Government of Canada
Symbol of the Government of Canada

Audit of the CFIA Operational Controls for Establishment 630

Approved December 4, 2008.
Risk Oversight Directorate
Audit Evaluation and Risk Oversight


TABLE OF CONTENTS


1.0 Introduction

Establishment  630 was a slaughter facility federally registered under the Meat Inspection Act, operated by Rancher’s Beef Ltd. in Balzac, Alberta.  The establishment operated from June, 2006 until August, 2007. Subsequent to the establishment’s closure, there was a recall of  meat products originating from the facility in the autumn of 2007.  Following the recall which affected both the Canadian and the United States’ markets, the Canadian Food Inspection Agency (CFIA) initiated an operational audit of the Agency’s inspection/oversight practices and processes associated with Establishment 630. 

2.0 Objective, Scope and Methodology

2.1 Objective

The objective of the audit was to provide assurance on the adequacy and effectiveness of CFIA operational controls for the inspection/oversight of Est. 630.

2.2 Scope and methodology

The audit covers the period of operation of Establishment 630 from June 29, 2006, to August 15, 2007 and touches upon key aspects of the ensuing food safety investigation in the autumn 2007. This time frame covers the licensing and registration of Est. 630 and the operation of the facility before the food safety investigation and parallel recalls in both Canada and the United States.  Appendix 1 provides a chronology of these events.

In carrying out the audit, the AERO team interviewed personnel from the CFIA Policy and Programs, Operations and Science Branches who had been involved with Establishment 630 from its conception to its closure. Personnel from Agriculture and Agri-Food Canada (AAFC) were also interviewed regarding the financing of Est. 630. In addition, the audit examined Food Safety Enhancement Program (FSEP) audit files, internal briefing notes and correspondence and documents pertaining to the Establishment.

The Policy and Programs, Operations and Science Branches were asked to respond to the audit findings.  A summary of the resulting action plan is presented in Appendix 2.

3.0 Background

In May 2003, the United States closed its border to Canadian cattle because of concerns with bovine spongiform encephalopathy (BSE), which had been confirmed in a Canadian-born animal from Alberta. The ban prevented Canadian producers from shipping live cattle to the US for slaughter, consequently creating a pressing need for more slaughter capacity within Canada.  Est. 630 was conceived in response to this need.

The company profile of Rancher’s Beef Ltd. indicated that it was a partnership of 48 unit holders, the majority of whom were cattle producers. As part of Est. 630’s initial funding, AAFC’s Ruminant Slaughter Loan Loss Reserve Program provided a $20 million loan guarantee to the company through the Alberta Treasury Branch.  The Rancher’s Beef business plan was based on high value-added traceable meat products to be sold in non-traditional export markets (the facility was certified to ship to 20 different countries).  Intended to be state-of-the-art, the facility made use of technology developed in Europe that would allow the establishment to trace the entire history of any piece of meat—from the originating animal and the farm where it lived.

The audit included an examination of public financial support and its impact on CFIA’s approval and inspection of the facility.

4.0 Observations and Recommendations

The adequacy and effectiveness of operational controls undertaken by CFIA staff personnel assigned to Est. 630 for both inspection/oversight and the food safety investigation were the focus of this audit. Six operational management areas served as the basis for the audit’s criteria: 

  • Appropriate CFIA response to the operating environment at Est. 630;
  • Effective staff recruitment, retention and training;
  • Clarity of the CFIA E. coli 0157:H7 policy;
  • Appropriate time limits for Food Safety Enhancement Program acknowledgement;
  • Appropriateness of laboratory testing confirmation protocols with the Public Health Agency of Canada; and,
  • Pre-approval of facility blueprints.   

In response, the Agency’s Policy and Programs, Science and Operations Branches have developed an action plan to better equip the Agency to prevent a reoccurrence of a similar situation. A summary of the action plan, including target dates, for implementation is attached in Appendix 2.  

4.1 Control of the operating environment

Est. 630’s Hazard Analysis Critical Control Point (HACCP) plan was reviewed by CFIA in accordance with the Meat Inspection Regulations, 1990, prior to the commencement of operations at the facility.  This pre-operational plan met the prescribed basic control requirements.  Once production began, initial production control was achieved, with some exceptions (e.g., ventilation, computer-based tracking and tracing system, sanitation issues). CFIA staff worked diligently with the facility’s management to address these shortcomings while ensuring that food safety requirements were fully met through daily inspection controls. 

