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Lessons Learned: The Canadian Food Inspection Agency's Recall Response to the 2008 Listeriosis Outbreak

April 17, 2009


Disclaimer: The information in this report was obtained by the Evaluation Directorate of the Audit, Evaluation and Risk Oversight (AERO) Branch through a review of relevant material and a series of interviews. This report does not draw exhaustive or definitive conclusions on fact on all the activities leading up to or taken by various individuals or entities during the Listeriosis outbreak. Rather, the observations set out in this report are meant to give a general overview to CFIA senior management of what worked well in this particular event and what needs further refinement for the CFIA to be better prepared for future outbreaks.


TABLE OF CONTENTS


Executive Summary

Context

The Canadian Food Inspection Agency (CFIA) conducts operational reviews after significant situations to ensure transparency and to improve responses to future emergency situations. The purpose of this particular exercise was to determine the lessons learned regarding the Agency's recall response to the 2008 listeriosis outbreak.

The Canadian food safety system is composed of the interaction of the medical, public health and food inspection systems, at both the federal and provincial/territorial levels. Food safety investigation and recall processes are the CFIA's primary activities in responding to a foodborne illness outbreak.

On August 6, 2008, the Toronto Public Health Unit informed the CFIA of two listeriosis cases at a Toronto nursing home. The food safety investigation conducted between August 7 to August 23, 2008, led by the CFIA Office of Food Safety and Recall (OFSR), linked the source of the Listeria (bacterium Listeria monocytogenes or L. mono) to ready-to-eat meats produced at a Maple Leaf Foods plant, located in Toronto.

On August 17, 2008, further to a Health Hazard Alert issued at 2:00 a.m. by the CFIA, Maple Leaf Foods voluntarily recalled two ready-to-eat meat products produced at this processing plant. This plant is a federally registered processing facility identified as Establishment 97B. Additional food safety investigations resulted in an expanded voluntary recall of other products from the same line in the plant on August 20. The number of products recalled expanded again on August 24, as all products from Establishment 97B were assessed as meeting Health Risk I1 by Health Canada. Secondary recalls continued over the following weeks after further investigation and traceback activity by the CFIA. In total, 192 Maple Leaf Foods products were recalled, and 29,000 recall effectiveness checks were completed. Production at Establishment 97B resumed in September 2008 with a "hold and test protocol."2

The outbreak involved 56 confirmed and two probable cases of illness. Of these confirmed and probable cases, there were 20 deaths3 in which listeriosis linked to products from Establishment 97B was an underlying or contributing cause.

Methodology

The CFIA Evaluation Directorate cooperated, shared information and consulted with evaluation teams assigned by Health Canada (HC) and the Public Health Agency of Canada (PHAC) during this exercise.

Each evaluation team has produced a separate report focused on its specific activities and areas of responsibility.

This report documents the findings derived from an extensive document and file review, as well as interviews with CFIA, HC, PHAC, and provincial representatives.4

General Observations

Communicating and Coordinating within the CFIA

There are several key players in the CFIA who are involved in food safety investigation and recall activities, such as the Office of Food Safety and Recall (OFSR) and the Science Branch (National Laboratory Operations and the Laboratory Network). These groups include technical assessors and program specialists. CFIA staff followed established procedures during the food safety investigation and recall implementation processes. OFSR demonstrated leadership, mobilized quickly and worked collaboratively. Overall, internal coordination was effective. However, communication processes could be streamlined for greater efficiency and effectiveness, as well as for better documentation of decision making. There is a need for greater clarity regarding the approval processes in the follow-up stage of the recall process. In addition, there is a need to re-examine and update the criteria for initiating a process for managing high-profile or urgent incidents to facilitate early engagement of senior level decision makers and to enhance coordination across CFIA branches.

