Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VIII— IMPORTS AND EXPORTS › § 384b
Creates a voluntary program to speed up the review and import of food for importers who choose to join. The Secretary must start the program no later than 18 months after January 4, 2011, and must work with the Secretary of Homeland Security. The Secretary must also set up a way to issue facility certifications under section 384d that go with the imported food and must publish guidance about joining, losing, getting back into, and following the program. An importer can ask to use the program and must send a notice and application when and how the Secretary says. Only importers bringing food from a certified facility can qualify. The Secretary will decide who qualifies by looking at risk factors such as known safety risks; foreign supplier history; the exporting country’s regulatory system; the importer’s compliance with section 384a; the importer’s recordkeeping, testing, inspections, traceability, temperature control, and sourcing; risk of intentional adulteration; and other relevant factors. Qualified importers will be reviewed at least once every 3 years and can be quickly removed if they do not meet the rules. Any statement to the Secretary is covered by section 1001 of title 18. "Importer" means the person who brings food from a foreign country into the United States customs territory.
Full Legal Text
Food and Drugs — Source: USLM XML via OLRC
Legislative History
Reference
Citation
21 U.S.C. § 384b
Title 21 — Food and Drugs
Last Updated
Apr 5, 2026
Release point: 119-73not60