Document O3geMOgaxL5BpRM14MMDGD2K

APR 2 2 m CHEMICAL MANUFACTURERS ASSOCIATION April 1, 1980 To: Subjects: Vinyl Chloride Project Panel I . Additional Histopathologic Examination of Brains from the IBT/VC Study ' II. Validation of Exposure Chamber Concentration*^, During IBT/VC Study by Means of G. C. Strip Chart Examinations. Gentlemen: As a result of Panel action on March 18, 1980, (please refer to page 2, Item 3.0 of the Record of Meeting), Dr. William Busey will per form additional histopathologic examinations of brains from the IBT/VC study. Dr. Busey's work will involve: Five trained histology personnel on his staff a On-location tissue accountability, search and retrieval at IBT facilities at Northbrook, Illinois. All material requiring histologic preparation (wet tissues and/or paraffin blocks) will be processed in Dr. Busey's laboratories. Experimental Pathology Laboratories, Inc. (EPL), Herndon, Virginia, onto microscopic slides. e At least three sections will be processed from each brain retrieved from XBT/Northbrook. Sr e a detailed? reading of each slide will be performed by Dr. Buseya final report will be prepared by Dr. Busey detailing his findings. t-. be tooo h ^1 ^2 cda -fpfl oCft 0oJ bCQ t-3 &< M E-t 55 > +-> - j . I-^P M. o' rt * !-l*| W -H M fo P Pbn oO ^ Is O o -oP . * 3 s,> S -H 2 WQ EPL charges for the work described above will be $16,460. Pursuit of the validation of chamber concentrations during the last six months of exposure will involve random studies of at least 10% of all G. c. strip charts. The Audit Task Group advises CMA that third Formerly Manufacturing Chemists Association-Serving the Chemical Industry Since 1872. 1825 Connecticut Avenue, NW Washington, DC 20009 Telephone 202/328-4200 * Telex 89617 (CMA WSH) CK OH CM o < r u . 2 party validation readings should be made of the IBT/G.C. strip charts. Bob West Associates gave CMA an estimate of $4,000 for validation readings of at least 10% of the strip charts; however, a contingency of at least $2,000 should be included. A contingency is necessary since we should assume that G. C. recordings for VC exposures will be similar to those observed during earlier sample validation readings made during the trichloroethylene audits. < Funds remaining from the IBT/VC study will cover the two studies described above. It is not anticipated that additional funding will be required unless findings by Drs. Busey and West indicate the ad* visability of further studies, in this event. Panel authorization will of course be secured. Work on both of these studies will begin as soon as possible. Should you wish to comment on these two actions please contact Dr. Shah or the undersigned immediately after receipt of this letter. Sincerely JTS:md cc: Audit Task Group Project Administrator Vinyl Chloride com? INITIAL Subject to Protectivere^ CG: rilor 1" Boss v. Concoo 14th Calcasieu ? Ho. 30-48' Court tr "iona CMA 012110 CHEMICAL MANUFACTURERS ASSOCIATION May 7, 1980 Hr. Richard L. Davis Director Health Management Services Environmental Health Associates, 2150 Shattuck Avenue Suite 414 Berkley, California 94704 Inc. Dear Mr. Davis: The following summary is being presented in order that a revised or modified bid/proposal can be prepared by Environmental Health Associates, Inc., (EHA) that reflects recent action of the Vinyl Chloride Panel and Research Coordinators. Wherever possible, Panel actions are summarized according to major sections of your bid/proposal of January 15, 1980. To facilitate subsequent reference, the following sections and subsections are numbered: 1.0 Evaluation of the Current Data Base' 1.1 In the light of our recent discussions it appears advisible that at the earliest possible time EHA give the Panel a written opinion on the exact current status of the data base. As you indicated, before a "Brain Case Control Study" or a "FiveYear Epidemiological Update" can be conducted, the data base must be augmented. 1.2 Panel action relevant to EHA's assessment and/or evaluation of existing data was as follows: r -`r rf Li I r rnCr; OOi CC r* 1--i ' Eh 1 7 "We agree that Environmental Health Associates (EHA) be authorized to examine the current records, prepare a protocol for a five-year update, and conduct a reanalysis of death certificates according to the EHA letter pro posal dated January 15, 1980." 2.0 "Brain Case Control Study" (BCCS) 1-- r-i 1 o co iU; -p v_ no.1 o0) > C3A wcOo:| P* 2.1 After EHA has completed necessary assessment of the data base that pertains to the BCCS, the Panel con firmed its earlier position by voting: EHA will be requested to prepare a protocol and a cost estimate for a "case control study" of Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872. 1825 Connecticut Avenue. NW Washington, DC 20009 Telephone 202/328-4200 Tele* 89617 (CMA WSH) CM o r<uc 2 3.0 4.0 5.0 6.0 cancers of the central nervous system. 2.2 The Panel confirmed an earlier stipulation that the protocol prepared by EHA for the BCCS will be open for bids in addition to the EHA bid. Study Plan A 3.1 The Panel is in agreement on proceeding with Study Plan A described on pages 6, 7 and 9 of EHA's letterproposal dated January 15, 1980. 