Document jgGZNdK2BdZwpazgaZnKE7pgO

GIOfKW . mr T1CHMCM. IMMCTOn /Cf.o MANUFACTURING CHEMISTS ASSOCIATION 1872 A CENTURY OF SERVICE 1972 1825 CONNECTICUT AVENUE, N.W. WASHINQTON, D. C. 20009 (202) 483*6128 March 13, 1972 To the Designated Representatives of Companies Contacted regarding Research on the Carcinogenic Potential of Vinyl Chloride This copy for W. Wheeler, Jr, RECEIVED MAR 181972 LR-JI. WHEELER Dear Sirs: Thirty companies, hav.e-^replied to my letter of ^ inuary 28, 13 having ind'i<^2S?^!raey- Wil contribute to sup^ 45 . t^^'.^port of research outlined; in thwtdraft Description dated January 27, and 17 having decl&qd; . Ho reply has yet been ; " received from the other 14 companies to which the comraunica- \..l ^vbion was sent. p pr - ' ,f f. *v> From the commitment ceilings. indicated, the funding V^Wso far subscribed falls far.short of the $350,000 called for proposal. Accordingly!^ the AdHoc Planning Group on `$'S Winy1 Chloride Research wi 11- lftK*meeting on March 22 to con- "P 'yaider its modification. Some fconsents received question the inclusion of testing with acetylene-derived vinyl chloride and express a preference for reserving a full-scale epidemi ological study for later consideration. All are hereby invited to submit consents or suggestions as guidance for the Planning Group, and those on hand by March 22 will be reviewed at the upcoming meeting. 4- Attached is ai list of the companies that have made a: conuitment to participate,, thote-'that have declined, and \those from which no reply has sofar been received. Will the representatives of those in the latter group please do their , best to respond prior to March 22 so that the Planning Group may have a better perspective of the probable base of support. &> :<&; ucc 000511 March 13, 1972 Page Two No further -communication on this development will be directed to those whose companies have declined, unless specifically requested. With appreciation for your cooperation. Sincerely yours. . (u*m GEB t tp Attachment ccs Dr. K. D. Johnson Information Copy K. S. Lane, m.D. ' "'i'l ucc 000512 4 Proposed Research Program on the Carcinogenic Potential of Vinyl Chloride Status as of Marc^ 10. 1972 7 Support Committed Support Declined No Response Air Products //S dO Allied Chemical Ashland Qil CIh Ethyl r- 2- > FMC f Borden Chemical / Diamond Shamrock - /HS Goodyear Tire &. Rubber Conoco (Continental OiUjf^Du Pont 7 Hooker chemical " & Dow * l.Kf Firestone PlastiLcoss "f 0, IGeneral Tire & Rubber-*^* ICI America Great Lakes Chemigal f Kerr-McGee B'. F. Goodrich t*3 s* Gulf Oil Canada ` Marbon Div/Borg-Wamer ? 01 in PPG, < US / lard j. )J? Gulf Oil Chemicals'? Phillips Petroleum ? p..,orL^ ( ? Monsanto --' Pantasote . Tenheco pi<e** *^ fer -'Union' Carbide '/A* UNIROYAL v oil (Calif.) \ StandFd Oil (Ind.) 7 Sun?*Qiil 7 American^ Atlantic.,' '-Commitment Pending Shell Chemical />*V Virginia Chemicals^ Vulcan-.,Materials 7 Great Arne Keysor-Ce isrican* ? A ?v` W ^Non-members of MCA MCA 3/10/72 A ? ucc 000513 Gconct t. e*T riCHNlCAL OtMCTOft MANUFACTURING CHEMISTS ASSOCIATION r' - 1 * * ,' V ~LI -_ ?. 2 1825 CONNECTICUT AVENUE, N.W, WASHINGTON, 0. C. 20009 (202) 483-8128 ) March 30, 1972 To the Designated Representatives of Companies indicating Support of Research on the Carcinogenic Potential of Vinyl Chloride This copy for Mr. R. N. Wheeler, Jr._____ Information copies to; k. S. Lane, M.D. A. B. Steele RECEIVED APR 03 \m !R'N.WHEELR Dear Sirs: Since my March 13th letter was sent to you, additional replies have increased to 17 the number of companies committing financial support, plus one indicating probable support but not definite commitment. These companies are as follows; Air Products & Chemicals Allied Chemical Borden Conoco Dow Ethyl* Firestone Plastics* B. F. Goodrich* ICX America!? Monsanto Olin PPG Industries* Shell* Standard Oil (N.J.)* Stauffer Tenneco* Union Carbide UNIROXAL Companiem marked with an asterisk have not yet furnished vinyl chlorite monomer plus polyvinyl chloride production capacity (publicly disclosed figures) on which to base a pro-ration of project costa. Meanwhile, as indicated in my letter of the 13th, the Ad HOc Planning Group met on March 22 as planned, and the revised program they now recommend ie detailed on the attached sheet. Ex cept for restricting the testing of acetylene-derived monomer t a single exposure level, this represents only minor changes in the ucc 000514 I March 30, 1972 Page Two animal studies. It does, however, eliminate the epidemiology study, the idea being to defer it for separate