Document Eqm44z77dQ5e20J2e91LV1OdN
, SHELL OIL CO.v.PaN
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c< -c.*cOS'bc:r 5Alf APRIL 16, 1974
to MESSRS. V. C. EDDLE2tAN<>
R. H. FINDLEY<3-
This Copy For
2. JOYNER, H.D.O
A. J. MARTIN O
R. L. KAYCOCK<>
R. F. NELSONS
R. J. REYNOLDSO
H. E. WALKER -5>
rtOM
MANAGER, INDUSTRIAL KYC HEAD'OFFICE
SUMJtCT VCM MEETING - APRIL 15,
The meeting vas held ac the Industrial Bio-Test offices in Northbrook (Chicago), Illinois. Attendees are noted on Attachment 1. Dr. Goode, who is in charge of the inhalation work at the Decatur Lab reported on mortality results to date. These are shown as Attachment 2. He emphasized that the pathology was only in the mice. Grossly, the effects are manifested as subcutaneous masses, probable liver tumors and can foci on the lungs. The first observed change in the animals is a swelling of the abdomen. Death say oceur suddenly within 48 hours with no ocher apparent symptoms. Goode ascribes this to internal hemorrhage. To dace there have been no gross observable- * effects on che control animals.
Dr. Cordon, che Bio-Test pathologist, then gave his impressions. Ke called attention to a higher incidence of tumors in the female mice. The compound-induced lung adenomas are iadistinguishable from che spontaneous adenomas seen in these animals, but che incidence appeared to be dose-related. Although some strains of mice dc show spontaneous heaangicsarcomas of the liver, Gordon has seen this occur spontaneously only once at 13T. Dr. Gordon, and Dr. Kociba who looked ac che slides, agreed chat the liver lesions are che same as seen and reported by Dr. Maltoni.
Gordon's data are presented in detail in Attachment 3. Note that there are some discrepancies with che gross data reported by Goode. This, however, vas explained as a sex-identification error in che mice on a gross basis. Microscopic visualization of che gonads vas used to verify Gordon's data. I asked aboue che discrepancies between che five-month and seven-month data. For example, six female mice ac 2,500 ppm should have died of tumors in that period. Gordon's data show IS females dying within chat period. The I3T people were unable to explain the differences, but were going to cheek into it.
The consensus of che group vas that despite these minor discrepancies, che euaors were real and they confirmed Malconi's findings. On a ppm-hour basis, the tumors appeared at 1/40 che level that were noted in Kalteni's rats. This may be species-- or strain-specific. Zvicker (BFG) and Kennedy (Conoco both stated that there was a report circulating In Europe chat MaiConi is seeing, M ... avalanches of hemangiosapeoaas in bis mice." Ho data were available, but che feeling vas chat these new Hal ton! results vere similar to chose ac I3T.
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The government people present would cuke no cot=itaent about new levels. During lunch, however, I asked Lassiter what he thought the action night be. He felt that CSKA would have to review their position and could either now promulgate a proposed permanent standard sooner or could revise the emergency standard. He felt that the results reported would support the NIOSH recosaendation of 1 ppm. Fairchild later agreed that any so-called "zero standard" would be based on feasible analytic techniques available. He stated chat although NIOSH could analyze to levels under 1 ppm, the methods were not feasible for most installations.
The discussion then turned to the nature of follov-up research. Dr. Scara stated chat he already has orders from EPA to start inhalation toxicity studies on VCM. His own attitude is that there should be no duplication of MCA work, but rather, there should be a coordinated governmentindustry approach. Fairchild also stated that NIOSH will not be doing any animal work - ic preferred to see what MCA will be doing before taking any action. He also stated that there is an HEW committee to coordinate toxicology and related programs which is active. A subcommittee has been formed to recommend protocols for testing carcinogens. The recotanendations of the subcommittee are to Include methods of determining levels of exposure which would lead to socially acceptable risks from carcinogens. (Emphasis mine). The Federal representatives thought that they would prefer to wait until the report was out before embarking on animal studies. Expected dace of publication is before the end of May.
With this the research coordinators recommended cvo action items. First was to cease mouse exposure at oine months. This will be equal to half a souse's lifetime and would be comparable to a one-year exposure for races and hamsters. Second, the coordinators recommended chat MCA investigate the costs of doing animal studies on larger numbers of animals at lover levels. The exact levels will be determined later, probably in conjunction with the HEW subcommittee report. An offhand estimate was chat such studies would add about $200M-$500M to the overall budget. Scare pointed out that EPA and FDA might help fund low-level toxicity studies. He suggested writing to Dr. Charles Edwards (Assistant Secretary of HEW for Health) and to Russell Train (EPA Administrator) for assistance In obtaining the cooperation of Che National Toxicity Research Center (Pine Bluff, Arkansas) in kilo- and mega-mouse studies.
