Document bBQEyL78nyZv2688vkZqrRL9y

September 11, 1986 Express Mail To: Members, Vinyl Chloride Special Programs Panel From: Has Shah, Program Manager Jf* Gabrielle H. Williamson, Assistant General Counsel G. H.Li). 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 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 Vv\, 00 *7#4 / 2 review EPA's Statement of Interpretation and Enforcement Policy, Notification of Substantial Risk, 43 Fed. Reg. 11110 "[March 1S~, 197~8) 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. 00027s*a f CHEMICAL MANUFACTURERS ASSOCIATION Route: September 2, 1986 Copy: Fils; Dear Vinyl Chloride Panel Members: I hope by now you would have reviewed the draft report on Epidemiologic Study of Vinyl Chloride Workers. Some of the Panel companies have raised concern regarding emphysema as a cause of death and consider this as a new finding reportable to the EPA under Section 8 of the Toxic Substances Control Act. If the Panel members agree, CMA could relieve each of the companies of their potential obligations by filing the finding with the Agency as "For Your Information." If the Panel decision, decided by a majority of votes received, is to file' the findings with the Agency; CMA would prepare a short paragraph on this finding while the draft report is being finalized. Only the final report approved by the Panel will be filed with Government agencies. Please complete the enclosed ballot with respect to a pro posed submission to the EPA and send it to me by Express Mail. The' deadline for receiving your completed ballot is September 9,' 1986. Please call me at 202-887 1192 if you need additional information. Your cooperation in this matter is greatly appreciated. Sincerely, vH&O " Has Shah, Ph.D Manager, Vinyl Chloride Progr KS/krnw P.S. Please send me your comments on the draft report by this Friday at the latest, so that I can discuss them with EHA staff on Monday. VVv 00a7849 Formerly Manufacturing Chemists Association --Serving the Chemical Inaustry Since 1872. 25C1 M St' set N'.V v.'ss"i'"ctcn. CC 2CC2 7 Te'echcne 2C2 567-1 ; 2T * "e-'e* i 7 . C `.`-1 3-; KZ sPx ^ Af ^Vj/ 0q &5q *N < L S M T ^H.T.fl.T T tt