Germany's E. coli Nightmare

More than three months after a higher-than-usual occurrence of hemolytic uremic syndrome (HUS) in Germany provided the first clues, the details of the deadliest Escherichia coli outbreak in modern history are well known.

Now, we’re left with the questions: Why did middle-aged adults—particularly women—make up the majority of victims, not children and the elderly? Why did investigation into the rare 0104:H4 strain appear so confused—resulting in millions of dollars in lost sales for European Union (EU) farmers and retailers? Most of all, what steps can and will be taken to improve the speed, reliability, and effectiveness with which future outbreaks of this magnitude are handled?

German and European authorities have endured withering criticism over what many say is an outdated food safety investigation system hindered by decentralization and miscommunication. Germany’s initial assertion that produce from Spain was the culprit caused a diplomatic furor, protests, and eventual agreement to compensate farmers for crops destroyed in the ensuing wave of consumer fear.

The toll of dead and seriously injured in more than a dozen nations is sobering: The official death toll is more than 40 or 50, depending on the source. More than 4,000 are ill—more than 800 of the stricken suffering from HUS, enduring brain and kidney complications that will likely afflict them for the rest of their lives. Blame for the outbreak veered from Spanish cucumbers to sprouts from an organic farm in Germany and briefly back to cucumbers found in the trash of a German family, before officials settled on Egyptian fenugreek seeds—many of which might still be on the market.

At the core of this confusing case is the 0104:H4 strain responsible, an unusually virulent Shiga toxin-producing variant documented in research published by The Lancet Infectious Diseases and The New England Journal of Medicine in June. The Lancet paper, by Helge Karch, PhD, and colleagues, characterized the strain as a hybrid of enterohemorraghic and enteroaggregative E. coli strains, with a corollary traced back to an HUS case in Germany in 2001, as well as an occurrence in Korea in the 1990s. Dr. Karch, head of the Robert Koch Institute’s EHEC [enterohemorrhagic E. coli] consulting lab at the University of Münster Hospital, led a team that spent two intensive days deciphering the bacteria.

Backlash and speculation continue. Food industry pundits called for all manner of investigatory reform, even as Congress wrangled over funding the E. coli-detecting Microbiological Data Program.

Time will tell if, as happened with the 1993 Jack in the Box outbreak, significant regulatory improvements emerge from this latest food safety crisis.

Geoff Giordano, veteran editor of numerous newspapers and magazines, has been acting editor of Food Quality since February. Contact him at geogiordan@wiley.com.

The ECDC’s Role and What We Learned

By Marc Sprenger, MD, PhD

Since the beginning of May, Europe has seen more than 40 deaths and more than 4,000 people hospitalized with an aggressive new strain of the E. coli bacterium. This has happened in the heart of Europe, in rich countries with well-resourced public health systems. Even worse, people hit by this outbreak were mostly women and men in their prime who thought they were eating healthy food. Hundreds of them have been damaged for the rest of their lives, suffering kidney failure, brain damage, and other long-term disabilities.

The SARS epidemic in 2003 and the outbreak of Creutzfeldt–Jakob or “mad cow” disease in the 1990s have shown that there is a need for the European Union (EU) to strengthen its defenses against epidemics. We have learned significant lessons over time from those emergencies and have therefore seen a clear improvement in alert-and-response systems, surveillance activities, and the collaboration needed to handle a public health crisis. The latest E. coli outbreak tested these systems and has shown that there is still room for improvement.

The ECDC’s main task during this outbreak was to develop and provide independent scientific evidence. We played an important role by making available the best technical and scientific expertise within our field, which allowed authorities at all levels to make the appropriate decisions to protect EU citizens. That is our mandate, and I am certain we made a difference in specific areas and created added value with our work during the E. coli outbreak.

Our initial task was to produce a rapid risk assessment to provide a clear EU perspective. We produced the first risk assessment on May 25 and two updated versions, one on May 27 and another one on July 12. At the end of June, when the cluster of hemolytic uremic syndrome (HUS) in Bordeaux, France, was identified, we also published a joint risk assessment with the European Food Safety Authority (EFSA). Likewise, since the outbreak was first reported by the German authorities, we have been closely monitoring the situation and publishing daily epidemiological updates on our website.

Once the EU’s Early Warning and Response System (EWRS) on health threats was activated, the European Commission (EC) took the lead in coordinating the EU-wide investigations and control measures together with the member states involved. The ECDC and EFSA contributed to and supported these EU-level activities. For example, the EWRS network and the EC rapidly agreed on a common EU case definition proposed by the ECDC. All member states have agreed to use this to ensure the accurate reporting of cases.

The ECDC also produced tools, such as a standard questionnaire, designed to facilitate coordination of EU-wide investigations. The ECDC’s Food and Water-Borne Diseases and Zoonoses Programme was in contact with national experts from the affected countries on a daily basis, increasing the preparedness of institutes and professionals outside Germany.

Cooperation Is the Key

Dr. Sprenger presides over a daily ECDC round table. He meets with experts from different areas at 11:30 a.m. at a session during which all current threats are analyzed.

I believe that good cooperation is, above everything else, the key to success in outbreak investigations. In the beginning of June, an ECDC expert was sent to the Robert Koch Institute to act as a liaison and to support the steps taken by the German authorities. Following a request from the EC, the ECDC joined forces with the EFSA and sent its top experts to help the German authorities. Their task was to get an overview of the situation and support existing German activities.

Once it became clear that this outbreak had been caused by a new strain of E. coli, laboratory experts from different networks worked intensively together to analyze the bacterium. ECDC’s microbiology team, EU reference laboratories, and the World Health Organization’s collaborating laboratories played a vital role in this cooperation. For example, the ECDC disseminated guidance on laboratory tests to confirm infection. This enabled us to get an accurate EU-wide picture of the developing outbreak. The latest results seem to support the hypothesis that sprout seeds contained E. coli O104:H4 contamination.

There were also a lot of questions about clinical treatment for patients. The EC asked ECDC to work on this, so we put together a group of leading clinical experts and some of the doctors involved in the outbreak. This led to clinical reference materials for treating patients, which the ECDC published on its website. Discussing best practices with doctors at the EU level had never been done before; we are very satisfied with the results of this initiative.

The ECDC and EFSA also produced a joint statement, giving public health advice on the prevention of diarrheal illness, with a special focus on E. coli. Guidelines on prevention measures related to good personal hand hygiene and to food handling have been available on our websites since the beginning of June.

The Future

I think that four key lessons have been learned from this public health crisis. First, it is important to keep strengthening collaboration with our partners in the EU. It was very useful to have an ECDC liaison officer embedded in the German outbreak investigation team, both for the ECDC and for our German partners. Information sharing was much easier and our cooperation was stronger. We are now working on some standard terms of reference for this role in the future and are looking forward to reaching agreement on these terms with our national partners.

Second, we need to keep investing in EU microbiology networks and public health institutions. We should continue to draw on the existing capacity in Europe, where we have excellent laboratories and experts well trained in infectious diseases.

Third, we must have cross-sectoral cooperation at all levels for joint risk assessment in order to streamline the different facets of our work and create “one-voice” information for the policy makers and citizens of the EU.

Last but not least, we need to bear in mind the fact that infectious diseases don’t respect borders, which is why a local outbreak can quickly become an EU-wide event. A health crisis like this one, with more than 40 patients dead, hundreds permanently disabled, and thousands more hospitalized, motivates us to be even better prepared and to do even better next time.

Lessons for the U.S. from Europe

By David Acheson, MD

The summer of 2011 will be memorable for many in Europe as the time of one of the most aggressive and extensive foodborne illness outbreaks in history. With thousands of people becoming sick, hundreds developing the life-threatening hemolytic uremic syndrome (HUS), and dozens dying, one has to look at this from the United States with the view that we dodged a bullet on this one—at least so far.

While we in the U.S. were clearly watching with rapt attention and lots of questions and criticism as the outbreak unfolded, the one thing we were not doing here with any great vigor was asking the most important question: What can we learn to make sure that we minimize the likelihood of such a devastating outbreak of foodborne illness in the U.S.?

Looking from the outside at the outbreak in the European Union (EU), it is natural to wonder if this could happen in the United States. There is little doubt that it could, and so we should not lose the opportunity to learn our own lessons from this outbreak.

While there are many lessons to be learned, some major points must be considered:

• The importance of preventive controls;
• Rapid and effective response systems;
• The importance of using new intervention tools; and
• The risks of reduced funding.

Prevention should be the goal of anyone handling food, from the farm to the fork. Yet prevention is always hard to do well and very difficult to measure. This is clearly not a new lesson, but looking at the situation in the EU and drawing parallels in the U.S. shows that we have become obsessed with a single serotype of E. coli, namely 0157:H7.

In recent months, there has been a large push to declare six other serotypes of E. coli adulterants in meat. The situation in the EU, with a previously unrecognized pathogen—in this case, E. coli 0104:H4—causing a major outbreak, demonstrates the lack of logic of this approach.

When it comes to E. coli, what constitutes an adulterant is any E. coli that is going to make someone sick—irrespective of its serotype. To this end, any preventive control strategy should focus on keeping all pathogens out of our food supply—and not be directed at just a handful of serotypes. This is fundamental both in the use of risk-based preventive controls in the meat industry and in the use of hazard analysis and critical control points (HACCP) systems.

This approach is not restricted to the meat industry but extends to all areas where pathogens like the European outbreak strains of E. coli 0104 can enter our food supply. Such entry points are on farms where the pathogens may get on fresh produce—as appears to have happened in the EU—or may be a constituent of the intestinal flora of animals that are destined to become part of our food supply.

However, no amount of on-farm control or careful use of HACCP systems will offer a guarantee, and what is needed is a multifaceted approach that includes controls throughout the supply chain, from farms during processing (of meat, fresh produce, or other higher risk items like raw milk) to food handling at home. The lesson from the EU is that you never know what is going to appear next as a food safety hazard, so keep the preventive strategies broad to deal with both known and, to the greatest possible extent, unknown pathogens.

Rapid and effective response from public health officials and industry is critical when outbreaks emerge. The E. coli outbreak in the EU did not go well from a response perspective. There was clearly an inability to determine the food vehicle early on. Cucumbers, tomatoes, and lettuce were all implicated, with broad consumer messages to avoid all three. Subsequently, sprouts were found to be the likely source of the problem, due to contaminated seeds.

The importance of having public health officials with the skills and tools to follow up with patients swiftly and thoroughly is key, as is the importance of an integrated food safety system. Extrapolating to the U.S., we need to ensure that we build our public health infrastructure with robust connectivity and integration among local, state, and federal food outbreak investigators and regulators.

E. coli: Schizocytes (hemolytic-uremic syndrome)

In concert with a robust public health infrastructure, we in the U.S. need to find an efficient way to interact with the food industry during outbreak situations. The food industry always knows more about the critical details of their industry and products during an outbreak than the regulators, yet having an open discussion with the food industry during an outbreak is frequently a challenge. Thus, important insights are lost that may be critical to finding a source and quickly stopping the spread of a contaminated food.

The strain of E. coli that caused the outbreak in Europe contained a combination of virulence factors that has not been seen before, emphasizing the constantly changing nature of foodborne pathogens—and the importance of staying one step ahead of them. While robust risk-based preventive controls will go a long way toward protecting food, it is time to revisit other available technology such as high-pressure treatments and irradiation.

Clearly, consumers need a choice, and products must be labeled appropriately. But as U.S. consumers look at hundreds of people in the EU with life-threatening complications from a foodborne illness, they may wish that the option of irradiated or high-pressure treated food were more readily available in the local supermarket. Offering such options in grocery stores would give consumers a role in determining the safety of the food they serve their families.

Finally, one must address a lesson about funding our food safety system infrastructures. States already face serious budget shortfalls, which are undermining the key public health infrastructure we need to ensure robust food defense control and response strategies. From a federal perspective, the current climate of reduced federal funding for food safety is worrying. A lesson from the EU situation to Congress is that our food safety system in the U.S. cannot afford to be undermined through lack of resources. We must ask Congress not to cut funding, but rather to ensure efficient use of current and future resources for the greatest food safety gain.

Too Often, Politics Trumps Safety

By Douglas Powell, PhD

My friend Jim called on a Friday afternoon. Jim is a dairy farmer located on the edge of a town in Ontario, Canada, called Walkerton, and he said a lot of people were getting sick. The community knew there was a problem several days before health types went public.

On Sunday, May 21, 2000, at 1:30 p.m., the Grey Bruce Health Unit in Owen Sound, Ontario posted a notice on its website to hospitals and physicians to make them aware of a boil water advisory and inform them that a suspected agent in the increase of diarrheal cases was E. coli O157:H7.

There had been a marked increase in illness in the town of about 5,000 people, and many were already saying the water was suspect. But because the first public announcement was also the Sunday of the Victoria Day long weekend, it received scant media coverage.

It wasn’t until Monday evening that local television and radio began reporting illnesses, stating that at least 300 people in Walkerton were ill.

At 11 a.m. on Tuesday, May 23, the Walkerton hospital held a media conference jointly with the health unit to inform the public of the outbreak, to make people aware of the potential complications of the E. coli O157:H7 infection, and to warn them to take the necessary precautions. This generated a print report in the local paper the next day, which was picked up by the national wire service Tuesday evening, and subsequently appeared in papers across Canada on May 24.

These public outreach efforts were neither speedy nor sufficient. Ultimately, 2,300 people were sickened and seven died—in a town of 5,000. All the gory details and mistakes and steps for improvement were outlined in the report of the Walkerton inquiry (www.attorneygeneral.jus.gov.on.ca/english/about/pubs/walkerton).

