Document 6w1OE7LBzg7xEMXnroeNKqRE

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. CMA 116216 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. CMA 116217 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) A manuscript suitable for publication in the peer-reviewed scientific literature, submitted to CMA for review and commentary by participating member companies. Timing 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 CMA 116218 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) CMA116219 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, Texas, 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. CMA 116220 ATTACHMENT A Plants Providing Information Involved in the Vinyl Chloride Update Study Company Air Products Air Products B.F. Goodrich B.F. Goodrich B.F. Goodrich B.F. Goodrich B.F. Goodrich B.F. Goodrich B.F. Goodrich Tech Borden Chemicals Bordon Chemicals Borden Petrochemical Conoco Chemicals Conoco Chemicals Diamond Shamrock Dow Chemical Dow Chemical Dow Chemical Dow Chemical - Oyster Dow Chemical Texas Ethyl Corporation Ethyl Corporation Goodyear Monsanto Monsanto _ Occidental Chemical Tenneco Chemicals Tenneco Chemicals Tenneco Chemicals Union Carbide Union Carbide Uniroyal Chemical DW871.TBL Location Calvert City, KY Pensacola, FL Avon Lake, OH Calvert City, KY Henry, IL Long Beach, CA Louisville, KY Niagara Falls, NY Avon Lake, OH llliopolis, IL Leominster, MA Geismar, LA Aberdeen, MS Westlake, LA Deer Park, TX Midland, Ml Ontario, Canada Piaqemine, LA Freeport, TX Freeport, TX Baton Rouge, LA Houston, TX Niagara Falls, NY Indian Orchard, MA Texas City, TX Pottstown, PA Burlingame, NJ Flemington, NJ Pasadena, TX S. Charleston, WV Texas City, TX Painesville, OH Number f Employee* 152 88 620 280 180 93 2,221 67 237 161 241 49 225 120 279 381 58 95 66 206 558 22 352 225 101 507 101 103 60 1,520 289 335 CMA 116221 CNIZ& CHEMICAL MANUFACTURERS ASSOCIATION August 30, 1994 Howard Rockette, M.D. Department of Biostatistics Graduate School of Public Health University of Pittsburgh 130 De Soto Street Pittsburgh, PA 15261 Dear Dr. Rockette: A request for proposal was sent to you on July 26, 1994. A chart of the plants providing information involved in the Vinyl Chloride Update Study is enclosed to help you in preparing your proposal to update the study. Also, in the scope of work for the study update, Texas inadvertently was omitted from Group C in the attachment entitled, "Status of ENSR Confidentiality Agreements with Individual States." If you have any questions, please contact me at (202) 887-1192. Sincerely Enclosure Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel 2501 M Street, NW, Washington, DC 20037 Telephone 202-887-1100 Fax 202-887-1237 CMA 116222 Responsible Care* A Public Commitment CHEMICAL MANUFACTURERS ASSOCIATION July 26, 1994 Howard Rockette, M.D. Department of Biostatistics Graduate School of Public Health University of Pittsburgh 130 De Soto Street Pittsburgh, PA 15261 Dear Dr. Rockette: The CMA Vinyl Chloride Panel requests your proposal to update a vinyl chloride epidemiology study as described in the enclosed scope of work. Additional documents to help you in preparing your proposal also are enclosed. Proposals should be sent to me at CMA by September 2, 1994. If you have any questions, please call me at (202) 887-1192. Sincerely, Enclosure Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel 1 M street. NW Washington DC 20037 Telephone 202-887-1100 Fax 202-887-1237 CMA 116223 Responsible Care A Public Commitment CPI\U\ CHEMICAL MANUFACTURERS ASSOCIATION July 26, 1994 Roy E. Shore, Ph.D. Professor, Environmental Medicine New York University Medical Center 341 East 25th Street, Room 204 New York, NY 10010-6500 Dear Dr. Shore; The CMA Vinyl Chloride Panel requests your proposal