Document Vjgegaa4wmx3dvg6zBKEzVv3q
CHEMICAL MANUFACTURERS ASSOCIATION
March 19, 1981
To: Members of the Vinyl Chloride Program Panel
Dear Panel Member:
The enclosed Annual Report on Vinyl Chloride was prepared by Dr. T. R. Torkelson and myself for presenta tion to the Special Programs Advisory Group (SPAG) on April 21, 1981. Please send your comments to me with a copy to Dr. Torkelson by April 1, 1981. The Panel Chairman and CMA will revise the annual report based on your comments and will send it to SPAG on April 8, 1981. All Panel members will receive a copy of the revised report.
If you have any questions on this report, or the functioning of SPAG, please call me at 202/887-1196.
Sincerely,
CRS :md Enclosure
Carol R. Stack, Ph.D. Administrator Vinyl Chloride Proaram
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Vinyl Chloride - SPAG Review
1.0 Charter (separate page)
2.0 Uses
Manufacture of polyvinyl chloride and copolymers;, organic synthesis; adhesives for plastics.
3.0 Background and Objectives
a. Introduction
CMA has had a long-standing interest in vinyl chloride monomer. In the early 1960s, the then Manufacturing Chemists Association arranged for a study at the University of Michigan on aeroosteolysis (softening of finger tip bones) in VCM/PVC workers. The findings wre published by the American Medical Association in the January 1971 issue of "Archives of Environmental Health".
In 1971, at the recommendation of MCA's Occupational Health Committee, U.S. VCM/PVC producers were approached with the proposal that they might wish to support a research program to answer questions on vinyl chloride carcinogenesis raised by Dr. Viola's studies at the Regina Elena Institute for Cancer Research in Italy. A conference of interested member companies was held in November 1971; twenty producers were represented. An ad hoc planning group for vinyl chloride research (precursor to the present Vinyl Chloride Research Coordinators) was formed at the conference to provide review of research proposals and funding require ments. By early 1972, it was established that seventeen companies would support a vinyl chloride research program. The group of sponsoring companies, known then as the "Technical Task Group on Vinyl Chloride" was the first Vinyl Chloride Program Panel. The objective of the Task Group (Panel) was to expand the toxicology data base, thereby lending support to certain health and safety issues surrounding exposure to vinyl chloride monomer in the workplace.
b. Research Programs
i. IBT Study
A research contract was negotiated with IBT Laboratories in February 1973 to conduct a chronic vinyl chloride inhalation study in rats, mice and hamsters. IBT submitted interim reports to CMA during the course of the two-year study but issued no final report. Subsequent audits by both CMA and third parties found irreparable deficiencies in the study. CMA entered into negotiations for settlement with IBT last year and an agreement was
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reached. Companies participating in the research program will be refunded on the same pro-rated basis as they contributed to the project.
ii. Dow Studies
In 1974, the Program Panel agreed to fund a tera tology study in mice, rats and rabbits to be conducted at Dow Chemical Research Laboratories. Results were published in a March 1977 issue of "Toxicology and Applied Pharmacology". The data indicated that vinyl chloride did not cause significant embryonal or fetal toxicity and was not teratogenic in any of the species at the concentrations tested (up to 2500 ppm).
A contract was executed with Dow in November 1976 to conduct a pharmacokinetic/metabolism study of vinyl chloride in rats. This research was an extension of similar studies being performed at Dow. A summary of the research was submitted to CMA in May 1977.
iii. University of Louisville Research Program (Phase ViT)
In 1975, the emphasis on research shifted from toxicological investigations to one more directly related to the early diagnosis and clinical management of vinyl chloride injuries resulting from past industrial exposure. Accordingly, the Panel approved support of a grant to the University of Louisville for the development of "Research Techniques and Methods for Detection and Prevention of Carcinogenesis in Industrial Workers". Support of the research continued and two further agreements were signed with the University in 1978 and 1979. Final reports for the first and second years were received; the third is antici pated shortly. Continued funding of this program by the Panel is not likely.
iiii. Epidemiology Studies
A contract was awarded to Tabershaw Cooper Associates, Inc. (TCA) in June 1973 to conduct an epidemi ology study of vinyl chloride workers. A final report issued by Equitable Environmental Health Associates (successor to TCA) included 10,173 individuals. Brain tumor incidence was found to be in excess but did not apear to be related to either the duration or intensity of exposure to vinyl chloride. Weak associations between vinyl chloride exposure and malignancies at other sites were noted. EEH suggested that the cohort be studied again five years hence, since observation time would be extended and more deaths available for analysis.
