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21 U.S.C. § 384d — Accreditation of third-party auditors
Federal law — U.S. Code and appendices · legal_authorities
**(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
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Source location: Title 21, Chapter 9, § 384d; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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) **Eligible entity** — The term “eligible entity” means a foreign entity, including a foreign facility registered under [section 350d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d&num=0&edition=prelim), in the food import supply chain that chooses to be audited by an accredited third-party auditor or the audit agent of such accredited third-party auditor.
(7) **Regulatory audit** — The term “regulatory audit” means an audit of an eligible entity—
(A) to determine whether such entity is in compliance with the provisions of this chapter; and
(B) the results of which determine—
(i) whether an article of food manufactured, processed, packed, or held by such entity is eligible to receive a food certification under [section 381(q) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/q&num=0&edition=prelim); or
(ii) whether a facility is eligible to receive a facility certification under [section 384b(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384b/a&num=0&edition=prelim) for purposes of participating in the program under [section 384b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384b&num=0&edition=prelim).
**(b) Accreditation system**
(1) **Accreditation bodies**
(A) *Recognition of accreditation bodies*
(i) *In general* — Not later than 2 years after January 4, 2011, the Secretary shall establish a system for the recognition of accreditation bodies that accredit third-party auditors to certify that eligible entities meet the applicable requirements of this section.
(ii) *Direct accreditation* — If, by the date that is 2 years after the date of establishment of the system described in clause (i), the Secretary has not identified and recognized an accreditation body to meet the requirements of this section, the Secretary may directly accredit third-party auditors.
(B) *Notification* — Each accreditation body recognized by the Secretary shall submit to the Secretary a list of all accredited third-party auditors accredited by such body and the audit agents of such auditors.
(C) *Revocation of recognition as an accreditation body* — The Secretary shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section.
(D) *Reinstatement* — The Secretary shall establish procedures to reinstate recognition of an accreditation body if the Secretary determines, based on evidence presented by such accreditation body, that revocation was inappropriate or that the body meets the requirements for recognition under this section.
(2) **Model accreditation standards** — Not later than 18 months after January 4, 2011, the Secretary shall develop model standards, including requirements for regulatory audit reports, and each recognized accreditation body shall ensure that third-party auditors and audit agents of such auditors meet such standards in order to qualify such third-party auditors as accredited third-party auditors under this section. In developing the model standards, the Secretary shall look to standards in place on January 4, 2011, for guidance, to avoid unnecessary duplication of efforts and costs.
**(c) Third-party auditors**
(1) **Requirements for accreditation as a third-party auditor**
(A) *Foreign governments* — Prior to accrediting a foreign government or an agency of a foreign government as an accredited third-party auditor, the accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) shall perform such reviews and audits of food safety programs, systems, and standards of the government or agency of the government as the Secretary deems necessary, including requirements under the model standards developed under subsection (b)(2), to determine that the foreign government or agency of the foreign government is capable of adequately ensuring that eligible entities or foods certified by such government or agency meet the requirements of this chapter with respect to food manufactured, processed, packed, or held for import into the United States.
(B) *Foreign cooperatives and other third parties* — Prior to accrediting a foreign cooperative that aggregates the products of growers or processors, or any other third party to be an accredited third-party auditor, the accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) shall perform such reviews and audits of the training and qualifications of audit agents used by that cooperative or party and conduct such reviews of internal systems and such other investigation of the cooperative or party as the Secretary deems necessary, including requirements under the model standards developed under subsection (b)(2), to determine that each eligible entity certified by the cooperative or party has systems and standards in use to ensure that such entity or food meets the requirements of this chapter.
(2) **Requirement to issue certification of eligible entities or foods**
(A) *In general* — An accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) may not accredit a third-party auditor unless such third-party auditor agrees to issue a written and, as appropriate, electronic food certification, described in [section 381(q) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/q&num=0&edition=prelim), or facility certification under [section 384b(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384b/a&num=0&edition=prelim), as appropriate, to accompany each food shipment for import into the United States from an eligible entity, subject to requirements set forth by the Secretary. Such written or electronic certification may be included with other documentation regarding such food shipment. The Secretary shall consider certifications under [section 381(q) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/q&num=0&edition=prelim) and participation in the voluntary qualified importer program described in [section 384b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384b&num=0&edition=prelim) when targeting inspection resources under [section 350j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350j&num=0&edition=prelim).
(B) *Purpose of certification* — The Secretary shall use certification provided by accredited third-party auditors to—
(i) determine, in conjunction with any other assurances the Secretary may require under [section 381(q) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/q&num=0&edition=prelim), whether a food satisfies the requirements of such section; and
(ii) determine whether a facility is eligible to be a facility from which food may be offered for import under 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).
(C) *Requirements for issuing certification*
(i) *In general* — An accredited third-party auditor shall issue a food certification under [section 381(q) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/q&num=0&edition=prelim) or a facility certification described under subparagraph (B) only after conducting a regulatory audit and such other activities that may be necessary to establish compliance with the requirements of such sections.
(ii) *Provision of certification* — Only an accredited third-party auditor or the Secretary may provide a facility certification under [section 384b(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384b/a&num=0&edition=prelim). Only those parties described in 11 So in original. Probably should be followed by “section”. 381(q)(3) of this title or the Secretary may provide a food certification under 1 381(q) 22 See References in Text note below. of this title.
(3) **Audit report submission requirements**
(A) *Requirements in general* — As a condition of accreditation, not later than 45 days after conducting an audit, an accredited third-party auditor or audit agent of such auditor shall prepare, and, in the case of a regulatory audit, submit, the audit report for each audit conducted, in a form and manner designated by the Secretary, which shall include—
(i) the identity of the persons at the audited eligible entity responsible for compliance with food safety requirements;
(ii) the dates of the audit;
(iii) the scope of the audit; and
(iv) any other information required by the Secretary that relates to or may influence an assessment of compliance with this chapter.
(B) *Records* — Following any accreditation of a third-party auditor, the Secretary may, at any time, require the accredited third-party auditor to submit to the Secretary an onsite audit report and such other reports or documents required as part of the audit process, for any eligible entity certified by the third-party auditor or audit agent of such auditor. Such report may include documentation that the eligible entity is in compliance with any applicable registration requirements.
(C) *Limitation* — The requirement under subparagraph (B) shall not include any report or other documents resulting from a consultative audit by the accredited third-party auditor, except that the Secretary may access the results of a consultative audit in accordance with [section 350c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c&num=0&edition=prelim).
(4) **Requirements of accredited third-party auditors and audit agents of such auditors**
(A) *Risks to public health* — If, at any time during an audit, an accredited third-party auditor or audit agent of such auditor discovers a condition that could cause or contribute to a serious risk to the public health, such auditor shall immediately notify the Secretary of—
(i) the identification of the eligible entity subject to the audit; and
(ii) such condition.
(B) *Types of audits* — An accredited third-party auditor or audit agent of such auditor may perform consultative and regulatory audits of eligible entities.
(C) *Limitations*
(i) *In general* — An accredited third party auditor may not perform a regulatory audit of an eligible entity if such agent has performed a consultative audit or a regulatory audit of such eligible entity during the previous 13-month period.
(ii) *Waiver* — The Secretary may waive the application of clause (i) if the Secretary determines that there is insufficient access to accredited third-party auditors in a country or region.
(5) **Conflicts of interest**
(A) *Third-party auditors* — An accredited third-party auditor shall—
(i) not be owned, managed, or controlled by any person that owns or operates an eligible entity to be certified by such auditor;
(ii) in carrying out audits of eligible entities under this section, have procedures to ensure against the use of any officer or employee of such auditor that has a financial conflict of interest regarding an eligible entity to be certified by such auditor; and
(iii) annually make available to the Secretary disclosures of the extent to which such auditor and the officers and employees of such auditor have maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.
(B) *Audit agents* — An audit agent shall—
(i) not own or operate an eligible entity to be audited by such agent;
(ii) in carrying out audits of eligible entities under this section, have procedures to ensure that such agent does not have a financial conflict of interest regarding an eligible entity to be audited by such agent; and
(iii) annually make available to the Secretary disclosures of the extent to which such agent has maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.
