CMA Making Better Science Through Money
Prospective Research Program on the Carcinogenic Potential of Vinyl Chloride
CMA Interoffice Confidential Memo 5jun72
Source: Manufacturing Chemists Association interoffice memorandum obtained through litigation and/or Freedom of Information Act
Manufacturing Chemists Association
INTEROFFICE MEMORANDUM
February 2, 1972
To: Mr. W.J.
Driver
From: George E. Fleet
Subjects: Prospective Research Program on the Carcinogenic Potential of
Vinyl Chloride
Herewith is the proposal concerning OCA administration ref subject research program as proposed by the Ad Hoc Planning Group on Vinyl Chloride Research, representing companies Which had shown interest.
On your suggestion. this is submitted now for consideration by the Executive Committee in principle, so that it can be presented swore promptly for board approval if. underwriting contributions are pledged.
Attachment
CC: Mr. J.R. Carnes (?)
Mr. V.M Peterson (?)
Dr. M.D. Johnson
CMA 004247
Prospective Research Program
on
Carcinogenic Potential of Vinyl Chloride
Since Dr. P. L. Viola of Route, Italy, reported findings of malignant tumors in experimental animals from inhalation of vinyl chloride monomer vapor, consideration by a group of interested companies has been given to a further investigation of this matter. A research proposal was formulated by an Ad Hoc Planning Group for Vinyl Chloride Research representing the interested companies, with a projected three-year budget of $350,000 to be supported collectively by voluntary contributions.
If commitment of the funds is forthcoming, and this opportunity is now before about fifty companies as potential contributors, it is proposed that this project go forward under MCA administration. A description outlining the nature of the research anal the terms under which it would proceed is attached.
The staff recommends approval, subject to funds becoming available.
MCA
2/8/72 - EC
CMA004248
DRAFT
Not for circulation or release
DESCRIPTION
Proposed
Research Program
on
Carcinogenic Potential of Vinyl Chloride
PURPOSE
The purpose of this program, collectively =ended by voluntary subscriptions from interested companies, is to provide technical information to clarify the status of vinyl chlorite (monomer) in reference to carcinogenicity.
INITIAL PROJECT
As recommended by an Ad Hoc Planning Group for Vinyl Chloride Research, composed of representatives of eight MCA .member companies, the immediate undertaking is as follows, with projected costs:
| Animal Exposure Study | |
| Contractor's costs* | $ 183,000 |
| Vinyl chloride supply and other sponsor-furnished services | 30,000 |
| Epidemiological Study | |
| Feasibility investigation | 20,000 |
| Main program | 100,000 |
| Contingency | 17,000 |
| $ 350,000 |
*Based on the attached testing protocol, which is subject to modification by common agreement as the project proceeds.
The contractor's cost cited is that given in a formal proposal by Industrial Bio-Test Laboratories, lac, dated June 28, 1971, supplemented by letter dated October 28, 1971. The Animal Exposure Study would be conducted under a contract between Industrial Bio-Test and MCA. The Epidemiological Study would be
CMA 004249
-2-
similarly contracted with an independent research organization or an educational institution, not yet selected. The projected duration of the initial undertaking is three years.
SUPERVISION
This program would be supervised on MCA's behalf by a Technical Task Group composed of one technical representative from each subscribing company plus an assigned MCA staff representative, who would serve as secretary.
Organizationally within MCA, the Task Group would function under the jurisdiction of the Occupational Health Committee.
FUNDING
In accord with preference expressed by representatives of companies taking part in exploratory consideration, subscribing companies would share in financial support approximately in proportion to their share of total-tonnage production capacity (vinyl chloride monomer plus polyvinyl chloride) so represented, based or, publicly available figures. For good reason, exceptions may be made by common consent.
In accord with prior commitments by subscribing companies, support funds would be subject to advance collection by MCA on the following schedule: Initially - 60% of share; one year later 30% of share; end o:. second year - remainder of share (if needed;. Disbursements would be subject to MCA staff clearance and approval.
