FDA amends food facility registration requirements.

• Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA. The registration requirement has been in effect since 2003. However, the FDA Food Safety Modernization Act (FSMA) added new provisions to the FD&C Act related to the registration of food facilities.

• On July 14, 2016, FDA published a final rule to amend the facility registration requirements as part of its FSMA implementation strategy.  The amended regulations codify the following new requirements (which were self-implementing and became effective upon FSMA’s enactment):

  • Domestic facility registrations must contain the email address for the contact person of the facility

  • Foreign facility registrations must contain the email address of the U.S. agent for the facility

  • Food facilities must renew their registrations with FDA every 2 years, between October 1 and December 31 of each even-numbered year

  • Facility registrations must contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act

• The amended regulations also provide for the following:

  • Beginning on January 4, 2020, FDA will require all facility registrations to be submitted in an electronic format

  • Registrants may submit a written request for a waiver to FDA explaining why it is not reasonable to submit the registration, registration renewal, or cancellation to FDA electronically or to explain why it is not reasonable to provide requisite email address contact information

  • The definition of the term “retail food establishment” (exempt from registration) is revised to expressly state that certain types of direct sales (including sales at roadside stands, farmers’ markets, and via community-supported agriculture programs) count toward demonstrating the primary function of such establishments

  • Registrations must include activity types performed with respect to each food product category being handled at the facility

  • An abbreviated registration renewal process is now codified for registrations that do not have any changes to the required information since submission of the preceding registration or renewal

• Finally, in upgrades intended to improve FDA’s food facility registration database:

  • Additional data elements will newly be required in food facility registrations (e.g., beginning October 1, 2020, facilities must submit a unique facility identifier (UFI) acceptable to FDA, which may be a D-U-N-S number)

  • Measures will be employed to verify certain information submitted in registrations

  • Additional steps will be taken to ensure that the registration database is up-to-date by identifying circumstances under which FDA will cancel registrations

• With the limited exception of certain clarifications relevant to the “retail food establishment” exemption, the final rule does not materially alter the scope of FDA’s registration requirement.  Food industry stakeholders required to register with FDA should review and familiarize themselves with the newly-revised registration requirements and their potential impact on food facilities.