On July 14, 2016, the U.S. Food and Drug Administration (FDA) issued a Final Rule amending its regulations for the registration of food facilities. These regulations require domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. The Final Rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities.

The following new food facility registration requirements were self-implementing and became effective upon enactment of FSMA. These FSMA amendments were included in the Final Rule in order to codify these provisions in 21 CFR part 1, subpart H, which is the food facility registration regulation.

1. Registrations for domestic food facilities are required to contain the email address for the contact person of the facility, and registrations for foreign food facilities are required to contain the email address of the U.S. agent for the facility.
Food facilities required to register with FDA must renew their registrations with FDA every 2 years, between October 1 and December 31 of each even-numbered year, by submitting registration renewals to FDA.
All food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Food, Drug and Cosmetics Act.
Food facility registrations are now required to contain the type of activity conducted at the facility for each food product category.
In addition, section 102(b) of FSMA authorizes FDA to require that all food facility registrations be submitted to FDA in an electronic format. This requirement will take effect on January 4, 2020. A waiver request provision is included in the rule to allow a registrant to submit a written request to FDA that explains why it is not reasonable to submit the registration, renewal, update, or cancellation to FDA electronically, or to explain why it is not reasonable to provide the email address of the owner, operator, or agent in charge of the facility.

The Final Rule also expands the number of establishments that are considered retail food establishments, which are not required to register with the FDA as food facilities. Section 102(c) of FSMA that directs FDA to amend the definition of the term “retail food establishment” to clarify that, in determining the primary function retail food establishments, the sale of food directly to consumers by such establishments includes: (1) The sale of food products or food directly to consumers at a roadside stand or farmers’ market where the stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a community supported agriculture program; and (3) the sale and distribution of such food at any other such direct sales platform, as determined by the Secretary.

Finally, the Final Rule outlines changes FDA is making to improve the utility of its food facility registration database. These changes include requiring certain additional data elements in food facility registrations (e.g., a unique facility identifier (UFI) for food facility registrations, such as a DUNS number); verifying certain information submitted in registrations (e.g., by verifying that the UFI number supplied is associated with the facility-specific address provided on the registration); and taking additional steps to ensure that the registration database is up-to- date by identifying additional circumstances under which FDA will cancel registrations (e.g., FDA will cancel a facility registration if it has expired because the facility has failed to renew its registration).

Please feel free to contact IACC Trade and Tariffs Advisor, Frank J. Desiderio, at 212.973.7740, if you have any questions.