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21 U.S.C. § 455 — Inspection in official establishments
Federal law — U.S. Code and appendices · legal_authorities
Page 724
TITLE 21—FOOD AND DRUGS
§ 455
1 See References in Text note below.
State at any time upon thirty days’ notice to
the Governor and publication in the Federal
Register in accordance with this paragraph, and
any State may be designated upon such notice
and publication, at any time after the period
specified in this paragraph whether or not the
State has theretofore been designated, upon the
Secretary determining that it is not effectively
enforcing requirements at least equal to those
imposed under said sections.
(4) The Secretary shall promptly upon August
18, 1968, and periodically thereafter, but at least
annually, review the requirements, including
the enforcement thereof, of the several States
not designated under this paragraph (c), with re-
spect to the slaughter, and the processing, stor-
age, handling, and distribution of poultry prod-
ucts, and inspection of such operations, and an-
nually report thereon to the Committee on Agri-
culture of the House of Representatives and the
Committee on Agriculture, Nutrition, and For-
estry of the Senate in the report required in sec-
tion 470 1 of this title.
(d) ‘‘State’’ defined
As used in this section, the term ‘‘State’’
means any State (including the Commonwealth
of Puerto Rico) or organized territory.
(Pub. L. 85–172, § 5, Aug. 28, 1957, 71 Stat. 443;
Pub. L. 90–492, § 5, Aug. 18, 1968, 82 Stat. 796; Pub.
L. 98–487, § 2, Oct. 17, 1984, 98 Stat. 2264; Pub. L.
103–437, § 8(1), Nov. 2, 1994, 108 Stat. 4588.)
Editorial Notes
REFERENCES IN TEXT
Section 470 of this title, referred to in subsec. (c)(4),
was omitted from the Code.
CODIFICATION
In par. (c)(1), (4), ‘‘August 18, 1968’’ substituted for
‘‘enactment of the Wholesome Poultry Products Act’’.
AMENDMENTS
1994—Subsec. (c)(4). Pub.
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Page 724
TITLE 21—FOOD AND DRUGS
§ 455
1 See References in Text note below.
State at any time upon thirty days’ notice to
the Governor and publication in the Federal
Register in accordance with this paragraph, and
any State may be designated upon such notice
and publication, at any time after the period
specified in this paragraph whether or not the
State has theretofore been designated, upon the
Secretary determining that it is not effectively
enforcing requirements at least equal to those
imposed under said sections.
(4) The Secretary shall promptly upon August
18, 1968, and periodically thereafter, but at least
annually, review the requirements, including
the enforcement thereof, of the several States
not designated under this paragraph (c), with re-
spect to the slaughter, and the processing, stor-
age, handling, and distribution of poultry prod-
ucts, and inspection of such operations, and an-
nually report thereon to the Committee on Agri-
culture of the House of Representatives and the
Committee on Agriculture, Nutrition, and For-
estry of the Senate in the report required in sec-
tion 470 1 of this title.
(d) ‘‘State’’ defined
As used in this section, the term ‘‘State’’
means any State (including the Commonwealth
of Puerto Rico) or organized territory.
(Pub. L. 85–172, § 5, Aug. 28, 1957, 71 Stat. 443;
Pub. L. 90–492, § 5, Aug. 18, 1968, 82 Stat. 796; Pub.
L. 98–487, § 2, Oct. 17, 1984, 98 Stat. 2264; Pub. L.
103–437, § 8(1), Nov. 2, 1994, 108 Stat. 4588.)
Editorial Notes
REFERENCES IN TEXT
Section 470 of this title, referred to in subsec. (c)(4),
was omitted from the Code.
CODIFICATION
In par. (c)(1), (4), ‘‘August 18, 1968’’ substituted for
‘‘enactment of the Wholesome Poultry Products Act’’.
AMENDMENTS
1994—Subsec. (c)(4). Pub. L. 103–437 substituted ‘‘Agri-
culture, Nutrition, and Forestry’’ for ‘‘Agriculture and
Forestry’’.
1984—Par. (c)(2). Pub. L. 98–487 inserted provisions re-
lating to operations conducted at a restaurant central
kitchen facility.
