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21 U.S.C. § 466 — Imports
Federal law — U.S. Code and appendices · legal_authorities
Page 732
TITLE 21—FOOD AND DRUGS
§ 465
Poultry Products Inspection Act and a study on an ex-
emption from requirements of such Acts for certain
wholesale meat outlets selling to hotels and other simi-
lar institutional users not later than 24 months after
Dec. 13, 1991, and on completion of each study to pro-
vide the results to Committee on Agriculture of House
of Representatives and Committee on Agriculture, Nu-
trition, and Forestry of Senate.
§ 465. Limitations upon entry of poultry products
and other materials into official establish-
ments
The Secretary may limit the entry of poultry
products and other materials into any official
establishment, under such conditions as he may
prescribe to assure that allowing the entry of
such articles into such inspected establishments
will be consistent with the purposes of this
chapter.
(Pub. L. 85–172, § 16, Aug. 28, 1957, 71 Stat. 448;
Pub. L. 90–492, § 15, Aug. 18, 1968, 82 Stat. 805.)
Editorial Notes
AMENDMENTS
1968—Pub. L. 90–492 substituted provisions author-
izing the Secretary to limit the entry of poultry prod-
ucts and other materials into any official establish-
ment for provisions that any person distributing un-
wholesome or adulterated exempted poultry or poultry
products intended for human consumption shall be
guilty of a misdemeanor and subject to penalties upon
conviction thereof.
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.
§ 466. Imports
(a) Compliance with standards and regulations;
status after importation
No slaughtered poultry, or parts or products
thereof, of any kind shall be imported into the
United States unl
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Page 732
TITLE 21—FOOD AND DRUGS
§ 465
Poultry Products Inspection Act and a study on an ex-
emption from requirements of such Acts for certain
wholesale meat outlets selling to hotels and other simi-
lar institutional users not later than 24 months after
Dec. 13, 1991, and on completion of each study to pro-
vide the results to Committee on Agriculture of House
of Representatives and Committee on Agriculture, Nu-
trition, and Forestry of Senate.
§ 465. Limitations upon entry of poultry products
and other materials into official establish-
ments
The Secretary may limit the entry of poultry
products and other materials into any official
establishment, under such conditions as he may
prescribe to assure that allowing the entry of
such articles into such inspected establishments
will be consistent with the purposes of this
chapter.
(Pub. L. 85–172, § 16, Aug. 28, 1957, 71 Stat. 448;
Pub. L. 90–492, § 15, Aug. 18, 1968, 82 Stat. 805.)
Editorial Notes
AMENDMENTS
1968—Pub. L. 90–492 substituted provisions author-
izing the Secretary to limit the entry of poultry prod-
ucts and other materials into any official establish-
ment for provisions that any person distributing un-
wholesome or adulterated exempted poultry or poultry
products intended for human consumption shall be
guilty of a misdemeanor and subject to penalties upon
conviction thereof.
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.
§ 466. Imports
(a) Compliance with standards and regulations;
status after importation
No slaughtered poultry, or parts or products
thereof, of any kind shall be imported into the
United States unless they are healthful, whole-
some, fit for human food, not adulterated, and
contain no dye, chemical, preservative, or ingre-
dient which renders them unhealthful, un-
wholesome, adulterated, or unfit for human food
and unless they also comply with the rules and
regulations made by the Secretary of Agri-
culture to assure that imported poultry or poul-
try products comply with the standards provided
for in this chapter. All imported, slaughtered
poultry, or parts or products thereof, shall after
entry into the United States in compliance with
such rules and regulations be deemed and treat-
ed as domestic slaughtered poultry, or parts or
products thereof, within the meaning and sub-
ject to the provisions of this chapter and the
Federal Food, Drug, and Cosmetic Act [21 U.S.C.
301 et seq.], and Acts amendatory of, supple-
mental to, or in substitution for such chapter
and Act.
(b) Rules and regulations; destruction and expor-
tation of refused imports
The Secretary of Agriculture is authorized to
make rules and regulations to carry out the pur-
poses of this section and in such rules and regu-
lations the Secretary of Agriculture may pre-
scribe the terms and conditions for the destruc-
tion of all slaughtered poultry, or parts or prod-
ucts thereof, offered for entry and refused ad-
mission into the United States unless such
slaughtered poultry, or parts or products there-
of, be exported by the consignee within the time
fixed therefor in such rules and regulations.
(c) Storage, cartage and labor charges for im-
ports refused admission
All charges for storage, cartage, and labor
with respect to any product which is refused ad-
mission pursuant to this section shall be paid by
the owner or consignee, and in default of such
payment shall constitute a lien against any
other products imported thereafter by or for
such owner or consignee.
