§384a Foreign Supplier Verification Program

Summary

Importers must do risk-based checks of their foreign suppliers to make sure imported food meets U.S. safety and labeling rules and is not unsafe or mislabeled. An "importer" means the U.S. owner or consignee when the food enters the country, or if there is none, the U.S. agent or representative of the foreign owner. Not later than 1 year after January 4, 2011, the Secretary must issue guidance to help importers set up these programs and must create rules saying what the programs must cover. The rules must make sure the programs give reasonable assurance that foreign suppliers use proper processes and preventive controls and that the food meets U.S. safety and labeling requirements. The rules can account for different types of importers and foods. Examples of verification activities include checking shipment records, certifying lots, yearly on-site checks, reviewing the supplier’s hazard analysis and preventive controls, and testing or sampling shipments. Importers must keep their verification records for at least 2 years and give them quickly to an authorized representative of the Secretary if requested. Facilities already following FDA Seafood HACCP, Juice HACCP, or the FDA standards for thermally processed low-acid foods are exempt (the low-acid exemption covers only the microbiological hazards those standards regulate). The Secretary may also exempt small amounts of food imported for research or personal use, if not for retail sale or public distribution, by publishing a notice in the Federal Register. The Secretary must post and keep an up-to-date list on FDA’s website of importers participating, including names, locations, and other needed information.