CFIA Assessment of Establishment 38, XL Foods Inc.
Section 3: CFIA Observations and Findings

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.