The facility continued to operate in spite of mounting financial difficulties due to a change in the economic environment since the conception and the start-up of Est. 630. The US-Canadian border re-opened to live cattle, thus reducing the number of animals available for slaughter in Canada.  The increase of the value of the Canadian dollar eroded the profitability of the meat processing industry.

Partly as a result of these difficulties, control problems were encountered and persisted which necessitated the intervention of CFIA inspection staff in matters typically the responsibility of facility management. CFIA inspection and operating procedures were adjusted accordingly, for example, E. coli testing results generated by the facility’s in-house laboratory were required to be shared with inspection staff and the Veterinarian-in-Charge on a daily basis.  This procedure was adopted to ensure product not meeting regulatory standards was diverted from the uncooked meat market to cooking or holding.  By July 2007, all product from Est. 630 was being shipped to cold storage and held rather than sold for consumption due to E. coli 0157:H7 contamination and inventory control problems at the establishment.

During the period in which Est. 630 was coming online and operating, CFIA was using parallel inspection systems in slaughter facilities. The first was traditional inspection system, the Multi Commodity Activities Program (MCAP).  In-house MCAP inspectors were responsible for identifying any deficiencies and regulatory compliance issues during their daily oversight of line operations and for obtaining commitments from management to correct those deficiencies.

The second was the HAACP-based Food Safety Enhancement Program (FSEP) which relied on regular audits of documented quality control processes in the establishment deemed critical to support food safety outcomes (e.g., metal detection, pathogen testing, temperature controls, etc.).  FSEP auditors were also responsible for following-up to determine whether establishments had corrected deficiencies identified by the FSEP audits within established timeframes.

The unique challenges presented by Est. 630 and subsequent operational control breakdowns at the facility demonstrated that the two inspection systems were not sufficiently aligned to allow for the aggregation of FSEP and MCAP observations of instances of non-compliance.  The result was a the time-lag between the point at which inspectors first notified management of a deficiency, the subsequent FSEP audit and the beginning of any enforcement action.

Recommendation 1:  The Agency should better integrate its existing inspection approaches in all federally-inspected meat establishments.

4.2 Staff recruitment, retention and training

The audit noted that because of staffing shortages associated with the Alberta employment market and the concentration of federally-registered slaughter operations resulting in a disproportionate volume of work for meat inspection in the Alberta South Region, key CFIA supervisory inspection staff there are often responsible for a greater number of establishments than their counterparts in other regions. 

As a result, inspection supervisors were regularly absent from Est. 630 while conducting required work in other federally-registered facilities. These periodic absences did not jeopardize export requirements or present a food safety risk as CFIA maintained its requirement for daily presence of inspection staff, however they did create temporary gaps in the chain of command which may have impeded communications relating to non-compliance issues both among CFIA staff and between the Agency and the management of the establishment.   

There was also a high rate of turnover in inspection staff as a result of alternate employment opportunities associated with the regional job market. The CFIA inspection staff assigned to the start-up and early operation of the establishment were new employees to the Agency and had received their inspection training at a facility that used traditional processing technology.

Recommendation 2: The CFIA should design a new staffing process for assigning staff – whether new or existing – to the initial coming on line of a new slaughter or processing facility. Inexperienced or new hires to the Agency should not be assigned to a new facility without the support of more experienced inspectors.

The Agency should also review the adequacy of the number of Regional Veterinary Officers in its regions based on an analysis of the geographically-based activity volume.

4.3 Clarity of the E. coli O157:H7 policy

The audit determined that the CFIA’s existing E.coli O157:H7 policy would benefit from review and revision in key respects.  Also, the increased prevalence of E. coli O157:H7 in Canada and the United States indicates that regulatory oversight and measures to control this pathogen need to be re-evaluated.

Based on the audit team’s observations, the were different interpretations of the requirements set out in the policy. Specifically, it did not provide adequate precision in its guidance for either CFIA staff or establishment operators in key areas, including lot sampling size and techniques, test result interpretation and the limits on re-testing requirements for products.

The audit also noted that the policy requires greater clarity with respect to critical control points (CCPs) for ensuring the identification, traceability, redirection and further processing or diversion of products such as beef trim (meat to be used to make ground beef).  

