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FDA Regs – More Questions Than Answers

WASHINGTON, D.C. - Nearly two months after the FDA started soft enforcement of its interim final rules for registration and prenotification for shipments entering the U.S., carriers north and south of...


WASHINGTON, D.C. – Nearly two months after the FDA started soft enforcement of its interim final rules for registration and prenotification for shipments entering the U.S., carriers north and south of the 40 are still puzzling over what to make of them.

Their confusion is no more evident than in the contents of commentary from the American Trucking Associations and the Canadian Trucking Alliance, submitted to the U.S. Food and Drug Administration prior to the comment period deadline set for Dec. 24, 2003.

(An additional comment period will open in March, once the trucking industry and the FDA have had a little more hands-on experience with the rules.)

With regards to prior notice, both associations are critical of the discrepancy between FDA prenotification time frames and those of U.S. Customs.

The CTA’s comment paper, submitted Dec. 24, asserts the discrepancy between the FDA and CBP (U.S. Customs and Border Protection) time frames is confusing and therefore more likely to detract from compliance than promote it.

“From a practical standpoint, what this means is that the trucking companies will have to abide by two different sets of rules depending on the commodities carried in a particular truck,” states the CTA. “…we see no practical advantage from a security standpoint in having the industry comply with two sets of advance prenotification rules. We would further suggest a common set of rules will lead to better compliance…”

The CTA paper also points out the two hour FDA advance notice period is deceiving, given that the amount of time it takes a broker to submit prior notification isn’t taken into account.

“Carriers have been telling CTA that brokers are advising clients to build additional time into the process, in some cases two or three hours,” states the CTA report.

“This may not be a problem for all shipments, but it will cause difficulties in many instances. A simple example is bulk flour shipments, which are timed to meet bakery schedules in the U.S. Currently a truck is dispatched as soon as the order arrives and can cross the border from Canada and reach the bakery in a couple of hours. If a four- to-five hour period is now required, this type of operation will have to be re-structured.”

Not surprisingly, the CTA believes the FDA should shorten its advance notification time frames to those required by the CBP.

The ATA makes the same suggestion in its own comment paper.

Additionally, both organizations believe the FDA should recognize FAST and C-TPAT importers and carriers, to further harmonize with CBP prior notice requirements and speed border crossing.

Also raised in the CTA commentary is the issue of crowding at Canada’s busier border crossings – most particularly in the case of trucks turned back for failure to meet requirements.

“The relevant agencies on both sides should have a plan to deal with the inevitable problems by larger volumes of returning trucks so that busy border crossings do not become a no-man’s land.”

LTL shipments are, of course, a primary concern for both associations.

“In an LTL environment, where an average trailer contains about 40 shipments, there is a potentially serious impact on several parties when a single shipment is not filed in a timely fashion,” states the ATA.

Because there is no established mechanism allowing the carrier to confirm whether the broker has in fact filed notice of a shipment and received a confirmation number from the FDA, the carrier could easily arrive at the border only to discover that the shipment has not been approved, points out the CTA.

LTL carriers will likely not want to wait simply because one or two of possibly hundreds of shipments on one load are missing PN (confirmation) numbers.

Time constraints in certain LTL scenarios may also come into play – for instance, when one of the items the carrier is hauling consists of fresh seafood.

Sheer volume of PN numbers being issued in particular to LTL carriers is also an issue – the ATA suggest that rather than issue hundreds to individual trucks, the FDA assign a single confirmation number clearing all the items carried on a single truck.

As for the FDA’s requirements for registration of food facilities, both associations raised concerns.

“Overly broad” is how the ATA refers to them, adding the broad definition for “holders of food” as defined in the FDA’s interim final rule, inappropriately includes truck terminals.

ATA points out LTL carriers and small package couriers routinely sort freight for delivery at one or more cross-docking facilities.

Does that mean LTL and couriers have to register as food facilities? The ATA cites a confusing meeting with FDA representatives during which FDA reps stated a terminal or motor carrier facility will have to register only if FDA regulated cargo is loaded or unloaded there, despite the ATA’s insistence that the Interim Final Rule (IFR) itself exempts “a transporter that holds food only in the normal course of business.”

The two statements would appear to contradict each other, argues the ATA.

The association goes on to re-iterate its position that trucking companies, including LTL carriers, should not be required to register as food facilities.

“The FDA needs to differentiate between ‘storing and warehousing’ and ‘sorting freight’ which generally takes a few hours, is done under supervision in a secure facility and performed in the usual course of business,” states the ATA.

“Motor carriers have no contractual agreements to store freight. If a motor carrier enters into a contractual agreement to store or warehouse freight for a shipper, then such a facility should be registered with the FDA.”

The ATA also points out other instances where the definition of a food facility becomes unclear:

1) Truck terminals at which trailers used to haul food are parked or based;

2) Rail terminals where FDA regulated items are loaded from rail cars to trucks;

3) Areas where long haul drivers pick up loaded trailers from short haul drivers. The food never leaves the trailer but it is transferred to another truck.

“Is FDA considering making time-limit distinctions if a loaded truck waits at the terminal for one hour, five hours or 12 hours,” the ATA comment paper asks, somewhat sarcastically.

Similar queries regarding instances when truck terminals must register are bandied in the CTA paper.

The paper asks whether a terminal must register if one of its drivers picks up bulk flour at a Canadian mill and then holds it in the terminal yard until the order comes from a U.S. bakery to deliver it.

And the paper also addresses the question of whether a terminal where items are switched from one truck to another must be registered.

Another sore point for the ATA is the FDA’s requirement that refrigerated trucks which ripen or preserve fruit in transit should register as “processors of food.”

Such equipment should be excluded from the requirement to register, says the ATA.

“ATA believes that in large measure refrigerated trucks simply transport perishable cargo and ‘conserve’ such cargo rather than ‘treat’ it or ‘process’ it.”

Finally, the ATA questions the ultimate purpose of the FDA’s truck terminal registration information.

“Any freight or tracking information the FDA needs will be readily available from the motor carrier’s bill of lading…”

The ATA says it wants an explanation of how the FDA will benefit from gathering such information.

Such an explanation would no doubt be of interest to Canadian carriers as well.


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