Note: This text has been updated to reflect changes in the proposed FSMA rules as of October 2014.
Gathering fruits and vegetables from several farms in one location to sell to buyers (“aggregating”) – such as grocery stores or institutions like a school or hospital – is an important strategy for farmers meeting demand for local and regional food. Many aggregators are calling themselves food hubs. Food hubs have emerged as a key business model for aggregation of product for sale into local and regional food markets. In addition, some community-supported agriculture farms (CSAs) aggregate products from other farms for distribution to consumers in their CSA boxes, while still other CSAs are now multi-farm entities.
Broadly, aggregation activities could trigger the “facility” definition that requires an operation – including a farm – to register with the Food and Drug Administration (FDA) and makes that operation subject to the proposed Preventive Controls Rule. To figure out whether you operate a facility, visit NSAC’s “Do I Operate a Farm or a Facility?” issue page.
If aggregation is done at an off-farm location (such as a warehouse), then packing and holding activities trigger the FDA definition of a “facility,” meaning an operation could be subject to the Preventive Controls Rule. Packing activities include putting individual unit cartons into a larger box used for shipping, and putting produce in shipping crates. Holding includes storing food in a warehouse. Additionally, any off-farm manufacturing and processing that occurs triggers the definition of a facility.
If you aggregate product on-farm – for example, if several farmers bring products to your farm to be packed together, you likely will not trigger the facility definition. This is regardless of who grew the agricultural products. [Initially, FDA proposed that determining whether aggregation activities on a farm trigger the facility definition depends on whether the farm is doing the activity to the farm’s own agricultural products or to someone else’s agricultural products. In the revised proposed rule, FDA has done away with this distinction.] Under the re-proposed rule, packing and holding agricultural products on-farm — whether your own or someone else’s — does not by itself trigger the facility definition. However, if you are also doing activities that are considered manufacturing or processing, then you could trigger the facility definition.
For a detailed discussion about activities – including processing – that trigger the facility definition, visit NSAC’s “Do I Operate a Farm or a Facility?” issue page.
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 these rules, CSAs that include products from other farms would have been considered facilities. In the revised proposed rule, however, FDA has done away with this distinction. It no longer matters if you or your neighbor grew the blueberries (for example), as long as you are packing and holding (collecting and storing) the blueberries on your farm.
It was also Congressional intent when passing FSMA that FDA not require CSAs to register as facilities. Congress required FDA to clarify that direct-to-consumer sales platforms like roadside stands, farmers markets, and CSAs were not facilities that had to register with FDA and therefore were not subject to the Preventive Controls Rule. Despite Congress’s clear mandate, FDA has not yet provided this clarification. In the revised rule, FDA has said that they will issue a separate proposed rule that specifically addresses this issue. Go to our direct-to-consumer marketing issue page for more information.