Safe Food En Route, LLC
Safe Food En Route, LLC
A Limited Liability Company


17.09.18 10:39 PM Comment(s) By Megan

The 5 most common mistakes I see in regard to FSVP plans

(edited 9/20/2019)

The biggest reason I left my job and founded Safe Food En Route, LLC was because I had several conversations with US importers unprepared for the new FSVP requirements. The definition of importer is probably one of the biggest reasons that companies get confused, but below include that one and the other 4most 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 it 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 3 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.

Here are 5 common mistakes I see:

  1. Suppliers outside the United States name their US Customers (or potential US Customers) as FSVP importers without their customer's knowledge. Major US retailers sent a letter stating the definition of FSVP importer meant US Customer or US Consignee and they did not want to be named unless there were no other entities. Yet this published LIST indicate their letters did not get to the right people. 
  2. FSMA Preventive Controls training does not meet ALL requirements for FSVP.  US importers must ensure that a risk assessment and hazard analysis is conducted by a “qualified individual” on all foods imported into the US from a specific facility (including samples).  Many foreign suppliers are taking FSPCA training. Great! That does help your US importing company, but that is only one step for the FSVP importer.  
  3. US 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 still consider.
  4. Modified rules do not equal exemption. US importers must consider other US regulations, such as low-acid canned regulationsseafood HACCPProduce Safety Rule, and many others. Some regulations do not consider 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. 
  6. This CFIA article explains to Canadian exporters their new regulation, FSSRA, is equivalent to FSVP. However, the named US FSVP importer is STILL responsible to ensure the Canadian supplier is on that list. Also, FDA registration nor visits from FDA equate to FSVP verification. The US importer must still conduct the evaluation.
Bottom line, FSVP importer is defined as the US Customer, US Consignee or US 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.

Have questions about your program? Contact us!

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