1968—Pub. L. 90–492 substituted provisions author-
izing the Secretary to cooperate with the appropriate
state agency in the development and administration of
state poultry product inspection programs in those
states having mandatory poultry product inspection
laws and those states having laws at least equal to the
provisions of section 460 of this title, provisions author-
izing planning, technical and financial assistance and
the appointment of advisory committees, provisions
designating the appropriate state agency with which
the Secretary may cooperate, provisions authorizing
the Secretary to designate states as subject to the reg-
ulatory provisions of this chapter when the require-
ments of the specified section have not been complied
with or when the specified intrastate activities are
present, provisions exempting from the requirements of
this chapter operations of the types traditionally and
usually conducted at retail stores and restaurants, pro-
visions authorizing the Secretary to terminate the
aforementioned designation of states as subject to the
regulatory provisions of this chapter, and provisions
authorizing the Secretary to review the operations in
nondesignated states and make an annual report there-
on, for provisions authorizing the Secretary, upon ap-
plication by any appropriate state or local official or
agency or by any appropriate local poultry industry
group and after public hearing, to designate major con-
suming areas as subject to the regulatory provisions of
this chapter where the Secretary finds that poultry or
poultry products are handled or consumed in such vol-
ume as to affect, burden or obstruct the movement of
inspected poultry products in interstate commerce.
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90–492 effective Aug. 18, 1968,
see section 20 of Pub. L. 90–492, set out as a note under
section 451 of this title.
§ 455. Inspection in official establishments
(a) Ante mortem inspection
For the purpose of preventing the entry into
or flow or movement in commerce of, or the bur-
dening of commerce by, any poultry product
which is capable of use as human food and is
adulterated, the Secretary shall, where and to
the extent considered by him necessary, cause
to be made by inspectors ante mortem inspec-
tion of poultry in each official establishment
processing poultry or poultry products for com-
merce or otherwise subject to inspection under
this chapter.
(b) Post mortem inspection; quarantine, segrega-
tion, and reinspection
The Secretary, whenever processing oper-
ations are being conducted, shall cause to be
made by inspectors post mortem inspection of
the carcass of each bird processed, and at any
time such quarantine, segregation, and reinspec-
tion as he deems necessary of poultry and poul-
try products capable of use as human food in
each official establishment processing such
poultry or poultry products for commerce or
otherwise subject to inspection under this chap-
ter.
(c) Condemnation; appeal; reprocessing
All poultry carcasses and parts thereof and
other poultry products found to be adulterated
shall be condemned and shall, if no appeal be
taken from such determination of condemna-
tion, be destroyed for human food purposes
under the supervision of an inspector: Provided,
That carcasses, parts, and products, which may
by reprocessing be made not adulterated, need
not be so condemned and destroyed if so reproc-
essed under the supervision of an inspector and
thereafter found to be not adulterated. If an ap-
peal be taken from such determination, the car-
casses, parts, or products shall be appropriately
marked and segregated pending completion of
an appeal inspection, which appeal shall be at
the cost of the appellant if the Secretary deter-
mines that the appeal is frivolous. If the deter-
mination of condemnation is sustained the car-
casses, parts, and products shall be destroyed for
human food purposes under the supervision of an
inspector.
(Pub. L. 85–172, § 6, Aug. 28, 1957, 71 Stat. 443;
Pub. L. 90–492, § 6, Aug. 18, 1968, 82 Stat. 798.)
Page 725
TITLE 21—FOOD AND DRUGS
§ 457
Editorial Notes
AMENDMENTS
1968—Par. (a). Pub. L. 90–492, § 6(a), substituted ‘‘of, or
the burdening of commerce by, any poultry product
which is capable of use as human food and is adulter-
ated,’’ for ‘‘or a designated major consuming area of
any poultry product which is unwholesome or adulter-
ated,’’ ‘‘each official establishment’’ for ‘‘any official
establishment’’, and ‘‘otherwise subject to inspection
under this chapter’’ for ‘‘in, or for marketing in a des-
ignated city or area’’.
Par. (b). Pub. L. 90–492, § 6(b), substituted ‘‘segrega-
tion, and reinspection’’ for ‘‘segregation, reinspection’’,
and ‘‘otherwise subject to inspection under this chap-
ter’’ for ‘‘in, or for marketing in a designated city or
area’’, and inserted ‘‘capable of use as human food’’
after ‘‘necessary of poultry and poultry products’’.
Par. (c). Pub. L. 90–492, § 6(c), inserted ‘‘other’’ before
‘‘poultry products’’, and substituted ‘‘to be adulter-
ated’’ for ‘‘to be unwholesome or adulterated’’, ‘‘made
not adulterated’’ for ‘‘made not unwholesome and not
adulterated’’, and ‘‘to be not adulterated’’ for ‘‘to be
not unwholesome and not adulterated’’.
