Monday, July 18, 2016

FSMA Update: Amendments to Registration of Food Facilities

Written by Errin McCaulley — Research Assistant

On July 14, 2016, the Food and Drug Administration (FDA) announced a final rule under the Food Safety Modernization Act (FSMA) titled Amendments to Registration of Food Facilities (81 Fed. Reg. 45,911). Primarily, this final rule sets out the additional requirements for food facility registration set forth by § 102 of FSMA, which amended § 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (codified as 21 U.S.C. § 350d). This final rule now requires that, during an initial registration, subsequent renewals, updates, or cancellations, the owner, operator, U.S. agent (for foreign facilities), or other authorized individual must provide an email address to FDA along with the facility's Unique Facility Identifier (UFI) number. These registrations must be renewed every other year between October 1 and December 31 of every even-numbered year. FDA will require by January 4, 2020 all facility registrations, renewals, updates, or cancellations to take place online at, unless FDA has granted a waiver for electronic registration. For facilities to use a paper-based system for registration, renewals, updates, and cancellations, they must, on a case-by-case basis, obtain a waiver from FDA. In order to submit registrations, renewals, updates, or cancellations in paper format, the facility must first submit a request for a waiver to FDA at the following address: 

U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
5001 Campus Dr. (HFS-681)
College park, MD 20740

Significantly, this final rule alters the definition of “retail food establishment” in 21 C.F.R. § 1.227 in accordance with the requirements set forth by Congress in § 102(c) of FSMA. According to FDA, a facility designated as a retail food establishment is exempted from the registration requirements of § 415 of FD&C Act (21 U.S.C. § 350d). The changes to the definition of “retail food establishment” in this final rule will increase the number of exemptions, especially for farm-related operations such as farmers’ markets, roadside stands, and Community Supported Agriculture (CSAs) programs. The exemption from registration requirements, however, does not mean a facility is exempted from any of the other final rules adopted by FDA under FSMA, such as the Preventive Controls for Human Food, Preventive Controls for Animal Food, the Produce Safety Rule, and others. These other final rules have separate exemption and applicability requirements.

Lastly, this final rule requires that any updates to registration information or cancellation of registration be submitted to FDA within sixty days of any change to required information for registration or state the reason for cancellation of registration.

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