FDA Issues Compliance Information on Prior Notice Submissions for Imported Foods
The Food and Drug Administration (FDA) has issued a document entitled, Compliance Summary Information: Prior Notice, which describes prior notice (PN) submissions received during the first two months after the interim final rule requiring prior notice of imported foods became effective December 12, 2003.
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The FDA states that this document provides a summary of the current pattern of submissions, and identifies the biggest areas of concern. The following are highlights of the FDA's findings with respect to PN compliance.
(Although the requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) technically entered into force on December 12, 2003, FDA and U.S. Customs and Border Protection (CBP) agreed to an eight month phase-in period for enforcement of the PN requirement (i.e., from December 12, 2003 through August 12, 2004).)
88% of Submissions Were Through ACS, 12% Came Through PNSI
The FDA's summary indicates that it received over 140,000 prior notice submissions per week during February. About 88% were submitted as additional information on transactions through CBP's Automated Commercial System (ACS), with about 12% of submissions occurring through FDA's new Web-based PN System Interface (PNSI). The FDA adds that with the exception of a small dip in late January, the number of submissions is slowly increasing.
Many PN Submissions Were Incomplete But Few Food Products Lacked All Data
With respect to ACS submissions, the FDA states that slightly less than half of the total number of lines submitted for the weeks of December 27, 2003 through February 21, 2004 had complete PN. Slightly over half of these submissions had some, but not all, of the PN information required and only a very few lacked any of the specific PN information.
FDA states that for PNSI submissions the percent complete was somewhat higher in several areas. The FDA attributes this to the fact that PNSI validation will not allow submission without some required information.
Compliance for Imports Via Land Lags Behind Other Modes of Transportation
The FDA states that with respect to ACS and PNSI submissions, compliance for imports via land (largely trucks) generally lags behind that for other modes of transportation. The FDA states that this may indicate an area, among others, where compliance is particularly challenging, and may require further outreach and cooperation between FDA and industry to obtain full compliance.
FDA Prior Notice Compliance Summary (dated 04/02/04) available athttp://www.cfsan.fda.gov/pn/pnsum.html