July 2012

Chicks073112-map.jpgA total of 76 persons infected with the outbreak strain of Salmonella Montevideo have been reported from 22 states.

The number of ill persons identified in each state is as follows: Alaska (1), California (2), Colorado (1), Florida (1), Georgia (1), Illinois (2), Indiana (9), Iowa (2), Kansas (10), Kentucky (1), Massachusetts (2), Missouri (24), Nebraska (8), Nevada (1), New York (1), North Carolina (1), Ohio (1), Oklahoma (4), South Dakota (1), Texas (1), Vermont (1), and Wyoming (1).

Seventeen ill persons have been hospitalized. One death was reported in Missouri, but Salmonella infection was not considered a contributing factor in this person’s death.

Thirty-seven percent of ill persons are children 10 years of age or younger.

Epidemiologic, laboratory, and traceback findings have linked this outbreak of human Salmonella infections to contact with chicks, ducklings, and other live baby poultry from Estes Hatchery in Springfield, Missouri.

cantaloupedangling-406-thumb-320x197-11031.jpgOn Saturday, Burch Farms of North Carolina announced a recall of Athena cantaloupes because the product may contain listeria monocytogenes. No illnesses have been associated with this recall, according to Burch Farms.

Hannaford, including both Bedford locations, is advising customers because its stores had carried Burch Farms Athena cantaloupes. The product has been removed. Athena cantaloupes, a variety grown in the Southeastern United States, are a whole cantaloupe produce item. If stickered, the label on the item will reference Burch Farms and read: Cantaloupe PLU 4319.

Customers should not consume these cantaloupes. Return the item to stores or dispose of the item and return the sticker for a full refund. Listeria has the potential to cause serious illness.

The Washington Post’s Dina ElBoghdady must not have had a busy social calendar this Summer weekend if she was stalking the pages of FoodNet for the latest in foodborne illness trends. Her story, “Food-borne illnesses not diminishing” which ran this morning on the Post’s website, I caught while sneaking a peak on my forbidden iPhone on a family camping trip. I will get to the trends in a second, but I was also struck by this line in the story:

the CDC released the data without reaching out to consumer groups and other key stakeholders who typically are notified in advance. Instead, the charts and graphs were quietly posted online Friday.

Can someone at the CDC explain the rationale for that?

On the numbers front, there are some things that you would think that the CDC would not want to release in the middle of the night:

Screen Shot 2012-07-29 at 3.00.00 PM.png

Although Campylobacter, Listeria, Salmonella, Vibrio and Cryptosporidium are up, Shigella, E. coli O157:H7 and Yersinia are down that does not seem to justify a late Friday night posting on the CDC’s website.  It will be interesting to watch the non O157 E. coli trends over the next years.  Here are the numbers for this year:

Screen Shot 2012-07-29 at 3.02.28 PM.pngAlso, hemolytic uremic syndrome (HUS) was up in 2011 as compared to some earlier years.  Since this outcome can be caused by both E. coli O157:H7 and non E. coli O157, that might well be the reason.  Time will tell.

Overall, however, we (public health and food producers) are doing better that when I started doing foodborne illnesses cases in the 1993 Jack in the Box E. coli outbreak – that is a good thing.  Now we just need to implement the Food Safety Modernization Act (FSMA) and drive the numbers done farther.  I really think it is time I spent more time camping.

Earlier this week Food Safety News reported that the CDC had increased the numbers of those considered to be culture-confirmed cases from the 2011 cantaloupe Listeria outbreak from 146 to 147 and confirmed that the death toll now stands at 33[1]

Of course, the death toll is in fact much larger – likely as high as 37 or 38 – and, there may well be many more that were sickened by the tainted cantaloupe who are not officially counted as part of the outbreak. 

