US: FDA updates food facility registration requirements
The Amendments to Registration of Food Facilities final rule updates FDA’s food facility registration requirements to better protect public health by requiring additional registration information that will improve the accuracy of the food facility registration database for facilities both in the United States and abroad.
Food facilities that manufacture/process, pack or hold food for consumption in the United States are required to register with the FDA, and this final rule adds new provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of FSMA. Those provisions include the requirement of an email address for registration, required renewal of registration every two years, and that all food facility registrations must contain an assurance that the 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 final rule adds certain new requirements that will improve the food facility registration system. All food facility registrations are required to be submitted to the FDA electronically, although this requirement does not take effect until January 4, 2020.
Registrations are now required to contain the type of activity conducted at the facility for each food product category. This will be required when the final rule becomes effective on July 14, 2016, which is prior to the October-December 2016 registration renewal period. Finally, beginning October 1, 2020, food facilities will need to provide a unique facility identifier (UFI) as part of the registration process.
The final rule also amends the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register with the FDA as food facilities. However, all food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe.
NSAC responds to new rule
The National Sustainable Agriculture Coalition (NSAC) welcomes the issuance of the Food and Drug Administration’s (FDA) final rule amending the Food Safety Modernization Act (FSMA) requirements for food facility registration. The local and regional farm and food community has long awaited this final rule, which provides much-needed clarity for direct marketing farms and food enterprises, preventing undue regulation of these businesses.
By redefining the term “retail food establishments”, the FDA provides clear distinctions between which farms and related businesses are subject to “food facility” registration under the Preventive Controls Rule, and which are not. Thanks to this new language, farmers and small food enterprises primarily selling value-added products directly to consumers can now rest assured that they are not subject to food facility registration requirements or regulations.
“For family farmers, one of the most concerning things about the new FSMA rules has been this confusion over classification of farms and registration requirements,” said NSAC Policy Specialist Sophia Kruszewski. “Conflicting and misleading guidance on farms that do or do not qualify as retail food establishments has been the order of the day for over a decade. Congress settled the matter in FSMA in 2010. We are pleased to see FDA finalize this long overdue clarification, and on first glance are optimistic that the final rule reflects the intent of Congress to shield local food producers who directly market to consumers from ill-fitting federal requirements.”
In FSMA, Congress clarified that sales through direct-to-consumer sales platforms like roadside stands, farmers markets, and community-supported agriculture (CSAs) operations were included within the exemption for retail food establishments. This amendment was sponsored by Senator Jon Tester (D-MT) and former Senator Kay Hagan (D-NC) and was strongly backed by NSAC.
The clarification serves two important purposes. First, it reinforces that CSAs, farmers markets, roadside stands, and other direct-to-consumer operations that sell the majority of their food directly to consumers are not food facilities, do not have to register with FDA as facilities, and therefore are not subject to the Preventive Controls Rule.
Second, it clarifies that the location of the direct sales does not trigger the facility definition – for example, delivering a CSA box to an off-farm location where customers could pick up their boxes would not make that location a “facility”. Neither, as the final rule makes clear, would use of an off-farm commercial kitchen to process value-added goods.
“We applaud FDA for addressing our comments and recommendations on the proposed rule,” said Kruszewski. “NSAC will analyze the rule thoroughly and provide more detailed information in the coming days.”