Document B8Q6NjY7VZ1GXyengz0vVeBqj

CM!Z& CHEMICAL MANUFACTURERS ASSOCIATION March 1,1995 Mr. Jose A. Saliceti Director Office of Health Statistics Department of Health-HFSA -^(S. tu-h? Commonwealth of Puerto Rico 1C 5a_\^d P.O.Box9342 Santurce, PR 00908 m- Dear Mr. Saliceti: The Chemical Manufacturers Association (CMA) currently is in the process of updating an industry-wide cohort mortality study of vinyl chloride workers. The previous update, through 1982, was conducted for CMA by Environmental Health Associates, now owned by ENSR Health Sciences of Alameda, California. The current update, through 1992, will be conducted for CMA by Applied Epidemiology Inc. (AEI) of Amherst, Massachusetts. AEI will be conducting a standard epidemiologic analysis of the data and will only be reporting summary results with statistical analysis. There will be no individual identifying information included in study reports, and no follow-back from the death certificates will be performed. In conducting the previous update, the principal investigator (Dr. Otto Wong) signed a confidentiality agreement with your state vital records office as a condition for receiving copies of death certificates for study subjects known to have died in Puerto Rico between 1942 and 1982. Some of these certificates were obtained based on information from the National Death Index (AppEcation No. 84-0012); others based on information obtained from other sources. To maintain the integrity of the existing dataset, ENSR Health Sciences requires documentation from your office allowing them to transfer all these death certificate copies to the new contractor (AEI). To complete the new update of the vinyl chloride epidemiology study expeditiously, we request your assistance in granting ENSR permission to transfer death certificates to AEI. We have enclosed a permission document for you to review, sign, and send to CMA using the enclosed envelope. CMA will coordinate your response with ENSR, who then will be able to . transfer all previous study data to the new contractor. The new contractor, AEI, will maintain the confidentiality of the data under similar conditions to those specified for the earlier study update. A signed statement of assurance of confidentiality of the data on part of AEI is enclosed. We thank you in advance for your cooperation in completing this important scientific project for CMA. If you have any questions concerning this matter, please call collect to Dr. Hasmukh Shah of the CMA at (202) 887-1192. Sincerely, R&S151235 Hasmukh C. Shah, Ph.D., D.A.B.T. Manager, Vinyl Chloride Panel Chemical Manufacturers Association Enclosures Christian Seigneur, Ph,D. General Manager ENSR Health Sciences 2501 M Street. NW, Washington, DC 20037 Telephone 202-887-1100 Fax 202-887-1237 %0 A Public Commitment i APPLIEI EPIDEMIOLOGY INC. March 9,1995 Mr. Jose A. Saliceti Director Office of Health Statistics Department of Health-HFSA Commonwealth of Puerto Rico P.O. Box 9342 Santurce, PR 00908 Dear Mr. Saliceti: In 1988, Environmental Health Associates Associates (now part of ENSR Health Sciences), performed a mortality update for the Chemical Manufacturers Association's industry wide cohort mortality study of vinyl chloride workers. CMA currently is further updating the study with a new contractor. Applied Epidemiology Incorporated (AEI). AEI acknowledges the importance of protecting the confidentiality of death certificates and information derived directly from them. As the new contractor for the CMA-sponsored vinyl chloride mortality update, AEI will uphold the confidentiality of death certificates received from the previous contractor, EHA. Specifically, AEI will 1) maintain all death certificates received in secured and locked files with access limited to key project personnel for the duration of this update study; 2) transfer copies of death certificates to a separate secured facility for storage on behalf of CMA upon completion of this update study; 3) limit the use of personal identifying data (e.g. names, sodal security numbers) to operations necessary for data linkage during the analysis of study data; 4) report information obtained from death certificates only as grouped data or as statistical results, with no personal identifying information, thus preventing the identification of individual study subjects in reports; 5) conduct no follow-back investigations using death certificate information; and 6) limit the use of death certificate information to the CMA Vinyl Chloride Mortality Update Study. We will be pleased to provide you with additional information as needed. Thank you for your cooperation. Sincerely, Kenneth A. Mundt, Ph.D. President and Senior Epidemiologist Applied Epidemiology, Inc. P.O. BOX 2424 AMHERST, MA 01004 W (413) 256-3556 FAX (413) 256-3503 R&S151236 t PERMISSION TO RELEASE DEATH CERTIFICATES FOR AN EPIDEMIOLOGY STUDY The Commonwealth of Puerto Rico This document is intended to grant permission to ENSR Health Sciences, Alameda, California, to release death certificates (and data derived from them) for subjects belonging to the industry-wide vinyl chloride workers study described in the March 1, 1995 letter from Dr, Hasmukh Shah of the Chemical Manufacturers Association and co-signed by Dr. Christian Seigneur of ENSR Health Sciences. It is understood that ENSR Health Sciences will release such death certificates (and data derived from them) ONLY to a representative of Applied Epidemiology Incorporated, of Amherst, Massachusetts, who has signed the enclosed letter to maintain the confidentiality of the death certificates and data derived from them. Name add title of person authorized to grant this permission Signature of person authorized to grant this permission Date R&S151237