Document kmYegRqvoyGYVD4B00DYG5xvJ

-5CA I-NT^r .; 1^ ; ) ", 107 7 Clark "object: Report on Events Leading to Current tatu- oi Equitable Environment31 Health (EEH) f-to'-'y On or about February 13, 1977 Dr. ?. r . Torkelson contacted tne Project Manager and requested a recapitulation of all tech nical members who nad responded by balloting on the additional 3EH work on further analyses of epidemiological lata. 3alloting by Panel members was to have been completed by February n at the latest in order that members of the SEH te3m assigned to th^c work would not be reassigned to other urgent programs for which 3EH had just received -ontracts. Dr. Torkelson then estimated the amount of time which woul be required for completion of Panel balloting and added, to th;e estimate the time usually required for the return of commitments by the Management Contacts. After evaluating with members of Dow's management the delay which would be incurred if the return of ballots and commitment form* proceeded aa expected, and further evaluating the importance to the chemical industry and, in turn, to the technical literature of an EBH report wherein critical co horts would be more accurately grouped thereby yielding a more v3Lid statistical analysis of the epidemiological data. Dr. Torkelofl secured his management's immediate authorisation to guarantee payment of the additional EBH work. Therefore, on or about February 23, 1977, Dr. Torkelson called Mr. R. S. Davis, Regional Manager of BEH and (1) authorised that EBH proceed im mediately with the work necessary for the revision of the final report, (?) stated that Dow Chemical TJ.S.A. would guarantee pay ment for this additional work, (3) secured a preliminary estimate from Mr. Davis of approximately $10,000, and stated further that he. Dr. Torkelson, would confirm in a letter to Mr. Davis the areas in the then existing report draft requiring further study and revision evolving from Panel critiques. The Project Manager was CMA 100311 informed of the foreqoing action on or about bebruiry 'i, 1977 in 1 t = Lv*ohone call from Dr. 7orkelcon. hi Marsh 11, 1977 Dr. Torkel?on confi.-'e- in j letter to ,,ir, Djvi^ actions outline - in the ^receding parigraoh. A copy of tha latter to Mr. Davis has not been rr'a available to MCA. After Panel balloting en orfef1 tne ab*ove mentions j-'ditional work an- prior to the preparation of commitments, ~ix, Davif wac request.-- to sen'- to the Project Manager confirmation of his original estimate to Dr. Torkelson. The Project Manager requested that Mr. Davis submit a complete estimate with appropriate cost analyses an- a description of the scope of the work to be accoraolifhed an er the SEH proposal covering their additional studies. This was one in Mr. Davis' letter dated August 18, 1977 'see copy attache!). The consensus of opinions express'ed by Panel members indicated that neither pertinent government agencies, concerned aca.;enici ans, nor tha public would be properly served by only approyimateLy 1.1 ey.tra copies of the final report {over and above those copies required for the Research Coordinators and for Monel distribur Ion) . Neither was it feasible for MCA to go into the reports repro duction business". As a result, the Chairman requested that SSH supply 50 extra copies for a cost of $300. His prompt action on this particular matter was necessitated by a call from Mr. Davi? wherein Mr. Davie stated that were there any loose ends requiring prompt action they should be handled immediately as SEH W3r in the process of closing its Berkeley office. All operations formerly nandled by Berkeley will now be handled by their Rockville office. Therefore, to Mr. Davis' total fixed cost (not to exceed $10,500) was added a cost of $300 to cover the 50 additional copies of the final report. The cost of these additional copies was reflected in the total amount {$10,300) entered on the commitment form sent to the Management Contacts on September ", 1977. All of the requested copies of the final report have been received. The required copies have been sent to the Vinyl Chloride Research Coordinators and to members of the Technical Panel. The final report has not been accepted by either the Research Coordinators nor the Technical Panel. CMA 100312 Vs of thi ? nav? >cr?P^ that out j: s> if tine . f^O.Ti ' ' Tip3P.Iflp , 'V-pr.t Zone ace .- 0" torr i n i i -'itiomi o u\ h<? 3' tt;. - -*'t irs iwiftjri'. rr-roor J'"" : " C ac: Hrr. A. Howard Mr. J. C. Van Ho n e awe i CMA 100313 August 18, 1977 EEH/S-77L-386 RICHARD L. DAVIS Regional Director Dr. Joseph T. Seawell Manufacturing Chemists Association 1825 Connecticut Ave., N.W. Washington, D.C. 20009 Dear Dr. Seawel1: This is in response to our various conversations and correspondence relative to completion of the Final Report on the Mortality Study of Vinyl Chloride Workers, a draft of which was forwarded to the Manufacturing Chemists Association for review. The following proposal specifies the necessary effort required to accommodate the suggestions of the reviewing committee and recommendations put forth by Dr. W. Clark Cooper, all of which are outside the scope of the agreement between Equitable Environmental Health, Inc. and the Manu facturing Chemists Association for a Supplementary Analysis of the Mortality of Vinyl Chloride Workers, dated April 28, 1975. The Scope of Work to be accomplished under this proposal includes both the suggestions of the review committee and those of Dr. Cooper, agreed to during the various conversations referenced above. I. Include a more adequate description of study methods as reflected in the initial report (dated May 3, 1974) so that this final report can "stand alone" rather than as a supplementary report. II. Include a description of the plants involved in the study, including how many made VCM, how many made only PVC, and how many made other polymers. III. Present the geographical distribution of the plants in the study. IV. Prepare a table to present data on individuals engaged only in the production of PVC. V. Prepare tables which present information about the study population on the distribution by birth-years, the distribution of years of first employment, and year-of-birth/year-of-observation used in person-year distribution. 