Document 3eJ1j8X7Z2ZRb4LMbD3g2mxoa

10/25/82.2 The Society of the Plastics Industry, Inc. 355 Lexington Ave P New York. New York 1001 fit, V DRGENT--IMMEDIATE RESPONSE FROM AFFECTED MEMBERS ESSENTIAL October 25, 1982 RECEIVED OCT 2 8 1982 R- W. Laundrie TO: SPI Public Affairs Committee SPI PVC Safety Group SPI Food, Drug, and Cosmetic Packaging Materials Committee SPI AN Polymers Group SPI Plastic Bottle Institute SPI Plastic Beverage Container Division RE: FDA Request for Marketing Data on PVC Ladies and Gentlemen: GENC 015825 The purpose of this letter is to determine whether we may instruct counsel to advise the Food and Drug Administration (FDA) that manufacturers of rigid and semi-rigid polyvinyl chloride (PVC) food packaging materials canjneet a.residual *1 msaesaB To put this request for your opinion in perspective, please recall that FDA is developing proposals on the food tact use of acrylonitrile (AN) and vinyl chloride polymers"under -----------~ SXJZ2^(y Je- 7 suzdccot* Cf t-dff m c Ykn id- Os ^ etcryuz. sQjCtiupjj&K JrfrWup ^^ October 25, 1982 Page 2 its new constitutents policy. Prior to taking any action, FDA requested that The Society of the Plastics Industry, Inc. (SPI) provide information on: (1) current marketing data for the regu lated and prior-sanctioned food contact uses of the polymers, (2) projected future markets as food contact materials, and (3) current data on residual monomer levels and extraction data for food grade polymers. Subsequently, it was decided that the AN Polymers Group and the PVC Safety Group would proceed independently to respond to FDA's request. The AN Polymers Group will be meeting on October 26, 1982 to review their situation. In a letter dated September 15, 1982, John Lawrence, SPI's Technical Director, requested that information relevant to PVC be sent directly to Keller and Heckman by October 1, 1982. The plan at that time was to have Keller and Heckman collect and compile the data for submission to FDA. Thus far, Keller and Heckman has received good data from two companies representing rigid and semi-rigid PVC interests. It seems unlikely that FDA would consider this data base sufficient for determining the amount of the diet packaged in PVC or commercially-feasible RVCM levels. In the absence of adequate data, we have been considering alternative approaches because interested members have indicated their desire that FDA quickly resolve the PVC issue. While PVC is prior-sanctioned for food packaging, it is our understanding that PVC may be disadvantaged in certain markets, such as that for liquor bottles, if FDA does not"move forward promptly. As for the liquor bottle situation, the Bureau of Alcohol, Tobacco and Firearms (ATF) will not act in the absence of an FDA statement that PVC is acceptable for alcoholic beve rages. We have been working diligently to obtain fair treatment for PVC in this area and others are supporting this through independent efforts. Nevertheless, some industry response to FDA's request must be forth-coming shortly. Based on the constitutents policy, FDA is in the process of establishing an acceptable daily intake (ADI) for vinyl chlo ride monomer. We have been informally advised that the tenta tive calculation for the vinyl chloride ADI will be approximately 0.25 ug/day. The marketing data that FDA requested would pro- GENC 015324 October 25, 1982 Page 3 vide the basis for determining a consumption factor, that is, the percentage of the diet expected to be packaged in PVC. With both the ADI and the consumption factor, FDA can calculate a permissible RVCM level based on VCM migration rates and shelf life data. Without substantial support for a specific consump tion factor, FDA is likely to assume that the entire diet will To help resolve the regulatory problems facing PVC we urgently need a response from affected members of the PVC Safety Group, Plastic Bottle Institute, and Food, Drug, and Cosmetic Packaging Materials Committee. Then we can inform FDA that manufacturers of rigid and semi-rigid PVC can produce a product with a 10 ppb RVCM level. This, in turn, should eliminate any public health concerns even if one assumes that the entire diet is packaged in PVC. We understand that this a sensitive issue, and we are extremely interested in receiving your views on this matter. Please contact Keller and Heckman by November 8, 1982. They will keep the identity of individual submissions in strict con fidence to avoid any antitrust or other difficulties. We look forward to hearing from you. Cordially yours. GENC 01582?