Operational procedure: Control response plan for the detection of Listeria in the ready-to-eat processing environment

Please be advised that this control response plan and the industry guidance on Control measures for Listeria monocytogenes in ready-to-eat foods have been revised to reflect the updated Policy on Listeria monocytogenes in Ready-to-Eat Foods (2023)

1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff on how to respond when Listeria species (Listeria spp.) or Listeria monocytogenes (Lm) is detected in an environmental sample taken on a food contact surface (FCS) or non-food contact surface (NFCS) in the ready-to-eat (RTE) processing environment.

This document is intended to be used in conjunction with Operational procedure: Control response plan for the presence of Listeria monocytogenes in a ready-to-eat (RTE) food product and the other guidance documents as referenced in section 3.0.

These procedures apply whenever Listeria spp. or Lm is detected in an environment sample during an inspection of a facility, CFIA sampling program, food safety assessment, or upon notification by a food business.

2.0 Authorities

Safe Food for Canadians Act (SFCA)
Safe Food for Canadians Regulations (SFCR)
Food and Drugs Act (FDA)
Food and Drug Regulations (FDR)

The inspection powers, control actions and enforcement actions authorized by the above legislation are identified and explained in the Operational guideline – Food regulatory response guidelines.

3.0 Reference documents

4.0 Definitions

Unless specified below, definitions are located in:

Listeria

Refers to any Listeria spp., including Lm

Persistence

Repetitive positive food contact surface testing results, for example, 2 positive results for Listeria spp. from the same production line (that is, using the same equipment) in the RTE food manufacturing environment within a short timeframe. This timeframe is operation specific and will vary based on factors such as production volume, production seasonality and testing frequency.

5.0 Acronyms

Acronyms are spelled out the first time they are used in this document and are consolidated in the Food business line acronyms list.

6.0 Operational procedure

Although the control response is presented in a linear format, in some scenarios the actions may repeated or be performed concurrently.

6.1 Conduct preliminary assessment

6.1.1 Confirm the validity of the reported assessment

Obtain and review the laboratory results. If a laboratory report is not available (analysis performed by a third party laboratory), obtain details of the environmental sampling and testing to verify that the correct assessment for compliance was made. Review the information in the laboratory report to assess whether :

an accredited laboratory performed the analysis
a recognized method from Health Canada's Compendium of Analytical Methods was used, for which the 'application' section of the method is appropriate for the intended purpose
the RTE food category made on the FCS was assigned according to figure 1: Categorization of ready-to-eat foods of Health Canada's Policy on Listeria monocytogenes in ready-to-eat foods (HC Listeria Policy) – category 1, 2 (2A or 2B), or the food is not subject to the HC Listeria Policy

When an accredited laboratory or a recognized method of analysis has not been used, consult the Operational Guidance and Expertise (OGE) Division using the established communication channels.

Note: licenced meat facilities eligible for export to the United States must treat all their RTE meat and poultry products and RTE production line(s) as category 1 RTE food. The response to the detection of Listeria spp or Lm on the FCS of their production line(s) should follow the 1 for the category 1 RTE foods.

6.1.2 Determine and initiate immediate next steps

It is important to perform environmental sampling to verify the presence of Listeria spp., on any FCS, since positive results could be indicative of the potential presence of Lm.

Table 1, below, identifies the immediate steps to be taken depending on whether Lm or Listeria spp. was detected and who conducted the sampling.

Table 1: Determination of immediate next steps
Scenario	Inspector action
Lm was detected on a FCS	notify supervisor, Regional Program Officer (RPO, if applicable) and the food business (if CFIA collected the sample) for samples collected by CFIA, document the lab result in the Digital Service Delivery Platform (DSDP) (see section 6.2.3) if product made on the same line or equipment has been or could have been distributed, including export, proceed to section 6.2.1 if product made on the same line or equipment is not distributed, proceed to the 3 steps in section 6.2.2
Listeria spp.^{Table Note 1} was detected on a FCS	notify supervisor, RPO (if applicable) and the food business (if CFIA collected the sample) for samples collected by CFIA, document the lab result in the DSDP (see section 6.2.3) if there is persistence of Listeria spp. and product made on the same line or equipment has been or could have been distributed, including export, proceed to section 6.2.1 if there is persistence of Listeria spp. and product made on the same line or equipment has not been distributed, or if there is no persistence of Listeria spp. proceed to the 3 steps in section 6.2.2
Listeria spp. or Lm detected on NFCS	notify supervisor, RPO (if applicable) and the food business (if CFIA collected the sample) for samples collected by CFIA, document the lab result in the DSDP (see section 6.2.3) follow up during normal Standard inspection process (SIP) inspection tasks

6.2 Conduct an incident response investigation

6.2.1 Conduct a food safety investigation

Initiate a food safety investigation (FSI) and consult the Operational guideline – Food incident response process (FIRP) for guidance. Open a case in the Issues and Management System (IMS) as per the IMS User Manual (accessible only on the Government of Canada networks – 1599661).

