Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER VIII— - IMPORTS AND EXPORTS › § 384b
By not later than 18 months after January 4, 2011, the Secretary must set up a voluntary program, working with the Secretary of Homeland Security, to speed up the review and import of food from importers who sign up. The program must include a process for a facility certification to accompany imported food (under section 384d), and the Secretary must issue guidance on how to join, how participation can be revoked or reinstated, and how to follow the program rules. An importer can ask to use the program. To take part for a fiscal year, an importer must send a notice and application when and how the Secretary requires. Only importers bringing food from a certified facility are eligible. The Secretary will judge applications by looking at the food’s safety risk, the importer’s and its foreign suppliers’ compliance history, the exporting country’s ability to meet U.S. food safety rules, the importer’s compliance with section 384a, the importer’s recordkeeping, testing, inspections, traceability, temperature controls and sourcing, the risk of intentional contamination, and any other factors the Secretary finds relevant. Approved importers will be reviewed at least once every 3 years, and the Secretary will quickly revoke approval if an importer does not meet the rules. Any statement to the Secretary is subject to penalties under 18 U.S.C. 1001. "Importer" means the person who brings, or causes food to be brought, from another country into the United States customs territory.
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Food and Drugs — Source: USLM XML via OLRC
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21 U.S.C. § 384b
Title 21 — Food and Drugs
Last Updated
Apr 6, 2026
Release point: 119-73