
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: 21USC601]

 
                        TITLE 21--FOOD AND DRUGS
 
                       CHAPTER 12--MEAT INSPECTION
 
   SUBCHAPTER I--INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
 
Sec. 601. Definitions

    As used in this chapter, except as otherwise specified, the 
following terms shall have the meanings stated below:
    (a) The term ``Secretary'' means the Secretary of Agriculture of the 
United States or his delegate.
    (b) The term ``firm'' means any partnership, association, or other 
unincorporated business organization.
    (c) The term ``meat broker'' means any person, firm, or corporation 
engaged in the business of buying or selling carcasses, parts of 
carcasses, meat, or meat food products of cattle, sheep, swine, goats, 
horses, mules, or other equines on commission, or otherwise negotiating 
purchases or sales of such articles other than for his own account or as 
an employee of another person, firm, or corporation.
    (d) The term ``renderer'' means any person, firm, or corporation 
engaged in the business of rendering carcasses or parts or products of 
the carcasses, of cattle, sheep, swine, goats, horses, mules, or other 
equines, except rendering conducted under inspection or exemption under 
this subchapter.
    (e) The term ``animal food manufacturer'' means any person, firm, or 
corporation engaged in the business of manufacturing or processing 
animal food derived wholly or in part from carcasses, or parts of 
products of the carcasses, of cattle, sheep, swine, goats, horses, 
mules, or other equines.
    (f) The term ``State'' means any State of the United States and the 
Commonwealth of Puerto Rico.
    (g) The term ``Territory'' means Guam, the Virgin Islands of the 
United States, American Samoa, and any other territory or possession of 
the United States, excluding the Canal Zone.
    (h) The term ``commerce'' means commerce between any State, any 
Territory, or the District of Columbia, and any place outside thereof; 
or within any Territory not organized with a legislative body, or the 
District of Columbia.
    (i) The term ``United States'' means the States, the District of 
Columbia, and the Territories of the United States.
    (j) The term ``meat food product'' means any product capable of use 
as human food which is made wholly or in part from any meat or other 
portion of the carcass of any cattle, sheep, swine, or goats, excepting 
products which contain meat or other portions of such carcasses only in 
a relatively small proportion or historically have not been considered 
by consumers as products of the meat food industry, and which are 
exempted from definition as a meat food product by the Secretary under 
such conditions as he may prescribe to assure that the meat or other 
portions of such carcasses contained in such product are not adulterated 
and that such products are not represented as meat food products. This 
term as applied to food products of equines shall have a meaning 
comparable to that provided in this paragraph with respect to cattle, 
sheep, swine, and goats.
    (k) The term ``capable of use as human food'' shall apply to any 
carcass, or part or product of a carcass, of any animal, unless it is 
denatured or otherwise identified as required by regulations prescribed 
by the Secretary to deter its use as human food, or it is naturally 
inedible by humans.
    (l) The term ``prepared'' means slaughtered, canned, salted, 
rendered, boned, cut up, or otherwise manufactured or processed.
    (m) The term ``adulterated'' shall apply to any carcass, part 
thereof, meat or meat food product under one or more of the following 
circumstances:
        (1) if it bears or contains any poisonous or deleterious 
    substance which may render it injurious to health; but in case the 
    substance is not an added substance, such article shall not be 
    considered adulterated under this clause if the quantity of such 
    substance in or on such article does not ordinarily render it 
    injurious to health;
        (2)(A) if it bears or contains (by reason of administration of 
    any substance to the live animal or otherwise) any added poisonous 
    or added deleterious substance (other than one which is (i) a 
    pesticide chemical in or on a raw agricultural commodity; (ii) a 
    food additive; or (iii) a color additive) which may, in the judgment 
    of the Secretary, make such article unfit for human food;
        (B) if it is, in whole or in part, a raw agricultural commodity 
    and such commodity bears or contains a pesticide chemical which is 
    unsafe within the meaning of section 346a of this title,
        (C) if it bears or contains any food additive which is unsafe 
    within the meaning of section 348 of this title,
        (D) if it bears or contains any color additive which is unsafe 
    within the meaning of section 379e of this title: Provided, That an 
    article which is not adulterated under clause (B), (C), or (D) shall 
    nevertheless be deemed adulterated if use of the pesticide chemical, 
    food additive, or color additive in or on such article is prohibited 
    by regulations of the Secretary in establishments at which 
    inspection is maintained under this subchapter;
        (3) if it consists in whole or in part of any filthy, putrid, or 
    decomposed substance or is for any other reason unsound, 
    unhealthful, unwholesome, or otherwise unfit for human food;
        (4) if it has been prepared, packed, or held under insanitary 
    conditions whereby it may have become contaminated with filth, or 
    whereby it may have been rendered injurious to health;
        (5) if it is, in whole or in part, the product of an animal 
    which has died otherwise than by slaughter;
        (6) if its container is composed, in whole or in part, of any 
    poisonous or deleterious substance which may render the contents 
    injurious to health;
        (7) if it has been intentionally subjected to radiation, unless 
    the use of the radiation was in conformity with a regulation or 
    exemption in effect pursuant to section 348 of this title;
        (8) if any valuable constituent has been in whole or in part 
    omitted or abstracted therefrom; or if any substance has been 
    substituted, wholly or in part therefor; or if damage or inferiority 
    has been concealed in any manner; or if any substance has been added 
    thereto or mixed or packed therewith so as to increase its bulk or 
    weight, or reduce its quality or strength, or make it appear better 
    or of greater value than it is; or
        (9) if it is margarine containing animal fat and any of the raw 
    material used therein consisted in whole or in part of any filthy, 
    putrid, or decomposed substance.

