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CHEMICAL MANUFACTURERS ASSOCIATION
October 28,1994
Dear Vinyl Chloride Health Committee Members:
As discussed on the October 24 conference call, I have enclosed a commitment form for your pro-rata share of the $300,000 budget for the 1994-1995 research and advocacy program. The details of the program and basis for your pro-rata share are attached.
Your completion of the commitment form is essential for CMA to execute any contract for the research projects, consultant agreements, and retention of counsel for the TSCA Section 4 testing requirement negotiations with EFA and ATSDR. Therefore, please return your commitment form to me by November 18. Please note that if you requested payment in two installments for your earlier commitment (See Table 1, Column 3), your second installment will be due in January 1995.
If you have any questions, please call me at (202) 887-1192.
Sincerely,
Enclosures
Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel
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2501 M Street, NW, Washington, DC 20037 Telephone ZZZ-zi' ' ' -
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CHEMICAL MANUFACTURERS ASSOCIATION Vinyl Chloride Panel Health Committee Commitment Form
My company (GEON) commits $30,480 for the 1994-1995 vinyl chloride research and advocacy program. I understand that this commitment is in addition to the $35,241 commitment my company has already made in the past several months. For the new commitment amount. $30,480. covered by this commitment form, please invoice me according to the box(es) checked below:
Please invoice me $in December 1994. Please invoice me $in January 1995. IS Please invoice me $ i 4 N C in April 1995.
Please invoice me $ i s~ err in July 1995.
While appreciating the opportunity, my company declines to participate.
CMA has estimated that 16% of the total CMA 1994/95 fiscal year "dues and similar income", which includes CHEMSTAR contributions, is allocable to lobbying and political expenditures to which Section 162 (e)(1) of the Internal Revenue Code of 1986, as amended, applies. Consequently, this portion of your commitment is not deductible as an ordinary and necessary business expense for federal income tax purposes. Further, contributions to CMA are not tax deductible as charitable contributions.
Panel Representative <C%X u. -tV'-A (v
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Please return signed form by NOVEMBER 18,1994 to:
Hasmukh C. Shah. Ph.D. CMA
2501 M Street. NW Washington. D.C. 20037
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COMMITMENTS NECESSARY BY COMPANY
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Budget $ 400,000
30,000 60,000
10,000
100,000 25,000
$ 625,000
Vinyl Chloride Health Committee
Proposed 1994-1995 Budget
Activity (Explanation Attached)
Epidemiology Study Update Contractor Cost - $ 350,000 ENSR Data Transfer Cost - $20,000 Dow Chemical's Monitoring Cost - $30,000
Outside Counsel for TSCA Section 4 Prop. Rule The estimated cost of the EPA recommended testing program is $850,000.
University of North Carolina Research Program Synthesis of 13C-vinyl chloride - $10,000 Determination of Half-Life of Etheno-Adducts in Animals & Determination of P-450 in Human Tissues at Diff. Ages - $50,000
Vinyl Chloride Risk Assessment Consultant for Modification of the Heast Table (R, Reitz) Consultant to Demonstrate a Biological Threshold for Vinyl Chloride Induced Liver Angiosarcoma and Absence of Cause-Effect Relationship Between Vinyl Chloride and Brain Cancers (C. Tamburo) International Workshop to be Sponsored by the Vinyl Chloride Panel to Assess Available Scientific Information and Review Work in Progress or Planned to Assess Vinyl Chloride Risk
Administration Direct Time Oct.1994 - Dec.1995 - $90,000 (Based on Estimated Level of Effort of Four Days/Month) Travel and Miscellaneous - $10,000
Contingency
TOTAL
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Detailed Explanation of 1994-1995 Proposed Activities
1) Epidemiology Study Update
Contractor Cost:
CMA conducted an epidemiology study of vinyl chloride workers from 1942-1972. The study was updated to cover the period of 1942-1982. The Vinyl Chloride Health Committee proposed to further update the study to 1992. The Committee requested proposals from potential contractors. After reviewing the proposals received, the Committee has narrowed its selection to Applied Epidemiology, Inc. (estimated cost - $350,000) and Applied Health Sciences, Inc. (estimated cost - $275,000). The Vinyl Chloride Health Committee is leaning toward Applied Epidemiology, Inc. based on an overall evaluation of the proposals.
ENSR Data Transfer Cost:
All raw data for the previous vinyl chloride epidemiology study are with ENSR Corporation. These data are extensive (100 banker's boxes) and will have to be reviewed, screened, and copied by ENSR prior to the release of the information to the selected contractor.
Dow Chemical's Monitoring Cost:
This cost will compensate Dow Chemical for its efforts in designing the study; evaluating the proposals; resolving technical issues with contractors; conducting site-visits; monitoring progress of the study; reviewing interim and draft reports; and, liaisoning with CMA and the Vinyl Chloride Health Committee.
