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Lessons Learned: The Canadian Food Inspection Agency’s Review of Est. 97B (Maple Leaf Consumer Foods Inc.)

April 17, 2009

Table of Contents

Executive Summary

Introduction

This report presents lessons learned from reviews of the Canadian Food Inspection Agency’s (CFIA) inspection activities at a meat processing facility owned and operated by Maple Leaf Consumer Foods Inc. (MLF) Establishment 97B (Est. 97B). 1  The review covers CFIA’s inspection and testing activities at Est. 97B during the time period when products implicated in the 2008 listeriosis2 outbreak were produced and shipped from this facility. Also included are considerations of an investigation by a panel of international experts conducted by Maple Leaf Foods and a subsequent in-depth review by CFIA staff of the facility after MLF suspended production at Est. 97B in August 2008. Finally, the report presents actions undertaken to date as well as those in the implementation phase.

In the summer of 2008, an extensive food safety investigation and subsequent epidemiological trace out by the CFIA, Health Canada (HC) and the Public Health Agency of Canada (PHAC) that also involved several provincial/local health authorities, revealed widespread Listeria3 contamination of meat products from Est. 97B. The source of illness was linked to ready-to-eat meats produced at Est. 97B. Of the 56 confirmed cases and 2 probable cases, there were 20 deaths4 where listeriosis was the underlying or contributing cause of death. By late August 2008 the entire production of the 192 meat products (e.g. sliced roast beef, bologna, etc.) produced and distributed from this facility was recalled from the market place.

Regulations and Requirements for Federally Registered Establishments

Meat processing facilities operating in Canada and shipping product inter-provincially or internationally are required to be registered and licensed under the federal Meat Inspection Regulations which fall under the provisions set out in the Meat Inspection Act (R.S.C. 1985, c.25). These regulations require the licensed operator to establish operating controls/food safety systems and practices and to comply with the regulations. Effective in 2005, changes to the Meat Inspection Regulations required all federally registered animal slaughter and processing facilities to develop and implement a risk-based food safety system, commonly known as Hazard Analysis Critical Control Points (HACCP). Under this system Health Canada and the CFIA set out the food safety requirements. The CFIA through its compliance and enforcement program inspects to verify compliance.  The licensed operator establishes the control system to meet these requirements and ultimately has responsibility to produce and distribute safe food.

With the introduction of mandatory HACCP regulations the CFIA developed and piloted a system to improve the efficiency and uniformity of the inspection approach to verifying operators’ compliance with HACCP’s food safety controls and other applicable federal regulations (e.g., labelling, grading, etc.). The new system is called the Compliance Verification System (CVS).

CVS Inspection and Sampling Results at Est. 97B (2007 – 2008)

The inspection records for Est. 97B show that, for the most part, the facility achieved acceptable levels of compliance with CVS inspection and sampling tasks. In cases when deviations were noted the facility staff undertook the required corrective actions within the prescribed time period and the subsequent follow-up verifications confirmed the deviations were corrected.

The majority of federally registered meat processing establishments, including Est. 97B, frequently conduct both environmental and end product sampling and testing as part of their own food safety quality assurance plans which is over and above the testing requirements set out by the CFIA. Environmental sampling covers the physical plant such as drains, and food contact surfaces.  MLF have confirmed that as part of its food safety quality assurance program, staff at Est. 97B undertook environmental swabbing of the plant for Listeria spp.  In addition, Est. 97B staff collected and tested at least one sample of ready-to-eat meat end product per month in accordance with the CFIA requirements for establishments eligible to export to the U.S. (risk-based L. mono sampling).

All of the end products sampled by MLF during the first 6 months of 2008 for L. mono showed no Listeria contamination. Subsequent to the outbreak, Est. 97B staff provided the CFIA with documentation that the environmental sampling program for Est. 97B had identified positive results for Listeria spp. on a number of occasions between May - August. The MLF Directive for Environmental Listeria spp. Swab Monitoring, outlines the corrective actions to be followed when a positive result is found, including additional sanitation action and retesting to verify that the site sampled no longer had Listeria. The retesting approach is consistent with the Health Canada Listeria Policy and aims to determine persistent Listeria contamination.5

The CFIA inspection staff verified Est. 97B general sanitation procedures according to the CVS frequency and procedures. At the time, Establishment 97B was not obliged to report the Listeria spp. positive environmental sample results to the CFIA’s inspectors.  As a result, the CFIA did not have the knowledge of the Listeria test results for Est. 97B and thus could not conduct a trends analysis or root cause assessment. Recently announced changes requiring registered establishments to conduct environmental Listeria testing and notify CFIA of positive test results have addressed this situation. 

Determining the Cause of the L. mono Contamination

Following the outbreak, MLF and the CFIA (in conjunction with Health Canada and the Public Health Agency of Canada) undertook extensive reviews of the circumstances surrounding the contamination at Est. 97B.  The purpose of the reviews was to identify the cause of the contamination and mitigating measures taken by Est. 97B as well as to develop new Listeria control policies and inspection approaches to assist in identifying and controlling Listeria in all federally registered meat processing establishments.

