Document nkm6VBRBYwGbnG7y1rqR5YYna

Chemical Manufacturers Association November 13,1995 Dear Vinyl Chloride Health Committee Members: This is a good news letter! ATSDR informs me that ERA will not require additional neurotoxicity data at this time and that a Memorandum of Understanding can be signed between CMA and ATSDR for a combined reproduction and developmental toxicity study in one species. This represents a saving of about $400,000. The following items are enclosed: 1) the October 31,1995, Record of Meeting; 2) the November 8,1995, letter from ATSDR approving the combined reproduction and developmental toxicity study protocol. A copy of the August 1995 ATSDR Toxicological Profile for Vinyl Chloride referred to in the letter also is enclosed for your review and files. The ATSDR letter proposes a collaborative research to address the Agency's need for dose-response data for chronic inhalation. I will have Bill Breslin of Dow look into the ATSDR data need and put it on the agenda for our conference call on November 30 at 10:00 a.m.; 3) the October 31,1995, letter to ENSR about the unacceptability of delays caused by ENSR in transferring all required information to AEI; and, 4) a manuscript by Harvey Clewell et al on vinyl chloride risk assessment. I will send you a commitment form for the 1996 research program and the agenda for the November 30 conference call tomorrow. Sincerely, Jiao Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel Enclosures EfftC l IV F CMA IS MOVING! \R\ I 996, l JL K NEA\ VPPREiS U ILL rff : 1 )00 WlLX'iN BOL LEV ^RL> ARLISGTOV V1RG1M V 22209 501 M S'rfft, NW. Wvshim-.tos, DC 20037 TtLFfHosr 202-887-1 100 Fm 202-887-1237 A Responsible Care W A Public Commitment CMA 114755 October 24,1995 Dear Vinyl Chloride Health Committee Members: The following items are enclosed: 1. agenda for our October 31,1995 meeting; 2. Questions for Consideration With Respect to the Proposed University of Louisville Brain Cancer/VCM Case-Control Study. Jonathan Ramlow, Ed Beeler and I plan to meet with Carlo Tamburo in the next several weeks. Please review the list and bring to the meeting any additional questions that you may want to ask of Carlo Tamburo; 3. comments on "Protocol for CMA Vinyl Chloride Mortality Study." Jonathan Ramlow prepared these comments on the AEI protocol based on both Mark Gruenwald's and his own review of the AEI protocol. The comments have been submitted to Ken Mundt of AEI. I have invited Ken Mundt to attend our Committee meeting on October 31,1995; 4. letter to ATSDR on Vinyl Chloride Protocol, for Combined Inhalation Two-Generation Reproduction and Developmental Toxicity Study in CD Rats. Bill Breslin of Dow Chemical responded to the ATSDR Peer Reviewers' comments and revised the first draft protocol; and, 5. Memorandum of Understanding for Voluntary Research Program Under Section 104 (I) (5) of CERCLA between ATSDR and Halogenated Solvents Industry Alliance, Inc. Please review this MOU prior to the meeting and bring your comments, as ATSDR may propose a similar MOU for the Vinyl Chloride Health Effects research program. Please call me at (202) 887-1192 if you have any questions. I am looking forward to seeing you at our October 31 meeting. Sincerely, Enclosures Hasmukh Shah Manager, Vinyl Chloride Panel CMA 114756 CM ,V_!-AC -'cjoCC'A-CN October 12,1995 Dear Vinyl Chloride Health Committee Members: The following items are enclosed: 1. comments prepared by Jonathan Ramlow on the draft protocol for Update of Mortality Among Vinyl Chloride Workers. These comments incorporate comments provided by Mark Gruenwald of Borden. No comments on the epidemiology study protocol have been received from any other member companies. Please review the enclosed comments and let me know if you have additional comments. I plan to send our final comments to Ken Mundt by October 20; and, 2. a revised protocol for the combined developmental/reproductive effects study. The revised protocol incorporates the ATSDR peer reviewer comments to the extent appropriate. Bill Breslin's response to the reviewer's comments also is included with the protocol. I have included ATSDR peer reviewer comments for your ready reference. Please call me with your comments on the revised protocol by October 19. I plan to send the protocol to the ATSDR on October 20. Dr. Breslin estimates the study cost at $650,000. Please call me at (202) 887-1192 if you need additional information. I am looking forward to seeing you on October 31. I will send you an agenda and other information for the meeting in the near future. Sincerely, Enclosures Hasmukh Shah Manager, Vinyl Chloride Health Committee CMA 114757