Document XbGQzX7RGNogQvJgjazG06Xw

B. A. D1LIDD0/ W. C.. BFCKER/F. J. DONAT R. K. HINDERER 5456 _2_/21/80 FDA POSITION ON ATSC One of our licensees, BIP (UK), has requested a statement from BFG on how the FTiA m'pus (unnlH view) Please review'' amFWiWBnHHsscawment ASAPV NOTE: Other individuals involved in the preliminary review were: W. C. Bachtel, H. H. Marty, R. F. Koebel, R. W. Strassburg. :kjs R. K. Hinderer lo o BFG51917 DRAFT ATSC - FDA STATUS Polyvinyl chloride resin is prior sanctioned for use in general food contact applications. Prior sanctioned substances are those which are used in accordance with an approval granted prior to September 6, 1958 by the FDA or USDA. The prior sanctioned status of PVC was established by Dr. A.J. Lehman of the FDA in publications in the Quarterly Bulletin of the Association of Food and Drug officials of the United States, 1951 and 1956. The specifications which apply to PVC under the prior sanction are: 1. Maximum volatility - 37a (1 hour @ 105C) 2. Inherent viscosity of not less than 0.35 ASTM Method D-1243-66, Method A FDA proposed a regulation^'Vinyl Chloride Polymer Resins". However, the regulation has never been promulgated. The proposed specifica tions for PVC were the same as those applying to the existing prior sanction. There are several use oriented regulations which list homo and copolymers of PVC. Examples of such regulations are 175.105. "Adhesives", 175.300 "Resinous and Polymeric Coatings" and 177.1200 "Cellophane". Other than the heat loss and viscosity specifications, the General Provisions Regulation 174.5 would apply to PVC resins. Briefly these are: 1. The quantity of substance used shall be no more than necessary to accomplish the intended physical or technical effect. 2. Shall not be intended to accomplish any physical or technical^ effect in the food 3. Be of a purity suitable for its intended use. 4. Shall not impart taste or odor to food. O 3 BFG51918 i 2. It is the responsibility of the manufacturer of a food contact article to determine that he is in compliance with the food additive regulations. In reviewing the acceptability of a polymer for food contact applications under current FDA regulations, the following criteria are taken into consideration: 1. In general, those substances necessary in the polymerization process to produce the polymer need not have specific FDA acceptance. Included are such ingredients as catalysts, salts, short stops, etc. However good manufacturing practices must prevail and would preclude the use of some substances. 2. Those ingredients added to the-polymer after polymerization must have FDA acceptance for their intended use or must not reasonably be-expected to migrate under the conditions of use. This has been the position taken by the Society of the Plastics Industry (SPI), Rubber Manufacturers Association (RMA) and others in an informal "good faith" agreement with the FDA. Also, in the past the FDA has informally agreed that the phrase certain extremely toxic substances or pesticides. Extraction tests have been performed on PVC films incorporating PVC resin short stopped with 75 ppm ATSC. The flHHNMHB were performed in accordance with FDA guidelines using the most severe solvent for ATSC or its assumed breakdown products. The BFG51919 3. Therefore, in my opinion, the use of acetone thiosemicarbozone at the current use level or lower use levels in the polymerization of polyvinyl chloride resins intended for use in the fabrication of VCB 2-12-80 BFG51920 ___ _ too