Document nkLDMZRKmO9767EvKVzQLZvL1

RULES AND REGULATIONS 12737 plicate. shall be filed within the 48 hours ' Title 21--Food end Drugs sanctloned Ingredients used In food pack with the district director at the Customs CHAPTER I--FOOD AND DRUG ADMINIS aging which are in cmtact with food, and port of entry nearest the U.S. port of TRATION, DEPARTMENT F HEALTH, consequently may become an Indirect destination. EDUCATION, AND WELFARE adulterant of food, are not excluded from (f) Within 80 days after the date of SUBCHAPTER a--FOOD AnO FOOD PRODUCTS regulation under section 402 of the act. mailing or personal delivery to a withdrawer of two copies of the consolidated PART 121--FOOD ADDITIVES 3. Expansion of subpart E under part 121 is intended to provide a listing of all report of all withdrawals under a given Subpart E--Prior-Sanctioned Food known prlor-sanctloned food Ingredients. warehouse entry, the wlthdrawer shall Ingredients Whether a food ingredient Is used as a sign the Certificate of Use on one copy of the report, return It to the district director together with a satisfactory documented reconciliation of all discrep ancies, and file a duty-paid withdrawal for any of the fuel not properly ac counted for. The other copy of the con solidated report shall be retained by the wlthdrawer. A Customs Form 7309 is not required with a duty-paid withdrawal. Customs Form 7505, filed In connection with the reconciliation. Oil Import li censes shall be charged when appro priate. (g) The certificate of use shall read as follows; I hereby certify that the fuel Indicated above, with the exceptions as noted, (1) was laden for use as supplies tor aircraft oper ated by the United States, or (3) was laden aboard an aircraft registered in the United States and, as reported to us by the respec tive airline, actually engaged In foreign trade or trade between the United States and any of Its possessions, or (3) was laden for use as suppUea for an aircraft registered In any foreign oountry where trade by foreign air craft la permitted, entitled to the reciprocal prlvUeges as provided in section 300(d) of the Tariff Act of 1930, as amended (19 U.S.C, 1309 (d)), and, as reported to us by the re spective airlines, actually engaged in foreign trade or trade between the United states and any of Its possessions, or (4) was laden board foreign military aircraft In accord ance with item 841.20 of the Tariff Schedules of the United States (19 U.S.C. 1303), on the basis of reciprocity. (h) The district director, upon written application, may extend the 60-day pe A proposal was published In the Fed eral Register of August 12, 1972 (37 FR 16407) to provide for regulation of prlorsanctioned ingredients by revising the title of subpart E of the food additive regulations and establishing general pro visions applicable to prior-sanctioned In gredients. Four comments were received in re sponse to this proposal. All four com ments were primarily concerned with the legality of regulating prlor-sanctloned food Ingredients and with providing pro cedural safeguards within the proposed regulation. Specific comments were that the exemption from food additive status of prlor-sanctloned ingredients set forth In the Federal Food, Drug, and Cosmetic Act section 201 (s) (4) cannot be changed as set forth in the proposal; that absence from listing under subpart E of 21 CFR part 121 cannot affect the prior-sanc tioned status of food ingredients; that food packaging materials employing prlor-sanctloned Ingredients cannot be considered food under section 402(a) (1) of the act; and that procedural safe guards permitting opportunity to submit additional evidence of safety of prlorsanctloned Ingredients before a proposal to change Its status, and a 60-day com ment period and opportunity for public hearing, should be Included In the reg ulation for any proposed or final regula tions generated from review of prlorsanctloned Ingredients. Having evaluated the comments and 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. Accordingly, the Food and Drug Administration will publish In this subpart all known prlor-sanctloned di rect and indirect food ingredients and any subsequent limitations placed upon the use of the Ingredient when scientific data Justifies such limitations. It Is ac knowledged that not all known priorsanctions are presently listed In this sub part. This will be remedied by publica tion of the prior-sanction status of those ingredients supplied In response to the Food and Drug Administration's request for Information on prior sanctions (35 FR 5810) and as requests for affirmation of the safety of prlor-sanctloned Ingredi ents are acted upon. 4. The respondents requesting pro cedural safeguards to permit submission of additional evidence of safety prior to any Food and Drug Administration pro posal to place limitations an the use of a prlor-sanctloned Ingredient, Is not feasi ble. The Food and Drug Administration does not have a