FDA Releases Guidance for Fresh-Cut Produce, Calls on Food Industry to Improve Safety Practices

Amid ongoing Salmonella and Cyclospora outbreaks linked to fresh produce, the U.S. Food and Drug Administration on Tuesday finalized guidance for manufacturers and processors of fresh-cut produce to help mitigate the risk of food contamination.

These include measures such as stricter supplier verification, antimicrobial wash of produce, sanitary plant design, refrigeration, and improved hygienic practices for employees, among others.

The new recommendations, which are not legally binding, apply to “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,” the FDA said.

Examples given by the agency included chopped lettuce, cut cantaloupe, diced onions, and shredded carrots.

“Fresh-cut produce can be particularly susceptible to contamination, which can be introduced in the environment where it’s grown, during transport, during manufacturing, when it’s commingled with other products or at retail, and the opportunity for contamination can be amplified through each of these steps as it makes its way to consumers,” the FDA said.

The agency added that “fresh-cut produce does not receive a kill step to eliminate pathogens that may be introduced during these processes and most are sold ready-to-eat.”

The new guidance came as the public is facing an outbreak of Salmonella linked to jalapeño peppers and an ongoing Cyclospora outbreak linked to fresh iceberg lettuce that has widened to at least 13,895 laboratory-confirmed cases in 47 states. The outbreak has also resulted in at least 740 hospitalizations and 2 deaths.  

FDA Acting Commissioner: Public Should Feel Confident Eating Leafy Greens

In a Tuesday interview with CNBC, acting FDA Commissioner Kyle Diamantas said that the public “should feel confident in eating fresh produce including leafy greens at this point,” and stated that the U.S. has “the safest food supply in the world.”

Diamantas said that the FDA “remains confident that all iceberg lettuce related to the cyclospora outbreak has been effectively removed from the market.”

The statement came shortly before a post made by the Department of Health and Human Services on X in which it said “Cyclospora: contained, American food: safe.”

“Sanitation is Not Magic”

Similar to the multi-layered approach proposed by the FDA, food expert Tracy Fink said last week that food facilities must take a multi-layered approach to fighting pathogens.

In a Food Safety Magazine webinar titled “Beyond Sanitation: Understanding the Hidden System Conditions That Allow Pathogens to Persist,” Fink said contamination events are a “canary in the coal mine” that help identify where you have vulnerabilities. She also said that the sanitation program often addresses the contamination event itself, but doesn’t tackle the underlying conditions.

Fink, the Founder & Principal Advisor at ThinkFink Solutions, said that if contamination events continue despite sanitation, it can indicate “a system weakness and not a single failure, so our pathogen control requires layers.”

She said that facilities can’t silo their different safety departments, and need an integrated approach in which they all work together.

“You have to work together. You have to break down those verticals, and we need your integrated pest management working with your cleaning sanitation provider. We need them working with operations.”

Fink also laid out these different layers, which include:

• Hygienic equipment and facility design
• Effective cleaning and sanitation
• Environmental monitoring program
• Moisture and waste management
• Airflow and traffic pattern control
• Employee practices and GMPs
• Preventive maintenance
• Data trending and root cause analysis
• Complementary environmental control technologies

Fink said that companies need to take a data-driven approach and “you need to be working with your laboratory and testing providers. We need all of this holistically working together and not in a silo approach.”

Fink also described her "multi-hurled approach to food safety,” which includes preventing introduction, sanitation foundation, preventing recontamination, targeted intervention, and verification program.

And like so much in food safety, this collaboration is so crucial because the stakes are high.

“If we have recurring positives and we’ve reached the leadership team and they’re aware of it, the issue becomes operational, it becomes reputational, regulatory, and financial. And it can tarnish your brand image if you have an event or an incident.”