§384a Foreign supplier verification program

Summary

Importers must do risk-based checks on their foreign suppliers to make sure imported food is made under the same safety controls required for U.S. food (as required by sections 350g or 350h) and is not adulterated (section 342) or misbranded (section 343(w)). An "importer" means the U.S. owner or consignee at entry, or if 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 and must create rules that say what each importer’s foreign supplier verification program must include. The rules must require adequate assurance that foreign suppliers use proper preventive controls, allow different approaches based on risk and type of food, and may include checking shipment records, lot-by-lot certifications, yearly on-site inspections, reviewing the supplier’s hazard analysis and preventive-control plan, and periodic testing or sampling. Importers must keep related records for not less than 2 years and give them promptly to an authorized FDA representative on request. The rules do not apply if a facility already follows the Seafood HACCP program, the Juice HACCP program, or the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards (or successor standards). The Secretary must publish in the Federal Register an exemption for small quantities imported for research, evaluation, or personal use that are not for retail sale. The Secretary must also keep a current list of participating importers on the FDA website.