Document pmKDwE06Vvo0QjLeNgemvdk0a

i MCA MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, 0, C. 20009 (202) 483-6126 April 17, 1974 kTo: 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 MCA from Industrial BIO-TEST personnel last week, a ' inference at the Northbrook, Illinois offices of IBT was up at which an oral status report on the chronic in halation studies with vinyl chloride was presented to MCA, idustry and federal agency representatives. in Those in attendance, and their affiliations, are below: Bell, Jr. Cummin Fairchild Goode Gordon Harris Johnson, M.D. Kennedy Keplinger Kociba Kusnetz Lassiter Rinehart Smith Stara fs> . Torkelson . Wheeler *'G. Zwicker -Blewitt Clark 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 ePL 00461 2- - r?.-: 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 seekj to demonstrate a "no effect level" of a human carcinogen j with a sensitive animal model of well-documented validity. Dr. Lassiter expressed a guarded judgment that the 4 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 retrospects morbidity and mortality studies being conducted by NIOSH/CDCj at nine or ten locations (six companies) around the country. No epidemiological data were presented. ms >ij 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 conducted 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 epl 0462 -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 : Mr. A. W. Barnes D. P. Duffield, M.D. Dr. Tiziano Garlanda Vinyl Chloride Management Contacts EPb 00463 TABLE 3 Mouse Mortality Data DATE Controls FM February 10, 1974 28 GROUP TI TII FM FM 6 26 24 Till FM 78 April 12, 1974 5 11 9 31 13 7 13 18 EPL 00464 ; mgm T1 102 3 Male i 1 10 Foma le J 11? Female 1200 Female T-H 1347 Female 1309 Female 1PP 9 Male 1 3R2 Female 13 4 0 Female 1299 Female T IIJ 1 5 38 Female 1532 Female 15 62 Female 1598 Female ] 4 0 5 Male 1494 Male 1574 Female 15 31 Female 1588 Female 1593 Frma lo 1505 Female 1 565 Female l-i0 9 Male 1543 ,Female 15)4 Temale 1546 Female 1535 Female 14 32 Male 1477 Female 'JtvihiAlAiul B! ) -TEST fr, hmJaWA, 9m. m io fronts or road MORTMCiROOK mii'IOi^ 6006? Summary of Tumors in Vinyl f hloridc Exposed Mice IDT Number 0u3-0322V-MCA TABLE II Histopathologic Findings Date of Death! Lung Liver Skin AA (s|* US (s); AA (s), Metastatic Skin Tumor HS (3) Metastatic Skin Tumor EC (para-aural) 3-20, \ At 3-24-7 EC k MC+ (Femoral It region) 3-30i Mela static Skin Tumor HS (s) AA (s) HS HS (s) AA (s) HS (s) AA (s) AA (s) AA (s) AA (s) A A (s) A A (s) A A (s) AA (s) HS (s) HS (s) HS (s) HS (s) HS (s) US (s) HS (s) A A (s) A A (s) AA (s) AA (s) A A (s) A A (S) A A (s) HS (s) HS (s) HS (s) HS (s) IIS (s) IIS (s) IIS HS (s) A A (f) AA (s) HS (s) A A (s) HS (s) Metastatic Ski n Tnmor ? gpL, 00465 EC( Abdomen) 3-5-74 3-18-7 3-25- 4-2-74 4-5; EC t MC (Inguinal ' Region) 4-9j LSO? 3-6-74 3-7, 3-8* 2-25] 3-221 3-22 EC & MC (Femoral* region) 3-231 3-25J 3-3$ 4-3 J 4-34 4-5j 4-5i 4* MC (Axillary region) 4-5j 4-7J 4*a EC (Para -Aural) MC ( Abdomen) EC( Pelvic region) -i: TABLE III 9njti&(/iUU BIO -TEST 1810 FRONTAGE ROAD NORTHBROOK, ILLINOIS 60062 Snc. Summary of Mortality & Tumor Data Among Vinyl Chloride Mice IBT Number 663-03222 (MCA) No. Mortalities with Neoplasms Location of Tumors Lung Liver Skin Metastasis-* Lun; 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 I* Alveologcnic Adenoma of J unp (AA) L** Hemangiosarcomn of Liver (US) I#** Epidermoid Carcinoma of Skin (EC) 3* Mammary Carcinoma of Skin (MC) Lymphosar coma of Thymus If) Multiple tumors of indicated type PL 00466