FSIS Is Watching More Than Listeria monocytogenes. Are You?

How Hygiena^® BAX^®, KLEANZ^®, UltraSnap^®, and SureTrend^® Data Management Platform Support Sanitation Corrective Action Under FSIS Notice 08-26 

The Food Safety and Inspection Service (FSIS) is the public health agency of the USDA that enforces safety standards for meat, poultry, and egg products. FSIS issues notices that set expectations for establishments and inspection of program personnel. One such notice is FSIS Notice 08-26, Testing for Non-Listeria monocytogenes (Lm) Listeria Species, which explains an expanded focus on all Listeria species, not just Lm. FSIS now tests non-Lm Listeria in environmental samples, food contact surfaces, and product, reporting findings directly to establishments and inspection personnel. This expanded reporting applies to FSIS sampling projects that already test for Lm in ready-to-eat (RTE) meat, poultry, and egg products, including product, food-contact surface, and environmental (non-food-contact) surface samples from post-lethality exposed RTE areas.  

With FSIS’s updated testing method and inspection instructions, findings of non-Lm Listeria species are treated as evidence that sanitation controls may be ineffective because FSIS indicates that, in well-controlled post-lethality exposed RTE environments, effective sanitation should prevent any Listeria spp. from being detected.  

For food safety teams, this means moving from pass-fail testing to a proactive focus on environmental monitoring, sanitation verification, trend tracking, and documented corrective actions. Importantly, FSIS may still classify an overall sample result as “acceptable” when Lm and Salmonella are negative (even if a non-Listeria spp. is detected). However, establishments are still expected to take corrective actions and document them. 

Why non-Lm Listeria Matters More Than Ever 

FSIS Notice 08-26 highlights that well-controlled sanitation programs should not allow any Listeria species to persist in product or the processing environment. In practical terms, FSIS uses non-Lm findings as an early indicator of conditions that could also allow Lm to persist or spread in the post-lethality exposed RTE environment.  

Non-Lm Listeria species such as Listeria innocua, Listeria welshimeri, Listeria seeligeri, and Listeria grayi do not, by themselves, make product adulterated. However, their presence can signal weaknesses in sanitation controls. FSIS laboratories began testing environmental and food contact surface samples for these non-Lm species in addition to L. monocytogenes under the regulatory sampling projects described in the notice. FSIS may report the specific non-Listeria monocytogenes species detected and, in some cases, classify results as “indeterminate” when the method cannot confirm the species name.  

Although FSIS does not label non-Lm species as adulterants, repeated non-Lm findings can lead to more scrutiny from inspection program personnel and may trigger follow-up actions such as directed verification or Food Safety Assessments. FSIS also notes that inspectors generally are not expected to issue a noncompliance record (NR) solely because non-Lm was detected. Still, an NR may be issued if required sanitation corrective actions are not taken or are not effective. 

What FSIS Expects Establishments To Do 

Notice 08-26 reinforces that sanitation is the basis for Listeria control. When non-Lm Listeria is found, establishments are expected to comply with regulatory requirements under 9 CFR 416.15. This includes identifying sanitation failures, restoring sanitary conditions, monitoring results over time, recognizing trends, and documenting corrective actions and verification. Corrective actions are expected even when non-Lm Listeria is found on non-food-contact environmental sites (e.g., floors, drains), because the same conditions that support non-Lm Listeria can support Lm harborage and cross-contamination. 

FSIS verification procedures for Listeria control programs remain focused on environmental monitoring design and execution that supports regulatory compliance. Various FSIS directives specify expectations for verifying environmental sampling plans and corrective actions for Listeria risk factors. In many cases, non-Lm Listeria findings are handled through Sanitation SOP corrective actions (9 CFr 416.15) rather than HACCP corrective actions unless an establishment has specifically identified Listeria spp. as a hazard requiring a CCP in its hazard analysis. 

Meeting these expectations requires effective sample collection, sensitive detection, and defensible data management that turns results into actionable insights. 

Start with the Right Sample: Stick Sponge^™ and Sponge N Bag^™ 

A Listeria control program is only as strong as its environmental samples. Hygiena’s Stick Sponge^™ and Sponge N Bag ^™ products help support thorough environmental monitoring across food contact, non-food contact, and hard-to-reach locations in facilities. 

