Document KGa1zzon2wZdmYKownpMpr40r

, sHELL Oil COr/>Pan' r ^ < i1 -// iLy-p 0*TC APRIL 16, 1974 -c-coSS to KESSR5. W. G. EDDLEUAfO R. H. FINDLEYO TO* Copy ^1* E * JOYNER, M.D.O A. J. MARTINC* R. L. HAYC0CKO R. F. NZLS0N<* R. J. REYNOLDS O- H. E. WALKERS ftQM MANAGER, INDUSTRIAL HYGIENE HEAD 'OFFICE 3LT*JICT * VCM MEETING - APRIL 15, 1974 The meeting was held as the Industrial Bio-Test offices In Korchbrook (Chicago), Illinois. Attendees are noted on Attachment 1. Or. Goode, who is in charge of the inhalation work at the Decatur Lab reported on mortality results to date. These are shown as Attachment 2. He emphasized that the pathology was only in the slice. Grossly, the effects are nianifesced as subcutaneous masses, probable liver tumors and can foci on the lungs. The first observed change in the animals is a swelling of the abdomen. Death may occur suddenly within AS hours with no other apparent symptoms. Goode ascribes this to internal hemorrhage. To date there have been no gross observable' * effects on the control animals. Dr. Gordon, the Bio-Test pathologist, Chen gave his impressions. He called attention to a higher incidence of Cubits in the female mice. The compound-induced lung adenomas are indistinguishable from the spontaneous adenomas seen in these animals, but the Incidence appeared to be dose-related. Although some strains of mice do show spontaneous hemanglesarcomas of the liver, Gordon has seen this occur spontaneously only once at 1ST. Dr. Gordon, and Dr. Kociba who looked at the slides, agreed that the liver lesions are the same as seen and reported by Dr. Kaltoni. Gordon's data are presented in detail in Attachment 3. Mote that there are some discrepancies vich the gross data reported by Goode. This, however, was explained as a sex-identification error in the mice on a gross basis. Microscopic visualization of the gonads was used to verify Gordon's data. I asked about the discrepancies between the five-month and seven-month data. For example, six female mice at 2,500 ppm should have died of tumors in that period. Gordon's data show 15 females dying within that period. The I3T people were unable to explain the differences, but were going to check into it. The consensus of the group was that despite these minor discrepancies, the tumors were real and they confirmed Malconi's findings. On a ppm-hour basis, the tumors appeared at 1/AO the level that were noted in Halconi's rats. This may be speeies- or strain-specific. Zwieker (BFG) and Kennedy (Conoco^ both stated that there was a repore circulating in Europe that Kaleoni is seslng, " ... avalanches of hemangiosarcomas in his mice." No data were available, but the feeling was chat these new Mai coni results were similar to those at I3T. V 30`^b'72 903vxmz BFG53653 2 The government people present would make no coraicaenc about new levels. During lunch, however, I asked Lassiter what he thought the action might be. He felt that OSHA would have to review their position and could either now promulgate a proposed permanent standard sooner or could revise the emergency standard. He felt that the results reported would support the NIOSH recosssendacion of 1 ppm. Fairchild later agreed chat any so-called "zero standard" would be based on feasible analytic techniques available. He stated chat although NIOSH could analyze to levels under 1 ppm, the methods were not feasible for most installations. The discussion then turned to the nature of follow-up research. Dr. Scara stated that he already has orders from EPA to start inhalation toxicity studies on VCM. His own attitude is chat there should be no duplication of MCA work, but rather, there should be a coordinated governmentindustry approach. Fairchild also stated chat HIOSH will not be doing any animal work - it preferred to see what MCA will be doing before taking any action. He also stated that there is an HEW committee to coordinate toxicology and related programs which is active. A subcommittee has been formed to recommend protocols for testing carcinogens. The recowBendations of the subcommittee are to Include methods of determining levels of exposure whieh would lead to socially acceptable risks from carcinogens. (Emphasis mine). The Federal representatives thought that they would prefer to wait until the report was out before embarking on animal studies. Expected dace of publication is before Che end of May. With this the research coordinators recommended two action items. First was to cease mouse exposure at nine months. This will be equal to half a mouse's lifetime and would be comparable to a one-year exposure for races and hamsters. Second, the coordinators recommended