FDA Posts Fact Sheet, Presentation on Its Prior Notice Final Rule That Takes Effect May 6th
The Food and Drug Administration has posted a fact sheet and a slide presentation on its November 2008 final rule on Prior Notice (PN) of imported food and on its draft compliance policy guide outlining FDA's enforcement policies regarding the final rule.
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Nov 2008 Final Rule on Prior Notice Will Take Effect May 6th
According to the fact sheet, FDA's November 2008 final rule will amend FDA's PN Interim Final Rule (21 CFR Part 1, Subpart I), which has been in effect since December 12, 2003, on the submission to FDA of PN of food, including animal feed, which is imported or offered for import into the U.S.1 The final rule takes effect May 6, 2009.2
FDA states that the final rule only revises the interim final rule in "a few key areas," which FDA has previously stated include (partial list):
"Shipper" will be revised. The term shipper will be revised 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).
More time to submit PN prior to arrival. PN submissions will be allowed 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 Automated Broker Interface (ABI), except in the case of an article of food imported or offered for import by international mail. (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 registration number will be required. Under the interim final rule, a registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage, and export, or further manipulation and export. However, the final rule will require the registration number of the manufacturer (or the full address of the manufacturer and a reason) in all circumstances.
Express consignment tracking number for arrivals. The final rule also includes a new provision for food arriving by express consignment operator or carrier since certain information may not be available to persons who ship food using an express consignment operator or courier. 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.
(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.)
Draft Compliance Policy Guide Expected to be Finalized May 6th
In November 2008, FDA also announced the availability of a draft compliance policy guide on FDA's enforcement of the requirements for submitting PN for food imported or offered for import into the U.S.
According to FDA sources, the draft policy guide is expected to be finalized on May 6, 2009, and to be the same or substantially the same as the draft version.
1PN must be submitted to FDA electronically via either CBP's ABI or FDA's 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/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held.
2FDA has previously stated that the long lead time before the rule's effective date is to allow time for software reprogramming, among other things.
FDA fact sheet (dated March 2009) available at http://www.cfsan.fda.gov/dms/fsbtac29.html
FDA presentation (dated March 2009) available at http://www.cfsan.fda.gov/dms/fsbtac28.html
FDA draft compliance policy guide (dated October 2008) available at http://www.cfsan.fda.gov/pn/cpgpn7.html
FDA final rule (FR Pub 11/07/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-26282.pdf.