Document OzkeR1oZ2raJGkLO588O5b1Dv

1 |Z\ CHEMICAL MANUFACTURERS ASSOCIATION August 4, 1994 Dear Vinyl Chloride Research Coordinators: The following items are enclosed for your Information: 1) request for proposal for the epidemiology study update. This RFP was sent to: Roy Shore of New York University Medical Center; Ken Mundt of University of Massachusetts; Howard Rockette of University of Pittsburgh; and, Otto Wong of Applied Health Sciences, Inc. The proposals from the potential contractors are due on September 2; and, 2) August 1, 1994 letter to the American Cancer Society in response to the TIME Magazine article (includes attached references). The next VCRC conference call is scheduled for September 9 at 3:00 p.m. The next VCRC meeting tentatively is scheduled for October 7 at 9:00 a.m. I look forward to talking to you on September 9. If you have any questions, please contact me at (202) 887-1192. Sincerely, Enclosures -A* ,v Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel <*> SL 107344 2501 M Street, NW, Washington, DC 20037 Telephone 202-887-1100 Fax 202-887-1237 Responsible Care* l W APuStecCCoommmitment SCOPE OF WORK UPDATE OF MORTALITY AMONG VINYL CHLORIDE WORKERS The Chemical Manufacturers Association (CMA) is interested in receiving proposals to update the mortality experience among an established cohort of workers employed in the vinyl chloride/polyvinyl chloride (VC/PVC) industry. This cohort was previously studies and reported on by Tabershaw and Gaffey (1974), Cooper (1981), and Wong et. al. (1991). The Scope of Work for this project is outlined below and includes some key elements which should be addressed in any proposals submitted. As you will note, CMA is interested in receiving two major work products at the conclusion of the project: 1) a written technical report summarizing an epidemiologic evaluation of the mortality experience of the cohort through 1992; and, 2) a manuscript which is suitable for publication in the peer-reviewed scientific literature. Background The original record which formed the basis for prior reports on the mortality experience of this cohort are currently in the possession of ENSR Health Sciences, located in Alameda, California. If a different study group is awarded the contract to conduct the update study, CMA will arrange for the transfer of all pertinent records from ENSR to that contractor. However, ENSR did make confidentiality agreements with some states (see attached list) precluding direct transfer of death certificates for some cohort members. Therefore, submitted proposals will need to indicate how other contractors would proceed to obtain such death certificates for persons dying prior to 1983, the end date for follow-up in the most recent update. Projected Scope of Work All proposals submitted in response to this request should address the following issues: 1) Verification of the completeness of the database, in comparison with the results of the most recent update (see Wong et. al., 1991, attached). 2) How to obtain death certificates for employees dying before 1983 which could not be transferred directly from ENSR to a different contractor. 3) Ascertainment of vital status for cohort members who survived through the end of the previous update period (i.e. as of 12/31/92). 4) Obtaining death certificates for employees determined to have died after 1982 and assigning a nosologically valid underlying cause of death to each. SL 107345 Scope of Work Page 2 5) Conduct of a Standardized Mortality Ratio (SMR) analysis comparing the cause-specific mortality experience of the cohort with age-, gender-, and period-specific mortality rates for the U.S. male population and individual state male populations. The analyses conducted should consider at least the following factors: Age at first exposure; Year of first exposure; Type of plant (VC monomer or PVC); Length of exposure; Elapsed time since first exposure. In addition to these points, any proposal should also include the investigator's thoughts on the feasibility and technical merit of the following: Updating the exposure histories of surviving cohort members from 1982 through 1992; Performing internally standardized mortality analysis using such methods as Poisson regression for comparing SMR's or Proportional Hazards modeling of time to death; Using race-specific comparison mortality rates in the epidemiologic analyses, which has not been done previously due to small numbers of non-white cohort members; Updating uniform coding of all death certificates according to the Eighth or Ninth Revision of the International Classification of Disease (in all previous updates certificates were uniformly coded to the Seventh Revision). Technical Criteria You may be interested in the criteria which the CMA Vinyl Chloride Panel Research Coordinators will use to evaluate proposals received. These are listed below for your consideration in the preparation of your response. The criteria are not listed in any particular order and should not be viewed as having equal weight. 