2) Outside Counsel for TSCA Section 4 Proposed Rule
On September 30, 1994, EPA published a "Notice of Opportunity to Initiate Negotiations for TSCA Section 4 Enforceable Consent Agreements; Solicitation of Testing Proposals for ATSDR Chemicals" (Fed. Reg. 59, 49934-49938, 1994). For vinyl chloride, the notice proposes testing for reproductive, developmental, and neurotoxic effects by the inhalation route. The estimated cost of these testing is $850,000 (developmental = $150,000; reproductive = $450,000; and neurotoxicity = $250,000). In its Federal Register notice, EPA did not provide a rationale for the testing requirements and has exceeded the ATSDR requirements. The Committee recommends retaining a counsel to effectively negotiate a testing program with EPA that requires only those studies necessary to meet the ATSDR data needs.
Please note that no provision is made in the 1994-1995 proposed budget for any testing cost because of uncertainty as to what studies ultimately will be included in the Enforceable Consent Agreement or the TSCA Section 4 final rule. If an Enforceable Consent Agreement is executed with EPA, an additional testing budget may have to be developed in 1995.
BFG41787
BFG 01300
Detailed Explanation October 12, 1994 Page 2
3) University of North Carolina Research Program:
This research program is designed to evaluate toxicity of vinyl chloride exposure at high concentrations over a short period of time. The information developed through this program may help in establishing levels of vinyl chloride to trigger catastrophic release evacuation plans.
The program also would enable industry to develop early diagnostic tools to determine significant vinyl chloride exposures and their relevance to health risk assessment.
4) Vinyl Chloride Risk Assessment:
Modification of Heast Table
The current EPA Heast Table for carcinogenicity of vinyl chloride mentions that the consideration of metabolism pharmacokinetics will result in increased risk. According to the table, one unpublished physiologically-based pharmacokinetic model may predict a 100-fold increased risk. In the Committee's communication with EPA, we now understand that this is a speculation on the part of EPA. Documents like the Heast Table often become the basis for regulatory activities at federal, state and local levels. It is critical, therefore, to correct the Heast Table to prevent potential regulations based on misinformation. The Committee plans to work with EPA to correct the Heast Table.
Biological Threshold for Vinyl Chloride Induced Liver Angiosarcoma and Lack of Correlation Between Vinyl Chloride Exposure and Brain Cancer
Dr. Carlo Tamburo of the University of Louisville has proposed a threshold for vinyl chloride induced human liver angiosarcoma. Dr. Tamburo also suspects, based on information available to him, that there is no association between vinyl chloride exposure and incidence of brain tumors. The Committee plans to pursue these hypotheses with Dr. Tamburo. If these hypotheses are substantiated by valid and credible scientific data, the benefits to the industry will be significant.
International Workshop on Vinyl Chloride
The Committee considers an international workshop on vinyl chloride an integral part of vinyl chloride risk assessment. The workshop participants may include: regulatory agency personnel (EPA, OSHA, ATSDR); academia; other scientific research organizations; ind, vinyl industry personnel.
BFG41788
BFG 01301
Detailed Explanation October 12, 1994
Page 3
5) Administration:
The following services are integral parts of the CMA administration:
a) General Services
1) meeting preparation, attendance, and action item follow-ups
2) coordination of Panel activities with outside counsel
3) financial management services including monthly financial statements
4) legal services (anti-trust protection; review of Records of Meetings; review of contractual agreements; guidance in cases of contractual non-compliance and/or earlier termination; guidance in protecting against restriction of trade practices; facilitating resolution of Panel/Task Force issues
5) communication services (press/news releases; responses to media/public inquiries; spokesperson for industry)
6) mail room services (copying; first class postage; local messengers)
7) management support in resolving Panel issues, if necessary
b) Advocacy Management
1) maintain awareness of pertinent regulations relating to the Panel's activities
2) communicate with government agencies on scientific and regulatory matters on behalf of the Panel
3) coordinate information flow to and from agencies, companies, other trade associations, and academic institutions
4) coordinate the development of advocacy positions with the CMA Office of General Counsel and other appropriate CMA standing committees and outside consultants
c) Research Management
1) assist in developing testing programs
2) develop budgets, assure commitments, and process invoices to participating companies
BFG41789
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Detailed Explanation
October 12, 1994
Page 4
3) work with Panel to prepare protocols, identify labs, and send Request for Bids
4) assist Panel in selecting contract laboratory for testing based on bids received or prior experience
5) conduct site visits, if necessary
6) prepare and negotiate contracts
7) manage activities of contractor and outside auditor/monitor for the research program
8) legal oversight by CMA
9) manage finances of contracts, set up budget areas, verify and pay invoices
10) facilitate information exchange between contract laboratories, monitor/auditors, and Panel members and government agencies
11) facilitate Panel consensus on technical issues and communicate the consensus position with contractors
12) prepare periodic status reports for submission to Panel and regulatory agencies
13) provide regulatory compliance (TSCA, FIFRA) services at Panel's request
14) arrange for and participate in Panel meetings and in meetings with contractors and agencies
15) assist in developing the next phase of activities
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CHEMICAL MANUFACTURERS ASSOCIATION Vinyl Chloride Panel
Vinyl Chloride Research Coordinators Commitment Form
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My company commits its pro-rata share of $300,000 research and
advocacy budget as described in the attached July 5, 1994
Explanation of VCRC Budget. The Vinyl Chloride Panel is conducted
under the policies and procedures outlined in the CHEMSTAR Panel
Guidelines and briefly noted on the reverse of this form.
