Jimmy Johns + Sprouts = E. coli O26 Outbreak

Raw clover sprouts served at Jimmy Johns restaurants are to blame for an outbreak of E. coli O26 – a shiga-toxin producing strain of E. coli – that has sickened at least 12 people in 5 states, according to a report released today by CDC. The illnesses developed between December 25, 2011 to January 15, 2012.

The outbreak-related illnesses were confirmed in Iowa (5), Missouri (3), Kansas (2), Arkansas (1), and Wisconsin (1). Two people were hospitalized.

Ten of the 12 outbreak victims reported having eaten at a total of 9 different Jimmy Johns restaurant locations in the week before becoming ill. Eight of the 10 said that they had consumed a sandwich containing raw sprouts; 9 reported eating a sandwich that contained lettuce. FDA has been conducting traceback investigations, with the following preliminary result:

FDA’s traceback investigation is ongoing. Preliminary traceback information has identified a common lot of clover seeds used to grow clover sprouts served at Jimmy John’s restaurant locations where ill persons ate. FDA and states conducted a traceback that identified two separate sprouting facilities; both used the same lot of seed to grow clover sprouts served at these Jimmy John’s restaurant locations. Preliminary distribution information indicates that sprouts grown from this seed lot were sold at a number of restaurant and grocery store locations in Iowa, Kansas, Missouri, and Wisconsin, and were likely distributed beyond these states. On February 10, 2012, the seed supplier initiated notification of sprouting facilities that received this lot of clover seed to stop using it. Investigations are ongoing to identify other locations that may have sold clover sprouts grown from this seed lot.

This is the third outbreak in five years that has been traced to raw sprouts consumed at Jimmy Johns restaurants. In 2008, twenty-one University of Colorado students fell ill after eating items containing raw alfalfa sprouts at two Jimmy Johns locations; 14 of the 21 students were confirmed to have been infected with E. coli O157:NM. And in 2010/2011, a 26-state (plus the District of Columbia) Salmonella outbreak was traced to contaminated Tiny Greens Alfalfa Sprouts or Spicy Sprouts served at Jimmy Johns restaurant outlets. That outbreak sickened 140 people, and sent almost one in four of the victims to hospital.

A single lot of clover seeds appears to have been the source of the contaminated sprouts, based on FDA’s traceback investigation. The agency has not yet determined where – other than Jimmy Johns – the clover sprouts grown from these seeds were distributed. While CDC has not issued specific recommendations, I urge eFoodAlert readers to avoid all clover sprouts – including those grown at home.

Lushlife Gardens Saladini Sprouts NOT Recalled

Last autumn, the New York State Department of Agriculture and Markets found Listeria monocytogenes in a sample of Saladini brand Alfalfa Sprouts produced by Lushlife Gardens (Milford, NJ). The state reported its finding to FDA.

FDA inspectors visited the sprout processing facility and carried out an inspection and environmental sampling that lasted for several days – November 15th to 21st, to be precise. Two of the 40 environmental swab samples yielded Listeria monocytogenes, demonstrating the continued presence of the human pathogen in the processing facility. In addition, inspectors documented insanitary conditions in the sprouting facility, including condensate dripping from dirty fabric onto seeds and sprouts.

In spite of a confirmed finding of Listeria monocytogenesa potentially deadly microbe – in a sample of the company’s alfalfa sprouts, in spite of the confirmed presence of the same strain of Listeria monocytogenes in the processing environment, and in spite of documented insanitary conditions, the contaminated Saladini Alfalfa Sprouts were never recalled.

As is typical, FDA gave Lushlife Gardens a deadline for taking necessary corrective actions to clean up its processing facility and procedures; however, the company’s January 2, 2012 response letter was found by FDA to be inadequate, as it did not provide documentation of the corrective actions that the company claimed to have taken. So FDA issued a Warning Letter to Lushlife Gardens on January 18th, which gave the company 15 working days to notify the agency of the steps taken to correct the violations. The Warning Letter included the following:

“During the inspection, the FDA investigators collected sample number 689489 consisting of 40 environmental swabs. Analysis of two swabs (one on the floor just inside the green house entrance and another on the floor underneath row (b)(4) of (b)(4) yielded L. monocytogenes. One of the isolates was indistinguishable from the strain that was isolated by the NYAG as analyzed with pulse gel electrophoresis (PFGE). We have attached a copy of the analysis which demonstrates that the isolates match for two different kinds of PFGE tests. These observations suggest that the L. monocytogenes isolated from your product by NYAG likely came from the facility.

