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MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE. N.W. WASHINGTON, D. C. 20009 (202) 483.6126 J ^ April 17, 1974 To: TECHNICAL TASK GROUP ON VINYL CHLORIDE RESEARCH Subject: Report on Conference with Industrial BIOTEST Laboratories, April 15. 1974 Gentlemen: As a result of the telephoned information received by MCA from Industrial BIO-TEST personnel last week, a conference at the Northbrook, Illinois offices of IBT was set up at which an oral status report on the chronic in halation studies with vinyl chloride was presented to MCA, industry and federal agency representatives. Those in attendance, and their affiliations, are shown below: Z. G. Bell, Jr. A. S. Cummin E. J. Fairchild J. w. Goode D. E. Gordon W. D. Harris M. N. Johnson, M.D. Flynt Kennedy M. L. Keplinger R. J. Kociba H. L. Kusnetz D. V. Lassiter W. E. Rinehart W. M. Smith J. F. Stara T. R. Torkelson R. N. Wheeler B. M. G. Zwicker R. F. Blewitt A. C. Clark K. D. Johnson PPG Industries, Inc. Borden, Inc. NIOSH Industrial BIO-TEST Laboratories Industrial BIO-TEST Laboratories UNI ROYAL, Inc. The B. F. Goodrich Company Continental Oil Company Industrial BIO-TEST Laboratories The Dow Chemical Company Shell Oil Company OSHA Ethyl Corporation Air Products & Chemicals, Inc. U. S. Environmental Protection Agency The Dow Chemical Company Union Carbide Corporation B. F. Goodrich Chemical Company MCA MCA MCA 0000836 J * 2- - Dr. Goode first presented the mortality data and gross observations, and then Dr. Gordon described the pathology observed in the mice. The data, as presented, are shown in the attached tables. There are apparent discrepancies between the total mortality data and the detailed listing of recent deaths. These will be re solved. No test-related pathology has yet been noted in any animals other than mice. Dr. Fairchild, of NXOSH, reported that Dr. David Rail, of HEW, had appointed a committee to coordinate departmental toxicology and related programs, and that under this committee there has been named a subcommittee to develop a ''white paper" on guidelines for research to determine "socially acceptable" levels of risk. A report from this subcommittee, which will cover both philosophical and statistical considerations, is expected in the next few weeks. Dr. Stara expressed the view that the vinyl chloride problem presented industry with a unique opportunity to seek to demonstrate a "no effect level" of a human carcinogen with a sensitive animal model of well-documented validity. Dr. Lassiter expressed a guarded judgment that the mouse data reported by IBT would not lead OSHA to modify the emergency temporary standard, but that it might well cause OSHA to accelerate the rule-making process for the development of a permanent standard. Dr. Lassiter also reported briefly on the retrospe ive morbidity and mortality studies being conducted by NIOSH/CLat nine or ten locations (six companies) around the country. No epidemiological data were presented. In an afternoon session of the Research Coordinators, it was agreed that the exposure of the mice in the present project should be terminated at nine months, but that exposures of both rats and hamsters should proceed for the initially-planned twelve months. It was further moved, seconded and carried that the chairman appoint a group to begin investigating the cost and availability of facilities of new experiments to be con ducted at lower levels of exposure, with larger groups of animals. He was asked specifically to seek to encourage the National Center for Toxicological Research, at Pine KSV 000083? -3- Bluff, Arkansas, to offer to undertake such a program. Details of the test protocol are to be left open until after the Rail committee makes its report available. The Research Coordinators asked MCA to call a meet ing of the Technical Task Group on Vinyl Chloride Research as soon as the report of Tabershaw^Cooper Associates on their epidemiological study reaches them. A copy of the MCA news release reporting the Industrial BIO-TEST mouse data has been sent to you in this morning's mail. Sincerely, Kenneth D. Johnson, Ph.D. Secretary Technical Task Group on Vinyl Chloride Research KDJ:mb Tables Attached cc s Mr. A. W. Barnes D. P. Duffield, M.D. Dr. Tiziano Garlanda Vinyl Chloride Management Contacts RSV 0000638 TABLE 2 Mouse Mortality Data DATE Controls FM February 10, 1974 28 GROUP TI Til FM FM 6 26 24 Till FM 78 April 12, 1974 5 11 9 31 13 7 13 18 RSV 0000839 9tv$uA-(Aiiil B1 J -TEST 'uzJ/yueA. Jnc. 1 8 tO FRONTAGP ROAD NORTHBROOK iMOIS 60062 Summary of Tumors in Vinyl f'Moride Exposed Mice iJJT Number 663-03222-MCA TABLE II Group, Animal No. . Sex T -1 1023 Male 1110 Female 1 1 1 9 Female 1200 Female Histopathologic Findings Date of Death Lung Liver Skin AA Is)* HS (s)** AA (s), Metastatic Skin Tumor HS (a) Metastatic Skin Tumor *** CC (para-aural) 3-20-74 3-24-74 EC & MC+ (Femoral region) 3-30-74 T -II 1347 Female 1309 Female 1889 Male 1382 Female 1350 Female 1299 Female T - III 1538 Female 1532 Female 1562 Female 1598 Female 1405 Male 1494 Male 1 574 Female 15 31 F emale 1588 Female 1593 Female 1505 Female 1565 Female 1409 Male 1543 Female 1544 Female 1546 Female 153 5 Female 1432 Male 1477 Female Metastatic Skin T umor HS (s) AA (s) HS HS (s) AA (s) HS is) AA (s) AA (s) AA (s) AA (s) AA (s) AA (s) AA (s) AA (s) HS (s) HS (s) HS (s) HS (s) HS (s) HS (s) HS (s) AA fs) AA (s) AA fs) AA (s) AA (s) AA (S) AA (s) HS (s) HS fs) HS (s) HS (s) HS (s) HS (s) HS HS (s) AA (s) AA (s) HS fs) A A (s) HS (s) Metastatic Skin Tumor? EC(Abdomen) 3-5-74 3-18-74 3-25-74 4-2-74 4-5-74 EC & MC (Inguinal Region) 4-9-74 LS<> 3-6-74 3-7-74 3-8-74 2-25-74 3-22-74 3-22-74 EC ?< MC (Femoral region) 3-23-74 3-25-74 3-30-74 4-3-74 4-3-74 4-5-74 4-5-74 MC (Axillary region) 4-5-74 4-5-74 4-7-74 4-8-74 EC (Para-Aural) MC ( Abdomen) EC( Pelvic region) 4-9-74 RSV 0000840 Group T-I T-II T-m TABLE III BIO -TEST 1810 FRONTAGE ROAD NORTHBROOK. ILLINOIS 60062 3nc. Summary of Mortality St Tumor Data Among Vinyl Chloride Mice IBT Number 663-03222 (MCA) No. Mortalities with Neoplasms Location ot 'iumors Lung Liver Skin Metastasis-> Luni 4 (1 Male, 3 Females) 2(50%) 2(50%) 2(50%) 2 6 (1 Male, 5 Females) 3(50%) 4(66.7%) 2(33%) 1 19 (4 Males, 15 Females) 17(89.5% 17(89.5 %) 3(15.8%) Key to Symbols * Alveologenic Adenoma of 1 un^ (AA) ** Hemangiosarcoma of Liver ( HS) *** Epidermoid Carcinoma of Skin (EC) + Mammary Carcinoma of Skin (MC) ^ Lymphosarcoma of Thymus (s) Multiple tumors of indicated type RSV 0000841