FDA issues guidance for food facility registration

by Jay Sjerven
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Following a delay of nearly a month, the Food and Drug Administration released its guidance to industry regarding the use of food categories in food facility registrations. Effective Oct. 22, all food companies under the F.D.A.’s jurisdiction were required to re-register their facilities, as called for under the Food Safety Modernization Act of 2010.

Facility categories added to the registration process include companies manufacturing:
• acidified foods;
• baby food products including infant formula;
• cheese and cheese products;
• dietary supplements;
• fishery/seafood products;
• fruit and fruit products;
• fruit or vegetable juice pulp or concentrate products;
• low-acid canned food products;
• nuts and edible seed products;
• shell egg and egg product categories; and
• vegetable and vegetable pro-duct categories.

The renewal registration process was to have begun on Oct. 1 and was scheduled to conclude on Dec. 31 of this year. But on the evening of Sept. 28, the F.D.A. issued a statement that read, “Biennial registration renewal for food facilities will not be available on October 1, 2012. We therefore will not be accepting food facility registration renewals at this time.”

Explaining the delay, an F.D.A. spokesman said, “The agency is still working to finalize related documents and implement certain policies and processes.”

Under the Bioterrorism Act of 2002, all facilities that manufacture, process, package, receive or store food for consumption in the United States were required to register with the F.D.A. The act required facilities to register only once with the understanding that any significant changes to the facility would have to be reported within 60 days.

The F.S.M.A. added the requirement that all food facilities would have to renew their registrations with the F.D.A. every two years, in even-numbered years, beginning this year. The act also required each food facility on registering to provide the agency not only basic information relating to owners, agents and trade names, but the types of activities conducted at the facility and the general categories of food products manufactured, processed, packed or stored in the facility.

In August, only weeks before the renewal process was set to begin, the F.D.A. issued a new guidance to industry titled “Necessity of the use of food categories in food facility registrations and updates to food categories,” in which it specified additional food categories it intended to include as mandatory fields in its food facility registration form (see Food Business News, Sept. 11, Page 26).

The F.D.A. also indicated on its web site “three additional updated food facility registration guidance documents will be released later this year to further clarify the process.”

With the clock ticking, the food industry voiced its concerns to the F.D.A. about the registration renewal process.

In a Sept. 21 letter to Boris Bershteyn, acting administrator, Office of Information and Regulatory Affairs of the Office of Management and Budget, Dr. Leon Bruner, senior vice-president, science and regulatory affairs, and chief science officer of the Grocery Manufacturers Association, on that behalf of the G.M.A. and 20 other food industry organizations, wrote, “Industry needs guidance to understand both the logistical and substantive requirements for re-registration. It would be extremely inefficient and costly for companies to re-register shortly after Oct. 1 based on the old procedures, only to find out later they have to do it all over again after F.D.A. clarifies the new procedures in its new guidance. Thus, it will be difficult, if not impossible, for food facilities to effectively and efficiently meet F.S.M.A.’s registration renewal mandate without guidance from F.D.A. Hundreds of thousands of facilities worldwide will be delayed in their efforts to reregister if F.D.A.’s guidance is not issued soon.”

With the issuance of the new guidance, the F.D.A. said it was accepting comments regarding the new facility categories. The guidance documents may be viewed by visiting www.fda.gov.
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