(C) *Regulations* — The Secretary shall promulgate regulations not later than 18 months after January 4, 2011, to implement this section and to ensure that there are protections against conflicts of interest between an accredited third-party auditor and the eligible entity to be certified by such auditor or audited by such audit agent. Such regulations shall include—
(i) requiring that audits performed under this section be unannounced;
(ii) a structure to decrease the potential for conflicts of interest, including timing and public disclosure, for fees paid by eligible entities to accredited third-party auditors; and
(iii) appropriate limits on financial affiliations between an accredited third-party auditor or audit agents of such auditor and any person that owns or operates an eligible entity to be certified by such auditor, as described in subparagraphs (A) and (B).
(6) **Withdrawal of accreditation**
(A) *In general* — The Secretary shall withdraw accreditation from an accredited third-party auditor—
(i) if food certified under [section 381(q) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/q&num=0&edition=prelim) or from a facility certified under paragraph (2)(B) by such third-party auditor is linked to an outbreak of foodborne illness that has a reasonable probability of causing serious adverse health consequences or death in humans or animals;
(ii) following an evaluation and finding by the Secretary that the third-party auditor no longer meets the requirements for accreditation; or
(iii) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements set forth in this section.
(B) *Additional basis for withdrawal of accreditation* — The Secretary may withdraw accreditation from an accredited third-party auditor in the case that such third-party auditor is accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(1)(C) is revoked, if the Secretary determines that there is good cause for the withdrawal.
(C) *Exception* — The Secretary may waive the application of subparagraph (A)(i) if the Secretary—
(i) conducts an investigation of the material facts related to the outbreak of human or animal illness; and
(ii) reviews the steps or actions taken by the third party auditor to justify the certification and determines that the accredited third-party auditor satisfied the requirements under [section 381(q) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/q&num=0&edition=prelim) of certifying the food, or the requirements under paragraph (2)(B) of certifying the entity.
(7) **Reaccreditation** — The Secretary shall establish procedures to reinstate the accreditation of a third-party auditor for which accreditation has been withdrawn under paragraph (6)—
(A) if the Secretary determines, based on evidence presented, that the third-party auditor satisfies the requirements of this section and adequate grounds for revocation no longer exist; and
(B) in the case of a third-party auditor accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(1)(C) is revoked—
(i) if the third-party auditor becomes accredited not later than 1 year after revocation of accreditation under paragraph (6)(A), through direct accreditation under subsection (b)(1)(A)(ii) or by an accreditation body in good standing; or
(ii) under such conditions as the Secretary may require for a third-party auditor under paragraph (6)(B).
(8) **Neutralizing costs** — The Secretary shall establish by regulation a reimbursement (user fee) program, similar to the method described in [section 1622(h) of title 7](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section1622/h&num=0&edition=prelim),2 by which the Secretary assesses fees and requires accredited third-party auditors and audit agents to reimburse the Food and Drug Administration for the work performed to establish and administer the accreditation system under this section. The Secretary shall make operating this program revenue-neutral and shall not generate surplus revenue from such a reimbursement mechanism. Fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to remain available until expended.
**(d) Recertification of eligible entities** An eligible entity shall apply for annual recertification by an accredited third-party auditor if such entity—
(1) intends to participate in 33 So in original. Probably should be followed by “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); or
(2) is required to provide to the Secretary a certification under [section 381(q) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/q&num=0&edition=prelim) for any food from such entity.
**(e) False statements** Any statement or representation made—
(1) by an employee or agent of an eligible entity to an accredited third-party auditor or audit agent; or
(2) by an accredited third-party auditor to the Secretary,
shall be subject to [section 1001 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1001&num=0&edition=prelim).
**(f) Monitoring** To ensure compliance with the requirements of this section, the Secretary shall—
(1) periodically, or at least once every 4 years, reevaluate the accreditation bodies described in subsection (b)(1);
(2) periodically, or at least once every 4 years, evaluate the performance of each accredited third-party auditor, through the review of regulatory audit reports by such auditors, the compliance history as available of eligible entities certified by such auditors, and any other measures deemed necessary by the Secretary;
(3) at any time, conduct an onsite audit of any eligible entity certified by an accredited third-party auditor, with or without the auditor present; and
(4) take any other measures deemed necessary by the Secretary.
