CFIA Assessment of Establishment 38, XL Foods Inc.

Table of Contents

Section 1: Purpose of Report

The purpose of this report is to:

  • Provide a comprehensive assessment of the food safety controls and the conditions required under the Meat Inspection Act observed by the Canadian Food Inspection Agency (CFIA) inspection staff at Establishment 38, XL Foods Inc., during the period of September 12 to October 16, 2012, for the purpose of assessing whether the suspension of the licence to operate may be lifted.
  • Set out the observations of the CFIA inspection staff in relation to establishment operations and the corrective actions implemented by Establishment 38, XL Foods Inc., in response to the identified deficiencies which led to the CFIA’s suspension of the plant’s licence to operate.
  • Provide a recommendation to the President of the CFIA regarding Establishment 38, XL Foods Inc.’s readiness to resume slaughter and processing operations.
  • Identify the conditions for start up operations and staged progression to normal operations.

Section 2: Background

On September 4, 2012, during routine testing, the CFIA identified a positive E. coli O157:H7 sample in raw beef trimmings produced at an Alberta facility supplied by Establishment 38, XL Foods Inc. That same day, the CFIA was notified by the United States Department of Agriculture, Food Safety Inspection Services (FSIS) of a positive E. coli O157:H7 sample in beef trimmings from XL Foods Inc. The CFIA quickly verified product distribution and determined that no affected product from the lot that tested positive on September 4, 2012, was in the marketplace. 

The CFIA immediately launched an investigation of Establishment 38, XL Foods Inc., to determine the source of the contamination. A food safety investigation involves gathering product and distribution information from a variety of companies (e.g. manufacturers, food processors, distributors, and retailers). A key factor at this stage was to examine the establishment’s distribution records, which took several days to obtain and assess. During this period, the CFIA enhanced its onsite inspection activities, including additional oversight of food safety controls intended to reduce the occurrence of E. coli.

As the CFIA's investigation continued, FSIS notified the CFIA on September 12, 2012, that it had found two more positive E. coli O157:H7 samples in beef trimmings originating from XL Foods Inc. The affected shipments were held at the border. No products from these affected lots were distributed in Canada.  Based on the CFIA's investigation and the US findings, the Agency sent in a team of technical experts to conduct an in-depth review of operations at Establishment 38, XL Foods Inc.

On September 13, 2012, the CFIA removed XL Food Inc. from the list of establishments eligible to export to the US.  Based on the preliminary findings of the in-depth review, and the two positive E. coli findings in the US, the CFIA and XL Foods Inc. began issuing public recall alerts on September 16, 2012, warning the public that specific ground beef products made from XL Foods Inc. beef trim may have been contaminated. FSIS issued its first public health alert to American consumers on September 20, 2012, warning them of potentially contaminated beef from XL Foods Inc. for the same dates covered by the CFIA alert. Ultimately, products produced on August 24, 27, 28, 29 and September 5, 2012, were voluntarily recalled by XL Foods Inc.  To date, there was no evidence to indicate that other dates of production posed a food safety risk, and as a result, no other products were recalled. 

The in-depth review of the establishment took place between September 12 to 18, 2012. During this time, the CFIA identified a number of deficiencies that indicated adequate controls for food safety were not fully implemented in the facility. The CFIA issued corrective action requests (CARs) to address the deficiencies. The establishment did not adequately implement corrective actions and did not present acceptable plans to address longer-term issues. As a result, on September 27, 2012, the CFIA suspended the operating licence for Establishment 38, XL Foods Inc. All the products in the establishment and in storage, at that time, were placed under CFIA detention and control. 

The CFIA worked with the Public Health Agency of Canada (PHAC) and provincial public health agencies, which were investigating cases of E. coli related illnesses potentially linked to XL Foods Inc. On October 1, 2012, PHAC announced four cases of illness linked to XL Foods Inc.

Between September 30 and October 6, 2012, the CFIA tested carcasses that had been detained in the establishment when its operating licence was suspended. This testing was undertaken to assess the adequacy of food safety controls in minimizing the risk of E. coli contamination. On October 9 and 10, 2012, a CFIA review team returned to the establishment to determine if the facility had addressed CARs uncovered as part of the CFIA's in-depth review. The team reviewed the sanitary conditions in both the slaughter and processing areas of the establishment.  On October 11, 2012, the CFIA granted a modified licence for a temporary period to allow the establishment to de-bone and cut the detained carcasses under strict conditions and enhanced CFIA oversight.  The CFIA review team monitored the establishment’s food safety controls as the carcasses were processed.

For a complete timeline of events, see the CFIA website.

Section 3: CFIA Observations and Findings

This assessment focuses on the following areas:

  • In-depth establishment review (September 12 to 18, 2012)
  • Pre-resumption of operations inspection (October 9 to 10, 2012)
  • Carcass sampling and testing (September 30 to October 6, 2012)
  • Review of cutting and boning operations under temporary license (October 12 to 16, 2012)
  • Management commitment to food safety

3.1 In-depth Establishment Review (September 12 to 18, 2012)

On September 12, 2012, CFIA launched an in-depth review that focused on the establishment’s preventative control measures, food safety policies and procedures, equipment and quality systems, and laboratory methodology.

