Food Poisoning Lawyer & Attorney : Marler Clark : Food Poison Journal

Officials with Grand Traverse County Health Department have reported three probable cases of  Shigatoxin-producing E.coli in the past week.  Information was not provided on the specific strain, but the most common pathogenic strain of the bacteria is E. coli O157:H7.   According to this report, "All cases were in children and all three attended the Northwestern Michigan Fair in Grand Traverse County between August 9 and August 13.  The onset of symptoms, including bloody diarrhea, were between August 15 and August 17.

It appears that the illnesses are linked to exposure to animals at the fair:

"Considering the number of animals in close proximity to people at that venue, it seems likely that their infections were contracted there", stated Dr. Michael Collins, Medical Director for the Grand Traverse County Health Department. "Though we will probably never know exactly which animal or animals were involved as sources".

E. coli O157:H7 is most often harbored by ruminants, including cattle, sheep, and goats.  Outbreaks of illness, and E. coli O157:H7, have been repeatedly linked to animal/child interaction at petting zoos and fairs.   For many years, the CDC and the National Association of State Public Health Veterinarians (NASPHV) has provided a list of guidelines and recommendations aimed at reducing or eliminating the risk of such transmission.

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The student newspaper at Penn State is reporting that an attendee to a tennis camp at PSU left early last week, and has been told that he had contracted E. coli.   There is no confirmation that the illness was contracted at the camp.   The report did not indicate the strain of E. coli to be E. coli O157:H7.  It is fairly likely that this is the strain involved however, as it is one of very few, and in some cases the only strain, that is tested for and reported.   According to the report:

Penn State spokeswoman Lisa Powers said Penn State officials couldn't confirm that the camper contracted the illness while at Penn State. University officials will meet this afternoon to discuss the situation, she said.

A natural question is whether any other attendees of the camp were ill.  It does appear that other campers reported digestive problems, but there is not yet any indication of other reports of E. coli.  A single commons provides food for all attendees at the university's sports camps.  

In 2002,  a number of attendees at a dance camp at Eastern Washington University developed E. coli O157:H7 infections eventually traced to lettuce served in the university kitchens. 

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In 2009, 93 people, mostly young children, were sickened in an outbreak of E. coli O157:H7 linked to the Godstone Farm in Surrey, U.K.  A year later, an independent inquiry into the matter has produced a report that concluded that dozens of cases of E. coli O157:H7 "could have been prevented if authorities had acted earlier and taken the outbreak more seriously" according to press reports.   Outbreaks of E. coli O157:H7 at petting zoos are not new.

Professor George Griffin, professor of infectious diseases at St George's University London, chaired the inquiry.  He warned that "regulations governing petting or 'open' farms were not robust enough to prevent a similar outbreak occurring again." 

The report was critical of medical practitioners and government officials alike:

The 250-page report said some local GPs did not recognise the illness as a medical emergency, telling parents their children would get better on their own only for them to deteriorate rapidly.

There were 'unacceptable delays' by the Health Protection Agency in setting up an outbreak control team and a 'failure in public health leadership', the report said.

It added: "If action had been taken sooner to stop all contact with ruminants (cows and sheep), a substantial number of the E.coli 0157 cases could have been prevented."

8 of the ill persons developed cases of HUS serious enough to need dialysis to survive.   Some victims may need a kidney transplant in the future.  Because HUS is much more likely to develop among children exposed to E. coli O157:H7, outbreaks at petting zoos are particularly damaging.  Such a sudden spike in children needing kidney treatment stretches medical care thin as well:

The outbreak was so severe that every specialist hospital bed to treat children with serious kidney problems in London and the South East was filled with cases from Godstone Farm.

The report suggested that thousands were permitted to visit the farm after the local Health Protection Agency was aware of at least cases of illness linked to the farm.  The report did not call for a ban on human/animal contact at such fairs:

Prof. Griffin said the report was in favour of common sense approach and not draconian measures. He said it was perfectly possible for children to pet animals on a farm safely if the animals are kept clean, on fresh bedding and handwashing facilities are readily available and well supervised.

In the U.S. the CDC has published guidelines created by the National Association of State Public Health Veterinarians for public animal exhibits.