file of all users of prlor- sanctloned ingredients. It Is suggested that anyone who has significant safety Information on a prlor-sanctloned In gredient submit such evidence to the Food and Drug Administration now, or as It becomes available to them, or as tfiey request affirmation of the safety of the prlor-sanctloned Ingredients. Publication of a proposal to place limitations on the riod for the filing of the documents and other relevant Information, the Commis use of a prlor-sanctloned ingredient will, any deposit of duties required under par sioner concludes as follows: In any event, provide for submission of agraph (f) of this section, if the dis 1. There is no merit to the argument such information. trict director Is satisfied that the wlth that prlor-sanctloned food ingredients The request for other procedural safe drawer has been or will be prevented by are exempt from safety evaluation under guards, including statements that Inter circumstances beyond his control from the adulteration provisions of the act. ested persons may comment within 60 filing the documents and depositing the such Ingredients are poisonous or del- days upon publication of any proposal to duties within the 60-day period. definition of "food additive" under sec change the regulatory status of a prlor- (1) For purposes of this section, a tion 201(B)(4) of the act but are sub sanctloned Ingredient and adversely US.-registered aircraft chartered and ject to all the requirements of section affected persons may have a right to re operated by a foreign airline shall be 402. Subpart E, as promulgated by this quest a hearing on any consequent final deemed to be a foreign-registered air order, will Incorporate the Commission order, are governed by the provisions of craft. The country of registry (fiag) of er's determinations with respect to the the act and the Administrative Procedure the aircraft shown on the Bonded Fuel safety of prlor-sanctloned Ingredients In Act. The Commissioner Is presently con Control Card, Customs Form 7309, shall accordance with section 402 of the act. sidering a revision of all Food and Drug be the country code of the foreign airline. 2. Section 701(a) of the act Is sufficient legal authority to permit promulgation of Administration procedural regulations, which will deal with these matters with (Sec. 309, 40 Stat. 690. as amended: 19 U.S.C. regulations determining the safety of respect to all regulations Issued under 1309): HA. 251, as amended, sec. 309, 46 Stat. prlor-sanctloned direct and indirect food section 701(a) of the act. 690, sec. 624. 46 Stat. 769; 19 UA.C. 66, 1309, 1634.) ingredients, Including a finding that any such Ingredients are poisonous or del Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic (PR Doc.73-9600 Filed 5-14-73:8:46 am) eterious adulterants of food. Prlor- Act (secs. 201 (s), 409, 701(a), 52 Stat. FtDOAl HOISTER, vot, 36, NO. 91--TUESDAY, MAY 18, 1979 ASI 00003315 ft J2738 RULES AND REGULATIONS \l loss and 72 Stat. 1784-58. as amended; 21 UJB.C. 321(s), 348, 371(a) > and under authority delegated to the Commissioner (21 CFR 2.L20), subpart E of part 121 la amended as follows: 1. Die title of subpart E Is revised to read. "Subpart E--Prior-Sanctioned Food Ingredients." 2. section 121.2001 is redesignated as i 121.2005 and a new i 121.2000 is added to read as follows: 121.2000 General. (a) An Ingredient whose use in food or food packaging is subject to a prior sanc tion or approval within the meaning of section 201(e) (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(e)(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 in violation of section 402 of the act, the Commis sioner will establish or amend an appli cable prior sanction regulation to Impose whatever limitations or conditions are necessary for the safe use of the Ingredi ent, or to prohibit use of the Ingredient. Effective date.--This regulation shall become effective June 14,1973. (Secs. 201(a), 409, 701(e), 52 Stat. 1065 and 72 Stat. 17B4-1788, as amended; 21 U.S.C. 331(e) .948.371 (a).) Dated May 10,1973. 8am D. Fine, Associate Commissioner for Compliance. [FH Doc.73-0621 Filed 5-14-73:8:45 amj PART 121--FOOD ADDITIVES Subpart F--Food Additives Resulting From Contact With Containers or Equipment and Food Additives Otherwise Affecting Food Resinous and Polymeric Coatings The Commissioner of Food and Drugs, having evaluated data in a petition (FAP 2B2812J filed by PPG Industries, Inc, P.O. Box 312, Delaware, Ohio 43015, and other relevant material, concludes that the food additive regulations should be amended as set forth below to provide for the additional safe use of the butyl acrylate - styrene - methacryllc acid-hydroxyethyl methacrylate copolymers specified In the regulations as a repair surface for coatings intended to contact food. Therefore, pursuant to provisions of the Federal Food. Drug, and Cosmetic Act (sec. 409(e)(1), 72 Stat. 1786; 21 UJB.C. 348(c)(1)) and under authority