There was one oeher area of importance at Che meeting. Jane Brodie of the New York Times phoned Dr. Fairchild at Northbrook. She seemed to know about the meeting, who would be attending, the agenda, and the results. She wanted a statement from Fairchild regarding the significance of the results and what the Government would be doing about ic. Fairchild said chat he was ae the meeting to listen, and was not sure he could get back to her in time for her deadline. By che time he left at 3:00 p.m. CDT, he had not called her back.
MCA was preparing a statement for distribution on April 16. Ic was not completed at che meeting and would probably be done by Clark, Johnson, and
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Blewict on their flight back co Washington. It was agreed 'that the statement would be factual (rather chan interpretive or speculative), would point out chat the results were preliminary, and that the results had been made available co government (OSHA, NIOSH, and SPA) the same time as they were released to che industry sponsors. It was to be clear chat any statements would come from MCA rather than from Bio-Test or from the individual company sponsors.
Blewict also mentioned that CBS was preparing a one-hour special on vinyl chloride. They were sending a camera co Goodyear at Niagara Palls along with Dr. Selikoff for the program.
The meeting adjourned at 4:30 p.m. CDT.
Attachments
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ATTEHDtZS
Zeb G. Bell
- ??C Industries
A* S. Cunain
- Borden Coapany
W. D. Harris
- tfniroyal Inc.
M. N. Johnson - B. F. Goodrich
F. Kennedy
- Conoco
R. J. Kociba
- Dow
K. L. Kustiecz Shell Oil Coapany
W. E. Rinehart - Ethyl Corporation
H. Snith
- Air Products
T. R. Torkelson - Dow
R. X. Wheeler - Union Carbide Corporation
3. F. Zvicker -3. B. Goodrich
R. F. Blevitt - MCA
A. C. Clark
- MCA
K. D. Johnson - MCA
J. V. Goode
- IBT
0. . Gordon
- IBT
M. L. Keplinger - IBT E. J. Fairchild - NIOSH
D. V. Lassiter OSHA
J. F. Scara
- E?A
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Attachment 2
SEVEN-MONTH MORTAlITV DATA - AS Or APRI L 15. 1974 (Deaths from all causes)
Species
Rat Mouse Hamster
Control M/F
4/4 (2/3$a)
16/5 (8/2)
13/22 (9/18)
50 ppm M/T
10/8 (5/1)
31/9 (26/6)
20/20 (16/6)
200 ppa M/F
6/9 (6/1)
7/13 (2/2)
22/29 (16/20)
2,500 ppmCb) M/F
5/7 (3/4)
18/13 (8/7)
27/27 (15/15)
NOTES: (a) Nos. in ( ) refer to corresponding five-month mortality data.
(b) In addition, one group of 100 female rats had been exposed to 2,500 ppm, but vich food available ad lib. There have been no deaths in this group to dace.
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Summary of Mortality k Tumor Data Among Vinyl Chloride Mice IBT Number 663-03222 (MCA)
No. Mortalities with Neoolasms
4 (1 Male, 3 Females) 6 (1 Male, S Females) 19 (4 Males, 15 Females)
Docation ot lumors
Duns
Dive r
2(50%)
2(50%)
3(50%)
4(66.7%)
Skin ' Metastasis-* L
\ 2(50%) \ 2
\ 2(33%) . 1
17(89. 5%: 17(89. 5*% 3(15. 8%) i
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Summary of Tumori in Vinyl 1 'Morale I13T Number fro J-0322 2 - Mr a
m,Cc
-.-rmn Animal No. . Sex
-I .12 3 Male . i 10 Female
I l 9 Fe ma tc .200 Female
Histopathologic Ftr
Lung
Live r
A A (s|*
HS {si**
AA {$), Metastatic
Skin Tumo r HS (a)
Metastatic Skin
Tumor
Skin
Dal's of a*.h
tS!* EC. (para-aural) 3-20-74
3-24-74
EC k MC*- (Femoral
region)
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'-II " ' 7 Female
20^ Female
= 8 9 Male 382 Female
50 Fema le 99 Female
III 3 8 Fema le
F emale 04 Female 98 Female 405 Male 4ah Male ___ F c ma le 5 3 1 Female
588 Female 393 Female 505 Female 565 Female
Metastatic Skin
Tumor
HS (s)
AA (s)
HS HS (s)
AA (s)
HS (s)
AA (*)
AA (s) A A (s) AA (3) AA (3) AA (3) AA (3) AA (3)
A A (l AA (3) AA (s)
HS (3)
HS (s) HS (3) HS (s) HS is) HS (3) HS ( 3 )
HS (s) HS (s) HS (3) HS (s)
EC(Abdonien) 3-5-74
3-18-74
3-25-74
4-2-74
4-5-74
EC lc NIC (Inguinal
Region)
4-9-74
L5
3-6-74 3-7-74 3-8-74
2-25-74
3-22-74
3-22-74
EC t* MC (Femoral
region)
3-23-74 3-25-74
3-30-74
4-2 -74
4-3-74
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