Document 44xrB0abp8nM0Qg4QMVDLXqXV

REVISED DRAFT 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 studied 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, the 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 records which formed the basis for prior reports of 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 R&S152254 REVISED DRAFT 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. 5) Conduct of a Standardized Mortality Ratio (SMR) analysis comparing the cause-specific mortality experience of the cohort with the 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). R&S152255 REVISED DRAFT Technical Criteria You may be interested in the criteria which the CMA Vinyl Chloride Research Coordinators Group 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 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) A manuscript suitable for publication in the peer-reviewed scientific literature, submitted to CMA for review and commentary by participating member companies. R&S152256 REVISED DRAFT Timing Investigators wishing to submit proposals should do so by, 1994. CMA would like to receive proposals in two separate documents--one containing the technical proposal and the containing the cost and timeschedule proposals. This will allow us to evaluate the technical merits of the proposal independently of cost and time-schedule considerations. Please supply an original plus ten copies of the technical proposal, and an original plus two copies of the cost/time-schedule proposal. CMA intends to evaluate all proposal received in, 1994, and will select a contractor in, 1994. CMA proposes to award a fixed-price contract to the successful applicant. If your project team prefers a different form of contract, please indicate your preference in your cost 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. R& S 152257 REVISED DRAFT 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. A fee must be paid for each death certificate obtained. [Has: wouldn't this be true for Group B as well? Jonathan] This group includes the following states: Alaska [Has: Alaska is listed in Group A too], 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 for three states: Hawaii, Nebraska, and Vermont. They have not as yet responded to multiple inquiries. R&S152258 REVISED DRAFT POTENTIAL CONTRACTORS Howard Rockette, Ph.D. Department of Biostatistics Graduate School of Public Health University of Pittsburgh 130 De Soto Street Pittsburgh, PA 15261 (412) 624-3022 Kenneth A. Mundt, Ph.D. Applied Epidemiology, Inc. P.O. Box 2424 Amherst, MA 01004 (413) 256-3556 Roy E. Shore, Ph.D., Dr.P.H. Professor, Environmental Medicine New York University Medical Center 341 East 25th Street, Room 204 New York, NY 10010-6500 (212) 340-6500 R&S152259