The previous chapter outlined the chain of events that culminated in the 2008 outbreak. As illustrated in our descriptive chronology, investigating a foodborne illness outbreak is highly complex. It is necessary to
As we have described earlier in the report, the various governments do not regularly work closely together to respond to the outbreak. In this chapter, we provide our conclusions about what worked well and what could be changed to better manage a foodborne emergency.
To understand what worked and what did not, we first need to explain the key challenges in managing a foodborne outbreak. Such a crisis brings together multiple jurisdictions and two sectors of the federal government that, on a day-to-day basis are not required to work closely together: the public health and food safety sectors. At the provincial level, in most provinces, food safety is a direct responsibility of public health through environmental health inspection.
Even though both sectors focus on human health and safety, the daily work of those in the food sector is to monitor the processes keeping food safe free from harmful agents. The public health sector monitors disease occurrence to make sure those processes have worked. Staff working in these areas approach an outbreak from different perspectives; their education, training and experience are complementary.
When an outbreak is viewed through the lens of public health, the focus is primarily on identifying what is making people ill. Consequently, the sector works to quickly determine the likely cause of the illness and remove this threat as rapidly as possible.
In an outbreak, the primary function of public health in such events is 'forensic' - assisting the food safety sector in rapidly identifying the food source so it can stop its distribution and consumption. This role is an important one, especially given the long incubation period of Listeria.
The food safety sector is focused primarily on identifying the exact food product that is causing the illness so that the correct food is removed from the market. This is not always easy, given that food distribution is less often local as consumers now have access to food products from all over the world. In the 2008 outbreak, contaminated deli meats from a single plant in Ontario that produces dozens of brands and products were distributed all across the country, resulting in a national outbreak. For this reason, it was essential to match the location of the people who were ill with the distribution patterns of the food products. This made the food safety investigation both a time-consuming and complex task.
Once the suspected food source was identified, even though it was not yet confirmed, public health officials assumed it was the food safety sector's responsibility to lead and that their role was to provide support. This view ran counter to public perception that the outbreak was primarily a health matter.
During the 2008 outbreak, the differing perspectives of who should lead were evident. From our observations, while the food safety sector assumed leadership in recalling the contaminated food products, other elements of the emergency that required attention were slow to get underway (e.g. the overall coordination of all involved in managing the outbreak and communications to the public).
Nonetheless, it is important to note that, due to the long incubation period of Listeria monocytogenes, much of the damage had already been done. We verified that, by the time the outbreak was detected, most of the individuals who became ill had already been exposed to the bacteria. So, while our report proposes improvements that could lead to a quicker and more efficient response in the event of another outbreak, little could have been done at the time of the 2008 outbreak to prevent others from becoming ill.
"I think consumers' confidence is shaken. We have an obligation to do everything humanly possible to restore, to the extent that we can restore, public confidence. We have to earn it every day. Every day we've got to go out and re-earn that and we have to be able to communicate a lot better with the public than we have."
Dr. Brian Evans
Executive Vice-President, CFIA
From our interviews
We believe that by being proactive - for example, advising the public sooner that certain foods were suspected - governments could have averted confusion during repeated recalls of deli meats. This ultimately amounted to the recall of 191 products from Maple Leaf Foods Bartor Road plant, many of which had been on the market for months. This confusion affected public confidence in Canada's food safety system and in governments' capacity to respond to such foodborne emergencies.
To explain our conclusions we have broken down the different issues under the following headings:
The 2008 outbreak clearly demonstrated that managing this type of emergency was not only complicated but was also not well understood by those involved.
Prior to 2005, there were less than one hundred cases of listeriosis reported in Canada annually. However, since 2005 this number has more than doubled.
At the outset, the outbreak was not considered a severe foodborne emergency. This view led to a void in leadership in managing the crisis. It took close to three weeks before senior executives in all key organizations became fully engaged in the event. The fact that many officials were on vacation during this period has been offered as one explanation for the slow response.
This should not have posed a problem, at least in theory, since an intergovernmental agreement - the Foodborne Illness Outbreak Response Protocol (FIORP) - had been endorsed by all federal, provincial and territorial governments in 2004 to coordinate the management of a foodborne emergency. Put into place following a national foodborne outbreak in 1999, FIORP was designed to guide a multi-jurisdictional response when such an emergency arose.
