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Adopt Best Practices To Minimize Cronobacter & Salmonella Risks

While not a new concern, recalls due to Cronobacter and Salmonella have prompted the CDC to add Cronobacter to its national list of reportable conditions1 and the FDA to issue a call-to-action to suppliers and manufacturers2 to increase focus on risk mitigation efforts.

To meet this call-to-action, low-moisture manufacturers and suppliers of ingredients and raw materials are highly encouraged to adopt best-in-class quality processes to minimize risk of Cronobacter contamination, Salmonella, and other microbiological hazards.

 

The Recommendation

Control Water In Dry Production Areas

Why: Reducing water in dry production environments for low moisture foods is essential to controlling environmental contamination.

How: Monitor Enterobacteriaceae (EB) populations on surfaces in dry production areas — presence of EB is an indicator that unexpected water may have been introduced.

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The Recommendation

Verify Effectiveness Of Controls Through Environmental Monitoring

Why: An environmental monitoring program (EMP) that covers all stages of processing can help ensure that the product does not become adulterated by microorganisms in the formula or in the processing environment.

How: Set up an EMP with a risk-based approach that directly tests for Cronobacter spp. and Salmonella within the processing environment.

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The Recommendation

Implement Corrective Actions When A Pathogen Is Found

Why: Corrective action plans are required under 21 CFR 106.6(c) and help determine the root cause of the problem and prevent affected products from entering the market.

How: Implement thorough Root Cause Investigations (RCIs) that utilize whole genome sequencing (WGS), which can provide the most complete information available about your facility.

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The Recommendation

Implement Effective Supply Chain Controls For Biohazards

Why: The supply chain for low-moisture foods such as powders and ingredients has complex and diverse risk profiles and kill steps.

How: Suppliers must implement their own risk mitigation processes, which manufacturers should verify. Manufacturers should always inform their suppliers of the intended use of raw materials and ingredients.

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The Recommendation

Identify All Relevent Biological Hazards

Why: In addition to Cronobacter spp., there are other dangerous pathogens associated with low-moisture food and ingredient production processes, including Salmonella.

How: Evaluate mitigation processes across the board for Cronobacter spp, Salmonella, and all pathogenic bacteria.

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Related Resources

References:

1. “Cronobacter to Be Added to the List of Nationally Noti able Diseases.” Food Safety RSS, Food Safety, 30 June 2023, www.food-safety.com/articles/8713-cronobacter-to-be-added-to-the-list-of-nationally-noti able-diseases.

2. FDA Letter Calling for Enhanced Safety Measures to the Powdered Infant ..., www.fda.gov/media/166044/download. Accessed 2 Nov. 2023. 

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