Operational procedure: Control response plan for the presence of Listeria monocytogenes in a ready-to-eat (RTE) food product

On this page

• 1.0 Purpose
• 2.0 Authorities
• 3.0 Reference documents
• 4.0 Definitions
• 5.0 Acronyms
• 6.0 Operational procedure
  • 6.1 Conduct preliminary assessment
  • 6.2 Conduct an incident response investigation
  • 6.3 Assess risk
  • 6.4 Mitigate risk
  • 6.5 Follow-up
  • 6.6 Close the incident response case

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 monocytogenes (Lm) is detected, or reported to be found, in a ready-to-eat (RTE) food product as defined in section 2.1 of Health Canada's Policy on Listeria monocytogenes in ready-to-eat foods (HC Listeria Policy), as well as other foods for which Lm has been identified as a food safety hazard to be controlled, either:

• imported, exported or marketed in inter-provincial trade
• manufactured, prepared, packaged or labelled by a food business under the Safe Food for Canadians Regulations (SFCR)

This document is intended to be used in conjunction with Operation procedure – Control response plan for the detection of Listeria in the ready-to-eat processing environment and with other guidance documents as referenced in section 3.0.

These procedures apply whenever CFIA is made aware of the detection of Lm in a RTE food product.

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

• Health Canada's Policy on Listeria monocytogenes in ready-to-eat foods (2023)
• Standard inspection procedures (SIP)
• Standard regulatory response process
• Operational procedure – Food preventive control and traceability inspection – Compliance verification of a system
• Operational guideline – Food regulatory response guidelines
• Operational guideline – Food incident response process
• Operational guideline – Food sample collection
• Operational guideline – Assessing, monitoring and documenting the disposition of non-compliant food
• Operational guideline -  Food preventive control inspection – Implementation verification
• Operational procedure – Procedure for seizure and detention, authorizing movement and disposition
• Operation procedure – Control response plan for the detection of Listeria in the ready-to-eat processing environment
• Operational procedure – Planned food sample collection
• Operational procedure – As required food sample collection
• Business Rules of Use for the Issues Management System (IMS) (accessible only on the Government of Canada network)
• Issues Management System (IMS) User Manual (accessible only on the Government of Canada networks – RDIMS 1599661)
• CFIA Sampling Information (accessible only on the Government of Canada network)
• Red Meat and Poultry, National Microbiological Monitoring Program – Sample Guidelines and Assessment Criteria (accessible only on the Government of Canada network – RDIMS 7565223)
• Industry guidance document – Control Measures for Listeria monocytogenes in Ready-to-Eat Foods
• Health Canada's Compendium of Analytical Methods
• Industry guidance document – Food export requirements library

4.0 Definitions

Definitions are located in either the:

• Safe Food for Canadians Regulations: Glossary of key terms
• My CFIA glossary of terms
• Control measures for Listeria monocytogenes in ready-to-eat foods
• Health Canada's Policy on Listeria monocytogenes in ready-to-eat foods (2023)

Listeria

Refers to any Listeria species, including Lm

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

The sections in this control response are presented in a linear format. However, some sections may be repeated or performed simultaneously depending on the scenario and as new information is made available.

6.1 Conduct preliminary assessment

6.1.1 Determine if the incident falls under CFIA jurisdiction

Whenever CFIA becomes aware of the detection of Lm in an RTE food, obtain the following details about the affected food product:

• the responsible food business (for example, manufacturer, importer, exporter)
• the origin of the product: domestic or imported
• where the food is distributed or marketed

6.1.2 Confirm validity of the reported assessment

Obtain and review a copy of the laboratory results. If a laboratory report is not available (analysis performed by a third party lab), obtain details of product 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 was assigned according to figure 1: Categorization of ready-to-eat foods of HC Listeria Policy – category 1, 2 (2A or 2B), or the food is not subject to the HC Listeria Policy
• for category 2 (2A or 2B) RTE foods for the general population, the enumeration results for Lm in the food (≤ or > 100 colony-forming unit (cfu)/g) was determined
• the intended consumers includes vulnerable populations (that is, people with weakened immune systems, pregnant people or adults ages 60 and over (for example, RTE foods that will be consumed in a hospital setting, convalescent care centres, long-term care facilities))

Based on this initial information, use the RTE food category and the information about the intended consumers to confirm that an appropriate assessment has been made for the production lot under consideration, as described in table 2 and consider the following:

• if the category of the food is unknown, treat it as a category 1
• licenced meat facilities eligible for export to the United States must treat all their RTE meat and poultry products as category 1 RTE foods and if so, the response to detection of Lm in these products should follow the category 1 RTE food assessment

When an accredited laboratory or a recognized method of analysis has not been used, but Lm was detected, the results may still be valid. The Operational Guidance and Expertise (OGE)  Division may be contacted for advice using the established communication channels.

