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7 U.S.C. § 1639 — Definitions
Federal law — U.S. Code and appendices · legal_authorities
Page 946
TITLE 7—AGRICULTURE
§ 1639
2008, except for ‘‘farm-raised fish’’ and ‘‘wild
fish’’ which shall be September 30, 2004.
(Aug. 14, 1946, ch. 966, title II, § 285, as added Pub.
L. 107–171, title X, § 10816, May 13, 2002, 116 Stat.
535; amended Pub. L. 108–199, div. A, title VII,
§ 749, Jan. 23, 2004, 118 Stat. 37; Pub. L. 109–97,
title VII, § 792, Nov. 10, 2005, 119 Stat. 2164.)
Editorial Notes
AMENDMENTS
2005—Pub. L. 109–97 substituted ‘‘2008’’ for ‘‘2006’’.
2004—Pub. L. 108–199 substituted ‘‘2006, except for
‘farm-raised fish’ and ‘wild fish’ which shall be Sep-
tember 30, 2004’’ for ‘‘2004’’.
SUBCHAPTER
V—NATIONAL
BIOENGI-
NEERED FOOD DISCLOSURE STANDARD
§ 1639. Definitions
In this subchapter:
(1) Bioengineering
The term ‘‘bioengineering’’, and any similar
term, as determined by the Secretary, with re-
spect to a food, refers to a food—
(A) that contains genetic material that
has been modified through in vitro recom-
binant deoxyribonucleic acid (DNA) tech-
niques; and
(B) for which the modification could not
otherwise be obtained through conventional
breeding or found in nature.
(2) Food
The term ‘‘food’’ means a food (as defined in
section 321 of title 21) that is intended for
human consumption.
(3) Secretary
The term ‘‘Secretary’’ means the Secretary
of Agriculture.
(Aug. 14, 1946, ch. 966, title II, § 291, as added Pub.
L. 114–216, § 1, July 29, 2016, 130 Stat. 834.)
§ 1639a. Applicability
(a) In general
This subchapter shall apply to any claim in a
disclosure that a food bears that indicates that
the food is a bioengineered food.
(b) Application of definition
The definition of the term ‘‘bioengineering’’
under section 1639 of this title shall not affect
any other definition, program, rule, or regula-
tion of the Feder
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Page 946
TITLE 7—AGRICULTURE
§ 1639
2008, except for ‘‘farm-raised fish’’ and ‘‘wild
fish’’ which shall be September 30, 2004.
(Aug. 14, 1946, ch. 966, title II, § 285, as added Pub.
L. 107–171, title X, § 10816, May 13, 2002, 116 Stat.
535; amended Pub. L. 108–199, div. A, title VII,
§ 749, Jan. 23, 2004, 118 Stat. 37; Pub. L. 109–97,
title VII, § 792, Nov. 10, 2005, 119 Stat. 2164.)
Editorial Notes
AMENDMENTS
2005—Pub. L. 109–97 substituted ‘‘2008’’ for ‘‘2006’’.
2004—Pub. L. 108–199 substituted ‘‘2006, except for
‘farm-raised fish’ and ‘wild fish’ which shall be Sep-
tember 30, 2004’’ for ‘‘2004’’.
SUBCHAPTER
V—NATIONAL
BIOENGI-
NEERED FOOD DISCLOSURE STANDARD
§ 1639. Definitions
In this subchapter:
(1) Bioengineering
The term ‘‘bioengineering’’, and any similar
term, as determined by the Secretary, with re-
spect to a food, refers to a food—
(A) that contains genetic material that
has been modified through in vitro recom-
binant deoxyribonucleic acid (DNA) tech-
niques; and
(B) for which the modification could not
otherwise be obtained through conventional
breeding or found in nature.
(2) Food
The term ‘‘food’’ means a food (as defined in
section 321 of title 21) that is intended for
human consumption.
(3) Secretary
The term ‘‘Secretary’’ means the Secretary
of Agriculture.
(Aug. 14, 1946, ch. 966, title II, § 291, as added Pub.
L. 114–216, § 1, July 29, 2016, 130 Stat. 834.)
§ 1639a. Applicability
(a) In general
This subchapter shall apply to any claim in a
disclosure that a food bears that indicates that
the food is a bioengineered food.
(b) Application of definition
The definition of the term ‘‘bioengineering’’
under section 1639 of this title shall not affect
any other definition, program, rule, or regula-
tion of the Federal Government.