Finally, it was also observed that at the time of the audit that no training specific to E. coli 0157:H7 existed for CFIA staff.

Recommendation 3: In consultation with stakeholders, the CFIA should redraft the E. coli 0157:H7 policy to address the concerns noted above and make it more clear and useful to users. While it is not necessary to dictate a specific CCP when revising the policy, the redrafted policy should require that all registered establishments that produce beef trim identify a satisfactory CCP for E. coli 0157:H7. Establishments should be required to do so before the Agency will accept their HACCP plan.

The Agency should also develop appropriate training material specific to E. coli 0157:H7. 

4.4 Time limits for FSEP acknowledgement

According to the FSEP requirements at the time, the CFIA was required to perform a preliminary review of Est. 630’s HACCP plan for basic content prior to the facility receiving its license to operate. 

While development of a complete FSEP system was a mandatory licensing requirement for meat establishments at the time of Est. 630’s licensing, the facility had to be able to begin production in order for the CFIA to verify and validate the effective implementation of the HACCP system.  In order to become FSEP acknowledged, Est. 630 would have had to undergo an FSEP audit subsequent to commencement of its operations and have no identified major outstanding recommendations (corrective action requests).  

The FSEP manual does not specify for how long a facility can continue to operate without receiving full FSEP acknowledgement.  Scheduled audits of Est. 630 continued to identify outstanding major corrective action requests on three separate occasions. The facility had HACCP system implementation problems and did not attain the level of "self-control" required to receive FSEP acknowledgment during its lifespan from June 2006 to August 2007.  Although Est. 630 never successfully completed the FSEP acknowledgement process, it is important to note CFIA inspection staff carried out regular daily inspections to ensure Est. 630 met the basic health/safety and other requirements set out in the meat inspection manual.

Recommendation 4: The FSEP policy should be revised to clarify the timeframe for obtaining FSEP acknowledgement.  The revised policy should require new establishments to meet all FSEP requirements for food safety, including formal validation of the effectiveness of the HACCP plan, within a specific timeframe and the FSEP Manual should be revised accordingly.

4.5 Laboratory testing for food safety investigations

As part of the recall of product from Est. 630 produced between June 8 and August 15, 2007, samples were taken of product that was being detained in a cold storage facility.  A number of samples were found to be positive for E. coli 0157:H7. These positive samples were sent to a third party laboratory for more specialized testing ("genetic fingerprinting") for which the CFIA does not have the capacity. Results of this testing are used to compare the E. coli findings in food products with those reported in human cases of illness which may be associated with consumption of the product. In the case of Est. 630, the need for third party testing resulted in a longer turnaround time for results in support of the food safety investigation and recall.

Recommendation 5: The Agency should work with the third party laboratory to improve communication and co-ordination and determine how best to get final laboratory results more quickly. In addition, the CFIA should explore various options for testing, including building in-house capacity.

4.6 Pre-approval of facility blueprints

The Meat Inspection Regulations, 1990 require establishments to submit detailed plans (i.e., blueprints) and specifications to the Agency when they apply for registration. The CFIA’s role in pre-approving blueprints is limited primarily to examining aspects of the flow of people and products that might create food safety hazards.

No regulation requires that the CFIA review and approve blueprints of federally-registered meat processing facilities in terms of design and construction. The applicant—not the CFIA—is responsible for ensuring that blueprints reflect and comply with all relevant construction standards and requirements.

The fact that an applicant must submit blueprints to the CFIA as a condition of obtaining an operating licence may lead to the inference or perception that the Agency is approving all aspects of a facility’s design and construction.

Recommendation 6: The Agency should phase out the current pre-approval process related to the Meat Inspection Regulations, 1990 while continuing to assess people and product flows only in the context of FSEP requirements

Appendix One: Chronology of key events relating to Est. 630

May 2006:  The CFIA completes and approves HACCP checklist for Est. 630.

June 2006:  Est. 630 begins operating.  The level of CFIA oversight at the establishment is consistent with the standard of inspection service provided to all federally-registered beef slaughter establishments.

September 2006:  The CFIA approves the export of Est. 630 products to the U.S. The first export shipment to the U.S. is certified by the CFIA in October 2006.

