Food manufacturers, exporters, and importers should all be familiar with the FDA Food Facility Registration requirement. What they may not be aware of are changes to the requirement as a result of the Food Safety Modernization Act that was signed by President Obama on January 4, 2011. I have listed out the major changes below:
1.) Frequency – every two years. In the past, food facilities only need register once. Under the FSMA, food facilities must re-register every two years.
2.) Start date: The official start date was October 1, 2012. However FDA has delayed the start of re-registration until further notice (http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm?source=govdelivery). Importers should continue to watch out for when the start date opens up.
3.) Requirement of food facilities to indicate secondary products produced (in addition to the primary product produced).
4.) “Voluntary” additional information – FDA will be sending out a separate form after the registration is complete. This separate form will ask for “voluntary” information that will be used to determine if the facility is “high risk.” It would seem obvious that it would be in the facility’s best interests to complete the form. However importers should be very careful when completing this form. It will ask for specific information about potential hazards the preventive control measures that the facility is taking.
5.) Re-Inspection Fee: FDA will have the right to inspect food facilities. The part that importers should be aware of is that FDA will be authorized to charge a “re-inspection” fee if a re-inspection is required. For domestic food facilities, the cost of the re-inspection will be born by the domestic facility. However for foreign facilities, the U.S. agent listed on the Food Facility Registration will be responsible for the costs related to the re-inspection.
More information about Registration can be found at the following FDA website: http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm
Registration should be be made via the following FDA website: http://www.access.fda.gov/
There is no fee for FDA Food Facility Registration.
Feel free to contact me with questions.