Document wDdmnGdORyVyjZbmDpOJmvxE3

FILE NAME Talc TALC DATE 1972 DOC TALC072 DOCUMENT DESCRIPTION Federal Register Notice ~ PROPOSED RULE MAKING 16407 ot however modify or abridge a party's Ight to any proceeding authorized by his part or by Chapter 46 of Title 42 of he United States Code order as the agency to administer the terms and provisions thereof The proposed amendment is designed to establish safeguards pursuant to $ 918.60 to prevent new containers Markets Only along with the handler's name and address and 2 have such fruit so shipped inspected as provided in 918.64 Dated August 9 1972 17.72 Finality of the proceedings Determinations and findings of fact nade by the Administration shall be final and conclusive if supported by substan- ial evidence upon all applicants or rantees in a compliance hearing under 17.31 or in an adjudicative hearing mder $ 17.33 or upon all parties in n administrative investigation under 17.32 except that a subsequent hearing hall constitute a trial de novo on the acts in a rehearing under 17.34 or in hearing under a petition for judicial eview except that the Administration may make new or modified findings or eterminations pursuant to 42 U.S.C. Section 3759 upon remand from a burt Such new or modified findings or feterminations when filled in the re- nanding court shall likewise be final and conclusive if supported by substantial widence 17.74 17.74 Limitation of > aminer's authority the hearing ex- ecommendations A hearing examiner may reopen a proceeding at any time prior to his submission of recommendations to the Administration After submission of his the hearing exami- der's jurisdiction is terminated except for the correction of clerical errors How- wer the Administration at its own disretion may remand a proceeding to a fearing examiner for further inquiry ifter the presentation of recommendaHons and before the making of determi- of bulk peaches which fail to meet re- quirements for shipment to markets other than the adjacent markets issued under 918.60 from being shipped to nonadjacent markets Until recently ungraded peaches shipped in bulk to adjacent markets were packed in used con- tainers which were readily distinguishable from peaches packed for shipment to nonadjacent markets Recently un- graded peaches for shipment to adjacent markets have been packed in new Duall and similar containers These new handling and packaging practices make it relatively simply to divert ungraded peaches meeting only the adjacent markets 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 All persons who desire to submit writ- ten data views or arguments for consideration in connection with the proposed 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 FEDERAL REGISTER 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 The proposal would be implemented CHARLES R. BRADER Acting Deputy Director Fruit and Vegetable Division Agri- cultural Marketing Service FR Doc.72-12809 Filed 8-11-72 am DEPARTMENT OF HEALTH - EDUCATION AND WELFARE Food and Drug Administration 21 CFR Part 121 FOOD ADDITIVES 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 without approval of a food additive regulation on the ground either that they are generally recognized as safe GRAS or that they are subject to a prior sanction The Commissioner has already published proposed procedures for the affirmation of GRAS status or the determination of food additive status It is therefore appropriate to establish comparable procedures for the regulation of ingredients subject to prior sanctions Section 201 of the Federal Food Drug and Cosmetic Act excludes from nations and findings of fact JERRIS LEONARD Administrator OREM Administrator Law Enforcement Assistance Administration by amending 918.130 Peaches shipped to adjacent markets to read as follows 918.130 Peaches shipped to adjacent markets 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 - FF R R Doc.72-12641 Filed 8-11-72 am Nge DEPARTMENT DEDPARTMENET PARTMENT OF AGRICULTURE et Agricultural Marketing Service Shey 7 CFR Part 918 1 OE HANDLING OF FRESH PEACHES Soo WB, GROWN IN GEORGIA ML, Beaches Shipped to Adjacent Markets a 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- mittee the following information with respect to each such shipment Provided That such reports shall not be required on shipments of adjacent market peaches which are exempt from inspection pursuant to 918.64 1 Name and address of the handler and date 2 Originating point 21 U.S.C. 451 and the following or Meat Inspection Act of March 4. 