21 U.S.C. § 379e — Listing and certification of color additives

Page 515 TITLE 21—FOOD AND DRUGS § 379e PART B—COLORS § 379e. Listing and certification of color additives for foods, drugs, devices, and cosmetics (a) Unsafe color additives A color additive shall, with respect to any par- ticular use (for which it is being used or in- tended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics, be deemed unsafe for the purposes of the applica- tion of section 342(c), 351(a)(4), or 361(e) of this title, as the case may be, unless— (1)(A) there is in effect, and such additive and such use are in conformity with, a regula- tion issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or (2) such additive and such use thereof con- form to the terms of an exemption which is in effect pursuant to subsection (f) of this sec- tion. While there are in effect regulations under sub- sections (b) and (c) of this section relating to a color additive or an exemption pursuant to sub- section (f) with respect to such additive, an arti- cle shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be consid- ered adulterated within the meaning of clause (1) of section 342(a) of this title if such article is a food, or within the meaning of section 361(a) of this title if such article is a cosmetic other than a hair dye (as defined in the last sentence of sec- tion 361(a) of this title). A color additive for use in or on a device shall be subject to this section only if the color additive comes in direct con- tact with the body of man or other animals for a significant period of time. The Secretary may by regulation designate the uses of color addi- tives in or on devices which are subject to this section. (b) Listing of colors; regulations; issuance, amendment or repeal; referral to advisory committee; report and recommendations; ap- pointment and compensation of advisory committee (1) The Secretary shall, by regulation, provide for separately listing color additives for use in or on food, color additives for use in or on drugs, or devices, and color additives for use in or on cosmetics, if and to the extent that such addi- tives are suitable and safe for any such use when employed in accordance with such regulations. (2)(A) Such regulations may list any color ad- ditive for use generally in or on food, or in or on drugs or devices, or in or on cosmetics, if the Secretary finds that such additive is suitable and may safely be employed for such general use. (B) If the data before the Secretary do not es- tablish that the additive satisfies the require- ments for listing such additive on the applicable list pursuant to subparagraph (A) of this para- graph, or if the proposal is for listing such addi- tive for a more limited use or uses, such regula- tions may list such additive only for any more limited use or uses for which it is suitable and may safely be employed. (3) Such regulations shall, to the extent deemed necessary by the Secretary to assure the safety of the use or uses for which a particular color additive is listed, prescribe the conditions under which such additive may be safely em- ployed for such use or uses (including, but not limited to, specifications, hereafter in this sec- tion referred to as tolerance limitations, as to the maximum quantity or quantities which may be used or permitted to remain in or on the arti- cle or articles in or on which it is used; speci- fications as to the manner in which such addi- tive may be added to or used in or on such arti- cle or articles; and directions or other labeling or packaging requirements for such additive). (4) The Secretary shall not list a color addi- tive under this section for a proposed use unless the data before him establish that such use, under the conditions of use specified in the regu- lations, will be safe: Provided, however, That a color additive shall be deemed to be suitable and safe for the purpose of listing under this sub- section for use generally in or on food, while there is in effect a published finding of the Sec- retary declaring such substance exempt from the term ‘‘food additive’’ because of its being generally recognized by qualified experts as safe for its intended use, as provided in section 321(s) of this title. (5)(A) In determining, for the purposes of this section, whether a proposed use of a color addi- tive is safe, the Secretary shall consider, among other relevant factors— (i) the probable consumption of, or other rel- evant exposure from, the additive and of any substance formed in or on food, drugs or de- vices, or cosmetics because of the use of the additive; (ii) the cumulative effect, if any, of such ad- ditive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or sub- stances in such diet; (iii) safety factors which, in the opinion of experts qualified by scientific training and ex- perience to evaluate the safety of color addi- tives for the use or uses for which the additive is proposed to be listed, are generally recog- nized as appropriate for the use of animal ex- perimentation data; and (iv) the availability of any needed prac- ticable methods of analysis for determining the identity and quantity of (I) the pure dye and all intermediates and other impurities contained in such color additive, (II) such ad- ditive in or on any article of food, drug or de- vice, or cosmetic, and (III) any substance formed in or on such article because of the use of such additive. (B) A color additive (i) shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such ad- ditive, if the additive is found by the Secretary to induce cancer when ingested by man or ani- mal, or if it is found by the Secretary, after Page 516 TITLE 21—FOOD AND DRUGS § 379e tests which are appropriate for the evaluation of the safety of additives for use in food, to induce cancer in man or animal, and (ii) shall be deemed unsafe, and shall not be listed, for any use which will not result in ingestion of any part of such additive, if, after tests which are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found by the Secretary to induce cancer in man or animal: Provided, That clause (i) of this sub- paragraph (B) shall not apply with respect to the use of a color additive as an ingredient of feed for animals which are raised for food production, if the Secretary finds that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in prac- tice, such additive will not adversely affect the animals for which such feed is intended, and that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regula- tions shall not be subject to subsection (d)) in any edible portion of such animals after slaugh- ter or in any food yielded by or derived from the living animal. (C)(i) In any proceeding for the issuance, amendment, or repeal of a regulation listing a color additive, whether commenced by a pro- posal of the Secretary on his own initiative or by a proposal contained in a petition, the peti- tioner, or any other person who will be ad- versely affected by such proposal or by the Sec- retary’s order issued in accordance with para- graph (1) of section 371(e) of this title if placed in effect, may request, within the time specified in this subparagraph, that the petition or order thereon, or the Secretary’s proposal, be referred to an advisory committee for a report and rec- ommendations with respect to any matter aris- ing under subparagraph (B) of this paragraph, which is involved in such proposal or order and which requires the exercise of scientific judg- ment. Upon such request, or if the Secretary within such time deems such a referral nec- essary, the Secretary shall forthwith appoint an advisory committee under subparagraph (D) of this paragraph and shall refer to it, together with all the data before him, such matter aris- ing under subparagraph (B) for study thereof and for a report and recommendations on such mat- ter. A person who has filed a petition or who has requested the referral of a matter to an advisory committee pursuant to this subparagraph (C), as well as representatives of the Department, shall have the right to consult with such advisory committee in connection with the matter re- ferred to it. The request for referral under this subparagraph, or the Secretary’s referral on his own initiative, may be made at any time before, or within thirty days after, publication of an order of the Secretary acting upon the petition or proposal. (ii) Within sixty days after the date of such re- ferral, or within an additional thirty days if the committee deems such additional time nec- essary, the committee shall, after independent study of the data furnished to it by the Sec- retary and other data before it, certify to the Secretary a report and recommendations, to- gether with all underlying data and a statement of the reasons or basis for the recommendations. A copy of the foregoing shall be promptly sup- plied by the Secretary to any person who has filed a petition, or who has requested such refer- ral to the advisory committee. Within thirty days after such certification, and after giving due consideration to all data then before him, including such report, recommendations, under- lying data, and statement, and to any prior order issued by him in connection with such matter, the Secretary shall by order confirm or modify any order theretofore issued or, if no such prior order has been issued, shall by order act upon the petition or other proposal. (iii) Where— (I) by reason of subparagraph (B) of this paragraph, the Secretary has initiated a pro- posal to remove from listing a color additive previously listed pursuant to this section; and (II) a request has been made for referral