3.1.1 Establishment Review

The in-depth review was conducted onsite to identify all possible cross-contamination concerns throughout the process flow, from live animal receiving through to product shipping. The protocol for the onsite review included the following Compliance Verification System (CVS) inspection tasks:

  • Review of all in-establishment process flows;
  • Review of ante-mortem screening; and
  • Review of the live animal receiving area through to stunning and bleeding area to ensure screening process addressed heavily contaminated animals.

The focus of the CVS tasks was to identify possibilities for cross-contamination, in the following areas:

  • Building maintenance;
  • Ventilation;
  • Waste and inedible disposal;
  • Water treatment;
  • Hand-washing stations and sanitizing installations;
  • Sanitation;
  • Equipment maintenance;
  • Pre-operational sanitation on-site;
  • Transportation, purchasing, receiving & shipping;
  • Generic E. coli sampling written protocol for carcasses; and
  • Sampling for control of E. coli O157:H7.

The team also assessed the establishment’s Hazard Analysis and Critical Control Point (HACCP) system, as it related to the control of E. coli O157:H7.  A key focus of this task was to evaluate whether the establishment’s deviation procedures, investigation practices and root cause analyses were sufficient to control contamination issues when they occurred. 

Based on the observations of the in-depth review team, the CFIA also issued a number of CARs that pointed to general maintenance and sanitation issues. By themselves, each of these findings would not typically lead to concerns about increased potential for E. coli O157:H7 contamination. Findings related to maintenance and sanitation were as follows:

  • Refrigeration units had not been cleaned as frequently as the establishment’s written sanitation plan required;
  • Ice build-up was observed on freezer doors;
  • Water was dripping from piping;
  • A drain near the rendering room was emitting a foul odour;
  • There was condensation above exposed containers of product in the sampling and weighing areas;
  • Sanitizer was dripping from overhead structures onto product below;
  • The establishment had no effective monitoring procedures to ensure that equipment design meets requirements;
  • The evisceration table thermometer was not functioning properly;
  • Some employees were not wearing beard nets; and
  • Employees sorting beef trim touched product without following appropriate washing and sanitizing procedures.

The CFIA also issued a CAR requiring the establishment to improve its management of E. coli O157:H7. Findings related to the management of E. coli O157:H7 risks were as follows:

  • The establishment had an appropriate HACCP system to control food safety risks and this plan had been verified by the CFIA. However, the plan was not being fully implemented or regularly updated. Specific observations included:
    • lack of detailed documents outlining required steps when product was positive for E. coli O157:H7 or when there were a high number of positives in a production period;
    • inconsistent trend analysis on positive samples;
    • insufficient record keeping related to ongoing monitoring and validation of processes, procedures, and equipment maintenance (e.g., 12 of 100 water nozzles clogged in the primary carcass wash area); and
    • deficiencies in sampling techniques and procedures, such as inconsistent sampling and no established monitoring program.

A complete summary of the various CARs issued during this period and the deficiencies noted, as well as the corrective action plans submitted by the establishment, are described in Annex A.

3.1.2   Assessment of Third Party Laboratory

On September 14, 2012, the in-depth review team conducted an assessment of IEH Laboratories and Consulting Group, a third party testing laboratory, used by the Establishment 38, XL Foods Inc. This assessment involved a review of documentation, methodology and testing protocols for Shiga-Toxin Escherichia coli (STEC) testing (including E. coli O157:H7). The CFIA laboratory assessment team conducted interviews with laboratory management and staff and conducted visual inspection and direct observation of the laboratory facilities and practices. The team reviewed methodology, analytical results, training, equipment performance, results of proficiency testing and laboratory accreditation.

This laboratory is accredited to ISO 17025 – the internationally recognized laboratory accreditation standard. It was noted that the laboratory successfully participated in the CFIA’s proficiency program since February 2011, using the E. coli O157:H7 and STEC methodology that was used for testing Establishment 38, XL Foods Inc., beef trim samples. It was also noted that the methodology used at IEH laboratories for E. coli O157:H7 and STEC testing had been assessed by FSIS and deemed equivalent to the FSIS method, with the provision of a letter of no objection.

The CFIA assessment did not identify any significant issues with respect to the testing protocols for E. coli O157:H7 or other STEC pathogens. 

3.1.3 Conclusion of In-Depth Review

Based on the in-depth review of the establishment’s preventative control measures, food safety policies and procedures, equipment and quality systems, and laboratory methodology, the CFIA concluded that there was no single factor that would lead to E. coli O157:H7 contamination.  It was determined that a combination of several deficiencies in relation to the implementation of the establishment’s food safety control plan played a key role.