    (n) The term ``misbranded'' shall apply to any carcass, part 
thereof, meat or meat food product under one or more of the following 
circumstances:
        (1) if its labeling is false or misleading in any particular;
        (2) if it is offered for sale under the name of another food;
        (3) if it is an imitation of another food, unless its label 
    bears, in type of uniform size and prominence, the word 
    ``imitation'' and immediately thereafter, the name of the food 
    imitated;
        (4) if its container is so made, formed, or filled as to be 
    misleading;
        (5) if in a package or other container unless it bears a label 
    showing (A) the name and place of business of the manufacturer, 
    packer, or distributor; and (B) an accurate statement of the 
    quantity of the contents in terms of weight, measure, or numerical 
    count: Provided, That under clause (B) of this subparagraph (5), 
    reasonable variations may be permitted, and exemptions as to small 
    packages may be established, by regulations prescribed by the 
    Secretary;
        (6) if any word, statement, or other information required by or 
    under authority of this chapter to appear on the label or other 
    labeling is not prominently placed thereon with such conspicuousness 
    (as compared with other words, statements, designs, or devices, in 
    the labeling) and in such terms as to render it likely to be read 
    and understood by the ordinary individual under customary conditions 
    of purchase and use;
        (7) if it purports to be or is represented as a food for which a 
    definition and standard of identity or composition has been 
    prescribed by regulations of the Secretary under section 607 of this 
    title unless (A) it conforms to such definition and standard, and 
    (B) its label bears the name of the food specified in the definition 
    and standard and, insofar as may be required by such regulations, 
    the common names of optional ingredients (other than spices, 
    flavoring, and coloring) present in such food;
        (8) if it purports to be or is represented as a food for which a 
    standard or standards of fill of container have been prescribed by 
    regulations of the Secretary under section 607 of this title, and it 
    falls below the standard of fill of container applicable thereto, 
    unless its label bears, in such manner and form as such regulations 
    specify, a statement that it falls below such standard;
        (9) if it is not subject to the provisions of subparagraph (7), 
    unless its label bears (A) the common or usual name of the food, if 
    any there be, and (B) in case it is fabricated from two or more 
    ingredients, the common or usual name of each such ingredient; 
    except that spices, flavorings, and colorings may, when authorized 
    by the Secretary, be designated as spices, flavorings, and colorings 
    without naming each: Provided, That to the extent that compliance 
    with the requirements of clause (B) of this subparagraph (9) is 
    impracticable, or results in deception or unfair competition, 
    exemptions shall be established by regulations promulgated by the 
    Secretary;
        (10) if it purports to be or is represented for special dietary 
    uses, unless its label bears such information concerning its 
    vitamin, mineral, and other dietary properties as the Secretary, 
    after consultation with the Secretary of Health and Human Services, 
    determines to be, and by regulations prescribes as, necessary in 
    order fully to inform purchasers as to its value for such uses;
        (11) if it bears or contains any artificial flavoring, 
    artificial coloring, or chemical preservative, unless it bears 
    labeling stating that fact: Provided, That, to the extent that 
    compliance with the requirements of this subparagraph (11) is 
    impracticable, exemptions shall be established by regulations 
    promulgated by the Secretary; or
        (12) if it fails to bear, directly thereon or on its container, 
    as the Secretary may by regulations prescribe, the inspection legend 
    and, unrestricted by any of the foregoing, such other information as 
    the Secretary may require in such regulations to assure that it will 
    not have false or misleading labeling and that the public will be 
    informed of the manner of handling required to maintain the article 
    in a wholesome condition.

    (o) The term ``label'' means a display of written, printed, or 
graphic matter upon the immediate container (not including package 
liners) of any article.
    (p) The term ``labeling'' means all labels and other written, 
printed, or graphic matter (1) upon any article or any of its containers 
or wrappers, or (2) accompanying such article.
    (q) The term ``Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 
et seq.]'' means the Act so entitled, approved June 25, 1938 (52 Stat. 
1040), and Acts amendatory thereof or supplementary thereto.
    (r) The terms ``pesticide chemical,'' ``food additive,'' ``color 
additive,'' and ``raw agricultural commodity'' shall have the same 
meanings for purposes of this chapter as under the Federal Food, Drug, 
and Cosmetic Act [21 U.S.C. 301 et seq.].
    (s) The term ``official mark'' means the official inspection legend 
or any other symbol prescribed by regulations of the Secretary to 
identify the status of any article or animal under this chapter.
    (t) The term ``official inspection legend'' means any symbol 
prescribed by regulations of the Secretary showing that an article was 
inspected and passed in accordance with this chapter.
    (u) The term ``official certificate'' means any certificate 
prescribed by regulations of the Secretary for issuance by an inspector 
or other person performing official functions under this chapter.
    (v) The term ``official device'' means any device prescribed or 
authorized by the Secretary for use in applying any official mark.

