1. I run a farm, but I also make foods on-farm. How are my food processing activities regulated?
If you are making processed foods on farm, your operation likely can be classified as either a retail food establishment or a farm-mixed type facility.
A retail food establishment is a business that manufactures foods and sells more than half those products directly to consumers, including through on-premises sales, farmers markets, community-supported agriculture, roadside stands, online, mail-order and other direct marketing platforms. Depending on state law and the kind of foods made, a retail food establishments may be regulated by the local health department or may be subject to a ‘cottage food’ law if there is one in your state. FSMA does not apply to retail food establishments.
If less than half of your processed food sales are directly to consumers, you are likely operating a farm mixed-type facility. A farm mixed-type facility is required to register with the US Food and Drug Administration (FDA), and the food processing done on-farm may be subject to at least portions of FSMA’s Preventive Controls Rules (PC Rules) for Human Food (or for Animal Feed if the only processed foods you make are for animals).
1. My business packs and distributes fruits and vegetables. What does FSMA mean for me?
The first thing to understand is whether your business is a ‘farm’ or not, as defined by FDA. This may seem obvious, but getting the answer right is critically important, because if your business is a farm, then it is not a food ‘facility’. If your business is treated as a ‘facility’ under FSMA, then it may be subject to FDA’s Preventive Controls for Human Food or Animal Feed (PC) Rules, which cover food processing. According to the FDA, the costs of compliance with the PC Rules can run into tens of thousands of dollars a year for a small business.
If your business meets FDA’s definition of either a Primary Production Farm (PPF) or a Secondary Activities Farm (SAF), then the PC Rule does not apply to you. The upshot of these definitions is that things that farmers and groups of farmers do not just to grow raw produce crops but also prepare them for market are, in general, protected as ‘farm’ activities.
1. My farm meets the criteria for a Qualified Exempt Farm. Does FSMA still apply to me?
Qualified Exempt Farms (QEFs) do not have to comply with FSMA’s regulations that govern growing, harvesting, holding and packing produce. However, there are special requirements for QEFs related to record-keeping, notice to customers, and losing QEF status.
Regulations under the FSMA Produce Rule require covered farms to address six potential routes of contamination for fresh produce: Workers, water, animal-derived soil amendments, animals, tools and equipment, and post-harvest handling. This document provides a top-level overview of those requirements; for a more in-depth discussion of the specifics of each area, see the report from the National Sustainable Agriculture Coalition, “Understanding FDA’s FSMA Rule for Produce Farms.”
1. I run a farm that grows fruits and/or vegetables. Do I have to take a FSMA training?
Before you take a FSMA training, determine whether your farm is even covered by the FSMA Produce Rule. If you are not covered, or are qualified exempt, you do not have to take a FSMA Produce Rule training.