On July 14th, the U.S. Food and Drug Administration (“FDA”) published a final rule amending the food facility registration requirement originally implemented under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  The final rule includes a number of changes that are designed to improve the accuracy of the food facility registration database.  It also amends the retail food establishments definition, expanding the number of establishments that are considered retail food establishments and, therefore, exempt from the registration requirement pursuant to 21 C.F.R. § 1.226.

Under Section 415 of the Federal Food, Drug, and Cosmetic Act, food facilities that manufacture, process, pack, or hold food for consumption in the United States are required to register with FDA. More specifically, a domestic registrant is now required to provide an e-mail address for the contact person at its facility and  a foreign facility registrant must provide the e-mail address for the U.S. agent for its facility.  Registration renewals must be completed every two years, and facilities must provide assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.

Additionally, the final rule adds a few new requirements intended to improve the food facility registration database:

  • as of July 14, 2016, registrations are required to contain the type of activity conducted at the facility for each food product category;
  • all food facility registrations are required to be submitted to the FDA electronically by January 4, 2020; and
  • food facilities will need to provide a unique facility identifier (“UFI”) as part of the registration process beginning October 1, 2020.

The amended regulations also permit registrants to submit a written waiver request explaining why it is not reasonable to submit the registration, registration renewal, updates, or cancellation to FDA electronically or to explain why it is not reasonable to provide the required e-mail address contact information. An abbreviated registration renewal process is now available for registrants who do not have any changes to the required information since submission of their proceeding registration or renewal.

Notably, the amendment to expand the scope of entities that fall within the definition of a retail food establishment, consistent with Section 102(c) of FSMA, is important to those who could have been subject to the prior rule but may no longer need to register. This includes growers who sell directly to consumers through local farmers markets, community supported agriculture programs, roadside stands, or similar avenues, as they will not need to register with the Food and Drug Administration as a food facility as long as they do not otherwise have qualifying operations.

Food facilities that are required to register with FDA should review the revised registration requirements and familiarize themselves with their potential impact on food facilities.

For more information about this Rule or other FDA Rules that implement FSMA, contact a member of the Husch Blackwell Food Safety Team.