Document J3dGkXj5NzbEVep3rd03xx4Me

CM\t& Chfmicai Manufacturers Association April 11,1997 Mr. Neil Hawkins The Dow Chemical Company 2020 Dow Center Midland, MI 48674 Dear Neil: The following items are enclosed for your information and action: 1) a copy of the Vinyl Chloride Health Committee commitment form that was sent to Jonathon Ramlow in November 1996; 2) a table containing the recent activities of the Vinyl Chloride Health Committee; 3) a report on the Vinyl Chloride Health Committee for 1995-1996; 4) the November 26 Record of Meeting; and 5) the February 18,1997 Record of Conference Call. I would appreciate your completing the 1997 commitment form as soon as possible. Please call me at 703/741-5637, if you need additional information. Sincerely, Has Shah, Ph.D. Manager Vinyl Chloride Health Committee (ft Responsible Care* 1 300 Wit SON BoL'tsAKt), Arlington, VA 22209 TutmoNt 703-741-.3000 Fw 70 5-741-0000 Tl f A Public Commitment R&S 154525 CHEMICAL MANUFACTURERS ASSOCIATION Commitment Form My company commits, Dow Chemical, commits $21,000 for services as described in the attached proposed budget commitments for 1997. The Vinyl Chloride Panel is conducted under the policies and procedures outlined in the CHEMSTAR Panel Guidelines, briefly noted on the reverse of this form. While appreciating the opportunity, my company declines to participate. CONFIDENTIAL not tax deductible as charitable contributions. Panel Representative ; -::'-V '- Management Contact (Optional) Name (Signed) Name (Signed) Name (Typed) Name (Typed) Title Title Company Company Address Address Address Address Telephone Telephone Fax Fax Please return signedform to Has Shah, Ph.D., Manager Vinyl Chloride Panel 1300 Wilson Blvd. Arlington, VA 22209 Tel: (703) 741-5637 Fax: (703) 741-6091 R&S 154526 Page 1 of 5 Vinyl Chloride Health Committee Activities MEMORANDUM OF UNDERSTANDING (MOU) WITH THE AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY (ATSDR) The MOU has been signed. A revised study plan was sent to ATSDR because of the delay in the initiation of the study. IMPORTANCE ACTION ITEMS 04/11/97 DEADLINES Initial progress reports are due at ATSDR April 25 with subsequent reports due every 6 months thereafter until studies are completed and final reports submitted. The MOU was developed to meet the research needs of ATSDR and the Environmental Protection Agency in lieu of a TSCA Section 4 testing requirement. REPRODUCTIVE & DEVELOPMENTAL TOXICITY STUDIES AT HUNTINGDON LIFE SCIENCES (HLS) Tie contract with Huntingdon has been signed. Analytical work on the test material is complete and the animal exposure has begun. Preliminary results of the analytical work were delivered to CMA for inspection. Jim Knaak reviewed the material and approved it. ACTION ITEMS Continue monitoring progress of study. DEADLINES Progress reports are due to CMA at intervals specified in the agreement. Jim Knaak, David Penney, and Wendy Sherman will visit Huntingdon in mid-April to monitor progress of studies. IMPORTANCE This research is in lieu of a potential TSCA Section 4 testing requirement. MOLECULAR CARCINOGENESIS SATELLITE STUDIES AT HLS/ UNIVERSITY OF NORTH CAROLINA-JAMES SWENBERG Ray Schroeder (HLS) and James Swenberg (UNC) revised the protocols for the satellite studies. Fewer animals will be needed to conduct the studies and studies will not be subject to GLP standards. This significantly reduces the cost of the satellite studies. IMPORTANCE ACTION ITEMS Execute agreement with HLS for in-life portion of satellite study. Prepare a gift letter for $5GK to University of North Carolina for the post-exposure treatment of animals and the adducts analyses. DEADLINES This series of studies on the formation and repair of DNA adducts induced by vinyl chloride should provide a better understanding of the mechanisms of vinyl chloride carcinogenesis. essbs i ssh Page 2 of 5 Vinyl Chloride Health Committee Activities 04/11/97 SYNTHESIS OF 13C2 VINYL CHLORIDE / CAMBRIDGE ISOTOPE LABORATORIES The product was delivered to Huntingdon. According to Gary Hoffman (HLS) the analytical specifications of the material are acceptable. ACTION ITEMS DEADLINES IMPORTANCE By utilizing 13C2-vinyl chloride, the formation and repair of vinyl chloride-induced DN A adducts can be studied relative to those adducts formed endogenously. This aspect of the satellite studies could provide important information for risk assessment dealing with low exposures, such as might be associated with accidental releases that reach the fenceline. INTERNATIONAL LIFE SCIENCES INSTITUTE (ILSI) The VCHC contributed $10,000 to ILSI for .a project on the use of non-tumor data in cancer risk assessment. Gino Scarano of ILSI provided a progress report on the project. Gino Scarano will notify CMA of the date of the meeting of the sponsors when it has been set. ACTION ITEMS Monitor ILSI activities on this project. DEADLINES IMPORTANCE The current scientific and regulatory climate is such that the use of endpoints other than tumors to quantitatively estimate cancer risk is on the horizon. This project was initiated to address the question of