Operational procedure: Control response plan for the detection of E. coli O157:H7/NM in raw beef products
On this page
- 1.0 Purpose
- 2.0 Authorities
- 3.0 Reference documents
- 4.0 Definitions
- 5.0 Acronyms
- 6.0 Operational guideline
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.
- 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
- Standard regulatory response process
- Standard inspection process (SIP)
- Operational guideline: Food incident response process
- Operational guideline: Food regulatory response guidelines
- Operational procedure: Food preventive control inspection – Implementation verification
- Operational procedure: Ordering removal or destruction of unlawful food imports
- Operational procedure: Port of entry violation reported by foreign competent authorities
- Operational procedure: Procedure for seizure and detention, authorizing movement and disposition
- Industry guidance: Preventive controls for E. coli O157/NM in raw beef products
- 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
- Industry guidance: Preventive control plan requirements for biological hazards in meat products / Control Measures for Escherichia coli O157:H7/NM in Raw Beef Products (document incorporated by reference)
- Issues management system user manual (accessible only on the Government of Canada network – RDIMS 1599661)
- National microbiological monitoring program sampling guideline & assessment criteria – Red meat and poultry (accessible only on the Government of Canada network – RDIMS 7565223)
- Health Canada's Compendium of Analytical Methods (access under review)
- Health Canada's Guidance Document on E. coli O157:H7 and E. coli O157:NM in Raw Beef (access under review)
- Standards Council of Canada's list of accredited laboratories
Unless specified below, definitions are located in the:
- Safe Food for Canadians Regulations: Glossary of key terms
- My CFIA Glossary of terms
- Preventive control plan requirements for biological hazards in meat products / control measures for Escherichia coli O157:H7/NM in raw beef products (document incorporated by reference)
- Health Canada's Guidance Document on E. coli O157:H7 and E. coli:NM in raw beef
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)
|the food is not manufactured by an SFC licence holder and is marketed in intra-provincial trade only||
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.
|Type of food||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 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 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 below to ensure the immediate control of the unsatisfactory lots.
|the domestically produced food product was sampled and tested by CFIA||
|the results were reported by licence holder (domestic manufacturer or receiving establishment)||
|an imported food product was sampled and tested by either CFIA or licence holder||
|an exported food 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:
- 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.
|implicated and suspect products are under control of the licence holder and have not been distributed||
|implicated and suspect products are in distribution or potentially in distribution including export||
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.
|DSDP Field||DSDP Field Selection|
|Inspection task type||
|Inspection level 1 task||
|Inspection level 2 task||
|Inspection Task Details||
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.
|investigation, notification and actions to mitigate the risk (interim measures) have been initiated||
|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, 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.
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: