(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.)
Section was formerly classified to section
of this title prior to renumbering by Pub. L. 102–571
In subsec. (d)(2), “section
” 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.
1993—Subsec. (b)(5)(D). Pub. L. 103–80
5703” for “section
1992—Subsec. (b)(5)(C)(i). Pub. L. 102–300
struck out “of Health, Education, and Welfare” after “representatives 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 direct contact with the body of man or other animals for a significant period of time and authorizing the Secretary to designate by regulation the uses of color additives 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 provisions authorizing members of an advisory committee to receive compensation at rates fixed by the Secretary, with a specific maximum amount, and travel expenses, including per diem in lieu of subsistence, as authorized by section
, for provisions authorizing such members to receive as compensation a reasonable per diem for time actually spent on committee work, and necessary traveling and subsistence expenses while serving away from their places of residence.
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 production, 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 adversely 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 accordance 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.”
Effective Date of 1962 Amendment
Amendment by Pub. L. 87–781
effective Oct. 10, 1962, see section 107 ofPub. L. 87–781
, set out as a note under section
of this title.
Effective Date of 1960 Amendment, Transitional Provisions, and Effect on Other Laws
Title II of Pub. L. 86–618
“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 effect, under the basic Act.
“Sec. 202. [Effective Date.] This Act [amending this section and sections
of this title and repealing sections
of this title] shall, subject to the provisions of section
, 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 reasonable period, through provisional listings, the use of commercially established color additives to the extent consistent with the public health, pending the completion of the scientific investigations needed as a basis for making determinations as to listing of such additives under the basic Act as amended by this Act. A provisional listing (including a deemed provisional listing) 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 ‘closing 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 additive or use thereof, such later closing date as the Secretary may from time to time establish pursuant to the authority of this paragraph. The Secretary may by regulation, 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 listing (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 postponement 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 conditions 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 certifiable for any use or uses under section
of this title], or under the third proviso of section
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 subsection, or (B) is the color additive known as synthetic 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, under section 406(b), 504, or 604 of the basic Act [section
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 provisional listing shall take effect on the date of publication.
“(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 respect 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 subsection (c);
“(C) provide, with respect to particular uses for which color additives are or are deemed to be provisionally listed, such temporary tolerance limitations (including such limitations at zero level) and other conditions of use and labeling or packaging requirements, if any, as in his judgment are necessary to protect the public health pending listing under section
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 additive 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 purposes 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 providing 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 section] as amended by this Act, and appropriations of fees (and advance deposits) available for the purposes specified 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 subsection; or
“(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of this subsection, initially established or rendered more restrictive a tolerance limitation or other restriction or requirement with respect to a provisional 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 suspend the effectiveness of such action. Such petition shall, in accordance with regulations, set forth the proposed 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 publishing such proposal and affording all interested persons an opportunity to present their views thereon orally or in writing, act upon such proposal by published order.
“(C) Any person adversely affected by an order entered under subparagraph (B) of this paragraph may, within thirty days after its publication, file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds for such objections, and requesting a public hearing upon such objections. The Secretary shall hold a public hearing on such objections 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 provisional 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 subparagraph shall be subject to judicial review in accordance with section 701(f) of the basic Act [section
of this title] except that the findings and order of the Secretary shall be sustained only if based upon a fair evaluation 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 section shall, for the purpose of determining whether an article is adulterated or misbranded within the meaning 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 exemptions 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 section shall not be the basis for any presumption or inference in any proceeding under section
706(b) or (c) [now 721(b), (c)] of the basic Act [subsec. (b) or (c) of this section].
“(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 practicable after enactment of this Act [July 12, 1960], afford by public notice a reasonable opportunity to interested 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 tolerances for such use or uses under paragraph (1)(C), the Secretary shall establish a temporary tolerance limitation 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
of this title and repealing sections
of this title] shall be construed to exempt any meat or meat food product, poultry or poultry product, or any person from any requirement imposed by or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat. 1260
, as amended or extended (21
and the following) [see section
et seq. of this title] or the Poultry Products Inspection Act (21
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 14 ofPub. L. 92–463
, Oct. 6, 1972, 86 Stat. 776
, set out in the Appendix to 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 Organization and Employees, see section
529 [title I, § 101(c)(1)] of Pub. L. 101–509
, set out in a note under section