Our investigators also observed condensate dripping onto seed and sprouts from black fabric, rope and string. The black fabric was not adequately cleaned and sanitized as evidenced by apparent mold growing on the fabric. These conditions are reasonably likely to result in contamination of your product with L. monocytogenes.”

I have to wonder why FDA remained silent in the face of these observations. I realize that the batch of sprouts documented by New York State to be contaminated probably had expired, but it’s clear from the FDA Warning Letter that the risk of contamination was ongoing. While the agency may not have been in a strong position to press for a recall of other production lots, it could have  – and, in my opinion, should have– issued a warning to the public. After all, as the Warning Letter said,

“The conditions observed during the inspection and the finding of L. monocytogenes in your facility cause the sprouts processed at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S. C.§342(a)(4)], in that your sprouts have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.”

It has now been more than one year since Congress passed, and the President signed, the Food Safety Modernization Act. This law, among other tools, gave FDA mandatory recall authority for the first time in its history. Does FDA have the backbone to use its new authority for the protection of the public?

Or is it “business as usual” at the agency on which US consumers depend to keep our food supply safe?

E. coli O104:H4 – How Big Is The Iceberg?

“I believe the HUS cases are the real tip of the iceberg.”

– Dr. Michael T. Osterholm, PhD, MPH, Director of the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP), the publisher of CIDRAP News.

One puzzling aspect of the E. coli O104:H4 outbreak has been the very high number of cases of hemolytic uremic syndrome (HUS) and the large number of deaths in comparison to the total number of reported infections.

The World Health Organization, as of July 7th, reported a total of 3,941 cases worldwide, including 909 cases of HUS and 52 deaths. This tally actually dropped from the previously reported total (on July 1st) of 4,137 cases. The change was due to a redefinition of outbreak-related cases issued by the European Union.

Determining the actual number of outbreak victims in a foodborne disease investigation is rarely easy. I’ve wondered for some time how many mild and/or asymptomatic illnesses have gone unreported. On July 5th, I gave voice to my suspicion that many cases of E. coli O104:H4 have gone unreported, saying, “It’s likely that an unknown number of milder gastrointestinal illnesses also can be blamed on this outbreak strain.”

It is now clear that my hunch was well-founded. The European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) have released an updated “Risk Assessment”which includes the following paragraph:

“The most significant development since June 29 relates to the preliminary results of the screening of children and staff in a school in Kreis Paderborn (Paderborn county), Germany, where three cases of HUS STEC and one case of non-HUS STEC infection have been identified since 13 June 2011 and onwards. In 22 of the 30 children tested (including the three HUS STEC cases, and the non-HUS STEC case), the epidemic strain of E. coli was isolated, indicating a significant level of asymptomatic infection. Asymptomatic carriage of STEC infection was also found in three kitchen workers at the school, in four guardians in four different child care centres in the district, and in three staff members of a supplying catering company. Further investigations of this cluster are ongoing.”

So, how big is the E. coli O104:H4 iceberg? Let’s do the math. First, we must decide on our multiplier. Let’s look at the two extreme cases.

  • The conservative estimate. The ECDC/EFSA report of asymptomatic cases documented a total of 22 children and 10 adults who were carriers of E. coli O104:H4 in its investigation of the Kreis Paderborn cluster of illnesses. Of these 32 carriers, only 4 developed active illnesses – including 3 cases of HUS. This gives us a multiplier of 8 (i.e., each reported case represents 8 actual infections).
  • The opposite extreme. In January 2011, CDC released its latest estimates of foodborne disease illness in the USA. The report details the multipliers that the authors developed for each pathogen to extrapolate actual illnesses from the numbers of reported illnesses. For non-O157 strains of enterohemorrhagic E. coli – the category into which E. coli O104:H4 falls – this multiplier is 106.8 (see Table 2 of report).

Taking these two multipliers and applying them to the most recent numbers reported by the World Health Organization, we arrive at the following:

  • The conservative estimate: 3,941 reported cases worldwide x 8 = 31,528 estimated symptomatic and asymptomatic infections.
  • The opposite extreme: 3,941 reported cases worldwide x 106.8 = 420,899 estimated symptomatic and asymptomatic infections.

The truth, no doubt, lies somewhere in between these two extremes.

Why is this important? Simply, the more people who have been infected – especially those who show no symptoms of illness – the more likely that E. coli O104:H4 will establish itself as thoroughly as E. coli O157:H7 already has done.

As for the “most probable source” of the outbreak, the Egyptian fenugreek seeds have been tracked forward to 25 countries so far – Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

As for the German outbreak investigation, the Federal Office of Consumer Protection and Food Safety has released its final Task Force report.

The German investigation may be complete, and the present outbreak winding down, but this is not the last we’ve heard from E. coli O104:H4.