4. Membership
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Panel
separate pp.
Task Group
5. Research Programs a. Completed studies (Table) b. Future studies
The Program Panel has considered a proposal from Environmental Health Associates, Inc. (EHA) to update the 1978 EEH epidemiology study (see above). In this study, work histories of the 10,000 member cohort will be .updated through December 1979. Twenty companies are supporting this program (re: Vinyl Chloride Program Panel - Phase VIII). A budget has been established and a contract agreement with EHA will be drawn up shortly. Of particular interest in this study are the number of additional brain tumor cases that may surface. Also, are the associations seen in the earlier study strengthened or weakened?
6. Advocacy
Although there has been limited activity, advocacy has not been emphasized by the Panel. This is partially the
result of the extremely close liaison of the members of the Panel with the Vinyl Chloride Health and Safety Committee of the Society of the Plastic Industries, Inc. This arrangement has appeared to work well and at the present time increased advocacy is not anticipated.
Several regulatory issues remain, however:
1. EPA is currently considering lowering the air standard for vinyl chloride. The Environmental Defense Fund is involved in these negotiations.
2. The FDA has delayed action on a request for approval of PVC liquor bottles.
3. OSHA appears interested in PVC dust and in VC, in itself. However, no notice has been published and no time table has been established.
7. Key Issues
A small number of key issues remain, but it should be emphasized that because of the extreme publicity and high visibility of vinyl chloride, these issues can change rapidly and dramatically.
1. Whether single exposures to vinyl chloride are capable of causing cancer is an important ques tion. The study sponsored by CPSC, at Edgewood Arsenal, porports to have shown a positive effect from single exposure. Study conditions and the
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type of response were questionable, but adverse publicity may result when the report is published.
2. Vinyl chloride has been shown to cause other cancers in animals. Human data is inconsistent; with some studies positive and others not.
3. Scientific quality of the proposed epidemiological study is critical. It is essential that the study
be acceptable by current scientific standards. Furthermore, it is essential that the study population include all those eligible from the Tabershaw Cooper study, so as to maintain the cohort. This may require liaison with companies who have lost interest in vinyl chloride as a product, but still have former employees that were in the original cohort.
4. The EPA air standard may be an issue, depending upon the pressure placed on that Agency by the Environmental Defense Fund.
5. Transportation accidents are a possibility. It may present an emotionally charged situation for activists.
8. Liaison
Liaison has been and continues to be an important activity. The relationship to the SPI has been very effective, primarily because of the significant overlap committee membership.
in
Liaison with European countries was extremely active and still continues at a lower activity. Several European based companies are represented on the Panel and many Panel members have European affiliates. The four European companies sponsoring Dr. Maltoni's studies have been most helpful. Working primarily through ICI (Dr. David Dufflefield and later Dr. John Stafford) we have succeeded in transmitting information rapidly between our groups.
9. Controversial Issues
None.
10. Financial Status
(See attached financial sheet).
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Report Title and Contract Number
Epidemiological Study of VC Workers ' (VC 1.41
Chronic Vaoor Inhalation Studv with Vinyl Chloride (VC 2.1)
vc Patholoav Report (VC 2.4)
Pathology Report on the Drains from Mice, Hamsters, and Rats Exposed to VC in IBT Study (VC 8.0A)
Validation of Strip Charts at IBT (VC 8.0B)
Summary of the Studies Conducted on the Pharmacokinetics/Hetaboli3m of VC In Rats (VC 3.1)
Effects of Maternally Inhaled Vinyl Chloride on Embryonal & Petal Development in Mice, Rats and Rabbits (VC 3.2)
Research Techniques and Methods for Detection and Prevention of Carcino genesis in Industrial Workers (Yr. 1) (VC 6.4)
Research Techniques and Methods for Detection and Prevention of Carcino genesis in Industrial Health Workers (Yr. 2} (VC 6.5)
Research Techniques and Methods for Detection 'and Prevention of Carcino genesis in Industrial Workers (VC 6.7)
VINYL CHLORIDE
Contractor
Contract Execution
Date
TabershawCoooer. Assoc.
Industrial BIOTEST Labs., Inc.
April 25, 75 Feb. 8, 73
Experimental PatholoqY Labs
Peb. 2, 78
Experimental Patholoqv Labs
April 15, 80
Bob West Assoc.