3.2 Pre-resumption of Operations Inspection (October 8 to 10, 2012)

The CFIA conducted a pre-resumption of operations inspection on October 8, 2012. This inspection entailed a walk-through by CFIA inspection staff to visually inspect and confirm the readiness of the establishment to resume operations under intensified CFIA oversight.

The team determined that the facility fulfilled the following requirements for being ready to resume operations:

  • The sanitary conditions were acceptable in all areas of the establishment including both the slaughter and processing areas;
  • All equipment was clean and acceptable for use; and
  • Sanitation records reflected the conditions observed on site.

The team noted the following improvements in their walk through of the establishment:

  • Cracks in the floor had been repaired;
  • Sinks at inspection stations had been refurbished and re-plumbed;
  • Wall in offal packaging area had been repaired;
  • Appropriate food grade oil was used to lubricate rails and overhead structures; and
  • Rough welded surfaces had been repaired.

The CFIA review also determined that all areas of the establishment had been appropriately cleaned and sanitized. The inspection report is attached as Annex B.

3.3 Carcass Testing (September 30 to October 6, 2012)

E. coli O157:H7 contaminates the surface of carcasses via aerosolized dust, dirt and fecal particles spread during the de-hiding process. It is expected that only a very small number of carcasses would be contaminated after successful intervention treatment on the production line (i.e. hot carcass washes, steam pasteurisation). However, any contaminated carcasses have the potential to cross-contaminate other clean carcasses, as well as equipment, work surfaces and workers’ protective clothing. Identifying and segregating contaminated carcasses as early as possible, before cross-contamination occurs, is a step to reducing overall pathogen pressure on the food safety controls.

The CFIA designed a verification sampling plan for beef carcasses in order to determine contamination rates of E. coli O157:H7 for carcasses detained in the establishment on September 27, 2012.  Only those lots of carcasses that tested negative for E. coli O157:H7 contamination were allowed to be processed (cut and de-boned).  This enhanced testing of the carcasses was designed for this unique situation involving Establishment 38, XL Foods Inc.

The sampling covered a total of 5183 carcasses, grouped into lots of 20 half-carcasses (sides). Sampling was carried out by CFIA inspection staff at Establishment 38 over three days and was completed on October 3, 2012.  A total of 5183 carcasses resulted in 518 samples, comprised of material from three surface locations on each half-carcass, which were analyzed at CFIA laboratories and the Alberta Agriculture laboratory.  Results were reported between October 2 and 6, 2012. Of the 518 samples analyzed, 514 were reported as E. coli O157:H7 not detected and four samples reported as being presumptive positive. This represents less than one per cent prevalence of E. coli O157:H7 and reflects that food safety controls in relation to these carcasses were adequate to minimize the risk of E. coli contamination.

In accordance with the verification sampling plan, each lot comprised of 20 sides that tested presumptive positive was segregated, as well as the sides immediately before and after the positive lot (leading and trailing sides) to form a new lot comprised of 22 sides. Including the leading and trailing side brings an additional level of certainty that all contaminated half-carcasses were segregated from all other half-carcasses.

Establishment 38, XL Foods Inc., decided to render all 44 presumptive positive carcasses, rather than subject them to more intervention treatment and re-testing.  Consequently, a total of 5139 beef carcasses remained for further processing, following the completion of the sampling and testing regime.

3.4 Review of Cutting and De-boning Operations Under Temporary Licence (October 12 to 16, 2012)

Effective October 11, 2012, the CFIA allowed the establishment to process carcasses currently present in the facility that had tested negative by the CFIA for E. coli O157:H7. These activities allowed CFIA inspection staff to carefully observe the establishment's food safety controls. All operations took place under specific conditions and enhanced CFIA oversight. Meat from these carcasses remained under CFIA detention.

3.4.1   Pre-Operational Inspections

Prior to the start of de-boning and cutting operations on October 12, 13, and 16, 2012, CFIA inspection staff performed daily pre-operational inspections to evaluate the effectiveness of the establishment’s sanitation program. These inspections include a detailed examination of the surfaces and equipment to be utilized in processing.  A number of minor issues with no immediate impact on food safety were identified.  For all issues identified, the establishment took immediate and effective corrective action to address them and no further CFIA action was required. 

The issues identified were as follows:

October 12, 2012

  • Slight residue of fat/protein observed on surface of some belts and tables;
  • Some isolated condensation observed on pipe in processing room; and
  • Small isolated pooling of water observed on processing floor

October 13, 2012

  • Small fat and meat particles observed on some saws and conveyors;
  • Excess grease observed on some conveyors and tables;
  • Rusty water observed on railing in pre-break; and
  • Condensation observed in various areas of processing room

October 16, 2012

  • Slight residue of fat/protein on non-contact surface of some belts and tables

3.4.2   CFIA Inspection Activities

In addition to routine inspection activities, the CFIA implemented enhanced inspection oversight of the establishment’s E. coli O157:H7 controls as follows:

  • Additional inspection staff were assigned to observe the processing;
  • Increased frequency of certain CVS tasks; and
  • Additional sampling of product

Between September 12 to 18, 2012, the CFIA issued six corrective action requests (CARs) related to deficiencies that contributed to the suspension of the establishment’s licence. During the limited operations related to cutting and de-boning, the following observations were made relating to the implementation of the corrective action plans relating to these CARs.

