Nov 10, 2008 (CIDRAP News) – The Food and Drug Administration (FDA) said recently it is making a few minor changes in its requirement for advance notice of imported food shipments, which is designed to give the agency time to decide which shipments need inspection for safety reasons.
The FDA released the final rule and a draft compliance policy guide Oct 31. An interim version of the rule, which was required by the Bioterrrorism Act of 2002, has been in effect since December 2003. The final rule will take effect May 6, 2009, the agency said.
Under the interim rule, food carriers are required to give the FDA at least 8 hours' advance notice of the arrival of food shipped by boat, 4 hours for food arriving by air or rail, and 2 hours for shipments arriving by road.
Those intervals will stay the same in the final rule. The FDA said it considered shortening them in an effort to match them better with time frames used by the US Customs and Border Protection (CBP), which co-administers the rules with the FDA. But the FDA determined that the existing intervals are the minimum it needs to review and respond to prior notices.
However, the final rule permits firms to notify the FDA longer in advance than is permitted under the interim rule. The latter allows notices to be filed no more than 5 days in advance. Under the final rule, firms can file up to 15 calendar days before the anticipated arrival date if they use the FDA's Prior Notice System Interface or up to 30 days in advance if they use CBP's Automated Commercial System.
In another change, the final rule closes a loophole that excuses importers from identifying the manufacturer of processed food if they don't know who it is, the FDA said.
Compliance called good
Sebastian Cianci, a spokesman for the FDA Center for Food Safety and Applied Nutrition, said compliance with the prior notice rules has been generally good.
"There have been very few instances when shipments arrived with no prior notice," he told CIDRAP News. "When this occurs the shipments are either turned away or held at the border until the prior notice requirements have been met."
"There are instances when some of the information required for prior notice is incomplete," Cianci added. "In those instances FDA and CBP follow the compliance policy guide to determine how the shipment will be handled."
About 1% of incoming food shipments are physically inspected, though all are screened through the FDA's prior-notice and other reporting systems, Cianci reported.
He said 212,267 foreign food-handling facilities had registered with the FDA as of Oct 9. Registration of all food facilities was another requirement of the Bioterrorism Act of 2002; imported food coming from unregistered facilities can be turned away.
The FDA and CBP are inviting comments on the draft compliance policy guide. To ensure they will be considered during work on the final version of the guide, comments should be submitted by Dec 8, the agencies said.
See also:
Current FDA compliance policy guide for the prior-notice rule
http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm122900.htm
Manuel of Compliance Policy Guides
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm
Jun 30, 2004, CIDRAP News story "FDA reports growing compliance with food security rules"
Dec 12, 2003, CIDRAP News story "Food import rules will have 8-month phase-in, FDA says"
