US – The United States Food and Drug Administration has directed that all human and animal food facilities both local and foreign must renew their registration this year before December 31.
Owners and operators of food facilities must submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver to submit a paper submission.
The US food agency further noted that it will consider the registration of a food facility to be expired if the facility does not renew its registration by the stipulated time.
Food facility registration helps the FDA determine the location and source of foodborne illness outbreak or potential bioterrorism incidents, and also helps the agency quickly notify facilities that may be affected.
Food facility registration requirements were initiated with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and amended by the FDA Food Safety Modernization Act (FSMA) in 2011.
FSMA’s requirements include additional information that facilities must submit, and a requirement that food facilities renew their registrations every other year.
In 2016, the FDA issued a final rule updating its registration regulation, which updated FDA’s regulations to include FSMA and other requirements.
Starting this year all facilities must include a unique facility identifier (UFI) recognized as acceptable to the FDA with the registration submission.
The requirement is being introduced in accordance with the 2016 rulemaking implementing the food facility registration provisions in the Food, Drug & Cosmetic Act.
The UFI will be used to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration.
To address stakeholder concerns with obtaining a DUNS number (which is critical in creating a UFI) in a timely manner, the FDA has released guidance, Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period.
The guideline is packed with information on what facilities should do if they are unable to obtain a DUNS number prior to the end of the renewal period.
The agency states that failure to update the registration with a valid DUNS number will result in cancellation of the registration.
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