For RTE products manufactured on a line or in an environment from which Lm was detected or which has persistently tested positive for Listeria spp. and if the food business has not placed them under voluntary control or has distributed them without testing:

consider seizure/detention if there is reasonable grounds that the food business will not effectively hold potentially affected product
if the product has been distributed in Canada, use the information gathered during the FSI when notifying the RRC or ARC as per the established communication pathway
if the product has been exported to a market where it does not meet the foreign country's requirements, notify Food Import/Export Division (FIED) by submitting an urgent electronic Request for Action Form (eRAF) (accessible only on the Government of Canada network) to the OGE Division

If RTE products are also positive for Lm, refer to Operational procedure: Control response plan for the presence of Listeria monocytogenes in a ready-to-eat (RTE) food product for immediate next steps.

6.2.2 Conduct or continue an inspection of the food business

Conduct or continue the inspection of the food business to verify that the food business is responding appropriately to the detection of Listeria. To do this, follow the 3 steps below in order.

1. Refer to the Food preventive control and traceability inspection – Compliance verification of a system and the Standard Inspection Process (SIP) or Operational guidance : Food preventive control inspection – Implementation verification and follow 1 of these situations:

Table 2: Inspection action for different scenario of *Listeria* detection
Scenario	Inspection action
if Lm or 2 or more Listeria spp. detections were reported on a FCS by the food business during a preventive control (PC) and traceability inspection, including an Implementation verification task	continue the inspection but consider modifying or expanding the scope as needed proceed to step 2
if Lm or 2 or more Listeria spp. detections were reported on a FCS by CFIA during a sample collection or if CFIA was made aware of Lm or 2 or more Listeria spp. detections on a FCS outside of a sample collection or inspection	open a PC and traceability inspection case in DSDP as soon as possible using the incident response (IR) trigger for the suspect or realized risk proceed to step 2
in the case of 1 Listeria spp. detected on a FCS by CFIA or reported by the food business during an inspection	verify only compliance to SFCR 82 as describe below in step 2 by either: opening a PC and traceability inspection case in DSDP as soon as possible using the incident response (IR) trigger or continuing the inspection and considering modifying or expanding the scope as needed

2. Verify compliance of the food business to SFCR 82 (investigation, notification and mitigation). by including PC and traceability elements – Element 7: Traceability, control and complaints, in the scope of the inspection or by completing the relevant implementation verification task and consider the following :

use Industry guidance – Control measures for Listeria monocytogenes in ready-to-eat Foods (Listeria industry guidance) and refer to the HC Listeria Policy and to help assess if the food business is responding appropriately
the food business should carry out the activities recommended in figures 2 to 4 of the HC Listeria Policy and its section 7.2.3 Corrective actions for positive test results of food contact surfaces and non-food contact surfaces
table 3, below, indicates the actions to be taken depending on the results of the inspection of the food business's compliance to SFCR 82

Table 3: Additional actions for SFCR 82 (investigation, notification and mitigation of risk)
Scenario	Inspection action
investigation, notification and measures to mitigate the risk have been effectively implemented (for example, implicated product under control, hold and test sampling initiated)	continue to monitor the immediate response and interim measures of the food business to ensure actions taken are appropriate and effective to mitigate risks ensure that products are held when follow-up testing is performed by the food business after corrective action(s) have been implemented verify that the food business retests the same FCS for Listeria spp. and the associated RTE foods for 3 or more consecutive production days in case of persistence until: Listeria spp. is not detected on the FCS and Lm is not detected in the RTE foods
investigation, notification or measures to mitigate the risk have not been implemented or are not effective (for example, implicated product not under control, no hold and test)	consider going back to section 6.2.1 consider seizing unsatisfactory product as per the Operational Procedure – Procedure for seizure and detention, authorizing movement and disposition issue a non-compliance report to SFCR 82 as appropriate consult the Standard regulatory response process and Operational guideline – Food regulatory response guidelines to determine if a licence action such as suspension due to risk of injury to human health may be appropriate

3. Evaluate additional PC and traceability elements and sub-elements to ensure the food business is addressing the root cause and correcting any non-compliance. For example :

if the preliminary information and the food business's investigation identifies the root cause as potential cross-contamination, PC sub-element 3.1: Hygiene and Biosecurity should be included
if the root cause is not identified, the scope should include all PC and traceability elements and sub-elements linked to controlling Listeria in the processing environment
if Lm is reported in a food product, refer to the Operational procedure: Control response plan for the presence of Listeria monocytogenes in a ready-to-eat (RTE) food product, which can be used in conjunction with this operational procedure to prevent any duplication of inspection activities

6.2.3 Document and report the inspection findings

Document the findings of the PC and traceability elements and sub-elements or the implementation verification task and report any non-compliance in DSDP in the applicable inspection case.

