Document zQxGDQMpp9BDGzJGxv21kN3KR

PROPOSED RULES 12931 Copied by MCA Amendment of 1958 and which has been FDA knows of no studies which estab widely used since that time. Not all poly lish a safe level of consumption when 5/18/73 vinyl chloride formulations can be used this monomer is leached from contain in food packaging. Polyvinyl chloride ers into alcoholic foods. Accordingly, the having a maximum volatility of not over Commissioner concludes that the use of 3 percent when heated for 1 hour at polyvinyl chloride for packaging alco 105* C., and having an inherent vis holic foods may cause such foods to be cosity of not less than 0.35 when deter adulterated. mined by American Society for Test There is no Indication at this time that ing and Materials (ASTM) standard polyvinyl chloride resins in contact with method D 1243-66, is prior-sanctioned nonalcoholic foods will result in migra for use as a component of a film for food tion of monomers, and such use need not wraps or as a can enamel. be restricted. An ingredient whose use in food or Therefore, pursuant to provisions of food packaging is subject to a prior-sanc the Federal Food, Drug, and Cosmetic tion or approval within the meaning of Act (secs. 201 (s). 402, 409, 701(a), 52 section 201 (s) (4) of the Federal Food. Stat. 1042, 1046-1047 as amended. 1049, Drug, and Cosmetic Act is exempt from 1055; 21 U.S.C. 321 (s), 342, 348, 371(a)) classification as a food additive and may and under authority delegated to him be used without pre-clearance by FDA. (21 CFR 2.120), the Commissioner of The sanction for PVC rests on an ar Food and Drugs proposes to amend part ticle entitled "Food Packaging" by A. J. 121 by adding a new section 121.2009 to Lehman, Chief of the Division of Phar read as follows; macology, FDA, published in the "Asso ciation of Food and Drug Officials of the 121.2000 Polyvinyl chloride resins. United States," volume 20, No. 4. Octo (a) Polyvinyl chloride resins consist ber 1956. It is clear in the article tnat of basic resins produced by the polymeri acceptance of the resins named therein zation of vinyl chloride. was based on their lack of migration (b) Polyvinyl chloride basic resins have when tested for solubility in the listed a maximum volatility of not over 3 per solvent systems. The publication cited cent when heated for 1 hour at 105* C., did not'refer to polyvinyl chloride bottles and an inherent viscosity of not less than and did not name n alcoholic medium 0.35 when determined by ASTM method as a test system. an' 10.1973. In January 1973, the Food and Drug <c) Polyvinyl chloride resins meeting Administration began to receive reports the criteria of paragraphs (a) and (b) of possible stability problems with PVC of this section may be used as a com bottles used for distilled spirits. These ponent of food packaging material, other bottles were part of an experimental than packaging material for use in con program first authorized by the Treasury tact with alcoholic foods. Department, Bureau of Alcohol, Tobacco, and Firearms in November 1968. Indus trial users of these bottles had discov ered an unpleasant taste in lightly fla vored alcoholic beverages which had been kept in storage. Preliminary analytical results indicated that vinyl chloride monomer, a component of PVC, was ex tracted from the bottle to the liquor dur ing storage. The level of vinyl chloride migrating varied, with some samples in a high range of 10-20 p/m. At that time Interested persons may, on or before July 16,1973, file with the Hearing Clerk, Department of Health, Education, and Welfare, room 6-88, 5600 Fishers Lane. Rockville, Mft 20852, written comments (preferably in quintupllcate) regarding this proposal. Comments may be accom panied by a memorandum or brief in support thereof. Received comments may be seen in the above office during work ing hours, Monday through Friday. the results had not been confirmed by Dated May 15,1973. mass spectrographic examination. During April a new series of analyti cal results. Including mass spectro graphic examination, was presented to FDA by industry which confirmed the William F. Randolph, Acting Associate Commissioner lor Compliance. |FR Doc.73-9981 Filed 5-16-73;9:42 am) early reports of vinyl chloride monomer in various distilled spirits. These bev erage samples had been stored in PVC bottles for up to 1 year. Information was Office of Education [45 CFR Part 188] also received which reported that wine FINANCIAL ASSISTANCE FOR THE IM DEPARTMENT OF HEALTH,! EDUCATION, AND WELFARE| Food and Drug Administration [21 CFR Part 121] PRIOR-SANCTIONED POLYVINYL CHLORIDE RESIN Notice of Proposed Rule Making Polyvinyl chloride (PVC) is a poly meric resin which was used as a compo nent of food packaging materials prior to the passage of the Pood Additives packaged in PVC bottles was similarly affected. PDA has now confirmed migration of the monomer in distilled spirits in its own laboratory. While analytical tests are continuing both at FDA and in in dustrial laboratories to resolve rru.ny un answered technical questions relative to this problem, it seems certain at this time that vinyl chloride monomer mi grates to alcohol from PVC bottles used to package distilled spirits and nine. Vinyl chloride monomer as such is a poisonous and deleterious substance. PROVEMENT OF EDUCATIONAL OPPOR TUNITIES FOR ADULT INDIANS Pursuant to the authority contained in section 314 of the Adult Education Act, as added by part C of title IV of the Education Amendments of 1972 'Public Law 92-318, 86 Stat. 342, 20 U.S.C. 1211a), the Commissioner of Edu cation, with the approval of the Secre tary of Health, Education, and Welfare. 1 Ccples may be obtained from: American Society lor Testing and Materials, 1916 Race Street, Philadelphia, Pa. 19103. FEDERAL REGISTER, VOL 38, NO. 95--THURSDAY, MAY 17. 597J DTH 000013495