Operational procedure: Control response plan for the detection of E. coli O157:H7/NM in raw beef products

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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 Escherichia coli O157:H7/Non-Motile (E. coli O157:H7/NM) is detected in raw beef products:

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

This document is intended to be used in conjunction with CFIA and other guidance documents as referenced in Section 3.0.

The procedure outlined below should be used when E. coli O157:H7/NM is detected in raw beef products tested by the CFIA, or when results are reported by the licence holder who produced or received it, an importer, or the foreign authority where the product was exported.

2.0 Authorities

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 the:

5.0 Acronyms

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

6.0 Operational guideline

E. coli O157:H7/NM contamination of raw beef is a hazard likely to occur, and the use of any meat components derived from a contaminated carcass to make finished raw ground beef products (FRGBP) or beef product processed for raw consumption (BPPRC) is considered a risk to human health.

Inspectors initiate the guidance outlined below whenever the CFIA becomes aware of the detection of E. coli O157:H7/NM in raw beef products including precursor material (PM), BPPRC and FRGBP.

6.1 Conduct preliminary assessment

6.1.1 Determine if the incident falls under CFIA jurisdiction

To determine jurisdiction, obtain the following details of the implicated raw beef product:

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

Use Table 1 to determine jurisdiction.

Table 1: Determining jurisdiction
Scenario Jurisdiction
  • the raw beef product is imported, exported or marketed in inter-provincial trade
  • or
  • the raw beef product is manufactured, prepared, packaged or labelled by a Safe Food for Canadians (SFC) licence holder
  • the issue falls under CFIA jurisdiction
  • proceed to section 6.1.2 to confirm validity of the concern
the raw beef product is not manufactured by an SFC licence holder and is marketed in intra-provincial trade only
  • although these products are not regulated by the SFCA, the FDA still applies and:
    • the incident may fall under the CFIA's jurisdiction, provincial jurisdiction or both
    • established protocols, communication pathways and agreements should be followed to ensure an appropriate response is conducted as per the Operational guideline: Food incident response process (FIRP)
    • all inspection activities would be based on authorities and requirements of FDA
    • CFIA's role will be determined on a case by case basis

6.1.2 Confirm validity of the reported assessment

Obtain product sampling information as follows:

If a proper sampling plan, an accredited laboratory or an appropriate method of analysis has not been used, inspectors should contact the Operational Guidance and Expertise (OGE) Division using the established communication channels.

Use Table 2 to assess laboratory results.

Table 2: Laboratory assessment for E. coli O157:H7/NM Table Note 1
Type of raw beef product Laboratory results Assessment
Carcass (if required as per export requirements) E. coli O157:H7/NM not detected Satisfactory
E. coli O157:H7/NM detected Unsatisfactory
PM Table Note 2 intended for use in FRGBP
  • Generic E. coli ≤ 100 cfu/g
  • E. coli O157:H7/NM not detected
 Satisfactory
Generic E. coli detected >100 cfu/g Investigative
Presumptive E. coli O157:H7/NM considered positive Unsatisfactory
E. coli O157:H7/NM detected Unsatisfactory
non-O157 E. coli Shiga Toxins-Producing Escherichia coli (STEC) not detected (establishments eligible to export to the US) Satisfactory
Presumptive non-O157 E. coli STEC considered as positive (establishments eligible to export to the US) Unsatisfactory
non-O157 E. coli STEC detected/confirmed (establishments eligible to export to the US) Unsatisfactory
FRGBP Table Note 3
  • Generic E. coli < 100 cfu/g
  • E. coli O157:H7/NM not detected
 Satisfactory
Generic E. coli detected ≥100 cfu/g Investigative
E. coli O157:H7/NM detected Unsatisfactory

6.1.3 Determine and initiate immediate next steps

Initiate the steps described in Table 3 to ensure the immediate control of the unsatisfactory lots.

Table 3: Immediate next steps when E. coli O157:H7/NM is detected
Scenario Inspection action
the domestically produced raw beef product was sampled and tested by CFIA
  • notify the supervisor, the Inspection Advisor, if applicable, and the licence holder of unsatisfactory or investigative results
  • in the case of unsatisfactory results, document the sample results in the opened inspection case and issue an inspection report (refer to section 6.2.1)
  • in the case of investigative results, provide the external Lab Sample Tracking System (LSTS) record of analysis to the licence holder for their records and follow up
  • if the raw beef product is not under control of CFIA or licence holder, refer to Table 4
the results were reported by licence holder (domestic manufacturer or receiving establishment)
an imported raw beef product was sampled and tested by either CFIA or licence holder
an exported raw beef product was sampled and reported positive by foreign authority

Advise the licence holder of their responsibility to perform a food safety assessment in accordance with SFCR 82 (investigation, notification and mitigation of risk) and confirm if an investigation has or will be initiated by the licence holder.

If the product was domestically produced, recommend to the licence holder that they initiate the follow-up actions per Industry guidance: Preventive controls for E. coli O157/NM in raw beef products.

Request information from the licence holder to determine whether any implicated product has been distributed. For any implicated product that remains in inventory:

Request information from the licence holder concerning suspect product and whether the licence holder has determined a need for holding and testing suspect product. For any suspect product that remains in inventory:

There is no requirement for licence holder to detain or dispose of product in case of an investigative laboratory result.

Follow the steps in Table 4 to determine any immediate needs for communication and notification.

