Document EmqM9b17jG1aV3m8vYVDjrr7x

DRAFT CHEMICAL MANUFACTURERS ASSOCIATION Vinyl Chloride Health Committee Tentative Conference Call Agenda DATE: TIME: July SO, 1997 10:30 a m. - 12 noon, EDT / 1.0 Approval of the April 23,1997 Record of Meeting and Administrative Items 2.0 Update on the Vinyl Chloride Cohort Study with Applied Epidemiology Inc. 3.0 Update on the University of Louisville Brain Cancer Study 4.0 Financial Update and Development of 1998 Budget 5.0 Update on the Developmental, Reproductive and Mechanistic Research Studies 5.1 Huntingdon Life Sciences Developmental and Reproductive Studies 5.2 University of North Carolina-J.Swenberg Satellite Study^^ ^ Q 6 0 Update on EPA's IRIS Pilot Project 7.0 Update on EVCM Presentation at SP1 8.0 Update on the International Life Sciences Institute Genotoxidty Project 9.0 Schedule Next Meeting or Conference Call ^ > Subject to Approval Wendy K. Sherman Manager Vinyl Chloride Health Committee -f\---------- JJ. jw-- ^xl JUL 28 '97 16:04 . BFG 00006 PAGE.02 Page 1 of 5 PQGE.03 Vinyl Chloride Health Committee Activities MEMORANDUM OF UNDERSTANDING 1MOU) WITH THE AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY (ATSDR) The MOU has been signed. In April 1997, a revised study plan was sent to ATSDR because of the dplay in the initiation of the study. IMPORTANCE ACTION ITEMS 07/28/97 DEADLINES The next set of progress reports for the developmental and reproductive studies are due to o ATSDR in October 1997. The final developmental report is due to ATSDR in December o 1997, 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 IHLS) Skeletal evaluations are taking place now for the developmental study. In the reproductive study, matings of the F(l) generation start July 29*. J. Knnak plans a visit to I luntingdon in late August. IMPORTANCE This research is in lieu of a potential TSCA Section 4 testing requirement. ACTION ITEMS Continue monitoring progress of study. DEADLINES The draft developmental report is due to CMA on August 24^. Huntingdon may ask for an extension According to the revised study plan of April 22, 1997, the next set of progress reports for the developmental and reproductive studies are due to ATSDR in October 1997. The final developmental report is due to ATSDR in December 1997. MOLECULAR CARCINOGENESIS SATELLITE STUDIES AT HLS/ UNIVERSITY OF NORTH CAROLJNA-JAMES SWENBERG The agreement with HLS for in-life portion of the satellite study has been executed. According to the terms of tire gift letter, J. Swenberg received the second $25,000 payment in mid-July 1997. The money is for the post-exposure treatment of animals and adducts analyses. ACTION ITEMS Clarify budget request from J. Swenberg. DEADLINES IMPORTANCE This series of studies on the formation and repair of DNA adducls induced by vinyl chloride should provided better understanding of the mechanisms of vinyl chloride carcinogenesis. JUL 29 9 7 16=04' Page 2 of 5 Vinyl Chloride Health Committee Activities 07/28/97 SYNTHESIS OF 13C2 VINYL CHLORIDE/ CAMBRIDGE ISOTOPE LABORATORIES The product was delivered to Huntingdon. According lo 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 1 )NA 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 L1FESCIENCES INSTITUTE (ILSI) The VCHC contributed $10,000 to ILSI for .a project on the use of non-tumor data in canner risk assessment. Case studies are being performed for three chemicals: bozene, vinyl chloride and butadiene. According toG Searanoof [LSI, the case study on VC is expected this fall. The meeting of Committee members and sponsors may he rescheduled from this fall to winter 1997. ACTION ITEMS Continue to monitor ILSI activities on this projec t through Gino Scarano 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 thp question of whether and how genotoxicity and oilier data could be used as part of a cancer risk assessment. EPA INTEGRATED RISK INFORMATION SYSTEM PILOT PROJECT ACTION ITEMS EPA has selected vinyl c hloride as one of ehrven plus chemicals for its IRIS pilot project The goal of the pilot is to improve the efficiency in gathering arid reviewing data and the quality of the information available through