FDA Issues Final Rule on Prior Notice of Imported Food (Part II - Significant Changes from Interim 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 II of the FDA's final rule on PN, and covers FDA's discussion of the significant changes from the interim final rule. See future issues of ITT for additional BP summaries of this final rule.

"Highlights" of the FDA's list of significant changes include (partial list):

New and Revised Definitions

The final rule will add the following definitions:

Full address - the facility's street name and number; suite/unit number, as appropriate; city; province or state as appropriate; mail code, as appropriate; and country.

Manufacturer - the last facility, as defined in 21 CFR 1.227(b)(2), that manufactured/processed the food. A facility is considered the last facility even if the food undergoes further manufacturing/processing that consists of adding labeling or any similar activity of a de minimis nature. If the food undergoes further manufacturing/processing that exceeds an activity of a de minimis nature, then the subsequent facility that performed the additional manufacturing/processing is considered the manufacturer.

The final rule will revise several definitions, including (partial list):

International mail - to state that the term does not include express consignment operators or carriers or other private delivery services unless such service is operating under contract as an agent or extension of a foreign mail service.

Port of arrival - to add specific sentences defining the port of arrival for articles of food arriving by water or air and articles of food arriving by land. The definition is amended by deleting the phrase "i.e., the port where the article of food first arrives in the U.S." and adding the following: "For an article of food arriving by water or air, this is port of unloading. For an article of food arriving by land, this is the port where the article of food first crosses the border into the U.S."

Shipper - to include express consignment operators or carriers or other private delivery service to the U.S. (to clarify that a shipper is involved with various types of transactions, and not just international mail shipments).

Longer Time Period for Submitting PNs Prior to Arrival

The FDA final rule will revise the regulation on when PN must be submitted to FDA (21 CFR 1.279) to permit PN to be submitted no more than 15 calendar days before the anticipated arrival for PN submissions made through the PNSI and not more than 30 calendar days before the anticipated date of arrival for PN submissions made through ABI, except in the case of an article of food imported or offered for import by international mail.

(21 CFR 1.279 currently states that, except in the case of an article of food imported or offered for import by international mail, PN may not be submitted more than 5 calendar days before the anticipated date of arrival of the food at the anticipated port of arrival.)

Revisions to the Information That Must be Provided in a PN

The final rule will amend the current information that must be provided in a PN in 21 CFR 1.281 as follows:

Shipper. The final rule will require the PN to include the name and full address of the shipper, if the shipper is different from the manufacturer (in order to eliminate duplicative requirements). If the address of the shipper is a registered facility, the submitter may also submit the registration number of the shipper's registered facility.

Port of arrival. The final rule will remove the requirement in 21 CFR 1.281(11)(a) that the PN include the identity of the anticipated border crossing within the port of arrival because FDA and CBP have determined that it is no longer necessary.

Express consignment tracking number for arrivals. The final rule will also revise the arrival information required in 1.281(a)(11) (general) and (c)(11) (refused articles) to include a new provision which states that if the article of food is arriving by express consignment operator or carrier, and neither the submitter nor transmitter is the express consignment operator or carrier, and the PN is submitted via PNSI, the express consignment operator or carrier tracking number may be submitted in lieu of the anticipated arrival information. The final rule further states that until such time as FDA and CBP issue a determination that ACS or its successor system can accommodate such transactions, the tracking number will not be able to be submitted in lieu of the information required in 21 CFR 1.281(a)(11)(i)-(iii) or 21 CFR 1.281(c)(11), as applicable, if the PN is submitted via ABI.

Identity of the manufacturer, for food no longer in its natural state. The final rule will revise the PN information requirements in 21 CFR 1.281(a)(6) for an article of food that is no longer in its natural state, to require the name of the manufacturer and either: (1) the registration number, city and country of the manufacturer or (2) both the full address of the manufacturer and the reason the registration number is not provided.

Identity of manufacturer if such food sent as a personal gift. The final rule will revise the PN information requirements for an article of food that is no longer in its natural state to remove the current option that allows the name and address that appears on the label under 21 CFR 101.5 to be submitted instead of the name, address, and registration number of the manufacturer for food sent by an individual as a personal gift (i.e., for nonbusiness reasons) to an individual in the U.S.

