The Perishable Specialist Inc., headquartered in Miami, issued a Dec. 13 memo to its customers and others of interest to advise them that the U.S. Food & Drug Administration has extended it deadline for Food Facility Registrations until Jan. 31, 2013.

“Foreign and domestic food facilities are getting a little more time to make sure they are properly registered with the Food & Drug Administration,” Ana and Frank Ramos, owners of The Perishable Specialist, stated in the memo. “The FDA had previously set a Dec. 31 deadline for facilities that manufacture, process, pack or hold food for human or animal consumption to register or renew their existing registrations, which must be done every other year. However, the FDA is now extending that deadline for a month in light of delays in this year’s registration process and the substantive changes to this process that were included in the Food Safety Modernization Act.”

Ms. Ramos said that the FDA opened its re-registration portal on Oct. 22, 2012 — 21 days after its original posted date of Oct. 1.

“However, no concession had been made on the due date and the deadline had remained as Dec. 31, 2012,” she said. “The FDA advised the trade on or around Dec. 12, 2012 that it would intend to exercise until Jan. 31 enforcement discretion with respect to registration renewals submitted after Dec. 31.”

The FDA, Ms. Ramos noted, has also issued two new guidance documents to further assist facilities that must comply with this registration requirement. “What You Need to Know About the Registration of Food Facilities — Small Entity Compliance Guide” contains information regarding who is required to register and who may be exempt, how often facilities must register and renew registrations, when FDA may suspend a registration and how facilities may submit their registrations and registration renewals to the FDA. “Questions and Answers Regarding Food Facility Registration (Fifth Edition)“ contains updated answers to questions regarding food facility registration that are based on the FSMA amendments.

Among other things, the memo also stated that this guidance highlights the additional information that must be provided in a facility’s registration pursuant to the Food Safety Modernization Act. This includes the email address of the U.S. agent for the foreign facility and an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug & Cosmetic Act.

“As a result of this, the FDA will not suspend the registration number for facilities that submit a renewal during this one-month period,” said Ms. Ramos. “We recommend that the trade not wait until the last days as the portal will significantly slow down with last-minute submissions.”

Although both foreign and domestic facilities require registration renewals, foreign facilities are reminded that a U.S. agent will need to be designated and these will now have a monetary responsible associated with this assignment because the FDA will hold the U.S. agent responsible for paying re-inspection fees, which could cost several thousand dollars per inspection visit.

Those affected by the new registration requirements are reminded that FSMA also imposes new burdens and potential liabilities on entities designated as U.S. agents to foreign food facilities.

The Perishable Specialist informed its clients and others that one of these liabilities stems from FSMA section 107 concerning re-inspection fees.

“It is believed that in 2013 the FDA will begin charging $289 per hour for the time it devotes to re-inspecting foreign food facilities, resulting in the potential for invoices to reach several thousands of dollars per re-inspection,” it stated. “The party that FDA will hold responsible for paying these invoices is the U.S. agent. Accordingly, brokers, forwarders and importers of record will likely want to find alternatives to becoming U.S. agents themselves, and foreign food facilities will need to seek out entities to become U.S. agents.

The FDA Solutions Group LLC, a consulting company affiliated with the customs and international trade law firm Sandler, Travis & Rosenberg, assists foreign and domestic clients with the registration and compliance requirements affecting FDA-regulated industry. FDA Solutions Group makes it easy for food facilities to protect against suspension and costly business interruptions through its turn-key registration and U.S. agent services.