Tip of the Week: Understanding the Foreign Supplier Verification Program

The Foreign Supplier Verification Program (FSVP) is a requirement that falls under the new FSMA regulations. The intent is to ensure food produced in other countries for export to the United States for consumption is as safe and follows the same food safety and food defense guidelines as if the facility was located in the United States. The responsible party that is required to ensure these programs are in place at the foreign facilities is the direct Importer, which is the agent that notifies the FDA of an incoming ingredient, raw material, or finished product. This direct importer can be a manufacturing facility, a distribution center, or even a broker.

This regulation is tied to the other FSMA regulations such as 21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, Mitigation Strategies to Protect Food from Intentional Adulteration, and others. It is tied to them by requiring the importer to verify that a facility, if required, is complying with the FSMA regulations. This means that if a facility located in China is exporting a product such as cooked rice and they are required to register with the FDA they may need to comply with the Preventive Controls for Human Food rule. The importer would be required to verify that the food safety plan has been implemented and is working as intended at the facility located in China.

Next we will discuss those verification activities and other specific requirements for this regulation.

The first requirement is that the importer is required to conduct a hazard analysis on the foreign supplier, considering the supplier and the nature of the product being exported. Second the importer is then required to develop verification activates to ensure the supplier has developed and is following the required FSMA or food safety programs. Those verification activities could include, reviewing the suppliers food safety and food defense plans, conducting either 2nd or 3rd party audits, conducting sampling and testing on products or ingredients, or any other verification activity as identified by the hazard analysis of the importer. Then the importer is required to maintain all the documents that support this program and if necessary make them available to the FDA or designated representative when and if they are inspected.

You may ask, If I am not an importer why is understanding this regulation important? Understanding the requirements of this regulation and ensuring your sources such as brokers, distribution centers, or suppliers are in compliance will ensure your ingredients, raw materials, or finished products that are produced in a foreign facility will not be interrupted due to non-compliance.

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