Communicating and Coordinating with Government Partners

There are a number of stakeholders involved in a public health and food safety investigation and recall, and this case was exceptionally large and complex. Overall, the relationship between the CFIA, HC, and PHAC was found to be effective, as evidenced by the timely and appropriate exchange of information, ongoing communications, and coordination between federal laboratories. However, some adjustments and clarifications are required to further streamline and coordinate communication efforts between federal partners.

To improve future multi-jurisdictional responses, a more formal implementation process of guiding protocols is required (e.g. the Ontario–Canada Foodborne Health Hazard and Illness Outbreak Investigations Memorandum of Understanding (Ontario-Canada MOU) and the Canada Foodborne Illness Outbreak Response Protocol (FIORP)). Additionally, these protocols should be revisited to provide clarity with respect to roles and responsibilities and information sharing. While the protocols describe roles and responsibilities at a general level, specific responsibilities for coordinating and managing different aspects of an outbreak are not fully documented.

Multi-jurisdictional protocols should be formally activated.5 In this case, the Ontario–Canada MOU and the FIORP were not formally activated, although multi-jurisdictional teleconferences were initiated by OFSR to help manage the food safety investigation and the initial stage of the epidemiological investigation. Formal activation of these multi-jurisdictional agreements would enhance coordination and communication. Formal implementation would alert stakeholders to appropriate roles and responsibilities, initiate assignment of responsibility for documenting and disseminating teleconference proceedings, and help establish communication and information sharing protocols across jurisdictions.

Early epidemiological evidence (e.g. initial samples collected by the Ontario public health authorities during the epidemiological stage) was insufficient to guide the food safety investigation and risk assessment processes. However, there was evidence of good cooperation between the CFIA and provincial jurisdictions during a sampling blitz in Ontario and during the recall effectiveness checks nationwide.

Industry Information Sharing

In general, the CFIA exercised its inspection and other statutory powers during the recall process. Some delays occurred due to availability and format of company information, particularly distribution lists from Maple Leaf Foods. These issues can be rectified in the future by

  • promoting industry awareness of its information sharing obligations,
  • ensuring that the lead investigator is the key contact for food safety investigation and recall issues,
  • clarifying industry information sharing responsibilities in appropriate documents such as the Food Safety Enhancement Program Manual, and
  • developing more specific protocols for Operations staff.

Enhanced product traceability would permit more efficient identification of the source of the outbreak, and improve traceability of the distribution of the product. Currently, this process can be time consuming and can result in multiple secondary recalls that spread out over several days or weeks. While current guidelines for sharing appropriate product information were generally adhered to, options for enhancing product traceability should be reviewed with stakeholders.

Communicating with the Public

Several documents provide guidelines on communicating with the public. The CFIA followed these procedures and provided timely and comprehensive notification to the public for the primary and secondary recalls. Communications with the public could be improved by streamlining the approvals process and proactively developing materials, where possible. While the federal partners collaborated effectively, greater coordination could be achieved by revisiting and exercising Annex 66 of the FIORP and broadening the existing HCPHAC working group to include the CFIA.

Surge Capacity

CFIA staff (Areas, Regions and National Headquarters) worked long hours for an extensive period of time. The CFIA was able to reallocate Area and Regional staff to meet operational needs. There is a need for additional resources with greater depth of technical expertise, particularly for staff in the Meat Hygiene Program. There is also a need to review and address workload issues created by meeting the surge demands of the outbreak and the subsequent backlog of activities (e.g. inspections, lab testing).

Summary Recommendations

This review identified 14 recommendations, some of which require that the CFIA work with government partners and other external stakeholders to implement.

Actions to Date

This report identifies a number of initiatives that the CFIA has already undertaken to address required improvements, including

  • updating the Food Emergency Response Manual (FERM);
  • updating existing criteria for initiating a process for managing high-profile incidents;
  • providing training on the Incident Command System (ICS);
  • actively participating in the Ontario Multi-Agency Working Group;
  • reviewing (with Health Canada) the Listeria policy and operational directives in order to enhance the control of Listeria in high risk, ready-to-eat foods
  • developing specific enforcement strategies pertaining to food safety investigations; and,
  • developing communications products to promote awareness and responsibility around food safety.

