CBP and FDA Officials Discuss the Bioterrorism Act's Prior Notice Requirements With COAC
The Departmental Advisory Committee on Commercial Operations of the Bureau of Customs and Border Protection (COAC) held a quarterly meeting on June 18, 2004 in Washington, DC to discuss and receive updates from U.S. Customs and Border Protection (CBP) officials on various trade and customs issues.
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This is Part IV of a multi-part series of summaries on the June 18, 2004 COAC meeting and highlights CBP and Food and Drug Administration (FDA) updates on issues related to the implementation of the requirements for prior notice (PN) of imported food contained in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act).
CBP officials report on failed entries, returned shipments, etc. since commencement of Phase 3. Phase 3 of the FDA/CBP discretionary enforcement plan for the PN requirements of the Bioterrorism Act was implemented on June 4, 2004. (See ITT's Online Archives or 06/03/04 news, 04060305, for most recent BP summary on Phase 3.)
During the June 18, 2004 meeting, CBP officials noted that since the commencement of Phase 3 on June 4, 2004, there have been:
- ABI failed entries
- non-ABI entries failed
- failed in-bond entries
- shipments returned to a foreign country
- shipments abandoned
(CBP officials noted that the use of the term "failed" refers to entries that did not pass the edits for Phase 3.)
CBP and FDA are now preparing for Phase 4. CBP officials state that they are now preparing for the August 13, 2004 commencement of Phase 4. CBP officials state that they are doing a thorough analysis of non-compliance, based on FDA and CBP data, in order to begin counseling individuals who are not in compliance so that the implementation of Phase 4 can be as successful as was the implementation of Phase 3.
FDA says PNSI intended for small filers, etc. At the June 18, 2004 meeting, FDA officials addressed various issues related to its PN System Interface (PNSI). According to FDA officials, PNSI is really intended for entries that would not normally go through the Automated Commercial System/Automated Broker Interface (ABI/ACS) or Automated Manifest System (AMS) and was set up to accommodate small filers and individuals that do not have access to brokers. FDA officials state that they expect and strongly recommend that PN for commercial shipments be made through ACS/ABI.
FDA officials respond to trade concerns about PNSI. FDA officials state that they are aware of the problems that filers have been having with PNSI, noting that while most of the problems that have been experienced are external to the PNSI system, they are working hard to fix those problems with PNSI that are internal to the system.
COAC members expressed concerns regarding PNSI, including (partial list): (1) the lack of visibility of PNSI-submitted data in ACS/ABI, especially in light of the fact that when ABI went down in June 2004, filers were told to use PNSI to file PN; (2) FDA's response to PNSI being down in June by instructing filers to file paper, something which the trade notes causes problems.
In response, FDA officials state that they are working on a more robust contingency plan to address some of the problems experienced to date.
(See ITT's Online Archives or 06/22/04, 06/23/04, and 06/25/04 news, 04062205, 04062315, and 04062510, for Parts I, II, and III.)