(c) Application to foods
This subchapter shall apply only to a food sub-
ject to—
(1) the labeling requirements under the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.); or
(2) the labeling requirements under the Fed-
eral Meat Inspection Act (21 U.S.C. 601 et seq.),
the Poultry Products Inspection Act (21 U.S.C.
451 et seq.), or the Egg Products Inspection
Act (21 U.S.C. 1031 et seq.) only if—
(A) the most predominant ingredient of
the food would independently be subject to
the labeling requirements under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.); or
(B)(i) the most predominant ingredient of
the food is broth, stock, water, or a similar
solution; and
(ii) the second-most predominant ingre-
dient of the food would independently be
subject to the labeling requirements under
the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.).
(Aug. 14, 1946, ch. 966, title II, § 292, as added Pub.
L. 114–216, § 1, July 29, 2016, 130 Stat. 834.)
Editorial Notes
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (c)(1), (2)(A), (B)(ii), is act June 25, 1938,
ch. 675, 52 Stat. 1040, which is classified generally to
chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For
complete classification of this Act to the Code, see sec-
tion 301 of Title 21 and Tables.
The Federal Meat Inspection Act, referred to in sub-
sec. (c)(2), is titles I to IV of act Mar. 4, 1907, ch. 2907,
as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, which
are classified generally to subchapters I to IV (§ 601 et
seq.) of Title 21, Food and Drugs. For complete classi-
fication of this Act to the Code, see Short Title note
set out under section 601 of Title 21 and Tables.
The Poultry Products Inspection Act, referred to in
subsec. (c)(2), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat.
441, which is classified generally to chapter 10 (§ 451 et
seq.) of Title 21, Food and Drugs. For complete classi-
fication of this Act to the Code, see Short Title note
set out under section 451 of Title 21 and Tables.
The Egg Products Inspection Act, referred to in sub-
sec. (c)(2), is Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620,
which is classified principally to chapter 15 (§ 1031 et
seq.) of Title 21, Food and Drugs. For complete classi-
fication of this Act to the Code, see Short Title note
set out under section 1031 of Title 21 and Tables.
§ 1639b. Establishment of national bioengineered
food disclosure standard
(a) Establishment of mandatory standard
Not later than 2 years after July 29, 2016, the
Secretary shall—
(1) establish a national mandatory bioengi-
neered food disclosure standard with respect
to any bioengineered food and any food that
may be bioengineered; and
(2) establish such requirements and proce-
dures as the Secretary determines necessary
to carry out the standard.
(b) Regulations
(1) In general
A food may bear a disclosure that the food is
bioengineered only in accordance with regula-
tions promulgated by the Secretary in accord-
ance with this subchapter.
(2) Requirements
A regulation promulgated by the Secretary
in carrying out this subchapter shall—
(A) prohibit a food derived from an animal
to be considered a bioengineered food solely
because the animal consumed feed produced
from, containing, or consisting of a bioengi-
neered substance;
(B) determine the amounts of a bioengi-
neered substance that may be present in
food, as appropriate, in order for the food to
be a bioengineered food;
Cross-references
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Federal law — U.S. Code and appendices · legal_authorities
Eggs and egg products are an important source of the Nation’s total supply of food, and are used in food in various forms. 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 the adoption of measures prescribed herein for assuring that eggs and egg products distributed to them and used in products consumed by them are wholesome, otherwise not adulterated, and properly labeled and packaged. Lack of effective regulation for the handling or disposition of unwholesome, otherwise adulterated, or improperly labeled or packaged egg products and certain qualities of eggs is injurious to the public welfare and destroys markets for wholesome, not adulterated, and properly labeled and packaged eggs and egg products and results in sundry losses to producers and processors, as well as injury to consumers. Unwholesome, otherwise adulterated, or improperly labeled or packaged products can be sold at lower prices and compete unfairly with the wholesome, not adulterated, and properly labeled and packaged products, to the detriment of consumers and the public generally. It is hereby found that all egg products and the qualities of eggs 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 the Secretary of Health and Human Services, 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.
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Federal law — U.S. Code and appendices · legal_authorities
Page 911
TITLE 21—FOOD AND DRUGS
§ 1031
CHAPTER 14—ALCOHOL AND DRUG ABUSE
EDUCATIONAL PROGRAMS AND ACTIVITIES
§§ 1001 to 1007. Repealed. Pub. L. 97–35, title V,
§ 587(a)(3), Aug. 13, 1981, 95 Stat. 480
Section 1001, Pub. L. 91–527, § 2, Dec. 3, 1970, 84 Stat.