CiriCAeto OF CONOREES OTHEN THAN nu fedeml, food, MU* and cosmetic Ji delegated to the Commissioner (21 CFR PART 295--REGULATIONS UNDER THE 2.1E0). part 121 (21 CFR part 121) as amended In {121.2514 in paragraph (b> POISON PREVENTION PACKAGING ACT OF 1970 (3) (xx> by revising the Item beginning Modification of the Testing Procedure for "Butyl acrylate - styrene methacryllc Special Packaging acld-hydroxyethyl methacrylate copoly In the Federal Rinisrra of January 15, mers * * *" to read as follows: 1973 (38 FR 1510), the Commissioner of 9 121.2514 Reelnmu end poijmerie coat Food and Drugs proposed to modify the ings. testing procedure for special packag ing (21 CFR 295.10(a) (3)) to change (b) * * (3) * * (xx) * * * Butyl eerylate-Htyrene-msthacrylic acldbydraxyethyl methacrylate copolymer* con taining no more than 20 weight percent of total polymer unite derived from methacryllc acid end containing no more *h the definition of a unit packaging test failure to any child who opens or gains access to the number of Individual units which constitute the amount that may produce serious personal Injury or seri ous illness, or a child who opens or gains access to more than 8 Individual units, whichever number is lower. At that time, the maximum number of Individual units T weight percent of total polymer unite constituting a test failure was more than derived from hydroxyethyl methacrylate; 5. for use only In coatings or surface repair coating!! that are applied by electrodepo-' sltion to metal subetratea as fallows: 1. In coatings that are Intended for con tact with food containing no more than 8 percent alcohol under condition* of use D, E.F, or described In table 2 of 1121.2514 Three comments were received in re sponse to the proposal, A pharmaceu tical manufacturer and a pharmaceutical trade association support the proposal and a city government agency does not. The city government agency ( <d). that the modification will reduce the 2. In surface repair coatings, provided that the repaired surface area In oontaet with food does not exceed 3 percent of the sur face area of the container part being re paired. . degree of child protection provided by special packaging because although the amount of substance which would pro duce serious Injury or prevails in. establishing the number of units con * * * a stituting a test failure, determining Any person who will be adversely af amount for all children la difficult doe fected by the foregoing order may at any to varying factors such as age and medi time on or before June 14,1973, file with cs* history. the Hearing Clerk, Department of The Commissioner, however, previ Health, Education, and Welfare, room 9~ ously acknowledged that variables exist 88, 5808 Fishers Lane, Rockville, Md. in establishing the amount of substance 20852, written objections thereto. Ob which would produce serious injury or jections shall show wherein the person filing will be adversely affected by the or der, specify with particularity the provislona of the order deemed objectionable, and state the grounds for the objections. If a hearing is requested, the objections Illness. Accordingly, {295.10(a)(3) (21 CFR 299.10) specifies that the determi nation of such amount shall be based on a 25-pound child. Dlls weight repre sents the average 2-year-old child, the shall state the issues for the hearing, age most prone to accidental ingestions. shall be supported by grounds factually The present maximum test failure level and legally sufficient to justify the relief sought, and shall Include a detailed de scription and analysis of the factual In formation intended to be presented In support of the objections in the event of 5 was established to provide the pack aging industry with parameters within which to develop unit packaging, but it has been found to be unnecessarily re that a hearing Is held. Objections may be strictive and has thus tended to stifle accompanied by a memorandum or brief industry Initiative in this area. This is In support thereof. Six'copies of all docu ments shall be filed. Received objections may be seen, in the above office during undesirable since unit packaging has the potential for being an effective form of working hours, Monday through Friday. child.protection packaging for many ap Effective date.--This order shall be come effective May 15,1973. (Sec. 409(c)(1), 72 Stat. 1788; 21 U-S.C. 348 (c)(1).) Dated May 8,1973. plications, particularly In the drug field. Having considered the comments, the Commissioner concludes that the pro posed modification win not reduce or compromise the child protection prop erties of special unit packaging. The ulti Sam D. Fine. Associate Commissioner for Compliance. mately controlling factor In determining the test failure level In the case of unit packaging remains the number ol in [FRDOC.73-9543 Filed 5-14-73:8:45 am] dividual units which constitute the FIQIAAL Ktlltit, VOL. 3, NO. J--TUESDAY, MAY 15, 1923 ASI 00003316