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A report on last summer's outbreak of E. coli O157:H7 , traced to the Godstone Farm in Surrey, U.K. is due shortly, according to the BBC.   Ninety-three people, mostly young children, were sickened in the outbreak.  

The inquiry was ordered by the Health Protection Agency.  The Agency was criticized for a slow response to the problem.  According to BBC:

The independent inquiry looked into how the outbreak occurred and the role of the regulatory agencies.  The farm was not closed until a month after the first case .During this time tens of thousands of people would have passed through it.  Some of the people affected are still ill with kidney damage and a group of parents are preparing to launch legal action for damages.

Outbreaks of zoonotic disease, generally, and E. coli O157:H7 in particular, has been a problem in both the U.K. and the U.S. that has been documented for over 20 years.  

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The raw milk controversy continues to generate press- both in print and in the "blogosphere."  Last Thursday on my layover in Minneapolis, this article was on the front page of the Star Tribune.   On June 4, the New York Times ran an Op-Ed from Michael Feldman discussing the Wisconsin Governor's veto of a bill that would have allowed retail sales of raw milk.   Finally, Marion Nestle weighed in as well. 

The Star-Tribune article was following up on an outbreak of E. coli O157:H7 linked to raw milk at Hartmann's dairy.   Last week, Minnesota health officials announced that the strain of E. coli O157:H7 associated with the illnesses was found at "multiple sites" on the farm. 

In the NY Times, Feldman painted a picture of the passion of raw milk advocates, while expressing some skepticism at their claims, "Standard pasteurization, they claim, kills a dubious-sounding 99.999 percent of milk’s good, bad and indifferent microorganisms..."

Nestle explained her personal choice not to consume raw milk.  She suggested that readers visit www.realrawmilkfacts.com, and stated "Putting a child at risk of hemolytic uremic syndrome from toxic E. coli just doesn’t make sense to me."

As usual, the comment sections of raw milk stories on line are active.   Before I go, I want to address a personal favorite of mine.  Over and over again, I see raw milk advocates explaining that the safety of raw milk is simply about "knowing your farmer."   I just don't see how this really changes the equation.  Does your farmer have the ability to spot microscopic bacteria?  Bacteria that are NOT pathogenic to cows, and present in the intestinal tracts of healthy animals?  We have represented the families of sick children who knew their farmer.  It did not remove the E. coli O157:H7 from the milk.

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The Washington State Department of Health (WDOH) announced today that two recent E. coli O157:H7 infections are connected to the consumption of "raw" unpasteurized milk.  According to WDOH  "The two cases confirmed this month bring the count of infections this year associated with one Bellingham dairy to eight."

Washington State Department of Agriculture (WSDA) is also involved in the investigation:

The two new patients say they drank raw milk produced by Jackie’s Jersey Milk in Whatcom County. WSDA has conducted additional testing of the firm’s product, but has not found E. coli in the milk. WSDA continues to work with the farm to review the dairy's production and producthandling practices.

The firm issued a product recall notice in February after WSDA found E. coli during routine sampling of the farm’s raw milk. Soon after the February recall, six patients with E. coli infections reported drinking the dairy’s product. People who were sick said they got the milk at retail stores in King, Snohomish, and Skagit counties.

Its getting hard to count all the raw milk outbreaks.  There is another currently being reported in Minnesota that has left a toddler in the hospital.

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Still not half way through 2010, and we have already seen at least six outbreaks of illness, involving three different dangerous pathogens, tied to raw milk.  There have been outbreaks in Minnesota, Nevada, Utah (2), and Pennsylvania, as well as a single outbreak that included illnesses in Michigan, Indiana, and Illinois.  Raw milk consumers have been sickened with E. coli O157:H7; Salmonella, and Campylobacter. 

For those of you scoring at home:

Just today, health department officials in Minnesota have reported three cases of E. coli O157:H7 illness linked to raw milk from a dairy farm in Gibbon, MN. The Minnesota Department of Health and the Minnesota Department of Agriculture are continuing to investigate the illnesses.  All of the sick share a strain of the bacteria that have the same “pulsed field gel electrophoresis” (PFGE) patterns, or DNA fingerprint.   One of the ill persons has developed HUS.  

