a reduction in scope of the MCA project for the U. S. portion of the work." Shell Recommends management level review prior to seeking approval of MCA. "It would appear that significant questions relating to the need, objectives, and effect of such a program need answering." Attachments MCA 3/22/72 Dow a) The analytical data of ethylene and acetylene derived vinyl chloride should be reviewed to determine if the difference is significant enough to warrant animal studies on each material. If not, the total costs of the animal exposure study could be reduced by approximately $90,000, by testing only the ethylene derived material. b) Although we will support the $20,000 feasibility epidemological investigation, we will not at this time commit to the main epidemiological program costing $100,000. However, upon completion of the feasibility investigation and a review of the protocol, we will again consider supporting our share of the main epidemiological program. c) Since the projected duration of the initial undertaking (animal studies) is three years, we suggest that our share of the funding be paid: Initially - 33 1/3% of share; one year later 33 1/5% of share; and end of second year - remainder of share. Ke suggest paying our share of the epidemiological feasibility investigation upon initiation of the study. URL 2 0 2 0 9 Ethyl 1. We have a continuing interest in participation in an industry supported study on the carcinogenic potential of vinyl chloride. 2. We believe the study should be limited to ethylene derived monomer. Acetylene derived monomer represents a very small amount of the total and even this amount is apparently declining. 3. We do not v/ish to incur any obligation in support of an epidemiology study at this time -- nor do we think the industry should commit itself to such a study until the re sults of the animal studies justify it. Thus, the epidemiology phase should be completely separate. 4. We believe the Planning Group should consider a review of the final protocols with governmental parties who might be interested. The MCA sponsoring group need not be bound from the input of such a review, but at least the bene fits of their thoughts on experimental adequacy would be available. 5. Once a revised protocol is developed by the Planning Group, an opportunity should be provided for all interested (sponsoring) companies to submit questions and comments prior to making a final committment. A group meeting might serve this purpose. URL 2021 I Carcinogenic Potential of Vinyl Chloride Research Proposal-Review Meeting MCA Conference Room-April 20, 1972-10 AM PROSPECTIVE ATTENDANCE Air Products & Chemicals Allied Chemical Corporation W. Mayo Smith William A. Knapp Borden Chemical Dow Ethyl Corporation Firestone Goodrich Monsanto PPG -SfeizTV Stauffer Tenneco Union Carbide UNIROYAL William Boyne Henry L. Schmidt# Jr. / T. R. Torkelson F. Conrad W. E. Rinehart W. W. Madden W. E. McCormick B. M. G. Zwicker E, P. Wheeler Zeb G. Bell, Jr. / / Brian R. Suthers (for M. V. Anthony) Arthur C. Siegel (for Marvin Rosen) R. N. Wheeler, Jr. *' W. D. Harris * / . Goodyear C. A. Johnson MCA Staff George E. Best K. D. Johnson 4/19/72 (l^JlufLA ** VmU- pua^j VINYL CHLORIDE MONOMER IMPURITIES (1971) URL 2 0 2 1 2 1. MANUFACTURING PROCESS: Catalytic reaction of Acetylene with Hydrogen Chloride 2. RAW MATERIALS: Acetylene; thermal cracking of Hydrocarbon feed stock Hydrogen Chloride: byproduct HC1 from the chlorination of Hydrocarbon feed stock 3. VCM Purity: Minimum Typical Maximum 99.32% 99.67% 99.80% 4. Impurities in the VCM: Analytical techniaue: By vapor phase chromatography, detector with flame ionization. Ethyl-Hexyl Sebacate column. Sensitivity 1 ppm. Impurities Detected: Substance Minimum Concentration ppm Light ends (C3H6,C2H2....) Isopentane n-Pentane Ethyl Chloride 2-Dichloropropene and Vinyl Bromide Isopropyl Chloride 1-cis-Chloropropene 1-1-Dichloroethylene 1-trans-Chloropropene tert - Butyl Chloride n-Propyl Chloride Methylene Chloride 1-2-trans-Dichloroethylene l-l-Dichloroethane 2-2-Dichloropropane 1-2-cis-Dichloroethylene Carbon Tetra Chloride Chloroform 1-2 Dlchloroethane Trichloroethylene 160 20 70 0 10 320 0 traces 15 traces traces 1 traces 100 traces traces traces traces 50 traces Typical Concentration ppm 450 340 400 0 40 405 traces 50 27 2 5 57 13 1240 traces traces traces traces 125 traces Maximum Con centration 580 2300 2000 Traces 200 670 traces 240 170 150 130 80 50 1500 5 10 40 3 300 150