However, few of those involved in the 2008 outbreak, especially senior executives, were familiar with FIORP. Even fewer acted in accordance with the multi-jurisdictional guidelines to manage such an event.
Through interviews we learned that, within the Canadian Food Inspection Agency, the Public Health Agency of Canada, Health Canada and the Ontario Ministry, few officials above the Director level (the management level charged with administering the protocol when required) were aware of FIORP`s existence when first alerted to the unfolding listeriosis crisis.
We were told that while front line and scientific staff on both the public health and food safety sides of the investigation were hard at work responding to the crisis, their superiors were not initially fully engaged.
Furthermore, no single organization took the overall role of coordinating the actions of the various parties involved. This left a vacuum in senior leadership that caused confusion and weak decision-making. Despite this, the epidemiological and food safety investigations were reasonably well done.
Recommendation:
Emergency management of a foodborne illness outbreak requires clear and concise planning, including:
Since national foodborne illness outbreaks of this magnitude are rare in Canada, opportunities to practice this emergency management approach are very limited. As a result, the system is not mature. We learned that both food safety and public health officials participating in the 2008 outbreak were not adequately prepared or equipped to properly manage this event. This lack of advance preparation, particularly in communicating to vulnerable groups, contributed to confusion.
The Foodborne Illness Outbreak Response Protocol has been ratified by Deputy Ministers for all fourteen jurisdictions, although not by Ministers of Health. To complement the protocol, bilateral agreements have been signed between the federal and provincial or territorial governments to recognize the particular circumstances of each jurisdiction.
"It is one thing to have protocols in place but if everyone doesn't act in accordance with them or they're not aware of their roles, they are not effective protocols."
Dr. Brian Evans
Executive Vice-President, CFIA
From our interviews
We heard that this protocol is valuable, but it is rarely needed nor fully understood by many of its signatories. We also heard that elements of the protocol are out of date.
In spite of having formal intergovernmental agreements to work collaboratively and share information in times of emergency, the events of the 2008 outbreak revealed that, at the time they were most needed, they were not fully used. Since the emergency provisions were not invoked the conference calls although helpful were informal. For example, the continuity between calls was not fully captured as minutes were not taken at any point in the management of the event. Several people with first-hand knowledge of these events reported that crucial information was circulated but not moved up the chain of command.
We heard repeatedly that the roles and responsibilities of various governments need to be clarified and better communicated. 'Lessons learned' reports prepared by all of the organizations involved in the outbreak came to similar conclusions.
"We have different organizations involved, so if we can just get it better coordinated and clearer lines of authority and responsibility, so that at an outbreak or a suspicion of outbreak, the public's protection is paramount."
Dr. David Williams
Acting Chief Medical Officer of Ontario
From our interviews
The unusual characteristics of a listeriosis outbreak underscore the need for maximum collaboration.
"The "Public Health Agency of Canada" was formed in large part in response to the report of Dr. David Naylor, "Learning from SARS." In particular, Dr. Naylor discussed the need for fulfilling the four Cs n collaboration, communication, cooperation and clarity n which I think is a pretty good description of what this new Agency and myself should strive for."
Dr. David Butler-Jones
Chief Public Health Officer of Canada, to the Standing Committee on Health, October 2004
When a listeriosis crisis emerges, it starts with just a few people from specific groups becoming ill. Since each person will develop the illness at a different rate (the incubation period varies from 3 to 70 days), each case is different. It is only when an increase in cases or unusual factors are noticed that local public health officers start investigating, as occasional cases are the norm. This is what happened in the 2008 outbreak, when two people from the same long term care home developed listeriosis a few days apart.
When the number of cases grows beyond a local health unit the provincial or territorial ministry gets involved. And when the number of cases extends beyond one province, the federal public health sector gets involved. At any point in this process when a food product is suspected, the provincial or federal organizations responsible for food safety are called in.
For example, the 2008 outbreak quickly expanded from a small number of cases in Ontario to, eventually, 57 cases across seven provinces. This complicated communications and management of the event. The lack of a clear understanding of which organization or level of government was responsible for doing what - including what organization should lead the crisis - contributed to the inconsistent management of the outbreak.
One of the goals in creating the Public Health Agency of Canada was to avoid just such situations, which Canada had learned when confronted with SARS. We are convinced that strong national leadership for foodborne emergencies is required as a national priority. We conclude that the PHAC is the organization best placed to take on this role.