Earlier this month, Nevada health officials reported that a child became seriously ill with a Campylobacter infection after eating homemade cheese that was illegally sold door-to-door.    The cheese was not properly pasteurized. 

In April, Utah was the site of Salmonella and Campylobacter outbreaks tied to raw milk. According to a Utah Public Health Press Release, there were two separate clusters of illness linked to the consumption of raw milk. The first cluster included nine reported cases of Campylobacter infection among residents in Weber, Davis and Cache Counties. This outbreak was linked to the Ropelato Dairy.  The second cluster, linked to the Redmond Dairy,  included six reported cases of Salmonella infection in residents in Utah, Salt Lake and Wasatch Counties. 

In March, raw milk caused at least 17 culture confirmed Campylobacter infections in Michigan, Illinois, Indiana.   Three cases were from Indiana, one from Illinois, and 13 from Michigan. 

Another outbreak of Campylobacter was reported in February in Pennsylvania. State health officials there said approximately 10 people became ill after drinking raw milk from Pasture Maid Creamery. One of the ill developed Guillain - Barre Syndrome, and became paralyzed.

Also, see www.realrawmilkfacts.com for more information.

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The USDA, on a new website on May 13, unveiled a cost of food poisoning calculator.  To date, the only two pathogens with reported yearly costs estimates are Salmonella and E. coli O157:H7.  The combined cost estimate for those two?  In excess of $3 Billion. 

According to the USDA, the estimates "include assumptions about disease incidence, outcome severity, and the level of medical, productivity, and disutility costs."  The calculator allows a user to input different assumptions and see how the total cost would be affected. 

The calculator will apparently be updated in the future to include additional pathogens and estimates, including Campylobacter, Listeria, and non-O157:H7 strains of shiga toxin producing E. coli. 

The site estimates the number of non-O157:H7 E. coli illnesses at over 31,000 annually.  An example of such a pathogen is E. coli O145, the cause of an recent outbreak of illness connected to romaine lettuce. 

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To update, two clusters of non-O157:H7 E. coli illnesses in Michigan and Ohio share the same genetic pattern and appear to be linked to a common food item.  10 Washtenaw County (MI) residents have suffered culture confirmed E. coli O145 infections, and the health department is awaiting stool test results on another 14.  Meanwhile, at least 5 Columbus, Ohio residents, including students at The Ohio State University, have also been confirmed as positive for E. coli O145, matching the Washtenaw County strain. 

Health officials say they are focusing on an area food distributor.  Laura Bauman, an epidemiologist with Washtenaw County Health, said there is a common link between both collections of reported cases in Washtenaw County and in Ohio and the food distributor they are investigating.

"Department of Agriculture officials are doing a 'trace-back' on the food products to determine the origin of the contamination," Bauman said.

When asked whether the contamination most likely occurred in the distribution or the production of the foods, Bauman said they are unable to determine that at this point and they are leaving that aspect of the investigation to the state's agriculture department investigators.

The good news:  Bauman said it has been a positive sign that they have not found a reported case from somebody outside of that time frame - meaning that, more than likely, the infected food product or products were exposed to E. coli for only a brief period of time.  As for the restaurant or restaurants involved in the outbreak, which have not been identified by health officials, Bauman said they are working closely with them but have not asked owners to stop using any specific distributor. "We don't have any answers right now. We won't ask them to take action until we have some more concrete answers," she said.

Multiple clusters of matching illness + regionally distributed food product + relatively confined exposure period (i.e. limited shelf-life) + pathogenic strain of E. coli = lettuce, spinach, or another leafy green? 

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Is it mere coincidence that the Marler Clark firm's petition to FSIS asking it to declare non-O157 strains of E. coli as adulterants in meat (submitted October 2009) is being considered in the midst of at least two outbreaks of non-O157 E. coli (O111 and O145)?  Or is it proof that there is actually a problem with non-O157 in our food supply.  New York Senator Kirsten Gillibrand would, I think, agree that this is a real problem. 

