While the final rule made a number of changes to the interim final rule, the final rule did not make any changes to the method or deadlines for submitting the prior notice for imported food products.
The final rule, which will take effect on May 6, 2009, requires that the prior notice be submitted to FDA electronically via either U.S. Customs or Border Protection's Automated Broker Interface of the Automated Commercial System or the FDA Prior Notice System Interface (PNSI). The information must be submitted and confirmed electronically by the following deadlines:
- For food arriving by water = 8 hours
- For food arriving by air or land/rail = 4 hours
- for food arriving by land/road = 2 hours
FDA has also issued a "Prior Notice Compliance Policy Guide" at http://www.cfsan.fda.gov/~acrobat/fsbtpn2.pdf.
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.
According to FDA’s guidance, some of the revisions include:
- 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.
- 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.
If you have any questions regarding the filing of PN on your imports, please contact your JSC Account Representative or Sales Representative.