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21 U.S.C. § 350e — Sanitary transportation practices
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **Bulk vehicle** — The term “bulk vehicle” includes a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.
(2) **Transportation** — The term “transportation” means any movement in commerce by motor vehicle or rail vehicle.
**(b) Regulations** The Secretary shall by regulation require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated.
**(c) Contents** The regulations under subsection (b) shall—
(1) prescribe such practices as the Secretary determines to be appropriate relating to—
(A) sanitation;
(B) packaging, isolation, and other protective measures;
(C) limitations on the use of vehicles;
(D) information to be disclosed—
(i) to a carrier by a person arranging for the transport of food; and
(ii) to a manufacturer or other person that—
(I) arranges for the transportation of food by a carrier; or
(II) furnishes a tank vehicle or bulk vehicle for the transportation of food; and
(E) recordkeeping; and
(2) include—
(A) a list of nonfood products that the Secretary determines may, if shipped in a bulk vehicle, render adulterated food that is subsequently transported in the same vehicle; and
(B) a list of nonfood products that the Secretary determines may, if shipped in a motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), render adulterated food that is simultan
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Source file: Laws/federal/codes/united-states-code/title-21/section-350e-sanitary-transportation-practices--11d428df47.md
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Source location: Title 21, Chapter 9, § 350e; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Definitions** In this section:
(1) **Bulk vehicle** — The term “bulk vehicle” includes a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.
(2) **Transportation** — The term “transportation” means any movement in commerce by motor vehicle or rail vehicle.
**(b) Regulations** The Secretary shall by regulation require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated.
**(c) Contents** The regulations under subsection (b) shall—
(1) prescribe such practices as the Secretary determines to be appropriate relating to—
(A) sanitation;
(B) packaging, isolation, and other protective measures;
(C) limitations on the use of vehicles;
(D) information to be disclosed—
(i) to a carrier by a person arranging for the transport of food; and
(ii) to a manufacturer or other person that—
(I) arranges for the transportation of food by a carrier; or
(II) furnishes a tank vehicle or bulk vehicle for the transportation of food; and
(E) recordkeeping; and
(2) include—
(A) a list of nonfood products that the Secretary determines may, if shipped in a bulk vehicle, render adulterated food that is subsequently transported in the same vehicle; and
(B) a list of nonfood products that the Secretary determines may, if shipped in a motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), render adulterated food that is simultaneously or subsequently transported in the same vehicle.
**(d) Waivers**
(1) **In general** — The Secretary may waive any requirement under this section, with respect to any class of persons, vehicles, food, or nonfood products, if the Secretary determines that the waiver—
(A) will not result in the transportation of food under conditions that would be unsafe for human or animal health; and
(B) will not be contrary to the public interest.
(2) **Publication** — The Secretary shall publish in the Federal Register any waiver and the reasons for the waiver.
**(e) Preemption**
(1) **In general** — A requirement of a State or political subdivision of a State that concerns the transportation of food is preempted if—
(A) complying with a requirement of the State or political subdivision and a requirement of this section, or a regulation prescribed under this section, is not possible; or
(B) the requirement of the State or political subdivision as applied or enforced is an obstacle to accomplishing and carrying out this section or a regulation prescribed under this section.
(2) **Applicability** — This subsection applies to transportation that occurs on or after the effective date of the regulations promulgated under subsection (b).
**(f) Assistance of other agencies** The Secretary of Transportation, the Secretary of Agriculture, the Administrator of the Environmental Protection Agency, and the heads of other Federal agencies, as appropriate, shall provide assistance on request, to the extent resources are available, to the Secretary for the purposes of carrying out this section.
