The FSVP rule requires U.S. importers of food and beverages to designate a “Qualified Individual,” defined by FDA as possessing either appropriate training or job experience reflecting the ability to develop a food safety system, to develop FSVPs for each food from each foreign supplier. This means that multiple foods from a single supplier or multiple units of a single food from multiple suppliers each require individual FSVPs. FSVPs require several components including hazard analysis, an evaluation of risk and supplier performance, documented supplier verification activities, and a plan for corrective actions should a supplier be found non-compliant.
In a single FSVP, a hazard analysis of the food item should be conducted, identifying any potential and foreseeable biological, chemical, or physical hazards that could cause illness or injury in the absence of preventive measures. The importer should assess the probability and severity of the illness or injury should these measures not be implemented, while considering a diverse array of variables, such as manufacturing procedures, raw materials and ingredients, and the transportation, storage, and distribution of the food.
An evaluation of risk and supplier performance should consider the results of the hazard analysis while assessing the supplier’s food safety practices and procedures, its compliance with U.S. food safety regulations, as well as its history of correcting food safety problems to determine the level of health risk when importing from the supplier. Importers should determine appropriate verification measures relative to the level of food safety risk the supplier poses. Verification activities may include onsite audits, sampling, and/or review of the supplier’s food safety records.
