Document 6RZYO9Oy1KrERK7JGB60rQbNo

FILE NAME: Talc (TALC) DATE: 1972 Aug 12 DOC#: TALC010 DOCUMENT DESCRIPTION: Federal Register Notice - Talc FEDERAL REGISTER, VOL. 37, NO. 157-- SATURDAY, AUGLST 12, 1972 . department of health, EDUCATION, AND WELFARE A *' Food and Drug Administration 121 CFR Part 121 1 FOOD ADDITIVES Proposal Regarding Regulation of Prior-Sanctioned Food Ingredients The Commissioner of Food and Drugs is conducting a study of food ingredients that .have been used in food products without approval of a food additive regu . latfon on .the ground either that they are generally recognized as safe (GRAS) or that they are subject to a prior sanc- t 5V Commissioner has already published proposed procedures for the affirmation of GRAS status or the deter ' filia tio n of food additive status. It is therefore appropriate to establish com- parable procedures for the regulation of | ingredients subject to prior sanctions. ecfLon 201 fs) of the Federal Food. 1 and Cosmetic Act excludes from the definition of "food additive": (4) Any substance used in accordance with I a sanction or approval granted prior to the enactm ent of th is paragraph p u rsu an t to , , , . l ' l h e P oultry Products In sp ectio n Act (21 US.c. 451 and th e follow ing) or the M eat In sp e c tio n Act of M arch 4 . 1907 (34 S ta t 1 2 6 ), as am en d ed and ex ten d ed i21 U.S.C. 71 and th e fo llo w in g ); ' Puisuant to this grandfather clause, a food mgredient subject to a prior sanc tion may not be regulated under the food additive provisions of the law. Such an , higredient may, however, be regulated , under the general adulteration and mis , brandmg provisions of the Act, and m .particular may be banned from food if .lounci. to be a "poisonous or-.deletorious jsuostance " - in v i o l a t i o n ^ -se^tibff ' 402(a) (1) of the Act. " 1 . and fOrug Administration. 'saan^cHtiConns19o3r8apapnrdov1a9l5s8g, rraenaftfeidrmuenddemr atnhve Federal Food and Drugs Act of 1906, and also granted additional sanctions and IggssswftW' i !,T VvS' The U'S' DePartment of Agri- j culture has similarly granted many sirnc- ' t d 'SS*- tlons and approvals. Not all of these these matters. The Food and . Eni;, Administration has requested in . .ormation on prior sanctions (35 1 f 810) an effort to make its files on 1these matters more complete. ij* C` f PROPOSED RULE MAKING /Whether or not a food ingredient is ^sed as a result of a determination that -- it is GRAS, or pursuant to a food addi tive regulation, or as a result of a prior sanction, the basis for such use should be a matter of public record. The Com missioner has therefore determined to expand Subpart E under Part 121, within which will be established regula tions governing all prior-sanctioned di rect and indirect food ingredients known to the Commissioner. , . New scientific information requires, on occasion, that additional limitations be placed on the use of prior-sanctioned in gredients ..Accordingly, the Commissioner has concluded that a procedure should also be established under which a regu lation in Subpart E stating the existence of a prior sanction may be established or amended to impose limitations upon the use of the ingredient when scientific data Justify such limitations. As the first action under this proposed new subpart, the Commissioner proposes to issue a regulation for talc, which has a prior sanction for use in coating polished rice. This use was first approved in a food inspection decision issued under the Federal Food and Drugs Act of 1906, and was subsequently recognized in the standard of identity for enriched rice, 15.525. Talc has also been listed as GRAS in 121.101(h) for use in paper and paperboard used in dry food pack aging, in I 121.101 Ci) for use in cotton and cotton fabrics used in dry food pack aging, in an FDA opinion letter for use in chewing gum base, and in an*FDA opinion letter for use as an antisticking agent in forms used in molding various food shapes. Talc is a naturally occurring hydrous magnesium silicate without well-defined specifications or limitations. A recent publication (Science 173:1141-1142, September 17, 1971) identifies the pres ence of asbestos-form particles m talc used to coat rice. Independent laboratory investigation by the Pood and Drug Ad ministration has confirmed this report. A copy of the FDA report is on file with the Food and Drug Administration Hearing Clerk. Since asbestos, another form of natural magnesium silicate, is carcinogenic_when. inhaled and ssbestosri/Mun. P5 rcTcicsrmwy"-tfierefdre^eriifl'urldus--Kf health when ingested, and since talc can be processed to remove asbestos-form particles, it is prudent to require that talc which is to be used in the manu facture of food or food packaging be free of asbestos-form particles. Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 201 (s), 409, 701(a), 52 Stat. 1055 and 72 Stat. 1784-88, as amended: 21 U.S.C. 321 (s), 348, 371(a) and under authority delegated to him (21 CFR 2.120), the Commissioner of Food and Drugs proposes to amend Part 121 as follows: 1. Section 121.101 is amended as follows: a. Paragraphs (h) and (i) are amended by adding the phrase "free of asbestos-form particles" after the word "talc". b. Paragraph (d) (8) is amended by adding the following entry in alphabet ical sequence: . 121.101 Substances that arc generally' recognized as safe. > A greem ent C A B 23184 R eso lu tio n ' Titlo- j R - l ............... 002..................... R -3 ............... 105(PAC)203 208 (PA C )203 305 (PA C )203 JT12 (5PAO203 JT23 (5PAO503 JT31 (5PAC)20i JT123 (5PACJ203. R e v a lu atio n Resolu tio n --Sales Agency R ules, Inclusive Tours Initiated by T o u r Operators. R ed u c ed F ares foe Passenger A gona (Except U .3.A J (A m ending). 2. Subpart E of Part 121 is amended as follows: a. The title of Subpart E is revised to read, ``Subpart E--Prior-Sanctioned rood Ingredients". b. Section 121.2901 is redesignated as ! 121.2005 and 121.2000 and 121.2006 1 are added to read as set forth below: 121.2000 General. (a) An ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning of section 201 (s) (4) of the act is exempt from classification as a food additive. The Commissioner will publish in this subpart all known prior sanctions. Any interested person may submit to the Commissioner a request for publication of a prior sanction, supported by evi dence to show that it falls within sec tion 201 (s) (4) of the act. (b) Based upon scientific data or in formation that shows that use of a prior- sanctioned food ingredient may be in jurious to health, and thus is in violation 1 of section 402(a) (1) of the act. the Com missioner will establish or amend tie ' applicable prior sanction regulation to impose whatever limitations or condi tions are necessary for the safe use cf the ingredient, or to prohibit use of tbe ingredient. 121.2006 Talc. : c&FTglc is a naturs-itv cccurrir. g.hv- ^ QrOUi ihagnesiunp silicate ToF which" rSr~ food grade specifications exist. Talc as subject to a prior sanction for use lir coating polished rice. . - (b) Talc containing asbestos-forro particles may be injurious to health. Ac cordingly, any food or food packaging; material containing talc that is not free of asbestos-form particles shall lie 1 deemed to be adulterated in violation tff section 402(a) (1) of the Act. Interested persons may, within 60 daj after publication hereof in the Feozr.u. Register, file with The Hearing Clcri: Department of Health. Education, and Welfare, Room 6- 88, 5600 Fishers Lane Rockville. Md. 208.32, written comment; (preferably in qumtupUcate) regarding this proposal. Comments may be accom panied by a memorandum or brief tn support thereof. Received comments may be seen in the above office during work ing hours, Monday through Friday. Dated: August 1 ,1972. Sam D. Firm, Associate Connnissioner , f r Complicuice. I [F R Doc.72-12714 F iled 8 -1 1 -7 2 :8 :4 5 am j FEDERAL REGISTER, VOL. 37, NO. 157-- SATURDAY, AUG15T 12, 1972