On April 22, she sent the following letter to US Dept. of Agriculture Secretary Tom Vilsack asking for action on the petition:

April 22, 2010

Dear Secretary Vilsack,

I am writing to you today to urge you to respond formally to two petitions to the USDA’s Food Safety Inspection Services: 1) Petition for an Interpretive Rule Declaring all enterohemorrhagic Shiga Toxin-producing Serotypes of Escherichia coli (E. coli), including Non-O157 Serotypes, to be Adulterants Within the Meaning of 21 U.S.C. § 601(m)(1) - Petition #09-03; and, 2) S.T.O.P.-Safe Tables Our Priority’s Call to Action and Public Petition.

These petitions detail the scientific and legal bases for listing non-0157 STECs as adulterants. Such listings will avoid the same kind of large-scale disaster that precipitated the 1994 declaration of E. coli O157:H7 as an adulterant. S.T.O.P.’s petition also calls for the expansion of the definition of adulterant to include E. coli O157:H7 and these six other STEC when they are in any type of beef, not just ground beef or beef intended for ground beef. With these actions, USDA will take a significant leap forward in ensuring the safety of American consumers.

In light of current scientific and medical research, the health hazards posed by STEC are undeniable. The CDC recognized these hazards in 2000

when the agency made all STEC nationally notifiable. Since reporting was implemented in 2001, instances of non-O157 STEC have steadily increased year by year. In 2005 alone, 501 cases of non-O157 STEC were reported through the National Notifiable Diseases Surveillance System. This has become an issue that is too important and too urgent to ignore any longer. Indeed, in a presentation given on September 14, 2009, L. Hannah Gould, MS, PhD from the CDC stated that non-O157 STEC causes an estimated 36,700 illnesses, 1,100 hospitalizations, and 30 deaths annually.

As the numbers of reported illnesses from non-O157 STEC steadily increase, immediate action on this issue is critical. Please respond formally to these petitions, and send me a copy of this response.

Sincerely,

Kirsten E. Gillibrand
United States Senator

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Currently, there are at least two outbreaks nationally that involve dangerous strains of E. coli that are not E. coli O157:H7.  Michigan and Ohio are investigating at least 13 illnesses that occurred in mid-April, all of which are genetically indistinguishable strains of E. coli O145.  (Incidentally, this was one of the strains involved in the infamous Spinach E. coli outbreak in September 2006, which also included E. coli O157:H7).  And at a Colorado prison, at least 11 inmates were recently sickened with another strain of E. coli:  E. coli 0111. 

These recent outbreaks are just two in a series of outbreaks linked to non-O157, shiga-toxin producing E. coli (STEC).  Shiga-toxins are what can eventually lead to the devastating condition hemolytic uremic syndrome (HUS).  As mentioned, E. coli O145 was involved in the 2006 spinach outbreak, and was the strain that eventually caused the death of June Dunning.  And in August 2008, over 341 people were sickened, some critically, in an outbreak of E. coli O111 linked to Country Cottage restaurant in Locust Grove, Oklahoma.  Of these 341 people, 70 were hospitalized, including 22 children.  17 people required dialysis because of kidney failure, and one man died. 

On October 5, 2009, Marler Clark submitted a petition to the Food Safety and Inspection Service to declare all non-O157, shiga-toxin producing strains of E. coli in meat as adulterants per se, as E. coli O157:H7 already is.  The petition is currently being considered, as we recently learned from Dr. Phillip Derfler, Assistant Administrator at the Office of Policy and Program Development.  These recent outbreaks allow little room for the argument that there is no need to take this action.  Non-O157 strains of E. coli certainly are a problem in our food supply.

The petition received some well-deserved support today:

Continuing her commitment to keep all families safe from contaminated food, U.S. Senator Kirsten Gillibrand today urged U.S. Department of Agriculture (USDA) Secretary Tom Vilsack to include six additional strands of E. coli as hazardous adulterants that need to be tested by the USDA.

In addition to the most common form of E. coli that is already regulated, the Centers for Disease Control and Prevention (CDC) has identified six other strands, known as non-0157 STECs, that are just as hazardous as E. coli and need to be regulated. The CDC estimates that non-0157 STECs cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths in America each year.

“In America, in 2010, it is unconscionable that food is still going straight to our kitchens, school cafeterias and restaurants without being properly tested to ensure its safety,” Senator Gillibrand said. “It’s spreading too many diseases and costing too many lives. The laws that are meant to keep us safe from hazardous foods are in critical need of updating. We need immediate action to keep our families safe.”
 

