Document ZB4J9pOZXB2LVkwodxNO9kVp

CHEMICAL MANUFACTURERS ASSOCIATION Vinyl Chloride Health Committee Record of Conference Call DATE: TIME: July 31,1996 10:00 a.m. EDT List of Participants: Ed Beeler Mark Gruenwald Jim Knaack Caffey Norman (p/t) David Penney David Pun Jonathan Ramlow (p/t) Jay Strange Has Shah Robert Venezia The GEON Company Borden Chemicals and Plastics Occidental Chemical Corporation Patton Boggs, LLP CONDEA Vista Company Formosa Plastics The Dow Chemical Company Georgia Gulf Corporation CMA CMA 1.0 Approval of May 9,1996 Record of Conference Call The record was approved as written. 2.0 Update on the Developmental and Reproductive Toxicity Studies 2.1 Status of the MOU with ATSDR Robert Venezia reported that the MOU has been signed by both CMA and ATSDR. 2.2 Update on the Shipment of Vinyl Chloride to Huntingdon Life Sciences Dr. Venezia reported that Ed Beeler and Dennis O'Keefe of the GEON Company have been handling the shipping logistics. They anticipate delivery of the vinyl chloride to Huntingdon by the end of August. The Panel approved up to $10,000 to be paid to the GEON Company for the cost associated with the shipment of vinyl chloride to Huntingdon Laboratories. The Panel agreed that a letter of thanks should be sent to Ed Beeler and Dennis O'Keefe their efforts at coordinating this aspect of the research. Dr. Venezia will send the letter on behalf of the Panel. 23 Update on the Molecular Carcinogenesis Satellite Study Dr. Venezia reported that Huntingdon's initial cost estimate for the satellite studies was more than anticipated. Dr. Venezia and Has Shah CMA 119485 Vinyl Chloride Health Committee Record of Conference Call - 7/31/96 8/26/96 Page 2 discussed with Jim Swenberg and Huntingdon research directors a revised protocol to reduce the costs of materials and labor for the studies. A discussion of the revisions is scheduled for the near future. The Panel approved a total of $635,000 for the main study, analytical work, and Dr. Swenberg's molecular research group for the satellite Huntingdon Research project. 2.4 Status of the Statement of Work for Consultant Services from Bill Breslin of Dow Chemical Jonathan Ramlow discussed a draft agreement with Bill Breslin for his services as a quality assurance consultant for the developmental and reproductive toxicity research studies. The Panel approved $25,000 for Bill Breslin's services. Dr. Ramlow will fax a copy of the draft to Dr. Venezia who will distribute it to the Panel. 3.0 Update on the Vinyl Chloride Cohort Study by Applied Epidemiology, Inc. Dr. Venezia summarized Interim Report #4 from AEI. 4.0 Discussion of the Peer Reviews of the Brain Cancer Case-Control Study at the University of Louisville and Status Report from Carlo Tamburro Carlo Tamburro was unable to participate on the conference call. Drs. Venezia and Ramlow summarized Harvey Checkoway's and Gary Marsh's reviews of the study protocol. The reviews contained several strong recommendations for areas of improvement. Dr. Tamburro received copies of Drs. Checkoway's and Marsh's reviews. He will incorporate changes where appropriate and formally respond to the reviewers comments in a revised protocol. Dr. Tamburro explained to Dr. Venezia that he will work on the revisions with Ralph Buncher of the University of Cincinnati. Dr. Venezia will recommend to Dr. Tamburro that he include Dr. Buncher when he contacts Ken Mundt to begin collaborating with AEI. Ed Beeler described a working relationship between Richard Lewis of the University of Louisville and The GEON Company that could be expanded to include a consultancy with Dr. Tamburro on the brain cancer study. The Panel agreed that Dr. Lewis would provide an opportunity to monitor the brain cancer study more closely if needed. 5.0 Discussion of the International Life Sciences Institute's Genotoxicity Case Study Using Vinyl Chloride Dr. Venezia reported that ILSI is developing a compendium of case-studies on the use of non-tumor (Genotoxicity) data in cancer risk assessment. ILSI is interested in the Panel's participation on the project because vinyl chloride is one CMA 119486 Vinyl Chloride Health Committee Record ot Conference Cail - 7/31/96 8/26/96 Page 3 of four chemicals to be studied. The Panel approved ILSI's formal request for $10,000 for partial funding of the project. 6.0 Update on EPA's IRIS Pilot Project 6.1 Discussion of Course of Action on the CHEMRisk Proposal to Update IRIS for Vinyl Chloride Dr. Venezia reported that HPA is interested in input from industry only during the external peer review phase of the IRIS Pilot Project. EPA will not guarantee attention to information submitted before that time. In light of this, the Panel reviewed CHEMRisk's proposal and decided against funding. Dr. Venezia will contact EPA to determine the timetable and format for the external peer review phase. 7.0 Discussion of ATSDR's Guidance for Establishing Minimal Risk Levels for Vinyl Chloride Jim Knaack reported that ATSDR is arranging a computational workshop on the MRLs. No date for the workshop has been announced yet. The Panel agreed that the MRL guidance warrants the consideration of outside expertise if necessary to develop an appropriate response. Tim Knaack will examine the MRL guidance before the ATSDR workshop. 8.0 Discussion of a Petition for Revision of EPA's "Reportable Quantity" for Vinyl Chloride Jim Knaack reported that the Vinyl Institute may also be interested in this issue. Dr. Venezia-will examine the ori$inai Reportable Quantity rulemaking to determine if it was set by policy or by assigning a default value. 9.0 Schedule Next Meeting or Conference Call Dr. Venezia will fax conference call scheduling forms Subject to Approval Robert A. Venezia, Dr.P.H. Manager, Vinyl Chloride Health Committee CMA119487