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FDA Brings Out Interim Final Regs

WASHINGTON, D.C. - The U.S. Food and Drug Administration's interim final rules for registration and prior notice requirements, announced in early October, and stipulating compliance by Dec. 12, have m...

WASHINGTON, D.C. – The U.S. Food and Drug Administration’s interim final rules for registration and prior notice requirements, announced in early October, and stipulating compliance by Dec. 12, have met with mixed reactions from the trucking industry.

Industry insiders were relieved to learn prior notice requirements have been considerably shortened for carriers, to two hours before arrival at Customs. Carriers previously feared they would have to report as much as 24 hours prior to lading. (The maximum allowed prenotification period will be five days)

And they were also relieved to learn reporting avenues will be streamlined: FDA prior notice reports can be sent through the Customs and Border Protection Automated Broker Interface of the Automated Commercial System (ABI/ACS) already in existence, or via the FDA’s own Prior Notice (PN) System beginning Dec. 12, putting the onus for reporting squarely on the shoulders of shippers/importers/brokers.

But carriers and association officials still expressed doubts about the FDA’s prior notice time frames, particularly with regards to the differences between them and the proposed time frames for non-food shipments, soon to be finalized by CBP.

The fact that CBP’s proposed final rule regarding prior notice requirements for non-food shipments crossing the border are shorter than those proposed by the FDA (one hour for non-FAST shipments and 30 minutes for FAST shipments) is cold comfort to carriers who carry mixed loads, several industry insiders pointed out.

Not to mention carriers involved in JIT transport. Or carriers who don’t report electronically at all. Or those who pick up or ship items from close to the border. Or those who work in intermodal chains, with items arriving by sea or by rail.

Items arriving by water, for example, must be reported to the FDA eight hours prior to arrival. Items arriving by rail or air have to be reported four hours in advance. But how do those time frames fit in with the prior notice time frame for carriers to get their product from pick up to customs?

These sorts of time frames, and the probability that carriers will have to trust other interested parties, brokers, importers, etc., to work land transfer times into their calculations, makes carriers nervous, to say the least.

“We move fresh fish,” explained Rob Gaw, a risk manager for Coastal Pacific Xpress in Cloverdale, B.C. “It comes off the boat, we throw it in the truck and we leave. It creates some problems.”

Stephen Evans, director of safety and compliance, H&R Transport, Lethbridge, Alta. pointed out many Canadian food processing plants are less than two hours from the border

“So there’s some potential for concern there.”

He added reporting load quantities in advance will be problematic.

“Many times you really don’t know how much stuff’s going on there until the load is finished.”

Association officials also had reservations.

“I think it’s safe to say that this set of proposals is better than the last one,” said Ron Lennox, vice president of regulatory affairs for the Canadian Trucking Alliance.

“It could have been much worse if they (the FDA) had proceeded as they were planning. But bear in mind that even two hours ends up being more than two hours – the clock only starts ticking once the information is actually received by the FDA – so the carrier or the exporter has to make sure the information goes through the broker and through the reporting system to the FDA prior to that. Just doing that will take up more time.”

(Not to mention processing – the FDA expects to receive about 25,000 notifications about incoming shipments each day.)

LTL carriers in particular will face difficulties under the new time frames, Lennox pointed out.

“If you’re an LTL carrier hauling non-food and food shipments what do you do? And what do you do if you’re qualified for the line release program like BRASS, which the CBP recognizes but which the FDA doesn’t? It would have been nice if these discrepancies had been sorted out prior to the rule being posted.” (See more on clearance programs for food shipments on p. 84.)

Accountability in cases where someone other than the carrier doesn’t provide information on time, or provides information that’s inaccurate, is a big issue, Lennox added.

“When someone gets stuck at the border because the information chain broke down somewhere along the way who pays?”

Whether carriers are actually prepared to comply with the new rules starting Dec. 12 is another question.

“I wouldn’t want to venture a guess on the readiness of our members, I think there are probably different degrees out there, but there are certainly some carriers who are not even communicating information to the border in advance right now. These carriers will have to find a way to deal with the new reporting requirements. For those who are already reporting electronically it won’t be a huge change, but for those who aren’t it’s major.”

Bruce Richards, president of the Private Motor Truck Council, also expressed concerns.

“Of course we’re glad to see the original time frames shortened,” Richards said. “But no one believed for a minute that the original proposal was really what the FDA had in mind.”

In an ideal world, the time frames for the FDA and the CBP would be identical, Richards pointed out.

“The two different time frames just don’t make sense,” said Richards, adding his members so far appear unperturbed by the FDA announcement.

“But the phone hasn’t been ringing off the hook. That may be because it could have been a lot worse. A lot of carriers may just be wiping their foreheads and going ‘Whew!'”

FDA is planing to impose “soft” (in other words, educational) enforcement of the new rule as of Dec. 12. The agency is also providing a 75-day comment period on the interim final rule. In addition, to ensure that those commenting on the rule have had the benefit of the FDA’s outreach and educational efforts and have experience with the new reporting systems, time frames and data elements included in the prior notice reports, the FDA intends to reopen the comment period in March 2004 for another 30 days.

According to FDA documentation, this date will coincide with the issuance of the final time frame plans by FDA and CBP. (Whether this means the industry will have to wait until March 2004 for news on the CBP prenotification time frames is not clear. What is clear is that the final CBP prenotification time frames for non-food have not yet been announced, even though the agency was slated to do so Oct. 1.)

For additional information on the new FDA interim regulations please refer to the following links:

Registration of Food Facilities Fact Sheet:

Full Text of New Rules:

Prior Notice of Imported Food Shipment Fact Sheet:

Full Text of New Rules:

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