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The ongoing E. coli outbreak in Michigan and Ohio is reminiscent of several other outbreaks, resulting in lots of illnesses, that have occurred in those states in the past several years:

    --Of course, residents of both states were sickened by E. coli O157:H7 in the infamous outbreak linked to Dole baby spinach in September 2006. 

    --More recently, 26 Michigan residents were sickened in an E. coli O157:H7 outbreak linked to iceburg lettuce grown by Santa Barbara Farms and distributed by Aunt Mid's produce company.   Additionally, nine individuals in Illinois and three from the Province of Ontario had also been identified with the same genetic strain of E. coli O157:H7

    --Also, in the summer of 2008, multiple residents of Ohio were sickened in the E. coli O157:H7 outbreak linked to ground beef products manufactured by Nebraska Beef.  Outbreak summary:

On June 24, 2008, the CDC announced an outbreak of E. coli O157:H7 illnesses among 24 residents of Michigan and Ohio. The next day, the CDC announced that the number of outbreak linked cases had grown to 32, and that ground beef sold at Kroger stores, the Cincinnati based grocery chain, was the likely outbreak vehicle. That afternoon, Kroger recalled all varieties and weights of ground beef products bearing a Kroger label sold between May 21 and June 8 at Michigan and Central and Northwestern Ohio Kroger retail establishments. By June 26, the outbreak had claimed 33 victims; and by June 30, the CDC counted 35 confirmed cases linked to ground beef sold by Kroger, with 19 people hospitalized and 1 known case of hemolytic uremic syndrome.

See details of 2008 E. coli O157:H7 outbreak linked to Nebraska Beef, Kroger, Coleman Meats, and Whole Foods. 

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A week ago, we reported on a developing E. coli outbreak in Washtenaw County, Michigan.  Notably, the outbreak is not attributable to E. coli O157:H7--the most notorious of all E. coli strains--but it does appear to be a shiga-toxin producing strain of E. coli.  Apparently, the outbreak is no longer confined to Washtenaw County, or even the state of Michigan, as Ohio has now reported illnesses in Columbus-area residents, including several students of Ohio State University. 

Certain press accounts have indicated that a single Washtenaw county restaurant is the source of the Washtenaw county portion of this outbreak, but the Ohio and OSU illnesses apparently match the Michigan illnesses, which means that we're probably dealing with an outbreak linked to a regionally distributed food product.  Could it be lettuce, as we saw in the September 2008 E. coli O157:H7 outbreak linked to Aunt Mid's and Santa Barbara Farms lettuce?  Ground beef?  Answers will likely, hopefully, come soon, as investigating health authorities compare the food histories of all infected people. 

The Columbus Post Dispatch reported as follows regarding the five Ohio and OSU E. coli illnesses:

Columbus Public Health has identified five cases of E. coli infection, some of them in Ohio State University students, and is looking into five others that might be connected to an outbreak in Washtenaw County, Michigan.

The five Columbus residents were sickened by the bacteria Escherichia coli starting in mid-April, said Dr. Mysheika LeMaile-Williams, the city's medical director.

Some were hospitalized, but none so far have developed hemolytic uremic syndrome, a potential complication that destroys red blood cells and can cause kidney failure and death.

The E. coli tests that have come back from the state indicate that its not E. coli 0157:H7, which is most commonly implicated in outbreaks, LeMaile-Williams said.

All types sicken people in the same way, she said. The primary symptoms are bloody diarrhea and abdominal cramps.

So far, the state lab has determined that two of the cases have genetic fingerprints that match an outbreak in Michigan, LeMaile-Williams said.

In Michigan, several cases have been linked to a restaurant, said Ohio Department of Health spokeswoman Jen House. She did not know the name of the restaurant. Calls to Michigan health officials were not immediately returned. Washtenaw County is home to Ann Arbor.

So far, there's no known source for the infections, nor any known risk for others in Columbus, LeMaile-Williams said.

OSU spokeswoman Liz Cook said the university is working closely with Columbus Public Health but would not provide any details about the students.
 

