FDA has begun to enforce the FSVP rule which requires food importers to maintain documentation and records verifying that certain steps have been taken to ensure that the foods they import meet US food-safety standards. Most food importers have been required to comply since May 30, 2017, and FDA is already inspecting food importers ranging from small to large companies!

For the purpose of the FSVP, FDA defines the importer (“FSVP importer”) as the US owner or consignee of the food shipment. If no US owner or consignee exists for the shipment, then the FSVP importer may be an agent or other authorized representative of the foreign supplier or owner. Each food from each supplier must have its own, separate FSVP! For example, if you import bean paste from two different suppliers, then each bean paste must have its own FSVP. If you import bean paste and also import dried noodles from the same supplier then again, each food must have its own FSVP. Certain foods such as foods that comply with the seafood or juice HACCP regulation are exempt from the rule.

The FSVP includes activities that must be performed, reviewed, and documented by one or more “qualified individuals”. FDA considers a qualified individual to be a person with the education and or experience that qualifies that person to accomplish the specific activity for the specific food. The activities include:

Hazard Analysis and Risk Evaluation – For each imported food, a qualified individual must identify and document all known or reasonably foreseeable food safety-related hazards including physical, chemical, and biological hazards. The qualified individual must then evaluate the risk of each hazard based on the severity of the hazard and the probability of the hazard occurring if not controlled.

Supplier Evaluation – A qualified individual must evaluate the food safety performance of the supplier taking into consideration, factors such as any FDA inspection results, third-party audit results, any FDA regulatory actions (e.g. warning letters, listing on import alerts, detentions, refusals, etc.), and effectiveness of any recalls. Note that FDA does not approve the suppliers. The importer must evaluate and approve the suppliers from which they import their food products and document the evaluation.

Verification Activity – The importer must periodically have a qualified individual(s) perform an activity that verifies that the supplier (or other entity responsible for controlling the food safety hazards) is effectively controlling the hazards. These activities may include on-site audits, private lab testing, or review of the supplier’s food safety records.
For example, if the importer’s qualified individual determines that Salmonella contamination is a reasonably foreseeable hazard for a food, then the company may choose to have the product periodically tested by a private lab for Salmonella. A qualified individual must determine the frequency and method of the activity. If the hazard could result in serious adverse health consequences or death, the importer should have an on-site audit of the supplier’s facility performed by a qualified individual at least once a year.

Corrective Actions – A qualified individual must review and document any corrective actions taken by the supplier in response to any problems related to the safety of the food.

Re-evaluation of FSVP – The importer must have a qualified individual re-evaluate the FSVP at least every 3 years to ensure it is sufficiently meeting the requirements of the FSVP rule. If the importer becomes aware of any changes or other new information that could affect the safety of the food, then the FSVP must be evaluated at that time as well.

Remember that a person FDA recognizes as a “qualified individual” must perform and document the above activities! Contact FDA Specialist to assist you as the qualified individual for your FSVPs!