Document 2q0vr3V1eXmNd5Y65VqqgQ77

ECElVE sP12\966 r.\N. FR^SE 9/12/86 cc: R. N. Johnson H. S. Wheeler September 11, 1986 Express Mail To: Members, Vinyl Chloride Special Programs Panel From: Has Shah, Program Manager Gabrielle H. Williamson, Assistant General Counsel CH.Lx). 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 will- note 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. v v. 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 GENC 006340 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 FY1 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. 6ENC 006341 T CHEMICAL MANUFACTURERS ASSOCIATION GERALDINE V. COX. Ph.D. Vice President Technical Director September 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 --' CCUTDO3 O moo RE: For Your Information Submission: Summary of Draft Results of an Epidemiology Study of Vinyl Chloride Workers Dear Sir/Madam: : NJ CD N 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. V The current study is an update of ari 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. GENC 006342 Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872. 7501 M Street. NW Washinaton. DC 20037 Teleohone 202/887-1260 Telex 89617 (CMA WSH1 t 2 In addition, the study showed an xcess 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 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 expecrted 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, i#-.-you have specific questions .T Sincerely yours. Geraldine V. Cox, Ph.D. Vice President-Technical Director cc: Vinyl Chloride Program Panel GENC 0063A3 'ft* ` 3 ATTACHMENT I Participating Companies of the Chemical Manufacturers Association's Vinyl Chloride Program Panel 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 Company Shell Oil Company Union Carbide Corporation Uniroyal Chemical Company Vista Chemical Company GENC 006344