So, now we know that a total of 147 persons infected with any of the five (5) and possibly six (6) outbreak-associated strains of Listeria monocytogenes were reported to CDC from 28 states.  The number of infected persons identified in each state was as follows:  Alabama (1), Arkansas (1), California (4), Colorado (40), Idaho (2), Illinois (4), Indiana (3), Iowa (1), Kansas (11), Louisiana (2), Maryland (1), Missouri (7), Montana (2), Nebraska (6), Nevada (1), New Mexico (15), New York (2), North Dakota (2), Oklahoma (12), Oregon (1), Pennsylvania (1), South Dakota (1), Texas (18), Utah (1), Virginia (1), West Virginia (1), Wisconsin (2), and Wyoming (4).  Deaths were scattered in Colorado, Indiana, Kansas, Louisiana, Maryland, Missouri, Montana, Nebraska, New Mexico, New York, Oklahoma, Texas, and Wyoming.

So, should brothers Ryan and Eric Jensen face criminal charges for these illnesses and deaths?

In 1938 Congress passed the Federal Food, Drug, and Cosmetic Act in reaction to growing public safety demands. The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce. Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health. The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce. Any person who commits a prohibited act violates the FDCA. A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by not more than three years or fined not more than $10,000 or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation. Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $1,000, or both.

However, did what the Jensen brothers do, or not do, constitute a crime?  Let’s look at the facts.

The FDA’s Investigation at Jensen Farms

On September 10, 2011, with Colorado state officials, the FDA conducted an inspection at Jensen Farms and collected multiple samples, both product and environmental, for laboratory testing.  Of the 39 environmental swabs collected from within the Jensen Farms packing facility, 13 were confirmed positive for Listeria monocytogenes with PFGE pattern combinations that were indistinguishable from three of the five outbreak strains.  Of the 13 positive environmental swabs, 12 were collected at the processing line and one was collected from the packing area.  Cantaloupe collected from the firm’s cold storage during the inspection also tested positive for Listeria—in fact, five of the ten samples collected were positive for Listeria—with PFGE pattern combinations that were indistinguishable from two of the five outbreak strains.

After finding evidence of extensive contamination at Jensen Farms, the FDA, again with the assistance of Colorado state officials, conducted an environmental assessment at the facility in an effort to identify the practices and conditions that lead to such widespread contamination.  The results of the assessment, which occurred on September 23 and 24, 2011, were disclosed in a report dated October 19, 2011.  Among other things, the report notes:

a.   Facility Design Certain aspects of the packing facility, including the location of a refrigeration unit drain line, allowed for water to pool on the packing facility floor in areas adjacent to packing facility equipment.  Wet environments are known to be potential reservoirs for Listeria monocytogenes and the pooling of water in close proximity to packing equipment, including conveyors, may have extended and spread the pathogen to food contact surfaces.  Samples collected from areas where pooled water had gathered tested positive for an outbreak strain of Listeria monocytogenes.  Therefore, this aspect of facility design is a factor that may have contributed to the introduction, growth, or spread of Listeria monocytogenes.  This pathogen is likely to establish niches and harborages in refrigeration units and other areas where water pools or accumulates.

Further, the packing facility floor where water pooled was directly under the packing facility equipment from which FDA collected environmental samples that tested positive for Listeria monocytogenes with PFGE pattern combinations that were indistinguishable from outbreak strains.  The packing facility floor was constructed in a manner that was not easily cleanable.  Specifically, the trench drain was not accessible for adequate cleaning.  This may have served as a harborage site for Listeria monocytogenes and, therefore, is a factor that may have contributed to the introduction, growth, or spread of the pathogen.

b.   Equipment Design FDA evaluated the design of the equipment used in the packing facility to identify factors that may have contributed to the growth or spread of Listeria monocytogenes.  In July 2011, the firm purchased and installed equipment for its packing facility that had been previously used at a firm producing a different raw agricultural commodity.

The design of the packing facility equipment, including equipment used to wash and dry the cantaloupe, did not lend itself to be easily or routinely cleaned and sanitized.  Several areas on both the washing and drying equipment appeared to be un-cleanable, and dirt and product buildup was visible on some areas of the equipment, even after it had been disassembled, cleaned, and sanitized.  Corrosion was also visible on some parts of the equipment.  Further, because the equipment is not easily cleanable and was previously used for handling another raw agricultural commodity with different washing and drying requirements, Listeria monocytogenes could have been introduced as a result of past use of the equipment.

