Document k64pz2RMQNoQJJaeby49byNEV

( JAh)-/30 PROPOSED RULES that the repayment charge exceeds the buioimt of positive dirac. investment so r nUiorived in sueii srk.'uukd area, fr- ii;ji -C.'c:, had be in rue : .:ov,'i of ok hiv--- aa::,: au thorized under Subprn. E of rhis part in Mrheoules C, 1., ana A, in ihnt order, end then in the amount of positive di rect te.vestuv..:'.t a a.'''Tired under Sub- pr-.vt M of this port: Provided, That a investor electing to bo governed by 1000.503 ilir.i n; .'.res negative di rect investmem t.s eci.ycd in ? i'.-oo.30P, may decrease the amount of the repay ment charge in the amount oi .such neg ative direct investment: And provided further. That the amount of the reduc tion of the amount oi positive direct investment rr.uhori.od under Subpart E or M of this t snail not exceed the repayment charge tas decreased by neg ative direct investment), and that such reduction she.!! r.ot reduce authorized ]'*05itdve direct ii: . . uimer said subparts in any year to an amount less than zero. (2) Reductions under subparagraph (1) of tins paragraph in the amount of positive direct investment authorized under Subpart E of this part shall be made first in the aggregate amount of positive direct investment authorized under 1C00.503 or 1000.504. whichever is elected by the direct Investor for the year, and then in the amount of positive direct investment authorized under 5 1000.506. * (5) [Revoked] (d) If the repayment charge incurred In any year exceeds the amount of au thorized positive direct investment re duced under this section, reductions shall be made in each succceeding year in the same manner and order as set forth in paragraph (c) of this section. * * These amendments shall be effective as of the -date: of publication in final form in the Federal Register and shall apply to all affected transactions on or after January 1, 1973. (Sec. 6, net of Oct. 6, 1017, 40 Stat. 415, as amended, 12 D.S.C. 95c.: Executive Order 11357, Jan. 1, 10C8, 33 TR 47.) Robert A. Anthony, Director, Office of Foreign Direct Investments. May 11, 1973. (Fit Doc.73-0700 Filed 5- 18-73:8:45 am] , DEPARTMENT OF HE/.LTH, 7- EDUCATION, AND WELFARE Food and Drug Adrninistrelion [21 CFR Part 121 ] PRIOR-SANCTIOfiED POLYVINYL CHLORIDE RESIN Notice of Proposed Role Making Polyvinyl chloride (PVC) is a poly meric re:.in v.t.icii v,;" u.-.c-d as a. compo nent of food packaging materials prior to the passage of the Po-xl Additives Amendment of 1S58 and which has been widely used since that time. Not all poly vinyl chloride formulations can be need In food packaging. Polyvinyl chlor<:A fcav-r; a ir...:;:mum voU.fiShy of not o or 3 percent when heated for 1 hour at 105' C., and having an inherent vis cosity of not less than 0.35 when deter mined by American Society for Test ing and Materials (ASTM) standard method D 1243-66, is prior-sanctioned for use as a component oi a film for food wraps or as a can enamel. An ingredient whose use in food or ft cd packaging Ls subject to a prior-sanc tion or approval within the meaning of section 201 (s) (4) of the Federal Food, Drug, and Cosmetic Act is exempt from classification as a food additive and may be used without pre-clearance by FDA. The sanction for PVC rests on an ar ticle entitled "Food Packaging" by A. J. I.: km mi. Chief of the Division of Pharmacj'.ogy, FDA, published in the "Asso ciation of Feed and Drug Officials of the United States." volume 20, No. 4, Octo ber 1956. It is clear in the article that acceptance of the resins named therein was based on their lack of migration when tested for solubility in the listed solvent systems. The publication cited did ret refer to polyvinyl chloride bottles and did not name an alcoholic medium as a test system. In January 1973, the Food and Drug Administration began to receive reports of possible stability problems with PVC bottles used for distilled spirits. These bottles were part of an experimental program first authorized by the Treasury Department, Bureau of Alcohol. Tobacco, and Firearms in November 1S68. 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 the results had not been confirmed by mass spectrographic examination. During April a new series of analyti cal results, including mass spectro graphic examination, was presented to IDA by industry which confirmed the 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 also received which reported that wine packaged in PVC bottles was similarly affected. FDA has now confirmed migration of the monomer in distilled spirits in its own laboratory. While analytical tests arc etmtimiim? both at FDA and in in dustrial laboratories to resolve many un answered technical questions relative to this problem, it seems certain at tills time tnat vinyl chloride monomer mi grates to alcohol from PVC bottles used to package distilled spirits and wine. Vi ay! chloride monomer as such is a poisonous and deleterious substance. FDA knows of no studies which e/o- lish a safe level of consumption v firm tills monomer is leached '*:?) c ad: ei., ir.to alcoholic i.ocls. A _.y 'he C.:auu:--:icni.'r concludes in. : . ' h polyvinyl chloride for pack: alco holic foods may cause such focus to be adulterated. Thera is no indlsr t-icrx at thi; Hike t.-.nt polyvinyl chloride resins in cor' of v. h nonalcoholic foods will result m /.ucta- lion of monomers, and such u.-e i.._2 not be restricted. Therefore, pursuant to provisions of the Federal Food. Drug, and Cosmetic Act (secs. 201 (s), 402, 409, 701 (ai, 52 Stat. 1042. 1046-1047 as amended. 1049, 1055: 21 U.S.C. 321 <s). 342. 3 :3. 371 <: : > and under authority deie-gAUi: to ::i.n (21 CFR 2.120), the Commi-Dioner ox Food and Drugs proposes to rr- r-r.d r~vfc 121 by adding a new section 121.20C9 to read as follows: 12122009 Polyvinyl chloride rc-iii>. (a) Polyvinyl chloride resins consist of basic resins produced by tire polymeri zation of vinyl chloride. (b) Polyvinyl chloride basic resins have a maximum volatility of not over 3 per cent when heated for 1 hour at 105' C., and an inherent viscosity of not less than 0.35 when determined by ASTM method ary 10,1973. (c) Polyvinyl chloride resins meeting the criteria of paragraphs (a) and (b) of this section may be used as a com ponent of food packaging material, other than packaging material for use hi con tact with alcoholic foods. Interested persons may. on or before July 16, 1973, file with the Hearing Clerk, Department of Health, Education, and Welfare, room 6-83, 5609 Fishers Lane, Rockville, Md. 20S52, written comments (preferably in quintuplicatc) 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. Dated May 15,1973. William F. Randolph, Acting Associate Commissioner for Compliance. [FR Doc.73-9981 Filed 5-16-73:9:42 am] Office of Education [45 CFR Part 1S8] FINANCIAL ASSISTANCE FOR THE IV!r.TCVEMENT CF EDUCATIONAL C?7C?.TUN1TIE3 FOR ADULT INDIANS Pursuant to the authority coni.imcj In section 314 of the Adult Education Act, as added by part C of title IV of the Education Aiiieiukiuiiw 1.: ih,2 (Public Law 92-318, 86 Stat. 342, 2U U.S.C. 1211a), the Commissioner 01 Edu cation. with the approval of the So< ro tary of Health, Education, and Y.'ch.ire, 'Copies may be obtained Worn: Ai.e rU an Society for Testing and Miitcvials, ItUC Street, Philadelphia, ha 10103. MDiRAi racism, vot. 38, no. 95--Thursday, may 17, 1973