FDA Posts Compliance Guide for Final Rule on Prior Notice of Imported Food Which Takes Effect May 6th

The compliance guide is intended to help all entities, especially small businesses, better understand the PN regulation. As guidance, it is not binding on either the FDA or the public.

Final Rule Retains Majority of 2003 Interim Final Rule With Certain Changes

The final rule, which takes effect on May 6, 2009, retains the majority of the requirements found in the FDA's interim final rule (IFR) on PN, which has been in effect since December 12, 2003, but includes revisions in a few key areas.

According to FDA's guidance, these revisions include (partial list):

More time to submit PN prior to arrival. To assist importers, the final rule now permits PN to be submitted no more than 15 calendar days before the anticipated date of arrival for submissions made through FDA's Prior Notice System Interface (PNSI) and no more than 30 calendar days before the anticipated date of arrival for submission made through U.S. Customs and Border Protection's (CBP's) Automated Broker Interface of the Automated Commercial System (ABI/ACS).

(Currently, 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.)

Manufacturer defined, registration number required, etc. The final rule adds a definition for "manufacturer" as the last facility, as that word is defined in 21 CFR 1.227(b)(2), that manufactured/processed the food. The final rule also requires the submission of the manufacturer's registration number but provides an alternative for identifying the manufacturer when the registration number is not known.

Express consignment tracking number for arrivals. The final rule allows, when certain conditions are met, for the submission of the express consignment operator or carrier tracking number in lieu of the anticipated arrival information, Bill of Lading, or Airway Bill number and flight number, which the IFR required.

Guidance Describes Who Is Affected, Timeframes, Exclusions, Submissions, Etc.

The guidance document also covers the following topics regarding PN and the final rule:

which industry sectors are affected;

how "food" is defined;

which food imports require PN;

exclusions;

who can give PN:

information required;

what happens if you fail to give adequate PN;

how and when to give PN;

getting help;

correcting errors during submission;

how PN is acknowledged;

presenting PN confirmation on shipment arrival;

what to do if information changes after confirmation; and

submitting PN for food previously refused for inadequate PN.

(See ITT's Online Archives or 03/31/09 news, 09033135, for BP summary of FDA fact sheet and, slide presentation on PN final rule.

See ITT's Online Archives or 11/03/08, 11/21/08, and 11/24/08 news, 08110308, 08112110, and 08112410, for Parts I-III of BP's summary of the final rule.)

FDA notice announcing the guidance (D/N 2009-D-0187, FR Pub 04/24/09) available at http://edocket.access.gpo.gov/2009/pdf/E9-9358.pdf

FDA guidance, "What You Need to Know About Prior Notice of Imported Food Shipments, A Small Entity Compliance Guide" (dated April 2009) available at http://www.cfsan.fda.gov/acrobat/fsbtpn2.pdf