CAR 038-2012-07: Verification of HACCP system - The establishment’s corrective action plan addressed the need to revise its written programs and to effectively implement the revised procedures onsite. The CFIA inspection staff reviewed the revised written programs and found them to be complete and acceptable.  During the assessment period, onsite follow-up by inspection staff verified that the establishment was effectively implementing their plan with no further non-compliance reported.   

CAR 038-2012-08:  Sanitation - The establishment’s corrective actions pertaining to the establishment’s employee welfare facilities and overhead sanitation were assessed and found to be acceptable by CFIA inspection staff.   

CAR 038-2012-09:  Building maintenance - The establishment’s corrective actions (repairs) pertaining to the establishment’s floors, walls and doors including associated relevant records were assessed and found to be acceptable by CFIA inspection staff.  

CAR 038-2012-10: Ventilation - The establishment’s corrective actions pertaining to the establishment’s ventilation and condensation program including relevant records were assessed and found to be acceptable by CFIA inspection staff.   

CAR 038-2012-11:  Equipment maintenance - The establishment’s corrective actions pertaining to the establishment’s equipment maintenance program, including relevant records, were assessed and found to be acceptable by CFIA inspection staff.  

CAR 038-2012-12:  Sanitary practices and operational sanitation - CFIA inspection staff evaluated all establishment training records related to recent employee training performed by the establishment to re-enforce proper hygienic practices and procedures. All training records were found to be acceptable and interviews with employees suggested they were knowledgeable about the training material. 

A summary of CFIA CARs and the corrective actions implemented by the establishment is attached at Annex A.

3.4.3 Sampling and Testing

Only lots of carcasses that previously tested negative for E. coli O157:H7 were allowed to enter the processing room of the establishment for cut-up and de-boning on October 12, 13 and 16, 2012.

The CFIA developed and implemented two customized sampling inspection tasks to enhance sampling for E. coli O157:H7 and generic E. coli when temporary operations resumed at the establishment.

Establishment Sampling

Although trim obtained from the carcasses was destined for rendering and would not be used for human consumption, the establishment implemented an enhanced sampling program for detecting E. coli O157:H7 in trim, as a means to assess the effectiveness of their food safety controls.

XL Foods Inc. took 551 samples of beef trim.  All of these samples were determined to be negative for E. coli O157:H7.

CFIA Sampling

During the three days of temporary operations, the CFIA implemented an enhanced protocol to test primal meat cuts in the processing area of the establishment. E. coli O157:H7 was not detected in any of the primal meat cut samples collected by the CFIA

The CFIA also tested these samples for generic E. coli.  All samples tested less than five colony forming units (cfu) per gram. This result is well below the Health Canada standard for generic E. coli of 100 cfu per gram.

Section 4: Commitment to Food Safety

4.1 Management Presence and Engagement

During the temporary resumption of processing operations, the CFIA observed the presence of senior establishment management in the processing and sampling rooms prior to and during operations. The managers were seen evaluating the implementation of the establishment’s food safety programs, and discussing and receiving feedback from front line employees and supervisors. 

An additional number of quality assurance personnel and supervisors were also noted to be present at the entrance of the processing area at start-up, and within the processing room during operations to ensure oversight of, and adherence to, the establishment’s good manufacturing practices program.

4.2 Establishment Cooperation with CFIA Staff

During the period of temporary operations, Establishment 38, XL Foods Inc., management acted upon all CFIA inspection staff requests in a timely fashion. 

Establishment representatives immediately addressed all onsite observations identified by CFIA inspection staff and implemented corrective actions in an appropriate manner. As time progressed through the three days of operations, CFIA inspection staff noted fewer deficiencies, and this finding suggests the establishment was becoming more proficient at correcting deficiencies without CFIA involvement.

All establishment documents and records were made available to the CFIA upon request.  Following receipt of laboratory results, the establishment’s  E. coli O157:H7 test results were made available without delay to CFIA inspection staff for verification.

4.3 Management Commitment to Food Safety

The adoption of an effective food safety culture, at all levels of the Establishment 38, XL Foods Inc. organization, is one of the most important means of assuring the production of safe food. There are a number of important elements that are key to achieving this objective, including:

  • Senior management affirmation and communication of the organizations’ commitment to food safety;
  • A robust food safety governance, including senior positions responsible for overseeing and implementing the organization’s food safety program and working with CFIA inspection staff to monitor overall food safety system performance; and
  • A strategy for ongoing employee engagement, including training and communication.