of such proposal to an advisory committee; the Secretary may not act by order on such pro- posal until the advisory committee has made a report and recommendations to him under clause (ii) of this subparagraph and he has con- sidered such recommendations, unless the Sec- retary finds that emergency conditions exist ne- cessitating the issuance of an order notwith- standing this clause. (D) The advisory committee referred to in sub- paragraph (C) of this paragraph shall be com- posed of experts selected by the National Acad- emy of Sciences, qualified in the subject matter referred to the committee and of adequately di- versified professional background, except that in the event of the inability or refusal of the Na- tional Academy of Sciences to act, the Sec- retary shall select the members of the com- mittee. The size of the committee shall be deter- mined by the Secretary. Members of any advi- sory committee established under this chapter, while attending conferences or meetings of their committees or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Sec- retary but at rates not exceeding the daily equivalent of the rate specified at the time of such service for grade GS–18 of the General Schedule, including traveltime; and while away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Govern- ment service employed intermittently. The members shall not be subject to any other provi- sions of law regarding the appointment and compensation of employees of the United States. The Secretary shall furnish the committee with adequate clerical and other assistance, and shall by rules and regulations prescribe the procedure to be followed by the committee. (6) The Secretary shall not list a color addi- tive under this subsection for a proposed use if the data before him show that such proposed use would promote deception of the consumer in vio- lation of this chapter or would otherwise result in misbranding or adulteration within the mean- ing of this chapter. (7) If, in the judgment of the Secretary, a tol- erance limitation is required in order to assure that a proposed use of a color additive will be safe, the Secretary— Page 517 TITLE 21—FOOD AND DRUGS § 379e (A) shall not list the additive for such use if he finds that the data before him do not estab- lish that such additive, if used within a safe tolerance limitation, would achieve the in- tended physical or other technical effect; and (B) shall not fix such tolerance limitation at a level higher than he finds to be reasonably required to accomplish the intended physical or other technical effect. (8) If, having regard to the aggregate quantity of color additive likely to be consumed in the diet or to be applied to the human body, the Secretary finds that the data before him fail to show that it would be safe and otherwise permis- sible to list a color additive (or pharmacologi- cally related color additives) for all the uses proposed therefor and at the levels of concentra- tion proposed, the Secretary shall, in deter- mining for which use or uses such additive (or such related additives) shall be or remain listed, or how the aggregate allowable safe tolerance for such additive or additives shall be allocated by him among the uses under consideration, take into account, among other relevant factors (and subject to the paramount criterion of safe- ty), (A) the relative marketability of the arti- cles involved as affected by the proposed uses of the color additive (or of such related additives) in or on such articles, and the relative depend- ence of the industries concerned on such uses; (B) the relative aggregate amounts of such color additive which he estimates would be consumed in the diet or applied to the human body by rea- son of the various uses and levels of concentra- tion proposed; and (C) the availability, if any, of other color additives suitable and safe for one or more of the uses proposed. (c) Certification of colors The Secretary shall further, by regulation, provide (1) for the certification, with safe dil- uents or without diluents, of batches of color ad- ditives listed pursuant to subsection (b) and con- forming to the requirements for such additives established by regulations under such sub- section and this subsection, and (2) for exemp- tion from the requirement of certification in the case of any such additive, or any listing or use thereof, for which he finds such requirement not to be necessary in the interest of the protection of the public health: Provided, That, with respect to any use in or on food for which a listed color additive is deemed to be safe by reason of the proviso to paragraph (4) of subsection (b), the re- quirement of certification shall be deemed not to be necessary in the interest of public health protection. (d) Procedure for issuance, amendment, or re- peal