Recommendations

  1. Update the criteria to identify high-profile and urgent incidents, use those criteria, and implement a process for managing these incidents. This will help to quickly identify high profile or urgent incidents, and will contribute to timely engagement of senior management and enhanced coordination across branches.
  2. Monitor implementation of Food Emergency Response Manual updates with respect to the follow-up phase of recall, including updates pertaining to clarification of roles and responsibilities for root-cause investigation.
  3. Develop and build on existing mechanisms for coordinating with provincial/territorial partners to clarify issues (e.g. information sharing and multi-jurisdictional agreements):
    • As a first priority, with federal partners, engage at the senior level with the Ontario Ministry of Health and Long-Term Care and the Chief Medical Officer of Health.
    • Continue to build on provincial/territorial operational level cooperation (including OFSR7) to increase awareness of standardized sampling procedures.
    • Revisit the Ontario-Canada MOU to clarify roles and responsibilities and information sharing protocols.
    • Increase provincial/territorial partner awareness of the CFIA's roles and responsibilities in responding to foodborne illness.
    • Consider mechanisms for enhancing information sharing with provinces and territories with respect to product distribution lists.
    • Enhance sharing at the federal and provincial/territorial levels of laboratory methodology, data, sampling protocols and other laboratory systems.
  4. Establish clear protocols for communication of laboratory testing and results at the federal level.
    • The primary CFIA contact for laboratory testing and results should be documented and communicated to the CFIA, HC, and PHAC laboratories.
    • Strengthen communications between federal laboratories and operations.
  5. In collaboration with federal partners, revisit the FIORP, particularly with respect to information sharing, communicating with the public, and advancements in science.
  6. Promote the need for awareness activities and training (e.g. simulation and scenario training) with provincial/territorial and federal involvement, to enhance awareness of roles and responsibilities and to improve multi-jurisdictional responses to foodborne outbreaks.
  7. Update the existing food safety surveillance system to capture, analyse and act on potential emerging issues (e.g. monitor PulseNet, ICTS). Report these events to the daily CFIA "Radar" meetings.
  8. Promote industry awareness of information sharing obligations.
  9. Clarify industry information-sharing protocols in the Meat Inspection Regulations and the Food Safety Enhancement Program Manual (e.g. specify that distribution records must be provided in readable and digitally accessible format).
  10. Continue to develop clear CFIA operational staff protocols and strategies for industry compliance with mandatory document production requirements (requirements that are laid out in legislation).
  11. Consult with stakeholders to consider options for implementing best practices and standards for enhancing product traceability.
  12. Revisit the FIORP, particularly with respect to communicating with the public, as well as increasing awareness and training.
  13. Develop a more coordinated approach among the federal partners with respect to communicating with the public.
  14. Consider strategies for increasing the pool of specialized expertise, including meat hygiene specialists, and the CFIA's food safety (ARC) group.

1 The health risk identified represents a situation where there is a reasonable probability that the consumption/exposure to a food will lead to adverse health consequences that are serious or life threatening, or that the probability of a foodborne outbreak situation is considered high. Source: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/
hpfb-dgpsa/fd-da/bmh-bdm/mras-serm-eng.php

2 This means that while production was resumed, products were not distributed to suppliers or consumers until testing for L. mono had been conducted and no positive results were found.

3 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

4 When the report refers to provincial and territorial authorities, this also includes the public health units.

5 For example, activation can be announced verbally. The objective is for all stakeholders to have a clear understanding that the agreement has been activated in order for the processes to be followed and information sharing to take place. It should also be made clear who is chairing the Outbreak Investigation Coordination Committee. 

6 Communication with the Public – Guidelines.

7 While the OFSR is currently consulted, consideration should be given to having the OFSR play a more active role in any mechanisms to enhance provincial/territorial and CFIA operational level cooperation and coordination

Next page: Section 1.0