FDA Foreign Supplier
Verification Program
Verification Program
The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) of 2011 mandates the creation of a food safety system in which the focus is on preventing contamination rather than primarily reacting to problems after they occur. The FSMA rules include those that require preventive controls for food facilities that manufacture/process, pack, and hold human and animal foods, and establish science-based standards for produce grown on farms.
These rules apply to domestic food producers and those in other countries who export to the United States. The import community will be most impacted by the Foreign Supplier Verification Programs (FSVP) rule, which requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations, if applicable, and the food is not adulterated or misbranded with respect to allergen labeling.
FSQP offers a mechanism for producers and manufactures to participate in the FDA FSVP. FSQP performs a hazard analysis that includes identifying known or reasonably foreseeable hazards associated for each type of food and determining whether they require a control. Potential hazards include:
- biological hazards, including parasites and disease-causing bacteria.
- chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved additives, food allergens, and (in animal food) nutrient deficiencies or toxicities; and
- physical hazards, such as glass.
- Evaluate risks posed by the food and the performance of the foreign supplier, considering:
- the hazard analysis for the food;
- the entity that will be applying hazard controls, such as the foreign supplier or the foreign supplier’s ingredient supplier;
- the foreign supplier’s food safety practices and procedures;
- applicable U.S. food safety regulations and information regarding the foreign supplier’s compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter or import alert; and
- the foreign supplier’s food safety performance history, including results from testing, audit results, and the supplier’s record of correcting problems.
- Conduct appropriate supplier verification activities to provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented. These activities may include:
- annual onsite audits (must be performed by a qualified auditor);
- sampling and testing of a food;
- a review of the supplier’s relevant food safety records; and/or
- other appropriate activities.
- Take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate).
- Reevaluate the food and foreign supplier every three years or sooner if the FSVP importer becomes aware of new information about the hazards in the food or the foreign supplier’s performance.
- Identify the FSVP importer when filing for entry with U.S. Customs and Border Protection using the FSVP importer’s name, electronic mailing address, and unique facility identifier (UFI) recognized as acceptable to FDA.