Document JrVyGONvJz4jqKzYwYbM1LOX

FILE NAME: Talc (TALC) DATE: 1972 DOC#: TALC072 DOCUMENT DESCRIPTION: Federal Register Notice PROPOSED RULE MAKING 16407 at, however, modify or abridge a party's ight to any proceeding authorized by ,his l>art or by Chapter 46 of Title 42 of he United States Code. ,17.72 F inality o f th e proceed in g s. 'Determinations and findings of fact Hade by the Administration shall be final md conclusive, if supported by substanial evidence, upon all applicants or aantees in a compliance hearing under 17.31 or in an adjudicative hearing Tpripr 17.33, or upon all parties in m administrative investigation under DEPARTMENT OF HEALTH, 17.32 (except that a subsequent hearing iball constitute a trial de novo on the EDUCATION, AND WELFARE acts), in a rehearing under i 17.34, or in hearing under a petition for judicial iwiew, except that the Administration hay make new or modified findings or ^terminations pursuant to 42 "U.S.C. lection 3759(b) upon remand from a urt. Such new or modified findings or ietenninations, when filed in the reaanding court, shall likewise be final and conclusive, if supported by substantial widence. ^17.74 Lim itation o f the h earing ex am in er's a u th o rity . | a hearing examiner may reopen a iroceeding at any time prior to his sub mission of recommendations to the Ad ministration. After submission of his commendations, the hearing exami ner's jurisdiction is terminated, except jiffthe correction of clerical errors. How- %er, the Administration, at its own dis cretion, may remand a proceeding to a fearing examiner for further inquiry liter the presentation of recommendaSfbns and before the making of determi nations and findings of fact. jt J erris Leonard, Administrator, Law Enforcement i Assistance Administration. ]FR Doc.72-12641 P iled 8 -ll-7 2 ;8 :4 5 a m i order as the agency to administer .the terms and provisions thereof. The proposed amendment is designed to establish safeguards pursuant to 918.60(c), to prevent new containers of bulk peaches which fail to meet re quirements for shipment to markets other t.vn.n the adjacent markets issued under 5 918.60(b), from being shipped to nonadjacent markets. Until recently, ungraded peaches shipped in bulk to ad jacent markets were packed in used con tainers, which were readily distinguish able from peaches packed for shipment to nonadjacent markets. Recently, un graded peaches for shipment to adjacent markets have been packed in new DuaJl and similar containers. These new han dling and packaging practices make it relatively simply to divert ungraded peaches meeting only the adjacent mar kets requirements to the nonadjacent markets. The proposed safeguards here inafter set forth are designed to prevent the diversion of such peaches from the adjacent markets to the nonadjacent markets. x .. __ .. All persons who desire to submit writ ten data, views, or arguments for con sideration in connection with the pro posed amendment shall file the same, in quadruplicate, with the Hearing Clerk, U.S. Department of Agriculture, Room 112, Administration Building, Washing ton, D.C. 20250, not later than the 15th day after publication of the notice in the F ederal R egister. All written submis sions made pursuant to this notice will be made available for public inspection at the office of the Hearing Clerk during regular business hours (7 CFR 1.27(b) ). The proposal would be implemented by amonriing 918.130 Peaches shipped to adjacent markets, to read as follows: 918.130 Peaches shipped to adjacent m arkets. () Each handler who ships adjacent market peaches shall report daily to the Industry Committee, in such manner and on such forms as prescribed by that com Markets Only," along with the handler's name and address; and (2) have such fruit so shipped inspected as provided in I 918.64. Dated; August 9, 1972. Charles R. B rader, Acting Deputy Director, Fruit and Vegetable Division, Agri cultural Marketing Service. , [FR Doc.72-12809 Filed 8-11-72:8:54 am ] Food and Drug Administration [ 21 CFR Part 121 ] 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 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 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 (s) of the Federal Food, Drug, and Cosmetic Act excludes from the definition of "food additive": . (4) Any substance used in accordance w ith a sanction or approval granted prior to -th e enactm ent of this paragraph p u rsu an t to th is Act, th e Poultry Products Insp ectio n Act (21 U.S.C. 451 a n d th e follow ing) or th e M eat In sp ectio n Act of M arch 4. 1907 (34 S ta t. 1260), as am ended and exten d ed (21 U.S.C. 71 a n d th e follow ing); I epartment o f agriculture 1 Agricultural Marketing Service l E7CFR Part 918 1 | HANDLING OF FRESH PEACHES | GROWN IN GEORGIA leaches Shipped to Adjacent Markets I Notice is hereby given that the De partment is considering a proposed jjknendment, as hereinafter set forth, to the rules and regulations (Subpart--In dustry Committee Regulations; 7 CFR Il8.100-918.131) currently in effect puxittant to the applicable provisions of the Marketing agreement, as amended, and Order No. 918, as amended (7 CFR Fart 918), regulating the handling of peaches grown in Georgia. This is a regulatory Brogram effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674). The amendment of the said rules and regu lations was proposed by the Industry Committee, established under the said amended marketing agreement and mittee, the following information with respect to each such shipment; Pro vided, That such reports shall not be re quired on shipments of adjacent market peaches which are exempt from inspec tion pursuant to 918.64: (1) Name and address of the handler; and date; (2) Originating point; (3) Destination in adjacent markets; (4) Truck license number, trailer li cense number, or other identification of the conveyance in which shipment was made; , , ,. , (5) Number of bushels so shipped; () The number of the inspection certificate or memorandum issued with respect to the shipment; and (7) A certification that the informa tion is complete and accurate. lb) Each handler who ships, in new containers, adjacent market peaches which do not meet the current regula tions for nonadjacent markets issued pursuant to 918.60(b) shall (1) stamp or print on the ends or sides of such containers in letters not less than onehalf inch in height "For Sale in Adjacent Pursuant to this grandfather clause, a. 