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21 U.S.C. § 384a — Foreign supplier verification program

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 384a — Foreign supplier verification program

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Stable record: federal_law:legal_authorities:record_usc_e93041badf5134caabe79e19
Source file: Laws/federal/codes/united-states-code/title-21/section-384a-foreign-supplier-verification-program--440901d9c5.md
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Source location: Title 21, Chapter 9, § 384a; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) In general** (1) **Verification requirement** — Except as provided under subsections (e) and (f), each importer shall perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer or agent of an importer is— (A) produced in compliance with the requirements of [section 350g of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350g&num=0&edition=prelim) or [section 350h of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350h&num=0&edition=prelim), as appropriate; and (B) is not adulterated under [section 342 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342&num=0&edition=prelim) or misbranded under [section 343(w) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/w&num=0&edition=prelim). (2) **Importer defined** — For purposes of this section, the term “importer” means, with respect to an article of food— (A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or (B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States. **(b) Guidance** Not later than 1 year after January 4, 2011, the Secretary shall issue guidance to assist importers in developing foreign supplier verification programs. **(c) Regulations** (1) **In general** — Not later than 1 year after January 4, 2011, the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection (a). (2) **Requirements** — The regulations promulgated under paragraph (1)— (A) shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported food in compliance with— (i) processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under [section 350g of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350g&num=0&edition=prelim) or [section 350h of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350h&num=0&edition=prelim) (taking into consideration variances granted under [section 350h of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350h&num=0&edition=prelim)), as appropriate; and (ii) [section 342 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342&num=0&edition=prelim) and [section 343(w) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/w&num=0&edition=prelim).11 So in original. (B) shall include such other requirements as the Secretary deems necessary and appropriate to verify that food imported into the United States is as safe as food produced and sold within the United States. (3) **Considerations** — In promulgating regulations under this subsection, the Secretary shall, as appropriate, take into account differences among importers and types of imported foods, including based on the level of risk posed by the imported food. (4) **Activities** — Verification activities under a foreign supplier verification program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments. **(d) Record maintenance and access** Records of an importer related to a foreign supplier verification program shall be maintained for a period of not less than 2 years and shall be made available promptly to a duly authorized representative of the Secretary upon request. **(e) Exemption of seafood, juice, and low-acid canned food facilities in compliance with HACCP** This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility: (1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration. (2) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration. (3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards). The exemption under paragraph (3) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter 22 So in original. Probably should be “title”. 21, Code of Federal Regulations (or any successor regulations). **(f) Additional exemptions** The Secretary, by notice published in the Federal Register, shall establish an exemption from the requirements of this section for articles of food imported in small quantities for research and evaluation purposes or for personal consumption, provided that such foods are not intended for retail sale and are not sold or distributed to the public. **(g) Publication of list of participants** The Secretary shall publish and maintain on the Internet Web site of the Food and Drug Administration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, importers participating under this section.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 350h — Standards for produce safety

**(a) Proposed rulemaking** (1) **In general** (A) *Rulemaking* — Not later than 1 year after January 4, 2011, the Secretary, in coordination with the Secretary of Agriculture and representatives of State departments of agriculture (including with regard to the national organic program established under the Organic Foods Production Act of 1990 [[7 U.S.C. 6501](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section6501&num=0&edition=prelim) et seq.]), and in consultation with the Secretary of Homeland Security, shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. (B) *Determination by Secretary* — With respect to small businesses and very small businesses (as such terms are defined in the regulation promulgated under subparagraph (A)) that produce and harvest those types of fruits and vegetables that are raw agricultural commodities that the Secretary has determined are low risk and do not present a risk of serious adverse health consequences or death, the Secretary may determine not to include production and harvesting of such fruits and vegetables in such rulemaking, or may modify the applicable requirements of regulations promulgated pursuant to this section. (2) **Public input** — During the comment period on the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in diff

