By Jack van der Sanden, International Food Safety Consultant, bioMérieux

In an industry where safety and compliance are not just priorities but also necessities, the introduction of Food Safety Modernization Act (FSMA) Section 204 has set new benchmarks. As the deadline of January 2026 inches closer, the need for a comprehensive and effective approach to achieving compliance is paramount. Enter FoodReady—your ultimate partner in not just meeting, but also excelling, in FSMA 204 compliance.

Pathogens such as Listeria monocytogenes, Salmonella, and E. coli are among the primary causes of foodborne illness outbreaks. These microorganisms can cause severe public health issues and damage company reputations, resulting in substantial financial losses. In some cases, outbreaks have led to fatalities, underscoring the critical importance of Environmental Pathogen Management (EPM) in food manufacturing. A good EPM program is designed to detect pathogens early in the production environment, minimizing contamination risks to product.

Key Reasons to Implement an EPM

Three primary reasons to implement an environmental pathogen management system are:

1. Regulatory compliance and global standards: The Food Safety Modernization Act (FSMA) emphasizes proactive food safety measures, setting a global benchmark for environmental monitoring standards. This regulatory shift requires facilities to implement an environmental monitoring program. EPM helps companies meet these evolving standards and regulations.
2. Proactive risk mitigation: EPM serves as an early warning system, enabling food facilities to address contamination risks before they impact products and consumers. Many food safety outbreak investigations have shown that the pathogens that caused an outbreak were well established in the factory environment. This suggests that a good environmental monitoring program can signal the risk of product contamination in advance.
3. Enhanced traceability and accountability: Advances in tracing technologies like whole genome sequencing (WGS) can link contamination to specific products and manufacturing locations. This increased traceability has heightened consumer expectations and accountability for food companies. Through WGS, regulators have successfully linked pathogen detections in patients, products, and facilities, providing hard evidence for prosecution.

Pathogen Testing Considerations and Effective Management Strategies

There are some important considerations when implementing an EPM program, particularly around testing accuracy and response timing. Some of these considerations include:

1. Using rapid testing for timely responses: Traditional pathogen tests take days to produce results, affecting production flow and causing delays. Rapid testing technologies like GENE-UP^® can produce results in under 24 hours, improving the ability to respond to detections. However, a fast result alone is insufficient; a predetermined response plan must be in place to ensure timely corrective action.
2. Handling false positives and negatives: Pathogen testing may yield false positives (detecting pathogens when none are present) or false negatives (failing to detect actual pathogens). False positives can lead to costly recalls, while false negatives may allow contaminated products to reach consumers. Reliable, accredited testing methods, along with strict sampling and handling protocols, are essential to minimize these risks.
3. Avoiding complacency with low-level positives: In some facilities, recurring, low-level pathogen positives may become normalized, leading to complacency. Treating these detections as minor issues can allow contamination risks to grow. Each positive result should prompt corrective actions to prevent small problems from escalating into significant issues and outbreaks.

Creating a Risk-Based and Targeted Pathogen Hunt Strategy

Effective EPM requires a planned and structured approach to pathogen monitoring, focusing on high-risk zones rather than random sampling, and careful selection of the sampling points. Key elements of this strategy include:

1. Pathogen selection: Monitoring must focus on the highest-risk pathogen associated with the product, like Listeria monocytogenes in soft cheeses and Salmonella in low-water-activity (A_w) products.
2. Proximity to product: Sample points should be chosen based on their closeness to food contact surfaces. For example, swabbing food processing equipment and nearby areas represent an increased risk to the product versus distant floors or walls.
3. Process steps: Facilities with validated "kill steps" like pasteurization should focus sampling efforts in "post-kill" areas, where pathogens could re-enter after the kill step. Sampling should be more frequent in these high-risk zones.
4. Risk matrix: Combining proximity and process steps into a risk matrix helps facilities prioritize sampling in areas most likely to harbor pathogens, improving both efficiency and safety.
5. Sample points: Selecting the right sample points is crucial. Environmental monitoring must use a "seek" approach, and sample points should be picked based on the likelihood of microbial harborage.

Response Protocol for Positive Pathogen Detections

When a pathogen is detected, an effective response plan is essential to contain and eliminate contamination. The response plan should outline actions based on the severity and location of contamination, enabling a good root cause analysis and preventing the spread of contamination.

1. Traceback sampling: The purpose of traceback sampling is to try and find the contamination source. Sampling surrounding areas may also help to map the contamination’s extent and offer insights into how pathogens may spread within the facility. Traceback sampling must happen before cleaning and sanitizing the area.
2. Intensive cleaning and sanitation: Following the traceback sampling, facilities should have deep-cleaning protocols for contaminated areas. Verification sampling is required to confirm that contaminants have been removed. Documenting these actions ensures compliance and transparency.
3. Continuous improvement and monitoring: EPM is an ongoing process; each detection is an opportunity to enhance practices. Reviewing traffic flow, equipment hygienic design, and production records should be part of a response plan. Implementing corrective actions based on these reviews reduces the risk of re-contamination.

Conclusion

EPM offers a proactive framework for maintaining food safety, minimizing contamination risks, and preventing costly recalls. By integrating risk-based monitoring, rapid testing, and structured response protocols, food manufacturers can better anticipate and mitigate hazards. As regulatory standards and consumer expectations continue to evolve, EPM becomes even more essential to the food industry. Positive detections should be seen not as failures, but as opportunities to reinforce systems, ensure consumer safety, and strengthen food supply resilience.

Jack van der Sanden is an International Food Safety Consultant with bioMérieux. He has been part of the global food industry for over 40 years and has managed production, technical, and food safety and quality teams. This cross-functional exposure has enabled him to find pragmatic solutions that have strengthened food safety and quality systems in different multinational organizations. During the past 10 years, he has specialized in Environmental Pathogen Management (EPM) and advised food industries in the design of preventive and effective EPM programs.