Under FSMA, who is responsible for ensuring foreign suppliers have adequate preventative controls in place?

• A. FDA
• B. Foreign governments
• C. Foreign suppliers
• D. Importers

Answer: (D)

Under FSMA, the importer is responsible for ensuring foreign suppliers have adequate preventive controls in place. The idea is that the entity bringing food into the United States must verify that its international suppliers are operating under a preventive controls system and maintaining appropriate records. This verification can include on-site audits, review of the supplier’s monitoring and corrective action records, and other arrangements to confirm the supplier’s preventive controls are in effect. The FDA sets the rules and can enforce them, and foreign governments play a role in regulation, but the importer bears the primary duty to ensure those foreign suppliers have the necessary controls.