All food, pet food and dietary supplement facility registrations must be renewed between October 1st and December 31st of even-numbered years. 2018 is a renewal year and prior to the renewal period FDA published two guidance documents on facility registration (guidance and supplemental guidance). All domestic facilities as well as foreign facilities that provide products to the US market are subject to this requirement.
These regulations have been on the books for a while but have been updated as a result of passage of the Food Safety Modernization Act. The most interesting update I noted was that facilities with multiple users will in many cases need to be registered by each user as well as by the owner of the facility. The determination of who must register is based on who has “physical control” over food in the facility. Accordingly, any business in a multiple-user commercial kitchen who “manufactures/processes, packs, or holds food” must have a separate registration as a food facility. In addition, the owner of the facility must register if they have “physical control over the food at any time.” The supplementary guidance suggests that the facility owner may have control over food if they have responsibility for the food in a common storage area. Many small producers will be surprised by this tidbit in the supplement to the guidance.
The information needed to register a food facility is part of an online User Guide on FDA’s website and is also listed in the guidance. The required information includes the facility name and address along with information about the parent company and all trade names the facility uses. In addition, the name and contact information for the owner, operator or agent in charge, the types of foods handled and the activities carried out at the facility (manufacturing, storage, etc.). In addition, foreign facilities are required to list a US Agent that has a physical presence in the United States.
Two very important bits of information are also required for registration:
- A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act;
- A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate.
These two requirements ensure that FDA will have cause and authority to cancel a facility’s registration if the agency is denied access to the facility or if there is a finding that the information submitted was incorrect.
It is also important to note that beginning with the 2020 registration period facilities must have a ”Unique Facility Identifier” (UFI). This identifier will have to meet FDA requirements. At this time only a Data Universal Numbering System D-U-N-S (DUNS) number is listed as an acceptable UFI. These numbers are recognized by FDA but at this time there is no place to enter the number on the form. It is possible that another type of number will be deemed acceptable by the 2020 registration period. DUNS numbers are assigned and managed by Dun & Bradstreet and you can obtain more information about them on the FDA website.
All the information required to register a facility will be known by the facility manager. As much as my team and I like to help companies comply with FDA regulations, FDA has changed the registration process so that a third party, such as FDA Compliance Simplified, cannot register a food facility on behalf of another company. This is an important safeguard for the registering business but doesn’t mean that we won’t try to answer your questions on this or other compliance topics. Let us know how we can help.
