CFSA has previously featured information about what counts as a ‘facility’ for purposes of the Food Safety Modernization Act (FSMA) regulations proposed by FDA (Link).  The principle challenge in the facility concept is that it encompasses a huge portion of the low-risk activities farms, food hubs, and cooperative produce distributors normally conduct—for example storing, packing, holding and packaging fruits and vegetables; milling grains; and making maple or sorghum syrups.

Despite the low-risk nature of these activities, the FSMA Preventive Controls rule imposes on farms or food hubs that carry them out the same of standards of recordkeeping, facility design, sanitation, allergen labeling, and worker training as manufacturing plants with over 500 employees that cut meat, manufacture heat-treated foods, or process fresh-cut salads.

And how do we know what activities are actually a minimal threat for making people sick?  The FDA says so.  In a review published along with the actual rules, FDA accepted the conclusions of food safety scientists that dozens of activities applied to a wide variety of raw fruits, vegetables, grains, legumes and nuts are a low risk for causing foodborne illness.  So low that FDA specifically proposes that those activity-food combinations would not be covered by the Preventive Controls rule, if they take place on ‘small’ or ‘very small’ facilities that are located on farms.  Bizarrely, however, if those same foods undergo those same processes on a ‘medium’ or ‘large’ farm, or any size plant that is not on a farm, FDA proposes to regulate that business at the most stringent level possible.

Similarly, FDA recognizes in the FSMA proposed rules that when a farm packs, packages, stores, and transports the intact raw fruits and vegetables it grows, it is conducting normal farming activities that don’t trigger treatment of that farm as a food processing plant.  But when any produce item that a farm packs is from another farm, such as in a multi-farm CSA, suddenly that farm becomes a risk to public health and safety.  And if it’s a distinct business entity that does the packing and distribution, even if it never washes nor cuts through the skin of any produce items, that entity is by its nature a significant food safety threat, by FDA’s logic.  In effect, FDA treats a legal event—the change in the possession of a crop—as a safety hazard, despite all scientific evidence to the contrary.

The consequences of being treated as a ‘facility’ under the Preventive Controls rule are extensive.  A facility must, for example:

  • register with FDA;
  • have on staff an individual qualified to be a food safety compliance officer;
  • take steps to eliminate pathogens in grounds and parking areas around buildings even if crop handling activities do not actually take place there;
  • train all employees annually on food manufacturing safety, even if the work that takes place is not actually food processing; and
  • have a documented cleaning schedule for non-food contact surfaces

The very design of the facility and the equipment used within it must be premised on avoiding pathogen transfer, which in practice will mean seamless stainless steel food contact surfaces.

A business subject to the Preventive Controls rule must conduct a ‘hazard analysis’ of all its operations to identify potential food safety threats and steps to control them.  Several small farm operations across the nation conducting activities covered under the Preventive Controls rule have evaluated the costs of such a ‘hazard analysis and critical control point (HACCP) plan,’ and have found that this step alone can cost an business $10,000 to $20,000 in the first year alone.  The rules then require annual ‘verification’ that the plan is working, with records of this verification process and its findings.

The local food movement has seen this movie before.  The imposition of HACCP planning in the 1990’s in the meatpacking industry directly lead to a reduction in the number of small-scale meat processors that would work with independent farmers and ranchers.  There simply weren’t sufficient profits in the processing business to cover the costs of implementing HACCP.  Twenty years later, meatpacking is highly consolidated and vertically integrated, and meat and poultry are still major contributors to foodborne illness.  Only a tiny handful of processing plants can cater to independent pasture-based livestock producers, and the high costs for processing drain those farmers’ profits.  Do we want to see this same sad state of affairs in produce and value-added local food marketing?

It is critical for you to take action today and comment on these rules, before it’s too late.  The deadline for comments is November 15th.  The Feds need to know the impact that these rules will have on your farm, your business, and your community.  Whether you are a local food producer or supporter, FDA has to hear from you.  Visit the CFSA website’s FSMA action page,, to find out how to submit your comments today!