FDA clarifies FSMA regs for farmers' direct-to-consumer food sales

FDA clarifies FSMA regs for farmers' direct-to-consumer food sales

New rule clarification under Food Safety Modernization Act defines what establishments must register with FDA and who's covered under the FSMA preventive controls rulemakings

The U.S. Food and Drug Administration on Wednesday released its proposed rule to update its Food Safety Modernization Act regulation on registration of food facilities, clarifying regulations on farmers markets, Community Supported Agriculture and other direct to consumer food sales.

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

"Retail food establishments" – an establishment that sells food products directly to consumers as its primary function – and farms, restaurants, and certain other entities, however, are exempt from the requirement to register.

REGISTERED OR NOT? New FDA proposed changes to FSMA food establishments aim to clarify what will be covered under preventive controls rulemakings. (USDA photo)

The proposed rule changes the definition of "retail food establishment" to include more establishments, therefore decreasing the number of required registrants.

Related: FDA Earns More Time For Food Safety Rule Implementation

The proposal specifies that the establishment's "primary function" is direct to customer sales if the value of food sold to directly to customers is more than the value of food sold to other buyers. Direct sales are clarified in the proposal to include sales conducted at roadside stands, farmers markets, and Community Supported Agriculture programs.

Because the amended definition would exempt additional establishments from the requirement to register, FDA noted that the establishments would not be subject to the requirements of the FSMA preventive controls rulemakings.

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.


The proposed rule was long-awaited among farmers operating CSAs and participating in farmers markets, the National Sustainable Agriculture Coalition said Wednesday, mostly because there has been confusion about when FDA will consider a farm to be a food facility.

Sophia Kruszewski, NSAC policy specialist, said the clarification "is critical to understanding and avoiding FSMA's adverse impacts on the growing local and regional food sector."

Kruszewski said there were two aims of the clarification – first to reinforce that CSAs, farmers markets, roadside stands, and other primarily direct-marketing operations are not facilities and aren't subject to the FSMA Preventive Controls Rule; and second 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.

"We are very pleased to see this proposed rule finally released for public comment," Kruszewski said, though she noted that NSAC will continue to review the proposal.

Related: 6 Stories to Read Right Now: FDA's FSMA and Animal Feed

"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," she said.

The full FSMA is the first major reform to food safety regulations since the 1930s, and focuses on prevention of foodborne illnesses, rather than reaction, among growers, processors and handlers of human and animal foods.

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