Just in time for the spring produce season, on April 9, FDA issued a proposed rule to amend its regulation on registration of food facilities. Among other things, the rule would amend the definition of a “retail food establishment” to expand the number of establishments considered “retail food establishments” and thus not required to register with the Agency. Under the expanded definition, establishments that sell food directly to consumers from an on-farm establishment at direct sales platforms (think roadside stands, farmers markets, and Community Supported Agriculture (CSA) programs) would be exempt from the requirement to register with FDA. It is important to note that in light of this definition change, these establishments would also not be subject to the requirements of the Food Safety Modernization Act’s preventive controls rulemakings (e.g., produce risk-prevention measures) (see our LawFlash on the topic) because the amended definition would exempt additional establishments from the requirement to register with FDA.

Currently, a “retail food establishment” is 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 an establishment’s primary function, the sale of food directly to consumers from an on-farm establishment includes sales at direct sales platforms, like those described above. Specifically, proposed § 1.227(b)(11) clarifies that all sales by an on-farm establishment do not have to be on the farm by specifically addressing how off-farm sales directly to consumers should be counted to determine whether the on-farm establishment is a retail food establishment (i.e., the roadside stand or farmers market would not need to be on the farm where the establishment is located).

For those facilities not exempt from FDA’s registration requirements, the proposed rule adds the following provisions (to codify certain self-implementing portions of FSMA):

  • 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 US agent for the facility.
  • Food facilities 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.

Moreover, the rule would require that

  • All food facility registrations be submitted to FDA electronically (requirement takes effect January 4, 2016).
  • Registrations contain the type of activity conducted at the facility for each food product category.
  • Information submitted in registrations be verified (e.g., US agent email address, D-U-N-S number, facility-specific address associated with that D-U-N-S number, etc.).

FDA is now accepting comments on the proposed rule. If you are interested in submitting comments to the Agency, please contact one of this post’s authors linked above.