FDA Amends Requirements for Registration of Food Facilities

July 14, 2016 – The Food and Drug Administration (FDA) pronounced that it will be amending its regulations for registration of food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA. This rule amends and updates FDA’s registration regulations and is part of their implementation of the FDA Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities. FDA notes this new requirement would use this information to better focus and utilize the Agency’s limited inspection resources.

Food facilities that manufacture/process, pack or hold food for consumption in the United States are required to register with the FDA, and this final rule adds new provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of FSMA. Those provisions include the requirement of an email address for registration, required renewal of registration every two years, and that all food facility registrations must contain 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 and Cosmetic Act.

In addition, the final rule adds certain new requirements that will improve the food facility registration system. All food facility registrations are required to be submitted to the FDA electronically, although this requirement does not take effect until January 4, 2020.

Registrations are now required to contain the type of activity conducted at the facility for each food product category. This will be required when the final rule becomes effective on July 14, 2016. The final rule also amends the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore, not required to register with the FDA as food facilities. However, all food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe.

To view the Federal Register notice, please click here.

If you have any questions, contact Chris Burroughs (burroughs@tianet.org, 703.299.5705).