What is down, up, and down again?
It’s the number of food facilities around the world that are registered with the U.S. Food and Drug Administration. The FDA deleted more than 47,600 facilities from its list because operators did not renew registrations by the end of 2018.
The Food Safety Modernization Act (FSMA) requires food facilities to renew their FDA registrations during the fourth quarter of each even-numbered year. The agency purged 20 percent of food facilities from its database recently for failing to renew registrations, according to Hampton, VA-based Registrar Corp., which helps foreign businesses comply with U.S. regulations.
After the purge, FDA was left with 186,016 food facility registrations at the start of 2019. More than half of those facilities are outside of the United States. Foreign registrations were off slightly more than domestic at 22 percent.
Before Dec. 31, 2018, the drop-dead date for renewing registrations, FDA was regulating 233,651 food facilities. The 2018 count was up about 56 percent, or 83,781 facilities, compared with 2017 when valid registrations totaled 149,933.
Registrar Corp. says failure to renew registrations by the deadline is the likely cause of the latest dramatic drop-off in food facility registrations. The fluctuations can cause grief for FDA as the raw numbers are certain to form the base for the agency’s budget and staffing.
The FSMA specifically requires the renewal of registrations between Oct. 1 and Dec. 31 during even-numbered years. The dates of food facilities’ initial registrations are inconsequential under the renewal requirements.
Registrar Corp. says if a food facility registers on the day before the renewal period begins, it still must submit a renewal request that year. FDA considers non-renewed registrations to be “expired.” Operators of facilities with expired registrations must re-register with the FDA and obtain new registration numbers.
Registrar Corp., which helps with compliance from 20 offices around the world, says many facilities do not realize their registrations have expired until their products are stopped at U.S. ports of entry by FDA compliance officers.
Manufacturing, processing, packing or storing food for U.S. consumption without a valid FDA registration is prohibited by federal law. An expired registration will lead to costly detention or other regulatory actions, especially for food facilities located outside the United States.
Top 10 FDA food facility registrations by country, according to Registrar Corp.
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