These sampling tools help establishments to: 

• Collect consistent and representative samples from drains, floors, equipment, and niches
• Reach difficult areas without compromising sample integrity
• Standardize sampling practices across shifts and sites
• Improve confidence that results reflect actual environmental conditions 

Environmental monitoring that misses potential harborage sites can fail to detect the conditions FSIS regards as risky, including the persistence of non-Lm Listeria species. This is especially important in post-lethality exposed RTE zones, where sanitation performance is foundational to Lm control.  

UltraSnap^® for Immediate Sanitation Verification 

UltraSnap ATP testing provides immediate feedback on cleaning effectiveness. This rapid sanitation verification helps facilities to: 

• Detect sanitation failures in real time
• Understand cleaning effectiveness across areas of concern
• Reduce conditions that allow Listeria species to persist
• Support corrective actions required by sanitation control regulations 

ATP testing can be a useful rapid verification tool for cleaning effectiveness and can help target improved sanitation. It should be used in tandem with robust microbiological environmental monitoring. 

BAX^® System for Confident Listeria Detection 

When microbiological confirmation is needed, BAX System real-time PCR assays provide reliable detection of both Listeria monocytogenes and non-Lm Listeria species. 

Under FSIS Notice 08-26, FSIS laboratories now test for and report non-Listeria monocytogenes Listeria in addition to L. monocytogenes. Importantly, the FSIS regulatory method includes Listeria grayi, and findings of this organism are reported by FSIS laboratories just like other non-Lm species. 

While Listeria grayi is discussed less often, it occupies the same environmental niches as L. monocytogenes and signals the same underlying sanitation risks. Its detection is therefore highly relevant to FSIS verification and trend-based assessments. 

BAX System PCR assays are designed to detect the same breadth of Listeria species that FSIS reports, including Listeria grayi. This alignment between establishment testing and regulatory laboratory methods is critical for effective environmental monitoring and for avoiding gaps between internal results and FSIS findings. 

BAX System testing supports: 

• Environmental monitoring programs
• Verification of food contact surfaces
• Root cause investigations
• Early detection of non-Lm Listeria species, including Listeria grayi, that FSIS may also identify 

Having testing methods that capture the same species reported by FSIS laboratories helps reduce surprises, strengthens trend analysis, and supports confident, proactive corrective action. 

SureTrend ^® for Trend Analysis and Documentation 

FSIS Notice 08-26 places strong emphasis on repeated non-Lm Listeria findings and trend analysis rather than single positives. Establishments need systems that can consolidate data, visualize patterns, and support documentation for verification processes. 

SureTrend Data Management Platform connects data from sample collection, ATP sanitation verification, and PCR results to enable establishments to: 

• Automatically capture and store results
• Trend data by zone, line, site, organism, or time
• Identify emerging risks early
• Document corrective actions and verification measures
• Demonstrate ongoing sanitation control during FSIS assessments 

This kind of trend awareness aligns with FSIS expectations for documented evidence of control effectiveness. Trend reporting is particularly valuable when establishments see repetitive non-Listeria monocytogenes findings, which FSIS describes as a potential indicator of an ineffective Listeria control program and a trigger to evaluate sanitation program design and maintenance. In these cases, tools such as KLEANZ® sanitation management software can be used to verify sanitation corrective actions in real time and support documented follow-up. 

A Proactive, FSIS-Aligned Listeria Control Strategy 

Hygiena’s solutions support an environmental monitoring approach aligned with FSIS Notice 08-26: 

1. Collect representative environmental samples using Stick Sponge and Sponge N Bag
2. Verify sanitation effectiveness with UltraSnap ATP testing
3. Detect Listeria species with BAX System Real-Time PCR Assays
4. Analyze trends and document actions with SureTrend Data Management Platform  
5. Correct issues before they escalate into regulatory findings 

This layered approach supports early detection and proactive management of environmental risks that matter to FSIS. 

Don’t Let FSIS Find What You Could Have Found First 

FSIS is now focused on the presence of any Listeria species in environments where sanitation must be effective. Facilities that succeed under Notice 08-26 are those that sample thoroughly, detect broadly, trend intelligently, and document control clearly. 

Using integrated tools, such as Stick Sponge, Sponge N Bag, UltraSnap, BAX, and SureTrend, helps you build a Listeria control program aligned with FSIS expectations and prepared for increased regulatory scrutiny. 

If your program does not routinely detect non-Lm Listeria, does not align with FSIS testing methods, and does not trend results over time, your facility may be managing risk with incomplete information. For imported RTE product sampling, FSIS indicates that when Lm and Salmonella are negative, shipments are generally released even if non-Lm Listeria is detected; however, results may still be communicated through official channels.  

Hygiena helps you stay one step ahead of FSIS findings.