Protecting families from contaminated food and water
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Protecting families from contaminated food and water
Posted in Food Policy,Our Blog,Outbreaks & Recalls on September 3, 2026
The recent update to the Fresh-Cut Produce operations rules have been a work in progress since the last update since 2018. The current document would replace the existing rules, which have been effective since 2008. This new attention on ready-to-eat fresh-cut produce comes at a turbulent time. Between Cyclospora in lettuce, Salmonella in jalapenos, and both Salmonella and E. coli in sprouts, the U.S. Food and Drug Administration (FDA) has garnered some attention.
So, what does this update entail and what changes have been made since 2008? Is the program strengthened or relaxed and who does it apply to?
Here’s what we know so far about the FDA’s new fresh-cut produce operations guidance and what it might mean for the consumer!
On August 11, 2026, the FDA issued a statement regarding the release of their new ready-to-eat fresh-cut produce operations guidance document.
This document reflects public comments received on the October 2018 draft guidance and replaces the existing 2008 FDA fresh-cut produce guidance.
It primarily focuses on preventative measures and improving food safety practices to ensure a safer food supply.
“This guidance represents the agency’s current thinking on the issues related to preventing contamination in fresh cut produce. The agency encourages the industry to continue advancing and improving food safety practices, including through the development and implementation of Best Practices documents tailored to their specific commodities and processes.”
The bulk of the guidance is just that.
Guidance.
It narrows the scope of what is covered. But mostly, it provides more clear examples of how processors can better comply with the existing Food Safety Modernization Act Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventative Controls rule.
What makes fresh-cut produce different from other farm-to-fork foods?
Yes, intact produce (especially leafy greens) are vulnerable to microbial contamination. But cut-produce operations provide additional risks.
In addition to the growing environment and transportation, there is potential for these products to be “commingled” with other products and susceptible to refrigeration deviations which could compound the contamination problem.
Additionally, ready-to-eat fresh-cut produce does not undergo a pathogen-killing heat step designed to eliminate potential biological hazards.
So, what counts as fresh-cut produce?
According to the guidance, “fresh-cut produce includes any fruit or vegetable that has been physically altered from its whole state (e.g., by chopping, dicing, peeling, shredding) without additional processing (such as freezing or cooking) and distributed in fresh form.”
Specific examples include cut cantaloupe, chopped lettuce, diced onions, and shredded carrots.
Additionally, this guidance does not simply apply to single produce products. Products containing cut produce must also comply with this new guidance. Things like fruit salad (containing cut melons) and coleslaw.
A noteworthy aspect of the new Ready-to-Eat Fresh-Cut Produce operations guidance is the exemption of certain foods and facility types.
The “scope” is narrowed to ready-to-eat fresh-cut fruits and vegetables with a water activity level above 0.85. This level is specifically indicated because the moisture content is high enough to support microbial growth.
Enforcement of this new fresh-cut produce guidance also does not apply to “on-farm manufacturing/processing activities conducted by a small or very small business for distribution into commerce.”
The guidance doesn’t explicitly say what defines a small or very small business. However, other documents like the Food Safety Modernization Act (FSMA), a related document, does.
A small business is one that employs fewer than 500 full-time employees. A very small business averages less than $1,000,000 in market value of food per year during the three-year period processing the applicable calendar year.
Some of the major points of the fresh-cut produce operations guidance involve existing FSMA and Good Manufacturing Practices topics. These aspects are covered in Section C (Hazard Analysis and Risk-Based Process Controls) and Section G (Supply Chain Program).
The Hazard Analysis and Risk-Based Preventive Controls aspect of the fresh-cut produce guidance involves a food safety plan, a hazard analysis, and prevention controls.
A Food Safety Plan is a required written document and record drafted, maintained, and monitored by a preventative agent. It includes the hazard analysis and preventative controls in compliance with the FSMA and good manufacturing practices specifically designed around the products produced by the facility.
The Hazard Analysis is a written document that accounts for “reasonably foreseeable hazards” for each type of food manufactured, processed, packed, or held at the facility. It anticipates where things might go wrong so that preventative measures can be anticipated and in place to prevent them. Biological, chemical, and physical hazards must be accounted for whether they are accidentally or intentionally encountered.
Once hazards are identified, preventative controls must be explicitly documented. These controls should significantly minimize or control risks identified in the hazard analysis. These may include but are not limited to written process controls, food allergen controls, sanitation controls and supply chain controls. Recall plans are also included in this document.
A written Supply Chain Program was also noted in the updated fresh-cut produce operations guidance.
This involves not only regularly evaluating approved vendors (including verifying foreign vendors) and determining if each ingredient shipment is in compliance and appears intact and unadulterated, it must also be revisited often to ensure ingredients meet safe criteria.
One of the major problems people have expressed with this new fresh-cut produce operations guidance is that it is fairly vague, redundant with the FSMA, and by it’s own admission, is not enforceable.
“FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe our current thinking on a topic and should be viewed only as recommendations, unless regulatory or statutory requirements are cited. The use of the word ‘should’ in FDA guidance means that something is suggested or recommended but not specifically required.
So, what exactly does this mean for consumers?
At the consumer level, not much changes. There is no major change in safety requirements. Most of the guidance mirrors existing FSMA and Good Manufacturing Practices already in place. It does, however, loosen regulation on smaller businesses. Allowing them to process these foods at their own facilities without a major infrastructure.
Reducing reliance on large-scale processing facilities could reduce the risk of cross-contamination. However, adding a significant number of small (or very small) businesses with minimal oversight could also put consumers at risk for foodborne illness.
Only time will tell how these relaxed categories will impact food safety in the United States.
If you’d like to know more about food safety topics in the news, like “FDA Finalized Guidance for Ready-to-Eat Fresh-Cut Produce Operations. What Has Changed?,” check out the Make Food Safe Blog. We regularly update trending topics, foodborne infections in the news, recalls, and more! Stay tuned for quality information to help keep your family safe, while The Lange Law Firm, PLLC strives to Make Food Safe!
By: Heather Van Tassell (contributing writer, non-lawyer)