1385; Pub. L. 93–422, § 2(b), Sept. 21, 1974, 88 Stat. 1154;
Pub. L. 95–336, § 2, Aug. 4, 1978, 92 Stat. 451, set forth
Congressional declaration of purpose for Alcohol and
Drug Abuse Education Act.
Section 1002, Pub. L. 91–527, § 3, Dec. 3, 1970, 84 Stat.
1386; Pub. L. 93–422, § 2(c), Sept. 21, 1974, 88 Stat. 1155;
Pub. L. 95–336, §§ 3, 4, Aug. 4, 1978, 92 Stat. 451, 452; S.
Res. 30, Mar. 7, 1979; Pub. L. 96–88, title III, § 301(a)(1),
(2)(Q), (b)(1), title V, § 507, Oct. 17, 1979, 93 Stat. 677, 678,
692, set forth grant and contract authority, etc., for
projects and programs.
Section 1003, Pub. L. 91–527, § 4, Dec. 3, 1970, 84 Stat.
1387; Pub. L. 93–422, § 2(d), Sept. 21, 1974, 88 Stat. 1157;
Pub. L. 96–88, title III, § 301(a)(1), title V, § 507, Oct. 17,
1979, 93 Stat. 677, 692, related to recordkeeping require-
ments, and access to and inspection of records.
Section 1004, Pub. L. 91–527, § 5, Dec. 3, 1970, 84 Stat.
1388; Pub. L. 93–422, § 2(e), Sept. 21, 1974, 88 Stat. 1157;
Pub. L. 96–88, title V, § 508(i), Oct. 17, 1979, 93 Stat. 693,
related to technical assistance to local agencies, etc.
Section 1005, Pub. L. 91–527, § 6, Dec. 3, 1970, 84 Stat.
1388, related to nature of payments.
Section 1006, Pub. L. 91–527, § 7, Dec. 3, 1970, 84 Stat.
1388, related to utilization of services and facilities of
Federal agencies and public and private agencies and
institutions.
Section 1007, Pub. L. 91–527, § 8, Dec. 3, 1970, 84 Stat.
1388; Pub. L. 93–422, § 2(f), Sept. 21, 1974, 88 Stat. 1157;
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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.
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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.
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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
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 legisl
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Federal law — U.S. Code and appendices · legal_authorities
Page 741
TITLE 21—FOOD AND DRUGS
§ 601
Sec.
SUBCHAPTER II—MEAT PROCESSORS AND
RELATED INDUSTRIES
641.
Prohibition of subchapter I inspection of arti-
cles not intended for use as human food; de-
naturation or other identification prior to
distribution in commerce; inedible articles.
642.
Recordkeeping requirements.
643.
Registration of business, name of person, and
trade names.
644.
Regulation of transactions, transportation, or
importation of 4–D animals to prevent use
as human food.
645.
Federal provisions applicable to State or Ter-
ritorial business transactions of a local na-
ture and not subject to local authority.
SUBCHAPTER III—FEDERAL AND STATE
COOPERATION
661.
Federal and State cooperation.
SUBCHAPTER IV—AUXILIARY PROVISIONS
671.
Inspection services; refusal or withdrawal;
hearing; business unfitness based upon cer-
tain convictions; other provisions for with-
drawal of services unaffected; responsible
connection with business; finality of Sec-
retary’s actions; judicial review; record.
672.
Administrative detention; duration; pending
judicial proceedings; notification of govern-
mental authorities; release.
673.
Seizure and condemnation.
674.
Federal court jurisdiction of enforcement and
injunction proceedings and other kinds of
cases; limitations of section 607(e) of this
title.
675.
Assaulting, resisting, or impeding certain
persons; murder; protection of such persons.
676.
Violations.
677.
Other Federal laws applicable for administra-
tion and enforcement of chapter; location of
inquiries; jurisdiction of Federal courts.
678.
Non-Federal jurisdiction of federally regu-
lated matters; prohibition of additional or
different requirements for establishments
with inspection services and as to marking,
labeling, pa
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Federal law — U.S. Code and appendices · legal_authorities
In this subchapter:
(1) **Bioengineering** — The term “bioengineering”, and any similar term, as determined by the Secretary, with respect to a food, refers to a food—
(A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and
(B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.
(2) **Food** — The term “food” means a food (as defined in [section 321 of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim)) that is intended for human consumption.
(3) **Secretary** — The term “Secretary” means the Secretary of Agriculture.
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