FDA rules raise concerns

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OTTAWA, ONT. — The CTA has mixed feelings about the recently published FDA interim rule on prenotification and registration for carriers and importers of food to the U.S.

“While we are still examining the details of the interim final rules, it is clear that FDA has come at least part way towards meeting the concerns of industry,” says CTA CEO David Bradley.

“The proposed rule issued earlier this year would have required that importers give notice by noon the day before the arrival of a shipment of food into the United States for all modes of transportation, including truck. FDA has advised that the final regulation could see time frames further reduced as part of the FDA-CBP (Customs and Border Protection) plan to coordinate border-management activities more efficiently.”

But the FDA’s advance notice time frames remain different from advance cargo information time frames proposed by U.S. Customs and Border Protection. The FDA rules require that cross borer shipments of food be reported to the FDA at least two hours prior to their arrival at the border. Under the CBP proposal, shipments qualified under the FAST program would be subject to a pre-notification interval of only 30 minutes and one hour for all other imports.

According to Bradley, “We remain concerned about differences between the FDA rules and advance cargo information rules proposed by CBP. Carriers are the ones who will bear the brunt of border delays if there is any break-down in the information flow among food importers, customs brokers, the CBP and the FDA.”

As for the registration rules, they require domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with the agency by December 12. The new rule on the registration of food facilities stipulates that “Transport vehicles that hold food only in the usual course of their business as carriers” do not have to register with the FDA.

The FDA rules on prenotification and registration for carriers were released this week this week published interim final rules requiring prior notice of imported food shipments and registration of food facilities. The industry now has 75 days to comment on the proposed rules.

To see the interim final rules, and to find out how to comment on them visit http://www.fda.gov/oc/bioterrorism/furls/

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