(d) Domestic standards and processing facilities
applicable; enforcement
(1) Notwithstanding any other provision of
law, all poultry, or parts or products of poultry,
capable of use as human food offered for impor-
tation into the United States shall—
(A) be subject to inspection, sanitary, qual-
ity, species verification, and residue standards
that achieve a level of sanitary protection
equivalent to that achieved under United
States standards; and
(B) have been processed in facilities and
under conditions that achieve a level of sani-
tary protection equivalent to that achieved
under United States standards.
(2)(A) The Secretary may treat as equivalent
to a United States standard a standard of an ex-
porting country described in paragraph (1) if the
exporting country provides the Secretary with
scientific evidence or other information, in ac-
cordance with risk assessment methodologies
determined appropriate by the Secretary, to
demonstrate that the standard of the exporting
country achieves the level of sanitary protec-
tion achieved under the United States standard.
For the purposes of this subsection, the term
‘‘sanitary protection’’ means protection to safe-
guard public health.
(B) The Secretary may—
(i) determine, on a scientific basis, that the
standard of the exporting country does not
achieve the level of protection that the Sec-
retary considers appropriate; and
(ii) provide the basis for the determination
in writing to the exporting country on re-
quest.
(3) Any such imported poultry article that
does not meet such standards shall not be per-
mitted entry into the United States.
(4) The Secretary shall enforce this subsection
through—
(A) random inspections for such species
verification and for residues; and
(B) random sampling and testing of internal
organs and fat of carcasses for residues at the
point of slaughter by the exporting country, in
accordance with methods approved by the Sec-
retary.
(Pub. L. 85–172, § 17, Aug. 28, 1957, 71 Stat. 448;
Pub. L. 99–198, title XVII, § 1701(a), Dec. 23, 1985,
99 Stat. 1633; Pub. L. 103–182, title III, § 361(e),
Page 733
TITLE 21—FOOD AND DRUGS
§ 467
Dec. 8, 1993, 107 Stat. 2123; Pub. L. 103–465, title
IV, § 431(k), Dec. 8, 1994, 108 Stat. 4969.)
Editorial Notes
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat.
1040, which is classified generally to chapter 9 (§ 301 et
seq.) of this title. For complete classification of this
Act to the Code, see section 301 of this title and Tables.
AMENDMENTS
1994—Subsec. (d)(1). Pub. L. 103–465, § 431(k)(1), amend-
ed par. (1) generally. Prior to amendment, par. (1) read
as follows: ‘‘Notwithstanding any other provision of
law, except as provided in paragraph (2), all poultry, or
parts or products thereof, capable of use as human food
offered for importation into the United States shall—
‘‘(A) be subject to the same inspection, sanitary,
quality, species verification, and residue standards
applied to products produced in the United States;
and
‘‘(B) have been processed in facilities and under
conditions that are the same as those under which
similar products are processed in the United States.’’
Subsec.
(d)(2)(A).
Pub.
L.
103–465,
§ 431(k)(2)(A),
amended subpar. (A) generally. Prior to amendment,
subpar. (A) read as follows: ‘‘Notwithstanding any
other provision of law, all poultry, or parts or products
of poultry, capable of use as human food offered for im-
portation into the United States from Canada and Mex-
ico shall—
‘‘(i) comply with paragraph (1); or
‘‘(ii)(I) be subject to inspection, sanitary, quality,
species verification, and residue standards that are
equivalent to United States standards; and
‘‘(II) have been processed in facilities and under
conditions that meet standards that are equivalent to
United States standards.’’
Subsec. (d)(2)(B), (C). Pub. L. 103–465, § 431(k)(2)(B),
(C), redesignated subpar. (C) as (B) and struck out
former subpar. (B) which read as follows: ‘‘The Sec-
retary may treat as equivalent to a United States
standard a standard of Canada or Mexico described in
subparagraph (A)(ii) if the exporting country provides
the Secretary with scientific evidence or other infor-
mation, in accordance with risk assessment methodolo-
gies agreed to by the Secretary and the exporting coun-
try, to demonstrate that the standard of the exporting
country achieves the level of protection that the Sec-
retary considers appropriate.’’
1993—Subsec. (d). Pub. L. 103–182, in par. (1), inserted
‘‘except as provided in paragraph (2),’’ before ‘‘all poul-
try’’ in introductory provisions, added par. (2), and re-
designated former pars. (2) and (3) as (3) and (4), respec-
tively.
1985—Par. (d). Pub. L. 99–198 added par. (d).
