Document 93RzxDzmNXOmV1zgXgjNobnKe

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Agency for Toxic Substances and Disease Registry Atlanta GA 30333 JuL 2 T |9S5 Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel Chemical Manufacturers Association 2501 M Street, N.W. Washington, DC 20037 Dear Dr. Shah: This is in response to your June 9 letter in which you enclosed a study protocol, "Vinyl chloride: Combined inhalation two-generation reproduction and developmental toxicity study in CD rats." The study protocol was submitted by the Chemical Manufacturers Association (CMA) to the Agency for Toxic Substances and Disease Registry (ATSDR) for the purpose of conducting voluntary research to address ATSDR's priority data needs for vinyl chloride. In the letter, you asked if ATSDR could consult with the Environmental Protection Agency (EPA) regarding EPA's interest in the neurotoxicity of vinyl chloride and the feasibility of satisfying EPA's identified testing needs by expanding the enclosed protocol to address neurotoxicity endpoints. Also, you requested that ATSDR discuss with EPA an extension of time for the testing that will be satisfactory to both ATSDR and EPA. As described in the Federal Register (57 FR 4758, February 7, 1992) , ATSDR established the Tri-Agency Superfund Applied Research Committee (TASARC) to assure coordination of ATSDR's substance-specific research efforts. The CMA combined study protocol was shared with EPA and the National Institute of Environmental Health Sciences at the June 16 meeting of the TASARC. The EPA is currently reviewing the protocol to assess the suitability of including a neurotoxicity component in the protocol. We expect to hear from EPA soon and will notify you of their decision immediately thereafter. Meanwhile, we have forwarded the CMA protocol for the combined reproductive and developmental study to ATSDR's Associate Administrator for Science who will identify and select peer reviewers. You will be requested to respond to the peer reviewers' comments. Upon satisfactory response, and upon agreement between our two organizations on the study plan (including the time schedule), ATSDR and CMA may then choose to enter into a memorandum of understanding. BFG 01860 Page 2 - Hasmukh C. Shah, Ph.D. It is clear that an MOU could not have been in place by May 31 as stated in your letter of June 9. However, we have notified EPA and NIEHS of the significant progress taken place and have agreed to continue to pursue voluntary research efforts with CMA beyond the deadline; hopefully leading to a successful voluntary research agreement between our two organizations. We will keep EPA informed of our progress on this effort. If you have any questions, please call me at 404-639-6300. Sincerely yours. Christopher T. DeRosa, Ph.D. Director, Division of Toxicology BFG 01861