3.2 As you reemphasized during your telephone call of May 6, 1980, the development of an accurate estimate of the probable cost to perform the five-year follow up requires more precise information than is now available. study Plan B Introductory Comment As discussed with you, the following summary of Panel action on Study Plan B is presented in an effort to assist you during the preparation of your modified bid/proposal. The preceding comment is relevant because the Panel voted to hold Study Plan B' in abeyance for consideration at a future date. 4.1 Study Plan B should be modified by identifing the plants as follows: Group I - Vinyl Chloride Monomer Group II - PVC By Dispersion or Emulsion Processes Group III - All Others 4.2 Under Study Plan B, EHA is to be requested to clarify the comment "...secure complete job histories for the approximate 3,300 cohort members with incomplete job histories". EHA is to characterize the deficiencies that exist in these 3,300 cohort members. Study Plan C Panel members expressed the opinion that there is little likelihood that Study Plan C will contribute anything new. They estimated that Study Plan C will not yield meaningful data until 10, 20 or perhaps 25 years hence. Request for EHA's "Opinion and Position" on Mortality Study Based on Type of Plant Production ~ ~~ The Panel Position" on ducing: requests that EHA analyzing data in present its "Opinion and terms of those ---------~ Subject to . _ Ross v. _C: - ' 14th * ' CeJclo - - r. a CMrt 0 1 2 1 1 2 3 (1) Vinyl Chloride Monomer (2) Emulsion or Dispersion Polymers (excluding latex), (3) All Others The analysis(s) to treat "significant differences with respect to mortality at a cost not to exceed $10,000". Please contact me immediately should any item in this letter need clarification. Sincerely, JTS:md cc: DDr. H. C. Shah Dr. T. R. Torkelson J. T. Seawell Staff Advisor Vinyl Chloride CMA 012113 \] injl O-foo'c^S - 16'7 3 7 - 16 - 7 7 -- 16-73 \o - to -13 - 10 - 7^ - to - n+ X- AT- 7-T" 4-. ;tf - 7iT oT- 7<r X - OX- lb t< <,&)- 76 J 1% 6 4s~ 6*rooO /, 6^5" %n,xsr> ift 000 1 ?, *4-iT" / $f beLS* 7, tfM-O X.0'00 0 \,6t0 io X&T b,S75~ m,SL& 37,*60 d},4-S 1 H7 6 11 77 1*11 i 171 17?0 1S6, 207 AOS', &a.C,oZ7 SUM, CM 7?, far Inxerertr lo3,61>0 """"m H>sa^^.-;rnTT?I!3r.'.T"~AjL ^stl v, Conoco. * I1Z4ttlst Jjuuddiicciiaall ^ Calcesi'"1 .?''r1-' Con- % CM" CHEMICAL MANUFACTURERS ASSOCIATION June 27, 1980 Mr. Fred R. Current Corporate Attorney Industrial Bio-Test Laboratories, Inc. 1810 Frontage Road Northbrook, IL 60062 Dear Fred: As per our telephone conversation, I have enclosed EPL and Bob West audit reports. The total cost of the study to date is $248,639 and can be broken down as follows: $169,825 20,147 4,000 54,667 $248,6T$ Payments to Industrial Bio-Test Payments to Experimental Pathology Labs Payments to Bob west Associates Administrative Expenses TOTAL Mr. Frost and I look forward to seeing you on July 16, 1980. Sincerely, Hasmukh C. Shah, Ph.D. Director, Special Projects HCS:am Enclosures r. Subject to Protoctivo rq Rss,v. Conoco, Ir.c.. SO-4*337 14th Judicial District Court" Calcasieu Parish, Louisiana Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872. 1825 Connecticut Avenue. NW Washinolon OC 20000 Telephone ?0?'3?8-4?00 . Telex twfi 17 (CMA WRH) CMA 0 1 2 1 1 5 CHEMICAL MANUFACTURERS ASSOCIATION August 8, 1980 Mr. Fred Current, President Industrial Bio-Test Laboratories, 1810 Frontage Road Northbrook, IL 60062 Inc. Dear Fred: I was out of the office for the last couple of weeks and so apologize'for not forwarding to you the information you requested during our'meeting on July 16, 1980. The total cost to conduct the study at XBT and the estimated interest are summarized below: $169,825 20,147 4,000 9,908 29,75$: 15,000 103,680 ?sir,yi5 Payments to IBT Payments to Experimental Pathology Labs Payments-to Bob West Associates. CMA administrative expenses from 1973 to 1977 CMA administrative_expenses from 1978 to present. Estimated expenses incurred by Panel members during various audits and related activities from 1978 to present Estimated interest from 1976 to present TOTAL Please do not hesitate to call me if you need additional information. 1 look forward to a mutually agreeable settlement of this issue. . Thank you. 9 U Z T 0 VW3 Hasmukh C. Shah, Ph.D. Director, Special Projects cc: Dr. Ted Torkelson-; Dr. Zeb Bell Mr. Roger Lockhead Subject to Prj"c-c,tiv3 '-i Ross v. Cor.cc:>, I":?'IZ 14th Judioi ~1 "';-j :'' ^ t Calcasieu Perl':'-, T ; T'la Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872. 1825 Connecticut Avenue. NW * Washington. DC 20009 Telephone 202/328-4200 Tele* 89617 (CMA WSH) fc VINYL CHLORIDE AUDIT TASK GROUP May 1980 Dr. Z. G. Bell, Jr. PPG INDUSTRIES, INC. One Gateway Center Pittsburgh, Pa. 15222 Dr. T. J. Benya ETHYL CORPORATION 451 Florida Ave Baton Rouge, La. 70801 Dr. Kent Hatfield DIAMOND SHAMROCK CORPORATION 1100 Superior Ave Cleveland, Oh. 44114 Dr. R. K. Hinderer BFGOODRICH COMPANY 6100 Oak Tree Blvd Cleveland, Oh 44131 Dr. Vince L. Kirkland SHELL OIL COMPANY One Shell Plaza P. O. Box 4320 Houston, Tx. 77090 Dr. Theodore R. Torkelson Health and Environmental Science DOW CHEMICAL U.S.A. 1603 Building Midland, Mi. 48640 Rosa v. Cor.oto l 14th Juii: Calcasieu . . Ko. 30-4337 i -'ot Court L-_isiana CHA 012U7