(Dec. 16) BUFFALO, N.Y. — While many wondered what was going to happen with the Food and Drug Administration’s bioterrorism regulations as they went into effect on Dec. 12, Jack Rafferty went and found out firsthand.

Rafferty, managing director of trade and regulatory services for PBB Global Logistics Inc., Fort Erie, Ontario, spent the day in Buffalo at the Peace Bridge border crossing observing operations and the enforcement of the new regulations.

He said he had good news to report.

“What I think was really significant is the fact that the day wasn’t significant in terms of any kind of backup,” he said. “There was no truck slowdown or rail, either.”

Rafferty said that could be because the FDA recently announced that, rather than begin enforcing the regulations all at once, they would be gradually phased in over an eight-month period, which began on Dec. 12.

“Until then, they are going to emphasize education and communication,” he said.

The regulations, which are part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, require all facilities that process, manufacture, pack or hold food to register with the FDA. The rule also encompasses companies that import food into the U.S.

What’s more, companies also are required to provide notification to the FDA no more than five days and no less than two hours prior to a shipment leaving for U.S. borders.

Rafferty said there was a lot of angst in the shipping industry as the Dec. 12 deadline approached. In spite of this, only 140,000 of an expected 400,000 companies had registered with the FDA and U.S. Customs by Dec. 12. Rafferty said that is part of the reason why the FDA decided to enforce the changes gradually.


That doesn’t mean companies should put off registering until then, Rafferty said. In fact, for companies that want to ship to the U.S., compliance with this rule has become even more important.

Rafferty said there should be improvements in the system as the gradual roll out of the regulations continues. He said there are some areas that have already improved.

“One of the problems we’ve had with the FDA is that they only have about 900 inspection officers nationally,” he said. “Now they have commissioned U.S. customs officials to act on behalf of the FDA. So there are 1,600-1,800 customs officers who have already been trained for that commission. One of the happy by-products of this regulation is that there might be better FDA service now than ever before.”

Rafferty said there is, however, one potential problem area. Smaller companies may have a more difficult time providing the amount of detail required by the FDA.

“The big companies will tend to be highly compliant and will have the staff to make sure that it is done properly,” he said. “The little guy is at somewhat of a disadvantage. There is more expense associated with this.”