The design of the packing facility equipment, especially that it was not easily amenable to cleaning and sanitizing and that it contained visible product buildup, is a factor that likely contributed to the introduction, growth, or spread of Listeria monocytogenes.  Cantaloupe that is washed, dried, and packed on unsanitary food contact surfaces could be contaminated with Listeria monocytogenes or could collect nutrients for Listeria monocytogenes growth on the cantaloupe rind.

c.   Postharvest Practices In addition, free moisture or increased water activity of the cantaloupe rind from postharvest washing procedures may have facilitated Listeria monocytogenes survival and growth.  After harvest, the cantaloupes were placed in cold storage.  The cantaloupes were not pre-cooled to remove field heat before cold storage.  Warm fruit with field heat potentially created conditions that would allow the formation of condensation, which is an environment ideal for Listeria monocytogenes growth.

The combined factors of the availability of nutrients on the cantaloupe rind, increased rind water activity, and lack of pre-cooling before cold storage may have provided ideal conditions for Listeria monocytogenes to grow and out-compete background microflora during cold storage.  Samples of cantaloupe collected from refrigerated cold storage tested positive for Listeria monocytogenes with PFGE pattern combinations that were indistinguishable from two of the four outbreak strains.  See FDA Environmental Assessment Report, Attachment No. 1.

After conducting this environmental assessment, the FDA issued a warning letter to Jensen Farms, indicating, “we may take further action to seize your product(s) and/or enjoin your firm from operating.  Additionally, the receipt of this warning letter and any action taken to correct the violations cited in it do not preclude a subsequent criminal prosecution by the United States Department of Justice.”  See FDA Warning Letter to Jensen Farms, Attachment No. 2.  To date, despite at least 33 deaths, one miscarriage, and 147 confirmed illnesses nationally, no criminal indictments have issued in this outbreak—yet.

But the FDA did not close its file on this outbreak after issuing its very clear warning.  Officials from the agency also participated in the much-publicized briefings with the House Committee on Energy and Commerce in October and December 2011.  At those meetings, FDA officials cited multiple failures at Jensen Farms, which, according to the Committee Report, “reflected a general lack of awareness of food safety principles.”  Those failures, several of which draw from the FDA’s Environmental Assessment Report, included:

  • Condensation from cooling systems draining directly onto the floor;
  • Poor drainage resulting in water pooling around the food processing equipment;
  • Inappropriate food processing equipment which was difficult to clean (i.e., Listeria found on the felt roller brushes);
  • No antimicrobial solution, such as chlorine, in the water used to wash the cantaloupes; and
  • No equipment to remove field heat from the cantaloupes before they were placed into cold storage.

In particular, the FDA heavily criticized the decision not to chlorinate the water used to wash cantaloupes, despite the fact that the wash was not re-circulated, as well as the use of improper processing equipment in the packinghouse.  As is discussed below, both of these factors not only contributed to the cause of the outbreak, but also were the subject of discussion and recommendation by Primus Labs and its agent Bio Food Safety during the latter’s 2011 audit at Jensen Farms.

In short, the conditions, personnel, and facility in general at Jensen Farms in summer 2011 did not just fall well-short of good manufacturing practices and industry standard, they violated FDA guidance on the safe production of cantaloupes.  In fact, this is specifically the opinion held by FDA officials who spoke with the Committee in October and December:  “FDA officials stated that the outbreak could have likely been prevented if Jensen Farms had maintained its facilities in accordance with existing FDA guidance.”’  See Energy and Commerce Committee Report, Attachment No. 3.

So, if you were the U.S Attorney in Colorado, or any of the other states with victims, would you charge Ryan and Eric Jensen with a crime?  Would it be a felony or a misdemeanor?  And, how many counts?