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by Pub. L. 103–465 effective, except as
otherwise provided, on the date of entry into force of
the World Trade Organization Agreement with respect
to the United States (Jan. 1, 1995), see section 451 of
Pub. L. 103–465, set out as an Effective Date note under
section 3601 of Title 19, Customs Duties.
EFFECTIVE DATE OF 1985 AMENDMENT
Pub. L. 99–198, title XVII, § 1701(b), Dec. 23, 1985, 99
Stat. 1633, provided that: ‘‘The amendment made by
this section [amending this section] shall become effec-
tive 6 months after the date of enactment of this Act
[Dec. 23, 1985].’’
§ 467. Inspection services
(a) Refusal or withdrawal; hearing; business
unfitness based upon certain convictions;
persons responsibly connected with the busi-
ness
The Secretary may (for such period, or indefi-
nitely, as he deems necessary to effectuate the
purposes of this chapter) refuse to provide, or
withdraw, inspection service under this chapter
with respect to any establishment if he deter-
mines, after opportunity for a hearing is ac-
corded to the applicant for, or recipient of, such
service, that such applicant or recipient is unfit
to engage in any business requiring inspection
upon this chapter because the applicant or re-
cipient or anyone responsibly connected with
the applicant or recipient, has been convicted,
in any Federal or State court, within the pre-
vious ten years of (1) any felony or more than
one misdemeanor under any law based upon the
acquiring, handling, or distributing of adulter-
ated, mislabeled, or deceptively packaged food
or fraud in connection with transactions in food;
or (2) any felony, involving fraud, bribery, extor-
tion, or any other act or circumstances indi-
cating a lack of the integrity needed for the con-
duct of operations affecting the public health.
For the purpose of this paragraph a person shall
be deemed to be responsibly connected with the
business if he was a partner, officer, director,
holder, or owner of 10 per centum or more of its
voting stock or employee in a managerial or ex-
ecutive capacity.
(b) Hearing to determine validity of withdrawal
or refusal of inspection services; continu-
ation of withdrawal or refusal
Upon the withdrawal of inspection service
from any official establishment for failure to de-
stroy condemned poultry products as required
under section 455 of this title, or other failure of
an official establishment to comply with the re-
quirements as to premises, facilities, or equip-
ment, or the operation thereof, as provided in
section 456 of this title, or the refusal of inspec-
tion service to any applicant therefor because of
failure to comply with any requirements under
section 456 of this title, the applicant for, or re-
cipient of, the service shall, upon request, be af-
forded opportunity for a hearing with respect to
the merits or validity of such action; but such
withdrawal or refusal shall continue in effect
unless otherwise ordered by the Secretary.
(c) Finality and conclusiveness of determination;
judicial review; record
The determination and order of the Secretary
when made after opportunity for hearing, with
respect to withdrawal or refusal of inspection
service under this chapter shall be final and con-
clusive unless the affected applicant for, or re-
cipient of, inspection service files application
for judicial review within thirty days after the
effective date of such order in the United States
Court of Appeals as provided in section 457 of
this title. Judicial review of any such order
shall be upon the record upon which the deter-
mination and order are based. The provisions of
section 194 of title 7 shall be applicable to ap-
peals taken under this section.
(Pub. L. 85–172, § 18, Aug. 28, 1957, 71 Stat. 448;
Pub. L. 90–492, § 16, Aug. 18, 1968, 82 Stat. 805.)
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), (
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Compliance with standards and regulations; status after importation** No slaughtered poultry, or parts or products thereof, of any kind shall be imported into the United States unless they are healthful, wholesome, fit for human food, not adulterated, and contain no dye, chemical, preservative, or ingredient which renders them unhealthful, unwholesome, adulterated, or unfit for human food and unless they also comply with the rules and regulations made by the Secretary of Agriculture to assure that imported poultry or poultry products comply with the standards provided for in this chapter. All imported, slaughtered poultry, or parts or products thereof, shall after entry into the United States in compliance with such rules and regulations be deemed and treated as domestic slaughtered poultry, or parts or products thereof, within the meaning and subject to the provisions of this chapter and the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.], and Acts amendatory of, supplemental to, or in substitution for such chapter and Act.
**(b) Rules and regulations; destruction and exportation of refused imports** The Secretary of Agriculture is authorized to make rules and regulations to carry out the purposes of this section and in such rules and regulations the Secretary of Agriculture may prescribe the terms and conditions for the destruction of all slaughtered poultry, or parts or products thereof, offered for entry and refused admission into the United States unless such slaughtered poultry, or parts or products thereof, be exported by the consignee within the time fixed therefor in such rules and regulations.
**(c) Storage, cartage and labor charges fo
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