Fresh-Cut Produce Without a Kill Step: What FDA’s New Guidance Means for Processors

Fresh-cut produce is once again in the food safety spotlight.

FDA and CDC are currently investigating a multistate outbreak of Cyclospora illnesses linked to iceberg lettuce sourced from central Mexico and recalled by Taylor Farms de Mexico. The investigation is an important reminder of one of the fundamental challenges with ready-to-eat fresh-cut produce: contamination may enter the supply chain before processing, spread during handling and processing, and reach consumers without a subsequent kill step.

Against that backdrop, FDA finalized updated guidance on August 11, 2026, addressing biological hazards in ready-to-eat fresh-cut produce.

The new FDA Guidance for Industry: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce replaces FDA's 2008 fresh-cut produce guidance and finalizes a draft originally issued in October 2018.

The guidance is intended to help manufacturers and processors of ready-to-eat fresh-cut produce understand and apply applicable requirements under 21 CFR Part 117, including Current Good Manufacturing Practice and the Hazard Analysis and Risk-Based Preventive Controls for Human Food requirements.

For processors, there is an important distinction running throughout the document:

FDA guidance is not the same thing as regulation.

Understanding what is required, what FDA recommends, and what a facility's own hazard analysis determines is necessary is critical.

What Is Fresh-Cut Produce?

FDA describes fresh-cut produce as fresh fruits or vegetables that have been physically altered from their whole state through activities such as chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing without additional processing such as cooking, freezing, or canning. FDA also identifies fresh-cut produce as a processed food.

Examples include:

• Chopped lettuce

• Sliced cantaloupe

• Diced onions

• Shredded carrots

• Coleslaw mixes

• Fresh fruit salads

That distinction can matter for businesses that think of their operation as simply washing, cutting, and packaging produce.

Cutting is processing.

Once produce is processed and distributed ready-to-eat, the food safety system must reflect the hazards associated with the actual product and operation.

Cutting Changes More Than the Shape of the Product

Whole produce has a natural exterior barrier.

Cutting, chopping, shredding, slicing, peeling, or otherwise physically altering produce disrupts that barrier and creates new opportunities for contamination and microbial growth.

Cellular fluids and nutrients released during cutting may support pathogen survival or growth if contamination is present.

Processing can also spread contamination.

A small contamination event affecting only part of an incoming lot can potentially be distributed much more widely when produce is washed, mixed, shredded, conveyed, or commingled during production.

FDA's guidance addresses biological hazards including:

• Salmonella spp.

• Pathogenic E. coli

• Listeria monocytogenes

• Cyclospora cayetanensis

The central challenge is straightforward:

Many ready-to-eat fresh-cut products receive no later treatment capable of significantly reducing pathogens before consumption.

That places greater importance on preventing contamination and controlling its spread throughout the process.

Washing Produce Is Not a Kill Step

This is one of the most important practical lessons in the guidance.

Produce washing and antimicrobial wash-water controls can play an important role in fresh-cut operations, but washing should not automatically be interpreted as pathogen elimination.

FDA explains that antimicrobial substances used in wash water may help control microorganisms released from contaminated produce into the water and reduce the potential for that water to transfer contamination to other product.

That is different from significantly reducing pathogens already attached to, or internalized within, the produce itself.

Wash-water control and product lethality are not the same thing.

This distinction becomes especially important in systems where large quantities of product move through common or recirculated water.

Processors need to understand what the wash system is intended to accomplish.

Questions may include:

• What hazard or process condition is the wash step intended to control?

• What operating parameters are necessary?

• How are antimicrobial concentration, pH, organic load, and other relevant conditions managed?

• How frequently are operating parameters monitored?

• What happens when established parameters are not met?

• Could the water itself become a vehicle for cross-contamination?

FDA's guidance provides practical examples involving antimicrobial wash systems, including sodium hypochlorite and peracetic acid.

The larger lesson is not that every processor must use a particular chemical or wash system.

It is that a processor must understand the function of the process it is relying on and support the controls identified through its hazard analysis.

Start With the Hazard Analysis

For facilities subject to the Preventive Controls for Human Food requirements, the hazard analysis remains the foundation.

The facility must identify known or reasonably foreseeable biological, chemical, and physical hazards and determine whether any require a preventive control.

For a ready-to-eat food that is exposed to the environment before packaging and does not receive a later treatment or control measure capable of significantly minimizing an environmental pathogen, the hazard evaluation must include consideration of environmental pathogens.

For fresh-cut produce operations, that evaluation may include:

• Incoming produce

• Cutting and processing

• Wash systems

• Product commingling

• Food-contact surfaces

• Employee practices

• Sanitation

• Environmental pathogens

• Cross-contamination

• Time and temperature

• Storage

• Packaging

• Transportation

The conclusions will not necessarily be identical from one facility to another.

The hazard analysis must reflect the actual product, ingredients, process, equipment, facility, intended use, and operating conditions.

When a Hazard Requires a Preventive Control

When a facility subject to PCHF determines that a hazard requires a preventive control, that determination carries regulatory responsibilities.

Under 21 CFR 117.135, the facility must identify and implement preventive controls capable of significantly minimizing or preventing the identified hazard.

Those preventive controls must be written.

Depending on the hazard and operation, controls may include:

• Process controls

• Sanitation controls

• Supply-chain controls

• Food allergen controls

• Other appropriate controls

Applicable preventive controls are also subject to preventive control management components, including monitoring, corrective actions, and verification, as appropriate.

