Document ykvLY7xXoO8vevE5rR6XVZLLd

CHEMICAL MANUFACTURERS ASSOCIATION May 7, 1980 Mr. 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: "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) 008046 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 c O Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872. 1825 Connecticut Avenue. NW Washington, DC 20009 Telephone 202/328-4200 Telex 89617 (CMAWSH) 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 ia nO.ta) available. Study Plan B Introductory Comment As discussed with you$ 3tse rollowing 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 requests that EHA present its "Opinion and Position" on analyzing data in terms of those plants pro ducing: oCD o # 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: Dr. H. C. Shah Dr. T. R. Torkelson J. T. Seawell Staff Advisor Vinyl Chloride ooao^Q