NOTE: This text has been updated to reflect changes in the proposed FSMA rules as of October 2014.
In communities across America, farmers are responding to increasing demand for locally produced food by growing and selling fresh fruits, vegetables, and value-added products directly to consumers and restaurants.
In writing the Food Safety Modernization Act (FSMA), Congress recognized that direct farmer-to-consumer supply chains posed different and lower risks to the food supply than multi-step, complex national and global supply chains. Through the Tester-Hagan amendment, Congress required the Food and Drug Administration (FDA) to implement modified requirements for direct marketers in both the Produce Rule and the Preventive Controls Rule.
If you are direct marketer who grows produce that is covered by the Produce Rule, you are eligible for the modified requirements if you:
The law allows for these direct-market farms – which FDA calls “qualified exempt” – to comply with less burdensome, modified requirements instead of with the full set of produce safety regulations. Congress also stipulated that qualified exempt farms could have their status withdrawn under certain circumstances.
To read more about the modified requirements, visit NSAC’s issue page on Qualified Exemptions and Modified Requirements.
Under the proposed Produce Rule, farms with $25,000 or less in annual gross sales of produce over a previous three-year period would be completely exempt from the Produce Rule. These farms would still be subject to pre-existing law that prohibits farms from selling “adulterated” food (e.g., food that consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is unfit for food), but they would not be subject to the requirements of the Produce Rule.
Before determining whether you are eligible for the modified requirements in the Preventive Controls Rule, you must determine if you operate a facility according to FDA’s definition. Check out our “Do I Operate a Farm or a Facility?” page to figure out if you fall under FDA’s definition of a facility. Facilities are subject to the Preventive Controls Rule.
If you are a facility, you are eligible for modified requirements if you either:
The law allows for these facilities – which FDA calls “qualified facilities” – to comply with less burdensome, modified requirements to the new Hazard Analysis and Risk-Based Preventive Controls requirements of the Preventive Controls Rule.
To read more about modified requirements, visit NSAC’s issue page on Modified Requirements for Qualified Facilities.
Many CSAs include products from a near-by farm in their CSA box. A CSA farm may buy blueberries from another farm to include in its CSA box because it doesn’t grow blueberries or because the CSA farm’s blueberry crop failed that year.
When FDA first proposed the regulations, including product from another farm in your CSA box would have made you a facility. In the re-proposed Produce Rule, FDA has clarified that you can aggregate produce on your farm without triggering the facility definition.
In FSMA, Congress also directed FDA to clarify direct-to-consumer sales platforms — like roadside stands, farmers markets, and CSAs — were not facilities. This means that they do not have to register with FDA and are not subject to the Preventive Controls Rule. FDA has not yet implemented this mandate, leaving it still unclear how the rules could impact CSAs or other direct-to-consumer platforms. FDA is expected to propose a separate rule on this issue — for more information, click here.