2020 Mil via Street, Berkeley, California 94704 - Telephone: 415/845-3355 CMA 100314 r 6QUITAQLE ENVIftONMCNTAL HEALTH INC U Dr. Joseph T. Seawell Page 2 August 18, 1977 VI. Add to the tumor case lists the hire dates, death dates, and integrated exposures. VII. Retabulate the following tables so as to reflect a single population: 3 and 4, 6 and 7, 8-18 with 19-24, 25 and 27, and 26 and 28. VIII. Delete the last four columns of Table 5, and the columns on type of facility and estimate of exposure in Tables 29 and 30. IX. Redraft the text of the report to reflect these changes plus the editorial comments contained in MCA's letter of December 13, 1976. X. Submit copies of the newly drafted report to the review committee for comments. XII. Prepare and submit copies of the Final Draft Report to the review committee reflecting any required changes. XIII. Submit 40 copies of a Final Report. , The above described Scope of Work requires significant retabulation of data, the preparation of a number of new tables, and a material redrafting of the report text. Following is our estimate of the cost related to this effort. Personnel services are presented by categories and composite hourly rates for each category have been applied to arrive at personnel costs. Direct costs have not been detailed since the total amount is relatively insignificant in relation to the total cost. The bulk of the direct cost is for reproduction of the various drafts and the final report to be submitted. Services: Estimated Costs Hours Composite Rate Cost Professional Staff Physician/Epidemiologist Statistician Total Professional Staff Technical Support Staff Secretarial/Typist Project Management Total Services 37 115 152 76 56 14 298 $44.42/hr. $17.19/hr. $16.39/hr. $51.73/hr. $6,752 $1,306 $ 918 $ 724 $9,700 Other Direct Costs: Reproduction, Telephone, Postage, etc. $ 500 TOTAL FIXED COST (not to exceed) $10,200 CMA 100315 eouiTAixe NVIPONMNTAL HAITH INC. Dr. Joseph T. Seawell Page 3 Auqust 18. 19 77 The above described effort and the associated costs will bring to completion this most important study which had its genesis in mid-1973. In more than one instance, events overran the effort which necessitated changes in approach and technique. This created difficulties which were not always under the control of EEH or MCA. As we approach the end of the project, it might be appropriate to review briefly several of the significant milestones: Original Agreement Executed Travel Expense Amendment Increased Follow-up Amendment Total for Initial Study June, 1973 August, 1973 March, 1974 $71,345 $ 3,950 $ 5,250 $80,545 A final report on this initial study was delivered to MCA on May 3, 1974. Additional-Plants Agreement Novemter, 1974 $10,350 A final report of this study was delivered to MCA on May 30, 1975. Supplemental-Population Study Agreement April, 1975 $32,000 The first draft of a report of the Supplemental Study was delivered to MCA on September 22, 1976. Total for All Studies $122,895 It should be noted that all of the work enumerated above was performed by EEH (or its predecessor company) under Fixed Price agreements. In order to fulfill its fixed-cost obligation to MCA, it was necessary for EEH to write-off $15,042 of costs at the end of 1976. In light of this action, we do not feel we are able to absorb additional unreimbursed costs. It is, therefore, necessary for us to require the additional funds requested in this proposal to complete the Final Report in accordance with the requests of the review committee. EEH is very pleased to have had this long association with MCA and feels that we have pursued the projects in a diligent manner. The subject matter has been of intense interest to both the scientific community and the general public. As mentioned earlier, rapidly developing information has caused shifts in study emphasis and analysis, making budget control extremely difficult. Extraneous demands with very short time responses have complicated the project's smooth flow. Considering all of these factors, we feel a real sense of pride to have been able to bring the study to a successful completion. We hope the members of MCA share that satisfaction with us. CMA100316 QU (TAQl NVIPONMKTAL health INC Dr. Joseph T. Seawel1 Page 4 August 18, 1977 Since it is the expressed desire of MCA that a paper reporting on the data contained in the Final Report be prepared for scientific publication in the spring of 1977, there is some need to expedite the completion of the project. We will greatly appreciate your consideration of this proposal and we shall await an early response. Sincerely, RLD:bw cc: Theodore Torkelson, Sc.D. Dow Chemical Corporation Richard L. Davis CWM00317 VINYL CHLORIDE - A. C. Clark letter of 9/2/77 EEH - Epidemiological Studies - Review statistical data - $10,500 Air Products Allied BP Chemicals Borden Certain-Teed Continental Oil Diamond Shamrock Dow Ethyl Exxon Firestone General Tire Georgia-Pacific B. F. Goodrich Goodyear W. R. Grace Hooker Keysor-Century Monsanto Olin Pantasote PPG CAM 100318 Robintech ll Stauffer Tenneco Union Carbide UNIROYAL Date YES NO ,^ 'h r":"- rci j r- /./<. \ V CMA 100319