Tuesday, July 26, 2016

FDA Food Registration Rule Change


Earlier this month the FDA Food Safety Center finalized the rule regarding the registration of food-handling facilities, making some changes in details. Generally, any facility that handles food must be registered with the FDA, and therefore, subject to FDA inspection (in addition to state and local food safety inspections).  The full update is at: http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/default.htm

The registration requirement was part of the 2010 Food Safety Modernization Act (FSMA).

The Amendments to Registration of Food Facilities final rule updates FDA’s food facility registration requirements by requiring additional registration information for the food facility registration database for facilities both in the United States and abroad.

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 technical requirements for the 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 is required as of the date of the final rule, July 14, 2016, which is prior to the October-December 2016 registration renewal period. Finally, beginning October 1, 2020, food facilities will need to provide a unique facility identifier (UFI) as part of the registration process.

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. The FDA states, "However, all food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe."