Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VIII — IMPORTS AND EXPORTS › § 384b
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.
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Food and Drugs, Source: USLM XML via OLRC
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Reference
Citation
21 U.S.C. § 384b
Title 21, Food and Drugs
Last Updated
Sep 22, 2026
Release point: 119-110