Fall 2006/Winter 2007: Ongoing CFIA inspection at the establishment. As in all federally-registered establishments, when non-compliance is identified during routine inspections and audits, establishment management is notified and corrective actions are taken.

March 2007:  CFIA personnel meet with Est. 630 management to discuss some on-going compliance issues and to obtain a commitment to improvement.

June 2007:  CFIA carries out an audit of Est. 630. Due to continuing non-compliance at the establishment, CFIA staff meets with Est. 630's management to discuss continuing non-compliance and the consequences of not addressing the outstanding concerns.

The CFIA requires that the company immediately put in place a process by which the company holds all product until negative results for microbial testing are received. The CFIA implements 100% inspection of shipments leaving the cold storage facility. If product tests positive, it is to be re-directed for use only in a fully cooked product (which destroys contaminating pathogens) or to be sent to rendering.

July 2007: CFIA follow-up in early July determines that remedial actions are not being appropriately implemented. The CFIA places all existing product from Est. 630 under detention and initiates action to remove the establishment's licence to operate.

August 2007:  On August 15, before the licence removal process is completed, Est. 630 ceases operations on their own accord. All remaining product remains under CFIA detention to prevent further movement. The CFIA requires that the company complete and present an in-depth food safety verification prior to release of any product for sale. As a result, from this point, only a small amount of product is shipped.

September 2007:  On September 29, the CFIA is contacted by the United States Department of Agriculture (USDA) regarding an E. coli outbreak in the US dating back to June 2007 which implicates the Topps Meat Company. The USDA recalls meat potentially contaminated with E. coli O157:H7.  Rancher's Beef is identified as one of several suppliers to the Topps Meat Company during the time period in question.

The CFIA begins a thorough food safety investigation. Rancher’s Beef product produced between April and August 2007 that are still under detention are sampled and tested.

October 26, 2007:  The CFIA issues a Health Hazard Alert for possible E. coli contamination of Est. 630's products.

October 27, 2007: Based on test results and a risk assessment conducted by Health Canada, the CFIA issues a Class I Recall and Public Advisory for Est. 630 products produced June 13, 2007.

November 2, 2007: After uncovering additional information at the establishment, the CFIA issues a Class II Recall for products produced by Est. 630 between June 8, 2007 and August 15, 2007. After November 2, the CFIA issued further alerts and recall updates on November 3, 6, 13 and 15.

December 2007: The CFIA supervises the disposal of the remainder of the Est. 630 product still under detention.

Appendix Two: Management Action Plan - Summary (July 2009)

Control of operating environment

Recommendation 1:

The Agency should better integrate its existing inspection approaches in all federally-inspected establishments.

Assessing management controls
ACTION PLAN ITEM ACCOUNTABILITY COMPLETION DATE

1. For establishments identified as having management challenges, local CFIA staff, in collaboration with their managers will undertake immediate actions to establish an Issue Analysis group and:

a. Review the operator’s written programs through CVS to verify the implementation and effectiveness.  Compliance will be determined by completing focused verification tasks by inspection staff. 

b. Conduct a systems review of the establishment using two Regional Veterinary Officers (RVOs).  One RVO will be from the Area where the establishment is located and the other RVO will be from another Region or Area and be a member of the CFIA National Correlation Team.

c. Ensure supervisors are conducting regular QMS verifications to ensure the quality of work.

d. Undertake a national verification of systems as required, involving national staff from both program and operational offices.

Executive Directors,  Operations Branch

Executive Director, Animal Products Directorate,  Policy and Programs Branch

Completed

2. As part of an internal evaluation of the full implementation of CVS, a two year pilot project will be conducted. A total of 5% of meat establishments will be annually subjected to review through the Issue Analysis Team (IAT), approach.  Establishments selected will be based on food safety findings (CARS issued), and other triggers noted by Area management warranting review.  The results of this process will be provided to the VP Operations and an assessment of the process will be made.

Executive Directors, Operations Branch

March 2010

 

Integrating inspection/audit activities
ACTION PLAN ITEM ACCOUNTABILITY COMPLETION DATE

1. CVS implementation in all federally registered meat establishments.

Area Executive Directors,  Operations Branch

Completed

Staff recruitment, retention and training

Recommendation 2:

The CFIA should design a staffing process for assigning staff – whether new or existing – to the initial coming on line of a new slaughter or processing facility. Inexperienced or new hires to the Agency should not be assigned to a new facility without the support of more experienced inspectors

The Agency should also review the adequacy of the number of Regional Veterinary Officers in its regions based on an analysis of the geographically-based activity volume.