After production was suspended at Est. 97B on August 20, MLF convened a panel of international experts to investigate the source of the product contamination in the facility. MLF management advised the CFIA that the expert panel identified five sources of contamination, four being environmental. The CFIA was further advised that the panel concluded the major probable cause of the listeriosis outbreak was contamination of the ready-to-eat meat products by a particular commercial meat slicer; the belief being the slicer harboured organic material and provided a site for growth of Listeria. This created a new risk that had not previously been identified in the Est. 97B HACCP plan. The existing sanitation protocols proved ineffective at removing the contaminated organic material harboured deep within the slicer.

The results of the CFIA in-depth review confirmed several of the MLF expert panel observations and identified additional factors that may have contributed to the Listeria contamination, including insufficient written disassembly and inspection procedures for slicers; potential for cross-contamination as a result of employee flow between different rooms; structural damages and poor maintenance in RTE rooms; and several biological, chemical and physical hazards not properly identified or addressed in the company’s HACCP plan.

Corrective Actions Taken Prior to Restarting Operations at Est. 97B

Following the expert panel review, MLF performed several thorough chemical sanitation cycles of the establishment followed by microbial testing of the plant environment and equipment. In response to the expert panel findings, MLF made several changes to its sanitation program, operating procedures within its HACCP system, and plant construction.

As a result of findings during its in-depth review, the CFIA issued four Corrective Action Requests for areas where non-compliance was identified. MLF was required to develop and implement corrective actions prior to the resumption of operations in the establishment. Upon the restart of operations, the CFIA intensified inspection coverage at Est. 97B.

Lessons Learned and Progress to Date

These lessons learned are derived directly from the experience of the listeriosis outbreak linked to Est. 97B and from a broader assessment conducted by the CFIA and Health Canada of issues related to Listeria control that identified changes required across the system as part of a commitment to continuous improvement of the food safety inspection system.

The lessons learned are grouped according to the following categories: CFIA’s inspection policies and procedures; Health Canada’s Listeria monocytogenes Policy for RTE Foods; and Enhanced Proactive Approach to Identifying Risks Posed by Microbial Contaminants in Food. The actions and progress to date are described for each set of lessons.

1. Strengthen CFIA’s Inspection Policies and Procedures

The following actions would strengthen CFIA’s inspection policy and procedures:

  1. Require establishments to notify the CFIA inspector immediately of any positive test results (environmental (i.e., food contact surface) and end product) with the potential to impact the safety of the food being produced.
  2. Enhance the current inspection approach to include a risk-based task of observing more frequent in-plant cleaning and sanitation cycles (where not currently being practiced).
  3. Improve the capacity to conduct trend analysis of test results in order to provide the CFIA with the information necessary to identify a persistent source of contamination.
  4. Reassess the adequacy of cleaning and sanitizing procedures for slicing equipment relative to any new risks identified.

Actions and Progress to Date – Inspection Policies and Procedures

On September 5, 2008, an industry and plant advisory notification was issued regarding the proper cleaning and sanitation of slicing equipment.6  Also in September, inspection procedures were strengthened and new inspection tasks were added requiring CFIA inspection staff to:

  • Review company records of finished product and environmental test results on a daily basis;
  • Review cleaning and sanitation programs used in all federally registered RTE meat plants to control bacteria and other foodborne diseases;
  • Analyse trends in positive environmental test results which would flag any potential problems early so that immediate corrective actions can be taken;
  • Enhance oversight of sanitation and equipment maintenance including on-site observation of equipment cleaning and inspection and testing;
  • Increase the frequency of on-site inspections.

In response to their own expert panel’s findings, as well as those of the CFIA’s in-depth review, MLF has undertaken significant changes to the sanitation control program, operating procedures within its HACCP system, and plant construction at Est. 97B. CFIA inspection staff verified the changes introduced and have subsequently re-assessed Est. 97B and found the operation to be compliant with relevant regulatory requirements. A phased in approach to production and distribution was adopted with enhanced oversight control and hold-test measures.

A CFIA-Health Canada Working Group reviewed and updated CFIA’s directives regarding the control of Listeria in federally-registered RTE meat processing plants. In February, 2009 the section of the Manual of Procedures7 on Listeria was updated. The main changes are as follows:

  • Operators producing RTE meat products must implement food contact surface testing programs in accordance with the prescribed requirements by April 1, 2009.
  • Where applicable, operators must also implement the "Risk based verification sampling of Ready-to-Eat (RTE) Meat and Poultry Products" by April 1, 2009.
  • Operators must perform trend analysis on their test results.
  • Plant operators to notify the CFIA immediately of any positive food contact surface area test results.
  • The CFIA has implemented a food contact surface testing plan in establishments producing RTE meat products (sampling plan M205).
  • Effective April 1, 2009, the food contact surface testing plan will be implemented jointly with the product testing plan (sampling plan M200). In 2009-10, the sampling frequency is six times per year per establishment for Listeria, e-coli, Salmonella and Campylobacter.
  • Affected staff will receive training in order to be able to complete the Compliance Verification System tasks associated with these requirements/controls in an effective and consistent manner.

