FSMA food facility rule clarified

FDA proposes rule clarification and seeks comment on amendment to registration requirements as it relates to direct farmer-to-consumer operations.

The U.S. Food and Drug Administration issued a proposed rule to amend and update its regulation on registration of food facilities. The proposed rule would provide for improvements to the food facility registration system, and would also implement certain provisions of the FDA Food Safety Modernization Act (FSMA), which adds new provisions to the requirements for food facility registration. 

Under the current regulation, food facilities that manufacture/process, pack, or hold food for consumption in the United States 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.

“One of the most concerning aspects of the FSMA rules for farmers has been the confusion surrounding when FDA will consider a farm to also be a food facility,” said Sophia Kruszewski, policy specialist with the National Sustainable Agriculture Coalition.  “This clarification is critical to understanding and avoiding FSMA’s adverse impacts on the growing local and regional food sector.”

There were two aims of this clarification – the first was to reinforce that Community Supported Agriculture (CSA), farmers markets, roadside stands, and other primarily direct-marketing operations are not facilities, do not have to register with FDA as facilities, and are not subject to the Preventive Controls Rule.  The second aim was to clarify that the location of the direct sale could not trigger the facility definition – e.g., that delivering a CSA box to a location where customers could pick up their boxes would not make that operation a facility.

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 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 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. FDA does not have the data to quantify how many of these farms are currently required to register and would, under the proposed rule, no longer be required to do so. The agency seeks comment on this issue, among others, in the proposed rule.

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 January 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.

“We are very pleased to see this proposed rule finally released for public comment,” said Kruszewski.  “We will undertake a thorough analysis of the rule, but on an initial read it appears FDA is proposing to do just what FSMA requires: ensure that these types of operations are not misclassified as food facilities and caught up by the preventive controls rule.” 

The FDA is accepting public comments beginning on April 9, 2015. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2002-N-0323 in the search box. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2002-N-0323 on each page of your written comments.

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