Today’s global marketplace has driven more companies to look abroad for suppliers. And while sourcing internationally has always been challenging, FSMA’s Foreign Supplier Verification Program (FSVP) doesn’t make it any easier. The FSVP rule shifts responsibility for ensuring the safety of imported food products from the government to companies. And the FDA holds importers accountable for ensuring the food entering the United States is up to the agency’s standards.
So, we’ve outlined seven recommendations that help businesses subject to the FSVP rule succeed.
What are the seven components of FSVP?
- Review supplier compliance status. The FSVP rule expects U.S. importers to review the compliance status and history of foreign suppliers to pinpoint potential risks. As a result, this assessment should include any “FDA warning letters, import alerts, and requirements for certification issued by the FDA under section 801(q) of the Food, Drug, and Cosmetic Act (FD&C Act).”
- Conduct a hazard analysis. Importers must investigate any hazards associated with everything they import, including the likelihood and potential severity of each hazard. Frequently, foreign suppliers have already performed a hazard analysis. But it’s vital not to take this at face value. U.S. importers must scrutinize this documentation and compare it with in-house hazard analysis to ensure its sufficient. If a supplier hasn’t performed a hazard analysis, the importer must shoulder the responsibility of examining the foreign supplier’s operations and identifying any hazards that require control. Product verification isn’t necessary if the review fails to uncover any risks. However, the U.S. importer should keep a record of the hazard analysis on file.
- Verify suppliers. Through verification activities, importers must provide sufficient assurances that potential risks are actively identified, controlled, and monitored. Verification activities can include onsite audits, periodic sampling, and reviewing foreign supplier documentation. Importers can conduct onsite audits or contract a third-party auditor to examine a foreign supplier’s operations. But onsite audits aren’t required unless there’s a good chance a hazard could cause serious adverse health consequences or death, according to the Code of Federal Regulations (CFR) Title 21. If the importer relies on product testing and sampling for verification, they must maintain detailed records on each test’s process and outcome.
- Take corrective actions as needed. Any complaint an importer receives about the food they import needs an investigation to uncover the cause and the appropriate corrective action. Further verification activities might determine a supplier isn’t storing products at the required temperature, or there aren’t bathroom facilities for field workers, for example. And each instance requires a unique and appropriate corrective action to demonstrate that remedies are specific to each situation, supplier, and product.
- Periodic reassessment of FSVP. Every three years, importers must reassess their FSVPs. The exception is if the importer is aware of new information about potential hazards. In which case, the reassessment needs to occur sooner in response to the discovery. And if the review finds an imported product doesn’t meet FSVP requirements, the importer must take corrective action. Steps might include not working with the supplier until they address the identified hazards or electing to update their FSVP plan to ensure they vet suppliers more thoroughly in the future.
- Importer identification at entry. The FSVP rule requires importers to provide a legal business name, electronic mailing address, and unique facility identifier (UFI) for all food products entering the U.S. The Data Universal Numbering System (DUNS) number, assigned and maintained by Dun & Bradstreet, is free and the only FDA-proved UFI.
- Recordkeeping. The FDA is taking more steps to increase the number of records kept. Under this rule, the FDA requires importers to maintain records related to compliance status, foreign supplier verification activities, hazard analyses, investigations, corrective actions, and FSVP reassessments, find a complete listing here. But what’s different about the FSVP rule is that the FDA insists the importer keeps a certain amount of records the agency can access easily. In addition, importers must retain original copies of their records, photocopies, or digital records for at least two years unless otherwise specified. Also, the documents must be available upon request.
A preference for digital records
Although the FDA hasn’t requested it for other rules, there are clear indications it prefers digital records for FSVP compliance. This preference is evident in two ways:
- Electronic access to records. The importer must provide electronic access to records immediately upon review. And if the FDA requests documents, they’ll visit a facility and make or receive copies. However, if you’re importing products from another country, the FDA doesn’t want to wait.
- Records can’t deteriorate. Additionally, companies must maintain all records in a way that’s not subject to deterioration and easily interpreted as digital.
Especially with the recent publication of the Food Traceability Final Rule, food and beverage companies tasked with keeping and sharing “key data” related to products on the Food Traceability List (FTL) should digitize their records to improve overall visibility. Find out how TraceGains solutions can help here.