Accordingly, the CFIA requested that Establishment 38, XL Foods Inc., provide a written description of the steps that the establishment has taken and plans to take, in order to ensure that a commitment to food safety is reflected in organizational practices on a daily basis.

On October 18, 2012, XL Foods Inc. responded by providing the CFIA with a letter, which described plans for senior management to:

  • Re-affirm and communicate the establishment’s commitment to food safety to all employees;
  • Provide enhanced food safety training sessions to management and staff; and
  • Re-validate certain food safety intervention strategies. 

The letter touches on some of the key elements required to put in place an effective food safety culture.  However, it did not define specific timelines or means to measure successful implementation. This letter is attached as Annex C.

The establishment also made a presentation to the CFIA and Health Canada that outlined its plans for enhancing food safety controls going forward. This presentation described XL Foods Inc’s plans to enhance their food safety controls, including revised sampling and testing protocols, enhanced corrective action processes, and employee training.

Section 5: Conclusions and Recommendations

5.1 Food Safety Controls

This assessment examined four areas relating to Establishment 38, XL Foods Inc.’s food safety controls.  First, the in-depth establishment review noted deviations from the establishment’s documented E. coli O157:H7 control measures and sampling and testing procedures.  The establishment was unable to demonstrate through its documentation that it was consistently and effectively implementing it’s agreed upon control program.  The detection of E. coli in slaughter facilities is not uncommon, and plants are expected to have adequate measures in place to monitor higher than normal detection rates and modify control measures accordingly. This trend analysis was not always conducted consistently.

In the three remaining areas (i.e. pre-resumption of operations inspection, carcass sampling and testing, and review of cutting and de-boning operations under temporary licence), which followed the in-depth establishment review, the CFIA found that the establishment’s control measures were effectively controlling the risk of contamination.

5.2 Corrective Actions

During the in-depth establishment review, the CFIA also observed some deficiencies with respect to sanitation and maintenance. In the later reviews (i.e. pre-resumption of operations inspection, carcass sampling and testing, and review of cutting and de-boning operations under temporary licence), the Agency found that appropriate measures had been taken to address these issues.

Between September 12 to 18, 2012, the CFIA issued six CARs related to deficiencies that contributed to the suspension of the establishment’s licence. During the limited operations related to cutting and de-boning, the CFIA found that the establishment was effectively implementing corrective action plans relating to these CARs.

Overall, the CFIA findings and observations indicate that  Establishment 38, XL Foods Inc., has made improvements in the following areas:

  • Demonstrating a stronger management commitment to food safety;
  • Performing cleaning and sanitation procedures;
  • Adequately implementing sanitary practices with respect to de-boning and cutting;
  • Effectively implementing sampling and testing protocols for trim;
  • Identifying and responding to identified deficiencies in a timely and effective manner;
  • Cooperating with the CFIA with respect to the timely provision of information;
  • Maintaining the cleanliness of their employee facilities;
  • Addressing maintenance issues identified in the reviews; and
  • Employee engagement on food safety matters, and employee training.

5.3 Recommendations

In consideration of the above, the CFIA recommends that the suspension of the licence to operate Establishment 38, XL Foods Inc., be lifted and that the establishment be allowed to resume slaughter and processing operations at the establishment, under the following conditions: 

  • Until further notice, for all production days with increased E. coli O157:H7 results above background levels (high event days), XL Foods Inc. will immediately provide to the CFIA documentation demonstrating its trend analysis and how it has implemented its event period protocols.
  • Upon restart of operations, the operator will follow its written plan as submitted to the CFIA for limiting animal throughput. As controls are found to be effective, the operators plan will be in place to gradually increase the slaughter and processing throughput subject to CFIA approval. The plan will remain in effect for as long as necessary to enable XL Foods Inc. and the CFIA to monitor the effectiveness of its enhanced food safety controls.  
  • Operations will not commence until a satisfactory pre-operational inspection has been completed by the CFIA in all rooms associated with slaughter and processing, prior to the re-start of operations and on every day of operation during the CFIA enhanced inspection period.
  • Until further notice, any private laboratory used by Establishment 38, XL Foods Inc., for the purpose of product testing will be directed by XL Foods Inc. to provide all product test results directly to the CFIA, as soon as they are available.
  • All meat products will be held by XL Foods Inc. until all related CFIA and XL Foods Inc. test results are received, reviewed, and found acceptable by the CFIA.

The above conditions remain in effect for as long as deemed necessary to ensure the meat products produced at Establishment 38, XL Foods Inc., comply with the Meat Inspection Regulations (MIR) and in order to protect public health and safety. Further, pursuant to s. 29(6) of the MIR, XL Foods Inc. shall comply with all of these conditions of the licence to operate the establishment. A failure to do so may result in the establishment’s licence being suspended again.