Something we heard during our interviews:
The federal organizations have initiated discussions to improve FIORP, and some of the enhancements considered have been exercised during the health emergency of H1N1.
Recommendations:
Beyond difficulties in federal, provincial/territorial and local coordination, we observed problems specific to the three federal organizations directly involved in the 2008 outbreak. Some of these problems were identified in the lessons learned reports prepared by the Public Health Agency of Canada, the CFIA and Health Canada.
Public Health Agency of Canada
The Public Health Agency of Canada was initially pulled in to the 2008 outbreak on July 29th through the foodborne epidemiological team. On August 22nd, the team partially activated the Agency's Emergency Operations Centre to 'Increased Vigilance' (Level 2). However, we heard it did not activate all the functions called for in the Agency's emergency plan. For example, no one was assigned to undertake the advance planning required to manage the outbreak, nor was a specific communications team established. While the PHAC personnel recognized the severity of the outbreak, their resources were not fully deployed to respond in an emergency situation.
Canadian Food Inspection Agency
The CFIA recall team was first made aware of the emerging outbreak and the suspected food source on August 6th. Senior executives were advised the next day, but were not fully involved in decision-making until the week of August 18th, after the first recall took place. This means that key decision makers who could have helped with the strategic management of the crisis were not involved. In the past, the Agency used an emergency management structure that engaged all critical senior personnel and technical resources to deal with significant food inspection events. This process was not used during the 2008 outbreak since the Agency did not foresee the magnitude of the outbreak early enough. In addition, the CFIA did not activate its Incident Command Structure, which is designed to coordinate this type of situation.
"No function is more important than the management of these high profile cases. No activity is so central to the credibility of the CFIA.
Ronald L. Doering
Former President of the Canadian Food Inspection Agency
Health Canada
When the CFIA receives confirmation that a particular food product is contaminated, it calls on Health Canada to evaluate the risk this food poses to the health of consumers based on the potential exposure to the bacterium and the severity of its impact. We learned that the department's team assigned to this task in the summer of 2008 was not operating on a 24/7 basis, leaving gaps in coverage during emergency response situations.
Recommendation:
Although there were gaps in reporting requirements for listeriosis, we have been advised it would not have made a difference in the 2008 outbreak, since listeriosis was already a notifiable disease in Ontario when the outbreak was first identified. There are currently 55 active diseases or conditions on the National Notifiable Diseases List1. Including a disease on the list means that, when provincial/territorial public health authorities (local and regional report to their province/territory) are able to confirm that someone has a listed illness, they voluntarily report the case(s) to the PHAC.
Listeriosis was a nationally notifiable disease from 1990 following the 1982 outbreak of Listeria in ready-to-eat coleslaw salad. However, since there were n. significant outbreaks between 1990 and the events of 2008, it was removed from the list in 1999. At the time of the outbreak, listeriosis was not a notifiable disease in many provinces. The doubling in listeriosis cases since 2005, and the fact that it is now in the process of becoming a national notifiable disease, reflects the growing awareness that the disease is a significant health threat for vulnerable populations. The process is underway of once again identifying listeriosis as a national notifiable disease.
In July, the Ontario Ministry of Health and Long-Term Care began to identify an increase in the number of listeriosis cases that were being reported by local public health units through Ontario's electronic surveillance system. With the help of one of its analysis systems2 the Ontario Ministry was able to statistically validate that something unusual was occurring. Officials in the Ontario Ministry began contacting both public health units, the Public Health Agency of Canada and Health Canada to discuss these findings.
A notice was posted on the national surveillance system on July 29th to alert other jurisdictions to the increase in cases occurring in Ontario. Within a few days, the federal-provincial epidemiological team, which was communicating daily via conference calls and postings on the national surveillance system, learned of a potential link between one of the listeriosis cases and a food source. Over the next few days, there were several new cases reported with possible links to a similar food source.
By August 6th, the daily conference calls included officials from the CFIA who were brought in to investigate the source of the contaminated food. This food investigation eventually led to the confirmation of the food source and the associated food product recalls (three main and 21 secondary recalls), which are discussed in the next section in more detail.