The FDA notes, however, that under the enforcement policy proposed in the PN final rule draft Compliance Policy Guide, FDA and CBP should typically consider not taking any regulatory action when no PN is submitted for food articles imported or offered for import for noncommercial purposes with a noncommercial shipper, irrespective of the type of carrier.

Shipment information for food articles. The FDA's final rule will revise the PN requirement of shipment information for general (21 CFR 1.281(a)) and refused food articles (21 CFR 1.281(c)) by:

1. clarifying that the required shipment information is applicable by mode of transportation and when it exists;
2. making the provisions in 21 CFR 1.281(a)(17)(i) and (c)(17)(i) for the Airway Bill number/Bill of Lading number and flight number, as applicable, since this information is generally not available to individual submitters;
3. allowing the express consignment operator or carrier tracking number to be submitted in lieu of the Bill of Lading or Airway Bill number(s), as applicable, for PNs submitted via PNSI for an article of food arriving by express consignment operator or carrier when neither the submitter nor transmitter is the express consignment operator or carrier and stating that until such time as FDA and CBP issue a determination that ACS or its successor system can accommodate such transactions, the tracking number may not be submitted in lieu of the Bill of Lading or Airway Bill number(s), as applicable, if the PN is submitted via ABI (with a corresponding provision that applies to the flight number for food that arrived by air carrier).
4. deleting the requirement for the six-digit Harmonized Tariff Schedule (HTS) number; and
5. moving the requirement for the license plate number (and state or province that issued the license) for an article of food that arrived by privately owned vehicle from the required planned shipment information to the required carrier information.

Name/address information for refused food articles. The final rule will revise the PN requirements for the name and address of the importer, owner, and ultimate consignee for refused food articles to insert the "full" in front of "address" to make clear that the complete address is required. Consequently, the FDA will revise the subsequent text to state that if the business address of the importer, owner, or ultimate consignee is a registered facility, then the facility's registration number may also be provided in addition to the facility's full address.

Arrival date for PN submissions for refused food articles. For PN submissions for refused articles, the actual date the article arrived at the port of arrival will be a required data element (so that FDA knows how long it has been since the refused food shipment arrived in the U.S. and how to connect the refused PN to the post-refusal PN submission for shipments where a previously refused PN was filed).

Food Refused Due to Inadequate, Inaccurate, or Untimely PN

The final rule will revise 21 CFR 1.283(a) to state that, except for food arriving by international mail or food carried by or otherwise accompanying an individual, refused food must be moved under appropriate custodial bond unless immediately exported under CBP supervision. The final rule will also clarify that such refused food may be held at the port or at a secure facility outside the port. In addition, the final rule will change the timeframe for notifying FDA of the hold location from within 24 hours of refusal to before such food is moved to the hold location.

The FDA final rule will also (1) include the carrier as one of the entities who can submit a request for FDA review (after refusal) and (2) delete acceptance of a request for review by mail and express courier and limit delivery methods for such requests to fax and email.

Food in "Diplomatic Bags" Will Not Require PN

The final rule will revise the list of food that does not require PN in 21 CFR 1.277 by adding articles of food subject to Article 27(3) of the Vienna Convention on Diplomatic Relations (i.e., shipped as baggage or cargo constituting the diplomatic bag).

Food from Unregistered Foreign Facilities Subject to Hold

The final rule will revise 21 CFR 1.285(a) to state that if an article of food from a foreign facility that is not registered as required is imported or offered for import into the U.S., the article of food is subject to a hold under 21 USC 381(l). (21 CFR 1.285(a) currently states that such food is subject to refusal of admission under 21 USC 381(l) and 21 CFR 1.283 for failure to provide adequate PN.)

The final rule will also revise 21 CFR 1.285(a) to delete the text that states that failure to provide the correct foreign manufacturer's registration number (if required) renders the identity of the facility incomplete for purposes of PN.

Singular Web Site Address for PNSI, OASIS Outage Notification, Etc.

The final rule will also simplify the provisions in 21 CFR 1.280(b)-(e) pertaining to PNSI or the Operational and Administration System for Import Support (OASIS) system outages by providing outage notification at one Web address (http://www.fda.gov) and will state that FDA will accept PN submissions in the format it deems appropriate during the system(s) outage.

¹According to FDA sources, the long lead time before this final rule is effective is due in part to allow time for software programming.

(See ITT's Online Archives or 11/03/08 news, 08110308, for BP summary of Part I of the multi-part series of summaries on 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.