Actions under Development or to be Implemented

The CFIA will review risk profiles of all federally registered ready-to-eat meat processing establishments with a view to adjusting the CVS inspection and sampling tasks and frequencies, as necessary.  Changes in production and distribution and marketing of products of potentially higher risk to vulnerable sectors of the population will be considered in the review of risk profiles.

The CFIA will provide training, tools and technical support to front-line inspection staff in investigating potential risks to food safety that may or may not be covered by the operator’s HACCP plan or CVS inspection and sampling tasks and to provide additional oversight of inspection activities (e.g. audits and quality management).

The CFIA will conduct an evaluation of foreign meat inspection program activities and requirements for the control of L. mono in RTE meat products, with a view of determining equivalency and/or additional export to Canada requirements (Estimated to be completed in the Fall 2009, depending on timeliness of information received from trading partners).

Upon publication, the CFIA, in collaboration with Health Canada, to review the industry best practices document, currently under development by the Canadian Meat Council-led working group.  The CFIA and Health Canada will establish criteria for verifying appropriate implementation of the practices in establishments manufacturing RTE meat products for Canadians (benchmarking process), and integrate the criteria within Canadian meat program requirements (i.e. through an eventual amendment to the Meat Hygiene Manual of Procedures - Fall 2009)

2. Clarify Health Canada’s Policy on Listeria monocytogenes in RTE Foods

The Health Canada Listeria Policy needs to be clarified in relation to action required by both CFIA and the food processing industry following identification of positive environmental test results.

Actions and Progress to Date – HC Listeria Policy

The CFIA, HC and PHAC are collaborating on a thorough review of the current Health Canada Listeria Policy (e.g. controls and inspection practices, use of inhibitors, outreach efforts).

In September 2008, Health Canada issued Interim Market Authorizations to allow the use of sodium acetate and sodium diacetate as food preservatives in a number of foods, including ready-to-eat meats.  These food additives can be used by food producers to help control the growth of potentially harmful bacteria such as L. mono.

3. Develop an Enhanced Proactive Approach to Identifying Risks Posed by Microbial Contaminants in Food

There is a need for greater collaboration among food safety/public health authorities, industry, the academic community, and the international community to engage in “foresighting”.8 This will promote continued consideration of new scientific knowledge, test methods development and food processing technologies in order to identify potential issues related to the risks posed by Listeria and other microbial contaminants in food.

Actions and Progress to Date – Enhanced Proactive Approach

An Academic Advisory Panel was convened to provide an external objective challenge function and to advise on emerging and changing risks in the food production system.

Actions under Development or to be Implemented

Enhanced regulatory research: The CFIA along with its partners will develop research projects to address gaps and to expand the scientific knowledge on Listeria. The focus of this research will be in biofilms, disinfectants, virulence factors and effective detention methodologies. Although the initial focus will be on Listeria, the knowledge obtained will have applications to other food pathogens.

The CFIA will enhance surveillance of pathogens in high risk foods. This will be conducted through baseline studies which will provide necessary data for policy setting, decision-making and risk determination. In addition, this will support a proactive food safety system which will focus on reducing the risk of the introduction of unsafe food entering the marketplace.

1 This facility is registered under the federal Meat Inspection Regulations as Establishment 97B and is located at 150 Bartor Road, Toronto, Ontario.

2 Listeriosis is a foodborne illness that may occur when a person consumes food contaminated with the bacterium L. monocytogenes (L. mono).  For further discussion, see Section 2.0.

3 Listeria spp. is a bacterium composed of six species, with the L. mono species as the primary cause of human infections. For further discussion, see Section 2.0.

4 PHAC reported, subsequent to the writing of this report, that in January 2009, an individual in Quebec died of listeriosis bringing the total confirmed cases to 57 and deaths to 21. PHAC reported that the strain of listeriosis matched the 2008 outbreak strain. However, the source of the individual’s infection could not be confirmed. Source: http://www.phac-aspc.gc.ca/alert-alerte/listeria/listeria_2009-eng.php

5 Persistent contamination is defined as two consecutive positive results for Listeria spp. in the plant environment.  This implies that good manufacturing practices are inadequate and end product should be immediately tested and corrective action taken.

6 Advisory to: Federally Registered Establishments that Manufacture Ready-to-Eat Meat Products. http://www.inspection.gc.ca/english/fssa/meavia/listpreve.shtml.  This advisory was also sent to provincial food inspection agencies.

7 Chapter 5 - Section 5.3.11 and Annex I, and Chapter 11 - Annex D-1 of the U.S. section.

8 Foresighting is about developing and applying new insight to the development of strategies, to anticipate, prevent and prepare for future threats.

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