to update a vinyl chloride epidemiology study as described in the enclosed scope of work. Additional documents to help you in preparing your proposal also are enclosed. Proposals should be sent to me at CMA by September 2, 1994. If you have any questions, please call me at (202) 887-1192. Sincerely, Enclosure Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel 2501 M Street, NW. Washington, DC 20037 Telephone 202-887 1100 Fax 202-88/ - '237 CMA 116224 ^Responsible Care A Public Commitment cml\ CHEMICAL MANUFACTURERS ASSOCIATION August 30, 1994 Ken Mundt University of Massachusetts School of Public Health 403 Arnold House Amherst, MA 01003 Dear Mr. Mundt: A request for proposal was sent to you on July 26, 1994. A chart of the plants providing information involved in the Vinyl Chloride Update Study is enclosed to help you in preparing your proposal to update the study. Also, in the scope of work for the study update, Texas inadvertently was omitted from Group C in the attachment entitled, "Status of ENSR Confidentiality Agreements with Individual States." If you have any questions, please contact me at (202) 887-1192. Sincerely, Enclosure Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel 2501 M Street, NW, Washington, DC 20037 Telephone 202-887-1100 Fax 202-887-1237 CMA 116225 Responsible Care' Jf1 A Public Commitment CHEMICAL MANUFACTURERS ASSOCIATION July 26, 1994 Ken Mundt University of Massachusetts School of Public Health 403 Arnold House Amherst, MA 01003 Dear Mr. Mundt: The CMA Vinyl Chloride Panel requests your proposal to update a vinyl chloride epidemiology study as described in the enclosed scope of work. Additional documents to help you in preparing your proposal also are enclosed. Proposals should be sent to me at CMA by September 2, 1994. If you have any questions, please call me at (202) 887-1192. Sincerely Enclosure Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel 501 M Street. NW. Washington DC 20037 Telephone 202 887-1100 Fax 202-887-1237 CMA 116226 Responsible Care A Public Commitment CM& CHEMICAL MANUFACTURERS ASSOCIATION July 26, 1994 Otto Wong, Sc.D. , F.A.C.F.. Chief Epidemiologist Applied Health Sciences, Inc, 181 Second Ave., Suite 628 P.0. Box 2078 San Mateo, CA 94401 Dear Dr. Wong: The CMA Vinyl Chloride Panel requests your proposal to update a vinyl chloride epidemiology study as described in the enclosed scope of work. Additional documents to help you in preparing your proposal also are enclosed. Proposals should be sent to me at CMA by September 2, 1994. If you have any questions, please call me at (202) 887-1192. Sincerely Enclosure Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel 8501 M Sfee-t. NW Washington. DC 20037 Telephone 202 887-1100 Fax 202-887-1237 CMA 116227 Responsible Care A Public Commitment Department of Epidemiology February 10, 1994 Elizabeth Festa Watson Panel Manager Dibenzofuran/Dioxins Panel Chemical Manufacturers Association 2501 M Street NW Washington, DC 20037 Dear Ms. Watson, Enclosed is a draft of our report on an independent epidemiologic analysis of the NIOSH dioxin study. We look forward to receiving your questions and comments and to discussing the report with you. Sincerely yours, Enclosure Elizabeth Delzell, S.D. Professor The University of Alabama at Birmingham 209 Tidwell Hall 720 South 20th Street Birmingham, Alabama 35294-0008 (205) 934-5257 FAX (205) 975-7058 CMA 116228 draft POTENTIAL CONTRACTORS Howard Rockette, Fh.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 J_ _ ^. % Roy E. Shore, Ph.D., Dr.P.H. Professor, Environmental Medicine New York University Medical Cent 341 East 25th Street, Room 204 New York, NY 10010-6500 (212) 340-6500 (510) 865-1888 pp\lc& )"?( , "Xkl- At/C. , 5u<^- CtAS* P.o. aov& SaA Wofao ) CJt 41 r-3^'W^ CMA 116229 TOTAL P.07