Document LJJZzGrbqp5aM4q0vQGXjv1pQ

FILE NAME Talc TALC DATE 1972 Aug 12 DOC TALC010 DOCUMENT DESCRIPTION Federal Register Notice - Talc  FEDERAL REGISTER VOL 37 NO SATURDAY AUGUST 12 1972 DEPARTMENT OF HEALTH vs EDUCATION AND WELFARE Food and Drug Administration . 21 CFR Part 121 FOOD ADDITIVES : : Soe Proposal Regarding Regulation of Sanctioned Food Ingredients The Commissioner of Food and Drugs is conducting a study of food ingredients that have been used in food products regu- without approval of a food additive ~ lation on the ground either that they are generally recognized as safe GRAS or that they are subject to a prior sanc- tion The Commissioner has already : published proposed procedures for the affirmation of GRAS status or the deter- fe mination of food additive status It is * . therefore appropriate to establish com- parable procedures for the regulation of ingredients subject to prior sanctions Section 201 of the Federal Food : Drug and Cosmetic Act excludes from the definition of food additive 4 Any substance used in accordance with a sanction or approval granted prior to the enactment of this paragraph pursuant to this Act the Poultry Products Inspection Act 21 U.S.C. 451 and the following or the Meat Inspection Act of March 4. 1907 34 Stat 1260 as amended U.S.C. 71 and the and extended 21 following Pursuant to this grandfather clause a my food ingredient subject to a prior sanc- tion may not be regulated under the food additive provisions of the law Such an ingredient may however be regulated under the general adulteration and mis- branding provisions of the Act and in particular may be banned from food if : _found to be a poisonous deleterious . substance in violation section = 402 1 of the Act The Food and Drug Administration . between 1938 and 1958 reaffirmed - many sanctions or approvals granted under the ' Federal Food and Drugs Act of 1906 and ~. also granted additional sanctions and SSeS] sanctions approvals 7 ' | approvals The U.S. Department of Agri- culture has similarly granted many sanctions and approvals Not all of these aseertained because of the destruction of old i records and the retirement of personnel involved in these matters The Food and _ Drug Administration has requested in. formation on prior sanctions 35 FR , +. 5810 in an effort to make its files on these matters more complete 2 pe : * 1 " : . i ; , - . .~ *. : . we Mae wed . conn : a -_ . & rt x PROPOSED RULE MAKING Whether or not a food ingredient is ased as a result of a determination that It is GRAS or pursuant to a food additive regulation or as a result of a prior sanction the basis for such use should be a matter of public record The Commissioner has therefore determined to expand Subpart E under Part 121 within which will be established regulations governing all sanctioned direct and indirect food ingredients known to the Commissioner . . New scientific information requires on occasion that additional limitations be placed on the use of sanctioned in- Accordingly the Commissioner has concluded that a procedure should also be established under which a regulation 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 b Paragraph d is amended by adding the following entry in alphabet- ical sequence | 121.101 Substances that are generally | recognized as safe ' Agreement CAB 23184 Resolution I to * Title i {i be seen in the above office during work- ing hours Monday through Friday Dated August 1 1972 FR Doc.72 SAM D. FINE Associate Associate Commissioner for Compliance 1271F4iled 8-11-72 am R 002 . ... ... ee 105 PAC 203 205 PAC 305 PAC JT12 5PAC JT23 5PAC JT31 5PAC JT123 5PAC Revalidation Resolu Sales Agency Rules Inclusivo Tours Initiated by | Tour Operators Reduced Fares for Passenger Agents Except U.S.A. Amending ! 2. Subpart E of Part 121 is amended as follows 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 a The title of Subpart E is revised to read Subpart Sanctioned Food Ingredients b Section 121.2001 is redesignated as : 121.2005 and 121.2000 and 121.2006 ' are added to read as set forth below 121.2000 General was subsequently recognized in the standard of identity for enriched rice 15.525 Talc has also been listed as GRAS in 121.101 for use in paper and paperboard used in dry food packaging in 121.101 for use in cotton and cotton fabrics used in dry food packaging in an FDA opinion letter for use in chewing gum base and in FDA opinion letter for use as an antisticking agent in forms used in molding various food shapes Talc a naturally occurring hydrous magnesium silicate without defined specifications or limitations A recent publication Science 1141-1142 September 17 1971 identifies the presence of asbestos particles in talc used to coat rice Independent laboratory investigation by the Food and Drug Administration 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 carcino- a An ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning of section 201 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 endence to show that it falls within sex- tion 201 4 of the act : b Based upon scientific data or in- | formation that shows that use of a priorsanctioned food ingredient may be injurious to health and thus is in violation : of section 402 1 of the act the Commissioner will establish or amend the applicable prior sanction regulation to impose whatever limitations or conditions are necessary for the safe use of the ingredient or to prohibit use of the ingredient 121.2006 Talc + aan is oc ur ing.hr- genio inhaled and asbestos_ =. a Telo a naturally occurring.hr_ thereforbe e injurious arous inagnesium silicate for which sa health when ingested and since talc can food grade specifications exist Talc % be processed to remove asbestos subject to a prior sanction for use in particles it is prudent to require that coating polished rice talc which is to be used in the manufacture of food or food packaging be free of asbestos particles Therefore pursuant to provisions of the Federal Food Drug and Cosmetic b Talc containing asbestos particles may be injurious to health Ac- cordingly any food or food packaging material containing talc that is not free of asbestos particles shall be 5 Oey Act secs 201 409 701 52 Stat 1055 and 72 Stat 1784-88 as amended deemed to be adulterated in violation of section 402 1 of the Act 21 U.S.C. 321 348 371 and under authority delegated to him 21 CFR Interested persons may within 60 days Ti 2.120 the Commissioner of Food and after publication hereof in the FEDER.LL Drugs proposes to amend Part 121 as REGISTER file with the Hearing Clerk follows Department of Health Education anti 1. Section 121.101 is amended as Welfare Room 6-88 5500 Fishers Lan follows Rockville Mid 20832 written comment a Paragraphs h and 1 are preferably in quintuplicate regarding amended by adding the phrase free this proposal Comments may be accom- mye of asbestos particles after the panied by a memorandum or brief in word talc . support thereof Received comments may i \ et ene oe OC RE Se erra LoenOe rnen cet Fee Ya te Takin te Meher ee pup ke ae dy ve FEDERAL REGISTER VOL 37 NO SATURDAY AUGUST 12 1972 er bye