STIPULATIONS
The scientific information developed from this program would be fully disclosed, without restriction. For purposes of consistency and control, however, all releases would be made solely through MCA, normally based on Task Group recommendations as to nature and timing. This requirement would not preclude private interchange of noncompetitive scientific information, including that among subscribing companies, useful to advancement of the program. It would be an obligation to inform the MCA staff representative about all such related communications other than those internal to the company.
OPERATION
The Task Group would be governed by the requirements of MCA's "General Principles Applicable to the Structure and Operations of Committees" and the Rules of Organization and Procedure of the occupational Health Committee.
MCA - 1/27/72
CMA 004250
Proposed
Research and Study Program
on
Environmental and Occupational Health hazards
or
Vinyl Chloride
Background
Since action by the Board on January 9, 1973, authorizing a special project to clarify the status of vinyl chloride monomer as an alleged carcinogen, it has become apparent from both animal studies and occupational health experience that this chemical must be so regarded. OSHA has promulgated temporary emergency standards and has proposed still more stringent permanent standards for vinyl chloride.
Purpose
MCA members and other companies involved in the synthesis and polymerization of vinyl chloride, who are now supporting the current project consider it essential to expand and accelerate --,search to ascertain conditions necessary to assure the safety of workers involved in the manufacture and use of these products, and oŁ the communities in which they are made.
Program
The Technical Task Group an Vinyl Chloride Research established by the 1973 Board action has recommended the support oŁ the following contract research projects:
1. a study of the. metabolism of vinyl chloride,
2. a study of teratogenesis by vinyl chloride,
3. chronic inhalation studies at concentrations below 50 ppm, in an effort to identify a "no-effects" level, and
4. an acute inhalation experiment in which animals will be subjected to a single, acute, massive exposure simulating conditions which might be experienced by a community fumigated by a tank car rupture in a transportation accident. The animals would then be observed for the remainder of their lifespan.
CMA 004251
- 2 -
Projects (1) and (2) would be conducted by The Dow Chemical Company with support by, and on behalf of the project sponsors
Protects (3) and (4.) would be conducted by Industrial 210-:25T Laboratories, Inc.
The Technical Task Group on Vinyl Chloride Research and its working subgroups, as appropriate to further the purposes of this program, would also develop and make publicly available technical reports on work practices, industrial hygiene monitoring and analysis, and the medical surveillance of exposed workers.
Funding
Funding commitments are now being -received from the thirty-one sponsors of the current program sufficient in the aggregate to cover the $400,000 to $500,000 estimated to be required for the completion of the indicated program. Because of the fluid status of scientific knowledge and regulatory climate with respect to vinyl chloride, upward revision of this cost estimate may be necessary to permit desirable modifications of test protocols. Any such cost increases will be funded by the sponsors.
Supervision
The program is to be supervised on MCA's behalf by the Technical Task Group on vinyl Chloride Research composed of one technical representative from each subscribing company, plus an MCA staff representative to serve as secretary.
Stipulations
The scientific information developed from this program is to be fully disclosed, without restriction. For purposes of consistency and control, however, all releases are to be made solely through MCA, normally based on 'Cask Group recommendations as to nature and timing. This requirement would not preclude private scientific interchange of non-competitive information useful, to advancement of the program, nor relevant non-competitive private communication within and among subscribing compasses. It would be an obligation to Lnform the MCA staff representative on a current basis about all such interchange communications ocher than those internal to the company.
CMA 004252
-3-
Recommendation
The staff recommends approval of this proposal.
MCA
EC - 5/74/72
BD - 6/5/72
CMA 004253
Proposed
Research Program
on
Carcinogenic Potential Of Vinyl Chloride
Purpose
The purpose o- this program is to provide scientific information to clarify the status of vinyl chloride (monomer) in reference to carcinogenicity.
