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FDA-regulated food facilities face new registration deadline of Dec. 31

WASHINGTON — Food shipments may be refused at U.S. ports if registered foreign food facilities do not renew their registrations with the Food & Drug Administration by Dec. 31, Amy Barringer, a director in FDA's Office of Compliance, warned during a Nov. 19 webcast.

The United Fresh Produce Association sponsored the more than an hour-long webcast on the looming facility registration requirements with David Gombas, vice president of food safety and technology at United Fresh, to keep the industry abreast of the change.

The FDA Food Safety Modernization Act amended the facility registration rules by requiring domestic and foreign food facilities to renew registration with FDA every two years, starting this year by Dec. 31, 2012. FSMA also requires facilities to supply more information about the foods they handle, and, in the case of a foreign facility, identify a U.S. agent who would be responsible for the cost of an FDA reinspection if a foreign facility passes on paying the fees.

It is a prohibited act to ship foods from a foreign facility that is not in compliance with the registration rules, and this could result in a shipment refusal at the border, Ms. Barringer explained.

Questions flooded in during the webcast on which facilities should be registering with FDA.

Businesses that handle food must register their facilities but brokers who never actually hold food are not required, Ms. Barringer said.

Farms are not required to register facilities under the law but processing facilities are covered, and one webcast participant asked whether a potato farmer who applies a sprout inhibitor, for example, during winter storage, would trigger the processing definition.

If the application occurs prior to harvest, then "we can consider that part of growing crops," and typically does not trigger the registration process, she said. "If it's a post-harvest application, then that's one that would be considered processing and would trigger the registration requirements."

Other questions focused on the new financial responsibilities of U.S. agents, who have been named by foreign facilities as simple U.S. contacts for FDA regulators since 2003.

But now if a foreign facility fails an inspection and the agency must return to check to see if violations were corrected, FDA can charge hourly, per-person fees for the reinspection, Ms. Barringer said.

The new law makes U.S. agents responsible for these fees and the food industry believes these return inspections can cost tens of thousands of dollars.

"It does sound like before a company becomes a U.S. agent for a foreign facility, they should be thinking about these new responsibilities carefully," Mr. Gombas said.