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

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 food product:

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

Table 1: Determining jurisdiction
Scenario	Jurisdiction
the food is imported, exported or marketed in inter-provincial trade or the food 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 food 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:

who sampled the product (CFIA, provincial authority, licence holder, foreign authority)
how CFIA became aware of results (internal reporting, reported by a licence holder reported by a foreign authority
type of sample taken, that is, intact raw beef, non-intact raw beef or comminuted beef
whether the proper sampling plan was used as per Industry guidance: Preventive controls for E. coli O157/NM in raw beef products
whether an accredited laboratory was used as per Standard's Council of Canada's list of accredited laboratories
whether the proper laboratory method was used as per Health Canada's Compendium of Analytical Methods
whether the licence holder considers a presumptive positive as positive

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, below, to assess laboratory results.

Table 2: Laboratory assessment for *E. coli* O157:H7/NM^{Table Note 1}
Type of food	Laboratory results	Assessment
Carcass (if required as per export requirements)	E. coli O157:H7/NM not detected	Satisfactory
Carcass (if required as per export requirements)	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

Table Notes

Table note 1

As per the National microbiological monitoring program sampling guideline & assessment criteria – Red meat and poultry and the Industry guidance: Annex D-2 CFIA risk-based Shiga toxin-producing E. coli verification sampling of beef trimmings for abattoirs eligible for export to the USA

Return to table note 1 referrer

Table note 2

As stated in section "Process awareness program to detect trends" of the Industry guidance: Preventive controls for E. coli O157/NM in raw beef products: It is recommended that operators that produce PM (slaughter/further processing/grinding establishments) also monitor trends of generic E. coli or other indicator organisms in addition to E. coli O157 as part of their process awareness program.

Return to table note 2 referrer

Table note 3

As stated in section "Process awareness program to detect trends" of the Industry guidance: Preventive controls for E. coli O157/NM in raw beef products: Operators that produce FRGBP should test their products for an indicator organism such as generic E. coli to monitor trends of contamination and verify control of the process.

Return to table note 3 referrer

6.1.3 Determine and initiate immediate next steps

Initiate the steps described in Table 3 below 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 food product was sampled and tested by CFIA	notify supervisor, regional program office (RPO, if applicable) and licence holder of unsatisfactory or investigative results in the case of unsatisfactory results, document the sample results in the opened inspection case and issues 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 food 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)	as per the Preventive control plan requirements for biological hazards in meat products / control measures for E. coli O157:H7/NM in raw beef products, licence holder must inform CFIA of any positive results for E. coli O157:H7/NM (presumptive or confirmed) for carcasses: in case of unsatisfactory results, ensure that each sampled carcass and any adjacent carcasses which are deemed implicated are considered contaminated and are disposed of by the licence holder as per section 6.4.2 other products except carcasses: in case of unsatisfactory results, open a preventive control inspection (PCI) in the Digital Service Delivery Platform (DSDP) using incident response as the trigger (refer to section 6.2.1) in case of unsatisfactory results for non-O157 E. coli STEC, refer to Industry guidance: Annex D-2 CFIA risk-based Shiga toxin-producing E. coli verification sampling of beef trimmings for abattoirs eligible for export to the USA if food product is not under control of CFIA or licence holder, refer to Table 4
an imported food product was sampled and tested by either CFIA or licence holder	in case of CFIA sampling, immediately notify supervisor, RPO (if applicable) and licence holder of unsatisfactory or investigative result in case of licence holder's sampling, as per the Preventive control plan requirements for biological hazards in meat products / Control measures for E. coli O157:H7/NM in raw beef products, licence holder must inform CFIA of any positive results for E. coli O157:H7/NM (presumptive or confirmed) obtain import documents to identify implicated products in case of unsatisfactory results, consider seizing the implicated product and issuing a notice to remove a food from Canada as per SFCA 32(1) as per Operational procedure: Procedure for seizure and detention, authorizing movement and disposition and Operational procedure: Ordering removal or destruction of unlawful food imports report unsatisfactory and investigative results to Food Import and Export Division (FIED) through established communication pathways verify with Area Operations if same lot has been imported elsewhere in Canada if food product is not under control of CFIA or licence holder, refer to Table 4
an exported food product was sampled and reported positive by foreign authority	notify the exporter and/or domestic licence holder (manufacturer) of the E. coli O157:H7/NM detection refer to Operational procedure: Port of entry violation reported by foreign competent authorities

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:

confirm if product will be held by the licence holder
if there is a concern that the licence holder will not effectively hold the implicated product, consider seizure of implicated product as per Operational procedure: Procedure for seizure and detention, authorizing movement and disposition

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:

confirm if product will be held by the licence holder
if there is a concern that the licence holder will not effectively hold the suspect product, consider ordering that the suspect product not be moved as per Operational guideline: Food regulatory response guidelines

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, below, 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 RPO (if applicable)
implicated and suspect products are in distribution or potentially in distribution including export	notify supervisor, RPO (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 Food Import/Export Division (FIED) by submitting an electronic Request for Action Form (eRAF) to the Operational Guidance and Expertise (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 below 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) compliance of the licence holder 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 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 food or production lots that may have been affected, including all food produced after the last acceptable monitoring result was taken
- stopping production, if necessary, to prevent unsafe food 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, below, 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	consider seizing unsatisfactory product or order not to move product requiring further inspection as applicable as per the Operational guideline: Food regulatory response guidelines and/or Operational procedure: Procedure for seizure and detention, authorizing movement and disposition issue an inspection report

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, an inspector 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 electronic Request for Action Form (e-RAF).

Date modified:: 2022-03-31

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