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 or deleterious substance'* in violation of section 402(a) (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 approvals. The U.S. Department of Agri culture has similarly granted many sanc tions and approvals. Not all of these sanctions and approvals can be ascer tained because of the destruction of old records and the retirement of personnel Involved in these matters. The Food and Drug Administration has requested in formation on prior sanctions (35 F.R. 5810) in an effort to make its files on these matters more complete. FEDERAL REGISTER, VCL. 37, NO. 157-- SATURDAY, AUGUST 12, 1972 -RsaasB^^ii iy . ife: '.- / .: . . -liti ! - ` 16408 PROPOSED RULE M A K IN G Whether or not a food ingredient is used 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 121.101(1) 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 in talc used to coat rice. Independent laboratory investigation by the Food 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 carcino genic when inhaled and asbestos-form particles may therefore be injurious to 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 ure generally recognized as safe. A greem ent C A B 23184 R esolution T itle R - l ................. 002.................... R - i ................ 1U5<PAC)20:> 205 (P A C )2 0 , 3U5 iP A C )2 0 3 JT 12 (5PAC)20n JT 23 <5PAC)203 JT31 (5PA O 203 JT123 (5PA O 203. R evakdation. R esolu tio n -S ales Agency R ules, Inclusive T ours Initiated by T o u r O perators. R ed u c ed F ares for Passenger A gents (E xcept U .S.A .) (A m endiog). 2. Subpart E of Part 121 is amended as follows: a. The title of Subpart E is revised to read, "Subpart E--Prior-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. (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 priorsanctioned food ingredient may be in jurious to health, and thus is in violation of section 402(a) (1) of the act, the Com missioner will establish or amend the applicable prior sanction regulation to impose whatever limitations or condi tions are necessary for the safe use of the ingredient, or to prohibit use of the ingredient. 121.2006 Talc. (a) Talc is a naturally occurring hy drous magnesium silicate for which no food grade specifications exist. Talc is subject to a prior sanction for use in coating polished rice. (b) Talc containing asbestos-form 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 be deemed to be adulterated in violation of section 402(a) (1) of the Act. Interested persons may, within 60 days after publication hereof in the F ederal R egister, file with the Hearing Clerk, Department of Health, Education, and Welfare, Room 6-88, 5600 Fishers Lane, Rockville, Md. 20852, written comments (preferably in quintuplicate) 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: August 1,1972. S am D. F in e, Associate Commissioner for Compliance [FR Doc.72-12714 Filed 8 -ll-7 2 ;8 :4 5 am] FEDERAL RESERVE SYSTEM ; E 12 CFR Part 226 ] [Reg. Z] ' TRUTH INLENDING ; Credit Cards; Issuance and Liability] 1. Pursuant to the authority contained] in the Truth in Lending Act (15 U.S.CLi 1601 et seq.), the Board of Governors"] proposes to amend Part 226 (Regulation] Z) in the manner and for the reasons'1 set forth below: I Amend 226.13 (a) (4) and (b) to read.1 as follows: -1 2 2 6 .1 3 C redit cards-- issuance and.; liability. ^ (a) Supplemental definitions applica-t He to this section. * * * J (4) "Cardholder" means any natural^ person or organization to whom a crdita card is issued for personal, family! household, agricultural, business, 3 commercial purposes, or any natural per-1 son or organization who has agreed witl$ the card issuer to pay obligations arising: from the issuance of a credit card td another person for such purposes. f ***** s (b) Issuance of credit cards. Regard-3 less of whether a credit card is to be usedj for personal, family, household, agricul-i tural, business, or commercial purposes;*] no credit card shall be issued to a natu ral person or organization except: (1) In response to a request or appli-3 cation therefor, or (2) As a renewal of, or in substitute . for, an accepted credit card whether suelnl card is issued by the same or a successor;! card issuer. 2. Considerable uncertainty has pre-^ vailed as to whether the exemption in.]) 226.3 of Regulation Z for extensions oi credit for business and commercial pur-; poses applies to the unsolicited issuance of credit cards and to the limits on liabil ity for their unauthorized use. The puspose of these proposed amendments is tor; make clear that all credit cards, regard.: less of use or cardholder status, are cov-il ered by the maximum liability limit and,"| by the same token, may not be distrib^ uted without an initial request from, the*" cardholder. These amendments would^ not affect the application of the business exemption to the disclosure, rescission,; and advertising requirements of Reguiation Z for which it was originally , intended. This notice is published pursuant to- section 553 Cb) of title 5, United States^ FEDERAL REGISTER, VOL. 37, NO. 157-- SATURDAY, AUGUST 2 , 1972