FDA Releases Draft Policies for Food Imports from Facilities w/ Lapsed & Suspended Registrations
The Food and Drug Administration released a draft guidance for its staff on food facility registration, including Food Safety Modernization Act provisions for registration renewal and suspension of registration. Policies recommended by the draft guidance include holding food imports from facilities with lapsed or suspended registrations at the port, and notifying the FDA Division of Food Defense Targeting (formerly the Prior Notice Center) so it can target food imports from the offending facilities. If finalized, the draft guidance will “represent FDA’s current thinking on this topic.”
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Comments on the draft guidance, titled “Compliance Policy Guide Sec. 100.250 Food Facility Registration -- Human and Animal Food” (here) are due by May 6.
FSMA Requires Facility Registration Renewal, Allows Suspension
FSMA requires all food facilities, domestic and foreign, to renew their Bioterrorism Act registrations with FDA every two years (see 12102221). FDA considers facilities that don’t renew their registrations to not have registered at all, it said. According to CBP, a “significant number” of foreign food facilities did not renew their registrations by the end of the 2012 renewal period on Jan. 31 (see 13022829).
FSMA also gave FDA the authority to suspend registration of food facilities for certain violations. According to the draft guidance, the Center for Food Safety and Applied Nutrition (CFSAN) should give “priority consideration” to recommending suspension of a food facility’s registration in the following cases, among others:
- An inspection or other evidence shows the firm with significant violations of the Food, Drug and Cosmetic Act and hasn’t permanently corrected the violations;
- The firm is subject to a prehearing order to cease distribution and give notice under FDA’s mandatory recall authority;
- The firm is subject to an emergency permit order or an emergency permit recommendation is being considered;
- Food from the firm is subject to an Import Alert that provides for detention without physical examination because the food may cause serious health consequences or death to humans or animals.
FDA to Hold Food Imports at Port of Entry
In its draft guidance, FDA said it will hold food imports from foreign facilities with lapsed registrations at the port of entry. The agency “will not permit the food to be delivered to the importer, owner, or consignee until the foreign facility is registered, and the appropriate registration number is provided in prior notice,” it said. FDA may allow the food held at the port of entry to be moved to a secure facility. The food may also be immediately exported from the port arrival if permission from CBP is obtained, FDA said.
In the case of facilities with suspended registrations, import or introduction into U.S. commerce of food from the facility is prohibited while the suspension order is in effect. In its draft guidance, FDA simply said it will “hold the food at the port of entry” when imported from facilities with suspended registrations.
When FDA discovers a lapsed registration, or suspends the registration of a facility, CFSAN or the Center for Veterinary Medicine should notify the Division of Food Defense Targeting (DFDT), the draft guidance said. DFDT will then be able to add prior notice targeting criteria into OASIS/MARCS to identify food offered for import into the U.S. from the facility with the lapsed or suspended registration, it said.