The E. coli O157:H7 was thought to have originated on a farm owned by a veterinarian and his family at the edge of town, someone my friend Jim knew well, a cow-calf operation that was the poster farm for Environmental Farm Plans. Heavy rains washed cattle manure into a long abandoned well-head, which was apparently still connected to the municipal system. The brothers in charge of the municipal water system for Walkerton, who were found to have been adding chlorine based on smell rather than something minimally scientific like test strips, were criminally convicted.

But the government-mandated reports don’t capture the day-to-day drama and stress that people like my friend experienced. Jim and his family knew many of the sick and dead. This was a small community. News organizations from around the province descended on Walkerton for weeks. They had their own helicopters, but the worst was the medical helicopters flying patients with hemolytic uremic syndrome to the hospital in London. Every time Jim saw one of those, he wondered if it was someone he knew.

I’m not an epidemiologist, but as a scientist and journalist with 20 years of contacts, I usually find out when something is going on in the world of foodborne outbreaks.

The uncertainties in any outbreak are enormous, and the pressures to get it right when going public are tremendous.

The public health folks in Walkerton may have been slow by a couple of days while piecing together the puzzle; what happened in Germany this summer in the sprout-related outbreak of E. coli O104, a relative of O157, was a travesty.

Worse, bureaucrats seemed more concerned about the fate of farmers than that of citizens. By at least one count, 53 have died, and more than 4,200 have been sickened.

Perils of Sprouts

Raw sprouts are one of the few foods I won’t eat, and as many epidemiologists have pointed out, sprouts top the list of any investigation involving foodborne illness.

We at bites count at least 55 outbreaks related to raw sprouts beginning in the U.K. in 1988, sickening thousands.

The first consumer warning about sprouts was issued by the U.S. Centers for Disease Control and Prevention (CDC) in 1997. By July 9, 1999, the U.S. Food and Drug Administration (FDA) had advised all Americans to be aware of the risks associated with eating raw sprouts. Consumers were informed that the best way to control the risk was to not eat raw sprouts. The FDA stated that it would monitor the situation and take any further actions required to protect consumers.

At the time, several Canadian media accounts depicted the U.S. response as panic, quoting Health Canada officials as saying that, while perhaps some were at risk, sprouts were generally a low-risk product.

That attitude changed in late 2005, as I was flying back to reunite with a girl I had met in Kansas and 750 people in Ontario became sick from eating raw bean sprouts.

Unfortunately, what food safety types think passes for common knowledge—don’t eat raw sprouts—barely registers as public knowledge. It’s hard to compete against food porn.

Sprouts present a special food safety challenge because the way they are grown, with high moisture at high temperature, also happens to be an ideal environment for bacterial growth.

Because of continued outbreaks, the sprout industry, regulatory agencies, and the academic community in the U.S. pooled their efforts in the late 1990s to improve the safety of the product, implementing good manufacturing practices, establishing guidelines for safe sprout production, and beginning chemical disinfection of seeds prior to sprouting.

Safety Shortfalls

But are such guidelines being followed? And is anyone checking?

Doubtful.

This was demonstrated by two sprout-related outbreaks earlier this year linked to sandwiches served by Jimmy John’s, a chain of gourmet sandwich shops based in Champaign, Ill.

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Sprouts served on Jimmy John’s sandwiches supplied by a farm called Tiny Greens sickened 140 people with Salmonella, primarily in Indiana. In January, Jimmy John’s owner Jimmy John Liautaud said his restaurants would replace alfalfa sprouts, effective immediately, with allegedly easier-to-clean clover sprouts. This was one week after a separate outbreak of Salmonella sickened eight people in the U.S. Northwest who had eaten at a Jimmy John’s that used clover sprouts.

If the head of a national franchise is that clueless about food safety, can we really expect more from others?

Sprout grower Bill Bagby, who owns Tiny Greens Sprout Farm, said in the context of the German outbreak that, for many like him, the nutritional benefits outweigh the risk:

“Sprouts are kind of a magical thing. That’s why I would advise people to only buy sprouts from someone who has a (food safety) program in place (that includes outside auditors). We did not have (independent auditors) for about one year, and that was the time the problems happened. The FDA determined that unsanitary conditions could have been a potential source of cross-contamination and so we have made a lot of changes since then.”

Independent auditors? Like the ones who said everything was cool, everything was OK, at Peanut Corporation of America (nine dead, 700 sick in 2008-09) and Wright County Egg (2,000 sick in 2010)?

Like the Walkerton E. coli O157:H7 outbreak in 2000, too many are using the filters of their politics to advance their own causes and saying too many dumb things in light of the sprout outbreak of 2011.

It’s really about biology and paying attention to food safety basics—no matter how much that interferes with personal politics.