IMPORTANT: This text has been updated to reflect changes in the proposed FSMA rules as of October 2014.
Figuring out whether the Food and Drug Administration’s (FDA’s) definition of “facility” applies to your operation, especially if you run a farm, is one of the most confusing parts of the proposed regulations. The key in determining whether you are subject to the Preventive Controls Rule is knowing whether your operation fits FDA’s definitions of “farm” or “facility” — even if you just consider your operation a farm. Adding to the confusion is the fact that FDA introduces a new term – “farm mixed-type facility” – to describe farms that may have to comply with both the Produce Rule and the Preventive Controls Rule. FDA has re-proposed some of the key definitions to help determine if you are covered as a farm, a facility, or both, which clears up some — but not all — of the confusion.
The definition of a facility goes back to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). In the Bioterrorism Act, Congress required any “facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States” to register with FDA. When FDA wrote the regulations for registration of food facilities, it defined a facility as any establishment that manufactures, processes, packs, or holds food for consumption in the U.S.
The Bioterrorism Act specified that farms were excluded from coverage, but provided this confusion definition of farms: “facilities in one general location devoted to the growing and harvesting of crops and/or raising animals,” and which extend only to certain types of manufacturing, processing, packing, and holding activities.
So although the Bioterrorism Act technically excluded farms, restaurants, and other retail food establishments (like grocery stores) from the definition of “facility,” in practice, the definition meant that some farms had to register as facilities and others did not. Under the Bioterrorism Act, some farms triggered the definition of facility because they conducted certain manufacturing, processing, packing, or holding activities. The types of activities that triggered the facility definition were many of the light processing activities that farms do to their products.
When Congress wrote the Food Safety Modernization Act (FSMA), it did not change the definition of “facility,” but it did clarify that farmers’ markets, community-supported agriculture (CSA) programs, and other direct-to-consumer sales platforms came under the definition of a retail food establishment and, therefore, were not facilities and did not have to register with FDA. However, FDA has not clarified this important distinction in the rules, which may force these kinds of operations to come under increased regulation (see below).
The proposed Preventive Controls Rule applies to facilities that are required to register with FDA. As described above, farms are not required to register, and therefore are not subject to the Preventive Controls rule unless they are doing activities that fall outside of FDA’s “farm” definition. FDA is currently proposing to define a farm as “an establishment under one ownership in one general physical location devoted to the growing and harvesting of crops, the raising of animals (or seafood), or both.” Farms may also:
If you do more manufacturing or processing than what is allowed above, you would no longer be an exempt farm because you would trigger the “facility” definition.
Remember, a facility is “any establishment that manufactures, processes, packs, or hold food for human consumption in the US.” In the proposed Preventive Controls Rule, FDA seeks to clarify further the definition of facility by revising the definitions of “manufacturing/processing,” “packing,” and “holding.” FDA has also proposed a new definition, “farm mixed-type facility,” for those farms potentially subject to both the Produce Rule and the Preventive Controls Rule.
FSMA requires FDA to clarify that farmers’ markets, community-supported agriculture programs, and other direct-to-consumer sales platforms come under the definition of a retail food establishment and, therefore, are not facilities and do not have to register with FDA. FDA did not make this clarification in the proposed Preventive Controls rule, but has said that it will do so through a separate rulemaking focused on the definition of retail food establishment. Until that critical clarification is made, however, operations like CSAs could be considered facilities, depending on the types of activities they do, and subject to increased levels of regulation – see the CSA section of “Am I Affected?” for details.
You operate a facility if you manufacture, process, pack, or hold food for consumption in the U.S. In the proposed rule, FDA provides definitions of “manufacturing/processing,” “packing,” and “holding.” What FDA considers manufacturing/processing, packing, and holding changes based on whether you are conducting those activities on-farm or off-farm. Activities done to foods for personal consumption do not fall under these definitions.
NOTE: FDA’s original proposed definition of farm only included those farms that harvested, packed, or held their own agricultural products. FDA has revised the definitions of “farm,” “harvesting,” “packing,” and “holding” in the re-proposal so that there is no longer a distinction between whether you are conducting the activities on your own agricultural products (“raw agricultural commodities”) or someone else’s agricultural products. However, the re-proposal did not change the original proposed rule’s distinction between activities that happen on-farm or off-farm. Read on for more details.
Many activities fall under the definitions of “manufacturing/processing,” and the key distinction for FDA is whether you are transforming a product in any way.
Manufacturing/processing activities always include:
For example, this means that if you chop or slice fresh produce for sale – like carrots or apples – FDA believes that you are conducting processing, which means you operate a facility. (Certain harvesting activities like trimming outer leaves of produce, or removing stems or husks, are not considered processing.)