The Dow Chemical Comoanv
The Dow Chemical Company
April 8, 80 Nov. 2, 76 Aug. 19, 74
University of Louisville
Dec. 12, 76
University of Louisville
Feb. 27, 78
University of Louisville
March 23, 79
Pre sent Level of Fundinq
$42,500
Comments Released Feb. 23, 78
188,450
Terminated
3,687
Released Mav 30, 80
16,460
Released Mav 30, 00
4 ,000 115,000
Released May 30, 80 Released Seot:. 2, 77
224,090
Released Sept. 5, 80
191,771
Released Mav 22, 80
252,820
Released Mav 22, 80
287,704
In Progress 9-22-80
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Vinyl Chloride Financial Statement Period Ending 31 January 1981 Phase VIII
Date Phase Began: 1 June 1980
Budget Service/Program_____________ Authorized
RESEARCH
5-Year Epidemiology Update
ADMINISTRATION
$ open $ open
Direct Charges (1/31/81)
Travel Mi. scellaneou s ________ i Subtotal Administration
$ open
TOTAL Phase VIII
$ open
Amount Committed
$ open $ open
$ open $ open
Unpaid Disbursements Balance
Available for Commitment
0$ -
-
$ 10,984 1,326 152
$ 12,462"
$ 12,462
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VINYL CHLORIDE FINANCIAL STATEMENT
Period Ending 31 January 1981
Phase VII - 17 Companies
Amount Pledged: Amount Received: Budget Authorized:
$325,055 333,488a 325,055
Service/Program
Budget Authorized
Amount
Unpaid
Committed Disbursements Balance
Available 5 Commitment
RESEARCH
VC 7.0 DP/PREV-UL
ADMINISTRATION Direct Charges (1/31/81) Travel Miscellaneous ________ _ Subtotal Administration
TOTAL PHASE VII
$ 287,784 $ 37,271I
I 37,271 $ 325,055
$ 287,784 $ 202,925
$ 37,271 $ 22,080 0 493
$ 37,271 | 22,573
$ 325,055 $ 225,498
$ 84,859 $
-0-
$ 14,$98 3 $ 99,557 $
-0-0 -
aIncludes carryover from Phase VI of $37,271
VINYL CHLORIDE FINANCIAL STATEMENT
Period Ending 31 January 1981
Phase II - 31 Companies
Date Phase Began: Amount Pledged: Amount Received: Budget Authorized:
February 8, $ 240,281
240,281 239,949
1972
Service/Program
Budget
Amount
Authorized _____ Committed Disbursements
Unpaid Balance
RESEARCH
VC 2.0-IBT Restart Agreement Holding 4 Chambers/14 Weeks Holding Animals/2 Years
Overrun Consulting-Dr. W. M. Busey I Subtotal Initial IBT Study Unpaid Balance Redistributed*8 Adjusted Subtotal
VC B.OA-AUD/IBT/EPL-Busey VC 8.OB-AUD/IBT-West Subtotal Research
$ 149,000 15,000
7,840 1,610
22,000
2,500
$ 195,950 (22,437)
r 173,513
$ 16,460 4,000
$ 193,973
$ 149,000 15,000
7,840
1,610
22,000
2,500
r 195,950
(22,437)
5" 173790"
$ 16,460 4,000
$ 193,973
$ 130,375 10,000 7,840 1,610 22,000 3,688
$ 173,513
$ 173,513
S 16,460
4,000 $ 193,973
$ 18,625 5,000
-0 -0 -
0- (1,188)
$ 22,437'
(22,437)
?--- 0 -
0$ - -
-0-
5 -o-
ADMINISTRATION Direct Charges (1/31/81) Travel Miscellaneous_______ ________ Subtotal Administration TOTAL PHASE II
$ 45,976
T 45,976 T 239,949"
$ 45,976 $ 45,976
r 239,949"
$ 32,930 6,157 734
$ 39,821
$ 233,794 "
? 6,155
$----- S7T57T
8 $ 22,437 was redistributed to subsequent audits by Drs. Busey 6 West and to Administration
Available for Commitment
CMA Vinyl Chloride Program Panel CHARTER
The Program Panel will be concerned with vinyl chloride monomer and polyvinyl chloride resin. The Panel will develop a program that examines the possible health effects of vinyl chloride through toxicological research and human (epidemiological) studies. The testing program will include appropriate monitoring to ensure adherence to sound scien tific practice and compliance with prevailing rgulations. The Program Panel will review and evaluate the results of all studies.
