Have thousands of facility registrations lapsed?

By Hank Schultz

- Last updated on GMT

© iStock Choreograph
© iStock Choreograph

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A quirk of the latest go round in the FDA facility registration process means thousands of foreign firms could find their registrations have lapsed, a leading consultant tells NutraIngredients-USA.

Registrar Corp, which acts as the US agent for thousands of foreign facilities, closely monitors the facility registration process.  The deadline is the turn of the year. This year the process included a notice period to the end of January to accommodate a new twist in the rules.

“There are companies that did renew this year. But unlike past years ​(the last deadline was in 2014), FDA has stipulated under FSMA that the US agent has to affirmatively agree to act as an agent,”​ said David Lennarz, CEO of Registrar Corp.

The Food Safety Modernization Act put into place a process by which all food facilities, both domestic and foreign, must  renew their facility registrations every two years.  When they first register, they receive a unique facility number that is part of the documentation associated with shipments. The number does not appear on labels, but companies must have a valid number for shipments to be approved for entry into the country. Foreign facilities must have a US agent, a company or individual who will agree to act as a domestic point of contact for the agency. 

All that has been true for several years now. What’s new, Lennarz said, is that the US agents of foreign firms must affirm that they are in fact the agent of that company. In the past the foreign firms merely had to list the contact information of the agent on their registration forms.

Liability comes with acting as an agent

It’s a potentially big step now to act as an US agent, Lennarz said.  Those companies are now not just an information portal; they bear liability for the business practices of their overseas correspondents.

“Under FSMA FDA was authorized to charge re-inspection fees. So if they conducted an initial inspection and they find that the foreign firm has food safety violations of significance, they are authorized to conduct a re-inspection.  They are allowed then under Sec. 743 to charge the US agent those fees, and they can easily run to $20,000 or more,” ​he said.

Lennarz said that firms whose registrations have lapsed often find out only when a shipment is delayed at the border when a check of the registration number comes up as invalid. He said FDA has told him that the lapsed registrations have yet to be uploaded to the agency’s website and in the interim FDA employees are doing hand checks. But the registrations will be updated online very soon, he said. When that’s done the industry could be in for a nasty surprise, he said.  

A lapsed registration is not the end of the world, but it does mean a company has to re-register. When that application goes through the company will receive a new facility number, which would need to be updated on all of the company’s records, all which costs time and money, not to mention the potential fallout from rejected and delayed shipments.

“We think that the number of registrants that will find they have been removed from the data base this cycle is likely to be significantly more than when they purged the database following the renewal period in 2014,” ​he said.

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