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90–492 effective Aug. 18, 1968,
see section 20 of Pub. L. 90–492, set out as a note under
section 451 of this title.
APPLICABILITY OF CHAPTER REQUIREMENTS TO BIRDS
OF THE ORDER RATITAE
Pub. L. 106–387, § 1(a) [title VII, § 752], Oct. 28, 2000, 114
Stat. 1549, 1549A–41, provided that: ‘‘Effective 180 days
after the date of the enactment of this Act [Oct. 28,
2000] and continuing for the remainder of fiscal year
2001 and each subsequent fiscal year, establishments in
the United States that slaughter or process birds of the
order Ratitae, such as ostriches, emus and rheas, and
squab, for distribution in commerce as human food
shall be subject to the ante mortem and post mortem
inspection, reinspection, and sanitation requirements
of the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.) rather than the voluntary poultry inspection pro-
gram of the Department of Agriculture under section
203 of the Agricultural Marketing Act of 1946 (7 U.S.C.
1622).’’
§ 456. Operation of premises, facilities and equip-
ment
(a) Sanitary practices
Each official establishment slaughtering poul-
try or processing poultry products for commerce
or otherwise subject to inspection under this
chapter shall have such premises, facilities, and
equipment, and be operated in accordance with
such sanitary practices, as are required by regu-
lations promulgated by the Secretary for the
purpose of preventing the entry into or flow or
movement in commerce or burdensome effect
upon commerce, of poultry products which are
adulterated.
(b) Refusal of inspection
The Secretary shall refuse to render inspec-
tion to any establishment whose premises, fa-
cilities, or equipment, or the operation thereof,
fail to meet the requirements of this section.
(Pub. L. 85–172, § 7, Aug. 28, 1957, 71 Stat. 444;
Pub. L. 90–492, § 7, Aug. 18, 1968, 82 Stat. 799.)
Editorial Notes
AMENDMENTS
1968—Par. (a). Pub. L. 90–492 substituted ‘‘otherwise
subject to inspection under this chapter’’ for ‘‘in or for
marketing in a designated major consuming area’’,
‘‘burdensome effect upon commerce’’ for ‘‘in a des-
ignated major consuming area’’, and ‘‘which are adul-
terated’’ for ‘‘which are unwholesome or adulterated’’.
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90–492 effective Aug. 18, 1968,
see section 20 of Pub. L. 90–492, set out as a note under
section 451 of this title.
§ 457. Labeling and container standards
(a) Requirements for shipping containers and
immediate containers; nonconsumer pack-
aged carcasses
All poultry products inspected at any official
establishment under the authority of this chap-
ter and found to be not adulterated, shall at the
time they leave the establishment bear, in dis-
tinctly legible form, on their shipping con-
tainers and immediate containers as the Sec-
retary may require, the information required
under paragraph (h) of section 453 of this title.
In addition, the Secretary whenever he deter-
mines such action is practicable and necessary
for the protection of the public, may require
nonconsumer packaged carcasses at the time
they leave the establishment to bear directly
thereon in distinctly legible form any informa-
tion required under such paragraph (h).
(b) Labeling requirements; definitions and stand-
ards of identity or composition or articles
and standards of fill of container; standards
consistent with Federal Food, Drug, and Cos-
metic Act; consistency between Federal and
State standards
The Secretary, whenever he determines such
action is necessary for the protection of the pub-
lic, may prescribe: (1) the styles and sizes of
type to be used with respect to material re-
quired to be incorporated in labeling to avoid
false or misleading labeling in marking and la-
beling any articles or poultry subject to this
chapter; (2) definitions and standards of identity
or composition or articles subject to this chap-
ter and standards of fill of container for such ar-
ticles not inconsistent with any such standards
established under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.], and there
shall be consultation between the Secretary and
the Secretary of Health and Human Services
prior to the issuance of such standards under ei-
ther Act relating to articles subject to this
chapter to avoid inconsistency in such standards
and possible impairment of the coordinated ef-
fective administration of this chapter and the
Federal Food, Drug, and Cosmetic Act. There
shall also be consultation between the Secretary
and an appropriate advisory committee provided
for in section 454 of this title, prior to the
issuance of such standards under this chapter, to
avoid, insofar as feasible, inconsistency between
Federal and State standards.
