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

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

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Stable record: federal_law:legal_authorities:record_usc_3b63f1658906d9f53c81212c
Source file: Laws/federal/codes/united-states-code/title-21/section-350j-targeting-of-inspection-resources-for-domestic-facilities-foreign-facili--37db1a12ef.md
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Source location: Title 21, Chapter 9, § 350j; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(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 shall ensure that each domestic facility that is not identified under paragraph (1) as a high-risk facility is inspected— (i) not less often than once in the 7-year period following January 4, 2011; and (ii) not less often than once every 5 years thereafter. (D) *Foreign facilities* (i) *Year 1* — In the 1-year period following January 4, 2011, the Secretary shall inspect not fewer than 600 foreign facilities. (ii) *Subsequent years* — In each of the 5 years following the 1-year period described in clause (i), the Secretary shall inspect not fewer than twice the number of foreign facilities inspected by the Secretary during the previous year. (E) *Reliance on Federal, State, or local inspections* — In meeting the inspection requirements under this subsection for domestic facilities, the Secretary may rely on inspections conducted by other Federal, State, or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation. **(b) Identification and inspection at ports of entry** The Secretary, in consultation with the Secretary of Homeland Security, shall allocate resources to inspect any article of food imported into the United States according to the known safety risks of the article of food, which shall be based on the following factors: (1) The known safety risks of the food imported. (2) The known safety risks of the countries or regions of origin and countries through which such article of food is transported. (3) The compliance history of the importer, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards. (4) The rigor and effectiveness of the activities conducted by the importer of such article of food to satisfy the requirements of the foreign supplier verification program under [section 384a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384a&num=0&edition=prelim). (5) Whether the food importer participates in the voluntary qualified importer program under [section 384b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384b&num=0&edition=prelim). (6) Whether the food 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). (7) Whether the food or the facility that manufactured, processed, packed, or held such food received a certification as described in section 381(q) or 384b of this title. (8) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources. **(c) Interagency agreements with respect to seafood** (1) **In general** — The Secretary of Health and Human Services, the Secretary of Commerce, the Secretary of Homeland Security, the Chairman of the Federal Trade Commission, and the heads of other appropriate agencies may enter into such agreements as may be necessary or appropriate to improve seafood safety. (2) **Scope of agreements** — The agreements under paragraph (1) may include— (A) cooperative arrangements for examining and testing seafood imports that leverage the resources, capabilities, and authorities of each party to the agreement; (B) coordination of inspections of foreign facilities to increase the percentage of imported seafood and seafood facilities inspected; (C) standardization of data on seafood names, inspection records, and laboratory testing to improve interagency coordination; (D) coordination to detect and investigate violations under applicable Federal law; (E) a process, including the use or modification of existing processes, by which officers and employees of the National Oceanic and Atmospheric Administration may be duly designated by the Secretary to carry out seafood examinations and investigations under [section 381 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381&num=0&edition=prelim) or section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004; (F) the sharing of information concerning observed non-compliance with United States food requirements domestically and in foreign nations and new regulatory decisions and policies that may affect the safety of food imported into the United States; (G) conducting joint training on subjects that affect and strengthen seafood inspection effectiveness by Federal authorities; and (H) outreach on Federal efforts to enhance seafood safety and compliance with Federal food safety requirements. **(d) Coordination** The Secretary shall improve coordination and cooperation with the Secretary of Agriculture and the Secretary of Homeland Security to target food inspection resources. **(e) Facility** For purposes of this section, the term “facility” means a domestic facility or a foreign facility that is required to register under [section 350d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d&num=0&edition=prelim).