1) The curriculum vitae for each of the scientists who will participate on your project team; 2) Your proposed approach to each of the technical items listed in the projected Scope of Work; 3) Your proposed schedule for completion of the required deliverable work products listed below; 4) Your description of the technical and physical resources at your disposal for completion of this project. SL 107346 Scope of Work Page 3 Required Deliverable Work Products The deliverables expected by CMA include the following: 1) A series of timely progress reports addressing the following: Verification of the completeness of the existing database against the tables presented in the 1986 report to CMA prepared by Wong et. al. (see attachment). Outcome of efforts to ascertain vital status of cohort members through 1992. Outcome of efforts to obtain death certificates for workers dying after 1982, and for employees dying before 1983 if necessary. 2) A detailed technical report summarizing the epidemiologic analysis, submitted to CMA for review and commentary by participating member companies. 3) Timing A manuscript suitable for publication in the peer-reviewed scientific literature, submitted to CMA for review and commentary by participating member companies. Investigators wishing to submit proposals should do so by August 1, 19941. CMA would like to receive proposals in two separate documents -on containing the technical proposal and the other containing the cost and time schedule proposals. This will allow us to evaluate the technical merits of the proposal independently of cost and time schedule considerations. Please supply one original unbound copy of the technical proposal, and one original unbound copy of the cost/time schedule proposal. Additional Information Please contact Dr. Has Shah of CMA at (202) 887-1192 if you have any questions about this request or about contract administrative details. Our lead scientist for this effort is Dr. Jonathan Ramlow of The Dow Chemical Company. You may contact him at (517) 636-1276 with questions about the scientific aspects of this Scope of Work. Attachments 1986 Final Report: An Update of An Epidemiologic Study of Vinyl Chloride Workers, 1942-1982 1989 ENSR Reassessment of Liver Cancer Among Vinyl Chloride Workers 1991 An Industry-Wide Epidemiologic Study of Vinyl Chloride Workers, 1942-1982 St- 107347 Scope of Work Page 4 1993 Letter to the Editor, Diagnostic Bias in Occupational Epidemiologic Studies (H. Shah) 1993 Response to Letter to the Editor, Diagnostic Bias in Occupational Epidemiologic Studies: An Example Based on the Vinyl Chloride Literature (0. Wong) SL 107348 Scope of Work Page 5 Status of ENSR Confidentiality Agreements with Individual States ENSR had to enter into agreements with different states to obtain death certificates. In some states there were no restrictions concerning with whom we could share the certificates, while with others there were variable restrictions. The following summarizes the status of agreements with the states as we understand them at this time: Group A: States that will allow ENSR to give the death certificates to individual companies or CMA as long as we document what is being transmitted. This group includes the following states: Alaska, California, Connecticut, Washington, D.C., Illinois, Iowa, Maryland, Massachusetts, Minnesota, Nevada, Ohio, and Washington. Group B: States that will allow ENSR to provide state file numbers, dates of death, and deceased names to companies or CMA. This group includes the following states: Colorado, Georgia, Idaho, Indiana, Kentucky, Louisiana, Maine, New Mexico, New York, Oregon, Rhode Island, South Carolina, West Virginia, Wisconsin, and Wyoming. Group C: States that require both ENSR and the companies or CMA to write and request the death certificates based on the study follow-up data. This involves completing application forms for each state (not identical for each), entering the state file numbers, and communicating with each company or CMA. This group includes the following states: Alabama, Arizona, Arkansas, Delaware, Florida, Kansas, Michigan, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New York City, North Carolina, North Dakota, Oklahoma, Pennsylvania, South Dakota, Tennessee, Utah, Virginia, and Puerto Rico. We are still investigating the process in three states: Hawaii, Nebraska, and Vermont. They have not as yet responded to multiple inquiries. SL 107349