Document 7R9J2dYRrKEBa78DBEpwm1K7B

UNION CARBIDE CORPORATION 39 ol.q rogebury road, oanbury. ct obbi7-0001 To |N*ma[ Division Locator* Ar*a SREB Copy ; 0 R. C. Wise H. L. Greenberg Data September 22, 1986 HS&EFr<ge*iats-ig D^t Arwm J3 SuOtact VINYL CHLORIDE EPIDEMIOLOGY STUDY Attached Is a copy of CMA's "FYI" submission of September 11, 1986 to EPA concerning a "Summary of Draft Results of an Epidemiology Study of Vinyl Chloride Workers". SREB reviewed this document at its August 27, 1986 meeting and Union Carbide sent a "FYI" report concerning this study to EPA on September 9, 1986. W. C. Kuryla Secretary, SREB WCK:vm Attachments UCC 004819 B EC i y ED SEP 19 1986 W.C.K.URXEA r/uj 4J- (+s . a-/t & '4 C4 ^f ^^ C So-t r rJ f To: Members, Vinyl Chloride Special Programs Panel From: Has Shah, Program ManagerJf* Gabrielle H. Williamson, Assistant General Counsel Cti.Lt). 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 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 EPAj 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 compani s 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 UCC 004820 2 r vi w EPA's Statem nt of Interpr tation and Enforc ment Policy, Notification of Substantial Risk, 43 Fed. R q. Til 10 (Marcn 16, 1978) in making your individual company decisions n whether or not to file additional FYI or Section 8(e) notic s 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. ucc 004821 CHEMICAL MANUFACTURERS ASSOCIATION GERALDINE V. COX. Pti.D. Vic* President Technical Director Septe.Tber 11, 1986 HAND-DELIVERY NGG SEP 11 fll 2: 02 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 Vlnvl 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 Cnomiata Aeaociaiton--Serving the Cnermcel Industry Since 1172. 2901 M Street. NW Waanington. DC 20037 Talepnena 202/M7-1260 Telex 0S617 (CMA WSH) UCC 004822 2 In addition, the study showed an exc ss mortality from emphysema, which includes br nchitis and chronic obstructiv pulmonary disease. However, the dose-r spons 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 persons whose 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 expected from the contractor in four t 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, Fh.D. Vice President-Technical Director cc: Vinyl Chloride Program Panel UCC 004823 3 ATTACHMENT I Participating Companies of the Chemical Manufacturers Associations Vinvl Chloride Program Panel Air Products and Chemicals, Inc. BFGoodrich Company Borden, Znc. 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 Shel*l Oil Company Union Carbide Corporation Uniroyal Chemical Company Vista Chemical Company