Document QJ2o6RKOgOw04XELQK2bwNDB7

MANUFACTURING CHEMISTS ASSOCIATION / 1fi25 CONNECTICUT AVENUS. N. W. WASHINGTON, 0. C. 20009 (202M83-6126 Q c frr RECEIVED To: 7jD is L/v is J SFC OHr APR 2 4 1974 April 17, 1974 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 MV N. Johnson, M.D. Plynt Kennedy M. L. Keplinger R. J. Kociba H. L-. Kusnet2 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 \f 1/ r ^ i"' bFG53661 frT S fclO S g 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 noced in any animals other than mice. Dr..Fairchild, of NIOSH, 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 dal^a 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 retrospective morbidity and mortality studies being conducted by NIOSH/CDC at 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 BFG53662 -3- Sluff, Arkansas, to offer to undertake such a program. Details of the test protocol are to be left CDen 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 : Mr. A. W. Barnes D. P. Duffield, M.D. Dr. Tiziano Garlanda Vinyl Chloride Management Contacts vvc 0000007^7 BFG53663 a c fj I" c ytidLtf.Ou&J. b: 3 -TEST XrJyjicMywu,. J'tic. 1010 f SOnIaGP OOAO jO T h o ROO r 'Cl S 6006? Summary of Tumors in Vit\H `)iloridc Exposed Mice i 131* Number 00 J - 03222 -MCA TABLE II Grouo, Aniinal No. . Sex T -1 1023 Male 1110 Female 1 119 Female 1200 Female mstopatnoioc Lung- Live r AA (s)55 HS {5)** AA (s), Metastatic Skin Tumor HS ( 3) 'Metastatic Skin Tumor jk i n EC (para-aural) 3-20-74 3-24-74 EC & MC+ (Femoral region) 3-30-74 T-11 1347 Female . 1309 Female 1889 Male 1382 Female 3350 Female 299 Female T-m 1538 Female 1532 Female1562 F emale 1598 Female 1405 Male 1494 Male 1574 Female 1531 Female 1588 Female 1593 Fcma le 3505 Ferriale 1565 Female 1409 Male 1543 Female 1544 Female 1546 Female 1535 Female 1432 Male *1477 Female . Metastatic Skin Tumor HS (s) AA (s) HS HS`(s) AA (s) HS (s) AA (s) . AA (s) AA (s) AA (s) AA (s) AA <s] AA (s) AA (s) - AA (s) AA .(s) AA (s) AA (s) AA (s) AA (S) AA <s> HS (s) HS (s) HS (s) HS (si HS (s) HS is) HS (s) HS (s) HS (s) HS (s) HS (s) HS (s) HS (s) HS HS (s) AA (s) AA (s) HS (s) AA (s) HS (s) Metastatic Skin Tumo r ? EC( Abdomen ) 3-5-74 . 3-18-74 * 3--2S -74 *4-2-74 4-5-74 EC & MC (Inguinal Region) 4-9-74 - LSO 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 4-5-74 MC (Axillary region) 4-5 - 4 4-7-74 cn c 4-8-"** EC (Para -Aural) *& c/ h MC ( Abdomen) EC( Pelvic region) 4 - - 1 BFG53664 Grouo T-I T-II T-III 9nduJ^iud B I o - t E s T 1810 FRONTAGE ROAD NORTHBROOK. ILLINOIS 60062 TAELE III Summary of Mortality & Tumor Data Among Vinyl Chloride Mice 1BT Number 663 -03222 (MCA) No. Mortalities with Neoolasms Location ot iumors Lune Liver Skin Metastasis-^ I 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 * Alveologcnic Adenoma of J uny (AA) Hcmangiosarcomn of Liver (MS) *** Epidermoid Carcinoma of Skin (EC) + Mammary Carcinoma of Skin (MC) ^ Lymphosarcoma of Thymus * (s) Multiple tumors of .indicated type oooooo759 wc BFG53665 BFG53666