Under the Food Safety Modernization Act (FSMA) facilities are required to renew FDA registrations between October 1 and December 31 of each even-numbered year.
Any registrations not renewed by the deadline are considered to be expired and are removed from the database.
Time to renew
David Lennarz, VP at Registrar Corp, said that based on client statistics and previous FDA information it was confident that thousands were removed.
A more precise number based on actual FDA statistics will be available in the coming months.
A total of 14% of food facilities registered with FDA were removed from the database after the 2014 renewal period.
There were 195,518 facilities registered as of January 22, 2014 and as of January 12, 2015, the number had dropped to 166,753.
“FDA food facility registration renewal is a fairly new requirement,” he told FoodQualityNews.
“It was established under the Food Safety Modernization Act in 2011 and the first renewal period took place in 2012. Before then, food facilities only had to complete an initial registration. So, some facilities are still unaware of the requirement.
“Some facilities may have gone out of business or stopped exporting to the US, so they just had no need to renew. Others may believe they renewed but the renewal may not have been finalized by FDA due to new verification requirements.”
There is no difference in renewal requirements based on facility size or the type of food they handle, added Lennarz.
Additional verification demands
Lennarz predicted the drop in registrations may be even greater this year due to verification requirements implemented during the 2016 renewal period.
Food facilities outside the US are required to designate a US Agent for FDA Communications in their registration renewal.
Prior to this new step, a US Agent could be designated in a foreign facility's renewal without the US Agent's affirmative written agreement.
Many previously designated as US Agents would have preferred to decline because a foreign facility's US Agent is liable for financial obligations, including payment of any FDA re-inspection fees related to the facility.
“The 2016 renewal period marked the first time that US Agents designated in non-US facility registrations had to affirmatively agree to their designation,” said Lennarz.
“If a non-US facility submitted a registration renewal, but its listed US Agent did not agree, the renewal would not have been successful.”
The re-inspection fee rate for foreign facilities for fiscal year 2017 is $285 per hour.
FDA may bill for every aspect of a re-inspection, including time spent preparing and traveling, so the fees can add up to thousands of dollars.
The agency also contacts US Agents regarding shipments, inspection scheduling, and other regulatory matters.
Registrar Corp was founded in 2003 to help FDA-regulated facilities comply with the agency’s regulations. It serves as a professional US Agent for more than 11,000 foreign food facilities.
The firm assists with areas from registration, labeling, detentions to inspection preparation.
It issues Certificates of Registration which allow facilities to verify valid registration status to buyers and suppliers as well as keep track of their registration number and facility information on record with FDA.
Facilities with expired registrations will need to re-register with FDA and obtain a new registration number before they manufacture, process, pack, or store food, beverages, or dietary supplements to be consumed in the US.
Importers and Customs Brokers cannot file entries for shipments without a valid registration number and facilities will not be able to submit the required prior notice for exporting food to the US.
Lennarz said the time it takes to re-register depends on how knowledgeable the registrant is on the facility's functions.
“The registrant will need information on whether the facility is a subsidiary of a parent corporation, the types of activities performed at the facility, the types of food products handled at the facility, important emergency contact information, and more.”
The ten countries with the most FDA registered facilities remained the same from 2015 to 2016.
The US was first, followed by Japan, France, Italy, China, Mexico and then Canada.
Registrar Corp has submitted a Freedom of Information Act (FOIA) to FDA for the 2017 data and will publish it upon receipt.