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.


2.       What is a Primary Production Farm?

A Primary Production Farm is an operation:

  1. in one general area, although it may include multiple non-contiguous parcels,
  2. with the principal focus of growing or harvesting crops, 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 your 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 your packing operation is part of a Primary Production Farm, it is not a ‘facility,’ so the PC rule doesn’t apply.  However, 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 an establishment:

  1. not located on a Primary Production Farm;
  2. majority-owned by the operator of a Primary Production Farm, or by multiple Primary Production Farm operators together;
  3. where the Primary Production Farms of the majority-owner or owners also provide the majority of the RACs handled by the establishment;
  4. 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.

What it means: A farmer cooperative or farmer-owned packing operation 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 the same the harvesting, holding and packing activities as a Primary Production Farm and still be treated as a farm.  A Secondary Activities Farm 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?

Operations that manufacture foods on the farm, in addition to the conducting 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?’ COMING SOON


DOWNLOAD THE FULL FACT SHEET: Is Your Produce-Packing Operation Covered by the Preventive Controls Rule for Human Food? (pdf)