(c) Use of trade names; false or misleading mark-
ing or labeling; misleading form or size of
container
No article subject to this chapter shall be sold
or offered for sale by any person in commerce,
under any name or other marking or labeling
Cross-references
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
Page 30
TITLE 21—FOOD AND DRUGS
§ 301
Sec.
398.
Notices to States regarding imported food.
399.
Grants to enhance food safety.
399a.
Office of the Chief Scientist.
399b.
Office of Women’s Health.
399c.
Improving the training of State, local, terri-
torial, and tribal food safety officials.
399d.
Employee protections.
399e.
Nanotechnology.
399f.
Ensuring
adequate
information
regarding
pharmaceuticals for all populations, par-
ticularly underrepresented subpopulations,
including racial subgroups.
399g.
Food and Drug Administration Intercenter
Institutes.
399h.
National Centers of Excellence in Advanced
and Continuous Pharmaceutical Manufac-
turing.
399i.
Food and Drug Administration Working Cap-
ital Fund.
SUBCHAPTER I—SHORT TITLE
§ 301. Short title
This chapter may be cited as the Federal
Food, Drug, and Cosmetic Act.
(June 25, 1938, ch. 675, § 1, 52 Stat. 1040.)
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES
Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro-
vided that:
‘‘[SEC. 1] (a) The effective date of the following provi-
sions of the Federal Food, Drug, and Cosmetic Act is
hereby postponed until January 1, 1940: Sections 402(c)
[342(c) of this title]; 403(e)(1) [343(e)(1) of this title];
403(g), (h), (i), (j), and (k) [343(g) to (k) of this title];
501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g),
and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of
this title]; and 602(b) [362(b) of this title].
‘‘(b) The Secretary of Agriculture shall promulgate
regulations further postponing to July 1, 1940[,] the ef-
fective date of the provisions of sections 403(e)(1)
[343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g)
to (k)]; 502(b), (d), (
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Federal law — U.S. Code and appendices · legal_authorities
Poultry and poultry products are an important source of the Nation’s total supply of food. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential in the public interest that the health and welfare of consumers be protected by assuring that poultry products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged. Unwholesome, adulterated, or misbranded poultry products impair the effective regulation of poultry products in interstate or foreign commerce, are injurious to the public welfare, destroy markets for wholesome, not adulterated, and properly labeled and packaged poultry products, and result in sundry losses to poultry producers and processors of poultry and poultry products, as well as injury to consumers. It is hereby found that all articles and poultry which are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce, and that regulation by the Secretary of Agriculture and cooperation by the States and other jurisdictions as contemplated by this chapter are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 451
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Federal law — U.S. Code and appendices · legal_authorities
Page 718
TITLE 21—FOOD AND DRUGS
§ 451
or actual charges for personal services, mate-
rials, equipment, information technology, and
other expenses. Charges for equipment and in-
formation technology shall include costs associ-
ated with maintenance, repair, and depreciation
(including improvement and replacement).
(b) Appropriations
Of any discretionary resources appropriated in
this Act for fiscal year 2018 for ‘‘Department of
Health and Human Services, Food and Drug Ad-
ministration, Salaries and Expenses’’, not to ex-
ceed $5,000,000 of amounts available as of Sep-
tember 30 may be transferred to and merged
with the Fund established under subsection (a),
notwithstanding any otherwise applicable pur-
pose limitations.
(c) Emergency funds excluded
No amounts may be transferred pursuant to
this section that are designated by the Congress
as an emergency requirement pursuant to a con-
current resolution on the budget or the Bal-
anced Budget and Emergency Deficit Control
Act of 1985.
(Pub. L. 115–141, div. A, title VII, § 722, Mar. 23,
2018, 132 Stat. 387.)
Editorial Notes
REFERENCES IN TEXT
This Act, referred to in subsec. (b), is div. A of Pub.
L. 115–141, Mar. 23, 2018, 132 Stat. 351, known as the Ag-
riculture, Rural Development, Food and Drug Adminis-
tration, and Related Agencies Appropriations Act, 2018.
For complete classification of this Act to the Code, see
Tables.
The Balanced Budget and Emergency Deficit Control
Act of 1985, referred to in subsec. (c), is title II of Pub.