Table 2: Assessment for compliance to Canadian guidelines for Lm in RTE food

Food	Lab results	Assessment
Category 1 and RTE foods for vulnerable populations	Lm not detected	Satisfactory
	Lm detected	Unsatisfactory
Category 2 (2A and 2B)	Lm not detected	Satisfactory
	Lm detected ≤ 100 cfu/g, in all samples	Investigative
	Lm detected > 100 cfu/g, in any sample or Lm detected but no enumeration was performed	Unsatisfactory
Product excluded from the HC Listeria Policy Table Note 1	Lm not detected	Satisfactory
	Lm detected	Investigative

Table Notes

Table Note 1

For a list of excluded product and additional information on them, consult the HC Listeria Policy

Return to table note 1  referrer

6.1.3 Determine and initiate immediate next steps

Obtain and review the following information:

• who sampled the product (for example, CFIA, provincial authority, manufacturer, importer, exporter or foreign country)
• how CFIA became aware of results (for example, internal reporting, reported by a food business, other government department, foreign regulatory agency or linked to an illness outbreak)

Table 3, below, identifies the next steps to be taken depending on the results. Use the assessment identified in table 2 to determine and initiate next steps as per table 3.

Table 3: Immediate next steps by inspectors for Lm detection

Assessment	Inspector action
unsatisfactory results	notify supervisor, Regional Program Officer (RPO, if applicable) and the food business (if CFIA, third party or other competent authority collected the sample) 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 electronic Request for Action Form (eRAF) (accessible only on the Government of Canada network) to the OGE Division for samples collected by CFIA, document the lab result in the Digital Service Delivery Platform (DSDP) (see section 6.2.3) if product has been or could have been distributed, including export, notify the Regional Recall Coordinator (RRC) or Area Recall Coordinator (ARC) as applicable and proceed to section, 6.2.1 if product has not been distributed, consider seizure and detention (see table 6) and proceed to section 6.2.2
investigative results Table Note 2(except product excluded from the HC Policy)	notify supervisor, RPO (if applicable) and the food business (if CFIA, third party or other competent authority collected the sample) for samples collected by CFIA, document the lab result in DSDP (see section 6.2.3) (refer to Operational guidance: Food sample collection) consider that the food may not be eligible for export (Food export requirements library) if the product has been exported to a market where it does not meet the foreign country's requirement, notify FIED by submitting an eRAF (accessible only on the Government of Canada network) to the OGE Division proceed to section 6.2.2
Lm was detected in a food product that is excluded from the HC Listeria Policy	notify supervisor, RPO (if applicable) and the food business (if CFIA, third party or other competent authority collected the sample) if the product has been exported to a market where it does not meet the foreign country's requirement, notify FIED by submitting an eRAF (accessible only on the Government of Canada network) to the OGE Division for samples collected by CFIA, document the lab result in DSDP (see section 6.2.3) if product has been or could have been distributed, including export, notify the RRC or ARC as applicable and proceed to section 6.2.1 if product is not distributed, consider seizure and detention (see Table 6) and proceed to section 6.2.2

Table Notes

Table Note 2

If first points of sale is for consumption by vulnerable populations (see HC Listeria Policy section 6.1.3) or product is to be used in the manufacture of category 1 food, it should be treated as an unsatisfactory result and actions by the inspector and the food business should be taken accordingly

Return to table note 2  referrer

6.2 Conduct an incident response investigation

6.2.1 Conduct a food safety investigation

Initiate a food safety investigation and consult the 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 – RDIMS 1599661).

In addition to the essential information obtained while following the FIRP, the food safety investigation should rapidly:

• confirm if the affected product has been distributed
• verify food product and process information (for example, pH, a_w, shelf life, storage conditions, cooking temperature, cooking instructions, US export status, intended consumers)
• identify the responsible importer or exporter and obtain information to identify the affected import or export shipment (if applicable, for example, the certificate or import transaction number, import or export documents)
• determine whether all food products (including rework) made on the same production line or with the same pieces of equipment used for the positive product between 2 sanitations are on hold or in distribution
• examine other sample results that could be linked, including food contact surface (FCS) results (consult the Operation procedure – Control response plan for the detection of Listeria in the ready-to-eat processing environment if Listeria is also detected on FCS)

If the product has been distributed in Canada, use the information gathered when notifying the RRC/ARC as per the established communication pathway.

After the initial risks of product in distribution have been mitigated, or if it was determined that the products are not in distribution, proceed with an inspection of the food business's preventive controls (section 6.2.2).

6.2.2 Conduct or continue an inspection of the food business

When Lm is found in an RTE food product, it is important to conduct an inspection of the food business, or to continue an inspection already underway, to verify that they are responding appropriately to the detection of Lm. To do this follow the 3 steps below, in order.

