October 4, 2016
Under the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA), not all farms are created equal. Some farms are just farms, and fall under one set of new rules, while other farms (farm mixed-type facilities to be exact) are also deemed to be facilities and fall under an additional set of rules. As of September 19, 2016, the largest food facilities are expected to be in compliance with the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Preventive Controls Rule. Unfortunately, many farms are still struggling with the myriad of new definitions created by the new FSMA rules, including whether their operations cross over into “facility” territory, which would require them to register with FDA and subject them to the Preventive Controls Rule.
As a result of this confusion, FDA has extended compliance dates for packinghouses that are only packing produce, or are just barely outside the so-called “secondary activities farm” definition. They have also issued draft guidance for agricultural operations to help them evaluate whether they are exempt from food facility registration as farms, or whether their activities render them “facilities.”
As we’ve discussed before, the question of whether or when a farm is also considered a facility is one of the most complicated aspects of the new FSMA rules. Through our “Am I Affected?” Flowchart and our analysis of the rules, the National Sustainable Agriculture Coalition (NSAC) seeks to help farmers and food businesses ask the right questions to determine if and how the FSMA rules apply to them.
FDA’s recently issued draft guidance can serve as another tool in the toolbelt of farmers as they navigate FSMA. The guidance provides additional information on the agency’s thinking regarding certain activities that you may be doing on your farm, including whether those activities would be considered “farm” or “facility” activities.
However, it is important to note that this guidance document is still in its draft form. FDA will consider input from the public before finalizing this document.
Guidance documents are often considered “quasi-regulatory.” That is to say they are not binding law, but rather serve to represent the agency’s current thinking on a regulation, as well as its recommendations for interpreting what’s required. Guidance documents often become the baseline interpretation of a regulation, even if they are not regulations themselves.
This post details the information contained within FDA’s new draft guidance, and points out some of the areas that remain confusing. NSAC will be submitting comments to FDA on the draft guidance to ensure further clarity in the final version. If you wish to submit comments on the draft guidance, you should do so here before February 17, 2017.
Farm Definition Refresher
This guidance is intended to help you evaluate whether the activities you perform on your farm fit within FDA’s definition of “farm.” This is important because farms (as defined by FDA) are not required to register as food facilities and are not subject to the new food safety rules for food processing facilities.
This guidance is also important for those operations that are “farm mixed-type facilities,” meaning that some of their activities are exempt from regulation under the Preventive Controls Rule, but that they also conduct activities that are regulated under the Preventive Controls Rule. If you are a “farm mixed-type facility,” then you are not exempt from registration, unless you satisfy some other exemption (e.g., the retail food establishment exemption).
Farm mixed-type facilities that have to register with FDA may be subject to the Preventive Controls Rule, but only for those activities that fall outside the “farm” definition activities. That is, your packing and holding activities would not be subject to the Preventive Controls requirements or current good manufacturing practices (CGMPs). However, your packing and holding activities may be subject to the Produce Rule if you’re packing and holding produce.
According to FDA, a “farm” can be either a Primary Production Farm or a Secondary Activities Farm.
A Primary Production Farm is an operation:
In addition, a primary production farm may:
If you are a primary production farm, then the Preventive Controls Rule does not apply to you. However, if your business is a primary production farm that grows or harvests produce, it may be regulated under the Produce Safety Rule.
A Secondary Activities Farm is an operation:
FDA’s guidance does not address all of the aspects of the farm definition. For example, it does not address the “under one management” or other ownership criteria, nor does it address the “in one general physical location” criterion. According to FDA, these issues will require a case-by-case determination given how fact specific they are. However, FDA does intend to issue additional guidance on facility registration requirements, which may provide more detail for farms evaluating whether or not they must register.
This guidance mainly focuses on the activities that fit within the definitions of harvesting, packing, holding, and manufacturing/processing because of how essential they are to the definition of a farm. (We covered these definitions in our initial analysis of the Preventive Controls Rule as well, so you may wish to review that post in addition to reading this one.)
Harvesting are those activities “traditionally performed on farms for the purpose of removing raw agricultural commodities, or RACs, from the place where they were grown and preparing them for use as food.” The guidance emphasizes that harvesting activities require a connection to the place where RACs were grown or raised, but “is not limited to the act of, for example, gathering RACs from a growing area (e.g., picking apples off of trees).”
FDA also notes:
Our classifications for regulatory purposes may not always align with how farms think of various activities for non-regulatory purposes. We consider that many activities on farms and farm mixed-type facilities can be classified as “harvesting” even though they may not be performed in the growing area itself or at the same time that the crop is removed from the plant.