In addition, the CFIA should implement the following enhancements to its oversight:

  • Interim onsite additional inspection resources should be assigned to provide support to inspection staff (i.e. one inspection manager) and to assess the effectiveness of implementation of the enhanced CVS daily tasks. (i.e. one inspection resource). The continued oversight of the establishment’s HACCP system will ensure effective implementation of preventative measures taken by the establishment.
  • In addition to measures taken by the establishment, the CFIA will implement an enhanced sampling protocol to monitor the effectiveness of the establishment’s control program for E. coli O157:H7 in raw beef products. The enhanced sampling protocol encompasses testing for generic E. coli and E. coli O157:H7 for trims and ground beef.  (Generic E. coli testing is conducted to determine if sanitation and good manufacturing practices issues may be occurring in the establishment). 

The establishment’s readiness to move from enhanced oversight to normal operations will be determined by the CFIA when:

  • The enhanced sampling plan has been completed with satisfactory results;
  • The CFIA has verified that all of the establishment’s corrective actions have been effectively implemented; and
  • The establishment has demonstrated effective implementation of planned enhancements to their food safety controls. 

If at any point, the CFIA determines that the establishment's controls are not effectively controlling food safety risks, the establishment may be subject to immediate enforcement measures, including but not limited to suspension of the licence to operate.

Annex A: Corrective Action Request and Action Plan Summary Table

CAR Number: 038-2012-07
Task Description: Verification of Hazard Analysis Critical Control Points (HACCP) System Design

Summary of Non-Compliance Summary of Corrective Action

HACCP system is not designed to control all hazards including E. coli O157:H7.

  • Operator does not meet regulatory requirements related to developing and maintaining an effective HACCP System, specifically:
  • Individual responsible for maintenance procedures not identified and ineffective to ensure implementation and monitoring of the HACCP system.
  • No description of reassessment procedures.
  • Incomplete log book regarding follow-up activities for positive sample investigations.
  • Plant schematic form 4 for processing does not meet requirements.
  • Critical Control Point (CCP) for offal chilling and steam pasteurizer did not meet requirements.
  • Validations not undertaken for alternative to Sanova in steam pasteurizer; CHAD wash validation incomplete.
  • Disposition guidance document does not include sufficient detail relating to investigations in response to positive samples.
  • Guidance decision document does not take into account high positive occurrences on an hourly or per shift basis.
  • Guidance document instruction for when positives exceed 20 per cent in a single production not consistent with company decision document.
  • Bracketing procedure not clearly identified or followed.
  • Lack of investigation procedures/guidance for root cause analysis on high event days.
  • No trend analysis procedures to explain rational for action limits and how action limits are linked to sampling plan.
  • N-60 sampling procedures not followed: employees were not sampling all areas of combo surface representatively and consistently. Sampling technique inconsistent.
  • Letter of commitment revised to include all required statements.
  • HACCP maintenance and reassessment procedures revised.
  • Log book reviewed for completeness based on interviews.
  • Plant schematic Form 4 was revised to meet requirements regarding flow/removal of waster.
  • Plant schematic Form 4 for slaughter and processing revised to identify hazards associated with flows.
  • CCP for offal chilling revised to ensure 7 degrees Celsius or less within 12 hours of production.
  • CCP for steam pasteurizer: inspection staff notified to record monitoring results.
  • Deviation procedures and protocol to revalidate statistical process control of CHAD cabinet redesigned in light of change to process.
  • Monitoring procedure for dwell time for CHAD revised.
  • Results for E. coli O157:H7/ Non-0157 Shiga Toxin-Producing Escherichia coli (STEC) are reviewed upon receipt and decision guidelines are followed per the current written standard operating procedures (SOP) and to record actions taken appropriately prior to performing pre-shipment review.
  • Confirmed that the establishment consistently engages in bracketing activities, diverting tested negative pre-grind raw material to cook only with lots that are found positive.
  • Senior management is committed to assess the potential for additional controls in association with trend analysis.
  • Establishment 38 commits to intensify bracketing activities on days with multiple positives by further assessing the need to take action on negatives produced adjacent in time to positive lots that occur within short or defined time frames.

CAR Number: 038-2012-08
Task Description: Sanitation and Maintenance Verification

Summary of Non-Compliance Summary of Corrective Action

Multiple unsanitary conditions.

  • Grease build-up and blood clots on evisceration table.
  • Cleaning of refrigeration unit frequency not recorded.
  • Cleaning of overhead structures in "old cow boning line" not undertaken.
  • Lunch room benches not thoroughly cleaned.
  • Large amounts of fat and meat build up throughout.
  • Boot foamer chemical bottle not labelled for identification.
  • Specified Risk Material (SRM) container used for conveyance of cleaning chemicals.

All unsanitary conditions were addressed, including:

  • Cleaning of all affected areas undertaken.
  • Cleaning chemicals were placed in a container, which was in turn placed inside SRM container; removed.
  • Boot foamer label addressed.

CAR Number: 038-2012-09
Task Description: Building Maintenance

Summary of Non-Compliance Summary of Corrective Action

Structural and Maintenance issues.