Consult the Business Rules of Use for the IMS (accessible only on the Government of Canada networks) to determine if an IMS should be created. If an IMS was opened, update the record with the findings.

For all CFIA sample results reported as anything other than satisfactory, reactivate the sample collection case in the DSDP and issue a SIP inspection report. Follow the Operational guideline – Food sample collection and the Operational procedure: Planned food sample collection (annex B) or Operational procedure: As required food sample collection (annex B) for additional information and instructions.

6.3 Assess risk

The inspection of the preventive controls and the food safety investigation provides information to help assess any ongoing risks presented by the detection of Listeria from the RTE processing environment and to help inform decision making.

When a food safety investigation has not been conducted (for example, product has never been distributed), inspectors may request a Health Risk Opinion (HRO) to help inform risk mitigation decisions such as product control or disposition options. To obtain an HRO, inspectors should contact the OGE Division using the established communication channels and submitting an eRAF (accessible only on the Government of Canada network).

6.4 Mitigate risk

Initiate CFIA control actions, as required, to mitigate risks associated with the detection of Lm or persistence of Listeria spp. on FCS. Consult the Operational guideline : food regulatory response guidelines for a list of available control actions related to food.

6.4.1 Disposition of affected product

If Lm was detected in a food product associated with the detection of Lm or persistence of Listeria spp. on a FCS, refer to the Operational procedure – Control response plan for Listeria monocytogenes in ready-to-eat food for further guidance.

6.4.2 Mitigating risk for new production

Verify that the food business has implemented necessary corrective actions, for example intensifying and increasing the cleaning and sanitation of equipment and processing environment to prevent the introduction of Listeria into RTE foods.

In order to determine when the corrective actions are effective, the food business should conduct the sampling and follow-up activities detailed in the HC Listeria Policy as follow:

figure 2 of HC Listeria Policy when Listeria spp. is detected on FCS of category 1 RTE foods (vulnerable and general population) and category 2 RTE foods specially produced for consumption by vulnerable population
figure 3 of HC Listeria Policy when Listeria spp. is detected on FCS of category 2 RTE foods (general population)

6.5 Follow-up

6.5.1 Follow up inspection

If a non-compliance was issued during the inspection in section 6.2.2, conduct a follow-up inspection, including directed sampling if applicable (see section 6.5.2), as per SIP, the Food preventive control and traceability inspection – Compliance verification of a system or the Food preventive control inspection – Implementation verification to confirm permanent corrective actions have been implemented and are effective to prevent the introduction of Lm into RTE foods.

Schedule the follow-up inspection as soon as possible after the food business has implemented corrective measures and completed required follow-up sampling.

6.5.2 Directed or follow-up sample

A directed or follow-up sample may be taken alone or in addition to the follow-up inspection to confirm permanent corrective actions have been implemented and are effective in preventing the introduction of Lm into the RTE foods. Consult the Operational procedure: As required food sample collection for additional information.

Table 4, below, indicates the samples (if applicable) to be taken after the satisfactory completion of the food business's corrective actions (including their follow up sampling).

Table 4: Commodity specific directed/investigative sampling
Scenario	Inspection action
meat and poultry products	take a directed/investigative samples as per Red Meat and Poultry, National Microbiological Monitoring Program – Sample Guidelines and Assessment Criteria (accessible only on the Government of Canada network – RDIMS 7565223)
dairy, processed egg, fish and seafood, other commodities	take a directed samples (if applicable) as per the commodity specific sampling guidelines accessible in the CFIA Sampling Information (accessible only on the Government of Canada network)

6.6 Close the incident response case

In the case of repetitive non-compliance and repetitive inspections and follow-up regarding Listeria, follow the Standard Regulatory Response Process and Food Regulatory Response guidelines to initiate licence action, and/or enforcement actions if appropriate.

Once all follow-up activities (section 6.5 above) are found to be satisfactory, record the results in the DSDP and close the inspection case.

If a food safety investigation was started as per section 6.2.1 or a case was opened in IMS, update, complete and close the IMS file.

For general inquiries related to this operational guidance document, please follow established communication channels, including submitting an eRAF (accessible only on the Government of Canada network).

Date modified:: 2023-09-29

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