that MCA investigate the costs of doing animal studies on larger numbers of animals at lower levels. The exact levels will be determined later, probably in conjunction with the HEW subcoannittee report. An offhand estimate was chat such studies would add about S200M-S50QM Co che overall budget. Scara pointed out chat EPA and FDA might help fund lov-level toxicity studies. He suggested writing to Dr. Charles Edwards (Assistant Secretary of HEW for Health) and to Russell Train (EPA Administrator) for assistance in obtaining the cooperation of the National Toxicity Research Center (Pine Bluff, Arkansas) In kilo- and mega-mouse studies. There was one ocher area of importance at che meeting. Jane Brodie of che New York Times phoned Dr. Fairchild at Northbrook. She seemed to know about che meeclngv who would be attending, the agenda, and che results. She wanted a statement from Fairchild regarding che significance of che results and what che Government would be doing about ie. Fairchild said chat he was at the meeting to listen, and was not sure he could get back to her in time for her deadline. By the time he left at 3:00 p.m. CDT, he had not called her back. MCA was preparing a statement for distribution on April 16. It was not completed at Che meeting and would probably be done by Clark, Johnson, and BFG53654 a> t-C* Cl o nF 3 Blevitt on their flight back to Washington. It was agreed'that the statement would be factual (rather than interpretive or speculative), would point out chat the results were preliminary, and that the results had been made available co government (OSHA, NIOSH, and I?A) the same time as they were released to the industry sponsors. It was to be clear that any statements would come from MCA rather chan from Bio-Test or from the individual company sponsors. Blevicc also mentioned that CBS was preparing a one-hour special on vinyl chloride. They were sending a camera co Goodyear at Niagara Falls along with Dr. Selikoff for the program. The meeting adjourned at 4:30 p.m. CDT. Attachments 30i-b74 BFG53655 25014508 ATTENDEES Zeb G. Bell A. S. Cusain w. D. Harris H. N. Johnson F. Kennedy R. J. Kociba H. L. Kusnecz W. E. Rinehart H. Smith T. R. Torkelson R. X. Wheeler B. F. Zvicker R. F. Blevitc A. C. Clark K. D. Johnson J. V. Goode D. E. Gordon M. L. Keplinger E. J. Fairchild D. V. Lassiter J. F. Stara PPG Industries Borden Company Uniroyal Iqc. B. F. Goodrich Conoco Dow Shell Oil Company Ethyl Corporation Air Products Dot/ Union Carbide Corporation B. B. Goodrich MCA MCA MCA IBT IBT IBT NIOSH CSHA EPA Attachment 1 25014509 BFG53656 Attachment 2 SEVEN-MONTH MORTALITY DATA - AS 0? APRIL 15, 19 74 (Deaths from all causes) Species Rat Mouse Hamster Control M/F 4/4 <2/3$a) 16/5 (8/2) 13/22 (9/18) 50 ppm M/F 10/8 (5/1) 31/9 (26/6) 20/20 (16/6) 200 ppm M/F 6/9 (6/1) 7/13 (2/2) 22/29 (16/20) 2,500 ppm^k) M/F 5/7 (3/4) 18/13 (8/7) 27/27 (15/15) NOTES: (a) Nos. in ( ) refer co corresponding five-month mortality data. (b) In addition, one group of 100 female rats had been exposed to 2,500 ppm, bue vich food available ad lib. There have been no deaths in this group to dace. 25014510 bKj53657 G rouo T-I T-II T -III !)nu~jJ/u&J BIO.- TEST taio frontage boao NOBTMBROOK.IUINOIS 60062 Jnc. Summary of Mortality Sc Tumor Data Among Vinyl Chloride Mice IBT Number 663-03222 (MCA) No. Mortalities with I'Jeoolasms location at lumors Lung Liver Skin ' Metastasis-a L 4 (1 Male, 3 Females ) 6 (1 Male, 5 Females) 2(50%) 3(50%) 2(50%) 4(66. 77) 2(5070 \ 2 \ 2(33%) . 1 19 (4 Males, IS Females) 17(89.5% 17(89. 54% 3(15. 8%) ; o i hi S^ ,'v \ i c-^j. 30^677. BFG53658 n o T > * o s CO K *' * 1 ' ` n 1 5 600t? Summary of 'rumors In Vinv-l <"Mtrifle Exposed Mice U3T Number 6(j3-03222-MCA I-rouo. Animal No., Sex Histowalholoc'^ Findings Date of Dcatl* -I .223 Male .110 Female 119 Female .200 Female Lime I-t vo r AA (SJ- HS (s)*" AA (si, Metastatic Skin Tumor HS (a) Metastatic Skin Tumor Skin EC. (para-aural) 3-20-74 3-24-74 EC k MC+ (Femoral region) 3-30-74 ? Female 309 Female 38 9 Male 38 2 Fema le 250 Female 299 Female '-ill 338 Female r Female do*: Female 598 Female 405 Male Male ..w* Fcma le 53 1 F emale 588 Female 393 Female 505 Female 565 Female Metastatic Skin T umo r - HS (s) AA (s) HS US (s) AA (s) HS (si AA (s) AA |s) AA (s) AA (s) AA (s) AA is) AA (s) AA is) AA (s) AA (a) AA (si HS (s) HS (s) HS (s) HS (s) HS (a) HS is) HS (s) HS (s) HS (s) HS (s) HS is) EC( Abdomen ) 3-5-74 3-18-74 3-25-74 4 -2-74 4-5-74 EC fc MC (Inguinal Region) 4-9-74 t-S<g> 3-6-"4 3-7-74 CO - j< 2-25-74 3-22-74 3-22-74 EC t< MC (Femoral region) 3-23-74 3-25-74 3-30-74 4-:- 74 4-3 -74 a,4-?a oO^G78 M g BFG53659 cisnosz BFG53660