of regulations The provisions of section 371(e), (f), and (g) of this title shall, subject to the provisions of sub- paragraph (C) of subsection (b)(5) of this section, apply to and in all respects govern proceedings for the issuance, amendment, or repeal of regu- lations under subsection (b) or (c) of this section (including judicial review of the Secretary’s ac- tion in such proceedings) and the admissibility of transcripts of the record of such proceedings in other proceedings, except that— (1) if the proceeding is commenced by the fil- ing of a petition, notice of the proposal made by the petition shall be published in general terms by the Secretary within thirty days after such filing, and the Secretary’s order (re- quired by paragraph (1) of section 371(e) of this title) acting upon such proposal shall, in the absence of prior referral (or request for refer- ral) to an advisory committee, be issued with- in ninety days after the date of such filing, ex- cept that the Secretary may (prior to such ninetieth day), by written notice to the peti- tioner, extend such ninety-day period to such time (not more than one hundred and eighty days after the date of filing of the petition) as the Secretary deems necessary to enable him to study and investigate the petition; (2) any report, recommendations, underlying data, and reasons certified to the Secretary by an advisory committee appointed pursuant to subparagraph (D) of subsection (b)(5) of this section, shall be made a part of the record of any hearing if relevant and material, subject to the provisions of section 556(d) of title 5. The advisory committee shall designate a member to appear and testify at any such hearing with respect to the report and rec- ommendations of such committee upon re- quest of the Secretary, the petitioner, or the officer conducting the hearing, but this shall not preclude any other member of the advi- sory committee from appearing and testifying at such hearing; (3) the Secretary’s order after public hearing (acting upon objections filed to an order made prior to hearing) shall be subject to the re- quirements of section 348(f)(2) of this title; and (4) the scope of judicial review of such order shall be in accordance with the fourth sen- tence of paragraph (2), and with the provisions of paragraph (3), of section 348(g) of this title. (e) Fees The admitting to listing and certification of color additives, in accordance with regulations prescribed under this chapter, shall be per- formed only upon payment of such fees, which shall be specified in such regulations, as may be necessary to provide, maintain, and equip an adequate service for such purposes. (f) Exemptions The Secretary shall by regulations (issued without regard to subsection (d)) provide for ex- empting from the requirements of this section any color additive or any specific type of use thereof, and any article of food, drug, or device, or cosmetic bearing or containing such additive, intended solely for investigational use by quali- fied experts when in his opinion such exemption is consistent with the public health. (June 25, 1938, ch. 675, § 721, formerly § 706, 52 Stat. 1058; Pub. L. 86–618, title I, § 103(b), July 12, 1960, 74 Stat. 399; Pub. L. 87–781, title I, § 104(f)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91–515, title VI, § 601(d)(2), Oct. 30, 1970, 84 Stat. 1311; Pub. L. 94–295, § 9(a), May 28, 1976, 90 Stat. 583; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–300, § 6(b)(2), June 16, 1992, 106 Stat. 240; renumbered § 721, Pub. L. 102–571, title I, § 106(4), Oct. 29, 1992, 106 Stat. 4498; Pub. L. 103–80, § 3(bb), Aug. 13, 1993, 107 Stat. 778.) Page 518 TITLE 21—FOOD AND DRUGS § 379e Editorial Notes CODIFICATION Section was formerly classified to section 376 of this title prior to renumbering by Pub. L. 102–571. In subsec. (d)(2), ‘‘section 556(d) of title 5’’ substituted for ‘‘section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))’’ on authority of Pub. L. 89–554, § 7(b), Sept. 6, 1966, 80 Stat. 631, the first section of which enacted Title 5, Government Organization and Employees. AMENDMENTS 1993—Subsec. (b)(5)(D). Pub. L. 103–80 substituted ‘‘section 5703’’ for ‘‘section 5703(b)’’. 1992—Subsec. (b)(5)(C)(i). Pub. L. 102–300 struck out ‘‘of Health, Education, and Welfare’’ after ‘‘representa- tives of the Department’’. 1976—Subsec. (a). Pub. L. 94–295, § 9(a)(2), (3), inserted reference to devices and inserted provisions directing that color additives for use in or on devices be subject to this section only if the color additives come in di- rect contact with the body of man or other animals for a significant period of time and authorizing the Sec- retary to designate by regulation the uses of color addi- tives in or on devices which are subject to this section. Subsec. (b). Pub. L. 94–295, § 9(a)(1), (2), substituted ‘‘drug or device’’ for ‘‘drug’’ and ‘‘drugs or devices’’ for ‘‘drugs’’ wherever appearing. Subsec. (f). Pub. L. 94–295, § 9(a)(1), substituted ‘‘drug or device’’ for ‘‘drug’’. 