FDA Proposes to Amend Regulation on Registration of Food Facilities

The U.S. FDA is issuing a proposed rule to update its regulation on registration of food facilities. The changes to definition of retail food establishments would expand exemption.

Under the current regulation, food facilities that manufacture/process, pack, or hold food for consumption in the U.S. must register with FDA. Notably, establishments that are “retail food establishments,” farms, restaurants, and certain other entities are exempt from the requirement to register. The proposed rule would amend the definition of a retail food establishment in a way that would expand the number of establishments that are considered retail food establishments, and that are therefore not required to register.

A retail food establishment is currently defined as an establishment that sells food products directly to consumers as its primary function. An establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The proposed rule would clarify that, in determining the primary function of an establishment, the sale of food directly to consumers from an on-farm establishment includes sales by the establishment at such direct sales platforms as roadside stands, farmers’ markets, and Community Supported Agriculture (CSA) programs. Because the amended definition would exempt additional establishments from the requirement to register, the establishments would not be subject to the requirements of the Food Safety Modernization Act (FSMA) preventive controls rulemakings, which apply to facilities that are required to register.

Based on currently available data, FDA estimates that there are approximately 71,000 farms that only sell food products directly to consumers in ways that include farmers markets, roadside stands, and CSA programs.

For facilities that are not exempt from registration, the proposed rule would add new provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of FSMA. Those provisions are:

• Registrations for domestic facilities must contain the email address of the contact person of the facility, and registrations for foreign facilities must contain the email address of the U.S. agent for the facility.
• Food facilities that are required to register with FDA must renew their registrations every two years, between October 1 and December 31 of each even-numbered year.
• All food 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 Federal Food, Drug and Cosmetic Act.

In addition, the proposed rule would add certain new requirements that would improve the food facility registration system. For example:

• All food facility registrations would be required to be submitted to FDA electronically (although this requirement would not take effect before Jan. 4, 2016).
• Registrations would be required to contain the type of activity conducted at the facility for each food product category.
• The proposed rule would provide for measures to verify certain information submitted in registrations.

The FDA is accepting public comments. To electronically submit comments to the docket, visit http://www.regulations.gov and type FDA-2002-N-0323 in the search box.