First identified in the 1920s as a zoonotic disease, Listeria monocytogenes (Lm) was not recognized as a foodborne pathogen until it was linked to a contaminated coleslaw outbreak in Canada in the 1980s. Today, an estimated 1,600 people in the US become ill from Listeria annually. Add to that the nearly 3,000 cases reported in the EU in 2023 – the highest since the start of ECDC surveillance – and it is evident why new Lm directives, guidance, and regulations are being issued globally.
With listeriosis being a serious and potentially fatal illness, particularly for pregnant women, newborns, older adults, and people with weakened immune systems, Lm contamination of food holds a critical need for control, which is gaining an ever-increasing focus of regulatory attention.
In the US
FSIS has issued an updated directive on Testing for Non-Listeria Monocytogenes (Lm) Listeria Species (FSIS Notice 08-26), instructing inspectors to test for non-Lm Listeria species in RTE facilities. In doing so, if a sample is found to be positive for non-LmListeria spp. but negative for Lm, the establishment must still take corrective actionsper the 9 CFR 416.15 sanitation SOPs to prevent Lm harborage and cross-contamination to product. This is being changed because:
- a non-Lm Listeria spp. finding in a product, food contact surface, or environmental non-food contact surface indicates that the sanitation program is ineffective at preventing conditions where contamination with Lm may occur to contaminate and adulterate product.
- conditions that allow Listeria spp. to thrive in a production facility (such as on floors, in drains, or in standing water) can also allow Lm to thrive there.
- sanitation and employee hygiene practices that allow Listeria spp. to cross-contaminate processing equipment, gloves, aprons, and product can also allow Lm contamination.
This section makes it very clear that actions are expected to be taken with any finding of a Listeria species isolate from a food contact or non-food contact site – even when no Lm is found.
In the EU
In the European Union (EU), the European Commission has amended (EC) No 2073/2005 on microbiological criteria for foodstuffs, and new guidances have been issued by the Food Safety Authority of Ireland and the Chilled Food Association of the UK – all focused on reducing the danger of Listeria contamination in RTE foods able to support the growth of Listeria (other than those intended for infants and for special medical purposes which are regulated by (EC) No 2073/2005).
- The (EC) No 2073/2005 regulation currently requires that Lm not be detected in 25g of an RTE food before it has left the immediate control of the producing food business, unless the business can demonstrate that the Lm level will not exceed 100 cfu/g throughout the shelf-life of the food. Because this does not provide criterion for the products once they’ve left the control of the business, the new amendment states that for RTE foods able to support the growth of Lm: “the food safety criterion ‘Listeria monocytogenes not detected in 25 g’ should apply to all situations where those foods are placed on the market during their shelf-life and for which the producing food business operator has not been able to demonstrate, to the satisfaction of the competent authority, that the level of Listeria monocytogenes will not exceed the limit of 100 cfu/g throughout their shelf-life.”
- To help businesses in the EU and other jurisdictions applying EU law, including Northern Ireland, prepare for the new requirement, the Chilled Food Association (CFA) has published new guidance. While there are no changes to fundamental legislated food safety assurance requirements including shelf-life determination, the CFA stated that the guidance brings “practical clarity to the steps manufacturers and other FBOs must take to assure the safety of RTE foods with respect to L. monocytogenes including how to establish and evidence shelf life.”
- In follow-up, the Food Safety Authority of Ireland (FSAI) published Guidance Note 45 on Environmental Monitoring of Lm in RTE Food Business Operation to help RTE food businesses meet the EC regulatory requirements. The FSAI states that although the regulation specifies that the processing area and equipment be sampled for Lm, it does not provide a microbiological criterion to assess the test results or provide information on actions to take when Lm is detected in the operation’s environment. Thus, the Ireland guidance provides best practice advice on development of a robust Lm environmental monitoring program, including recommended actions to be taken in the event of a detection.
What is the takeaway from all this? That Listeria presence, particularly in an RTE facility, is becoming an increasingly important issue worldwide. Regulations are becoming more stringent, and food facilities need to become just as stringent in your environmental monitoring and control programs. While the finding of non-Lm Listeria spp. does not necessarily indicate a contaminated food, it is an indicator of potential Lm harborage sites and should be seen as a signal for intensive cleaning – a practice encouraged by the regulatory bodies.
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