In the draft guidance, FDA provides additional examples of what activities can be considered harvesting, building on the list established in the Preventive Controls Rule:
|Examples of “Harvesting” Activities Included in the Definition||Additional Examples of “Harvesting” Activities|
|Cutting (or otherwise separating) the edible portion of the RAC from the crop plant
Removing or trimming part of the RAC (e.g., foliage, husks, roots, or stems)
|Aging/curing/fermenting/oxidizing that occurs passively over time (e.g., cocoa beans, coffee beans, and vanilla beans)|
|Cooling||Blending (e.g., blending different lots of the same RAC together)|
|Field coring||Braiding (e.g., garlic)|
|Filtering||Bunching (e.g., garlic, onions)|
|Gathering||Cleaning seeds that are the harvested crop including removal of leaves, stems, and husks, such as for flax seeds|
|Hulling||Drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (e.g., drying/dehydrating grains in the growing area)|
|Shelling||Hydro-cooling and icing|
|Trimming of outer leaves||Trimming the tops or roots of bunches of allium crops and root crops|
|Washing||Using pesticides in wash water|
|Braiding (e.g., garlic)|
|Bunching (e.g., garlic, onions)|
|Cleaning seeds that are the harvested crop including removal of leaves, stems, and husks, such as for flax seeds|
|Drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (e.g., drying/dehydrating grains in the growing area)|
|Hydro-cooling and icing|
|Trimming the tops or roots of bunches of allium crops and root crops|
|Using pesticides in wash water|
Packing means placing food into a container that is not a consumer container, and includes re-packing and activities performed incidental to packing or re-packing (e.g., activities performed for the safe or effective packing or re-packing).
Packaging, on the other hand, means placing food into a container that directly contacts the food and that the consumer receives, for example, putting strawberries in a clamshell, or oranges in a net bag. Packaging is technically a manufacturing/processing activity, but is within the farm definition when done on a farm to an intact RAC.
This means that, as FDA states in the guidance, “if you place RACs into a container, it makes no difference whether that activity is “packing” or “packaging” – for the purposes of determining whether your business is a farm, you can do either.”
FDA also expands upon the examples of packing activities in the draft guidance:
|Examples of “Packing” Activities Included in the Definition||Additional Examples of “Packing” Activities|
|Activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing of that food)||Blending different lots of the same food together|
|Sorting||Cooling (including hydro-cooling and icing)|
|Culling||Filtering (e.g., filtering honey to remove debris)|
|Grading||Mixing intact RACs in a packing container (e.g., oranges and grapefruits together in a box for further distribution)|
|Weighing or conveying||Hulling|
|Removing or trimming parts of RACs (e.g., removing stems/husks, trimming outer leaves, trimming tops or roots of bunches of allium crops and root crops)|
|Sifting (e.g., sifting grains to remove debris)|
|Washing (e.g., to remove dirt from RACs)|
Holding means storing food, and also includes those activities performed incidental to food storage (e.g., performed for the safe or effective storage of the food) or as a practical necessity for food distribution. FDA emphasizes in the draft guidance that the latter activities are limited to those “truly necessary” for distribution or storage.
The draft guidance includes additional examples of activities that fit within this definition, as well as a list of activities that are never classified as holding because they are not truly necessary for food distribution:
|Holding Activities Included in the Definition||Additional Examples of “Holding” Activities||Activities NOT Considered Holding|
|Fumigating food during storage||Aeration for safe or effective storage (e.g., to manipulate grain temperatures)||Filtering|
|Drying/dehydrating RACs (e.g., hay or alfalfa – does not create a distinct commodity)||Aging/curing/fermenting/oxidizing that occurs passively over time (e.g., cocoa and coffee beans)||Hulling|
|Blending of the same RAC||Coating RACs for safe/effective storage (e.g., coating grains with diatomaceous earth for insect control; coating fruit with wax)||Labeling|
|Breaking down pallets||Cooling (e.g., refrigerating, maintaining already-frozen food in frozen state)||Mixing different foods together|
|Storing food||Heat treatment for pest control||Packing/Re-packing|
|Turning (e.g., grain, to manage temperature and moisture)||Loading food into a vehicle, or in a building or its associated fixtures||Packaging|
|Sampling food for grading or quality control purposes||Removing or trimming parts of RACs|
|Turning (e.g., to manage grain temperature and moisture)||Washing|
|Weighing or conveying|
The activities that cannot be classified as holding can be classified as harvesting, packing, or manufacturing/processing depending on the situation.
