FDA Food Facility Registration Renewal Begins; All Facilities Must Register by Dec. 31
The Food and Drug Administration began the period for registration renewal for food facilities Oct. 22 at 12:01 a.m. The biannual registration renewal, required by the Food Safety Modernization Act, had been on hold pending release of related guidance documents, but FDA said it's ready for the registration renewals, which may be submitted either online, by mail, or by fax, after it finalized its guidance on additional food categories in food facility registrations. All food facilities must renew their registration by Dec. 31. Foreign facilities must designate a U.S. Agent that will be liable for foreign facility reinspection fees.
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FSMA requires all food facilities to renew their registrations every two years, between Oct. 1 and Dec. 31, on even numbered years. All domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to register, including those already registered with FDA. Food facilities that fail to register will be subject to import refusal.
New Mandatory Food Product Categories
The new registration includes new mandatory fields, such as additional food product categories that were previously optional fields on the food facility registration form like food product categories for animal consumption. A list of the food product categories is available in the FDA’s guidance on “Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories” (here), updated Oct. 19.
Facilities may complete the registration forms online (here) between 7:00 a.m. and 11:00 p.m. ET. Instructions for online registration are available here. Alternatively, facilities may register by mail, fax, or CD-ROM (here).
Foreign Facilities Must Designate U.S. Agent Liable for Reinspection Fees
Foreign facilities must also designate a U.S. Agent for their facility and must include that agent’s email address. Pursuant to FSMA, the U.S. Agent will now be liable for reinspection fees assessed on foreign facilities, which were set at $289/hour if foreign travel is required for fiscal year 2013. FDA has said that it will not begin invoicing for reinspections until it finalizes its guidance on small business fee reductions.
(See ITT’s Online Archives 12100333 for summary of FDA delaying registration renewal pending finalization of guidance documents. See also ITT’s Online Archives 12101902 for summary of new liability for U.S. Agents of foreign facilities, and 12073133 for summary of associated fees for FY 2013. See ITT’s Online Archives 11010426 for summary of the Food Safety and Modernization Act.)