| Title: | Reminder FDA Food Facility Registration Renewal and Impact on Food Imports |
|---|---|
| Date: | 2013-02-27 |
| To: | abi |
| Links: | previous, original, next |
From: Food and Drug Administration
Subject: Reminder FDA Food Facility Registration Renewal and Impact on Food Imports
As previously communicated under CSMS# 13-000020 & CSMS #13-000044, 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 Cosmetic 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 registration 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 for the 2012 cycle, FDA issued guidance stating that due to the delay in FDA's implementation of the biennial registration renewal (the registration renewal system did not become available until October 22, 2012), FDA was exercising enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 and accepted 2012 renewals until January 31, 2013.
As mentioned in CSMS# 13-000020 & CSMS #13-000044, beginning on February 1, 2013, if a foreign food facility is required to register with FDA, but failed to do so, food from that facility imported or offered for import into the U.S. is subject to refusal under section 801(l) of the FD&C Act. Please note that a significant number of food facility registrations (FFRs) that were not renewed by January 31, 2013 are currently in the process of being modified to an invalid status by FDA. As a result, imported food shipments manufactured by those facilities without valid registrations may be held at the port or refused upon arrival in the U.S. FDA continues to encourage 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 import food shipment delays related to food facility registration. Please note that ABI prior notice transaction rejections indicating a transmitted FFR(s) is invalid may occur. When this happens, please contact the individual providing 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 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
CSMS #13-000621