In May of 2017, the first compliance date passed for the Foreign Supplier Verification Programs regulation under the Food Safety Modernization Act (2011). Other than changing our approach to imported food safety from a reactive to a proactive way of thinking, what are some common misconceptions about this regulation, and where do we see it going in the next five to ten years?
As a Lead Instructor for the FSPCA curriculum for this course, and an administrator of public courses, I have personally had the pleasure of instructing several FDA representatives, as well as people from many different segments of the food industry, from brokers and distributors to manufacturers and retailers. This regulation affects a more diverse cross-section of people than even Preventive Controls for Human Food, but fewer people have elected to take the FSPCA course because it is not strictly required. This has resulted in a few misconceptions about the regulation being propagated throughout the industry by a few well-meaning but woefully misinformed people, the most common of which is, “I am not the importer, so I do not need to worry about this regulation,” to which I always respond, “do you mean the Importer of Record (IOR) or Importer for FSVP purposes, as they are not the same?” Invariably I get the classic deer-in-the-headlights stare, and often the subject is changed abruptly. If this is a sentiment you have heard expressed by anyone in your supply chain, please encourage them to attend our class, as we spend quite a long time discussing this very issue, and explaining why it is such a dangerous assumption.
Another frequent misconception is that the size of the importer dictates the compliance date for a food/supplier combination. This is also often not correct, as the size of the importer is only a factor when the importer is “Very Small” (less than $1 million per year average over the last three years preceding the current calendar year, including ALL subsidiaries and affiliates, whether foreign or domestic).
Right now, we are in a phase of education and outreach wherein FDA inspections often result in a recommendation for training if the result of the inspection is not NAI (no action indicated). In the next five to ten years, it is fair to assume that this initial phase will eventually expire, and companies not in compliance with the regulation may expect some additional enforcement activities. Remember that FSMA expanded the regulatory toolbox of the FDA to include additional tools for compliance enforcement activities. No one has a crystal ball to know what will happen in the future, but based on the feedback from agency representatives so far, it is expected that the education and outreach timeframe will extend for a few years at least. Therefore, we are estimating that the next five years will continue education and outreach, and then after about five years we may expect to see further enforcement if companies continue to claim ignorance or refuse to act in compliance with the tenets of the regulation.
Remember, if you use or sell food that was imported at any point in the past, whether you are acting as the Importer and/or Importer of Record or not, it is of paramount importance that you communicate with your supply chain to determine who is acting in each of those roles. As always, if you didn’t write it down, it wasn’t done, so keep a record of your communications. You may be surprised to learn how many misconceptions you uncover!