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Largely due to a string of E. coli O157:H7 outbreaks linked to lettuce and other leafy greens, the FDA will soon announce new rules (as opposed to voluntary recommendations) for the production and packing of fresh produce.  See FDA Produce Rule Announcement.  The new rules will set enforceable standards for fresh produce safety at the farm and packing house.  The purpose of the proposed rule:

is to reduce the risk of illness associated with contaminated fresh produce. The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the agency issued general good agricultural practice guidelines entitled “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (GAPs Guide). The prtoposed rule also will reflect comments received on the agency's 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons. Although the proposed rule will be based on recommendations that are included in the GAPs guide, it does not make the entire guidance mandatory. FDA’s proposed rule would, however, set out clear standards for implementation of modern preventive controls.

One positive thing to come from the produce-related outbreaks of the past several years is a lot of data--about, among other things,  the importance of traceability, how and why outbreaks happen, and measures to take at the farm and processing level to reduce the potential for proliferation of disease causing bacteria. 

Here are several accounts of severe foodpoisoning illnesses suffered by produce outbreak victims:

Kelly Cobb--developed hemolytic uremic syndrome (HUS) after consuming E. coli O157:H7 contaminated romaine lettuce.

Heather Whybrew--hospitalized three weeks after consuming E. coli O157:H7 contaminated romaine lettuce.

Regan Erickson--developed HUS after consuming E. coli O157:H7 contaminated Dole baby spinach.

Ashley Armstrong--developed HUS after consuming E. coli O157:H7 contaminated Dole baby spinach.

June Dunning, Betty Howard, and Ruby Trautz--women who died after consuming E. coli-contaminated Dole baby spinach. 

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The Associated Press and New York Times just reported on the impetus behind the testing that caused WinCo to issue its large-scale meat recall:  us.  The positive tests were generated during a study that Marler Clark had comissioned on the presence of E. coli in retail beef samples.  The Times reports:

A ground beef recall that has expanded to WinCo Foods stores in six Western states was prompted by a law firm's investigation of contaminated beef products.

Saying the meat could be contaminated with E. coli, California officials issued the recall Sunday for WinCo Foods fresh ground beef that was packaged in Styrofoam trays at the stores and marked with sale dates from March 28 to April 9. The warning covers about 70 stores in California, Idaho, Nevada, Oregon, Utah and Washington.

The announcement expanded a voluntary recall last week at one store in Modesto, Calif. California officials say an additional sample from that store tested positive for E. coli Friday, prompting the expanded recall. No illnesses have been reported.

The supermarket chain learned about the bacterial contamination from an independent lab that was conducting a nationwide survey of ground beef for Marler Clark, a Seattle law firm specializing in food-borne illness cases.

The ground beef likely came from one of two national beef companies that supply many grocery stores, said Michael Read, WinCo Foods vice president of public and legal affairs.

WinCo has no reason to believe any ground beef that was sold was contaminated, he said. Read had no estimate of how many pounds of ground beef could be affected, but he noted that much of the meat has probably already been consumed and no illnesses have been reported.

''That's the truly nice thing,'' he said. ''We've recalled all ground beef from all stores, even though there's only a suggestion that there's a problem with one store, but we want to do everything possible to protect the public.''

Read said WinCo is cooperating with the investigation by California and federal officials. 

Bill Marler represented more than 100 victims in the 1993 Jack in the Box E. coli outbreak that killed four children. He commended WinCo Foods for issuing the recall, given that the information came from a private study.

''They certainly could have pushed back and said, 'What is this, it's a lawyer doing testing in a lab in Seattle,'' he said. ''They could have taken the much less pro-consumer point of view, because obviously this is not something a company wants to do. Under the circumstances, I certainly appreciate what they did.''

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Kyle Wolden, a nine year old boy from Mount Vernon, Washington and the son of a baseball coach at Stanwood High School, got to run the bases at Safeco Field before the Seattle Mariners' game yesterday.  45,876 fans of Seattle Mariners baseball became even bigger fans of Kyle's, and now probably have a better understanding of what E. coli O157:H7 and hemolytic uremic syndrome are. 

Kyle fell ill from an E. coli O157:H7 infection a little over a year ago, which developed into a very severe HUS illness.  HUS is a condition that occurs in 10-15% of E. coli O157:H7 infections--most often in children and the elderly--and is characterized by kidney failure, anemia, and platelet destruction. 

