CSMS# 13-000044 - FDA Food Facility Registration Renewal and Impact on Food Imports (Reminder)

Automated Broker Interface

From: Food and Drug Administration



The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), signed into law on Jan. 4, 2011, enables FDA to better protect public health by strengthening the food safety system. Among many other changes, FSMA amended section 415 of the federal food, drug, and cosmetics act (FD&C act) [21 U.S.C. § 350d], which requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with FDA. Under FSMA, all food facilities that are required to register with FDA under section 415 of the FD&C act must renew their registrations with FDA, every other year, during the period of time beginning on October 1 and ending on December 31 of each even-numbered year. However, FDA issued guidance stating that due to the delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.



Beginning on February 1, 2013, if a foreign food facility is required to register with FDA, 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 FD&C act. Food facility registrations (FFRs) that were not renewed by January 31, 2013, 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. As a result, 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 February 1, 2013.



In the event of an import prior notice ABI transaction rejection indicating the transmitted FFR is invalidated; please contact the individual submitting the information and request updated FFR information for correction.



A brief review of the FDA registration reject reason codes sent by FDA:

The registration codes appear in the BN application, FD02 record in position 65.



R, F, M, I, C invalid registration

R = missing registration

F = registration not on file

M = mismatch in registration

I = invalidated registration

C = cancelled registration



"F" will be returned when the number provided via the “PFR” 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 cancelled



For ABI BN record layout information above, refer to the Customs and Trade Automated Interface Requirements (CATAIR) document, Other Government Agencies chapter, page OGA 37, or consult your ABI software provider. CATAIR chapters available here:

www.cbp.gov/xp/cgov/trade/automated/automated_systems/abi/catair/chapters/

Select the Other Government Agencies chapter.



For more information on the FDA food facility registration requirement, see FDA’s website at http://www.FDA.gov/food/foodsafety/FSMA/ucm314178.htm



For assistance with registration issues contact FDA Industry Systems Help Desk at 800-216-7331 or 301-575-0156.



For assistance via email, utilize the form on FDA’s website http://www.accessdata.fda.gov/scripts/email/cfsan/bioterrorismact/helpf2.cfm




Related CSMS No. 13-000020