Document 6vQvZxyrYYR6ovjD0zz4bo99

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. In April 1997, a revised study plan was sent to ATSDR because of the delay in the initiation of the study. IMPORTANCE 07/28/97 o ACTION ITEMS DEADLINES 0 fa CQ 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. 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) Skeletal evaluations are taking place now for the developmental study. In the reproductive study, matings of the F(l) generation start July 29*. J. Knaak plans a visit to Huntingdon 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 CAROLINA-JAMES SWENBERG The agreement with 1ILS for in-life portion of the satellite study has been executed. According to the terms of the 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 adducts induced by vinyl chloride should provide a better understanding of the mechanisms of vinyl chloride carcinogenesis. Page 2 of 5 Vinyl Chloride Health Committee Activities 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 07/28/97 tt I o o gj 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 fonceline. 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: hezene, vinyl chloride and butadiene. According to G. Scarano of ILSI, the case study on VC is expected this fall. The meeting of Committee members and sponsors may be rescheduled from this fall to winter 1997. Continue to monitor ILSI activities on this project 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 the question of whether and hoWjgenotoxicity 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. EPA's Vinyl Chloride Peer Review Panel meet on June 3"1 and 4". After peer review comments are incorporated, the report is expected to go through EPA's consensus review process by the end of August. According to A. Mills, EPA hopes to have the reviews of all the pilot chemicals completed by late September/October. Monitor EPA activities on this project through Amy Mills (202/260-0569), the project manager and William Pepelko (202/260-5904), the chemical manager for the vinyl chloride risk assessment. DEADLINES The pilot study is scheduled to conclude this summer, with a decision on the success of the program expected by the fall of 1997. According to Mike Gargns, Harvey Clewell is the EPA contractor examining vinyl chloride. Page 3 of 5 Vinyl Chloride Health Committee Activities IMPORTANCE 07/28/97 IT) 1 i BFG 1 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 W. Sherman will forward comments from K. Mundt and panel members to Dr. 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 CM A on dates indicated in the agreement. VINYL CHLORIDE COHORT STUDY UPDATE / APPLIED EPIDEMIOLOGY INC. ACTION ITEMS Progress report no. 7 (July 8th) was received from K. Mundt. DEADLINES IMPORTANCE 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. 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. Follow up with ATSDR on Committee comments. DEADLINES IMPORTANCE ATSDR MEDICAL MANAGEMENT GUIDELINES FOR VINYL CHLORIDE Committee provided comments on the guidelines. As of July 1997, there was no established timeline for finalizing the Guidelines. ACTION ITEMS Follow-up with Jennifer Hiese (617/674-7358) on when the guidelines will be finalized. DEADLINES IMPORTANCE Page 4 of 5 Vinyl Chloride Health Committee Activities 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 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." 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 ooo O u. 09 Page 5 of 5 Vinyl Chloride Health Committee Activities 07/28/97 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 & H.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 (ACGU I) for Frank Borelli. IMPORTANCE ACTION ITEMS The Committee will examine the Simonato paper and make contact with William Waddell to propose presenting information to ACGIH. DEADLINES t"- S Oo BFG 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