**(g) Publicly available registry** The Secretary shall establish a publicly available registry of accreditation bodies and of accredited third-party auditors, including the name of, contact information for, and other information deemed necessary by the Secretary about such bodies and auditors.
**(h) Limitations**
(1) **No effect on section 374 inspections** — The audits performed under this section shall not be considered inspections under [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
(2) **No effect on inspection authority** — Nothing in this section affects the authority of the Secretary to inspect any eligible entity pursuant to this chapter.
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Federal law — U.S. Code and appendices · legal_authorities
**(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
**(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
**(a) Records inspection**
(1) **Adulterated food** — If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.
(2) **Use of or exposure to food of concern** — If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such pe
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350c
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Federal law — U.S. Code and appendices · legal_authorities
**(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
**(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions**
(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in [section 350c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c&num=0&edition=prelim), when the standard for records inspection under paragraph (1) or (2) of [section 350c(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/a&num=0&edition=prelim) applies, subject to the limitations established in [section 350c(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/d&num=0&edition=prelim). In the case of a facility (as defined in [section 364 of this title](https://uscode.house.gov/vi
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** Except as otherwise provided in this section, whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully—
(1) falsifies, conceals, or covers up by any trick, scheme, or device a material fact;
(2) makes any materially false, fictitious, or fraudulent statement or representation; or
(3) makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry;
shall be fined under this title, imprisoned not more than 5 years or, if the offense involves international or domestic terrorism (as defined in section 2331), imprisoned not more than 8 years, or both. If the matter relates to an offense under chapter 109A, 109B, 110, or 117, or section 1591, then the term of imprisonment imposed under this section shall be not more than 8 years.
**(b)** Subsection (a) does not apply to a party to a judicial proceeding, or that party’s counsel, for statements, representations, writings or documents submitted by such party or counsel to a judge or magistrate in that proceeding.
**(c)** With respect to any matter within the jurisdiction of the legislative branch, subsection (a) shall apply only to—
(1) administrative matters, including a claim for payment, a matter related to the procurement of property or services, personnel or employment practices, or support services, or a document required by law, rule, or regulation to be submitted to the Congress or any office or officer within the legislative branch; or
(2) any investigation or review, conducted pursuant to the authority of any committee, subcommittee, commission or office of the Congress, consistent with applicable rules of the House or Senate.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1001
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Page 658
TITLE 21—FOOD AND DRUGS
§ 384c
agreements to which the United States is a party, see
sections 2251 and 2252 of this title.
§ 384c. Inspection of foreign food facilities
(a) Inspection
The Secretary—
(1) may enter into arrangements and agree-
ments with foreign governments to facilitate
the inspection of foreign facilities registered
under section 350d of this title; and
(2) shall direct resources to inspections of
foreign facilities, suppliers, and food types, es-
pecially such facilities, suppliers, and food
types that present a high risk (as identified by
the Secretary), to help ensure the safety and
security of the food supply of the United
States.
(b) Effect of inability to inspect
Notwithstanding any other provision of law,
food shall be refused admission into the United
States if it is from a foreign factory, warehouse,
or other establishment of which the owner, oper-
ator, or agent in charge, or the government of
the foreign country, refuses to permit entry of
United States inspectors or other individuals
duly designated by the Secretary, upon request,
to inspect such factory, warehouse, or other es-
tablishment. For purposes of this subsection,
such an owner, operator, or agent in charge
shall be considered to have refused an inspection
if such owner, operator, or agent in charge does
not permit an inspection of a factory, ware-
house, or other establishment during the 24-hour
period after such request is submitted, or after
such other time period, as agreed upon by the
Secretary and the foreign factory, warehouse, or
other establishment.
(June 25, 1938, ch. 675, § 807, as added Pub. L.
111–353, title III, § 306(a), Jan. 4, 2011, 124 Stat.
3958.)
Statutory Notes and Related Subsidiaries
CONSTRUCTION
Nothing in this sec
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 384d
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.