This week begins the second time ever that the FDA is requiring food companies to renew their registrations with the agency. It’s a provision under the Food Safety Modernization Act (FSMA), passed in 2011, that requires food companies to renew every even-numbered year between Oct. 1 and Dec. 31. So any company that manufactures, processes, packs or holds food for the U.S. market must now access its existing registration in the FDA's database and follow the steps to renew that status.
What that means in practice, mainly, is ensuring emergency contact information is up to date, confirming that the products a company is registered as producing are accurate, and so on.
According to David Lennarz, vice president of Registrar Corp, which assists companies in complying with FDA regulations, it's not a difficult or daunting process—just one that needs to be taken care of on time. That's his biggest piece of advice for food companies right now: "Don't forget to do it, make sure it stays up to date, and make sure you're in compliance."
In early 2013, after the first registration renewal period, Lennarz said there was aftermath for companies that procrastinated, particularly foreign ones. “These folks delayed and didn't take action until their shipments were detained, resulting in delays and angry U.S. customers,” he said.
And over the course of that year, the FDA "purged" its database of companies that didn't renew, so by early 2014, the agency had a total of about 197,000 companies registered, down from more than 400,000.
Lennarz said the real question now is, what will the current registration renewal period do to that database?
We won't know the answer to that until 2015. But for any business dealing with food in the U.S., there's nothing but incentive to comply with the new rules. Neglecting to register or renew registration is essentially a crime.
Because they'll be required to show proper documentation, foreign companies exporting goods to the U.S. will have a hard time just getting past the ports. Domestic companies may have a little easier time slipping under the radar with noncompliance, but the penalties could be steep if they're caught. Under the FSMA, the FDA is not only required to increase inspections—it’s also authorized to charge facilities for any reinspections that result from violative practices found during an initial inspection.
Those reinspection fees aren't cheap—$217 an hour for domestic facilities and $305 for foreign facilities—and they apply to both hours of an inspection and travel time. "That could easily amount to a $10,000 or $30,000 bill," Lennarz said.
While the agency hasn't charged any reinspection fees yet, “they have started to issue guidances for FDA field staff," said Lennarz. "It's very clear they are not far off.”