[1] The CDC has recently reported that 32 people have died (http://www.denverpost.com/breakingnews/ci_20021384).  We believe that number should now be 37 with the additional deaths of Sharon Jones, Paul Schwarz, Michael Hauser, Betty Mills and Dale Braddock who we do not believe the CDC has yet counted.

The CDC just released its final report on this ongoing outbreak.

A total of 425 persons infected with the outbreak strains of Salmonella Bareilly (410 persons) or Salmonella Nchanga (15 persons) were reported from 28 states and the District of Columbia. 55 ill persons were hospitalized, and no deaths were reported.

Collaborative investigation efforts of state, local, and federal public health agencies linked this outbreak to a frozen raw yellowfin tuna product, known as Nakaochi Scrape, from Moon Marine USA Corporation.

Consumers should not eat the recalled product, and retailers should not serve the recalled raw Nakaochi Scrape tuna product from Moon Marine USA Corporation.

This particular outbreak appears to be over. However, additional cases may be reported over the next several months since some food establishments may be unaware that they received recalled product and continue to serve this frozen raw yellowfin tuna product, which has a long shelf-life.

It is interesting to note the number if ill AFTER the April 13, 2012 recall:


And, thanks to Food Safety News:

David Theno, former VP of Food Safety at Jack in the Box and I were the keynote speakers at the Beef Industry Safety Summit. Our topic was the 20 year post the Jack in the Box E. coli Outbreak. For those who want to read the book read Poisoned at www.poisoned.com. Here is the video of Dave’s and my talk:

Bill Marler Speaking at 2012 Beef Safety Summit from Marlerclark on Vimeo.

Peggy O’Farrell of the Dayton Daily News has become the latest in two decades of reporters who are thrust into the middle of yet another E. coli outbreak. This one, as she reports today, “claimed its first fatality Tuesday, a longtime area school superintendent known for his dedication to children. Lowell Draffen, 73, of Germantown, was one of at least 75 people sickened after consuming food served at a July 3 customer appreciation picnic at Neff’s Lawn Care in German Twp. He retired in 2010 as superintendent of Trotwood-Madison City Schools, and had also been superintendent at Valley View and Mad River schools.”

As the health department announced, “two others remain hospitalized — a 4-year-old girl and a 14-year-old boy. A total of 14 people have been hospitalized, and health officials still do not know the cause of the contamination.”

I spoke to Ms. O’Farrell early this morning after the news of Mr. Draffen’s death was announced:

Bill Marler, managing partner for Marler Clark, a Seattle law firm that specializes in foodborne illness outbreaks, said he found it “a little perplexing” that investigators hadn’t identified the source of the outbreak three weeks after the event.

Marler handled lawsuits filed after a 1993 E. coli outbreak tied to 73 Jack in the Box restaurants that sickened 700 people in Washington state, California, Nevada and Idaho. Four people died in that outbreak, which was linked to beef that wasn’t cooked to the proper temperature.

“It’s obviously a significant, significant outbreak you’re dealing with,” Marler said.

Yet, every preventable outbreak and preventable death is significant. Not far from my mind – especially in an E. coli outbreak in Ohio – is the needless loss of Abby Fenstermaker.  I think about her and her parents alot:

E. coli Victim: Abby Fenstermaker from Marlerclark on Vimeo.  It is time for all of us to remember Abby and Lowell.

Hamburger.jpgAccording to the CDC today, the number of ill linked to ground beef produced by Cargill held steady. A total of 33 persons infected with the outbreak strain of Salmonella Enteritidis have been reported from 7 states. The number of ill persons identified in each state is as follows: Maine (1), Massachusetts (3), New Hampshire (2), New York (14), Rhode Island (1), Virginia (2), and Vermont (10). 11 ill persons have been hospitalized, and no deaths have been reported. Collaborative investigation efforts of state, local, and federal public health (CDC) and regulatory agencies (FSIS) indicate that ground beef produced by Cargill Meat Solutions at a single production facility is the likely source of this outbreak. This evening FSIS announced an expanded list of retail outlets that received Cargill meat that is now subject to a 30,000 pound recall:

