FDA Issues Final Rule Amending Food Facility Registration Regulations

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FDA Issues Final Rule Amending Food Facility Registration Regulations

Rule effective date: September 12, 2016

Published: Thursday, July 14, 2016

On July 13, 2016, FDA issued the final rule, “Amendments to Registration of Food Facilities.” The final rule implements the food facilities registration provisions of section 415 of the Food Drug and Cosmetic Act, as amended by the Food Safety Modernization Act (FSMA); amends and updates Food and Drug Administration (FDA) registration regulations; and improves the utility of the food registration database. The day the final rule was issued, AHPA staff participated in a stakeholder call with FDA to better understand how the new food facility registration amendments will impact AHPA’s members.

Food facilities registration

Domestic and foreign facilities that provide food for human or animal consumption in the United States are generally required to register with FDA. The food facilities registration database provides FDA with information necessary to address actual and potential safety concerns and determine to whom certain FSMA provisions, including hazard analysis and risk-based preventive controls and mandatory recall authority, apply.

Key Provisions of the Final Rule

Codifies in regulations self-implementing FSMA provisions including:

  • Domestic and foreign food facilities registrations contact information requirements
  • Biennial registration renewal dates and requirements
  • Requirement of assurance that FDA will be permitted to inspect the facility

Expands the definition of “retail food establishment”

Retail food establishments are exempt from food facility registration. The final rule expands definition of "retail food establishment," thus expanding the number of exempt facilities. Exempt facilities now include certain roadside stands or farmers’ markets and community supported agriculture programs.

Adds “activity type” to information required for food facility registration

Food facility registrations must include the type of activity conducted at the facility for each food product category identified. One or more activity may apply per product category. FDA lists 14 activity type options for registration including manufacturer/processor, labeler/relabeler, and packer/repacker.

Mandatory electronic food facility registration submission

Effective January 4, 2020, all food facility registrations must be submitted to FDA in an electronic format unless a waiver is filed and granted. 

Use of UFI numbers required for food facility registration

  • Food facilities registrations must include a unique facility identifier (UFI), not a D-U-N-S number. (In comments submitted in June 2015, AHPA raised strong opposition to FDA’s proposed amendment to require the exclusive use of D-U-N-S numbers for facilities registrations.) 
  • FDA extended the time for compliance with the UFI requirement until October 1, 2020, after FDA expects to have issued guidance on what types of UFI numbers will be acceptable. 

If you have questions about food facility registration, contact AHPA staff or FDA’s designated food facility registration help desk at: furls@fda.gov.

Compliance Dates

  • Rule effective date: September 12, 2016
  • Compliance date for mandatory electronic submissions: January 4, 2020
  • Compliance date for UFI number requirement: October 1, 2020