Document 3NOn3Y3837pJ3yoee9ky8V596

a/m/att PAlit 1/6 CMA CM* Chemical Manufacturers Association Vinyl Chloride Health Committee FAX March 31,1998 TO: COMPANY: Dr. James Barter-- PPG Industries, Inc. Mr. Ed Beeler GEON Company Mr. Mark Gruenwald Borden, Inc. Dr. Steve Phillips Occidental Chemicals Mr. Caffey Norman Patton Boggs, L.LT. Dr. Colin Park The Dow Chemical Co. Dr. David Penney CONDEA Vista Company Mr. David Pun Formosa Plastics Mr. Jay Strange Georgia Gulf Corp. PHONE: (412)434-2801 (440) 930-3030 (614) 225-3459 (972)404-2413 (202)457-5270 (517) 636-1159 (281) 588-3059 (973) 716-7279 (504) 685-2642 FAX: (412) 434-2137 (440) 930-3034 (614) 225-7639 , (972) 404-3287 (202) 457-6315 (517) 638-2425 (281) 588-3478 (973) 716-7283 (504) 687-0294 FROM: Wendy K. Sherman CMA (703) 741-5639 (703) 741-6091 MESSAGE The attached material will be discussed on today's conference call at 2:00 pm. The Access Conference Call Service will contact you for the call. If you have any questions, please call me at 703/741-5639. Thank you. SENDER: Cynthia Barrett PHONE: 703/741-5642 PAGE(S) 6 (including cover) 004603.001 Innovation, Technology and Responsible Cake* At Work 1300 Willon Bivn., Akuncton, VA 22209 Telephone 703-711*5000 Fa* 703-741-6000 ReanmilitoCarc* * * AftifcComnarart CiflA 3/31/98 PAGE 2/6 CMA March 30,1998 VINYL CHLORIDE HEALTH COMMITTEE 1998 ACTTVmES TIME LINE PROJECT DATE Update of Mortality Among Vinvl Chloride Workers /Applied Epidemiology, Inc. April IS, 1998 June 1,1998 August 1,1998 October 1,1998 Vinvl Chloride Combined Inhalation Two-Generation Reproductive and Developmental Toxicity Study in CP Rats/ Huntingdon Life Sciences April 1998 April 1998 May 1998 June 1998 Use of Non-Tumor Data in Cancer Risk Assessment/ International Life Sciences Institute Brain Cancer Study/ University of Louisville June 1998 (tentative) ACTIVITY Complete overall and causespecific SMR analyses on updated cohort Complete sub-cohort and advanced statistical analyses. Prepare first complete draft of final study report and outline for journal manuscript, submit to Expert Advisory Panel and CMA for review and comment. Submit final report and manuscript to CMA for approval. Draft reproductive report due to CMA for review by midApril. Status report on reproductive study due to CMA, to forward to ATSDR. CMA comments on draft reproductive report due to Huntingdon by mid-May. Final Reproductive Study due to CMA for ATSDR July due date. Draft vinyl chloride case study to CMA for review. [W. Sherman to call for timeline.] 004603.002 3 /3 1 /8 8 Page I of4 Vinyl Chloride Health Committee Activities MEMORANDUM OF UNDERSTANDING (MOU) WITH THE AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY (ATSDR) The final developmental study was sent lo ATSDR in January 1998. ATSDR acknowledged receipt of the report; acceptance erf the report is subject to Agency review and the Committee's satisfactory response to ATSDR's comments. IMPORTANCE 03/31/98 ACTION ITEMS A progress report on the status of the reproductive study, and then a final report are due lo ATSDR. DEADLINES ^< , A progress reports on the reproductive study is due to ATSDR In April 199/. The final reproductive study report is due to ATSDR in July 1998. The MOU was developed to meet the research needs of ATSDR and the Environmental Protection Agency in lieu of a T9CA Section 4 testing requirement. REPRODUCnVE & DEVELOPMENTAL TOXICITY STUDIES AT HUNTINGDON LIFE SCIENCES (HLS) A preliminary macroscopic and microscopic pathology report and terminal organ weight data on the reproductive study have been submitted for Committee review. IMPORTANCE This research is in lieu of a potential TSCA Section 4 testing requirement ACTION ITEMS A progress report on the reproductive study is due to CMA by mid-April 1998. DEADLINES A progress report on the reproductive study to CMA by mid-April 1998. The draft reproductive report is due to CMA by mid-April; CMA comments due to Huntingdon by mid-May; and final report to CMA by June 1998. MOLECULAR CARCINOGENESIS SATELLITE STUDIES AT HLS/ UNIVERSITY OF NORTH CAROLINA-JAMES SWENBERG Dr.Swenberg made a presentation to the Committee at their February 1998 VCHC meeting in North Carolina. At that time Dr. Swenberg clarified his request for financial support from the Committee. ACTION ITEMS Respond to '98 and '99 budget request from J. Swenberg. DEADLINES IMPORTANCE 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 chionde carcinogenesis. 