consideration depending on the outcome of the animal studies. it will be necessary to obtain a revised quotation from Industrial Bio-Test Laboratories, Inc., for the animal studies. The Planning Group estimates laboratory costs at about $150,000; allowing $5,000 to defray the cost of the monomer supply and $10,000 as contingency would round out the total to about $165,000, over a three-year period. Several companies urged that a review meeting be called of representatives of all the prospective sponsors, including management as well as technical representatives if desired, before presenting any revised program for formal approval and specific financial com mitment. In response to that desire, a meeting for this purpose is scheduled for Thursday, April 20, at the MCA offices beginning at 10 AM, and a reply sheet to indicate attendance is enclosed. It will be helpful, of course, if those attending are able to make ten tative commitments on the company's behalf, in order to expedite final resolution of the program. A letter is also being sent to the other companies pre viously contacted in this connection, on the chance that some might reconsider participation. Sincerely yours. GEBtgr . ` ' Enclosures*-, ..-VT . ./> -i ` ccr Drv ltd Johnson Ad- Hoc- Planning Group ------*?!SF ucc 000515 Revised Pregram proposed by the Ad Hoc Planning Group for Vinyl Chloride Research ,March 22 1972 AniTM'."i S'" 'd-'- 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 Test Animals; Rats, Wistar strain weanlings, equally divided between sexes Mice, strain not hypersusceptible to tumors, wealings, equally divided between sexes 2C0 animals of each species per test (2,000 total) Exposure Schedule: Rate, 7 hours/day, 5 days/week, for 24 months Mice, 7 hours/day, 5 days/week, for 12 months Epidemiology Study -- Hone (Deferred for subsequent consideration) * VCM-A - Vinyl chloride monomer, acetylene-derived VCM-E Vinyl chloride monomer,, ethylene-derived. UCc OOOSls UNION CARBIDE CORPORATION I.. CHEMICALS AND PLASTICS p. O. BOX *004. SOOTH CHARLESTON, w. VA. 25303 SOUTH CHARLESTON plant February 9, 1972 Dr. Kenneth D. Johnson Manufacturing Chemists Association 1825 Connecticut Avenue, N. W. Washington, D. C. 20009 Re: Revised Industrial Biotest Proposal Dear Doctor Johnson: Consideration of the revised Industrial Biotest Proposal would appear to be the first task of the Steering Committee after the program is funded. The letter requesting funding pledges has been sent to resin and monomer producers with returns requested by February 18, 1972. If the program is fully subscribed and approved by MCA in March, then the Steer ing Committee can make modifications to secure additional data and to stay within the proposed budget. If, however, the industry is provided with an increased budget and increased subscriptions before the first proposal is digested, the least that can happen is further delay. If I were on the Steering Committee for the program, my r actions to the revisions would be as follows; 1. Both T-m groups should be increased to 200 rats and 200 mice. 2. Histology on all groups may be necessary and should be funded. However, Groups I & II would not be studied unless warranted by results from the control and Group HI studies'. 3. The- control group needs to be only 200 rats and 200 . mice; thus all groups have the same population. 4L-. Commitment of contingency funds early in the program is not desirable. RNWJr/ra be; Dr. Kenneth S. Lane, NYO-4 UCC 000517 jjl v c.--RlESTO.'i Rl-ANT CCA?CaA7.C.\ ChciVuCAuS aa_i A^mST.C^ a. o. sox aoo*. sooth charleston, w. va. 2530s February 14, 1972 Mr. George E. Best Technical Director 'Manufacturing Chemists Association 1825 Connecticut Avenue, N. W. Washington, D. C. 20009 Subject: Proposed Research Program on the Carcinogenic Potential of Vinyl Chloride Dear Mr. Best: Union Carbide will act favorably on the subject program. However, return of the approved form will be delayed beyond the requested return date of February 18. Very truly yours, J* RNWJr/ra R. N. Wheeler, Jr. ucc 000518 Manufacturing Chemists Association MINUTES OP 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 ABSENTi 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 Dew Chemical Company MCA Staff PPG Industries Stauffer Chemical Company B. F. Goodrich Chemical Co. 1.0 Minutes of the Meeting Dumber 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 UCC 000519 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 rata + 200 mice, /* t j *r a:. /2--s* Exposure Schedule - ' 0.