FDA Issues Final Rule on Prior Notice of Imported Food (Part III - Comments on Interim Final Rule)

The final rule will modify FDA's interim final rule that implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) on December 12, 2003. The interim final rule requires PN to be submitted to FDA electronically via U.S. Customs and Border Protection's (CBP's) Automated Broker Interface (ABI) or FDA's Prior Notice System Interface (PNSI).

The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land via rail), and 2 hours (for food arriving by land via road) before the food arrives at the port of arrival. Food imported or offered for import without adequate PN is subject to refusal and, if refused, must be held. (These time requirements are unchanged by the final rule.)

This is Part III, the final part of BP's summary of the FDA's final rule on PN, and highlights the comments the FDA received on its interim final rule.

Highlights of Comments on FDA's Interim Final Rule

"Highlights" of FDA's responses to certain comments it received on its interim final rule include:

No graduated enforcement policy. FDA states that since the final rule retains most of the requirements in the interim final rule, and with the 180-day delay in the effective date, the FDA is not implementing a graduated enforcement policy for the final rule.

Guidance on HTS codes flagged for PN. FDA received a comment asking whether CBP's Adm: 03-2605 (dated 10/31/03) is a definitive list of HTS codes flagged for PN (both FDA3 and FDA4). FDA states that Adm: 03-2605 is not a definitive list. FDA and CBP are continuously reviewing and updating the FDA flags associated with the HTS codes. Guidance regarding the HTS flags is posted at http://www.cfsan.fda.gov/dms/htsguid3.html. FDA warns that the lack of an FD3 or FD4 designation does not mean that PN is not required. If the article of food fits the definition of food provided in 21 CFR 1.276 of the final rule, then PN is required for that article of food.

Coordination of C-TPAT, FAST with PN requirements. FDA states that it received numerous comments regarding special trade programs, such as Customs-Trade Partnership Against Terrorism (C-TPAT) and the Free and Secure Trade (FAST) program which recommended that FDA and CBP modify these CBP programs to reflect the criteria required by FDA and to develop integrated data elements for low risk FAST/C-TPAT shipments, which would meet both agencies' requirements.

FDA states that while it welcomes the additional information provided by C-TPAT and FAST, these programs would require relatively significant changes to be useful in helping FDA to carry out the PN program. FDA notes that C-TPAT focuses on security risks whereas the PN program considers all health and safety risks to the food.

FDA notes that it has determined not to provide C-TPAT members with special treatment in terms of reduced PN information requirements or reduced timeframes, and will continue exploring use of these programs in making decisions regarding which products to inspect for the purposes of admissibility (801(a) decisions).

FDA is working with CBP to ensure PN requirements are reflected in ACE. In response to a comment that suggested that FDA participate in the International Trade Data System (ITDS), FDA states that it is actively participating in the development of the Automated Commercial Environment (ACE) and has long been a participant in ITDS. However, FDA notes that ACE is not yet a complete reality and PN requirements have been in effect since December 12, 2003. FDA is working with CBP and others in the international trade community to ensure that the PN requirements are reflected in ACE once ACE is fully operational.

FDA and CBP will conduct training focused on final rule's changes. FDA and CBP will conduct training focused on changes between the final rule and the interim final rule.

Depending on resources, the education and outreach may take the form of public meetings, Web-based interactive training, or posting on the FDA and CBP Web sites of guidance and other outreach materials. As resources permit, FDA and CBP also may translate their guidance and other outreach materials into other languages.

FDA and CBP have increased integration. FDA also responded to comments it received about the April 2004 Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes by noting that FDA and CBP have increased their integration and are continuing to do so in the following ways:

• co-location of all FDA PN staff with CBP's targeting staff;
• further refinement to FDA's targeting rule sets in CBP's targeting system, coupled with additional training in targeting techniques;
• continued targeting support from CBP and other federal law enforcement analysts; and
• enhancement of communications and cooperation with CBP to facilitate information exchange and to ensure expeditious access and examination of food shipments FDA has decided to inspect upon arrival.

(See ITT's Online Archives or 11/03/08 and 11/21/08 news, 08110308 and 08112110, for Parts I and II of BP's summary of this final rule.)

FDA contact - Laura Draski (866) 521-2297

FDA final rule (FR Pub 11/07/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-26282.pdf.

FDA announcement of draft policy compliance guide (FR Pub 11/07/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-26281.pdf.