Enforcement delayed as FDA rules take effect today

TORONTO, (Dec. 12, 2003) — The long-awaited Food and Drug Administration food import rules officially take effect today, although there isn’t going to be the delays and hassles at the border much of the cross-border transport industry was bracing for.

The rules, part of the Bioterrorism Act of 2002, require companies that make, process, pack, or store food for export to notify the FDA of manifest details before their goods arrive for inspection at the United States border. Such data for goods travelling on the ground, would need to be electronically sent to FDA two hours before the shipment arrives at the border. For rail, the timeframes are four hours, or eight hours before arrival by water. The agency also requires companies to register certain pieces of equipment and terminals with the FDA, depending on the operation.

As Today’s Trucking reported yesterday, the FDA has announced last minute changes to both components of the act. While carriers hauling food cargo between two points will still have to register their terminals with the FDA, they are now excused from registering equipment like trucks and trailers.

However, companies that process or sort food en route, such as some logistics or LTL operations, must still register their equipment, Martin Rojas, American Trucking Associations director for cross border operations, told Today’s Trucking. “What they’re saying is, if in that trailer some processing occurs, for example, you apply a certain type of gas to ripen the fruit, then that trailer would have to be registered,” he said. However, details regarding which situations excuse certain equipment from others, still need further clarification from FDA, he said.

The FDA also announced it would delay enforcement of the pre-note rule until March 12, using the time to remind and educate carriers and shippers of the rule’s specifics, and to allow companies to become familiar with new electronic line release systems needed to comply with the regulation. From March until May 2, the Bureau of Customs and Border Protection — the agency that will enforce the rule at the border — will fine companies that repeatedly violate the rules. Full compliance, the agencies said, will be enforced by Aug. 12.

While the two-hour requirement for trucks may seem onerous, it could have been worse: the FDA initially wanted notification by noon the day before the shipment arrived at the border. Similarly, the U.S. Customs and Border Protection eased its own pre-note requirements (which take effect Jan. 5, 2004) — amid complaints it would damage just-in-time shipping. A “strawman” proposal in January recommended that carriers submit cargo data to U.S. Customs four hours before a truck is loaded in Canada for shipment to the United States, and 24 hours prior to loading a truck in the United States destined for Canada. The final rule was changed to 30 minutes for carriers, shippers, and drivers in the Free and Secure Trade (FAST) program, and one hour for those using PAPS (Pre-Arrival Processing System). Enforcement starts next year.

One clearance system — the line-release program known as BRASS (Border Release Advanced Screening and Selectivity), which currently handles about 50 per cent of the food volume — will not be an option for clearing food shipments. FDA is asking carriers and exporters to familiarize themselves with PAPS or a new electronic program the agency is promoting known as OASIS, which will also be streamlined with CBP’s system to offer an integrated reporting process between both agencies.

“The way I understand it, information will be submitted to the filer or the broker, who will submit it (electronically) to Customs, who forwards it to FDA through OASIS. A prior notice confirmation number will come back, signifying the shipment is approved,” he says. However, Lennox adds that carriers who want to take advantage of the dual process should be aware the pre-notification requirement automatically defaults to the FDA rule of two-hours-prior for both agencies.

A bigger problem, Lennox says, involves LTL loads. Each shipment on the trailer needs to be reported to FDA and separately to CPB if not using OASIS. “A complex series of events has to happen in order to move a shipment of food across the border,” he says. “Meanwhile, the truck is rolling down the road, and if there’s a break in the chain — if there’s a problem with any of the data for any of the shipments — the potential exists for that truck and all the shipments on board to get hung up at the border and even returned to Canada.”


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