Staffing and Workload
ACTION PLAN ITEM ACCOUNTABILITY COMPLETION DATE

1. CVS implementation in all federally registered meat establishments.

Area Executive Directors,  Operations Branch

Completed

2. Quality Management System implemented and a review of the necessity to hire additional RVO for specific geographic regions.

Area Executive Directors,  Operations Branch

Completed

3. Continuation of staffing recruitment and retention strategies and facilitation of training.  This will include recruiting additional staff, where possible, to cover absences.

Area Executive Directors,  Operations Branch

Human Resources Branch

Completed

4. A review of the workload of RVOs will be undertaken to determine if and where additional RVOs should be staffed.  This may result in an increase in the number of RVOs in Regions with a greater number of operational meat establishments. 

Executive Directors, Operations Branch 

Completed

 

CFIA Staff Experience and Training
ACTION PLAN ITEM ACCOUNTABILITY COMPLETION DATE

1. Full CVS implementation in April 2008 will initiate the verification process for registered establishment compliance to regulations.

Area Executive Directors,  Operations Branch

Completed

2. Quarterly QMS verifications will be conducted by supervisors (RVOs) to ensure the quality of work. Results are kept in QMS records and reviewed on a regular basis.

Area Executive Directors, Operations Branch

Completed

3. For new establishments, a special staffing process of pairing an experienced team of inspectors to assist the new permanent inspection staff will be developed.  This would entail staffing new establishments with an experienced team of inspectors to assist the new permanent inspection staff.  The new establishment assistance team would remain until operations are considered satisfactory shift the responsibilities completely to the regular inspection team as they develop expertise to manage.

Area Executive Directors,  Operations Branch

Completed

4. A clear national training protocol for new inspectors including CVS and FSEP will be developed by the Professional and Technical Development Division in collaboration with Policy and Programs Branch and Operations Branch.

National FSEP/HACCP Coordinator,  Operations Branch

Professional and Technical Development, Human Resources Branch

Completed

CFIA’s E. coli 0157:H7 Policy

Recommendation 3:

In consultation with stakeholders, the CFIA should redraft the policy to address the concerns noted above and make it more clear and useful to users. While it is not necessary to dictate a specific CCP when revising the policy, the redrafted policy should require all registered establishments that produce beef trim to identify a satisfactory CCP for E. coli 0157:H7. Establishments should be required to do so before the Agency will accept their HACCP plan.

The Agency should also develop appropriate training material specific to E. coli 0157:H7. 

ACTION PLAN ITEM ACCOUNTABILITY COMPLETION DATE

1.  Provide an amended draft CFIA E. coli 0157:H7 policy, including a requirement for a satisfactory CCP related to E. coli 0157:H7 control and improved clarity of direction, to stakeholders for consultation.

Director, Meat Programs Division,

Policy and Programs Branch

National FSEP/HACCP Coordinator , Operations Branch

Completed

2.  Publication of the amended CFIA E. coli 0157:H7 Policy in the CFIA Meat Hygiene Manual of Procedures (MOP).

Director, Meat Programs Division, Policy and Programs Branch

National FSEP/HACCP Coordinator,  Operations Branch

Completed

3.  Develop Compliance Verification System (CVS) tasks related to the amended E. coli 0157:H7 policy.

  • Task to verify operator sampling activities required in the revised E. coli Policy
  • Task to verify that the operator’s E. coli policy meets program requirements (to be developed in conjunction with the development of the training materials)

Director, Meat Programs Division, Policy and Programs Branch

National FSEP/HACCP Coordinator,  Operations Branch

Completed

4.  Contact USDA concerning feasibility of developing and delivering joint training on E. coli0157:H7.

Director, Meat Programs Division, Policy and Programs Branch

Completed.

5. Train CFIA staff on the new E. coli 0157:H7 Sampling Plan through:

  • Holding a Train-the-Trainer session.
  • Rolling out training across the country with inspection staff.

