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Q&A: Food Facilities and FDA Registration

Food Manufacturing spoke with Registrar Corp Senior Regulatory Specialist Mary Hancock to address some of the issues involved in the FDA registration process for food facilities.

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Last month, food companies around the world found that the U.S. Food and Drug Administration is in the process of removing all food facilities that did not renew their FDA registration by the Dec. 31, 2014 deadline from its registration database.

According to Registrar Corp, the Food Safety Modernization Act requires food facilities to renew their FDA registrations every even-numbered year between October 1 and December 31. Any food facility that did not renew its registration by December 31, 2014 should re-register with FDA before it continues to ship food products to the United States, as its registration is now invalid.

Food Manufacturing spoke with Registrar Corp Senior Regulatory Specialist Mary Hancock to address some of the issues involved in the FDA registration process for food facilities.

Q. How will an invalid registration affect a food company’s day to day functions?

A. Distributing food in the United States without a valid FDA registration is a prohibited act. If a facility is distributing food with an invalid registration, FDA may take civil action in Federal Court against the owner/operator of the facility. An invalid registration could also deter retailers and distributors from buying a product. Any foreign facility that exports food to the U.S. and any domestic facility that imports food or ingredients from outside of the U.S. must file a Prior Notice submission with FDA prior to the arrival of each shipment of food to the United States. FDA’s Prior Notice System Interface will reject a submission that indicates an invalid registration number, effectively preventing customs brokers from filing an entry and often resulting in shipments being held at the port. Typical demurrage fees for shipments held at the port while prior notices, entry documents and registrations are sorted out can cost importers $1,000 per day. 

Q. How long does it take to re-register a facility with an expired registration?

A. The time it takes to re-register depends on the user’s familiarity with FDA’s requirements for food facility registration, FDA’s online registration database, and the facility’s legal details, structure and activities.  The registrant must be able to correctly provide legal information such as the corporate designation of the owner/operator of the facility or the contact information for a parent company when registering a subsidiary. In its 2003 Interim Final Rule for food facility registration, FDA estimated that domestic facilities that have Internet access and are fluent in English would need, on average, 2 hours to research the regulation and complete and certify the form. (68 FR 58894 at 58932). Individuals may re-register a food facility directly by creating an account using FDA’s United Registration and Listing System (FURLS) to access and navigate the Food Facility Registration Module (FFRM), or they can use a third-party, like Registrar Corp, to re-register for them.  The benefit of using Registrar Corp is we can complete a registration quickly and properly, as we are familiar with the process and terminology.  We equate registering through a third party with having a third party file your taxes.

Q. When and why did registration renewal become a regulation?

A. The Food Safety Modernization Act was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to food safety incidents to preventing them.   The initial requirement for food facilities to register with FDA came in 2002 in response to the terrorist attacks of September 11, 2001. After fulfilling the initial registration requirement, many facilities neglected to update their registrations despite the fact that FDA is supposed to be notified of any changes to a registration within 60 days. By 2011, FDA’s database included registrations which had not been updated for the better part of a decade; this outdated information would not serve the agency’s initial purpose of facilitating expedient contact in case of food-borne illness or other emergencies. Biennial Registration Renewal ensures that the facility information in FDA’s database will remain current and useful.

Q. What are other requirements for distributing food in the U.S.?

A. Products labeled for consumer use must comply with FDA’s specific and extensive requirements. Facilities must consent to FDA inspection and should always be prepared, because FDA can come at any time, and FSMA granted FDA the ability to charge re-inspection fees if they must return to a facility due to non-compliance issues. Non-US facilities exporting food products to the United States must designate a US Agent for emergency and routine FDA communications.  Shipments of food must be accompanied by a Prior Notice document notifying FDA of the quantity, destination and intent of the product.