
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC379e]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                    SUBCHAPTER VII--GENERAL AUTHORITY
 
                             Part B--Colors
 
Sec. 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 particular use (for 
which it is being used or intended 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 application 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 regulation 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) of this section, 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 conform to the terms of 
    an exemption which is in effect pursuant to subsection (f) of this 
    section.

While there are in effect regulations under subsections (b) and (c) of 
this section relating to a color additive or an exemption pursuant to 
subsection (f) of this section with respect to such additive, an article 
shall not, by reason of bearing or containing such additive in all 
respects in accordance with such regulations or such exemption, be 
considered 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 section 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 contact with the 
body of man or other animals for a significant period of time. The 
Secretary may by regulation designate the uses of color additives 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; 
        appointment 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 additives are suitable and 
safe for any such use when employed in accordance with such regulations.
    (2)(A) Such regulations may list any color additive 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 establish that the 
additive satisfies the requirements for listing such additive on the 
applicable list pursuant to subparagraph (A) of this paragraph, or if 
the proposal is for listing such additive for a more limited use or 
uses, such regulations 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 employed for such use or uses (including, but not 
limited to, specifications, hereafter in this section referred to as 
tolerance limitations, as to the maximum quantity or quantities which 
may be used or permitted to remain in or on the article or articles in 
or on which it is used; specifications as to the manner in which such 
additive may be added to or used in or on such article or articles; and 
directions or other labeling or packaging requirements for such 
additive).
    (4) The Secretary shall not list a color additive under this section 
for a proposed use unless the data before him establish that such use, 
under the conditions of use specified in the regulations, will be safe: 
Provided, however, That a color additive shall be deemed to be suitable 
and safe for the purpose of listing under this subsection for use 
generally in or on food, while there is in effect a published finding of 
the Secretary 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 additive is safe, the Secretary shall consider, 
among other relevant factors--
        (i) the probable consumption of, or other relevant exposure 
    from, the additive and of any substance formed in or on food, drugs 
    or devices, or cosmetics because of the use of the additive;
        (ii) the cumulative effect, if any, of such additive in the diet 
    of man or animals, taking into account the same or any chemically or 
    pharmacologically related substance or substances in such diet;
        (iii) safety factors which, in the opinion of experts qualified 
    by scientific training and experience to evaluate the safety of 
    color additives for the use or uses for which the additive is 
    proposed to be listed, are generally recognized as appropriate for 
    the use of animal experimentation data; and
        (iv) the availability of any needed practicable 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 additive in or on any article of food, 
    drug or device, 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 additive, if the additive is found by the Secretary to induce 
cancer when ingested by man or animal, or if it is found by the 
Secretary, after 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 subparagraph (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 
practice, 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 regulations shall not be subject to subsection (d) of 
this section) in any edible portion of such animals after slaughter 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 proposal of 
the Secretary on his own initiative or by a proposal contained in a 
petition, the petitioner, or any other person who will be adversely 
affected by such proposal or by the Secretary's order issued in 
accordance with paragraph (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 recommendations with 
respect to any matter arising under subparagraph (B) of this paragraph, 
which is involved in such proposal or order and which requires the 
exercise of scientific judgment. Upon such request, or if the Secretary 
within such time deems such a referral necessary, 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 arising under subparagraph (B) for study thereof and for a 
report and recommendations on such matter. 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 referred 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 referral, or within an 
additional thirty days if the committee deems such additional time 
necessary, the committee shall, after independent study of the data 
furnished to it by the Secretary and other data before it, certify to 
the Secretary a report and recommendations, together with all underlying 
data and a statement of the reasons or basis for the recommendations. A 
copy of the foregoing shall be promptly supplied by the Secretary to any 
person who has filed a petition, or who has requested such referral 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, underlying 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 proposal 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 proposal until the advisory 
committee has made a report and recommendations to him under clause (ii) 
of this subparagraph and he has considered such recommendations, unless 
the Secretary finds that emergency conditions exist necessitating the 
issuance of an order notwithstanding this clause.
    (D) The advisory committee referred to in subparagraph (C) of this 
paragraph shall be composed of experts selected by the National Academy 
of Sciences, qualified in the subject matter referred to the committee 
and of adequately diversified professional background, except that in 
the event of the inability or refusal of the National Academy of 
Sciences to act, the Secretary shall select the members of the 
committee. The size of the committee shall be determined by the 
Secretary. Members of any advisory 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 Secretary 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 Government service employed intermittently. The members shall not be 
subject to any other provisions 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 additive under this 
subsection for a proposed use if the data before him show that such 
proposed use would promote deception of the consumer in violation of 
this chapter or would otherwise result in misbranding or adulteration 
within the meaning of this chapter.
    (7) If, in the judgment of the Secretary, a tolerance limitation is 
required in order to assure that a proposed use of a color additive will 
be safe, the Secretary--
        (A) shall not list the additive for such use if he finds that 
    the data before him do not establish that such additive, if used 
    within a safe tolerance limitation, would achieve the intended 
    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 permissible to list a color additive (or 
pharmacologically related color additives) for all the uses proposed 
therefor and at the levels of concentration proposed, the Secretary 
shall, in determining 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 
safety), (A) the relative marketability of the articles involved as 
affected by the proposed uses of the color additive (or of such related 
additives) in or on such articles, and the relative dependence 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 reason of the various uses and levels of 
concentration 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 diluents or without diluents, of batches of 
color additives listed pursuant to subsection (b) of this section and 
conforming to the requirements for such additives established by 
regulations under such subsection and this subsection, and (2) for 
exemption 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 requirement of 
certification shall be deemed not to be necessary in the interest of 
public health protection.

