Guest blog post - Dr. David Acheson, The Acheson Group
It is October of an even-numbered year … which means it's time for the biennial renewal of your facility registration in FDA's Food Facility Register (FFR) (at http://bit.ly/2asTGhE). This is a have-to-do by year end for all who manufacture, process, pack, or hold food. In fact, if a registration is not renewed by 11:59 PM on December 31, the registration will expire and be removed from the account.
You also need to be sure you are accurately categorizing your food facility/facilities, because FDA could take regulatory action if they are not accurate. And that is where the new guidance issued last week by FDA becomes of critical importance.
The FFR Food Product Category guidance (or more specifically Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates) provides information on categories as a mandatory field in FFR registration and updates for some categories.
But what is most important about this guidance is that, contrary to the general definition of guidance being nonbinding, this is, in fact, binding; it does establish legally enforceable responsibilities, and FDA points that out in the document a few different times and ways.
The updates in the guidance apply to facilities that manufacture, process, pack or hold acidified or low-acid canned foods, animal foods, and molluscan shellfish:
- Acidified foods and low acid canned foods are no longer listed as food product categories because they are now activity types.
- Additions to animal food categories of botanicals and herbs, direct fed microbials, animal protein products, forage products, human food byproducts not otherwise listed, and technical additives. (The “animal protein products” category replaces the previous “animal derived products” category, and the “processed animal waste products” category replaces the “recycled animal waste products” category.)
- Molluscan shellfish is now a food product category. (Previously, molluscan shellfish establishment was listed among the optional activity types.)
The reason accuracy in category registration is so important is because FDA references the FFR to respond to food-related emergencies. Sorting the database by category enables the agency to quickly alert facilities potentially affected by an incident when the specific type of food is known, and to conduct investigations and surveillance operations in response to food-related emergencies. FDA includes an example of receiving information indicating that soft drinks could be affected by a bioterrorism incident or other food-related emergency. By selecting facilities in the soft-drink category, FDA is able to alert those facilities about the incident.
In connection with the prior notification requirements, the categories also help FDA verify that imported products are correctly identified by where and when they were produced. For example, if the registration information identifies a facility as producing only dairy products and FDA receives a prior notice for a shipment of nuts purporting to have been produced at that facility, the agency can examine the shipment to verify its contents based on the discrepancy.
While it's a good thing to be able to understand the why of a regulatory requirement, as FDA provides in the above explanations and examples, the real take-away from this newsletter is the need to register under the correct category: If you manufacture, process, pack, or hold food, you have a little under three months to register or renew your facility in the FFR, and it is important to make sure that your food categories are accurate. If you don't register/renew by December 31, or your categories are not accurate, you could be subject to regulatory action.