(Mar. 4, 1907, ch. 2907, title I, Sec. 1, as added Pub. L. 90-201, 
Sec. 2, Dec. 15, 1967, 81 Stat. 584; amended Pub. L. 96-88, title V, 
Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-571, title I, 
Sec. 107(14), Oct. 29, 1992, 106 Stat. 4499.)

                       References in Text

    The Federal Food, Drug, and Cosmetic Act, referred to in pars. (q) 
and (r), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which 
is classified generally to chapter 9 (Sec. 301 et seq.) of this title. 
For complete classification of this Act to the Code, see section 301 of 
this title and Tables.


                               Amendments

    1992--Subsec. (m)(2)(D). Pub. L. 102-571 substituted ``379e'' for 
``376''.

                         Change of Name

    ``Secretary of Health and Human Services'' substituted for 
``Secretary of Health, Education, and Welfare'' in par. (n)(10) pursuant 
to section 509(b) of Pub. L. 96-88, which is classified to section 
3508(b) of Title 20, Education.


                             Effective Date

    Section 20 of Pub. L. 90-201 provided that: ``This Act [see Short 
Title note below] shall become effective upon enactment [Dec. 15, 1967] 
except as provided in paragraphs (a) through (d):
    ``(a) The provisions of paragraph (b)(1) and (c) of section 10 and 
the provisions of section 20 of the Federal Meat Inspection Act, as 
amended by sections 7 and 10 of this Act [sections 610 and 620 of this 
title], and the provisions of section 18 of this Act repealing paragraph 
(b) of section 306 of the Tariff Act of 1930 [section 1306(b) of Title 
19, Customs Duties], shall become effective upon the expiration of sixty 
days after enactment [Dec. 15, 1967], hereof.
    ``(b) The provisions of title I of the Federal Meat Inspection Act, 
as amended by this Act [this subchapter], shall become effective with 
respect to equines (other than horses) and their carcasses and parts 
thereof, meat, and meat food products thereof upon the expiration of 
sixty days after enactment [Dec. 15, 1967] hereof.
    ``(c) Section 11 of this Act, amending section 23, of the Federal 
Meat Inspection Act [section 623 of this title], shall become effective 
upon the expiration of sixty days after enactment hereof [Dec. 15, 
1967].
    ``(d) Section 204 of the Federal Meat Inspection Act, as added by 
section 14 of this Act [section 644 of this title], shall become 
effective upon the expiration of sixty days after enactment hereof [Dec. 
15, 1967].''


                      Short Title of 1986 Amendment

    Pub. L. 99-641, title IV, Sec. 401, Nov. 10, 1986, 100 Stat. 3567, 
provided that: ``This title [amending sections 606, 609, 621, 671, and 
676 of this title and enacting provisions set out as notes under 
sections 606, 609, 621, 671, and 676 of this title] may be cited as the 
`Processed Products Inspection Improvement Act of 1986'.''


                      Short Title of 1978 Amendment

    Pub. L. 95-445, Sec. 1, Oct. 10, 1978, 92 Stat. 1069, provided: 
``That this Act [amending sections 603, 610, and 620 of this title and 
sections 1902 and 1904 of Title 7, Agriculture, repealing sections 1903 
and 1905 of Title 7, and enacting provisions set out as notes under this 
section and section 603 of this title] may be cited as the `Humane 
Methods of Slaughter Act of 1978'.''


                               Short Title

    Section 1 of Pub. L. 90-201 provided in part: ``That this Act 
[enacting this section and sections 602, 624, 641 to 645, 661, 671 to 
680, and 691 of this title, amending sections 603 to 623 of this title, 
repealing section 96 of this title and section 1306(b) of Title 19, 
Customs Duties, and enacting provisions set out as notes under this 
section] may be cited as the `Wholesome Meat Act'.''
    Section 1 of Pub. L. 90-201 provided in part that the provisions of 
act Mar. 4, 1907, as amended, classified to subchapters I to IV of this 
chapter, are designated as the ``Federal Meat Inspection Act''.


                              Separability

    Section 19 of Pub. L. 90-201 provided that: ``If any provision of 
this Act or of the amendments made hereby [see Short Title note above] 
or the application thereof to any person or circumstances is held 
invalid, the validity of the remainder of the Act and the remaining 
amendments [see Short Title note above] and of the application of such 
provision to other persons and circumstances shall not be affected 
thereby.''

                    Act Referred to in Other Sections

    The Wholesome Meat Act is referred to in section 1053 of this title.

                  Section Referred to in Other Sections

    This section is referred to in sections 607, 673, 676 of this title; 
title 15 sections 2052, 2602.
