Document yrYDmVoQ3m3KEBNJaB46dgqKE

PRINTED BY 2020 U077632 DILLON JR, GEORGE S. 636-4982 95/02/06 10:44:03 From: U246074 --S21VM To: U077399 --S08VRNA U076129 --S21VM U073763 - -S08VRNA U303653 --TXDECD Date and time BOND, GREGORY G. / U077632 - -S08VRNA DOMORADZKI, JEANNE U075024 - -SOQVRNA MCCREEDY, R L. / 2 U095202 --S14VM NUILA, CARLOS C E U134803 - -S08VRNA 02/06/95 09:35: 1 DILLON JR, GEORG1 HAYES, WILLIAM C MCLEMORE, MARY K STEARNS JR, W J. FROM: RAMLOW, JONATHAN M. Subj ct: Trip Report Hi George: 1) The final contracted cost for the epi study update is $346,225, In addition to the final report, interim reports are currently scheduled for 6/1/95, 12/1/95, and 6/1/96. The first draft of the final report is now due as of 11/1/96. Sorry about leaving these out, I just wanted to give a general idea of the total projected study period. 2) With regard to Dr. Tamburro, the Health Committee members express d some concern at the meeting that he has not yet given us enough assurance that he can complete his brain cancer case-control study within the 7-9 month frame that he indicated in his letter of last October 27th. Since much of the value to the businesses would come from the availability of new data regarding brain cancer within calendar year 1995, we feel we would need to `'pin him down* about this before making a strong recommendation to proceed with him. 3) Sorry about the 'acronym-itis' in my trip report. ATSDR is the Agency for Toxic Substances and Disease Registry, an arm of the Centers for Disease Control and Prevention which is actually funded via the EPA and Superfund. ATSDR in 1992 identified priority VCM data needs in the areas of developmental and reproductive toxicity. ATSDR got no response from industry, to my knowledge, regarding voluntary research efforts to meet those data needs, so ATSDR passed them up to EPA. EPA then announced these data needs in a September 30 Federal Register notice of proposed test rules for VCM and other chemicals. In addition, EPA added its own proposed requirement for neurotoxicity testing for VCM; we do not know exactly why at this time. In any case, CMA has indicated that the industry is interested in going forward with a voluntary research program at this time, but through our outside counsel we also indicated that we feel some discussion is in order with both ATSDR and EPA to better define the data needs and an optimal research program to meet them. ATSDR has clearly signaled a willingness to engage in this type of discussion, but only after we have submitted the repro. study protocol proposal to them. We have not yet heard back from the EPA about their willingness/unwillingness to negotiate. My understanding, based on what our counsel has said, is that EPA probably will be willing to do this, but it is not clear yet whether they will want to do so conjointly with ATSDR (which is what we proposed). Th bottom line here is that we feel we have a clear understanding of how to proceed with ATSDR, but we are still waiting R&S 14 to hear from EPA about what they want to do. I hope this clears things up somewhat. Please don't hesitate to let me know if there is anything else you'd like to know about what is going on. Jonathan Forwarding note from U077632 --S08VRNA 02/04/95 19:03 *** To: U246074 --S21VM cc: U303653 --TXDECD NUILA, CARLOS C E U077632 - -S08VRNA DILLON JR, GEORGE U073763 --S08VRNA MCCREEDY, RON R L U077399 - -S08VRNA BOND, GREGORY G. *** Reply to note of 02/03/95 14:34 From: G-S- Dillon, Jr, Ind Solvents & Chlorides, 2020 Bldg, 6-4982 Subject: Trip Report Jonathon, thanks for the summary of the 1/30/95 meeting of CMA VCM Panel Health Committee. 1) AEI study of 'industry-wide cohort mortality.' What was the final cost to hire AEI and will there be any interium reports or just a final report on 2/1/97? 2) Dr. Tamburro's proposed study of brain cancer among VCM-exposed workers: Please expand on your comments about what would be needed before obtaining financial support from the business...you mentioned 'more detailed studyproto* ol' and 'adherence to a well-defined studyschedule.' What are you concerned about with Dr. Tamburro,,.? 3) ATSDR data needs for VCM. Last year in a broad review of your committee's 1994-95 proposed activities, you noted that the EPA testing requirements exceeded ATSDR data needs and recommended hiring an outside lawyer to n gotiate a testing program with EPA that involves only those studies necessary to meet ATSDR data needs. Your summary of the 1/30 meeting says that ATSDR won't meet with your committee until you provide a 2-generation inhalation repro study protocol. Perhaps my problem is that I don't know what ATSDR stands for, but it isn't clear to me what happened to negotiating with the EPA. Please explain what is happening. Jonathon, thanks again for the report. R&S 142822