whether and how genotoxicity and other data could be used as part of a cancer risk assessment. EPA INTEGRATED RISK INFORMATION SYSTEM PILOT PROJECT EPA has selected vinyl chloride for its IRIS pilot project. According to Mike Gargas, Harvey Clewell is the EPA contractor examining vinyl chloride. ACTION ITEMS Monitor EPA activities on this project. DEADLINES IMPORTANCE IRIS is an EPA database which contains consensus scientific positions on potential human health effects from environmental contaminants. The database has expanded 6ZQPQ l S'SH CHEMICAL MANUFACTURERS ASSOCIATION Vinyl Chloride Health Committee Proposed Budget Commitments 1997 Company Dow Chemical Capacity (millions of lbs.) 2,960 %of Total Canacitv 21.1 1997 Commitment and Invoice Dates 44,000 1/97 44,440 7/97 1997 Proposed Additional Commitment* 21,100 * For consultant services and a workshop for EPA/IRIS and ACGIH/TLV activities (external peer review services of Dick Reitz, and Mike Gargas of CHEMRisk and Mike Dourson of Toxicology Excellence for Risk Assessment) and 1997 administrative and legal services* CONFIDENTIAL 13 Qo c/} CJl ccAno o Page 3 of 5 Vinyl Chloride Health Committee Activities and its use has increased over the last decade. It is the primary source of risk assessment and management information for many other agencies at the federal, state and local levels. 04/11/97 BRAIN CANCER STUDY / UNIV OF LOUISVILLE ACTION ITEMS The Study is proceeding on schedule. IMPORTANCE The Committee and University of Louisville representatives will meet on April 18"' to explore alternative methods for analyzing data so the final study is seen as credible by both clinical and traditional epidemiological communities. The 20-year prospective assessment of B.F. Goodrich's Louisville cohort provides a unique opportunity to determine whether there is any association between brain cancer and vinyl chloride exposure. DEADLINES Study progress reports are due at CMA on dates indicated in the agreement. VINYL CHLORIDE COHORT STUDY UPDATE / APPLIED EPIDEMIOLOGY INC Ken Mundt received the remaining death certificate information from ENSR. He asked for assistance from Committee members to track employment and vital status on some of the cohort members. IMPORTANCE ACTION ITEMS DEADLINES Study progress reports are due at CMA on dates indicated in the study agreement. ATSDR TOXICOLOGICAL PROFILE FOR VINYL CHLORIDE ACTION ITEMS Committee provided comments on the health and environmental portions of the profile to ATSDR. Data on production volume, facilities and use in the profile, is inaccurate. Caffey Norman is drafting a letteT to ATSDR correct the data and suggest an alternative to the presentation of the storage data in Chapter 4 of the Tox Profile. Follow up with ATSDR on Committee comments. DEADLINES IMPORTANCE iest^s tssy Page 4 of 5 Vinyl Chloride Health Committee Activities 04/11/97 ATS DR MEDICAL MANAGEMENT GUIDELINES FOR VINYL CHLORIDE Committee provided comments on the guidelines. ACTION ITEMS Follow-up with Jennifer Hiese (617/674-7358) on when the guidelines will be finalized. IMPORTANCE DEADLINES EPA / PETITION TO RAISE THE "REPORTABLE QUANTITY' (RQ) OF VINYL CHLORIDE The Vinyl Institute will take the lead on determining whether a petition to raise the RQ is feasible. The VCHC will provide technical expertise if the VI decides that it is feasible. Caffey Norman will provide background on the criteria for determining the RQ. ACTION ITEMS DEADLINES IMPORTANCE EPA / AIR TOXICS PROGRAM ACTION ITEMS EPA identified vinyl chloride and 36 other chemicals as "high priorities" for regulation underits Air Toxics Program. The Agency plans to develop a comprehensive integrated strategy for establishing an "air toxics management model." Caffey Norman provided background on EPA's activities with the Air Toxics Program, and CMA has asked to be a stakeholder. DEADLINES IMPORTANCE ASSOCIATION OF PLASTICS MANUFACTURERS IN EUROPE (APME) / REGISTRY OF CASES OF ANGIOSARCOMA APME has developed a protocol for the maintenance of a register of cases of angiosarcoma related to PVC production. IMPORTANCE ACTION ITEMS CMA will monitor the development of the registry. DEADLINES AMERICAN CONFERENCE OF GOVERNMENTAL INDUSTRIAL HYGIENISTS (ACGIH) / INITIATIVE TO LOWER THE THRESHOLD LIMIT VALUE (TLV) FOR VINYL CHLORIDE The concern from ACGIH is based on an article by Simonato, et al. in the Scand J. Work ACTION ITEMS The Committee will examine the Simonato paper and make contact with William Waddell to propose presenting information to ACGIH. seshsis'sa Page 5 of 5 Vinyl Chloride Health Committee Activities &E.H. ACGIH met on October 5, 6, 7, 1996 in Philadelphia. Peter de la Cruz of Keller & Heckman (Vinyl Institute) responded to Dr. William Waddell of the Univ. of Louisville (ACGIH) for Frank Borelli. DEADLINES 04/11/97 IMPORTANCE CALEPA / DEVELOPMENTAL AND REPRODUCTIVE TOXICANT (DART) IDENTIFICATION COMMITTEE PRIORITY LIST Vinyl chloride is a potential candidate for listing under Proposition 65. The VCHC submitted comments to CalEPA. ACTION ITEMS The Committee will monitor this issue. IMPORTANCE DEADLINES eest-stssa