By: Fabiola Negrón, Director of Food Safety at Registrar Corp
The Foreign Supplier Verification Program (FSVP) rule under the FDA’s Food Safety Modernization Act (FSMA), mandates US importers to conduct risk-based activities to verify their foreign suppliers adhere to FDA food safety standards and produce food in a manner that provides the same level of public health protection as domestic producers.
Certain foods are exempt from this requirement, including seafood and 100% juice (covered under HACCP), meat, poultry, and egg products (regulated by the USDA), alcoholic beverages (regulated by the TTB), samples imported for research or testing not intended for distribution, food processed in the U.S. for export and returned, and food transshipped through the U.S.
For Canadian suppliers shipping food products to the US, understanding their US importer’s FSVP requirements is critical to maintain market access and simplify compliance.
What Does FSVP Compliance Involve?
Standard FSVP requirements mandate that importers develop, implement, and maintain a verification program tailored to the level of risk presented by the imported food and the supplier’s compliance history. The requirements include conducting:
- Hazard Analysis: Assessing potential hazards that could affect food safety, including biological, chemical, and physical risks.
- Supplier Evaluation: Reviewing the supplier’s food safety practices, history of compliance, and any relevant certifications.
- Verification Activities: Conducting activities such as sampling, testing, record reviews, and on-site audits, depending on the risk profile of the food and process to ensure food safety.
- Corrective Actions: Acting promptly when a supplier falls out of compliance, which may include working with the supplier to resolve issues or finding alternative sources.
Modified FSVP requirements apply for very small businesses, countries with food safety system recognition agreements (FSSRA), foods that cannot be consumed without the application of a control, or those with hazards controlled after importation.
FSVP for Canadian Suppliers
The Canadian Food Inspection Agency (CFIA) has an active FSSRA with the FDA. Under these modified requirements the importer is required to document that the food is covered by the agreement, that the supplier is in Canada and in good compliance standing with the CFIA (holding a valid SFC License or Canada GAP certification). Foods excluded from these modified requirements include foods intended for further processing, Grade A milk products, dietary supplements, infant formula, and animal food.
For US importers whose Canadian suppliers are not eligible for modified requirements the complete FSVP requirements apply. Canadian suppliers must provide evidence needed for importers to evaluate their compliance with the FDA such as:
- Food Safety-related records such as copy of your food safety plans, control procedures, and control monitoring records
- 3rd party audit or inspection reports
- Certificates of analysis
- Qualifications of the person(s) in charge of food safety
- Other as applicable
The Bottom Line
For Canadian suppliers, understanding and aligning with FSVP requirements is essential for smooth operations and continued trade with the US. By ensuring compliance with FDA food safety standards and maintaining open communication with importers, Canadian businesses can simplify their importer’s FSVP compliance process.