Consistent with CMA practices and policies, the Program Panel wil represent the interests of the Chemical Manufac turers Association (CMA) before Federal agencies in all matters relating to safety and health issues arising out of the production, reaction, release, packaging, storage, handling or use of vinyl chloride.
The Program Panel will also be responsible for certain administrative matters, including the election of officers, deciding the basis for sharing the cost of the program among the participating companies, designation of appropriate task and/or working groups, and liaison with interested non-participating parties.
The Program Panel will function as a special committee under CMA's bylaws, and as such will be subject to the Special Program's Guidelines.
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VINYL CHLORIDE PROGRAM PANEL PHASE VIII
W. Mayo Smith AIR PRODUCTS AND CHEMICALS,
INC. P.O. Box 538 Allentown, Pa. 18105 215-481-7215
Dr. Eugene N. Skiest BORDEN, INC. 990 Kingsmill Parkway Columbus, Ohio 43229 614-225-4958
M. N. Johnson, M.D. BFGOODRICH COMPANY 500 S. Main Street Akron, Ohio 44318 216-374-3298
Dr. A. C. Johnson THE GOODYEAR TIRE & RUBBER
COMPANY 1144 East Market Street Akron, Ohio 44316 216-796-7676
H. W. Blakeslee Environmental Engineer CERTAINTEED CORP. 1400 Union Meeting Rd. Blue Bell, Pa. 19422 215- 542-0500 ext. 4403
Dr. C. P. Wen GULF SCIENCE & TECHNOLOGY P.O. Box 2100 Houston, Texas 77001 713-754-1832
Flynt Kennedy
CONOCO, INC. P.O. Box 1267 Ponca City, Oklahoma 74601
405-767-4411
John R. Semancik DIAMOND SHAMROCK PLASTICS,
1100 Superior Avenue Cleveland, Ohio 44114 216- 694-5000
CORP.
T. r. Torkelson DOW CHEMICAL U.S.A. 1803 Building Midland, Michigan 48640 517-636-5197
Theodore J. Benya ETHYL CORPORATION
451 Florida Street Baton Rouge, La. 70801 504-388-7856
Robert W. Laundrie GENERAL TIRE AND RUBBER
COMPANY
1 General Street Akron, Ohio 44329 216-798-2992
Harold F. Dubec, Jr. HOOKER CHEMICALS & PLASTICS
CORP. P.O. Box 456 Burlington, N.J. 08016 609-499-2300 ext. 226
W. R. Gaffey MONSANTO COMPANY 800 N. Lindbergh Blvd. St. Louis, Missouri 63166 314-694-8811
Zeb G. Bell, Jr. PPG INDUSTRIES One Gateway Center Pittsburgh, Pa. 15222 412-434-2585
V. L. Kirkland SHELL CHEMICAL COMPANY One Shell Plaza P.O. Box 4320 Houston, Texas 77090
P. E. Roggi STAUFFER CHEMICAL COMPANY Westport, Connecticut 06881 203-222-4414
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^^Vinyl Chloride Program Panel Phase VIII (Cont.) Donald H. Hunter TENNECO CHEMICALS, INC. P.0. Box 365 Piscataway, New Jersey 08854 201-981-5221 R. N. Wheeler, Jr. UNION CARBIDE CORPORATION Building 3005, Room 350 P.O. Box 8361 South Charleston, W. Va. 25303 304-747-2164 Walter D. Harris, Ph.D. UNIROYAL, INC. World Headquarters Middlebury, Connecticut 06749 203-573-2139
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VINYL CHLORIDE PROGRAM PANEL - PHASE VII
Dr. W. M, Smith Group R & D. Coordinator AIR PRODUCTS & CHEMICALS,
INC. Allentown, Pa. 18103 215-481-7215
Mr. Russell Park FIRESTONE PLASTICS COMPANY Research Division P.O. Box 699 Pottstown, Pa. 19464 215- 326-2000 ext. 402
Mr. Allan G, Wheeler Supervisor Industrial Toxicology ICI AMERICAS, INC. Safety & Environmental Affairs Wilmington, De. 19897 302-575-4533
Mr. H. William Blakeslee Environmental Engineer CERTAIN-TEED CORPORATION Pipe & Plastics Group P. O. Box 1100 Blue Bell, Pa. 19422 215- 542-0500 ext. 4402
Dr. Flynt Kennedy CONTINENTAL OIL COMPANY 1000 South Pine P.O. Box 1267 Ponca City, Oklahoma 74601 405-767-4411
Dr. R. W. McBurney Vice President and Corporate
Medical Director DIAMOND SHAMROCK CORPORATION 1100 Superior Avenue Cleveland, Ohio 44114 216- 694-5252
Mr. Robert. W. Laundrie THE GENERAL TIRE & RUBBER
COMPANY P.O. Box 951 Akron, Ohio 44329 216- 798-2990
Dr. M. N. Johnson Director Environmental Health THE BFGOODRICH COMPANY Chemical Division B 0020 Building 5-H 500 S. Main Street Akron, Ohio 44318 216-379-3299 or 3298
Dr. Paul Cohen Vice President GREAT AMERICAN CHEMICAL CORP. 650 Water Street Fitchburg, Ma. 01420 617-343-6973
Mr. R. J. Abramowitz Technical Director HOOKER CHEMICALS & PLASTICS P.O. BOX 456 Burlington, N.J. 08016 609-499-2300 ext. 216
Dr. T. R. Torkelson Health & Environmental
Science DOW CHEMICAL U.S.A.
