Document ZB6pBwzVy6YXOBOoJavVeK4JL

Page i of 5 Vinyl Chloride Health Committee Activities MEMORANDUM OF UNDERSTANDING (MOU) WITH THE AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY IATSDR) 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 05/07/97 DEADLINES Initial progress reports are due at ATSDR in April 1997 with subsequent reports due every 6 months thereafter until studies are completed and final reports are 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) The contract with Huntingdon has been signed. Analytical work on the test material is complete and the exposure portion of the study has begun. Preliminary results of the analytical work were delivered to CMA for inspection. Jim Knaak reviewed the material and approved it. Jim Knaak, David Penney, and Wendy Sherman visited Huntingdon on April 10,1997 to monitor the progress of the studies. ^, ACTION ITEMS Continue monitoring progress of study. DEADLINES Progress reports are due to ATSDR at intervals specified in the revised study plan of April 22,1997. IMPORTANCE This research is in lieu of a potential TSCA Section 4 testing requirement. MOLECULAR CARCINOGENESIS SATELLITE STUDIES AT HLS/UNIVERS1TY 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. ACTION ITEMS Execute agreement with HLS for in-life portion of satellite study. Prepare a gift letter for $50K to University of North Carolina for the post-exposure treatment of animals and the adducts analyses. 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 chloride carcinogenesis. CMA114982 Page 2 of 5 Vinyl Chloride Health Committee Activities 05/07/97 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 DNA 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. Case studies are being performed for three chemicals: bezene. vinyl chloride and butadiene. Gino Scarano of ILSI provided a progress report on the project. y ACTION ITEMS Continue to monitor ILSI activities on this project through Gino Scarano. DEADLINES A meeting of committee members and sponsors is expected sometime this fall. Gino Scarano will notify CMA of the date of tire meeting. 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 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. A peer review of vinyl chloride is scheduled for the week of May 12th. The pilot study is scheduled to conclude this summer, with a decision on the success of tire program expected by the fall of 1997. Monitor EPA activities on this project through Amy Mills (202/260-11569), the project manager and William Pepelko (202/260-5904), the chemical manager for the vinyl chloride risk assessment. DEADLINES V CMA 114983 Page 3 of 5 Vinyl Chloride Health Committee Activities 05/07/97 According to Mike Gargas, Harvey Ciewelt is the EPA contractor examining vinyl chloride. IMPORTANCE IRIS is 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 of risk assessment and management information for many other agencies at the federal, state and local levels. BRAIN CANCER STUDY / UNIV OF LOUISVILLE ACTION ITEMS The study is proceeding on schedule. IMPORTANCE 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. ,1 !i , The Committee and University of Louisville representatives met on April 18* to explore alternative methods for analyzing data so die final study is seen as credible by both clinical and traditional epidemiological communities. Dr. Carlo Tamburo will revise die protocol to incorporate the comments received at the meeting and will send a revised draft protocol to Has Shah at CMA by May 18,1997. DEADLINES VINYL CHLORIDE COHORT STUDY UPDATE / APPLIED EPIDEMIOLOGY INC. Study progress reports are due at CMA on dates indicated in the agreement. ACTION ITEMS 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. DEADLINES Study progress reports are due at CMA on dates indicated in the study agreement. IMPORTANCE 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 has drafted a letter to ATSDR correcting the data and suggesting an alternative to the presentation of the storage data in Chapter 4 of the Toxicological Profile. Follow up with ATSDR on Committee comments. DEADLINES CMA 114984 Page 4 of 5 Vinyl Chloride Health Committee Activities IMPORTANCE 05/07/97 ATSDR MEDICAL MANAGEMENT GUIDELINES FOR VINYL CHLORIDE Committee provided comments on the guidelines. As of April 1997, there was no established timeline for finalizing the Guidelines. IMPORTANCE ACTION ITEMS Follow-up with Jennifer Hiese (617/674-7358) on when the guidelines will be finalized. 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 priprities" for regulation under its Air Toxics Program. The Agency plans to develop a Ai'mprehensive integrated strategy for establishing an "air toxics management model." Caffey Norman provided background on EPA's activities with the Air Toxics Program, arid 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. ACTION ITEMS CMA will monitor the development of the registry. DEADLINES IMPORTANCE CMA 114985 AMERICAN CONFERENCE OF GOVERNMENTAL INDUSTRIAL HYGIENISTS (ACGIH) / INITIATIVE TO LOWER THE THRESHOLD LIMIT VALUE (TLV) FOR VINYL CHLORIDE ACTION ITEMS The Committee will examine the Simonato paper and make contact with William Waddell to propose presenting information to ACC1H. Page 5 of 5 Vinyl Chloride Health Committee Activities The concern from ACGIH is based on an article by Simonato, et al. in the Stand J. Work ScE.H. ACGIH met on October 5,6,7,19% in Philadelphia. Peter de la Cruz of Keller & Heckman (Vinyl Institute) responded to Eh. William Waddell of the Univ. of Louisville (ACGIH) for Frank Borelli. DEADLINES 05/07/97 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 i CMA 114986