1970—Subsec. (b)(5)(D). Pub. L. 91–515 substituted pro- visions authorizing members of an advisory committee to receive compensation at rates fixed by the Sec- retary, with a specific maximum amount, and travel expenses, including per diem in lieu of subsistence, as authorized by section 5703(b) of Title 5, for provisions authorizing such members to receive as compensation a reasonable per diem for time actually spent on com- mittee work, and necessary traveling and subsistence expenses while serving away from their places of resi- dence. 1962—Subsec. (b)(5)(B). Pub. L. 87–781 provided that clause (i) of this subparagraph shall not apply to a color additive in feed of animals raised for food produc- tion, if under the conditions of use specified in proposed labeling, and which conditions are reasonably certain to be followed in practice, such additive will not ad- versely affect the animals and no residue will be found in any edible portion of such animal after slaughter or in any food from the living animal. 1960—Pub. L. 86–618 amended section generally. Prior to amendment, section read as follows: ‘‘The admitting to listing and certification of coal-tar colors, in accord- ance with regulations prescribed under this chapter, shall be performed only upon payment of such fees, which shall be specified in such regulations, as may be necessary to provide, maintain, and equip an adequate service for such purposes.’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1962 AMENDMENT Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title. EFFECTIVE DATE OF 1960 AMENDMENT, TRANSITIONAL PROVISIONS, AND EFFECT ON OTHER LAWS Pub. L. 86–618, title II, July 12, 1960, 74 Stat. 404, pro- vided that: ‘‘SEC. 201. [DEFINITIONS.] As used in this title, the term ‘basic Act’ means the Federal Food, Drug, and Cosmetic Act [this chapter]; the term ‘enactment date’ means the date of enactment of this Act [July 12, 1960]; and other terms, insofar as also used in the basic Act (whether before or after enactment of this Act) shall have the same meaning as they have, or had when in ef- fect, under the basic Act. ‘‘SEC. 202. [EFFECTIVE DATE.] This Act [amending this section and sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371 of this title and repealing sections 354 and 364 of this title] shall, subject to the provisions of section 203, take effect on the enactment date [July 12, 1960]. ‘‘SEC. 203. [PROVISIONAL LISTINGS OF COMMERCIALLY ESTABLISHED COLORS.] (a)(1) The purpose of this section is to make possible, on an interim basis for a reason- able period, through provisional listings, the use of commercially established color additives to the extent consistent with the public health, pending the comple- tion of the scientific investigations needed as a basis for making determinations as to listing of such addi- tives under the basic Act as amended by this Act. A provisional listing (including a deemed provisional list- ing) of a color additive under this section for any use shall, unless sooner terminated or expiring under the provisions of this section, expire (A) on the closing date (as defined in paragraph (2) of this subsection) or (B) on the effective date of a listing of such additive for such use under section 706 [now 721] of the basic Act, [this section], whichever date first occurs. ‘‘(2) For the purposes of this section, the term ‘clos- ing date’ means (A) the last day of the two and one-half year period beginning on the enactment date [July 12, 1960] or (B), with respect to a particular provisional listing (or deemed provisional listing) of a color addi- tive or use thereof, such later closing date as the Sec- retary may from time to time establish pursuant to the authority of this paragraph. The Secretary may by reg- ulation, upon application of an interested person or on his own initiative, from time to time postpone the original closing date with respect to a provisional list- ing (or deemed provisional listing) under this section of a specified color additive, or of a specified use or uses of such additive, for such period or periods as he finds necessary to carry out the purpose of this section, if in the Secretary’s judgment such action is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary for making a determination as to listing such additive, or such specified use or uses thereof, under section 706 [now 721] of the basic Act [this section]. The Secretary may terminate a post- ponement of the closing date at any time if he finds that such postponement should not have been granted, or that by reason of a change in circumstances the basis for such