Grace Period

Grace Period

Copyright 2003, Traffic World, Inc.

Shippers will get a respite of several months before feeling the brunt of new Food and Drug Administration food safety rules - time shippers say they will need.

The bioterrorism rules, which require advance notice for a wide range of food imports, took effect Dec. 12 but FDA Commissioner Mark B. McClellan said shippers will have a grace period of about six months to comply with them.

The FDA "will exercise discretion for the initial months following implementation," he said. "We are going to phase into enforcement in a timely way."

He noted that the FDA rules are being imposed at the same time as other federal advance shipment notification requirements for shippers and carriers.

Customs, which puts its own set of advance notice rules into effect Jan. 5, will share the FDA''s enforcement burden. Customs Deputy Commissioner Douglas M. Browning agreed to allow customs agents to conduct food security inspections in addition to their usual duties.

So far, more than 1,600 customs agents have been trained to do FDA inspections. However, there are more than 18,000 customs inspectors at U.S. ports of entry and thousands more could be cross-trained for the inspections.

National Industrial Transportation League Executive Vice President Peter Gatti hailed the cooperative agreement between FDA and Customs. "The FDA rules did not seem to be promulgated with any kind of coordination with, in particular, Customs," Gatti said. "I think it''s a positive sign that we see the groups working together now."

He noted that the Customs advance notification rules and the FDA rules came out within weeks of each other yet set different criteria for shippers, many of whom are subject to both rules. "The idea that the two groups are coordinating their efforts, that is critically important," Gatti said. "The thing that has been a concern is the lack of coordination among these two groups in the past."

He said shippers will be happy to have a few months of trial runs to make sure the rules work smoothly.

The FDA''s bioterrorism regulations require "food facilities" to register with the agency and give prior notice of food imports into the United States. A week before the rules took effect, some 100,000 facilities - mostly overseas - had registered. Officials hoped to have all registrations by Dec. 11 via an online registration system open 24 hours a day.

"A lot of people are still working through it," Gatti said. "There''s no question about that. At this juncture, I think it''s really a matter of getting up to speed on what products are going to be impacted by this."

"The key point here is the issue of compliance," Browning said. "I think what we have here is a very complicated regulatory regime. Most legitimate traders want to comply. What we have to do is educate them."

Gatti agreed that shippers want to comply but said they expect compliance to cost them. As yet neither the NITL nor its members have calculated exactly how much the advance notice rules will cost. "I don''t think anyone''s got a handle on that," Gatti said. "I expect it''s going to be significant."

He said costs would vary based on the size of the shipper, with small and midsize shippers facing different challenges than large shippers. "It takes (small and midsize shippers) more time to get caught up, while the larger companies certainly have the challenge of being able to do this on a scale on which they operate," Gatti said.

McClellan and Browning acknowledge monetary and time-cost concerns of shippers. But McClellan said the FDA listened closely to industry in developing its rules and still is listening. A comment period extends until Dec. 24.

Browning said the plan is to reopen the FDA rules in March and to make any changes necessary. "This is not intended to be a burden to legitimate traders," Browning said.

The idea behind the FDA rules is to protect the nation''s food supply from acts of terrorism. "The United States faces a number of new and more sophisticated terrorist threats. As (Health and Human Services) Secretary (Tommy) Thompson has pointed out, one of our greatest areas of vulnerability is our food supply," McClellan said. A side benefit, he said, is that the rules also will protect the food supply from naturally occurring food-borne threats. He cited as an example the recent hepatitis outbreak in Pennsylvania linked to tainted green onions imported from Mexico.