FDA Proposes to Update the Food Facility Registration Rules

By Riëtte van Laack –

On April 9, 2015, FDA published a proposal to amend the regulations regarding registration of food facilities.  The proposal addresses a multitude of issues: codification of certain self-implementing provisions of the Food Safety Modernization Act 0f 2011 (FSMA), amendment of the regulations as directed by FSMA (e.g., to amend the definition of retail establishment), and update and improvement of the food facility registration system. 

The Bioterrorism Act of 2002 amended the Federal food, Drug, and Cosmetic Act (FDC Act), adding section 415, which directs FDA to issue regulations to require registration of facilities engaged in the manufacturing, processing, packing or holding food for consumption in the United States.  FDA issued implementing regulations in 2003. FSMA amended section 415 to require that facilities submit additional registration information to FDA and renew their registration every two years. 

Under the current regulation, food facilities that manufacture/process, pack, or hold food for consumption in the United States must register with FDA.  However, retail food establishments, farms, restaurants, and certain other entities are exempt from the requirement to register.  FDA proposes to amend the definition of a retail food establishment to increase the number of establishments that are considered retail food establishments (and therefore are not required to register).

Currently, the regulation defines a retail food establishment as “an establishment that sells food products directly to consumers as its primary function.”  Whether the primary function is selling food directly to consumers depends on whether the annual monetary value of sale of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers.  FDA proposes to amend the regulation so that the sale of food directly to consumers from an on-farm establishment will include direct sales by the establishment at direct sales platforms such as roadside stands, farmers’ markets, Community Supported Agriculture (CSA) programs, and other direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.  This expansion of sales direct to consumers applies only to on-farm establishments.

FDA further proposes to codify certain self-implementing provisions of FSMA that have been effective upon enactment of FSMA (i.e., provide e-mail address for the contact person or U.S. agent, bi-annual renewal of registration and assurance that FDA will be permitted to inspect the facility at the times and in the matter permitted by the FDC Act).  In addition, FDA proposes to add certain new requirements that the Agency anticipates will improve the food facility registration system.

• All food facility registrations will be required to be submitted to FDA electronically.  FSMA authorizes FDA to require electronic registration no earlier than 5 years after enactment of the law, i.e., not before Jan. 4, 2016.  Among other things, electronic registration will reduce time and cost of processing forms, reduce registration errors, and reduce search and retrieval time. This provision will include a waiver for establishments that cannot register electronically.  
• Registrations will be required to identify the type of activity conducted at the facility for each food product category.
• FDA proposes various measures to assure that the food facility registration database is up to date by verifying accuracy of certain information submitted in registrations and reducing the time for updates and cancellation of registration from 60 to 30 days. For example, to prevent any uncertainty whether a US agent is authorized to register a foreign facility, FDA will not register the facility until it has been able to verify that the U.S. agent is indeed authorized.

The proposed rule does not address the suspension of food facility registration provisions of FSMA.  FDA intends to address these provisions in a separate rulemaking.

Public comments on FDA’s proposed rule may be submitted electronically or by regular mail until June 8, 2015.