  • Improperly sealed doors.
  • Poor condition of floors causing water pooling.
  • Walls do not meet program requirements.
  • Eye/Hand wash tap broken.
  • One drain had no P-trap insert.
  • Three drain lines from overhead structure in combo storage not effectively plumbed into floor drains causing water pooling.
All structural and maintenance issues were addressed, including:
  • All doors repaired.
  • Floors repaired to prevent pooling.
  • Walls refurbished.
  • Hand/eye-wash station re-plumbed to prevent pooling.
  • P-Trap in drain installed.
  • Drain lines in combo storage fixed.
  • Quality Assurance (QA) manager will re-train QA inspectors on assessing building maintenance.

CAR Number: 038-2012-10
Task Description: Condensation

Summary of Non-Compliance Summary of Corrective Action

Water dripping from overhead structures and beading condensation.

  • Condensation in the offal hallway dripping onto boxed product.
  • Condensation present in combo storage area and slaughter floor
  • Antimicrobial dripping onto rusty pipe and onto product.
  • Improper air flow at the processing floor, maintenance hallway door and CH4 stairwell door.

All ventilation issues were addressed including:

  • Condensation in offal hallway dried and boxed product on which condensation was observed dripping was either repacked or discarded.
  • Plastic barrier placed over affected pipes; pipes repaired or replaced.
  • Store room receiving dock and processing door sealed properly.
  • Enhanced/revised air flow monitoring SOP implemented for monitoring air flow throughout the plant.
  • QA manager has re-trained QA inspectors on assessing and controlling condensation.

CAR Number: 038-2012-11
Task Description: Equipment Maintenance & Calibration

Summary of Non-Compliance Summary of Corrective Action

Equipment maintenance issues.

  • Pitted welds throughout slaughter floor and processing floors were observed.
  • Evisceration table sanitizer water temperature gauge was not functioning.
All equipment maintenance issues were addressed including:
  • Water temperature gauge was replaced.
  • Quality assurance function to detect pitted welds including training of QA inspectors has been instituted.

CAR Number: 038-2012-12
Task Description: General Food Hygiene

Summary of Non-Compliance Summary of Corrective Action

Multiple Food Hygiene issues.

  • Company employees not wearing beard nets.
  • Company employee pulled trim from pipe and then returned to sorting trim without washing/changing gloves.
  • Clean up employee pushed inedible colour coded bucket in a manner that allowed contact with back side of production team members white smocks.
  • Grease and fat build up on grading stamp handles
  • Mesh gloves left on pipe during break.
  • Garbage cans in proximity of white smocks hanging area.
  • Sanitizer in offal packaging below 180 degrees Fahrenheit.
  • Bung bags in contact with sink.

All Food Hygiene issues were addressed including:

  • Supervisor instructed employees to employ beard nets.
  • Employee handling trim without washing/changing gloves immediately halted from handling product.
  • Smocks were changed.
  • Grading stamp handles were cleaned.
  • Gloves were removed from pipe and cleaned.
  • Smocks in proximity to garbage were replaced and cleaned.
  • Sanitizer temperature was addressed.
  • Bung bags were discarded
  • QA manager has retrained all QA and production supervisors on sanitation requirements.

Annex B: CFIA Pre-Resumption Report for XL Foods Inc.

The following text was taken from an official CFIA inspection report regarding the details of the ongoing E. coli O157:H7 investigation at Establishment 38, XL Foods Inc. This document provides accurate information on the status of this inspection and describes the proper precautions taken to ensure facilities have been thoroughly inspected.

Report of Inspector

Reference: Alberta South E. coli Investigation

Owner Information

Owner Name: XL Foods Inc.
R.R. or Street Address: Hwy 1 West
City: Brooks
Province: Alberta
Postal Code: T1R 1C6

Category: Other: Pre-resumption of Operations Inspection
Activity : Inspection
Sub-activity: Other: Pre-resumption of Operations Inspection

Report:

Hallway leading to Kill Zone #3 – Floor was found to be cracked and the company has repaired the floor.

Kill Zone #2 – Sink at heart inspection station required refurbishing and has been repaired.

Chill #3 – Observed some minor beading condensation and was not over product. The company responded immediately and improved air circulation in the affected area.

Grading Cabinet – Used gloves stored with edible product utensils. Gloves were removed, cabinet and utensils were cleaned. Was a minor GMP issue. Employee was verbally retrained. Will be reassessed when operations resume as part of the follow-up to CAR 12 regarding GMPs.

Offal Hallway – Observed rusty battery support for forklifts and the company has finished the refurbishing.

Offal Packaging – Observed a wall that was not smooth and impervious. The company has repaired.

Combo Storage Area – Hand wash sink drain was causing minor water flow on the floor. The sink has been re-plumbed and is directly drained.

Chill #1 – High Line Speed Inspection stand (finals) needs direct drain from hand wash sink. The sink has been re-plumbed and is directly drained.

