The biggest reason I left my job and founded Safe Food En Route, LLC, was because I had several conversations with U.S. importers unprepared for the new FSVP requirements. The definition of an importer is probably one of the biggest reasons that companies get confused. Below I clarify what it means to be an importer and other four of the most common mistakes I see with my clients and with other importers.
If you were unaware, the first warning letter was issued in July 2019, and there is now a new import alert classification related to FSVP. If you received this example letter in your email recently, you are headed down an inspection path. Here are the mistakes that I have seen in the three years that the law has been in effect, and it has not changed much in the 18 months Safe Food En Route, LLC, has been in business.
5 common FSVP importer mistakes
1. Suppliers outside the United States name their US Customers (or potential US Customers) as FSVP importers without their customer’s knowledge. Major U.S. retailers sent a letter stating the definition of FSVP importer meant U.S. Customer or U.S. Consignee, and they did not want to be named unless there were no other entities. Yet this published LIST indicates their letters did not get to the right people.
2. FSMA Preventive Controls training does not meet all requirements for FSVP. U.S. importers must ensure that a risk assessment and hazard analysis is conducted by a “qualified individual” on all foods imported into the U.S. from a specific facility (including samples). Many foreign suppliers are taking FSPCA training. Great! That does help your U.S. importing company, but that is only one step for the FSVP importer.
3. U.S. Manufacturers under Preventive Controls are exempt. For the most part, this is true. US facilities meeting FSMA’s Preventive Controls or Supply Chain rules are exempt from FSVP. However, there are many considerations to consider still.
4. Modified rules do not an equal exemption. U.S. importers must consider other U.S. regulations, such as low-acid canned regulations, seafood HACCP, Produce Safety Rule, and many others. Some regulations do not find all foreseeable or economically motivated hazards and importers must consider this.
5. Equivalent countries (Canada, New Zealand, Australia) are not exempt from ALL FSVP activities. This CFIA article explains to Canadian exporters their new regulation, FSSRA, is equivalent to FSVP. However, the named U.S. FSVP importer is still responsible for ensuring the Canadian supplier is on that list. Also, FDA registration nor visits from FDA equate FSVP to verification. The U.S. importer must still conduct the evaluation.
FSVP importer is defined as the U.S. Customer, U.S. Consignee or U.S. Agent. If the FDA finds that the appropriate entity did not conduct their FSVP correctly, a citation could lead to warning letters, import alerts, fines, and even criminal penalties.
Don’t ignore it. That is why we exist – to help you navigate these laws.