Hannaford, Stores in ME, MA, NH, NY and VT

Country Market in CT

Brackett’s Market, Will’s Shop N’ Save and Gray Shop N’ Save in ME

Pure Food Market, Inc, IGA in MAHunter’s Shop ‘n Save in NH

IGA, Peck’s Market, Hurley Ridge Market, Wilson’s Lakeside Market and G-Mart in NY

IGA, Town Market in NJ

Lake Region IGA in PA

vlcsnap-2012-07-09-16h08m00s102_20120709160825_320_240.PNGAccording to Dayton Daily News, one of the victims, 73-year old man, of an E. coli outbreak linked to a July 3 picnic in Germantown has died, health officials said this morning.

UPDATE:  According to WDTN, Lowell Draffen, former superintendent of a handful of area school districts died Monday night.  Draffen served as superintendent at Mad River Schools and Valley View Schools. Most recently he served as superintendent at Trotwood-Madison Schools. Draffen retired from that district in 2010.

As a result of eating food at a picnic at Neff’s Lawn Care in Germantown, at least 75 individuals have become ill. Of those, 14 have been hospitalized. Public Health – Dayton & Montgomery County is continuing an investigation into the cause of the foodborne outbreak. Estimates are that as many as 300 people may have attended an annual customer appreciation picnic held by Neff’s Lawn Care, 9400 Ekhart Road, on July 3. Of the ill, 18 have been confirmed as being infected by E. coli O157. Three individuals are experiencing hemolytic uremic syndrome (HUS), a disease that destroys red blood cells, and can cause sudden, short-term-acute-kidney failure. Those affected include a 4-year old female, a 14-year old male, and the 73-year old male.

Cases that have involved residents of Ohio over the last decades include:

ConAgra Ground Beef E. coli Outbreak Lawsuits – Nationwide (2002)

Cuyahoga County E. coli outbreak – Ohio (2009)

Dole Spinach E. coli Outbreak Lawsuits – Nationwide (2006)

Freshway Lettuce E. coli Outbreak Lawsuits – Multistate (2010)

JBS Swift E. coli Outbreak Lawsuits – Nationwide (2009)

Jimmy John’s Clover Sprouts E. coli O26 Outbreak Lawsuits – Multistate (2012)

KFC E. coli Outbreak Lawsuit – Ohio (1999)

Nebraska Beef E. coli Outbreak – Nationwide (2008)

Nestle Toll House Cookie Dough E. coli Outbreak Lawsuits – Nationwide (2009)

Tyson Fresh Meats E. coli Lawsuit – Ohio (2011)

Valley Meats E. coli Outbreak Lawsuits – Ohio, Illinois, Pennsylvania (2009)

The CDC reports that a total of 37 persons infected with the outbreak strain of Salmonella Hadar have been reported from 11 states.

The number of ill persons identified in each state is as follows: Arizona (2), California (1), Colorado (3), Idaho (5), Illinois (2), Oregon (5), Tennessee (2), Texas (1), Utah (5), Washington (9), and Wyoming (2).


Eight ill persons have been hospitalized. No deaths have been reported.

37% of ill persons are children 10 years of age or younger.

Epidemiologic, laboratory and traceback findings have linked this outbreak of human Salmonella infections to contact with live poultry from Hatchery B in Idaho.

Is this like “Mexican-style fast food restaurant chain, Restaurant Chain A,” Errr, Taco Bell?

Oddly, the CDC did out Estes Hatchery in Springfield, Missouri after its chicks, ducklings, and other live baby poultry sickened a total of 66 with Salmonella Montevideo in 20 states.  Earlier in 2012 the CDC named Mt. Healthy Hatchery in Ohio as the source of chicks and ducklings that sickened 144 with Salmonella Infantis, Salmonella Newport, and Salmonella Lille in 26 states.

So, why not “Hatchery B in Idaho?”