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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. § 350d — Registration of food facilities

**(a) Registration** (1) **In general** — The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. To be registered— (A) for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and (B) for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility. (2) **Registration** — An entity (referred to in this section as the “registrant”) shall submit a registration under paragraph (1) to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and, when determined necessary by the Secretary through guidance, the general food category (as identified under section 170.3 of title 21, Code of Federal Regulations, or any other food categories as determined appropriate by the Secretary, including by guidance) of any food manufactured, processed, packed, or held at such facility. The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this chapter. The registrant shall notify the Secretary in a timely manner of changes to such information. (3) **Biennial registration renewal** — During the period beginning on October 1 and ending on December 31 of each even-numb

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

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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. § 384a — Foreign supplier verification program

**(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

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

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

21 U.S.C. § 2241 — Inspection by the Secretary of Commerce

(1) **In general** — The Secretary of Commerce, in coordination with the Secretary of Health and Human Services, may send 1 or more inspectors to a country or facility of an exporter from which seafood imported into the United States originates. The inspectors shall assess practices and processes used in connection with the farming, cultivation, harvesting, preparation for market, or transportation of such seafood and may provide technical assistance related to such activities. (2) **Inspection report** (A) *In general* — The Secretary of Health and Human Services, in coordination with the Secretary of Commerce, shall— (i) prepare an inspection report for each inspection conducted under paragraph (1); (ii) provide the report to the country or exporter that is the subject of the report; and (iii) provide a 30-day period during which the country or exporter may provide a rebuttal or other comments on the findings of the report to the Secretary of Health and Human Services. (B) *Distribution and use of report* — The Secretary of Health and Human Services shall consider the inspection reports described in subparagraph (A) in distributing inspection resources under [section 350j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350j&num=0&edition=prelim).

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2241

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

21 U.S.C. § 384d — Accreditation of third-party auditors

**(a) Definitions** In this section: (1) **Audit agent** — The term “audit agent” means an individual who is an employee or agent of an accredited third-party auditor and, although not individually accredited, is qualified to conduct food safety audits on behalf of an accredited third-party auditor. (2) **Accreditation body** — The term “accreditation body” means an authority that performs accreditation of third-party auditors. (3) **Third-party auditor** — The term “third-party auditor” means a foreign government, agency of a foreign government, foreign cooperative, or any other third party, as the Secretary determines appropriate in accordance with the model standards described in subsection (b)(2), that is eligible to be considered for accreditation to conduct food safety audits to certify that eligible entities meet the applicable requirements of this section. A third-party auditor may be a single individual. A third-party auditor may employ or use audit agents to help conduct consultative and regulatory audits. (4) **Accredited third-party auditor** — The term “accredited third-party auditor” means a third-party auditor accredited by an accreditation body to conduct audits of eligible entities to certify that such eligible entities meet the applicable requirements of this section. An accredited third-party auditor may be an individual who conducts food safety audits to certify that eligible entities meet the applicable requirements of this section. (5) **Consultative audit** — The term “consultative audit” means an audit of an eligible entity— (A) to determine whether such entity is in compliance with the provisions of this chapter and with applicable industry standards and practices; and (B) the results of which are for internal purposes only. (6) **El

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

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

21 U.S.C. § 393 — Food and Drug Administration

**(a) In general** There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the “Administration”). **(b) Mission** The Administration shall— (1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner; (2) with respect to such products, protect the public health by ensuring that— (A) foods are safe, wholesome, sanitary, and properly labeled; (B) human and veterinary drugs are safe and effective; (C) there is reasonable assurance of the safety and effectiveness of devices intended for human use; (D) cosmetics are safe and properly labeled; and (E) public health and safety are protected from electronic product radiation; (3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and (4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products. **(c) Interagency collaboration** The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 393

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

21 U.S.C. § 350j — Targeting of inspection resources for do-

Page 150 TITLE 21—FOOD AND DRUGS § 350j § 350j. Targeting of inspection resources for do- mestic facilities, foreign facilities, and ports of entry; annual report (a) Identification and inspection of facilities (1) Identification The Secretary shall identify high-risk facili- ties and shall allocate resources to inspect fa- cilities according to the known safety risks of the facilities, which shall be based on the fol- lowing 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, out- breaks of foodborne illness, and violations of food safety standards. (C) The rigor and effectiveness of the fa- cility’s hazard analysis and risk-based pre- ventive controls. (D) Whether the food manufactured, proc- essed, packed, or held at the facility meets the criteria for priority under section 381(h)(1) of this title. (E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as de- scribed in section 381(q) or 384b of this title, as appropriate. (F) Any other criteria deemed necessary and appropriate by the Secretary for pur- poses of allocating inspection resources. (2) Inspections (A) In general Beginning on January 4, 2011, the Sec- retary shall increase the frequency of in- spection 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) Domes

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 350j

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