Offal Packaging – Hand wash sinks need to be directly drained. The sink has been re-plumbed and is directly drained.

Young Tempering Cooler – Observed beads of maintenance oil on rails and overhead structures. The oil was an edible oil and did not pose a product contamination risk as commonly used in this type of operation.

Combo rework bin had poor spotty welds and was repaired.

Sample grinder area – West wall – aluminum joints have numerous open/exposed holes not smooth and impervious. Item was corrected.

Grinder Room – Upper trim sirloin chute has poor welds, pitting, not smooth and was corrected.

Processing Area Main Lunch room – Air gates were dirty and dusty. Items were corrected.

The pre-resumption of operations assessment team consisted of the following members:

Mr. Tom Graham, National Inspection Manager
Mr. Paul K. Littlewood, Regional Director Alberta South, West Incident Commander
Dr. Mike Roberts, Veterinary Program Officer, Meat programs, West
Dr. Jim McClendon, Regional Veterinary Officer, BC Coastal
Dr. Aman Bath, Managing Veterinarian, Est. 93
Mr. Bill Gannon, Area FSEP/CVS Coordinator, West

Date of Report: 2012-10-10

Inspector’s Name: Dr. Satnam Dhothar – Managing Veterinarian, Est. 38

The information on this document is collected by the Canadian Food Inspection Agency under the authority of the Health of Animals Act for the purpose of detecting diseases of toxic substances or ensuring compliance with this Act and the regulations. Information may be accessible or protected as required under the provisions of the Access to Information Act.

Annex C: Letter to CFIA from XL Foods Inc.

PDF (51 kb - english only)

Barbara Jordan,
Associate Vice President, Operations Branch,
Canadian Food Inspection Agency

October 18, 2012

Ms. Jordan;

RE: XL Foods’ Affirmation of Commitment to Food Safety

XL Foods Inc. is committed for converting the cultural behaviour of all management related to Food Safety throughout the organization by the implementation of the following changes from the top down through the organization.

Senior management will verbally state in a meeting to all staff, and post the letter of commitment for all employees to read and understand. That the safety of all food products manufactured in the facility is the utmost importance to provide safe and wholesome food to our customers and the end consumer. All employees (top down) understand that the basic fundamentals of sanitary dress, intervention strategies, job requirements and expectations they must perform to ensure safe handling practices are employed by all employees within the facility.

Food Safety organizational structure – see the attached organizational chart within the facility. All Management has responsibilities for overseeing the foods safety program and ensuring compliance to these programs and procedures.

  • The Director of Technical Services, Technical Service Managers work closely together to oversee the programs, data and trend analysis (both daily tests and ongoing data collection for trending and verification of processes).
  • QA staff is responsible for working with CFIA inspection staff to monitor the foods safety performance with the use of tools such as micro data, CCP and OPSAN observations, compliance to FSEP pre-requisite programs and CVA tasks.
  • Ongoing educational training for QA staff and management with the enhanced educational sessions on food safety related topics by 3rd party training partners
  • We are working with senior business consultants to assist and advise the staff on food safety, training and research objectives to assist in ongoing improvements related to the process.
  • QA staff will be selecting 2 additional staff members to work on the sanitary dress performance on an ongoing basis to drive improved sanitary dress performance.

The facility is committed to becoming recertified under the requirements of the Global Food Safety initiative (GFSI), the facility lost certification of the BRC program in October by not completing the audit. This audit has been rescheduled for early 2013 by the certification body.

The management and hourly work force will participate in enhanced training sessions related to food safety to improve their know and understanding of important principles. With the use on new observation tools such as Remove Video Auditing (RVA), Management will be notified of discrepancies in performance and will be able to council the employee in one on one situation with video evaluation results. Performance can be documents and tracked as to high performers or poor performers. This provides Senior management and Supervisory level management with tools to assess individual employee or job performance rating system.

Intervention strategies will continue to be assessed. Once operational we ill re-validate the Hot water wash intervention due to recent extension of the cabinet and the fabrication primal intervention where a conversation of the chemical to Lactic Acid has occurred. The company has also committed to modifying the Pre-Evisceration Carcass wash (PECS) cabinet to a Hot water wash that CFIA provided approval on September 14, 2012. This PECS hot water was will be installed in the facility by February 2013. This time frame is needed to build the necessary infrastructure to support the cabinet with the needed hot water volumes, recirculation tank and ventilation system to ensure we meet the food safety policies of the company and CFIA.

The plant management and QA staff will provide prompt and compete responses to CFIA on all issues. We will commit to providing these responses in a timely manner and ask necessary clarifying questions as needed to provide the desired information in an efficient concise manner, Warren Klymchuk is the technical Services Manager at the plant and the first point of contact for CFIA.

Everyone has a responsibility to perform and ask questions or bring concerns to the management.

Sincerely,

Brian Nilsson Co-CEO
Lee Nilsson Co-CEO