Pause, and Quick Recap
At the most basic level, the farm definition does not allow for activities that change raw agricultural commodities (agricultural products in their unprocessed, intact, natural state) into processed foods. You can grow, harvest, pack, or hold, but once you go beyond that, you are manufacturing/processing, and you trigger the facility definition. (Except for those limited-processing activities allowed under the farm definition: drying/dehydrating, artificial ripening, and packaging/labeling RACs, as long as there is no additional processing).
FDA considers many activities to be manufacturing/processing that do not always align with the common understanding of the term (e.g., packaging, washing). The key is that, for farms and farm mixed-type facilities, if an activity is technically defined by FDA as manufacturing/processing but it is done as part of harvesting, packing, or holding, then it is a farm activity.
As FDA acknowledges in the guidance,
“[T]he fact that we included a particular activity in one definition does not mean that it cannot also be included as an example in another definition. Depending on the circumstances, activities may be classified in different ways, and there may even be more than one possible classification of an activity for a single circumstance.”
FDA recommends that farms first consider whether the activity fits the definition of harvesting, packing, or holding. If it does not, then it’s probably manufacturing/processing.
Manufacturing/processing means making food from one or more ingredients, or “synthesizing, preparing treating, modifying or manipulating food.” An activity doesn’t have to transform a RAC into a processed food to still be considered manufacturing/processing (e.g., washing, labeling). The definition of manufacturing/processing in the rule includes some examples of activities that fit within this definition. The draft guidance provides additional examples:
|Examples of Manufacturing/Processing Activities Included in the Definition||Additional Examples of “Manufacturing/Processing” Activities|
|Baking||Bleaching (e.g., walnuts)|
|Bottling||Coating (non-storage; e.g., chocolate covered)|
|Cooling||Cracking (e.g., corn)|
|Distilling||Extracting oils, juice|
|Drying/dehydrating (e.g., grapes to raisins)*||Extruding|
|Evaporating||Fermenting fruits and vegetables|
|Packaging (including modified atmosphere)*||Shelling|
|Peeling||Slaughtering and post-slaughter|
|Treatment to manipulate ripening*||Smoking|
|Trimming||Sorting, culling, grading (e.g., before canning)|
|Washing||Using pesticides in wash water|
|Weighing or conveying ingredients to be used during manufacturing/processing (e.g., ingredients to be used in production of baked goods)|
Some of these activities (designated with a *) are explicitly allowed in the farm definition. Additionally, many activities that are technically manufacturing/processing can also fall within the “farm” definition when done as part of harvesting or packing.
The draft guidance also has a (non-exhaustive) list of activities that can be classified in more than one way. Below, we list some examples; see Table 7 of the draft guidance for more.
Some common crosscutting examples discussed in more detail below and in the draft guidance include blending, mixing, washing, and trimming.
Blending vs. Mixing
According to FDA, “blending” means combining the same type of food, while “mixing” means combining different types of food. Blending and mixing may often be a necessary part of packing activities; it depends on the situation.
Here are some examples from FDA’s guidance:
Unfortunately, these examples still do not provide much sought-after clarity regarding bagged salad mixes. It is very clear that any chopping that is done after harvest is processing (e.g., bagged, chopped lettuce mixes), but it is still not clear how these definitions apply to salad greens where there is no additional chopping beyond the harvest cut (e.g., baby kale, baby arugula, baby spinach). It also appears that FDA considers different varieties of a commodity to be different commodities (e.g., red versus yellow versus green peppers). NSAC is seeking further clarity on these questions.
Depending on when and where a RAC is being washed, the washing may be part of the farm definition as part of harvesting or packing. If it is not done as part of harvesting or packing, then it is probably manufacturing/processing, and would trigger the facility definition. Here are some examples from the draft guidance:
The important thing to note is that, for practical or regulatory purposes, it does not matter if the farm classifies the activity as harvesting or packing; as long as the activity fits into one of those categories, then the farm definition is satisfied.
However, a farm that washes, slices, and then packs apples cannot claim that the washing is incidental to or merely for the purpose of packing. In such a case, the washing is considered manufacturing/processing, and the facility definition triggered.
Like washing, trimming can occur as part of harvesting, packing, or manufacturing/processing.
These are just a few of the key examples – the draft guidance contains many more. In some cases, the examples may make things more confusing because the way FDA chooses to classify a particular activity does not necessarily align with the way you would on your farm. But keep in mind that – for purposes of understanding how you fit in the FSMA compliance landscape – it’s FDA’s definitions that count.
We will continue to provide updated information throughout the process, but if you have any specific questions, you can submit them to FDA’s Technical Assistance Network or to the open docket on the draft guidance. The draft guidance is available via FDA’s website or the Federal Register. Or you’re also welcome to contact us at email@example.com.