L. 99–177, Dec. 12, 1985, 99 Stat. 1038, which enacted
chapter 20 (§ 900 et seq.) and sections 654 to 656 of Title
2, The Congress, amended sections 602, 622, 631 to 642,
and 651 to 653 of Title 2, sections 1104 to 1106, and 1109
of Title 31, Money and Finance, and
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Ante mortem inspection** For the purpose of preventing the entry into or flow or movement in commerce of, or the burdening of commerce by, any poultry product which is capable of use as human food and is adulterated, the Secretary shall, where and to the extent considered by him necessary, cause to be made by inspectors ante mortem inspection of poultry in each official establishment processing poultry or poultry products for commerce or otherwise subject to inspection under this chapter.
**(b) Post mortem inspection; quarantine, segregation, and reinspection** The Secretary, whenever processing operations are being conducted, shall cause to be made by inspectors post mortem inspection of the carcass of each bird processed, and at any time such quarantine, segregation, and reinspection as he deems necessary of poultry and poultry products capable of use as human food in each official establishment processing such poultry or poultry products for commerce or otherwise subject to inspection under this chapter.
**(c) Condemnation; appeal; reprocessing** All poultry carcasses and parts thereof and other poultry products found to be adulterated shall be condemned and shall, if no appeal be taken from such determination of condemnation, be destroyed for human food purposes under the supervision of an inspector: Provided, That carcasses, parts, and products, which may by reprocessing be made not adulterated, need not be so condemned and destroyed if so reprocessed under the supervision of an inspector and thereafter found to be not adulterated. If an appeal be taken from such determination, the carcasses, parts, or products shall be appropriately marked and segregated pending completion of an appeal inspection, which appeal shall be at the cost of the appellant if the S
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Federal law — U.S. Code and appendices · legal_authorities
The Secretary of Agriculture is directed and authorized:
**(a) Determination of methods of processing, packaging, marketing, etc.; publication of results** To conduct, assist, and foster research, investigation, and experimentation to determine the best methods of processing, preparation for market, packaging, handling, transporting, storing, distributing, and marketing agricultural products: Provided, That the results of such research shall be made available to the public for the purpose of expanding the use of American agricultural products in such manner as the Secretary of Agriculture may determine.
**(b) Determination of costs** To determine costs of marketing agricultural products in their various forms and through the various channels and to foster and assist in the development and establishment of more efficient marketing methods (including analyses of methods and proposed methods), practices, and facilities, for the purpose of bringing about more efficient and orderly marketing, and reducing the price spread between the producer and the consumer.
**(c) Improvement of standards of quality, condition, etc.; standard of quality for ice cream** To develop and improve standards of quality, condition, quantity, grade, and packaging, and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices. Within thirty days after September 29, 1977, the Secretary shall by regulation adopt a standard of quality for ice cream which shall provide that ice cream shall contain at least 1.6 pounds of total solids to the gallon, weigh not less than 4.5 pounds to the gallon and contain not less than 20 percent total milk solids, constituted of not less than 10 percent milkfat. In no case shall the content of milk solids not fat
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Page 897
TITLE 7—AGRICULTURE
§ 1622
State funds in support of specialty crops grown in
that State, rather than replace State funds.
‘‘(e) PLAN REQUIREMENTS.—The State plan shall iden-
tify the lead agency charged with the responsibility of
carrying out the plan and indicate how the grant funds
will be utilized to enhance the competitiveness of spe-
cialty crops.
‘‘(f) REVIEW OF APPLICATION.—In reviewing the appli-
cation of a State submitted under subsection (d), the
Secretary of Agriculture shall ensure that the State
plan would carry out the purpose of grant program, as
specified in subsection (a). The Secretary may accept
or reject applications for a grant under this section.
‘‘(g) EFFECT OF NONCOMPLIANCE.—If the Secretary of
Agriculture, after reasonable notice to a State, finds
that there has been a failure by the State to comply
substantially with any provision or requirement of the
State plan, the Secretary may disqualify, for one or
more years, the State from receipt of future grants
under this section.
‘‘(h) AUDIT REQUIREMENTS.—For each year that a
State receives a grant under this section, the State
shall conduct an audit of the expenditures of grant
funds by the State. Not later than 30 days after the
completion of the audit, the State shall submit a copy
of the audit to the Secretary of Agriculture.
‘‘(i) REALLOCATION.—
‘‘(1) IN GENERAL.—The Secretary shall reallocate to
other States in accordance with paragraph (2) any
amounts made available for a fiscal year under this
section that are not obligated or expended by a date
during that fiscal year determined by the Secretary.
‘‘(2) PRO RATA ALLOCATION.—The Secretary shall al-
locate funds described in paragraph (1) pro rata to the
remaining States that applied during the specified
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