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FDA Clarifies Facility Rule Exemption for Direct-to-Consumer Sales

April 9, 2015


On April 8, the US Food and Drug Administration (FDA) published a proposed rule to amend food facility registration requirements under the Food Safety Modernization Act (FSMA). This proposed rule includes a long-awaited clarification to the definition of “retail food establishment,” which has particular importance for farms that sell products through direct-to-consumer marketing platforms.

One of the most concerning aspects of the FSMA rules for farmers has been the confusion surrounding the issue of which farms FDA will consider to be food facilities, and will therefore be subject to food facility registration requirements and the new Preventive Controls Rule. Under pre-existing law, retail food establishments that sell the majority of their food directly to consumers – such as grocery stores and restaurants – are not facilities and do not have to register with FDA.

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 particular amendment to FSMA was sponsored by Senator Jon Tester (D-MT) and former Senator Kay Hagan (D-NC) and strongly backed by NSAC.

This clarification had two goals – the first was to reinforce 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 are not therefore subject to the Preventive Controls Rule. The second was to clarify that the location of the direct sale could not trigger the facility definition – for example, delivering a CSA box to a location where customers could pick up their boxes would not make that location a facility.

Last November, FDA made changes to the facility registration guidance to reflect FSMA’s intent. This proposed rule, once finalized, will put this clarification into the regulations themselves.

In the proposed rule, FDA makes this critical clarification by amending the definition of “retail food establishment” to clarify that manufacturing and processing operations co-located on farms are exempt from registration when the majority of sales by that operation is direct to consumer, and that exemption still applies where those sales occur off-farm through a roadside stand, CSA drop-off site, farmers’ market, or “other such direct-to-consumer sales platforms.”

The proposed rule also proposes to codify the self-implementing provisions of FSMA that relate to biennial facility registration requirements, and proposes some changes to the data that FDA will request from food facilities that must register.

NSAC will be thoroughly reviewing the proposed rule, and will provide an updated analysis as it becomes available.

The public comment period will run for 60 days, until June 8, 2015. You can view the federal register notice here, and submit comments to the docket here.


Categories: Food Safety, Local & Regional Food Systems


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