Document 3QROeZg5OdORv8kX0O43Rjn3y

CHEMICAL MANUFACTURERS ASSOCIATION GERALDINE V. COX. Ph.D. Vice President Technical Oirector Septe.Tbsr 11, 1986 HAND-DELIVERY Document Control Officer TS-790 : Office of Toxic Substances Room 220, East Tower U.S. Environmental Protection Agency '^*401 M Street;. SW Washington/ D.C. 20460 RE: For Your Information Submission: Summary of Draft Results of an Epidemiology Study of Vinyl Chloride Workers Dear Sir/Madam: : The Chemical Manufacturers Association (CMA) has just learned of the draft results of an epidemiology study of vinyl chloride workers conducted by Environmental Health Associates. The study was sponsored by the Vinyl Chloride Program Panel ("the Panel**) of CMA. The significant findings from this study are reported here for your information on behalf of the Panel. The member companies of the Panel are listed on Attachment I. The current study is an update of an earlier mortality study of vinyl chloride workers. The draft report received by CMA on the current study shows an excess mortality from three causes not previously associated with vinyl chloride exposure. The study showed an excess.of liver and biliary cancer over and above the observed mortality from angiosarcoma of the liver. Without the known angiosarcomas, there were 22 observed deaths from.liver and biliary cancer versus 6 expected. Because some of the deaths from liver and biliary cancer may, in fact, be undiagnosed deaths from angiosarcoma, it is not certain at this time that there is, in fact, a vinyl chloride related excess in these cancers. Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872. 2i01 M Street. NW * Washington. DC 20037 * Telephone 202/887-1260 * Telex 89617 (CMA WSH) 2 In addition, the study showed an excess mortality from emphysema, which includes bronchitis and chronic obstructive pulmonary disease. However, the dose-response relationship is not consistent with vinyl chloride as a causal agent. If it were, one would expect that the excess would become greater with increasing duration of exposure when, in fact, the opposite is observed in the study. Also, one would expect that the excess would be greatest in those hired at the youngest ages. Again, the reverse is true. Finally, one would expect that personswhose exposure began a long time ago would have more emphysema than those whose exposure began recently, which was also not observed in the study. Therefore, although the excess deaths due to emphysema appear to be real, their relationship to vinyl chloride is questionable. A final report is expedted from the contractor in four to six weeks and will be submitted to the Agency for its detailed review. Meanwhile, please call Dr. Has Shah, Program Manager, of my staff at 887-1192, if you have specific questions. Sincerely yours. Geraldine V. Cox, Ph.D. Vice President-Technical Director cc: Vinyl Chloride Program Panel R&S 142344 ATTACHMENT I Participating Companies of the Chemical Manufacturers Association's Vinyl Chloride Program Panel R&S 142345 Air Products and Chemicals, Inc. BFGoodrich Company Borden, Inc. , Certain Teed Corporation Diamond Shamrock Chemicals Company DiversiTech General Dow Chemical USA Ethyl Corporation Exxon Chemical Company ' The Goodyear Tire and Rubber Company Gulf Oil Products Company Monsanto Company Occidental Chemical Corporation PPG Industries, Inc. Stauffer Chemical Compariy Shell Oil Company Union Carbide Corporation Uniroyal Chemical Company Vista Chemical Company R&S 142346 September 11, 1986 Express Mail To: Members, Vinyl Chloride Special Programs Panel From: Has Shah, Program Manager'll Gabrielle H. Williamson, Assistant General Counsel GMJj). Re: Informational Submission to EPA: Summary of Draft Results of an Epidemiology Study of Vinyl Chloride Workers Enclosed for your information and' review for possible -t individual company notification to EPA is a copy of the referenced submission CMA made today on behalf of the Panel. Pursuant to Has Shah's request for your reactions, ten Panel member companies indicated that CMA should file an FYI notice with EPA on this study, while two believed the results of the study were inconclusive and that a filing was, therefore, not warranted. Has's earlier communication to you included only a request for your reaction on the emphysema finding. You willnote that the enclosure also refers to the excess liver and biliary cancer shown in the study above the observed mortality from angiosarcoma of the liver, with a statement that it remains unclear whether vinyl chloride is related to this development. This statement was included in CMA's informational filing to EPA at the request of your Panel Chairman, Bill Gaffey of Monsanto, who also drafted this portion of the letter. We also note that CMA's enclosed filing was sent only as an informational notice to EPA; it was not a Section 8(e) filing on behalf of the Panel, nor does it refer to Section 8(e) anywhere in its text. Given the general content of the notice, the timeliness of submission, etc., EPA may decide, as a practical matter, that CMA's informational notice provides the Agency with adequate data to avoid the need for additional FYI or Section 8(e) filings of the same information by Panel members. ' However, since the CMA FYI notice is not formally a Section 8(e) submission, EPA might determine that the companies which manufacture (including import), process, or distribute vinyl chloride in commerce remain technically liable for filing individual Section 8 (e) notices if they believe that the information contained in the study reasonably supports the conclusion that "substantial risk" exists. We urge you to 2 review EPA's Statement of Interpretation and Enforcement Policy, Notification of Substantial Risk, 43 Fed. Reg. 11110 (March 16, 1978) in making your individual company decisions on whether or not to file additional FYI or Section 8 (e) notices concerning results of this study. Please call either of us (Has Shah (202/887-1192); Gabrielle H. Williamson (202/887-1356)) if you have any questions or comments on this matter. R&S 142347 CHEMICAL MANUFACTURERS ASSOCIATION Record of Meeting of Vinyl Chloride Panel Meeting with Environmental Health Associates Date: September 8, 1986 Time: 9:30 a.m. List of Attendees: Place: Environmental Health Associates Oakland, CA Villiam Gaffey Sally Cowles Donald Whorton Otto Wong Has Shah Monsanto Company Shell Oil Company Environmental Health Associates Environmental Health Associates CMA 1.0 Dr. Bill Gaffey discussed comments received by CMA on the Epidemiology Study of Vinyl Chloride Workers draft report. Some of the comments made by Air Products could not be incorporated in the final report because they would require additional work not included in the scope of work for the current contract. Dr. Gaffey will prepare a written record of comments that could not be addressed for various reasons. 2.0 EHA will revise the draft report based on the comments received and will submit the final report by the end of September. 3.0 A Panel meeting will be scheduled soon after the final report is received to discuss a future course of action. / 4.0 The meeting adjourned at approximately 12:00 noon. R&S 142348 Has Shah, Ph.D. Manager, Vinyl Chloride Program