IRIS. EPA's Vinyl Chloride Peer Review Panel meet on June 3"* and 4r. After peer review comments are incorporated, the report is expected to go through EPA's consensus roview'process by the end of August. According lo A. Mills, EPA hopes to have the reviews of all the pilot chemicals completed by late September/October Monitor EPA activities cm this project through Amy Mills (202/260-0569), the project manager and William Pepelko (202/260-5904), the chemical manager for Ihe vinyl ddoride risk assessment. DEADLINES The pilot study is scheduled to conclude this summer, with a decision on thp success of die program expected by the foil of 1997. According to Mike Gargas, Harvey CleweU is the EPA contractor examining vinyl chloride. co 00 o o o O u* CQ JUL 28 '9 7 1 6 : 04 fiGE. PAGE.05 Page 3 of 5 \) S' \ J`> Vinyl Chloride Health Committee Activities 3 S' IMPORTANCE 1 IRIS is an BPA 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. fi is the primary source of risk assessment and management information for many other agencies at the federal, state and local levels 07/28/97 BFG 00009 BRAIN CANCER STUDY / UNIV Oh LOUISVILLE ACTION ITEMS The study is proceeding on schedule. IMPORTANCE W. Sherman will forward comments from K. Mundt and panel members to l>r. Carlo Tamburoon his revised protocol. 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. Progress report no. 7 Only 8*) was received from K. Mundt ACTION ITEMS DEADLINES IMPORTANCE Study progress reports are due al CMA on dates indicated in the study agreement. ATSDR TOXICOLOGICAL PROniETOR VINYL CHLORIDE ACTION ITEMS Committee provided comments on the health and environmental portions of the profile to ATSDR Data on pioduction volume, facilities and use in the profile, is inaccurate. 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. hollow up with ATSDR on Committee comments DEADLINES JUL 28 97 1& :05' IMPORTANCE -) J ATSDR MEDICAL MANAGEMENT GUIDELINES FOR VINYL CHLORIDE ACTION ITEMS J 3 Follow-up with Jennifer Hiese(617/67T7358) on whpn the guidelines will be finalized. Committee provided comments on the guidelines. As of July 1997, there was no established r. timeline for finalizing the Guidelines. Ti < i 3U IMPORTANCE 1 DEADLINES PAGE.06 BFG 00010 Tage 4 of 5 Vinyl Chloride Health Committee Activities CPA / PETITION TO RAISE THE "REPORTABLE QUANTITY' (RQ) OF VINYL CHLORIDE The Vinyl Institute will take the lead on determining whether a ppfition to raise the RQ is feasible. The VOHC svill provide technical expertise if the VI derides that it is feasible Catfey Norman will provide background on the criteria for determining the RQ. ACTION ITEMS DEADLINES 07/28/97 IMPORTANCE 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." Caifey Norman provided background on EPA's activities with the Air Toxics Progiani, and CMA has asked lobe a sta keholder. DEADLINES IMPORTANCE ASSOCIATION OF PLASTICS MANUFACTURERS IN EUROPE (APME) / REGISTRY OF CASES OF ANGIOSARCOMA APMB has developed a protocol for the maintenance of a register of cases of angiosarcoma relate*! to PVC production. ____________________________________________________________________________ s ACTION ITEMS / ---------- r"" t/-4- r CMA will monitor the development of the registry. A/"" DEADLINES IMPORTANCE ___________ " ____________**> JUL 28 97 18:05' j Page 5 of 5 3 3 Vinyl Chloride Health Committee Activities 3 1 AMERICAN CONFERENCE OF GOVERNMENTAL INDUSTRIAL HYGIENISTS ACTION ITEMS 07/28/97 Cd (3 a a_i io- LU (aJ a (ACGIH) / INITIATIVE TO LOWER THE THRESHOLD LIMIT VALUE <TLV) FOR VINYL CHLORIDE The concern from ACGIH is based on an article by Simonato, et aJ. in the Scand J. Work & The Committee will examine the Simonato paper and make contact with William Waddell lo propose presenting information to ACGIH. o EH. ACGIH met on October 5,6r7,1996 in Philadelphia Peter de la Cruz of Keller & Heckman DEADLINES (Vinyl Institute) responded lo Dr William Waddell of the Univ. of Louisville (ACGIH) for Frank Borelli. U f*4 CO 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 toCalEPA. IMPORTANCE ACTION ITEMS The Committee will monitor this issue. DEADLINES Jd L -e 'd -.L '^ lV rO-'