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Federal law — U.S. Code and appendices · legal_authorities
The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
**(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title.
**(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm).
**(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
*
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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
A food shall be deemed to be adulterated—
**(a) Poisonous, insanitary, etc., ingredients**
(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 food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.11 So in original. The period probably should be “; or”. (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of [section 346 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section346&num=0&edition=prelim); or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of [section 346a(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section346a/a&num=0&edition=prelim); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of [section 348 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section348&num=0&edition=prelim); or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim); or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions wher
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** For the purpose of enforcing the provisions of this chapter, carriers engaged in interstate commerce, and persons receiving food, drugs, devices, tobacco products, or cosmetics in interstate commerce or holding such articles so received, shall, upon the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times, to have access to and to copy all records showing the movement in interstate commerce of any food, drug, device, tobacco product, or cosmetic, or the holding thereof during or after such movement, and the quantity, shipper, and consignee thereof; and it shall be unlawful for any such carrier or person to fail to permit such access to and copying of any such record so requested when such request is accompanied by a statement in writing specifying the nature or kind of food, drug, device, tobacco product, or cosmetic to which such request relates, except that evidence obtained under this section, or any evidence which is directly or indirectly derived from such evidence, shall not be used in a criminal prosecution of the person from whom obtained, and except that carriers shall not be subject to the other provisions of this chapter by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, tobacco products, or cosmetics in the usual course of business as carriers, except as provided in subsection (b).
**(b) Food transportation records** A shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to [section 350e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350e&num=0&edition=prelim) shall, on request of an officer or employee designated by the Secretary, permit the officer or employee, a
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Inspection Procedures.—**
(1) **In general.—** — The Secretary of Transportation, in consultation with the Secretary of Health and Human Services and the Secretary of Agriculture, shall establish procedures for transportation safety inspections for the purpose of identifying suspected incidents of contamination or adulteration of—
(A) food in violation of regulations promulgated under section 416 of the Federal Food, Drug, and Cosmetic Act;
(B) a carcass, part of a carcass, meat, meat food product, or animal subject to detention under section 402 of the Federal Meat Inspection Act ([21 U.S.C. 672](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section672&num=0&edition=prelim)); and
(C) poultry products or poultry subject to detention under section 19 of the Poultry Products Inspection Act ([21 U.S.C. 467a](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section467a&num=0&edition=prelim)).
(2) **Training.—**
(A) *In general.—* — The Secretary of Transportation shall develop and carry out a training program to conduct enforcement of this chapter and regulations prescribed under this chapter or compatible State laws and regulations.
(B) *Conduct.—* — In carrying out this paragraph, the Secretary of Transportation shall train inspectors, including Department of Transportation personnel, State employees described under subsection (c), or personnel paid with funds authorized under sections 31102 and 31104, in the recognition of adulteration problems associated with the transportation of cosmetics, devices, drugs, food, and food additives and in the procedures for obtaining assistance of the appropriate departments, agencies, and instrumentalities of the Government and State authorities to support the enforcemen
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Federal law — U.S. Code and appendices · legal_authorities
Page 137
TITLE 21—FOOD AND DRUGS
§ 350e
‘‘(2) FINAL
REGULATIONS.—Not later than 9 months
after the close of the comment period for the proposed
rulemaking under paragraph (1), the Secretary shall
adopt final rules with respect to—
‘‘(A) activities that constitute on-farm packing or
holding of food that is not grown, raised, or consumed
on such farm or another farm under the same owner-
ship for purposes of section 415 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350d), as amended
by this Act;
‘‘(B) activities that constitute on-farm manufac-
turing or processing of food that is not consumed on
that farm or on another farm under common owner-
ship for purposes of such section 415; and
‘‘(C) the requirements under sections 418 and 421 of
the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
350g, 350j], as added by this Act, from which the Sec-
retary may issue exemptions or modifications of the
requirements for certain types of facilities.’’
Pub. L. 107–188, title III, § 305(e), June 12, 2002, 116
Stat. 669, provided that: ‘‘Not later than 18 months
after the date of the enactment of this Act [June 12,
2002], the Secretary of Health and Human Services shall
promulgate proposed and final regulations for the re-
quirement of registration under section 415 of the Fed-
eral Food, Drug, and Cosmetic Act [21 U.S.C. 350d] (as
added by subsection (a) of this section). Such require-
ment of registration takes effect—
‘‘(1) upon the effective date of such final regula-
tions; or
‘‘(2) upon the expiration of such 18-month period if
the final regulations have not been made effective as
of the expiration of such period, subject to compli-
ance with the final regulations when the final regula-
tions are made effective.’’
CONSTRUCTION OF 2011 AMENDMENT
No
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 350e
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