Food facilities that manufacture/process, pack, or hold food for consumption in the United States are required to register with the U.S. Food and Drug Administration (FDA) and the 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, require 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 intended to 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.
Items of Interest to IWLA Members
Use of D-U-N-S or a Unique Facility Identifier
The final rule requires that registrations eventually will include a Unique Facility Identifier (UFI). FDA will issue guidance specifying which UFIs or identifiers FDA recognizes as acceptable, and FDA expects to recognize D-U-N-S numbers as acceptable identifiers.
FDA is delaying the compliance date for the requirement to submit a UFI recognized as acceptable to FDA until the registration renewal period beginning October 1, 2020.
Registrations for foreign food facilities are required to contain the email address of the U.S. agent for the facility. FDA will verify by email that the person identified as the U.S. agent for the foreign facility has agreed to serve as the U.S. agent of a foreign facility. FDA will not provide an electronic confirmation of the foreign food facility registration update until the designated agent confirms that he has agreed to serve as the U.S. agent.
Requirements for a Warehouse to Update the Registration (the following is excerpted directly from the final rule)
“(Comment 60) Comments suggest that FDA should not require warehouses and storage facilities to identify food product categories that they handle because this information constantly changes. The comments state that it would therefore be burdensome for these facilities to be required to “constantly update” their food product category information.
“(Response 60) Information about the categories of food a facility handles helps FDA conduct investigations and surveillance operations in response to food-related emergencies and to quickly alert facilities affected by such an incident if FDA receives information indicating the type of food affected. This is true for warehouse and storage facilities, as well as other facilities that manufacture/process, pack, or hold food. We therefore disagree with the suggestion to exempt warehouses and storage facilities from the requirement to include food product category information in their registrations. That said, it may not be necessary for warehouse facilities to “constantly update” their registrations. For warehouse facilities engaged in ongoing operations that frequently change food product categories, these facilities may select all of the food product categories that are normally part of their operations. If the warehouse has any updates to the food product categories that it handles, it is required to update its registration in accordance with § 1.234. The Agency will consider possible IT solutions to reduce the burden associated with selection of food product category information.”
FDA is hosting a webinar on Aug. 3 to review these changes. Register today!