Document BkYNLQKgROJJdQ05yvjzgdZw
CM/T\
CHEMICAL MANUFACTURERS ASSOCIATION
April 13, 1981
TO: Vinyl Chloride Program Panel
Dear Panel Members:
Enclosed is the final revision of the Vinyl Chloride Annual Report to the Special Programs Advisory Group (SPAG). This report is scheduled for presentation to SPAG on April 21, 1981.
Sincerely,
CRS:cr Enclosure
Carol R. Stack, Ph.D. Administrator Vinyl Chloride Program
CMA 007983
Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872. 2501 M Street. NW Washington DC 20037 Telephone 202/887-1100 Telex 89617 (CMA WSH)
Vinyl Chloride - SPAG
1.0 Charters
a. 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 regulations. 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 Programs Guidelines.
b. 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. The Group will provide the necessary protocol design or pro tocol review and will conduct or make provision for appro priate monitoring and auditing of all research programs.
2.0 Uses
Manufacture of polyvinyl chloride and copolymers; organic synthesis; adhesives for plastics.
CMA 007984
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 acroosteolysis (softening of finger tip bones) in VCM/PVC workers. The findings were 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
E*? C 60
Si |
T) m u oo
1-3 M
Qj
So
p-g o
: + ^
p^ I!
a>
g
WH
o
_C
A research contract was negotiated with Industrial Bio-Test 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 reached. Companies participating in the research program will be refunded on the same pro-rated basis as they contributed to the program.
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
2 CMA 007985
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 VlT)
In 1975, the emphasis on research shifted from toxicological investigations to one more directly relat d 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 th 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.
CONFIDENTIAL
Membership
Subject to Protective Order in
See attachments A, B and C.
Ross v. Conoco, Inc., No. 90-4837 14th Judicial District Court
Research Programs
Calcasieu Parish, Louisiana
a. Completed studies (See attachment D).
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,
3
007986 CMA
21
f-'l
i;
4-i
b
M'o P-,
f
O
O
9 w &s
pq
work histories of the 10,173 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 is whether or not the brain tumor incidence remains in excess. 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 Plastics 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 vinyl chloride 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 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, purports to have shown a positive effect
c from single exposure. Study conditions and the 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 besides angiosarcoma. Human
GQ AH
data is inconsistent; with some studies positive and others not.
Ah
*wddoH iHo
3. Scientific quality of the proposed epidemiological study is critical. It is essential that the study be acceptable by current scientific standards.
d
o4
CMA 007987
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. This 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 in committee membership.
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 Duffield and later Dr. John Stafford) we have succeeded in transmitting information rapidly between our groups.
9. Controversial Issues None.
10. Financial Status
cornm-T-iAii
Subject to Protective Order In Ross v. Conoco, Inc. ^Ho. -0-4837 TZth Judicial District Court
(See attachments E, F and G).
11. Critical Dates
June 1981 - start of vinyl chloride epidemiology study update (Environmental Health Associates, Inc.).
Spring 1983 - epidemiology study completed.
May 15, 1981 - final report on University of Louisville study expected.
12. Future Needs
None.
5
CMA 007983
13. Summary.
The Panel has undertaken several animal studies to expand the toxicological data base on vinyl chloride monomer. These phases of the program were completed and it is not anticipated that the Panel will sponsor further research in this area. The University of Louisville Program is winding down and continued funding of this research is unlikely. At the moment, the Panel's attention is focused on human studies and the use of epidemiological research to clarify the relationship between the etiology of certain diseases and vinyl chloride exposure.
The Panel's pursuit of an advocacy program has been limited. Members of the Program Panel have maintained a close liaison with the VC Health and Safety Committee of the Society of the Plastics Industries, Inc. (SPI), the lead organization in the vinyl chloride advocacy area. Several regulatory issues do remain and the Panel will continue to maintain interest through its association with SPI.
oo
rrj
o
~o-tl
o . -o
6
CMA 00798V
ATTACHMENT A
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
CMA OO7990
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
CONFIDENTIAL
Subject to Protective "
15
]?gas_v. Conoco, Inc., r.a. 90-4g|f
14th Judicial District Court? Calcasieu Paris??, Louisiana
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
c ri
to 00
P
of
1 0o*
3
0 0
ta
(-=
O
0
-p
0h 3
o cso r*3= i_; i B 03
rJi! o 'u
P-> o
Ucd
o
O -P o
0
o -op
0C30
0) 3 H
&
t3o
CMA 007991
ATTACHMENT B
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. 0. 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
Subject to Protective Order in ~n,C0' Irlg^No- 90-48^7
14th Judicial District Court pr1sht Loui8U^
CMA 007992
Vinyl Chloride Program Panel - Phase VII (Cont.)
Dr. T. J. Benya Toxicology & Industrial
Hygiene Department ETHYL CORPORATION 451 Florida Avenue Baton Rouge, La. 70801 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
Dr. Zeb G. Bell, Jr. Manager Environmental Health and
Toxicology Chemicals Division PPG INDUSTRIES, INC. 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
v, In c ,
c-
C tO
CO -p
Jn
0
Go\
u a
CoJ
c
03
s j-1- 1 o +-1 a
3 --'
i ii
-j--^"jt*
_' o
> --wJ
-uH ^ WH ^~
M -H
- i! om '-iH
oo
rH
o
o OG
S
E?
b CcUO
0O
& CgO
C0O3 O
r*
CMA 007993
ATTACHMENT C
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. Z. 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 UNIROYAL, INC.
Oxford Management & Research Center
Middlebury, Ct. 06749 203-573-2139
CONFIDEffTIAL''
Subject to Protective Order in Boss V. Conoco, Inc.. No. 90-4837
14th Judicial District Court Calcasieu Parish, Louisiana
007^A
CMA 0 0 7 9 9
coiiyiri'.i'.i^iAL Subject to Protective Order In Ross v. Conocoi Inc.i Mo. 90-4837 ' 14th Judicial District Court
Calcasieu Parish,, Louisiana
Report Title and Contract Number
vinyl CHLORIDE
Contractor
Contract Rxecution
Date
Epidemioloqical Study of VC Workers (VC 1.4)
Chronic Vaoor Inhalation Studv with Vinyl Chloride (VC 2.1)
VC Patholoqy Report (VC 2.4)
TabershawCooper. Assoc.
Industrial 8IOTBST Labs., Inc.
Bxoerimental Patholoqy Labs
April 21, 75 Feb. 8, 73 Feb. 2, 78
Pathology Report on the Brains from Mice, Hamsters, and Rats Exposed to VC in TBT Study (VC 8.0a)
Validation of Strip Charts at IBT (VC 8.0B)
Experimental Patholoqy Labs
April 15, 80
Bob West Assoc.
April 8, 80
Summary of the Studies Conducted on the Pharmacokinetics/Metabolism of VC in Rats (VC 3.1)
The Dow Chemical Company
Nov. 2, 76
Effects of Maternally Inhaled Vinyl Chloride on Embryonal fc Petal Development in Mice, Rats and Rabbits (VC 3.2)
The Dow Chemical Company
Auq. 19, 74
Research Techniques and Methods for Detection and Prevention of Carcinoqenesis in Industrial Workers (Yr. 1) (VC 6.4)
University of Louisville