postponement no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other condi- tions attached to such postponement. ‘‘(b) Subject to the other provisions of this section— ‘‘(1) any color additive which, on the day preceding the enactment date [July 12, 1960], was listed and cer- tifiable for any use or uses under section 406(b), 504, or 604 [section 346(b), 354, or 364 of this title], or under the third proviso of section 402(c) [section 342(c) of this title], of the basic Act, and of which a batch or batches had been certified for such use or uses prior to the enactment date [July 12, 1960], and ‘‘(2) any color additive which was commercially used or sold prior to the enactment date [July 12, 1960] for any use or uses in or on any food, drug, or cosmetic, and which either, (A), on the day preceding the enactment date [July 12, 1960], was not a material within the purview of any of the provisions of the basic Act enumerated in paragraph (1) of this sub- section, or (B) is the color additive known as syn- thetic beta-carotene, shall, beginning on the enactment date [July 12, 1960], be deemed to be provisionally listed under this section as a color additive for such use or uses. ‘‘(c) Upon request of any person, the Secretary, by regulations issued under subsection (d), shall without delay, if on the basis of the data before him he deems such action consistent with the protection of the public health, provisionally list a material as a color additive for any use for which it was listed, and for which a batch or batches of such material had been certified, Page 519 TITLE 21—FOOD AND DRUGS § 379e under section 406(b), 504, or 604 of the basic Act [section 346(b), 354, or 364 of this title] prior to the enactment date [July 12, 1960], although such color was no longer listed and certifiable for such use under such sections on the day preceding the enactment date. Such provi- sional listing shall take effect on the date of publica- tion. ‘‘(d)(1) The Secretary shall, by regulations issued or amended from time to time under this section— ‘‘(A) insofar as practicable promulgate and keep current a list or lists of the color additives, and of the particular uses thereof, which he finds are deemed provisionally listed under subsection (b), and the presence of a color additive on such a list with re- spect to a particular use shall, in any proceeding under the basic Act, be conclusive evidence that such provisional listing is in effect; ‘‘(B) provide for the provisional listing of the color additives and particular uses thereof specified in sub- section (c); ‘‘(C) provide, with respect to particular uses for which color additives are or are deemed to be provi- sionally listed, such temporary tolerance limitations (including such limitations at zero level) and other conditions of use and labeling or packaging require- ments, if any, as in his judgment are necessary to protect the public health pending listing under sec- tion 706 [now 721] of the basic Act [this section]; ‘‘(D) provide for the certification of batches of such color additives (with or without diluents) for the uses for which they are so listed or deemed to be listed under this section, except that such an additive which is a color additive deemed provisionally listed under subsection (b)(2) of this section shall be deemed exempt from the requirement of such certification while not subject to a tolerance limitation; and ‘‘(E) provide for the termination of a provisional listing (or deemed provisional listing) of a color addi- tive or particular use thereof forthwith whenever in his judgment such action is necessary to protect the public health. ‘‘(2)(A) Except as provided in subparagraph (C) of this paragraph, regulations under this section shall, from time to time, be issued, amended, or repealed by the Secretary without regard to the requirements of the basic Act [subsec. (e) of this section], but for the pur- poses of the application of section 706(e) [now 721(e)] of the basic Act (relating to fees) and of determining the availability of appropriations of fees (and of advance deposits to cover fees), proceedings, regulations, and certifications under this section shall be deemed to be proceedings, regulations, and certifications under such section 706 [now 721, this section]. Regulations pro- viding for fees (and advance deposits to cover fees), which on the day preceding the enactment date [July 12, 1960] were in effect pursuant to section 706 [now 721] of the basic Act [this section], shall be deemed to be regulations under such section 706 [now 721, this sec- tion] as amended by this Act, and appropriations of fees (and advance deposits) available for the purposes speci- fied in such section 706 [now 721] as in effect prior to the enactment date [July 12, 1960] shall be available for the purposes specified