/ While appreciating the opportunity, my company declines to participate.
CMA has estimated that 16X of the total CMA 1994/95 fiscal year "dues and similar income", which includes CHEMSTAR contributions, is allocable to lobbying and political expenditures to which Section 162 (e)(1) of the Internal Revenue Code of 1986, as amended, applies. Consequently, this portion of your commitment is not deductible as an ordinary and necessary business expense for federal income tax purposes. Further, contributions to CMA are not tax deductible as charitable contributions.
Panel Representative
Management Contact
Name (Signed) EkyPMA L.
Name (Typed)
Name (Signed) Name (Typed)
Title
Title
Company
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Please return signed form to:
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Hasmukh C. Shah, Manager Chemical Manufacturers Association 2501 M Street, NW Washington, D.C. 20037
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01305
VII
July 5, 1994 Explanation of Vinyl Chloride Research Coordinator Budget
An initial budget of $300,000 is proposed for the following activities:
Contractor cost for the update of vinyl chloride epidemiology study
Dow Chemical's expenses for designing, monitoring, consulting with the selected contractor, and reviewing interim, draft and final reports for the epidemiological update
Consultant expenses for vinyl chloride risk assessment and short-term exposure effects studies
Administrative expenses for update of the epidemiology study; follow-ups with EPA on VC risk assessment; follow-ups with EPA on VC and/or EDC testing under TSCA Section 4; follow-ups with consultants on VC risk assessment and short-term exposure effects studies; meeting planning, attendance, and other routine services; follow-up of action items resulting from meetings and conference calls; and, monitoring of regulatory activities impacting vinyl chloride manufacturing companies
The VCRC has proposed to share the estimated $300,000 budget based upon the 1993 VC nameplate capacity. CMA has used the nameplate capacities for VC published in the attached chart from Chemical Data Inc., September 1993, to determine each company's pro-rata share as follows:
Total 1993 VC Nameplate Capacity Westlake 1993 VC Nameplate Capacity Total 1993 VC Nameplate Capacity
Used in Determining VCRC Member Companies Pro-Rata Share
12.918 M lbs. 1,000 M lbs.
11.918 M lbs.
COMPANY
NAMEPLATE CAPACITY (Mill ion Lbs.)
PRO-RATA SHARE
Borden Chemical Dow Chemical Formosa Plastics 6E0N Georgia Gulf Occidental (w/OxyMar) PPG Industries Vista Chemical
135 :.2 i o 1 , '93 1 ,-.oo 1 . 260 2 .too
340 ___ 380
23,536 55,630 45,133 35,241 31,717 65,447 21,145 22.151
TOTAL
11,918
300,000
If the above budget is committed by all companies , one-half of the commitment will be due in August, 1994 and the remainder in January, 1995. If Westlake joins the VCRC at a later date, your 1995 amount due will be adjusted accordingly.
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SEPTEMBER 1990
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July 5, 1994 Explanation of Vinyl Chloride Research Coordinator Budget
An initial budget of $300,000 is proposed for the following activities:
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study \'\ ------ *
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Dow Chemical's expenses for designing, monitoring, consulting
with the selected contractor, and reviewing interim, draft and
final reports for the epidemiological update
/
Consultant expenses for vinyl chloride risk assessment and short-term exposure effects studies
Administrative expenses for update of the epidemiology study; follow-ups with EPA on VC risk assessment; follow-ups with EPA \ L on VC and/or EDC testing under TSCA Section 4; follow-ups with consultants on VC risk assessment and short-term exposure effects studies; meeting planning, attendance, and other routine services; follow-up of action items resulting from meetings and conference calls; and, monitoring of regulatory activities impacting vinyl chloride manufacturing companies
The VCRC has proposed to share the estimated $300,000 budget based upon the 1993 VC nameplate capacity. CMA has used the nameplate capacities for VC published in the attached chart from Chemical Data Inc., September 1993, to determine each company's pro-rata share as follows:
Total 1993 VC Nameplate Capacity Westlake 1993 VC Nameplate Capacity Total 1993 VC Nameplate Capacity
Used in Determining VCRC Member Companies Pro-Rata Share
12.918 M lbs. 1,000 M lbs,
11.918 M lbs.
COMPANY
NAMEPLATE CAPACITY (Million Lbs.)
PRO-RATA SHARE
Borden Chemical Dow Cliemical Formosa Plastics GEON Georgia Gulf Occidental (w/OxyMar) PPG Industries Vista Chemical
935 2,210 1,793 1,400 1,260 2,600
840 880
23,536 55,630 45,133 35,241 31,717 65,447 21,145 22,151
7 h.
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TOTAL
11,918
300,000
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If the above budget is committed by all companies, one-half of the
'tv-*-''
commitment will be due in August, 1994 and the remainder in January,
1995. If Westlake joins the VCRC at a later date, your 1995 amount due
will be adjusted accordingly.
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