Update on FDA Registration and Prior Notice

Apr. 23, 2004

The Food and Drug Administration (“FDA”) has reopened the comment period on the interim final rules (“IFRs”) governing the registration of food facilities and the prior notice requirement for the importation of food.  The IFR on registration requires domestic and foreign facilities that manufacture or process, pack, or hold food (including animal feed) for consumption in the United States to register with FDA by December 12. 2003; the IFR on prior notice requires the submission of an electronic notification to FDA prior to the importation into the United States of food, including animal feed. Notice is to be provided either via the Customs and Border Protection (“CBP”) Automated Broker Interface (“ABI”) or the FDA Prior Notice System Interface (“PNSI”).

Reopening of Comment Period on Registration

With respect to registration, the FDA invited comments on the effects on both foreign facilities and domestic small businesses of the requirement for foreign facilities to designate a U.S. agent to act as a communications link between FDA and the foreign facility for both emergency and routine communications. 

Reopening of Comment Period on Prior Notice

Comments invited by FDA on prior notice pertain to the interest expressed in the IFR in exploring flexible alternatives for submission of prior notice for foods or firms covered by programs of other agencies, such as CBP’s Customs-Trade Partnership Against Terrorism (“C-TPAT”) and the Free and Secure Trade (FAST) Program, or for food imported by other government agencies.  Questions raised by FDA’s request with respect to C-TPAT and FAST include whether or not food products subject to prior notice requirements should be eligible for full expedited processing and information transmission benefits allowed with these programs, and whether or not the security and verification processes in C-TPAT should be modified to handle food and animal feed shipments by FDA.  FDA also requests comments regarding the possible need for flexible prior notice alternatives for those entities that participate in FAST or for food imported by other agencies if timeframes are reduced in the Prior Notice final rule; factors FDA should consider regarding food importers regulated by other agencies; additional means for ensuring that registration information is updated and verified; whether or not the food product category should be considered in Prior Notice processing procedures; whether FDA should consider harmonizing the prior notice requirements with the CBP electronic advanced manifest rule; and whether FDA should offer a Prior Notice submission training program.

Comments are to be submitted in both cases by May 14, 2002.  FDA has further indicated that it will not address any comments that have been previously considered during this rulemaking.