Document reb9emRkJm4nJmv7x4grwOkz7
INTER-OFFICE CORRESPONDENCE
Date:
April 23, 1974
From:
Zeb G. Bell, Jr.
Location; 19 East
Subject:
Report on Conference With Industrial BiorTest on April 15, 1974
The attached are MCA's minutes of the Chicago meeting. I previously wrote a report on this subject on April 16, 1974.
Attachments
cc:
J. A. Clapperton L. B. Grant, M.D. W. R. Harris L. F. Sargert F. J,_ Trunzo_______
FORM 503-A REV 6-1-70
^J SL 092382
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 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
UNIROYAL, 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
W it i v [)
APR 2 21974
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MFG. DFt>r
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 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
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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
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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
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%\ AuU BI ) T E S T Iclxnabyi One.
1010 frontagf road
NORTHBROOK Illinois 60062
Summary of Tumors in Vinyl f'hloride Exposed Mice IBT Number 603 -03222 -MCA
TABLE
XX
- G- *roup. A....n..i..m. al N--o. .---S---e--x--
Tf MV? Male
'0 Female
1 i i V Female 1200 Female
Histopathologic Findings
Date of Death
Lung
Liver
Skin
A A (s)*
HS (s)**
AA (s), Metastatic
Skin Tumor
HS (s)
Metastatic Skin
Tumor
EC (para-aural) 3-20-74
3-24-74
EC k MC+ (Femoral
region)
3-30-74
* . y r i.'J i Female
1 `10') Female ! f- F '} Male i ''82 Female : '50 Female 12 99 Female
T UJ 1538 Female 1532 Female 1562 Female 1578 Female 1405 Male 1494 Male 1574 Female 1531 F emale
1588 Female 1 593 Female 1505 Female 1 565 Female 1409 Male 1 543 Female 1544 Female 1640 Female
1535 Female 14 32 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) A A (s) AA (s) AA (s)
HS (s)
HS (s) HS (s) HS (s) HS (s) IIS (s) HS (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 HS (s)
AA (s)
HS (s)
AA (s)
AA (si
HS (s)
Metastatic Skin
Tumor?
EC( Abdomen ) 3-5-74
3-18-74
3-25-74
4-2-74
4-5-74
EC k MC (Inguinal
Region)
4-9-74
LS<5>
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)
4-5-74 4-7-74
4-8-74
EC (Para-Aural)
MC ( Abdomen) EC( Pelvic region) 4-9-74
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Group
T-I T-II T -III
TABLE III
9ndiUt'ucuL BIO-TEST XalxMd/ymb, 3nc.
1810 FRONTAGE ROAD NORTHBROOK. ILLINOIS 60062
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-> Ll
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
Alveologonic Adenoma of 1 un^ (AA) ** Hemangiosarcoma of Liver ( HS) *** Epidermoid Carcinoma of Skin (EC) + Mammary Carcinoma of Skin (MC)
Lymphosarcoma of Thymus
(a) Multiple tumors of indicated type
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