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350h

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 342 — Adulterated food

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

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 342

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 331 — Prohibited acts

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. *

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 331

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 350g — Hazard analysis and risk-based preventive controls

**(a) In general** The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under [section 342 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342&num=0&edition=prelim) or misbranded under [section 343(w) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/w&num=0&edition=prelim), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice. **(b) Hazard analysis** The owner, operator, or agent in charge of a facility shall— (1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including— (A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and (B) hazards that occur naturally, or may be unintentionally introduced; and (2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and (3) develop a written analysis of the hazards. **(c) Preventive controls** The owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that— (1) hazards identified in the hazard analysis conducted under subsection (b)(1) will be significantly minimized or prevented; (2) any hazards identified in the hazard

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350g

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 350j — Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report

**(a) Identification and inspection of facilities** (1) **Identification** — The Secretary shall identify high-risk facilities and shall allocate resources to inspect facilities according to the known safety risks of the facilities, which shall be based on the following factors: (A) The known safety risks of the food manufactured, processed, packed, or held at the facility. (B) The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards. (C) The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls. (D) Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under [section 381(h)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/h/1&num=0&edition=prelim). (E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 381(q) or 384b of this title, as appropriate. (F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources. (2) **Inspections** (A) *In general* — Beginning on January 4, 2011, the Secretary shall increase the frequency of inspection of all facilities. (B) *Domestic high-risk facilities* — The Secretary shall increase the frequency of inspection of domestic facilities identified under paragraph (1) as high-risk facilities such that each such facility is inspected— (i) not less often than once in the 5-year period following January 4, 2011; and (ii) not less often than once every 3 years thereafter. (C) *Domestic non-high-risk facilities* — The Secretary sha

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350j

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 381 — Imports and exports

**(a) Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission** The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or [section 387e(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/h&num=0&edition=prelim) and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of [section 360j(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 381

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 384b — Voluntary qualified importer program

**(a) In general** Beginning not later than 18 months after January 4, 2011, the Secretary shall— (1) establish a program, in consultation with the Secretary of Homeland Security— (A) to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program; and (B) consistent with [section 384d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384d&num=0&edition=prelim), establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in such program; and (2) issue a guidance document related to participation in, revocation of such participation in, reinstatement in, and compliance with, such program. **(b) Voluntary participation** An importer may request the Secretary to provide for the expedited review and importation of designated foods in accordance with the program established by the Secretary under subsection (a). **(c) Notice of intent to participate** An importer that intends to participate in the program under this section in a fiscal year shall submit a notice and application to the Secretary of such intent at the time and in a manner established by the Secretary. **(d) Eligibility** Eligibility shall be limited to an importer offering food for importation from a facility that has a certification described in subsection (a). In reviewing the applications and making determinations on such applications, the Secretary shall consider the risk of the food to be imported based on factors, such as the following: (1) The known safety risks of the food to be imported. (2) The compliance history of foreign suppliers used by the importer,

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 384b

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 384a — Foreign supplier verification program

Page 656 TITLE 21—FOOD AND DRUGS § 384a 1 So in original. characterized by price controls and significant barriers to entry, the parallel trade of drugs has existed for dec- ades and has been estimated to reduce the price of cer- tain drugs by up to 20 percent. Accordingly, my Admin- istration supports the goal of safe importation of pre- scription drugs. SEC. 2. Permitting the Importation of Safe Prescription Drugs from Other Countries. The Secretary of Health and Human Services shall, as appropriate and consistent with applicable law, take action to expand safe access to lower-cost imported prescription drugs by: (a) facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, pro- vided such importation poses no additional risk to pub- lic safety and results in lower costs to American pa- tients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2); (b) authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care pursuant to section 801(d) of the FDCA, 21 U.S.C. 381(d); and (c) completing the rulemaking process regarding the proposed rule to implement section 804(b) through (h) of the FDCA, 21 U.S.C. 384(b) through (h), to allow im- portation of certain prescription drugs from Canada. SEC. 3. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 384a

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