While progress on the recall was being made, efforts to link the food source and cases of listeriosis across the country were just beginning. DNA fingerprinting of the food source enabled public health teams to refine their analyses of listeriosis cases occurring within their jurisdictions. Eventually, they were able to match the cases of illness with the consumption of contaminated products from Maple Leaf Foods.
This was a significant accomplishment and a reflection of the increasingly important role technology, such as DNA fingerprinting, plays in identifying foodborne illnesses. As recently as five years ago, foodborne diseases were not easily linked to a specific food product.
Thanks to the use of a test known as pulsed-field gel electrophoresis (PFGE), it is now possible to link human cases more quickly by comparing DNA fingerprints. Similarly, this technology can link human cases and the foods that caused the illnesses.
Foodborne illness outbreaks that are traced back to a commercial production source are rare. According to US data, up to 97% of foodborne illnesses result from the handling or preparation of food once it has left the food processing plant. In such cases, investigating the food source of the illnesses is less complicated. Such investigations are led by public health officials and do not often involve the food safety sector.
However, in the remaining two to three percent of cases, a food safety investigation is required because the cause of the outbreak is not evident. Several different organizations become involved in this type of investigation. Public health teams identify the cause of the illness while the CFIA tracks down the product that is causing it. Health Canada provides an assessment of the risk associated with the contaminant, the exposure of humans and the risks to peoples' health.
In the 2008 outbreak, the CFIA was notified by Toronto Public Health that three samples of deli meats tested positive for Listeria monocytogenes. The CFIA initiated a food safety investigation to determine the exact food product, its source, production date and code. In the course of Toronto Public Health's epidemiological investigation, which involved collecting a variety of food samples, they were advised by the Toronto area long term care home staff that the likely source of the food product was Maple Leaf Foods. The company produced the larger packages of deli meats which both of the home's ill residents had eaten. The food samples initially collected by Toronto Public Health were from 'retention' samples of meals that had been served to the residents earlier in July. Long-term care homes, hospitals and other large institutions keep samples for this purpose.
The original packages containing the deli meats had long been discarded by the time the CFIA became involved in the investigation. This was understandable, as the time between the original collection of the food samples and confirmation of positive results from the lab spanned three weeks. Access to the original packages was essential to pinpoint the information required to identify the precise product and production date.
As part of the food safety investigation, the CFIA investigators had to methodically sort out the following:
Sampling Procedures and Information
World Health Organization
If a packaged food item is suspected of being the cause of a foodborne illness, it is particularly important to collect unopened packages of that food—ideally from the same lot.
This can help to establish the stage of production when the food was contaminated before the package is handled or opened and its contents are used in meal preparation.
Samples should be accompanied by product information such as the circumstances in which samples were collected, the names of the suppliers and distributors, and coding information on packaged foods should be recorded. This facilitates the determination of the distribution channels of the product.
Source: Foodborne Disease Outbreak: Guidelines for Investigation and Control. 2008
As Ontario public health units undertook investigations into cases in their jurisdictions, a pattern linking Maple Leaf Foods deli meat products to ill individuals started to emerge. We were told that, as their investigations progressed, some public health officials believed that sufficient information was available to proceed with a recall of these food products.
There are differing views about when to advise the public about potential food contamination. Some advocate for a precautionary approach, based on epidemiological evidence, to protect the public from potential harm. Put simply, this means that, in the absence of absolute certainty, it is better to err on the side of caution, using reasonable and probable grounds.
Salmonella Saint Paul Outbreak, 2008
What Was Learned?
There are numerous examples of food recalls by the federal government that have been undertaken without the definitive proof established by laboratory confirmation. However, in those instances, all the evidence pointed toward the same food product.
The other approach is to wait for more conclusive evidence, before alerting the public to a health threat. The practice usually followed by Health Canada, based on the recommendation of the World Health Organization and years of experience is to, wherever possible, rely on laboratory confirmation before recommending a recall of specific food products.
Laboratory confirmation is based on extensive testing and conclusive results that provide proof that a specific food product is contaminated. This is often referred to as the 'unopened packages' approach.
Health Canada has relied on this standard of proof, which provides evidence that the product was contaminated during the production stage and not cross-contaminated after leaving the plant or while being handled in consumers' kitchens.
Salmonella Peanut Butter Recall 2008-09
What Was Learned?
The quality of the information is crucial to identify the correct food in order to ensure the real contaminated product is removed from the marketplace.
