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CITE

    21 USC Sec. 601                                             01/05/2009

EXPCITE

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

HEAD

    Sec. 601. Definitions

STATUTE

      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 or 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.
      (w) The term "amenable species" means -
        (1) those species subject to the provisions of this chapter on
      the day before November 10, 2005;
        (2) catfish, as defined by the Secretary; and
        (3) any additional species of livestock that the Secretary
      considers appropriate.

SOURCE

    (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; Pub. L. 109-97,
    title VII, Sec. 798[(a)](2), Nov. 10, 2005, 119 Stat. 2166; Pub. L.
    110-234, title XI, Sec. 11016(b)(1)(A), May 22, 2008, 122 Stat.
    1369; Pub. L. 110-246, Sec. 4(a), title XI, Sec. 11016(b)(1)(A),
    June 18, 2008, 122 Stat. 1664, 2130.)

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.

CODIFICATION

      Pub. L. 110-234 and Pub. L. 110-246 made identical amendments to
    this section. The amendments by Pub. L. 110-234 were repealed by
    section 4(a) of Pub. L. 110-246.

AMENDMENTS

      2008 - Subsec. (w)(2), (3). Pub. L. 110-246, Sec. 11016(b)(1)(A),
    added par. (2) and redesignated former par. (2) as (3).
      2005 - Par. (w). Pub. L. 109-97 added par. (w).
      1992 - Par. (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.

MISCELLANEOUS

                     EFFECTIVE DATE OF 2008 AMENDMENT
      Amendment of this section and repeal of Pub. L. 110-234 by Pub.
    L. 110-246 effective May 22, 2008, the date of enactment of Pub. L.
    110-234, except as otherwise provided, see section 4 of Pub. L. 110-
    246, set out as an Effective Date note under section 8701 of Title
    7, Agriculture.
      Pub. L. 110-234, title XI, Sec. 11016(b)(2)(A), May 22, 2008, 122
    Stat. 1369, and Pub. L. 110-246, Sec. 4(a), title XI, Sec.
    11016(b)(2)(A), June 18, 2008, 122 Stat. 1664, 2131, provided that:
    "The amendments made by paragraph (1) [enacting sections 606 and
    625 of this title, amending this section, and repealing former
    section 606 of this title] shall not apply until the date on which
    the Secretary of Agriculture issues final regulations (after
    providing a period of public comment, including through the conduct
    of public meetings or hearings, in accordance with chapter 5 of
    title 5, United States Code) to carry out such amendments."
      [Pub. L. 110-234 and Pub. L. 110-246 enacted identical
    provisions. Pub. L. 110-234 was repealed by section 4(a) of Pub. L.
    110-246, set out as a note under section 8701 of Title 7,
    Agriculture.]
                     EFFECTIVE DATE OF 2005 AMENDMENT
      Pub. L. 109-97, title VII, Sec. 798(b), Nov. 10, 2005, 119 Stat.
    2166, provided that: "The amendments made by subsection (a)
    [amending this section and sections 603 to 605, 608, 609, 615, and
    617 to 621 of this title] shall take effect on the day after the
    effective date of section 794 of the Agriculture, Rural
    Development, Food and Drug Administration, and Related Agencies
    Appropriations Act, 2006 [section 794 of Pub. L. 109-97, 119 Stat.
    2164, effective 120 days after Nov. 10, 2005]."
                              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-
    A of this chapter, are designated as the "Federal Meat Inspection
    Act".
                                REGULATIONS
      Pub. L. 110-234, title XI, Sec. 11016(b)(2)(B), May 22, 2008, 122
    Stat. 1370, and Pub. L. 110-246, Sec. 4(a), title XI, Sec.
    11016(b)(2)(B), June 18, 2008, 122 Stat. 1664, 2131, provided that:
    "Not later than 18 months after the date of the enactment of this
    Act [June 18, 2008], the Secretary of Agriculture, in consultation
    with the Commissioner of Food and Drugs, shall issue final
    regulations to carry out the amendments made by paragraph (1)
    [enacting sections 606 and 625 of this title, amending this
    section, and repealing former section 606 of this title]."
      [Pub. L. 110-234 and Pub. L. 110-246 enacted identical
    provisions. Pub. L. 110-234 was repealed by section 4(a) of Pub. L.
    110-246, set out as a note under section 8701 of Title 7,
    Agriculture.]
                               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."
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