Dec. 12, 76
Research Techniques and Methods for Detection and Prevention of CarcinoO genesis in Industrial Health Workers J5P (Yr. 2) (VC 6.5)
Researct^Pechniques and Methods for
Detect
Prevention of Carcino-
jjj genesIndustrial Workers (VC 6.7)
University of Louisville
University of Louisville
Feb. 27, 78 March 23, 79
ATTACHMENT D
Present t.eve 1 of Funding
$4 2,500
Comments Released Feb. 2 3, 70
188,450
Terminated
3,6B7
Released Mav 30, 80
16,460
Released Hav 30, 80
4,000 115,000
Released Nay 30, BO Released Sept. 2, 77
224,090
Released Sent. 5, 80
191,771
Released Mav 22, 80
252,820
Released Mav 22, 80
2B7,784
Tn Progress
ATTACHMENT E Vinyl Chloride Financial Statement - Phase VIII
Period Ending 30 March 1981
Date Phase Began: 1 June 1980
Budget
Amount
Unpaid
Service/Program_____________ Authorized_____ Committed_______Disbursements Balance
RESEARCH
5-Year Epidemiology Update
$ open
$ open
$- 0-
ADMINISTRATION
open
Direct Charges (3/30/81) Travel Miscellaneous_______ Subtotal Administration
$ open
$ open $ open
11,817 1,326 159
$ 13,302
TOTAL Phase VIII
$ open
$ open
$ 13,302
Available for Commitment
::: 4 * o i1
pc- O
tJ
}L)
p
-i
'-I
J ys
o
o t3t *=l
$
H *+
4*r cq
CD
O
td
c+ t-3
nx
>
t* 3. * < W
S2S
&* ? o
> tr<
o O VO P>
IIo O (D i *i
o >0 O'
e
- - r .* T._ jv-iivu C^o.r i_n
SuTo'Jtci. co ^ ^ - - ' ; ]i0 _ c,() 4037
^ V* fSSrDiitiiot Court
14 tn Jlfltial , h LoulsiftM gal6aiu J,iri h
VINYL CHLORIDE FINANCIAL STATEMENT Period Ending 30 March 1981 Phase VII - 17 Companies
ATTACHMENT P
Amount Pledged: Amount Received: Budget Authorized:
$325,055 333,488a 325,055
Budget
Amount
Service/ProgramAuthorized______Committed
RESEARCH
VC 7.0 DP/PREV-UL
$ 287,784
ADMINISTRATION
$ 37,271
Direct Charges (3/30/81)
Travel Miscellaneous Subtotal Administration
$
37,271
TOTAL Phase VII
$ 325,055
$ 287,784 $ 37,271
$ 37,271 $ 325,055
Unpaid Disbursements Balance
Available for Commitment
202,925
$ 84,859
$ -0-
$ 22,080 0
493 $ 22,573
$ 225,498
$ 14,698 $ 99,557
$ -0$ -0-
aIncludes carryover from Phase VI of $37,271
ATTACHMENT G
VlHlfl. CHLORIDE FINANCIAL STATEMENT
Period Ending 30 March 1981
Phase 11-31 Companies
Dale Phase Hogan: Amount Pledged: Amnunl Peer i ved:
IBT Refund Budget Authorized
Set v ice/l'l wjrnm_________
February 8, 1972
$ 240,201
/
240,201
110,000b
349 949 ' midget
Amount
Author I r.cd______ Committed
Disbursements
Unpaid Halancc
rescahcii
VC 2.0-HIT lies! ai I Aqi erment Holdiii<| 4 Chambern/14 Hecks Holding Anlmals/2 Vears Overun Conr.uJ L ing-lh . H. M. Ilusey 1 KuliiciiaT Initial " lilT Study Unpaid llalancc Redistributed^ Ad jur'd cd Subtotal VC 0. OA-AHH/lMT/KPl.-Husey VC II. (HI-All!)/HIT-He st Subtola 1 Research
$ 149,000 15,000 7,040 t,610 22,000
2,500 095,55K
(22,4371 011710 $ 16,460
4,000 0517513
$ 149,000 15,000
7,040 1,610 22,000 2,500 195,955 (22.437J ri7i75ir $ 16,460 4,000 093,973
$ 130,375 10,000 7,040 1,610 22,000 3,600
5 173,13
OTT,m" $ 16,460
4,000 $ ITT,973
$ 10,625 5,0110
-0 -0-0-
r u.inoi ~13,l3l (22,437)
r -0-
$ -0-0-
r -0-
ADMINISTRATION
___ _____
iilrcct Charges (3/30/81)
Travel Hi see 11 ancons Soldo!al Administration TOTAL PHASE II
5 45,976
?ni1w5757i6r~
$ 45,976
f0194755,9175?""
