FDA Issues Updated Compliance Information on Prior Notice Submissions for Imported Foods
The Food and Drug Administration (FDA) has issued a May 2004 version of a document entitled, "Compliance Summary Information: Prior Notice," which updates an April 2004 version.
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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 updated version of this document describes activity from December 2003 through April 2004, including a comparison of the status of transmissions in February and mid-April. The first version described information received during the first two months after the interim final rule became effective on December 12, 2003.
(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 prior notice (PN) requirement (i.e., from December 12, 2003 through August 12, 2004).)
As of March 2004 Most PN Submissions Made Through ACS Have Been Complete
The FDA's updated document contains a chart which illustrates that, beginning in March 2004, most of the PN submissions made through CBP's Automated Commercial System (ACS) have been complete, and very few submissions of food products through ACS contain no PN data. The FDA states that this appears to show that most of those involved in the food import industry are moving toward compliance.
In contrast, the FDA had previously reported that with respect to ACS submissions, 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. During this time, 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
Identity of Carrier is Only Data Element Consistently Absent in PN Submissions
In its analysis of charts on the completeness of certain specific data elements in PN submissions in mid-February and mid-April, the FDA deduces that more complete information is being submitted as of mid-April and the submission of information through ACS interface has increased substantially.
FDA states that the only element that remains consistently absent is the identity of the carrier. In the updated versions of this document, FDA has included charts which show that the lack of identity of the carrier is particularly associated with arrivals by land by road.
88% of Submissions Were Through ACS, 11% Came Through PNSI
The FDA's updated summary indicated that about 88% of PN submissions were submitted as additional information on transactions through CBP's ACS, the same percentage as reported in the FDA's original document. Prior Notice System Interface (PNSI) submissions now account for 11% of PN submissions, compared with 12% in the original document.
The remaining PN submissions are transactions in the new form that CBP and FDA provided for submitting information through ACS on food shipments that do not require CBP ACS submission at the time of arrival in the U.S. (e.g. transportation and exportation, immediate transportation, and foreign trade zones).
(See ITT's Online Archives or 04/08/04 news, 04040815, for BP summary of the April 2004 version of this document.)
FDA Updated Compliance Summary (updated May 2004) available athttp://www.cfsan.fda.gov/pn/pnsum.html