Table 4: Immediate communication needs
Scenario Inspection action
implicated and suspect products are under control of the licence holder and have not been distributed
  • notify supervisor and Inspection Advisor, if applicable
implicated and suspect products are in distribution or potentially in distribution including export
  • notify supervisor, Inspection Advisor, if applicable and Regional Recall Coordinator (RRC) or Area Recall Coordinator (ARC), as applicable, as per established communication pathway
  • if the product has been exported to a market where it does not meet the foreign country's requirements, notify FIED by submitting an electronic Request for Action Form (eRAF) to the OGE Division

6.2 Conduct an incident response investigation

6.2.1 Conduct a food safety investigation

If the preliminary assessment indicates that implicated or suspect product is in distribution, refer to the Operational procedure: Food incident response process. This should include imported product in distribution. Open a case in the Issues and Management System (IMS) as per the IMS user manual (accessible only on the Government of Canada network - RDIMS 1599661).

6.2.2 Conduct an inspection of the food business

Use Table 5 to initiate an inspection of the licence holder and open an inspection case in DSDP.

Table 5: Recording inspection data in DSDP
DSDP Field DSDP Field Selection
Trigger
  • Incident response
Inspection task type
  • Preventive control inspection
Inspection level 1 task
  • Implementation verification
Inspection level 2 task
  • E. coli O157 incident response
Inspection Task Details
  • N/A

Verify that the licence holder is responding appropriately to the detection of E. coli O157:H7/NM and is in compliance with the requirements for a Preventive control plan (PCP), as per SFCR 86(1), 88 and 89(1)(c).

Verify (on the same day of notification or the following working day) the licence holder's compliance to SFCR 82 (investigation, notification and mitigation of risk) and SFCR 47(1)(2) (biological, chemical and physical hazards).

Obtain details of action taken by the licence holder since the detection or notification of E. coli O157:H7/NM to verify that the licence holder:

  • notified the CFIA and any other involved party (for example the supplier in the case of a receiving establishment conducting verification testing) of any raw beef product that is presumptive positive (unconfirmed positive) or confirmed positive for E. coli O157:H7/NM immediately after their investigation established that the results indicated the product was non-compliant, as per the Industry guidance: Preventive control plan requirements for biological hazards in meat products / Control Measures for Escherichia coli O157:H7/NM in Raw Beef Products
  • notified the CFIA of their root cause analysis results which identified trends, during the monitoring of activities, and could indicate a loss of control of the process (in other words, an increase in the number of samples that test positive for E. coli O157)
  • notified CFIA of their investigation results for monitoring procedures for high event period (HEP), which determined lots of PM or BPPRC that tested negative and the lots of untested intact primal and sub-primal products from the same source material as the raw beef products that tested positive, are contaminated with E. coli O157
  • took appropriate action on implicated and suspect product, which may include:
    • immediately isolating and identifying all products or production lots that may have been affected, including all products produced after the last acceptable monitoring result was taken
    • stopping production, if necessary, to prevent unsafe product from being produced
    • initiating an investigation and implementing interim measures to control risk to the public consistent with Industry guidance: Preventive controls for E. coli O157/NM in raw beef products
  • conducted an investigation into the possible root cause(s) and extent of contamination
  • conducted follow up testing as per Industry guidance: Preventive controls for E. coli O157/NM in raw beef products, if applicable

Table 6 indicates additional activities to be taken depending on the results of the inspection of the licence holder.

Table 6: Additional activities
Scenario Inspection action
investigation, notification and actions to mitigate the risk (interim measures) have been initiated
  • continue to monitor the immediate corrective actions to ensure actions taken are appropriate and effective to mitigate risks
investigation, notification and actions to mitigate the risk (interim measures) have not been initiated or interim measures are not effective

If the root cause of the contamination cannot be determined, the licence holder should maintain a report of their assessment that includes the rationale used to reach that conclusion.

6.2.3 Document and report of inspection findings

Document findings and report non-compliance as per the Operational procedure: Food preventive control inspection – Implementation verification requirements and in IMS, as applicable.

6.3 Assess risk

If a licence holder proposes a disposition method in a manner which does not conform to the methods outlined in Section 6.4.2, inspectors can seek guidance as per the established communication pathway.

6.4 Mitigate risk

Initiate CFIA control actions, as required, to mitigate risks associated with the detection of E. coli O157:H7/NM.

6.4.1 Product control actions

If at any point, an inspector is concerned that the licence holder will not effectively hold implicated and suspect product, they may consider seizure of implicated product and order not to move suspect product as per Operational procedure: Procedure for seizure and detention, authorizing movement and disposition and Operational guideline: Food regulatory response guidelines.

6.4.2 Disposition of non-compliant product

The options for implicated and suspect product are cooking, denaturing and condemning or rejection by receiving establishment. Refer to Industry guidance: Preventive controls for E. coli O157/NM in raw beef products and the Operational guideline: Assessing, monitoring and documenting the disposition of non-compliant food to ensure that the licence holder is following the correct disposition procedures as per SFCR 125(1)(e) and 156. Regardless of the option selected, the traceability requirements of SFCR 90 must be met.

6.5 Follow-up

If a non-compliance was issued during the inspection in section 6.2.2, conduct a follow-up inspection to ensure that the licence holder's corrective actions were effective in addressing immediate risks and that corrective measures have been implemented to prevent re-occurrence of the non-compliance. The follow-up inspection should be conducted as soon as possible after the licence holder has implemented corrective measures. Refer to the Standard inspection process and the Operational procedure: Food preventive control inspection – Implementation verification.

6.6 Close the incident response case

Once all follow-up activities conducted in Section 6.5 are found to be satisfactory:

  • record results of the inspection in DSDP and close the incident response case
  • if a food safety investigation was started as per Section 6.2.1 and a case was opened, update, complete and close the file in the IMS
  • if control actions were taken, resolve them according to relevant operational procedures, as appropriate

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).

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