Document jBV5V4eEnMRYqDX2vQKY39ON5

MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE. N.W. WASHINGTON. D. C. 20009 (202)483-6126 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 l5 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: G. Bell, Jr. S. Cummin J. Fairchild W. Goode E. Gordon D. Harris N. Johnson, M.D. fnt Kennedy L. Keplinger J. Kociba L. Kusnetz V. Lassiter E. Rinehart M. Smith F. Stara R. Torkelson R. N. Wheeler B. M. G. Zwicker R. F. Blewitt A. C. Clark D. Johnson PPG Industries, Inc. Borden, Inc. NIOSH Industrial BIO-TEST Laboratories Industrial BIO-TEST Laboratories UNIROYAL, Inc. The. B. F. Goodrich Company Continental Oil Company Industrial BIO-TEST Laboratories The Dow Chemical Company Shell Oil Company OS HA 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 ** <09 it-- BFG09172 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 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 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 retrospectiv 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. ,r 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 BFG09173 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 1s 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 BFG09174 \ TABLE 3 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 to V* BFG09175 JlU.ib.iAi-bul Bl 3-TEST J'uhvataw.A, Stic. ini') rRONlAGf r?o AO moptmoroo*-' . 11 i ' i o i r 60 06? Sumina r y of Tumors in Vinvl < hlorble Exposed Mice TABLE II 1UT Number Obi - 0 3 22 2 - MC A Group, Animal No. , Sex Histopathologic Findings Dale of Deaths T -1 J 02 3 Male 1 1 10 I V: male J 1 19 Female 1 200 Fernale Lung Liver A A (s ) * US (s)! A A (s ), Mctaslatic Skin Tumor US (s) Metastatic Skin Tumor L> k i n *4* EC (para-aural) 3-20- 7 'M EC h MC*- (Femoral Gsi region) 3-30-74j T -1 i 1347 Female 1 3 09 Eema le If-99 Male 13RZ Female J 7 C f) p,> rn;, J J. 1?.99 Female T- f77 15.33 Female 1 5 3 2 Female 1562 Female 1598 Female 1405 Male 1494 Male 1674 Female 15 31 Female 1 588 Female 1 5 93 Foma le 1505 Female 1 56 5 Foma le 1409 Male 1543 Female 1544 Female 154.6 Female 1535 Female 1432 Male 1477 Female Mela static Skin Tumo r ns (s) AA (s) US US (s> A A (s ) HS (s) AA (s) AA (s) A A (s) AA (s) AA (s) AA (s) AA (s) AA (s) HS (s) HS (s) IIS (s) HS (s) HS (s) IIS (s) HS (s) A A (s ) A A (s) AA (s) A A (s) A A (s) A A (S) AA (s) HS (s) HS (s> HS (s) HS (s) US (s) ns (s) MS HS (s) A A (s) AA (s) HS (s) AA (s) HS (s) M r 1 a s f. a 11 c Sktn Tumor ? EC( Abdomen ) 3-5-74] EC b MC (Inguinal Region) 4-9-7` LSGP 3-6-74 3-7-7^ 3-8-74 2 - 253 3-2 ZS 3-22J EC b MC (Femoral region) 3 - 2i MC (Axillary reg ion) EC (Para -Aural) MC ( Abdomen) EC( Pelvic regionJJ 2X081023 M BFG09176 Uh: proup aarf.-;. H|- 74s -74; SgJ'" TABLE III 9nduA-UiCoL BIO -TEST 1810 FRONTAGE ROAD NORTHBROOK. ILLINOIS 60062 3nc. Summary of Mortality & Tumor Data Among Vinyl Chloride Mice IBT Number 663-03222 (MCA) No. Mortalities with Neoplasms Location ot Tumors 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%) l-i- jKcy to Symbols Alveologcnic Adnnoma of ] unp (AA) Hemangiosarcomn of Liver ( HS) ** Epidermoid Carcinoma of Skin (EC) Mammary Carcinoma of Skin (MC) Lymphosarcoma of Thymus l) ' Multiple tumors of indicated type mmorz 0 - nL BFG09177