There is a natural erosion for this data set as with others. Companies merge, go out of business, or simply neglect to renew their registrations at the appropriate time. But the highest drops by far, when measured as a percentage of existing registrations, occurred in overseas facilities. This leads one expert, David Lennarz, vice president of FDA regulatory compliance for Registrar Corp., to conclude that the vast majority of these purged registrations for overseas facilities happened as a result of of a new twist in U.S. regulations. A U.S.-based agent for a foreign firm must now affirmatively respond to FDA that it is acting in that capacity and that is accepts the potential liability that comes with it. Without that assurance, FDA purges that particular registration, he said.
“The data we have shows that it was basically a doubling of the reduction of registrations from the last cull in 2014. What this is really attributed to is the requirement for a U.S. agent to affirmatively assert that, yes, I agree to have my name associated with this foreign supplier and I accept what comes with that,”Lennarz told NutraIngredients-USA.
Bloodbath in foreign registrations
To give some context, by far the biggest number of food facility registrations sent in to FDA come from domestic firms. In this latest cull, FDA purged 9% of domestic registrations, bringing the total number of U.S. food facilities registered with FDA down to 78,957 from 86,773, according to data collected by Registrar Corp. So, to make up the total 28% drop, the declines in registered facilities overseas are truly eye-opening in some cases. Here are some of the biggest declines among countries that are major food and dietary ingredient exporters to the U.S.:
- Japan – a 34% drop (13,942 registrations down to 9,211)
- France – 30% drop (10,450 down to 7,336)
- Italy – 39% drop (10,125 down to 6,169)
- China – 46% drop (9,667 down to 5,236)
- Mexico – 53% drop (9,575 down to 4,499)
- Canada – 38% drop (6,690 down to 4,169)
- Spain – 32% drop (4,688 down to 3,208)
- South Korea – 39% drop (3,921 down to 2,393)
- India – 44% drop (3,455 down to 1,944).
Responsibilities of a U.S. agent
One of the requirements for a U.S. agent of a foreign firm is to act as a communications link between FDA and the overseas facility. FDA uses the U.S. agent to communicate important information to the foreign supplier (such as a Notice of Inspection), and the U.S. agent must accept responsibility for the communications between FDA and the foreign firm. The U.S. agent must also accept the liability for FDA re-inspection fees associated with the foreign firm.
In some cases, Lennarz said, foreign firms may have sent in registrations listing their U.S. agent and have been unaware of these new requirements. FDA then queries the agent, and if it receives no response, out the registration goes. There is no requirement for the U.S. agent to inform its overseas partners that this has happened. So a number of foreign facilities may only find out their registrations are invalid when a shipment gets held up because the registration number listed on the shipping documents comes up as invalid, Lennarz said.
In a number of cases, as this new requirement phased in, Lennarz said U.S. agents may have concluded that certain foreign facilities were no longer worth the bother, as in the cases of facilities that only ship a few lots of material to the U.S. per year. But in other cases, major shipments of goods could be held up at the border.
Lennarz said having an expired registration is not the end of the world and is something that can potentially be cleaned up on the fly. But it poses questions of delay and potential unnecessary expense, he said.
“Something might be sitting in the port for two or three days before people even figure out what happened. If this in an air shipment, then time is even more of the essence,” he said.
FSVP looms in distance
Lennarz said to avoid the hassle, foreign firms should check to make sure that their U.S. agents have responded to FDA (full disclosure: Registrar Corp. acts as the U.S. agent for many foreign firms). And he said this current issue with facility registrations is only a taste of what might happen when the rules associated with the Food Safety Modernization Act start to go into full swing in 2018. In that case, under the Foreign Supplier Verification Program, U.S. agents of foreign firms that meet the definition of importers will have to ensure that food and dietary ingredients imported into the U.S. meet applicable U.S. food safety standards, including having a preventive controls plan in place.
“Having a food safety plan is something completely new and up to now no one has had to have one,” Lennarz said. “Over the next six to 18 months companies will be asking their foreign suppliers to see their plans. The vast majority of companies don’t even know what you are talking about.”