(d) Procedure for issuance, amendment, or repeal of regulations

    The provisions of section 371(e), (f), and (g) of this title shall, 
subject to the provisions of subparagraph (C) of subsection (b)(5) of 
this section, apply to and in all respects govern proceedings for the 
issuance, amendment, or repeal of regulations under subsection (b) or 
(c) of this section (including judicial review of the Secretary's action 
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 filing 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 (required by paragraph (1) of section 
    371(e) of this title) acting upon such proposal shall, in the 
    absence of prior referral (or request for referral) to an advisory 
    committee, be issued within ninety days after the date of such 
    filing, except that the Secretary may (prior to such ninetieth day), 
    by written notice to the petitioner, 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 
    recommendations of such committee upon request of the Secretary, the 
    petitioner, or the officer conducting the hearing, but this shall 
    not preclude any other member of the advisory 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 requirements 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 sentence 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 
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.

(f) Exemptions

    The Secretary shall by regulations (issued without regard to 
subsection (d) of this section) provide for exempting 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 qualified experts when in his opinion such exemption is 
consistent with the public health.

(June 25, 1938, ch. 675, Sec. 721, formerly Sec. 706, 52 Stat. 1058; 
Pub. L. 86-618, title I, Sec. 103(b), July 12, 1960, 74 Stat. 399; Pub. 
L. 87-781, title I, Sec. 104(f)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 
91-515, title VI, Sec. 601(d)(2), Oct. 30, 1970, 84 Stat. 1311; Pub. L. 
94-295, Sec. 9(a), May 28, 1976, 90 Stat. 583; Pub. L. 96-88, title V, 
Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-300, Sec. 6(b)(2), 
June 16, 1992, 106 Stat. 240; renumbered Sec. 721, Pub. L. 102-571, 
title I, Sec. 106(4), Oct. 29, 1992, 106 Stat. 4498; Pub. L. 103-80, 
Sec. 3(bb), Aug. 13, 1993, 107 Stat. 778.)

                          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, Sec. 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 ``representatives of the Department''.
    1976--Subsec. (a). Pub. L. 94-295, Sec. 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, Sec. 9(a)(1), (2), substituted ``drug 
or device'' for ``drug'' and ``drugs or devices'' for ``drugs'' wherever 
appearing.
    Subsec. (f). Pub. L. 94-295, Sec. 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 5703(b) of Title 5, 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 
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

    Title II of Pub. L. 86-618 provided 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 effect, 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 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 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 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 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 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 371(f) 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 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 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 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, Sec. 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 of Pub. 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, 
Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note under section 5376 
of Title 5.

                  Section Referred to in Other Sections

    This section is referred to in sections 321, 331, 342, 343, 351, 
352, 360j, 361, 362, 453, 601, 1033 of this title.
