Document k673r4QpYn7dj5OD3X06xGNwE

^DCM c. KKliiH jrtom n. hccnmam CHAJUS* MCCMAM WILktAH M. lOWlll wurtiN w. m^Mtovici jomm s- budio caiwuC. imhww WtCMACk F. MOMMOMS k*MT ft. |OmHH ^OMM D, PUDNCH wokaum CNMITlM a. VHlRUt PtMIM C. fiovvul JANMtTT IOWAMUUMODDIM perm a. imw IHVU A, MUAH mum it ii ran ICC M. WWC* ILSMC MMDCk MStUEH MANN C. MAVIS* ADWtttD IM NtW VPM AMD VIMDIMIA QHkV LAW OFFICES Kelleh and Heckman UBO IT'* STREET. N.W. SUITE IOOO WASHINGTON. D.C. 80000 (808) S7-lIOO July 9, 1985 received JUL 111985 V DR. R. T. GOTTESMAN run f i TM* s TfkfCOPtW* <*OSl *DN7D* wmrciri oiubct cmal. mumdcn (202) 457-1110 To; SPI Vinyl Institute SPI Food, Drug, Cosmetic Packaging Materials Committee SPI Plastic Bottle Institute Re: FDA PVC Status Report Ladies and Gentlemen: The purpose of this letter is to inform you about th latest intelligence we have on the status of the Food and Drug Administration's (FDA) long-awaited proposal to regulate the food-contact uses of polyvinyl chloride (PVC). As you are aware, efforts by SPI's Vinyl Institute members and others have generated correspondence between FDA and several Congressmen. The most recent example is a June 20, 1985 letter from FDA Commissioner Frank E. Young to Representative Christopher H. Smith (R-NJ). That letter states: "The agency is presently reviewing a proposal which will set forth conditions of use, including liquor bottle use, that we believe will be safe. He anticipate publishing this new proposal in the Federal Register during the current year and will do everything we can to expe dite it." To say we are disappointed and frustrated by FDA's delay in publishing a proposal is to state the obvious. He all recall that the Agency made similar promises to Congressmen last year that a proposal would be published in late 1984. Through discussions with FDA personnel, we have been trying to establish the cause of delay and to urge prompt action. By patching together information from a variety of sources, it is our conclusion that there is still little or no concern with the substance of the draft PVC proposal. In other VEV-I439p5> SPI Mailing July 9, 1985 ' Page 2 Keller and Heckman words, there is no real health or safety Issue in the presence of adequate controls on the levels of residual vinyl chlorid . Thus, we consider statements in Commissioner Young's letter referring to the Agency's need to reassess the carcinogenic potency of vinyl chloride monomer to be a disingenuous explanation for PDA's delay. It is our opinion that progress on the PVC proposal is being hindered by other activities in FDA, particularly relat ing to color additives. We detailed the color additive situa tion in our letter of July 5, 1985. Given our familiarity with the toxicological and risk assessment data on vinyl chloride monomer, it appears to us that the risk presented by PVC is substantially lesai than that posed by certain color additives that FDA presently permits despite congressional inquiry, judi cial proceedings, and mounting press attention. The color additive proceedings have diverted the Agency's attention from other matters, including the PVC rule. As far as we can determine, the proposed rule is still inside FDA and has not been circulated to the Department of Health and Human Services (HHS) or the Office of Management and Budget (OMB) for review. Given the political and other pressures being brought to bear on FDA in relation to color additives, we would not be at all surprised if FDA was again revising the preamble to the draft PVC regulation to make it "consistent" with the Agency's more recent statements in the color additive proceedings relat ing to the regulation of carcinogens. On top of all this. Commissioner Young has been clear d for the post of Assistant Secretary for Health at HHS. Although it is not yet clear when Dr. Young will change positions, if he departs before the PVC proposal is forwarded to HHS and OMB for clearance, it could lead to further delays if Young's successor at FDA does not act decisively. Earlier this year we anticipated that a proposed rule might be published by summer. However, since FDA has yet to circulate the proposal to HHS and OMB, it now appears unlikely that the PVC proposal will appear in the Federal Register until late this year. In light of new information on the delays that the PVC proposal is encountering, I am initiating a series of calls to VEV-144000 SPI Mailing July 9, 1985 Page 3 Keller and Heckman high level management officers within PDA's Center for Food Safety and Applied nutrition to verify that there is no problem in that key organisation. If there is no delay in the Center, we will then need to follow-up with the General Counsel's Office and finally the Commissioner's Office. The primary objective of the calls will be to press for prompt action on the PVC proposal. Me also hope to confirm and refine our und r standing of the status of the PVC rule. If you have any comments or questions pending your receipt of our follow-up reports, please let us know. cc: Charles E. O'Connell Thomas J. McGrath 44001