-T 7 hours per day (or maximum attainable in one. shift operation) ,, 5 days per week. .v 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 s*a 7-*'*'"'*_ /lJ0^ . The Secretary was asked to seek written confirmation from Industrial Bio-Test of the cost estimate given by them to Or. Torkelson for the performance of the reduced scope test program. 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. UCC 000520 5.0 Consultation with Current Research The Secretary reported that Dr. Knoepfel of Solvay -- American was now in Europe and would be back in the U. S. 7**^ the first of next week. Upon his return he would be -< 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. :ir f1 ^ ^ 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 details / 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). /c nv i. ro/90 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 ucc 000521 \ -4 from 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 Pai Oi -Rausch r Dr. T. R. Torkelson R. N. Wheeler, Jr. PPG Industries Uniroyal B. F. Goodrich Chemical Co. r Ethyl Corporation The Dow Chemical Company Union Carbide Corporation MCA was asked to 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 KDJ:mkb ucc 000522 Proposed Research Program on the Carcinogenic Potential of Vinyl Chloride Status as of March 22. 1972 Support Committed or Probable Air Products Allied Chemical Borden Conoco Dow Ethyl Firestone Goodrich ICI America Monsanto Olin PPG Shell Standard Oil (N. Stauffer Onion Carbide UNIROYAL J.) Support Declined or Improbable No Response Ashland C1L 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 & Rubbe Great American Chemical Keysor-Cen tury* Solvay American* *Non-members of MCA MCA 3/22/72 UCC 000523 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 UCC 000524 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 1/3% of share; and end of second year - remainder of share. IVe suggest paying our share of the epidemiological feasibility investigation upon initiation of the study. UCC 000525 Ethvi 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 wish 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. ucc 000526 Revised Program fart - 63d3 pr poaed by th Ad Hoc planning Group for vinyl Chlorlda Research ' March 22, 1972 Animal Inhalation Bxpoaura Lavalst Sat A Control 10,000 ppm VCM-A 10,000 ppm VCM-E 3.000 ppm VCM-S 1.000 ppm VCM-S (Tentative, subject to apaclfIcation bafora atart of testing) Sat Control 5,000 ppm VCM-A 5.000 ppm VCM-S 1.000 ppm VO!-E 500 ppm VCM-S Taat Animals* Rata, Wlatar atraln weanlings, equally divided between a xaa Mica, atraln not hyperauaceptlble to tumors, wealInga, equally divided battaaaa aaxes 200 animals of each apaeiaa par taat (2,000 total) Exposure Schedule* Rata, 7 hours/day, 5 days/weak, for 24 months Mica, 7 hours/day* S days/weak, for 12 aonthn Epidemiology gtndMfc* son* (Deferred for subsequent consideration) VCM-A vinyl chlorldm monomer* acetylene-derived VCM-S vinyl chlorldm monomer* ethylene-derived UCC 000527 UNION CARBIDE CORPORATION 370 PARK AVCNUC. N3W YORK, N. V. 10017 RECEIVED APR 03 19/2 [R. N. WHEELER March 30, 1972 Mr. W. E. McCormick The B. F. Goodrich Co. 500 S. Main Street Akron, Ohio 44318 Or. T. R. Torkelson Toxicology Specialist Chemical Biology Research 1803 Building The Dow Chemical Co. Midland, Michigan 48640 M.< N. Johnson, M. D. Monsanto Co. 800 Lindbergh Blvd. St. Louis, Missouri 63166 Gentlemen: At Dr. Torkelson*s suggestion 1 discussed the proposed protocol for the vinyl chloride inhalation study with Mr. Carrol Weil at Mell n Institute. - From the brief description I gave him, he had two recommendati the first was to specify that the strain of rats also be selected for a 1 w incidence of spontaneous tumors, as we have already done for the mice, and the other was. to expose the mice for 18 months instead of 12 months. . If it leant possible to use an 18 month exposure span for the mice, then he feels they should be exposed 12 months and retained uxtil the-end of the IS month period. " a I have also sent a copy of the protocol to Mr. Weil and asked for any other comments after he has read it in detail* r;"' ucc 000528 Mr. W, E. McCormick Dr. T. R. Torkeison M. N. Johnson, M. D. 2- March 30, 1972 I notice International Research & Development Corporation also recommended extending the mouse exposures to 18 months in their proposal. I had neglected this point when 1 first read the proposals. Very truly yours. Assistant Medical Director K. S. Lane, M. D. Ik cc: Mr. N. V. Hendricks Dr. K. D. Johnson fl Mr. Carrol Weil y/&T. R. N. Wheeler, Jr. r * ucc 000529