$ 32,930 6,157 734
?01309,50211"
rr 6,155 6,155
$ 22,437 was redistributed to subsequent audits by Drs. Dusey ( Hest and to Administration
b To be refunded, based on pro-rate share, to participating companies.
AvnI I able Cnmmilinen I
CMrt 0 0 7 9 9 8
CMA 0 0 7 9 9 9
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 ycu 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 Program
CMA 008000
Vinyl Chloride
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 tne 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
CMA 008001
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 Proqram
TPhase VH7----- ------------^------------------------------ ------
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
CO-PIPr::. -IAL Subject to Protective Order in Ross v. Conoco, Inc., No. 90-4837
14th Judicial District Court Calcasieu Parish. Loin si
CMA 008002
Panel
separate pp.
Task Group
5. Research Programs a. Completed studies (Table) b. Future studies
Subject to prot^^eKor90T-4837
InsR V * ConocoI_Jnc:_t
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
CMA 008003
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 in committee membership.
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).
CMA 008004
CMA 0 0 8 0 0 5
Report Title and Contract Number
Epidemiological Study of VC Workers (VC 1.4)
Chronic Vaoor Inhalation Study with Vinyl Chloride (VC 2.1)
VC Patholoqy Report (VC 2.4)
Patholoqy Report on the Brains from Nice, Hamsters, and Rats Exposed to VC in IBT Study (VC 8.0A)
Validation of Strip Charts at IBT (VC 8.OB)
Summary of the Studies Conducted on the Pharmacokinetics/Metabolism of VC in Rats (VC 3.1)
Effects of Maternally Inhaled Vinyl Chloride on Embryonal 6 Fetal Development in Mice, Rats and Rabbits (VC 3.2)
Research Techniques and Methods for Detection and Prevention of Carcinogenesis in Industrial Workers (Yr. 1) (VC 6.4)
Research Techniques and Methods for Detection and Prevention of Carcinogenesis in Industrial Health Workers (Yr. 2) (VC 6.5)
Research Techniques and Methods for Detection and Prevention of Carcinogenesis in Industrial Workers (VC 6.7)
VINYL CHLORIDE
Contractor
Contract Execution
Date
TabershawCooper. Assoc.
April 25, 75
Industrial BIOTEST Labs., Inc.
Feb. 8, 73
Exoerimental Patholoqy Labs
Reb. 2, 78
Experimental Patholoqy Labs
April 15, 80
Bob West Assoc.
The Dow Chemical Company
The Dow Chemical Comoany
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
Present Level of Funding
$42,500
Comments Released Feb. 2 3, 78
188,450
Terminated
3,687
Released May 30, 80
16,460
Released May 30, 80
4,000 115,000
Released May 30, 80 Released Seot. 2, 77
224,090
Released SeDt. 5, 80
191 ,771 252,820 287,784
Released May 22, 80
Released Mav 22, 80
o n 'D P1 H2^- Ohj OAi 4 3-
03 3
In Progress 9-22-80
Vinyl Chloride Financial Statement Period Ending 31 January 1981 Phase VIII
Date Phase Began: 1 June 1980
Budget
Amount
Unpaid
Service/Program______________Authorized_____ Committed_______ Disbursements Balance
RESEARCH
5-Year Epidemiology Update
$ open
$ open
$ -0-
ADMINISTRATION
$ open
$ open
Direct Charges (1/31/81) Travel Miscellaneous
Subtotal Administration
$ open
$ open
$ 10,984 1,326
152
T 12,462
TOTAL Phase VIII
$ open
$ open
$ 12,462
Available for Commitment
ui
S *Pr * cj-
4
a\toe eH
9 0 0 8 0 0 VWO
i\*
e h- si \. !>???'*
IJ 4 y>
P 03 5
oa -i
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 foi Commitment
RESEARCH VC 7.0 DP/PREV-UL
