Document b53rOJyO5J8OYqZ6OkY6vGEq1

/* / CM CHEMICAL MANUFACTURERS ASSOCIATION 1 j'l n September 11, 1986 >v & Exoress Mail To: Members, Vinyl Chloride Special Programs Panel From: Has Shah, Program ManagerH' Gabrielle H. Williamson, Assistant General Counsel Re: Informational Submission to EPA: Summary of Draft Results of an Epidemiology Study of Vinyl Chloride Workers HU Enclosed for your information and review for possibl 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 Pan 1 member companies indicated that CMA should file an FYI notic 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 1 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. 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 th notice, the timeliness of submission, etc., EPA may decid , 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 distribut 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 Fermrty Manufacturing cnemijts Aijoeiation -- Serving tne Cnemieai mauitry Since '872 250' V Si reel NW Waanmgton DC 20037 Teleonone202 887-U00 Teiei 89617 | CMA 014543 review EPA's Statem nt of Interpretation and Enforcement Policy, Notification of Substantial Risk, 43 red. 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. A CMA 014544