Operations Branch,

Policy and Programs Branch

Completed

6. Development of formalized training materials and training plan for overall E. coli 0157:H7; and deliver the first round of training to CFIA personnel.

Director, Meat Programs Division, Policy and Programs Branch

National FSEP/HACCP Coordinator,  Operations Branch

Completed

7. Continue efforts to harmonize requirements for E. coli 0157:H7 policy and testing work with USDA by:

  • Initiating regulatory raw beef trim testing requirements for imported product to maintain equivalency with the USDA.
  • Providing comments to the further elaboration of the USDA Pathogenic E. coli 0157:H7policy with a view to greater harmonization.

Director, Meat Programs Division, Policy and Programs Branch

Completed

Time limits for formal FSEP acknowledgement

Recommendation 4:

The FSEP policy should be revised to clarify the timeframe for obtaining FSEP acknowledgement.  The revised policy should require new establishments to meet all FSEP requirements for food safety, including formal validation of the effectiveness of the HACCP plan, within a specific timeframe and the FSEP Manual should be revised accordingly.

ACTION PLAN ITEM ACCOUNTABILITY COMPLETION DATE

1a. The FSEP Manual – Appendix VIII – Mandatory FSEP/HACCP will be reviewed and amended to clearly define the HACCP system acknowledgment process under the Meat Inspection Act and its regulations.  This will reflect the CFIA verification of implementation of the HACCP system using the meat Compliance Verification System (CVS).

1b. Verification of implementation of the HACCP plan will be required no later than two months of an establishment becoming operational.

1c. A meeting with the Area FSEP Coordinators is scheduled in March 2008.  The Area FSEP Coordinators will be instructed to implement the new procedure immediately.

National FSEP/HACCP Coordinator, Operations Branch

Completed

 

2. Harmonize the FSEP Manual with the Meat Programs internal procedure for CFIA staff regarding the process of registration of an establishment and licensing of an operator (dependent on Action Plan Item 1 completion).

National FSEP/HACCP Coordinator, Operations Branch

National Plant & Equipment Evaluation Specialist, Meat Programs Division, Policy and Programs Branch

Completed.

3. The USA export section of Chapter 11 of the Meat Hygiene Manual of Procedures will be amended to remove reference to the basic compliance checklist.  An establishment meeting Canadian FSEP requirements (as required for domestic production) will be considered equivalent to meeting USA requirements.

Director, Meat Programs Division,  Policy and Programs Branch

Completed

Laboratory testing for food safety investigations

Recommendation 5:

The Agency should work with the third party laboratory to improve communication and co-ordination and determine how best to get final laboratory results more quickly. In addition, the CFIA should explore various options for testing, including building in-house capacity.

ACTION PLAN ITEM ACCOUNTABILITY COMPLETION DATE

The CFIA labs undertake the initial testing for the presence of E. coli 0157:H7.  Once confirmed, the isolates are sent to a third party laboratory for PFGE patterning.  PFGE results are then compared to those from human health cases.

 

1. CFIA and the third party laboratory staff have met and agreed to:

  • a single point of contact between CFIA and the laboratory to deal with laboratory testing during an investigation
  • CFIA providing a prioritized list/and the urgency of samples for testing
  • the laboratory providing a service standard for this service
  • the laboratory has increased its capacity to handle larger volumes of isolates
  • CFIA will continue to investigate delivery of this testing in-house

Director, National Laboratory , Operations Branch

Science Branch

Completed

CFIA Pre-approval of facility blueprints

Recommendation 6:

The Agency should phase out the current pre-approval process related to the Meat Inspection Regulations, 1990 while continuing to assess people and product flows only in the context of FSEP requirements.

ACTION PLAN ITEM ACCOUNTABILITY COMPLETION DATE

1. Identify and amend current parts of the meat inspection program (and associated FSEP or CVS tasks), so CFIA approval of blueprints is no longer required.  CFIA will however continue to review blue prints or plant schematics as required for HAACP recognition in order to assess people and product flows as well as humane treatment of animals.

Director, Meat Programs Division,  Policy and Programs Branch

Completed.

2. Remove the requirements for CFIA blueprint approval from Chapter 2 of the CFIA Meat Hygiene Manual of Procedures (MOP), and all other points where such approval is referenced in the MOP.

Director, Meat Programs Division,  Policy and Programs Branch

Completed.