Project
As recommended by an Ad Hoc Planning Group for Vinyl Chloride Research, composed of representatives of eight MCA member companies, the project is to contract for animal testing research under which experimental animals would inhale vinyl chloride monomer vapor at selected concentration levels and be examined in accord with an agreed-upon testing and examination protocol. Planned duration of the project is three years.
According to quotations from Industrial Bio-Test Laboratories, Inc., with which the contract is in prospect, and an allowance for vinyl chloride supply and contingencies, the projected cost is $193,000.
Funding
Funding commitments have been received from seventeen MCA member companies sufficient in the aggregate to cover the stated cost. Company shares are pro-rated on the basis of publicly announced tonnage production capacity for vinyl chloride monomer plus polyvinyl chloride.
Disbursements are to be subject to MCA staff clearance and approval.
Supervision
The program is to be supervised on MCA's behalf by a Technical Task Group on Vinyl chloride Research composed of one technical representative from each subscribing company, plus an MCA staff representative to serve as secretary.,
Administratively, the Task Group is to function under the jurisdiction of the occupational Health Committee.
CMA 004257
Stipulations
The scientific information developed from this program is to be fully disclosed without restriction. For purposes of consistency and control, however, all releases are to be made solely through MCA, normally based on Task Group recommendations as to nature and timing. This requirement would not preclude private scientific interchange of non-competitive information useful to advancement of the program, nor relevant private communication within and among subscribing companies. it would he an obligation to inform the MCA staff representative on a current basis about all such related interchanges and communications other than those internal to the company.
Operation
The Task Group is to be governed by the requirements of MCA's "General Principles Applicable to the Structure and operations of Committees" and the Rules of Organization and Procedure of the Occupational Health Committee.
MCA
EC - 11/20/72
CMA 004258
Prospective Research Project
Carcinogenic Potential of Vinyl Chloride Monomer
|
Contributors |
Combined |
% |
Proportionate |
Division of |
First & second |
Final payment |
|
Air Products |
160 |
1.9 |
$ 3,1.35 |
$ |
$1,254 |
$627 |
|
Allied chemical |
440 |
5.1 |
8,415 |
|
3,366 |
1,683 |
|
Borden Chemical |
390 2 |
4.5 |
7,425 |
9,334 |
6,703.60 |
3,351.80 |
|
Conoco |
830 |
9.7 |
16,005 |
|
6,402 |
3,201 |
|
Dow |
1,200 |
14_0 |
23,100 |
|
9,240 |
4,620 |
|
Ethyl |
450 |
5.3 |
8,745 |
|
3,498 |
1,749 |
|
Exxon |
(150) 3 |
1.8 |
2,970 |
|
1,186 |
594 |
|
Firestone |
240 |
2.8 |
4,620 |
|
1,848 |
924 |
|
Goodrich |
1,600 |
18.7 |
30,855 |
|
12,342 |
6,171 |
|
Monsanto |
150 |
1.8 |
2,970 |
|
1,188 |
594 |
|
Olin |
150 |
1.8 |
2,970 |
|
1,188 |
5911 |
|
PPG |
900 |
10.5 |
17,325 |
|
6,936 |
3,465 |
|
Shell |
800 |
9.4 |
15,510 |
|
6,204 |
3,102 |
|
Stauffer |
150 |
1.8 |
2,970 |
|
1,180 |
594 |
|
Tenneco |
300 |
3.5 |
5,775 |
9,333 |
6,043.20 |
3,021.60 |
|
Union Carbide |
350 |
4.1 |
6,765 |
|
2,706 |
1,353 |
|
UNIROYAL |
285 |
3.3 |
5,445 |
9,333 |
5,911.20 |
2,955.60 |
|
|
8,545 |
100.0 |
$165,000 |
$28,000 |
$77,200 |
$38,600 |
1 For one additional exposure level with
acetylene-derived monomer
2 Includes Monchem capacity
3 Non-producer; participation based on matching
lowest capacity level among producer participants
CMA 004258
|
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