$ 287,784
$ 287,784 $ 202,925
$ 84,859 $ - 0 -
ADMINISTRATION Direct Charges (1/31/81) Travel Miscellaneous________ Subtotal Administration
$ 37,271 $ 37,271
$ 37,271 $ 22,080 0 493
$ 37,271 $ 22,573
TOTAL PHASE VII
$ 325,055
$ 325,055 $ 225,498
aIncludes carryover from Phase VI of $37,271
m .lei 4* O ** O
Cf,,t &\o cv\o D SW o ^ t\
$ 14,698 $ $ 99,557 $
- 0- 0-
CMA 0 0 8 0 0 7
' tpr* ooizl oV..'r' . <* H `
S%?* 33 Htt CD hd-
-ft
8 0 0 8 0 0 VW3
'iY Ilit& a iiL lld O l
VINYL CHLORIDE FINANCIAL STATEMENT
Period Ending 31 January 1981
Phase II - 31 Companies
Date Phase Began: Amount Pledged: Amount Received: Budget Authorized
February 8, $ 240,201
240,281 239,949
1972
Service/Program
Budget Authorized
Amount Committed
Disbursements
Unpaid Balance
RESEARCH
VC 2.0-IBT Restart Agreement Bolding 4 Chambers/14 Meeks Holding Animals/2 Years Overrun Consulting-Dr. W. M. Busey I Subtotal Initial IBT Study Unpaid Balance Redistributed! Adoust'ed Subtotal VC 8.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
5"1557950 (22,437)
5" 111,513 $ 16,460
4,000
T" 193,973
$ 149,000 15,000 7,840 1,610
22,000 2,500
$ 195,950 (22,437) 171,513
$ 16,460 4,000
$ 193,973
$ 130,375 10,000 7,840 1,610 22,000 3,688
$ 173,513
$ 113,513 $ 16,460
4,000 $ 193,973
$ 18,625 5,000 -0-
-0 -
-0-
(1,188)
r 22,437
(22,437) T" - 0 $ -0-
-0 -
r -0-
ADMINISTRATION Direct Charges (1/31/81) Trav 1 Miscellaneous Subtotal Administration TOTAL PHASE II
$ 45,976
r 45,976 r 219,949
$ 45,976
$ 45,976 $ 219,949
$ 32,930 6,157
734 $ 39,821 $ 213,794
V 6,155
r 6,155
a $ 22,437 was redistributed to subsequent audits by Drs. Busey & West and to Administration
Available for Commitment
S|1l" |M
o
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.
CMA 008009
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
TinoC
CMA 008010
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
CMA 008011
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. 0. 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. T. J. Benya Toxicology & Industrial Hygiene
Department ETHYL CORPORATION 451 Florida Avenue Baton Rouge, La. 70801
Dr. Robert Brookman Vice President Research and Development PANTASOTE, INC. 26 Jefferson Street Passaic, N.J. 07055 201-777-8500
Dr. Zeb G. Bell, Jr. Manager Environmental Health and
Toxicology Chemicals Division PPG INDUSTRIES, INC.
00801
co::tid3::?iax.
Subject to Protective Order in Ross v. Conoco, Inc., Ho. 90-4837
14th Judicial District Court Calcasieu Parish, Louisiana
Vinyl Chloride-Program Panel - Phase VIX (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
CMA 008013
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.
CMA 008014
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. Z. 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
CMA 00801
January 8, 1981 Mr. William A. Bittender Borden Chemical 960 Kingsmill Parkway Columbus, Ohio 43229 Dear Bill,
As per our phone conversation, I am enclosing copies of the vinyl chloride material that was sent to all companies expressing interest in supporting the program. The Phase VIII Commitment form should be completed and sent back to me.
Thank you for your attention in this matter, and I look forward to hearing from you soon.
Sincerely,
Carol R. Stack Administrator Vinyl Chloride Program
r.nrc? I INITIAL Sc ubject ttoo Pnruottective Oradne.r&ainz Boss v. CoPOCo. Jnc^Ho. 90-482 --^th Judicial Distnct Court
Calcasieu Parish, Louisiana
CM* 008016