Document zzzK5BmxZLOGMowpj2XbNwZ43

- I ' j1tR**J*2*8*73*3*1*3*2*4*8*$*****,***************************ifc**'*****************'************ PRINTED BY 2020 U075024 HAYES, WILLIAM C. 636-2664 95/02/03 14:39:10 ***************************************************************************** From: U246074 --S21VM To: U060785 - -S21VM U077632 - -S08VRNA U075024 - -S08VRNA U095202 - -S14VM U134803 - -S08VRNA U077494 - -S21VM U063460 - -S21VM U079317 - -S21VM U090844 - -S08VRNA U033173 - -S21VM U074840 - -S21VM Date and time MAY, VERN V T U077399 --S08VRNA DILLON JR, GEORGE U076129 --S21VM HAYES, WILLIAM C. U073763 --S08VRNA MCLEMORE, MARY K. U303653 --TXDECD STEARNS JR, W J. / U285329 --S21VM BODNER, KEN M. / 1 U287971 --S21VM CARTMILL, JAN B. / NUS7014 --S21VM HEARN, SUE S U085139 --S21VM MOHLER, RANDY R. / U084891 --S21VM TORRES, KATHY A. / U098205 --S21VM PINGEL, RON J. / 1 02/03/95 14:34:0 BOND, GREGORY G. DOMORADZKI, JEAN. MCCREEDY, R L. / NUILA, CARLOS C BARCIA, STEFFANi: BURNS, CAROL C J CHAU, MONICA L. , JAMMER, BRENDA L OLSEN, GEARY W. , WAMSLEY, MICHELE FROM: RAMLOW, JONATHAN M. SUBJECT: Trip Report 1803 Building February 3, 1995 TRIP REPORT - MEETING OF CMA VINYL CHLORIDE PANEL HEALTH COMMITTEE On Monday, January 30, I chaired the meeting of the CMA Vinyl Chloride Panel Health Committee in Washington, D.C. The primary purposes of the meetings were 1) to introduce Dr. Kenneth Mundt of Applied Epidemiology Inc. (AEI) to the Committee as a whole; 2) to hear a discussion by Dr. Carlo Tamburro, University of Louisville, of his request for funding to complete a case-control study of brain cancer among vinyl chloride-exposed workers; and 3) to discuss the current status of negotiations with ATSDR and EPA concerning developmental and reproductive toxicity testing. My trip expenses were paid for by Environmental Affairs, C&PP. Dr. Mundt, I feel, impressed the Committee with his research background, knowledge of the history of VCM research, and professional demeanor. He clearly spelled out what kind of assistance he will need from the member companies in order to complete the industry-wide cohort mortality study update on schedule. Specifically, he asked each Committee member to identify for him the appropriate contact person within each company, with whom he can work to obtain current vital status information for cohort members considered alive at the end of the last update study. I will let him know that Jan Cartmill, administrator of the Epidemiology Surveillance System, will be the appropriate contact person for Dow. Dr. Mundt and Dr. Shah of CMA reported to the Committee that a satisfactory contract had been worked out between CMA and AEI for the epidemiology study. The contract went into effect on February 1, 1995, and the current anticipated date for delivery of a final report to CMA is February 1, 1997. R&S147702 f Dr. Carlo Tamburro described the history of his involvement in VCM related ; - health research at some length. Through cooperative efforts by the `--University of Louisville and the B.F. Goodrich company, he was able to reach agreements with all 12 hospitals in the Louisville area whereby he can obtain clinical data and biological material for every VCM-exposed Goodrich employee hospitalized in the area. He proposes using these resources to obtain tissue samples from exposed employees thought to have died of brain cancer and to have these samples examined at the Armed Forces Institute of Pathology to obtain definitive diagnoses. He would compare the relative cumulative VCM (and 21 other chemicals) exposures of the actual primary brain cancer cases with that of matched controls, in a manner he used successfully in an earlier liver angiosarcoma study. The Committee will be discussing the merits and limitations of his proposal at length next Monday in a conference call. My sense now is that the Committee does perceive substantial scientific merit in what Dr. Tamburro proposes to do. However, the Committee also perceives that in order to obtain financial support from the businesses, it will be necessary to demonstrate that a contract with Dr. Tamburro could contain stringent requirements for a more detailed study protocol and adherence to a welldefined study schedule. CMA received a response from ATSDR to our inquiry late last year about the prospects for negotiating with them a Memorandum Of Understanding (by May 31 of this year) for the conduct of a study (ies) intended to address ATSDR's stated data needs for VCM. We had hoped that they would be willing to meet with us at an early date to discuss scientific issues in the areas of developmental and reproductive toxicity. It turns out that ATSDR's lawyers have advised them not to meet with us until after we have submitted a 2-generation inhalation repro. study protocol to ATSDR for review. After we submit a protocol, ATSDR will consider it appropriate to discuss the study plan with us. Accordingly, I asked Jean Domaradzki to help me out by obtaining a "generic" 2-generation inhalation repro. protocol from H&ES Reproductive Toxicology, , This she did, and I will send it to.CMA and to the Health Committee's outside counsel. They, with advice from toxicologists on the Health Committee, will re-draft the protocol as a CMA document with specific references to vinyl chloride which we can then submit to ATSDR Finally, the Committee discussed a request for information from the California Environmental Protection Agency, which is currently preparing a new risk assessment of communities exposed to airborne VCM from the BKK landfill site in West Covina, CA. They are concerned that the currently available carcinogenic potency estimates for VCM, based on animal data, will yield unrealistically high risk estimates for the communities adjacent to the site, at which air levels of VCM between 10-20 parts per billion have been measured. In response, CMA will send CalEPA a copy of Dick Reitz's report of PBPK modeling-based risk assessment methods, which yield potency estimates for humans that are much lower than the current ones. We have also indicated that, should it seem useful, we would consider supporting Dick's going out there to discuss his work with CalEPA as he did for us with the US EPA last Fall. V Should you wish to discuss any of this material in more detail, please feel free to call me at the number below. Jonathan M. Ramlow, Ph.D., M.P.H. Epidemiology, H&ES Phone (517) 636-1276 33 0= o CO