F.D.A. revises food facility registration requirements

by Jay Sjerven
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Jay Sjerven
The U.S. Food and Drug Administration has begun to process registration renewals for the agency’s Food Facility Register (F.F.R.). By law, all facilities that manufacture, process, pack or hold food must renew the required registration with the F.D.A. during the fourth quarter (October-December) of every even-numbered year. Facilities must renew their registration by 11:59 p.m., Dec. 31, 2016, or the current registration will expire and be removed from their account.

As it opened the registration renewal period, the F.D.A. issued guidance for industry on the “necessity of the use of food product categories in food facility registrations.” It also provided a few updates to food product categories. Food facilities were directed to make certain they are accurately categorizing the food they produce, process, pack or store.

The registration renewal process was a huge undertaking for the agency. The F.D.A. indicated as of February 2016, 88,356 domestic facilities and 212,539 foreign facilities were registered in the F.F.R.

The F.D.A. was mandated to establish the register by The Public Health Security and Bioterrorism Act of 2002. Food facilities have been required to register with the F.D.A. since the establishing regulations of that act became effective in December 2003.

The F.D.A. Food Safety Modernization Act, enacted on Jan. 4, 2011, required food facilities to submit additional registration information to the F.D.A., including an assurance that the agency will be permitted to inspect the facility at the times and in the manner permitted by the Food, Drug and Cosmetics Act as amended by FSMA.

The FSMA also introduced the requirement that food facilities must renew their registrations every other year, and provided the F.D.A. with authority to suspend the registration of a food facility in certain circumstances.

Specifically, if the F.D.A. determines that food manufactured, processed, packed, received or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the agency may by ordered to suspend the registration of a facility that “created, caused, or was otherwise responsible for such reasonable probability; or knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.”

The guidance for industry issued ahead of the registration renewal period carried special weight. It was not a typical F.D.A. “guidance for industry,” said David Acheson, president and chief executive officer, The Acheson Group.

“What is most important about this guidance is that, contrary to the general definition of guidance being nonbinding, this is, in fact, binding,” Mr. Acheson said. “It does establish legally enforceable responsibilities, and F.D.A. points that out in the document a few different times and ways.”

The F.D.A. said the new guidance will help enhance its ability to respond quickly and accurately to food-related emergencies by updating the food product categories that companies can select when registering with the agency.

The F.D.A. said information about the categories of food a facility manufactures or distributes helps the agency conduct investigations and surveillance operations in response to food-related emergencies. The categories also enable the agency to quickly alert facilities potentially affected by such an incident if the F.D.A. receives information indicating the type of food affected.

The F.D.A. gave the example of the agency receiving information indicating that soft drinks may be affected by a bioterrorism incident or other food-related emergency. With the product category information provided by facilities during registration renewal, it would be able to alert all soft drink facilities about the incident.

The F.D.A. also said food product categories help it 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 the F.D.A. 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 between the registration information and prior notice data,” the F.D.A. said.

The guidance announced three updates to the list of food product categories that must be considered as food facilities renew their registrations.

First, acidified foods and low-acid canned foods are no longer listed as food product categories because they are now considered activity types. Second, the guidance added new animal food categories, including botanicals and herbs, direct-fed microbials, animal protein products, forage products, human food byproducts not otherwise listed and technical additives. And third, the guidance said molluscan shellfish is now a food product category.

The F.D.A. noted it would address further amendments of the food product categories on the registration form through future updates in guidance documents.

“If you manufacture, process, pack or hold food, you have a little less than three months to register or renew your facility in the F.F.R., and it is important to make sure that your food categories are accurate,” Mr. Acheson said. “If you don’t register/renew by Dec. 31, or your categories are not accurate, you could be subject to regulatory action.”

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