If inspection activities determine at any point that affected products have been distributed, go back to table 3 and to section 6.2.1 above, if applicable.

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

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 CFIA's industry guidance Control Measures for Listeria monocytogenes in Ready-to-Eat Foods (Listeria industry guidance) and refer to the HC Listeria Policy to help assess if the food business is responding appropriately
• the food business may carry out the activities recommended in the section "7.3 Unsatisfactory RTE food samples" of the Listeria industry guidance including follow up samples (also see section 6.4.3)
• table 5, below, indicates additional actions to be taken depending on the results of the inspection of the food business's compliance to SFCR 82

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 information does not indicate a particular area of concern, include all PC and traceability elements linked to controls for bacteriological contamination of the food and processing environment in the scope of the inspection
• if the nature of the product, preliminary information and the investigation conducted by the food business indicates a process control deviation may have occurred, assess PC and traceability Element 1: Process controls
• for imported product, conduct an inspection of PC and traceability sub-Element 1.3: Import controls if there is concern that the response from the importer will not mitigate the risk for future importations from the same supplier
• if Lm positive product has been exported, conduct an inspection of PC and traceability sub-element 1.4 to verify that the exporter has controls in place to ensure foreign country requirements are met
• if Listeria is detected in a domestic food processing environmental sample, refer to the Operational procedure – Control response plan for the detection of Listeria in the ready-to-eat processing environment, which can be carried out in conjunction with this operational procedure to prevent any duplication of activities

6.2.3 Document and report the inspection findings

Document the findings of the inspection of the PC and traceability elements and sub-elementsand report any non-compliances in DSDP in the applicable inspection case.

Consult the Business Rules of Use for the IMS (accessible only on the Government of Canada network) 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.

For all third party and referred sample results reported as anything other than satisfactory consult the Operational procedure: Planned food sample collection  (annex C) for complete instructions.

6.3 Assess risk

The inspection of the preventive controls and the food safety investigation provides information to help assess any ongoing risks due to the detection of Lm and to help inform decision making.

When no product has been distributed, a health risk opinion (HRO) may be requested to help inform risk mitigation decisions such as product control or disposition options. To obtain an HRO, contact the Food OGE Division by following the established communication channels and submitting an eRAF (accessible only on the Government of Canada network).

When product is in distribution, a food safety investigation is conducted according to the FIRP, section 6.2.1 above, and a health risk assessment (HRA) is requested via the RRC or ARC when needed to inform risk mitigation decisions.

6.4 Mitigate risk

Initiate CFIA control actions, as required, to mitigate risks associated with the detection of Lm in RTE food. Consult the Operational guideline: food regulatory response guidelines for a list of available control actions related to food.

6.4.1 Product control actions

Ensure that any products that may present a health risk have been effectively controlled by the food business (such as voluntary recall, voluntary disposal). When a food related risk must be controlled by CFIA, the following control actions may be taken (table 6).

6.4.2 Disposition of affected product

Verify that any non-compliant product has been effectively disposed of or brought into compliance. Where the proposed disposition action is reworking, reprocessing, further manufacturing or any other means to bring the affected product back into compliance, refer to the HRO obtained in section 6.3 above or the Operational guideline: Assessing, monitoring and documenting the disposition of non-compliant food to determine if the food business' plan for disposition of the product is acceptable.

For product affected in a food safety investigation, refer to the FIRP for guidance on appropriate product disposition.

6.4.3 Mitigating risk for new production

Unless their licence has been suspended, the food business may end their voluntary closure or resume processing on the affected line when effective interim measures are sufficient to control the risk. For example, the food business has a plan to hold and test future products to confirm the effectiveness of their corrective actions while they complete all the follow-up activities recommended in the Listeria industry guidance.

As indicated in the Listeria industry guidance document, for the RTE food that was assessed unsatisfactory, corrective actions are considered effective only when, as applicable the RTE food samples and the associated FCS are satisfactory for a period of 5 consecutive days.

If there are reasonable grounds that a risk of injury to human health may occur if the food business resumes or continues to operate, consult the Operational guideline – Food regulatory response guidelines to determine if a regulatory response such as suspension is warranted.

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 samples if applicable (see section 6.5.2) according to the SIP, the Food preventive control and traceability inspection – Compliance verification of a system or the Food preventing control inspection – Implementation verification to confirm permanent corrective actions have been implemented and are effective to prevent the introduction of Lm in the 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 in the RTE foods. Consult the Operational procedure: As required food sample collection for additional information. Table 7, below, indicates the sampling (if applicable) to be taken after the satisfactory completion of the food business corrective actions (including their follow up sampling).

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 (as per section 6.5) are found to be satisfactory, record the results in the DSDP and close the incident response 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).