in such section 706 [now 721, this section] as so amended. ‘‘(B) If the Secretary, by regulation— ‘‘(i) has terminated a provisional listing (or deemed provisional listing) of a color additive or particular use thereof pursuant to paragraph (1)(E) of this sub- section; or ‘‘(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of this subsection, initially established or ren- dered more restrictive a tolerance limitation or other restriction or requirement with respect to a provi- sional listing (or deemed provisional listing) which listing had become effective prior to such action, any person adversely affected by such action may, prior to the expiration of the period specified in clause (A) of subsection (a)(2) of this section, file with the Secretary a petition for amendment of such regulation so as to revoke or modify such action of the Secretary, but the filing of such petition shall not operate to stay or sus- pend the effectiveness of such action. Such petition shall, in accordance with regulations, set forth the pro- posed amendment and shall contain data (or refer to data which are before the Secretary or of which he will take official notice), which show that the revocation or modification proposed is consistent with the protection of the public health. The Secretary shall, after pub- lishing such proposal and affording all interested per- sons an opportunity to present their views thereon orally or in writing, act upon such proposal by pub- lished order. ‘‘(C) Any person adversely affected by an order en- tered under subparagraph (B) of this paragraph may, within thirty days after its publication, file objections thereto with the Secretary, specifying with particu- larity the provisions of the order deemed objectionable, stating reasonable grounds for such objections, and re- questing a public hearing upon such objections. The Secretary shall hold a public hearing on such objec- tions and shall, on the basis of the evidence adduced at such hearing, act on such objections by published order. Such order may reinstate a terminated provi- sional listing, or increase or dispense with a previously established temporary tolerance limitation, or make less restrictive any other limitation established by him under paragraph (1) or (3) of this subsection, only if in his judgment the evidence so adduced shows that such action will be consistent with the protection of the public health. An order entered under this subpara- graph shall be subject to judicial review in accordance with section 701(f) of the basic Act [section 371(f) of this title] except that the findings and order of the Sec- retary shall be sustained only if based upon a fair eval- uation of the entire record at such hearing. No stay or suspension of such order shall be ordered by the court pending conclusion of such judicial review. ‘‘(D) On and after the enactment date [July 12, 1960], regulations, provisional listings, and certifications (or exemptions from certification) in effect under this sec- tion shall, for the purpose of determining whether an article is adulterated or misbranded within the mean- ing of the basic Act by reason of its being, bearing, or containing a color additive, have the same effect as would regulations, listings, and certifications (or ex- emptions from certification) under section 706 [now 721] of the basic Act [this section]. A regulation, provisional listing or termination thereof, tolerance limitation, or certification or exemption therefrom, under this sec- tion shall not be the basis for any presumption or infer- ence in any proceeding under section 706(b) or (c) [now 721(b), (c)] of the basic Act [subsec. (b) or (c) of this sec- tion]. ‘‘(3) For the purpose of enabling the Secretary to carry out his functions under paragraphs (1)(A) and (C) of this subsection with respect to color additives deemed provisionally listed, he shall, as soon as prac- ticable after enactment of this Act [July 12, 1960], af- ford by public notice a reasonable opportunity to inter- ested persons to submit data relevant thereto. If the data so submitted or otherwise before him do not, in his judgment, establish a reliable basis for including such a color additive or particular use or uses thereof in a list or lists promulgated under paragraph (1)(A), or for determining the prevailing level or levels of use thereof prior to the enactment date [July 12, 1960] with a view to prescribing a temporary tolerance or toler- ances for such use or uses under paragraph (1)(C), the Secretary shall establish a temporary tolerance limita- tion at zero level for such use or uses until such time as he finds that it would not be inconsistent with the protection of the public health to increase or dispense with such temporary tolerance limitation. ‘‘SEC. 204. [EFFECT ON MEAT INSPECTION AND POULTRY PRODUCTS INSPECTION ACTS.] Nothing in this Act [amending this section and sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371 of this title and repeal- ing sections 354 and 364 of this title] shall be construed to exempt any meat or meat food product, poultry or poultry product, or any person from any requirement Page 520 TITLE 21—FOOD AND DRUGS § 379f imposed by or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended or extended (21 U.S.C. 71 and the following) [see section 601 et seq. of this title] or the Poultry Products Inspection Act (21 U.S.C. 451 and the following).’’ EFFECTIVE DATE; ACCELERATION This section was made ‘‘immediately effective’’ by act May 2, 1939, ch. 107, title I, § 1, 53 Stat. 631. TERMINATION OF ADVISORY COMMITTEES Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2- year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees. REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY RATES References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organi- zation and Employees, see section 529 [title I, § 101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5. PART C—FEES SUBPART 1—FREEDOM OF INFORMATION FEES § 379f. Recovery and retention of fees for free- dom of information requests (a) In general The Secretary, acting through the Commis- sioner of Food and Drugs, may— (1) set and charge fees, in accordance with section 552(a)(4)(A) of title 5, to recover all reasonable costs incurred in processing re- quests made under section 552 of title 5 for records obtained or created under this chapter or any other Federal law for which responsi- bility for administration has been delegated to the Commissioner by the Secretary; (2) retain all fees charged for such requests; and (3) establish an accounting system and pro- cedures to control receipts and expenditures of fees received under this section. (b) Use of fees The Secretary and the Commissioner of Food and Drugs shall not use fees received under this section for any purpose other than funding the processing of requests described in subsection (a)(1). Such fees shall not be used to reduce the amount of funds made to carry out other provi- sions of this chapter. (c) Waiver of fees Nothing in this section shall supersede the right of a requester to obtain a waiver of fees pursuant to section 552(a)(4)(A) of title 5. (June 25, 1938, ch. 675, § 731, formerly § 711, as added Pub. L. 101–635, title II, § 201, Nov. 28, 1990, 104 Stat. 4584; renumbered § 731, Pub. L. 102–571, title I, § 106(6), Oct. 29, 1992, 106 Stat. 4499.) Editorial Notes CODIFICATION Section was formerly classified to section 379c of this title prior to renumbering by Pub. L. 102–571. SUBPART 2—FEES RELATING TO DRUGS § 379g. Definitions For purposes of this subpart: (1) The term ‘‘human drug application’’ means an application for— (A) approval of a new drug submitted under section 355(b) of this title, or (B) licensure of a biological product under subsection (a) of section 262 of title 42. Such term does not include a supplement to such an application, does not include an appli- cation with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an applica- tion with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product sub- mitted pursuant to a notification to the appli- cant from the Secretary regarding the exist- ence of a potency test that measures the aller- genic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with re- spect to an in vitro diagnostic biologic prod- uct licensed under section 262 of title 42, does not include an application with respect to a large volume parenteral drug product ap- proved before September 1, 1992, does not in- clude an application for a licensure of a bio- logical product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not dis- tributed commercially. Such term does in- clude an application for licensure, as described in subparagraph (B), of a large volume biologi- cal product intended for single dose injection for intravenous use or infusion. (2) The term ‘‘supplement’’ means a request to the Secretary to approve a change in a human drug application which has been ap- proved. (3)(A) The term ‘‘prescription drug product’’ means a specific strength or potency of a drug in final dosage form— (i) for which a human drug application has been approved, (ii) which may be dispensed only under prescription pursuant to section 353(b) of this title, and (iii) which is on the list of products de- scribed in section 355(j)(7)(A) of this title (not including the discontinued section of such list) or is on a list created and main- tained by the Secretary of products ap- proved under human drug applications under section 262 of title 42 (not including the dis- continued section of such list). (B) Such term does not include whole blood or a blood component for transfusion, does not