FDA/CBP Announce 3-Month Delay in Effort to Coordinate Timeframes for Food Prior Notice/Advance Cargo Information
The Food and Drug Administration (FDA) has posted to its Web site a revised "Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice (PN) Timeframes" (FDA/CBP Joint Plan).
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(The FDA and U.S. Customs and Border Protection (CBP) issued the initial version of this joint plan in April 2004. See ITT's Online Archives or 04/14/04 news, 04041405, for BP summary.)
Beginning of Joint Plan's Efforts to Coordinate Timeframes Delayed
The FDA/CBP Joint Plan has been revised to indicate that these agencies intend to begin their timeframe assessment in November 2004 (rather than in August 2004 as previously announced). Other than this three month delay, there are no significant changes from the April 2004 version of the joint plan.
(Among other things, the joint plan will assess whether the timeframe requirements in FDA's interim final rule for prior notice (PN) of imported food could be the same as the advance notice timeframes for cargo arriving by land via road or rail, or arriving via air in CBP's final rule on the advance electronic presentation of cargo information.)
The schedule for FDA/CBP's timeframe assessment, reflecting the date changes, is summarized below:
November 1, 2004 - January 3, 2005 - FDA and CBP plan to assess existing procedures and staffing needed to receive, review, and respond to the prior notices submitted in accordance with the PN interim final rule. The timeframes currently in place are 2 hours before arrival by land by road, 4 hours before arrival by air or land by rail; and 8 hours before arrival by water.
January 4, 2005 - February 3, 2005 - FDA and CBP intend to identify what changes to work practices and staffing would be necessary to determine if FDA could continue to receive, review, and respond to all PN submissions with reduced timeframes (e.g., 1 hour (or 30 minutes for Free and Secure Trade (FAST)/Customs-Trade Partnership Against Terrorism (C-TPAT) participants) before arrival by land by road; 2 hours before arrival by land by rail; and by "wheels up" for flights originating in North and Central America, South America (north of the Equator only), the Caribbean, and Bermuda; otherwise 4 hours before arrival by air.)
February 4, 2005 - May 3, 2005 - FDA and CBP plan to implement necessary changes and make appropriate adjustments to ensure that they could receive, review, and respond to all PN submissions with reduced timeframes.
June 2005 - FDA and CBP intend to issue a PN final rule that responds to the comments received on the PN interim final rule, including this plan, during the two open comment periods.
Evaluation of Whether to Reduce Timeframes for PN Still Depends on Compliance
In the revised plan, the FDA continues to state that any timeframe must be sufficient to receive, review, and respond to PN submissions, as set out in certain provisions of the Federal Food, Drug, and Cosmetic Act. FDA and CBP continue to emphasize that the evaluation of whether to reduce the timeframes for PN review will depend on the level of compliance industry achieves during the assessment.
FDA continues to stress that if it and CBP are unable to make such an assessment, the intended timeframe for issuing a PN final rule may be delayed.
FDA and CBP Continue to Work to Increase Integration
In addition to the above-described assessment of PN timeframes, FDA and CBP state that they are continuing to work to increase integration in the following ways:
Co-location of all FDA PN staff with CBP's National Targeting Center (NTC 1);
Further refinement to FDA's targeting rule sets in CBP's Automated Targeting System (ATS), coupled with additional training in targeting techniques;
Continued targeting support from CBP and other Federal law enforcement analysts at the NTC; and
Enhancement of communications and cooperation with CBP to facilitate information exchange and ensure expeditious access to foods subject to PN holds.
See ITT's Online Archives or 11/10/03 news, 03111010, for BP summary of the FDA's interim final rule on PN. See ITT's Online Archives or 01/20/04 news, 04012035, for BP summary of CBP final rule on advance electronic presentation of cargo information.)
FDA/CBP Revised Plan (dated 08/04) available at http://www.cfsan.fda.gov/pn/pnplan2.html.
CBP press release (08/12/04) on revised FDA/CBP joint plan, etc. available at