1. I’ve heard FSMA has different rules for farms versus other businesses. How do I know if my business is a farm?
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 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. The costs of compliance with the PC Rules can be tens of thousands of dollars a year for a small business.
If your business meet 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 to grow raw produce crops and to prepare them for market are treated as ‘farm’ activities, not ‘facility’ activities.
2. What is a Primary Production Farm?
A Primary Production Farm is an operation:
- in one general area, although it may include multiple non-contiguous parcels,
- with the principal focus of growing or harvesting crops and/or raising livestock, including seafood.
In addition, a Primary Production Farm may:
- pack and hold raw agricultural commodities (RACs, defined as a food crop in its raw or natural state), including RACs grown on that farm and RACs supplied from other farms;
- dry/dehydrate RACs to create a distinct product with no other processing (for example drying grapes to make raisins); and
- artificially ripen RACs (for example tomatoes in controlled storage).
What it means: If you are a Primary Production Farm, the PC 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 (See the FSMA FAQ Sheet ‘Is Your Farm Covered by the Produce Rule?’).
3. What is a Secondary Activities Farm?
A Secondary Activities Farm is a business:
- not located on a Primary Production Farm;
- majority-owned by the operator of a Primary Production Farm, or by multiple Primary Production Farm operators together;
- where the Primary Production Farms of the majority-owner or owners also provide the majority of the RACs handled by the Secondary Activities Farm; and
- that harvests, shells, hulls, washes, packs, holds, packages, and labels RACs, and/or artificially ripens RACs or dries RACs to create a distinct product with no other processing (such as grapes into raisins).
What it means: The Secondary Activities Farm definition means that a farmer cooperative or farmer-owned packing house where the majority of the product handled by the packing house is grown by the farmer owner or owners is NOT regulated under the PC Rule, even if it is in a different location from a farm that grows the crops. A Secondary Activities Farm can do all same the harvesting, holding and packing activities as a Primary Production Farm and still be treated as a farm.
A Secondary Activities Farm is not subject to the PC Rules, but may be regulated under the Produce Safety Rule (See the FSMA FAQ Sheet ‘Is Your Farm Covered by the Produce Rule?’).
4. What exactly does harvesting, packing and holding RACs mean?
Harvesting, packing, and holding are activities performed on RACs to remove them from the field and prepare them for storage or distribution, and includes the following:
- separating the edible portion of the crop from the plant
- field coring
- trimming or removing outer leaves, stems, roots, tops and husks
- washing
- sorting/culling
- grading
- sifting/filtering
- threshing
- shelling
- curing/drying/dehydrating that does not create a distinct commodity (curing garlic, winter squash, onions, potatoes, sweet potatoes, etc.)
- cooling and hydro-cooling
- weighing
- packaging in consumer containers
- labeling and stickering containers and individual produce items
- bunching
- braiding (garlic)
- blending different lots of the same RAC together
- mixing different intact RACs together in a container
- repacking
- waxing
- using pesticides in wash water
- fumigating during storage
- loading for transportation
- holding/storing previously frozen items
Note: Cutting/slicing/crushing RACs after the initial harvesting, trimming and shelling/threshing activities listed above—i.e. cutting through the intact leaf, skin or flesh of a RAC—and freezing RACs (as opposed to keeping previously frozen items frozen) are NOT harvesting, packing or holding, and so those activities may be regulated under the PC Rules.
5. What if I meet FDA’s ‘farm’ requirements, but I also perform activities on food that are not listed in the definitions above?
Farms that manufacture foods on the farm, in addition to conducting the farming activities covered above, fall into a special category: a ‘farm mixed-type facility’. The food manufacturing activities may be regulated under the PC Rule, but the farming activities as described above in Questions 2, 3 and 4 are not. See the FSMA FAQ Sheet ‘Are You a Farm Mixed-Type Facility?’ to learn more about the PC Rule and Farm Mixed-Type Facilities.
6. What if my produce business only performs the harvesting, packing and holding activities listed above, but is not located on a PPF and is not majority owned by a farmer or farmers?
Non-farm businesses that pack, hold and store produce RACs may be facilities under FSMA, and may be covered by the Preventive Controls Rule for Human Food. See the FSMA FAQ Sheet ‘Is Your Produce-Packing Operation Covered by the Preventive Controls Rule for Human Food?’