This is where carefully reading FDA guidance becomes especially important.

"Should" and "Must" Do Not Mean the Same Thing

FDA makes this distinction explicitly.

FDA guidance documents describe the agency's current thinking. They do not, by themselves, establish legally enforceable responsibilities unless the guidance is referencing a requirement established by statute or regulation.

When FDA uses the word should in guidance, the agency means that the practice is suggested or recommended.

That does not make the underlying regulations optional.

When Part 117 requires an activity, the facility must comply with that requirement if it applies to the operation.

For example, when applicable:

• A facility must conduct a hazard analysis.

• Hazards requiring preventive controls must be addressed through appropriate controls.

• Required preventive controls must be written.

• Applicable monitoring, corrective action, and verification requirements must be implemented.

• Supply-chain program requirements must be followed when they apply.

The guidance then provides recommendations, examples, and approaches that may help processors meet those responsibilities.

A processor should not accidentally turn every FDA recommendation into a universal regulatory requirement.

But a processor also should not see the words Contains Nonbinding Recommendations and conclude that the underlying food safety obligations are optional.

The Processing Environment Matters

Contamination does not only originate upstream.

Once ready-to-eat produce enters the processing environment, the facility itself becomes part of the food safety system.

Food-contact surfaces, employees, equipment, water, drains, traffic patterns, condensation, cleaning practices, and facility design can all create opportunities for contamination or cross-contamination.

This is particularly important when considering Listeria monocytogenes in an exposed ready-to-eat processing environment.

Where the hazard analysis determines that L. monocytogenes is a hazard requiring a preventive control, sanitation controls and associated verification activities may become an important part of the food safety plan.

Environmental monitoring may also be required as verification of sanitation controls when applicable under Part 117.

This is also why hygienic equipment and facility design matter.

A written food safety plan cannot continually compensate for equipment that cannot be effectively cleaned, uncontrolled water movement, poor traffic patterns, difficult-to-access food-contact surfaces, or facility conditions that repeatedly create contamination opportunities.

Temperature Still Matters

Fresh does not mean microbiologically inactive.

Fresh-cut fruits and vegetables frequently have high moisture, available nutrients, and other characteristics capable of supporting pathogen survival or growth under favorable conditions.

FDA's guidance therefore addresses time and temperature throughout processing, storage, and distribution.

Whether temperature is managed through CGMPs or identified as a preventive control depends on the product, process, hazard analysis, and regulatory applicability.

The important point is that "keep it cold" is not a complete food safety strategy.

The facility needs operating parameters appropriate to the product and process and, where temperature is relied upon as a preventive control, the required monitoring, corrective action, and verification activities.

Supplier Controls Still Matter, But They Are Only the Beginning

We recently explored upstream ingredient risk in our AskHACCP article, The Recall Is Upstream. Your Product May Still Be at Risk.

That lesson remains important here, but fresh-cut processing adds another layer of responsibility once the produce enters the facility.

Produce may arrive carrying contamination originating from growing, harvesting, packing, transportation, or another point in the supply chain.

Where a biological hazard requires a supply-chain-applied control, the applicable requirements of Subpart G must be addressed.

But receiving acceptable produce does not eliminate the need to evaluate what happens after it enters the operation.

The processor must also consider whether its own cutting, washing, handling, equipment, employees, environment, storage, and packaging could introduce contamination or spread contamination already present.

Supplier controls and in-plant controls are not interchangeable.

They are parts of the same food safety system.

What Should Fresh-Cut Produce Processors Do Now?

FDA's final guidance is not a replacement food safety plan.

It is an opportunity to compare an existing system against FDA's current thinking.

Fresh-cut processors may want to review:

• Product and process descriptions

• Hazard analyses

• Wash-water systems

• Antimicrobial controls, where used

• Scientific or technical support for operating parameters

• Sanitation controls

• Environmental monitoring programs, where applicable

• Employee hygiene and training

• Food-contact surface controls

• Hygienic equipment design

• Facility traffic and product flow

• Cross-contamination controls

• Time and temperature parameters

• Preventive control monitoring

• Corrective action procedures

• Verification activities

• Supplier controls

• Food safety plan records

Most importantly, the written food safety system must match what is actually happening on the production floor.

The Bigger Lesson

The current Taylor Farms investigation brings attention to fresh produce risk, but the issue is much larger than one company, one commodity, or one outbreak.

Ready-to-eat fresh-cut produce presents a particular food safety challenge because contamination may enter at multiple points, processing may amplify or spread that contamination, and the finished product may reach consumers without a subsequent kill step.

FDA's new guidance does not establish a universal checklist of mandatory controls for every fresh-cut operation.

It does provide processors with an updated and detailed look at the agency's current thinking on controlling biological hazards within the existing Current Good Manufacturing Practice and Preventive Controls framework.

For processors, the question is not simply:

"Do we wash our produce?"

The better questions are:

What biological hazards are reasonably foreseeable in our product and process?

Where can contamination enter or spread?

What does our hazard analysis determine requires control?

Which controls are regulatory requirements, and which practices are FDA recommendations?

Can we demonstrate that the food safety system is working as intended?

Those are the questions that build systems capable of holding when something goes wrong.

Questions about fresh-cut produce, preventive controls, or reviewing your food safety program? The AskHACCP Hotline provides free and confidential food safety and regulatory support to food businesses nationwide.