FDA to request more comments of prior notice regulations

Food & Drink Weekly, March 29, 2004

The Food and Drug Administration (FDA) will soon reopen its comment period for interim final regulations requiring prior notice on all food imports, according to Deborah Ralston, director of FDA's Office of Regional Operations. Ralston told a Border Trade Alliance conference that FDA has been working closely with the Bureau of Customs and Border Protection to synchronize the timeframes for prior notice with the Customs automated manifest regulations.

The plan has been drafted and is expected to be published in the Federal Register. FDA plans to review comments received so far on the prior notice regulation as well as comments it will receive when it publishes its plan, Ralston said.

Prior notice of food imports must received and confirmed electronically two hours before arrival by land by road; four hours before arrival by air or by land by rail; and eight hours before arrival by water. The prior notice requirement took effect on December 12, 2003, but FDA is in a period of enforcement discretion. Ralston revealed that enforcement discretion on the prior notice rule would technically end August 12. However, "there is no such thing as 100 percent compliance. There always will be enforcement discretion to some degree that will be exercised," she remarked.

Customs' automated manifest regulations established advance electronic manifest notification requirements for inbound and outbound cargo on all four modes of transportation. For inbound cargo the requirements are:

* Air cargo, including cargo by air express couriers: four hours prior to arrival in the United States, or by "wheels up" from North America and South American locations above the equator;

* Rail: two hours prior to arrival at US port of entry;

* Truck: one hour prior to arrival in the United States, or 30 minutes for participants in the Free and Secure Trade program, which enables expedited processing for carriers that follow certain guidelines;

* Sea: 24 hours prior to lading at a foreign seaport.