Document 3JRedbJ9zyBmQLMr2ke5EpNoa

I V % CHEMICAL MANUFACTURERS ASSOCIATION March 28, 1980 To: Vinyl Chloride Audit Task Group (ATG) Dr. Z. G. Bell, Chairman Dr. T. J. Benya Dr. G. K. Hatfield Dr. R. K. Hinderer Dr. V. L. Kirkland Dr. T. R. Torkelson PPG Industries, Inc. Ethyl Corporation Diamond Shamrock Corporation The BFGoodrich Company, Chemical Division Shell Chemical Company The Dow Chemical Company Gentlemen: As a result of Panel action on March 18, 1^80 (please refer to page 2, Item 3.0 of the Record of Meeting), Dr. William Busey submitted the enclosed bid/proposal covering additional histo- . pathologic examination of brains from the IBT/VC study. We request your immediate review of Dr. Busey1s proposal. Should you have questions regarding the proposed work or should you believe that changes are necessary, please telephone the undersigned immediately. We shall expect all responses on or before April 4, 1980. Should no response be received on or before this deadline, we shall assume you approve Dr. Busey1s proposal and bid. Sincerely, JTS:md Enclosure J. T. Seawell Project Administrator Vinyl Chloride Research DMA 006552 Formerly Manufacturing Chemists Associat ion --Serving tne Chemical Ir.custry S'^ce 1S72 i nneci'Cut Aven noton DC 2C3CS "eieoncne 202 32S--2CC c-/ 29 1' A iVSH EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. P.O. BOX 474 HERNDON, VIRGINIA 22070 (703) 471-7060 March 25, 1980 Dr. Hasmukh C. Shah Director, Special Projects Chemical Manufacturers Association 1825 Connecticut Avenue, N.W. Washington, D.C. 20009 Dear Dr. Shah: Experimental Pathology Laboratories is happy to respond to your request for proposal dated March 21, 1980, for conducting additional histopathologic examination of brains from your vinyl chloride study conducted at Industrial Bio-Test Laboratories. In your request, you have outlined two specific tasks: (1) to reread all brain slides and to process and read all brain material that has not previously been processed; (2) conduct a tissue accountability and validation of animal identification. Experimental Pathology Laboratories' personnel will examine all of the wet tissue bags, paraffin blocks, and microscope slides for brain material. This examination will be conducted on all animals for which tissues have been preserved and will be conducted at the IBT facilities in Northbrook, Illinois. All of the brain material that is Identified by EPL personnel will be retrieved and transported to EPL's laboratories in Viriginia. The material that requires histologic preparation (wet tissues and/or paraffin blocks) will be processed at EPL onto microscope slides and stained with hematoxylin and eosin. Routinely, at least three sections of brain will be processed from the material retrieved from IBT. These microscope slides, along with the slides prepared by IBT, will be examined by Dr. Busey at EPL, and a report will be prepared detailing the microscopic findings and summarizing the results. As part of the search for the available brain material at IBT, EPL will validate the animal identification of the brain material retrieved and will document the animal identification for which brain material was found and for which brain material was not found. CMft 006553 Dr. Hasmukh C. Shah March 25, 1980 Page 2 The following EPl personnel will travel to IBT's research facility in Northbrook, Illinois; find the brain material; and transport it to EPL in Virginia: Dr. William M. Busey, Pathologist; Ms. Mary Bickford, Supervisor of Histology, North Carolina Laboratory; Ms. Beth Smithson, Unit Supervisor of the Gross Trimming Laboratory; Ms. Sharon Dyke, Pathology Technician, Quality Assurance Unit; Ms. Linda Eades, Pathology Technician, Quality Assurance Unit; and Mr. Tim McGinley, Laboratory Assistant, Gross Trimming Laboratory. Based on the tissue counts provided CMA by IBT, it is estimated that there would be approximately 452 brains available if the number of skulls and brains are combined. Assuming three sections of brain, the total number of tissues would be approximately 1356 for histologic processing and evaluation. EPL proposes to conduct the tissue accountability, animal identification, and retrieving of all brain materials from IBT beginning April 14 and ending April 18. Immediately upon receiving the material at EPL, thenecessary slides will be prepared and evaluated, and a final report will be prepared and submitted to CMA by May 19, 1980. The estimated cost for these services is as follows: 1. Tissue accountability and validation of animal identification and retrieval of all brain material $ 9,680 2. Histologic processing, microscopic evaluation, and reporting on 1356 tissues 6,780 Total $ 16,460 I have proposed the utilization of five trained histology personnel for the tissue accountability and retrieval at IBT so that this phase can be done in a timely fashion. As you know, there were 2500 animals on this study, some of which were partially necropsied and some of which were never necropsied. Past experience with the records from this study has indicated that the pathology material is not in any order, so the finding of the brain material will be a large task. In addition to the retrieval of all the brain material, the necropsy/pathology sheets will be examined and any gross observations of brain lesions will be noted and correlated with microscopic findings. Dr. Hasmukh C. Shah March 25, 1980 Page 3 If you have any questions about this proposal, please don't hesitate to call me. Sincerely, WILLIAM M. BUSEYpD.V.M., Ph.D. Pathologist WMB/sfh CMA 006555