CBP Posts Instructions for FSMA Food Facility Registration
CBP provided some advice on how to reduce the likelihood of holds as a result of new food facility registration requirements. Beginning Feb. 1, if a foreign food facility is required to register with the Food and Drug Administration, but fails to do so, food from that facility that is being imported or offered for import into the U.S. is subject to refusal under section 801(l) of the Food, Drug and Cosmetics Act. Food facility registrations (FFRs) that are not renewed by Jan. 31 will be subject to invalidation of registration and could result in food shipments manufactured by those facilities without valid registrations to be held at the port or refused upon arrival in the U.S., said CBP in a CSMS message.
FDA encourages import filers who file prior notices for food shipments to take proactive action and contact clients with high-volume food shipments, inquire about the FSMA food facility registration renewal status of foreign manufacturing facilities associated to their shipments, and confirm any new registration numbers. Doing so could greatly mitigate any prior notice shipment delays related to registration on or after Feb. 1. If an import prior notice ABI transaction rejection indicates the transmitted FFR is invalidated, contact the individual submitting the information and request updated FFR information for correction.
Below are FDA registration reject reason codes sent by FDA via ABI to the filer:
- “R” is for missing registration.
- "F" will be returned when the number provided via the affirmation of compliance is not and has never been on file
- "M" is returned when there is a mismatch between the registration number and the firm transmitted as the manufacturer in the FD01 record.
- “I” means that FDA has invalidated the registration
- “C” means the registration has been canceled
The registration reject codes appear in the BN application, FD02 record in position 65.
(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.)