Title 21, Food and DrugsRelease 119-110

§384b Voluntary Qualified Importer Program

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VIII — IMPORTS AND EXPORTS › § 384b

Last updated Sep 22, 2026|Official source

Summary

No later than 18 months after January 4, 2011, the Secretary must create a voluntary program, working with the Secretary of Homeland Security, to allow importers who join to get faster review and importation of their food. The Secretary must also set up a process, consistent with section 384d, to issue a facility certification that travels with the food. The Secretary will publish guidance that explains how to join the program, how a participant can be removed or reinstated, and how to follow the program rules. An importer may ask to join and must send a notice and application when and how the Secretary requires. To be eligible, the food must come from a certified facility. The Secretary will judge applications by factors like the food’s safety risk; foreign suppliers’ compliance history; the exporting country’s food safety system; the importer’s compliance with section 384a; the importer’s recordkeeping, testing, inspections, traceability, temperature controls, and sourcing; the risk of intentional tampering; and other relevant factors. Qualified importers will be reviewed at least once every 3 years, and the Secretary will quickly revoke status for noncompliance. False statements to the Secretary are subject to 18 U.S.C. 1001. Importer: the person who brings or causes food to be brought into the U.S. customs territory.

Full Legal Text

Title 21, §384b

Food and Drugs, Source: USLM XML via OLRC

(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, 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.
(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.
(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.

Legislative History

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see section 2251 and 2252 of this title.

Reference

Citations & Metadata

Citation

21 U.S.C. § 384b

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110