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21 U.S.C. § 384b — Voluntary qualified importer program
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,
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Source file: Laws/federal/codes/united-states-code/title-21/section-384b-voluntary-qualified-importer-program--d51da3655a.md
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Source location: Title 21, Chapter 9, § 384b; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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, as appropriate.
(3) The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards for a designated food.
(4) The compliance of the importer with the requirements of [section 384a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384a&num=0&edition=prelim).
(5) The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.
(6) The potential risk for intentional adulteration of the food.
(7) Any other factor that the Secretary determines appropriate.
**(e) Review and revocation** Any importer qualified by the Secretary in accordance with the eligibility criteria set forth in this section shall be reevaluated not less often than once every 3 years and the Secretary shall promptly revoke the qualified importer status of any importer found not to be in compliance with such criteria.
**(f) False statements** Any statement or representation made by an importer 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).
**(g) Definition** For purposes of this section, the term “importer” means the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States.
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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
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
**(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) 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
**(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) In general**
(1) **Purpose and authority** — For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from—
(A) the responsible party for each domestic facility (as defined in section 350d(b) 11 See References in Text note below. of this title) and the United States agent for each foreign facility subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year;
(B) the responsible party for a domestic facility (as defined in section 350d(b) 1 of this title) and an importer who does not comply with a recall order under section 350l of this title or under [section 350a(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350a/f&num=0&edition=prelim) in such fiscal year, to cover food recall activities associated with such order performed by the Secretary, including technical assistance, follow-up effectiveness checks, and public notifications, for such year;
(C) each importer participating 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) in such year, to cover the administrative costs of such program for such year; and
(D) each importer subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year.
(2) **Definitions** — For purposes of this section—
(A) the term “reinspection” means—
(i) with respect to domestic facilities (as defined in section 350d(b) 1 of this title), 1 or more inspections conducted under [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=preli
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379j–31
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Federal law — U.S. Code and appendices · legal_authorities
Page 657
TITLE 21—FOOD AND DRUGS
§ 384b
2 So in original. Probably should be ‘‘title’’.
(2) The Juice Hazard Analysis Critical Con-
trol Points Program of the Food and Drug Ad-
ministration.
(3)
The
Thermally
Processed
Low-Acid
Foods Packaged in Hermetically Sealed Con-
tainers standards of the Food and Drug Ad-
ministration (or any successor standards).
The exemption under paragraph (3) shall apply
only with respect to microbiological hazards
that are regulated under the standards for Ther-
mally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers under part 113
of chapter 2 21, Code of Federal Regulations (or
any successor regulations).
(f) Additional exemptions
The Secretary, by notice published in the Fed-
eral 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 con-
sumption, provided that such foods are not in-
tended for retail sale and are not sold or distrib-
uted 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 Ad-
ministration a current list that includes the
name of, location of, and other information
deemed necessary by the Secretary about, im-
porters participating under this section.
(June 25, 1938, ch. 675, § 805, as added Pub. L.
111–353, title III, § 301(a), Jan. 4, 2011, 124 Stat.
3953.)
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE
Section effective 2 years after Jan. 4, 2011, see section
301(d) of Pub. L. 111–353, set out as an Effective Date of
2011 Amendment note under section 331 of this title.
CONSTRUCTION
Nothing in this section to be construed to apply to
certain alcoh
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 384b
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