Where does one start in a discussion on the Foreign Supplier Verification Programs Rule? I’ll begin with the fact that nearly 60% of the 5680 FSVP inspections between 2020-2023 show a lack of compliance. FDA seems to still be in the process of educating the industry about this rule, since the vast majority of those out of compliance (about 3120 inspection) are marked as having voluntary action indicated (VAI), with 272 being dinged with official action indicated (OAI; the more serious offense). I predict that as FDA begins a second round of inspections, the agency will not be as forgiving, and more OAIs will be issued, as well as warning letters.
This is one of the trickier FSMA related rules for a few reasons: it affects importers, many of which never had a food safety obligation before and remain unaware that this rule exists, as evidenced by the fact that of all the violations related to FSVP, over half were because there was no FSVP in place. Second, determining which entity in a complex supply chain meets the definition of FSVP importer can be confusing and in fact more than one entity can meet the definition. Finally, this rule has very specific requirements that deviate from historical supplier approval programs.
Here are my key observations about this rule, based on having taught many classes as an FSPCA lead instructor, and having fielded scores of inquiries on this rule, mainly from the produce industry, in my roles as a trade association representative and now as a food safety consultant:
· The supplier approval programs that are adequate to pass a food safety audit are probably not sufficient to comply with the rule. Even when firms had an FSVP, their supplier approval procedures, evaluation of suppliers and the risk posed by the food, and documentation of using approved suppliers were often lacking (over 18% violations fell into these categories)
· Many companies are still of the opinion that they are only responsible for food safety within the 4 walls of their operation; their growers/ suppliers manage food safety before that point
· While FDA states that an annual onsite audit (which can include a 3rd party audit) is the minimum default when a SAHCODHA hazard (e.g., on that would trigger a class I recall) is associated with the imported food, this is perceived to be sufficient for compliance. In my view, it’s usually not.
If you want to be compliant with the rule AND truly want to minimize the chance that you’ll inherit a food safety issue from a supplier that could make people sick and damage your business, here is what I suggest:
· Understand the rule! And not just by reading articles like this. Read the information from FDA.
· Do a great job understanding hazards and risks
o The reason Programs is plural in FSVP is because the intent is to customize the verification program for each supplier-product pair. Depending on the part of the world, pesticides might be a concern; in other regions heavy metals might be more of an issue. In regions or situations where the likelihood that the hazard will occur is increased (e.g., higher risk situations), build a verification program that takes this into account. Go above and beyond the audit. For example, if USDA pesticide sampling shows that the product you’re importing from a certain country has a relatively high rate of pesticide violations, ask to review their spray application records and verify compliance with quarterly testing.
· Do a great job evaluating your supplier
o Again, tailoring the verification program to fit the risk profile of that food-supplier is key. Some suppliers might be using older equipment that is harder to clean. Are you asking the right questions to learn more about their production environment? And as you build the verification program, would it be helpful to review the records of their environmental monitoring program on a regular basis? Again, the audit may not give you enough information to manage risk.
· Use FDA’s Firm/ supplier evaluation resources database to find compliance information, recalls, import alerts and refusals as applicable.
· Think about the spectrum of risk. Which supplier/product combos present the greatest risk? Which are the least risky? Build your verification program based on this. When the (importers) hazard analysis shows that there is a risk associated with a SAHCODHA hazard (major pathogens, undeclared allergens etc.), think hard about the best way to ensure that the foreign supplier is controlling the hazard. A thorough review of an annual onsite audit can be helpful as a minimum, but to really protect consumers- and your supply chain- think about how other tools—review of records, testing, etc. can be used to better assure the safety of the imported food.
Before wrapping up, I have to note how much I LOVE the FDA compliance dashboard. One can easily filter by year, type of product (food vs other FDA regulated products), etc. Seeing the lack of compliance with FSVP was alarming. I’ll be keeping an eye on these trends using the dashboard.
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