NOTE: This text has been updated to reflect changes in the proposed FSMA rules as of October 2014.
Many diversified farms conduct various processing activities to make products like jams, salsas, and pickles that add value to the agricultural products they grow. Figuring out how on-farm processors would be regulated under the proposed Produce and Preventive Controls Rules requires some patience, because it is one of the most confusing aspects of the proposed regulations.
Some on-farm processors are eligible for certain modified requirements and certain exemptions depending on a number of factors. The focus of this page is demystifying how FDA proposes to regulate on-farm processing. For more information on what the regulations require, click here.
Let’s walk through it.
On-farm processing falls under FDA’s definition of a “farm mixed-type facility.” A farm mixed-type facility is a farm that grows and harvests crops and/or raises animals, and conducts activities that requires it to be registered as a facility with the Food and Drug Administration (FDA). Figuring out whether your farm is also a “facility” according to FDA’s definition is another one of the most confusing aspects of the proposed rules. To figure out whether you are a facility, visit NSAC’s “Do I Operate a Farm or a Facility?” issue page.
If you are a farm and operate a facility, then you are, according to the proposed rules, a farm mixed-type facility. Farm mixed-type facilities are subject to the Preventive Controls Rule, and if they grow produce covered by the Produce Rule, then they are also subject to the Produce Rule. Most farm mixed-type facilities will be subject to both the Produce Rule and the Preventive Controls Rule if they grow produce and conduct processing activities.
If you direct market the majority of your products, you may be eligible for modified requirements under both proposed rules. To determine whether you are eligible for modified requirements for direct marketers, and what those requirements are, click here.
If you run a farm mixed-type facility, you may be eligible for certain exemptions if you are a “small” or a “very small” business. FDA is proposing the following definitions in the proposed Preventive Controls Rule:
To make matters more confusing, FDA has proposed different definitions of “small” and “very small” in the proposed Produce Rule. It is unclear which of these definitions will apply to farm mixed-type facilities. For the purposes of understanding the requirements that apply to on-farm processing activities, we are going to stick to the bulleted definitions above.
Very small businesses are eligible for modified requirements under the Preventive Controls Rule. To read more about those modified requirements, click here.
If you are a farm mixed-type facility, and you are small or very small business, you may be eligible for certain exemptions if you only conduct certain “low-risk” activities as part of the facility part of our operation. Read more below.
Farm mixed-type facilities that are small or very small businesses are eligible for an exemption from the Hazard Analysis and Risk-Based Preventive Controls (HARPC) requirements in the Preventive Controls Rule, if the only activities they conduct as part of their facility operation are ones that FDA considers to be “low risk.”
Those low-risk activities fall into the following categories:
In these lists, FDA distinguishes between activities done on a farm’s own products and someone else’s products. FDA has revised this approach, and is no longer drawing a distinction between activities done on your own versus someone else’s products. However, these lists have not yet been updated to reflect this change. FDA has stated that the lists will be revised in the final rule to clarify that it no longer matters who grew or raised the products.
For example, the activities listed in categories (1) and (2) above would be combined, because it no longer matters if you are processing your own versus someone else’s agricultural products. As long as the activity is on the list, the exemption still applies regardless of who grew or raised the products. The lists would also be revised to longer include activities more appropriately classified as harvesting, packing, and holding. For example, mixing different lots of intact fruits and vegetables, grains, honey, sap, and peanuts and tree nuts would be removed from the list because farms that mix intact raw, or unprocessed, agricultural products from different farms are covered by the Produce Safety rule, not the Preventive Controls rule.
Category (3) would also be revised to eliminate any reference to packing and holding raw (unprocessed) agricultural products, because the proposed Preventive Controls rules no longer cover on-farm packing and holding of raw agricultural products. The rule would continue to exempt on-farm packing and holding of certain processed foods (e.g. maple syrup).
Let’s go back to the jam, salsa, and pickles.
A farm that makes jam would have to register with FDA as a facility, be subject to the Preventive Controls Rule, and be subject to the Produce Rule if it grows produce covered by the rule. Making jam qualifies as a low-risk processing activity, however, so a farm that makes jam would be eligible for the exemption from the HARPC requirements in the Preventive Controls Rule if it is a small or very small business, regardless of whether the fruit for the jam was grown on that farm or someone else’s farm.
A farm that makes salsa would have to register with FDA as a facility, be subject to the Preventive Controls Rule, and be subject to the Produce Rule if it grows produce covered by the rule. Making salsa does not qualify as a low-risk activity because it involves cutting, chopping, and slicing, which are not defined by FDA as low-risk activities. A farm that makes salsa would not be eligible for an exemption from the HARPC requirements. However, that farm may be eligible for modified requirements to the HARPC requirements.
A farm that makes pickles would have to register with FDA as a facility, be subject to the Preventive Controls Rule, and be subject to the Produce Rule if it grows produce covered by the rule. Making pickles does not qualify as a low-risk activity. Canning and fermentation are not on the proposed FDA list of low-risk activities. A farm that makes pickles would not be eligible for an exemption from the HARPC requirements. However, that farm may be eligible for modified requirements to the HARPC requirements.
It’s important to note that a farm that makes both jam and salsa (or both jam and pickles) won’t qualify for the exemption. As written, the proposed rule would only exempt these small and very small farm mixed-type facilities from the HARPC requirements if all of the processing activities they conduct have been identified by FDA as “low risk.” That means a farm mixed-type facility that makes both jam and maple syrup is eligible for the exemption, but not a farm that makes both jam and salsa (or jam and pickles). However, that farm may be eligible for modified requirements to the HARPC requirements.