5 PAGE 3 /6 C8O Vinyl Chloride Health Committee Activities 03/31/98 INTERNATIONAL LIFE SCIENCES INSTITUTE (ILSI) ACTION ITEMS The VCHC contributed $10,000 to ILSI for a project on the use of non-tumor data in cancer risk assessment Case studies are being performed for three chemicals: bezene, vinyl chloride and butadiene. Case study reports are due to ILSI from the work groups by April 1998. A oopy of the draft vinyl chloride report is tentatively scheduled to be forwarded to the Committee for their review by June 1998. Continue to monitor ILSI activities on this project. DEADLINES IMPORTANCE The current scientific and regulatory dimate 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 genotojddty and other data could be used as part of a cancer risk assessment EPA INTEGRATED RISK INFORMATION SYSTEM PILOT PROJECT ACTION ITEMS EPA has selected vinyl chloride as one of eleven plus chemicals for its IRIS pilot project The goal of the pilot is to improve the efficiency in gathering and reviewing data and the quality of the information available through IRIS. The revised document has been through the external peer review process, and has been commented on by BPA's Consensus Work Group. After undergoing another revision, the report is expected to be resubmitted to the Consensus Work Group by mid-April. Acceptance of the report by the Consensus Work Group is the last step prior to finalizing die revised IRIS report. Monitor EPA activities on this project through Amy Mills (202/260-0569), the project manager and William Pepelko (M2 /564-3309), the chemical manager for the vinyl chloride risk assessment. DEADLINES IMPORTANCE IRIS b an EPA database which contains consensus scientific positions on potential human health effects from environmental contaminants. The database has expanded and its use has increased over the last decade. It is the primary source o( risk assessment and management information for many other agendes at the federal, state and local levels. 8 98/T E /C Page 3 of4 Vinyl Chloride Health Committee Activities 03/31/98 BRAIN CANCER STUDY / UNIV OF LOUISVILLE ACTION ITEMS At the February VCHC meeting in North Carolina, the Committee accepted the most recent version of the revised protocol submitted by Dr. Carlo Tamburro. IMPORTANCE The 20-year prospective assessment of BF. Goodrich's Louisville cohort provides a unique opportunity to determine whether there is any association between brain cancer and vinyl chloride exposure. W. Sherman will forward the Committee's acceptance of the revised protocol to Dr. Tamburro. W. Sherman will forward a copy of the revised protocol to the protocol peer review consultants, Gary Marsh and Harvey Checkoway. DEADUNES Study progress reports are due at CMA on dates Indicated in the agreement VINYL CHLORIDE COHORT STUDY UPDATE fAPPLIED EPIDEMIOLOGY INC In March 1998, K. Mundt submitted a revised time line for completion of the VCM cohort update. Delays in receiving requested death certificates from several states necessitated a revised delivery schedule. IMPORTANCE ACTION ITEMS Continue to monitor this activity. DEADLINES Draft study reports and manuscripts are due at CMA following the revised schedule. 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 tnacrurate. A letter was sent In April 1997 to ATSDR correcting the data and suggesting an alternative to the presentation of the storage data in Chapter 4 of the Toxicological Profile. A recent Federal Register Notice announced the release of the latest version of the Vinyl Chloride Toxicology Profile. Review tire revised toxicology profile to see if Committee's comments were addressed. DEADLINES IMPORTANCE ATSDR MEDICAL MANAGEMENTGUIDELINES FOR VINYL CHLORIDE Committee provided comments on the guidelines. As of March 1998, there was no established timeline for finalizing the Guidelines. ACTION ITEMS Follow-up with Jennifer Hiese (781/674-7358) on when the guidelines will be finalized. DEADLINES IMPORTANCE 9 /S 3DVd 004603.005 3 /3 1 /9 8 Page 4 of4 Vinyl Chloride Health Committee Activities EPA / AIR TOXICS PROGRAM ACTION ITEMS EPA identified vinyl chloride and 36 other chemicals as "high priorities" for regulation under its Air Toxics Program. The Agency plans to develop a comprehensive integrated strategy for establishing an "air toxics management model." The Committee submitted comments on EPA's inclusion of vinyl chloride as a "high priority'" chemical. DEADLINES IMPORTANCE ASSOCIATION OF PLASTICS MANUFACTURERS IN EUROPE (APME) / REGISTRY OF CASES OF ANGIOSARCOMA ACTION ITEMS APME has developed a protocol for the maintenance of a register of casta of angiosarcoma related to PVC production. DEADLINES IMPORTANCE 03/31/98 AMERICAN CONFERENCE OF GOVERNMENTAL INDUSTRIAL HYGIENISTS (ACGIH) / INITIATIVE TO LOWER THE THRESHOLD LIMIT VALUE (TLV) FOR VINYL CHLORIDE ACGIH has proposed a change in the 1998 Threshold Limit Value for vinyl chloride. IMPORTANCE ACTION ITEMS Determine if the Committee will submit comments on ACGTH's proposed change to the vinyl chloride TLV and/or the aupporting documentation. DEADLINES CALEPA / DEVELOPMENTAL AND REPRODUCTIVE TOXICANT (DART) IDENTIFICATION COMMITTEE PRIORITY LIST Vinyl chloride is a potential candidate for fisting under Proposition 65. The VCHC submitted comments to CalEPA. IMPORTANCE ACTION ITEMS The Committee will monitor this issue. DEADLINES PAGE 6 /6 004603.006