Direct-to-Consumer Marketing – Preventive Controls Rule

NOTE: This text has been updated to reflect changes in the proposed FSMA rules as of October 2014.

Background

Many farms selling directly to consumers do a variety of activities beyond growing and harvesting crops in order to prepare food for sale to the consumer.  Those farms may conduct light processing activities that may trigger the definition of a “facility” that requires an operation to register with the Food and Drug Administration (FDA) and makes the facility subject to the Preventive Controls Rule.  For a full discussion of the definition of a “facility” and what that may mean for you, click here.

In writing the Food Safety Modernization Act (FSMA), Congress recognized that additional clarifications were needed to the definition of “facility”to clear up confusion about when a farm is also a facility.

Under pre-existing law, retail food establishments – establishments such as grocery stores and restaurants that sell the majority of their food directly to consumers – 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 counted in the definition of a retail food establishment.

There were two aims of this clarification – 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 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 location a facility.

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FDA Has Not Made This Clarification

Despite this mandate from Congress, FDA has not yet made this clarification in the proposed Preventive Controls Rule.  In the re-proposed rule, FDA acknowledges that it needs to make this clarification.  FDA states that it will be issuing a separate proposed rule specifically focused on this issue.  At that time, there will be opportunity for public comment.  FDA intends for this clarification to be finalized around the same time as the Preventive Controls and Produce Safety rules are also finalized.

Without this clarification and under the regulations are currently proposed, CSAs or other direct marketers – in addition to being subject to the proposed Produce Rule – could be considered facilities that have to register with FDA and are subject to the Preventive Controls Rule.  The facility regulations are inappropriate for direct-market farms and would subject those farms to unnecessary additional requirements and costs.  As an example, many CSAs drop off their boxes to customers at off-farm locations.  Without this clarification, these locations – as well as farmers markets and off-farm roadside stands – could be considered facilities by FDA.

Once FDA issues the separate proposed rule, we will update this page to provide information about the proposed rule and how to comment.

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