If an activity is part of harvesting, packing, or holding, then it is not considered manufacturing or processing. However, some activities can fall within several categories:
NOTE: The revised language in the re-proposal has removed the distinction between activities done on your own agricultural products or someone else’s agricultural products. However, FDA still distinguishes between activities done on-farm or off-farm. If you are conducting the following activities off-farm, then the following are also considered to be manufacturing or processing:
These activities, when conducted on-farm, are not considered manufacturing or processing.
Packing means putting food in a container, and includes activities that are incidental to packing (e.g. activities that are necessary to safely or effectively store or transport agricultural products). Packing does not trigger the facility definition, as long as the activities are done to raw agricultural products on your farm.
Specific activities in this definition of packing include:
These activities, when done on a farm do not trigger facility registration. When done off of a farm, these activities trigger the manufacturing/processing definition above and would mean that you operate a facility.
Additionally, the following activities trigger the facility definition when they are conducted off-farm:
Placing food into a container that directly contacts the food and that the consumer receives is considered “packaging” and also triggers the manufacturing/processing definition above when done off-farm. If you package agricultural products on your farm, then packaging does not trigger the facility definition.
As an example, under this definition, an on-farm packing house would not be considered a facility. However, an off-farm packing house would be considered a facility.
When done on your farm, holding (or storing) agricultural products — or activities incidental to storage (e.g. activities necessary for the safe or effective storage of agricultural products, like blending the same commodity or breaking down pallets) — do not trigger the facility definition. These activities specifically include:
You operate a facility if you hold or store raw agricultural commodities off-farm. If you only store agricultural commodities on your own farm, then you do not fall under the definition of holding that makes you a facility.
As an example, under this definition of “holding,” you can aggregate produce on your farm from several farms for a shared delivery run to restaurants. But, an off-farm aggregation location would be considered a facility.
Part of the way FDA is choosing to define “farm” is that a farm is under “one ownership” and in “one general physical location.” This makes the distinction between “farm” and “facility” even less clear – for example, if a farmer OWNS the property where she grows produce and LEASES or OWNS a packing shed on a different piece of property nearby, it’s unclear whether FDA would consider the packing and storing of her fresh produce to be a “farm” activity or a “facility” activity.
If you operate a facility:
The fact that you operate a facility does not necessarily mean that you will be subject to the full regulations outlined in the Preventive Controls Rule. Certain facilities are either exempt from the Hazard Analysis and Risk-based Preventive Controls (HARPC) requirements of the proposed Preventive Controls Rule or subject to “modified requirements.”
Facilities that are fully exempt from the HARPC requirements include facilities that manufacture products covered by pre-existing regulations (e.g., juice, seafood, and dietary supplements), and facilities such as grain elevators and warehouses that are solely engaged in storing agricultural commodities other than fruits and vegetables (such as wheat) intended for further processing.
Certain facilities are eligible for modified requirements to the HARPC requirements. These modified requirements apply to facilities that are very small businesses, as defined by FDA, and facilities that average less than $500,000 in average annual gross sales of all food in a previous three-year period and sell the majority of their food directly to consumers or restaurants or retailers within the same state or within a 275-mile radius. For more detailed information on modified requirements, click here.
If you believe that you do operate a facility according to FDA’s definitions above and that you do not fall under the circumstances that would make you eligible for the modified requirements, then you are likely subject to the full requirements of the proposed Preventive Controls Rule.
Additionally, exemptions from the HARPC requirements are available to certain “farm mixed-type facilities” under certain circumstances. Farm mixed-type facilities are operations that must comply with both the Produce Rule and the Preventive Controls Rule. If the farm mixed-type facility is a small business (fewer than 500 employees) or very small business (FDA proposes to define very small businesses as those with less than $1 million in annual gross sales of human food), and it conducts certain low-risk activities (e.g., making jam or maple syrup), then it is exempt from the HARPC requirements.
For the list of these low-risk, on-farm processing activities, click here. For the list of low-risk packing and holding activities, click here. In these lists, FDA originally proposed to distinguish between activities done on a farm’s own products and someone else’s products. Because the revised language in the re-proposal removes the distinction between activities done on your own products versus someone else’s products, these lists will be updated when the rules are finalized to:
Regardless of their exemption status under the Preventive Controls Rule, all facilities must register with FDA.
If you are a facility, or a farm mixed-type facility, or are thinking of becoming a facility, FDA needs to hear from you about how these definitions might impact your operation. FDA will benefit from specific examples and scenarios of activities and processes that you do that would trigger the facility definition.
Here are some questions to guide your comments on this part of the proposed rules:
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