1907 Stat 1260 as amended and extended U.S.C. 71 and the following the 34 21 7 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 misbranding provisions of the Act and in particular may be banned from food if found to be a poisonous or deleterious Notice Beaches is hereby given that the De- partment is considering a proposed mendment as hereinafter set forth to the rules and regulations Subpart dustry Committee Regulations 7 CFR 18.100-918.131 currently in effect pur- suant to the applicable provisions of the marketing agreement as amended and Order No. 918 as amended 7 CFR Part 918 regulating the handling of peaches grown in Georgia This is a regulatory program effective under the Agricultural Marketing Agreement Act of 1937 as ^^//mmeennddemdent iations 7 U.S.C. 601-674 The of the said rules and regu- was proposed by the Industry Committee established under the said amended marketing agreement and 3 Destination in adjacent markets 4 Truck license number trailer license number or other identification of the conveyance in which shipment was made 5 Number of bushels so shipped 6 The number of the inspection certificate or memorandum issued with respect to the shipment and 7 A certification that the information is complete and accurate b Each handler who ships in new containers adjacent market peaches which do not meet the current regulations for nonadjacent markets issued pursuant to 918.60 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 substance in violation of 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 approvals The U.S. Department of Agriculture has similarly granted many sanctions 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 information on prior sanctions 35 F.R. 5810 in an effort to make its files on these matters more complete FEDERAL REGISTER VOL 37 NO SATURDAY AUGUST 12 1972 ot scan oneagy HMEEY cog ee PROPOSED RULE MAKING Whether or not a food ingredient is used 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 ingredients 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 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 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 an FDA opinion letter for use as an antisticking agent forms used in molding various food shapes Talc is 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 carcinogenic when inhaled and asbestos particles may therefore be injurious to health when ingested and since talc can be processed to remove asbestos particles it is prudent to require that 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 Act secs 201 409 701 52 Stat 1055 and 72 Stat 1784-88 as amended 21 U.S.C. 321 348 371 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 particles after the word talc 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 Title R R- 002_ 002_ 203 105 PAC 205 PAC 305 PAC JT12 5PAC JT23 5PAC JT31 5PAC JT123 5PAC 203 Revahdation ResoluSales Agency Rules Inclusive 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 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 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 evi- dence to show that it falls within section 201 4 of the act b Based upon scientific or information 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 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 particles may be injurious to health Ac- cordingly any food or food material containing talc that of asbestos particles packaging is not free shall be deemed to be adulterated in violation of section 402 1 of the Act Interested persons may within 60 days after publication hereof in the FEDERAL REGISTER 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 SAM D. FINE Associate Commissioner for Compliance FR Doc.72-12714 Filed 8-11-72 am FEDERAL RESERVE SYSTEM 12 CFR Part 226 Reg Z TRUTH IN LENDING ; Credit Cards Issuance and Liability 1. Pursuant to the authority contained in the Truth in Lending Act 15 U.S.C 1601 et seq the Board of Governors Regulation proposes to amend Part 226 Z in the manner and for the reasons set forth below . Amend 226.13 a 4 and b to as follows 226.13 Credit liability issuance and 3 a applica- ' a Supplemental definitions ble to this section * * * 4Ade 4 Cardholder means any natural person or organization to whom a credit card is issued for personal family household agricultural business commercial purposes or any natural per- son or organization who has agreed with the card issuer to pay obligations arising from the issuance of a credit card another person for such purposes * * * * * b Issuance of credit cards Regardless of whether a credit card is to be used for personal family household agricultural business or commercial purposes no credit card shall be issued to a natural person or organization except 1 In response to a request or application therefor or 2 As a renewal of or in substitutions for an accepted credit card whether such card is issued by the same or a successor card issuer * * * * * 2. Considerable uncertainty has prevailed as to whether the exemption in 226.3 of Regulation Z for extensions of 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 purpose of these proposed amendments is to make clear that all credit cards regardless of use or cardholder status are covered by the maximum liability limit and by the same token may not be distributed without an initial request from the 3% cardholder These amendments would not affect the application of the business- exemption to the disclosure rescission and advertising requirements of Regulation Z for which it was originally- sy intended This notice is published pursuant tosection 553 of title 5 United States FEDERAL REGISTER VOL 37 NO SATURDAY AUGUST 12 1972