1803 Building Midland, Michigan 48640 517-636-5197
Dr. Robert Brookman Vice President Research and Development PANTASOTE, INC. 26 Jefferson Street Passaic, N.J. 07055 201-777-8500
Dr. T. J. Benya Toxicology & Industrial Hygiene
Department ETHYL CORPORATION 451 Florida Avenue Baton Rouge, La. 70801
Dr. Zeb G. Bell, Jr. Manager Environmental Health and
Toxicology Chemicals Division PPG INDUSTRIES, INC.
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Vinyl Chloride Program Panel - Phase VXI (Cont.)
504-388-7856 or 7858
Dr. Vance L. Kirkland SHELL OIL COMPANY One Shell Plaza P.O. Box 4320 Houston, Texas 77210 713-241-0044
Mr. John P. Murphy STAUFFER CHEMICAL COMPANY Product Regulations Westport, Connecticut 06880 203-222-3493
One Gateway Center Pittsburgh, Pa. 15222 412-434-2585
Mr. R. N. Wheeler Production Manager UNION CARBIDE CORPORATION Chemicals & Plastics Division P.O. Box 8004 South Charleston, W. Va. 25303 304-747-2164
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Vinyl Chloride Research Coordinators CHARTER
The Vinyl Chloride Research Coordinators, operating within the Charter of the Vinyl Chloride Program Panel, will provide interpretation of available data on the toxicology of vinyl chloride. The coordinators will advise the Panel on appropriate studies, both in the areas of toxicological research and human .studies, required to expand the data base. TRTG will provide the necessary protocol design or protocol review and will conduct or make provision for appropriate monitoring and auditing of all research programs.
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VINYL CHLORIDE RESEARCH COORDINATORS
Dr. T. R. Torkelson, Chairman Occupational Health Associate DOW CHEMICAL U.S.A. 1603 Building Midland, Michigan 48640 517-636-5197
Dr. W. M. Smith Group R&D Coordinator AIR PRODUCTS & CHEMICALS,
P.O. Box 538 Allentown, Pa. 18104 215- 395-7215
INC.
Dr. M. N. Johnson Director Environmental Health THE BFGOODRICH COMPANY
Cheical Division Medical Center 500 S. Main Street Akron, Ohio 44318 216- 379-3298 or 3299
Dr. 2. G. Bell, Jr. Manager Environmental Health &
Toxicology PPG INDUSTRIES One Gateway Center Pittsburgh, Pa. 15222 412-434-2585
Dr. V. L. Kirkland SHELL CHEMICAL COMPANY One Shell Plaza P.O. Box 4320 Houston, Texas 77210 713-241-0044
Mr. R. N. Wheeler Production Manager Chemicals & Plastics Division UNION CARBIDE CORPORATION P.O. Box 8004 S. Charleston, W. Va. 25303 304-747-2164
Dr. T. J. Benya ETHYL CORPORATION
451 Florida Avenue Baton Rouge, La. 70801 504-388-8011
Dr. W. D. Harris Industrial Toxicolgist Oxford Management & Research
Center Middlebury, Ct. 06749 203-573-2139
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