In the 2008 outbreak, the early findings were not converging or conclusive. Although there were indications the product originated at Maple Leaf Foods, there was no conclusive information on the specific food or its production dates. Therefore, the CFIA investigators sought unopened packages of the same product, which were eventually found and tested positive for Listeria monocytogenes.
Based on this confirmation, Maple Leaf Foods undertook a voluntary recall of two specific brands of Sure Slice Roast Beef and Corned Beef.
Following the confirmation of the source, the epidemiological investigation broadened. It quickly identified and linked other cases associated with the outbreak. As the investigation continued, two additional recalls of Maple Leaf Foods products took place, followed by 21 secondary recalls. Secondary recalls were necessary since a variety of food products (e.g. sandwiches, meat and cheese platters, pizza) were prepared using Maple Leaf Foods deli meat products that had been recalled. These products were packaged and sold by different companies under various brand names.
Following each of the 24 product recalls, it was necessary to verify that all the contaminated products had been removed from the marketplace. It was also important to ensure they were not continuing to be served in institutions especially those caring for vulnerable populations.
In total, over 29,000 verification checks post-recall were carried out over a three week period by the CFIA staff and local public health inspectors from across the country. This put a tremendous strain on all involved and disrupted their efforts in conducting their normal duties. We have learned that, while these activities were necessary, there was very little information circulating which would have helped the public health officials to better understand why they were being asked to repeatedly visit the same facilities. During these events, more information was needed on the reasons behind the successive secondary recalls.
Recommendations:
The listeriosis outbreak revealed gaps in the laboratory system that contributed to delays in detecting the disease and in notifying the public.
"What we can do to make that better is decentralize to the provinces, which we've already started to do. That will take a bit of time off the time it takes to detect cases - a few days, three or four maybe - but it will improve the system."
Dr Frank Plummer
Scientific Director General, National Microbiology Laboratory
Public Health Agency of Canada
In health emergencies, human biological samples and the follow-up test results may be circulated between private and hospital labs as well as both provincial and federal public health laboratories. This complex system of human biological laboratories was not fully networked at the time of the 2008 outbreak and not all provincial or federal laboratories were accredited to test for Listeria monocytogenes.
Testing for Listeria
The following tests are used to find out if a food is contaminated with Listeria:
Furthermore, we learned that there are only a few laboratories with the capacity and certification to test food products for Listeria monocytogenes, and none of those were networked. We have also learned that many provinces did not have the capacity to test for Listeria and relied on Health Canada's National Reference Laboratory to test their food samples during investigations. As a result, opportunities may have been missed to confirm the food source of the outbreak sooner.
We heard from many interviewees that methods to collect and retain food samples as well as testing methodologies are not standardized. There is also no cross-coding3 of the human biological samples and corresponding food samples. Consequently, more time was needed to reconcile results. This could have been avoided with pre-approved processes and practices.
Another complication was that current confirmation testing for Listeria monocytogenes and the DNA fingerprinting involves a series of tests. It can take up to 14 days to complete all these tests before identifying the fingerprint of the bacteria.
"Research is needed to develop rapid, inexpensive and easy-to-use methods to detect Listeria in the environment and in food that can be completed within a working day."
Dr Mansell Griffith
Chair of Dairy Microbiology in the Food Science Department at the University of Guelph
Member of the Listeriosis Investigation Expert Advisory Group
Due to all of these factors, we consider that there might have been earlier opportunities to identify the link between the human infection and the food source of the outbreak.
"Laboratory testing needs to be improved so there is either centralized or standardized testing for foodborne bacteria to avoid confusion over lab results. In addition, all health care institutions and emergency personnel should have computer access to patients' health records."
A suggestion by a family affected by the outbreak
Recommendations:
"From everything we heard, if there is a single issue that garnered near unanimous agreement, it is that the public was confused and did not understand what they should be doing following news of the food recalls..."
1 Public Health Agency of Canada - National Notifiable Diseases (Table 1: Current List of Nationally Notifiable Diseases and Year the First Positive Report was Recorded) - online
2 The Early Aberration Reporting System is a system that detects statistical increases in the number of cases above the norm and therefore can help public health officials detect an outbreak.
3 Cross-coding: a method of identifying human samples and corresponding food samples to make it easier to link their test results