HUS illnesses do not frequently result in kidney transplantation during the acute phase of the disease; more frequently, HUS causes problems for its victims later in life, when transplantation or maintenance dialysis is necessary because the kidney's filtering units, which have no capacity to regenerate or repair themselves, can no longer perform their multifaceted job. 

HUS illnesses are a frequent cause of death in children and the elderly; and other, life-altering illnesses and conditions as well.  Stephanie Smith is another HUS victim who was sickened by E. coli O157:H7 in an outbreak linked to Cargill ground beef.  Stephanie can no longer walk.  Michael Moss, a journalist with the NY Times, just won a Pulitzer Prize for his in depth story on Stephanie's illness and the contaminated ground beef that caused it.  Read a short summary of Stephanie's HUS illness and resulting injuries. 

In Kyle's case, the damage during the acute phase of his HUS illness was extreme.  Ultimately, he required kidney transplantation for survival; and survive he did, having already progressed to the point that he's apparently able to compete for a spot on the Seattle Mariners' baseball team (the M's are 3 and 6; last in the AL West).

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Not exactly fresh out of committee, but out of committee nonetheless, senate bill 510 (a/k/a the Food Safety Modernization Act) makes its way to the senate floor soon, possibly this week.  The full senate debate and subsequent vote is certainly timely, as just today Michael Moss was awarded the Pulitzer Prize for his story on Stephanie Smiths E. coli O157:H7 illness and Linda Rivera's long-awaited emergence from a Nevada hospital where she has spent almost a year after also being infected by E. coli O157:H7.  Stephanie was sickened by a hamburger made by Cargill, and Linda by contaminated cookie dough made by Nestle. 

The Food Safety Modernization Act is truly an important piece of legislation, in that it affects every citizen of this country, and even some abroad, on a daily basis.  The bill substantially modifies the Federal Food Drug and Cosmetics Act, and generally gives the Food and Drug Administration better authority and ability to monitor the safety of our food supply, and take quicker and more effective action for food companies that don't adequately protect against foodpoisoning risks. 

Among other, more specific, things, the Food Safety Modernization Act:

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Secretary of Health and Human Services (the Secretary) to regulate food, including by authorizing the Secretary to suspend the registration of a food facility.

Requires each food facility to evaluate hazards and implement preventive controls.

Directs the Secretary to assess and collect fees related to: (1) food facility reinspection; (2) food recalls; and (3) the voluntary qualified importer program.

Requires the Secretary and the Secretary of Agriculture to prepare the National Agriculture and Food Defense Strategy.

Requires the Secretary to: (1) identify preventive programs and practices to promote the safety and security of food; (2) promulgate regulations on sanitary food transportation practices; (3) develop a policy to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; (4) allocate inspection resources based on the risk profile of food facilities or food; (5) recognize bodies that accredit food testing laboratories; and (6) improve the capacity of the Secretary to track and trace raw agricultural commodities.

Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to enhance foodborne illness surveillance systems.

Authorizes the Secretary to order an immediate cessation of distribution, or a recall, of food. Requires the Administrator of the Environmental Protection Agency (EPA) to assist state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency.

Provides for: (1) foreign supplier verification activities; (2) a voluntary qualified importer program; and (3) the inspection of foreign facilities registered to import food.
 

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Michael Moss has won the Pulitzer Prize for his article detailing the E. coli O157:H7 illness of Stephanie Smith and the outbreak, linked to Cargill ground beef, that changed her life forever.  Mr. Moss's article, published in October 2009 (two years after the Cargill outbreak), was titled "The Burger that Shattered Her Life." 

Mr. Moss's investigative reporting detailed the path of the ground beef that was eventually purchased by Stephanie Smith’s family. The burger she ate was contaminated with E. coli O157:H7, and her illness was so severe that she was put into a medically induced coma for months. When doctors were able to bring her out of the coma, she was paralyzed and suffered organ failure and cognitive damage. Two years later, Stephanie remains in rehab, trying to walk again.  Stephanie Smith's E. coli O157:H7-induced HUS illness was the most severe we have ever seen. 

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Senate hearing on food safety legislation (SB 510) (Food Safety Modernization Act) will occur soon, maybe even next week.  Senator Dick Durbin (D-IL) and a group of colleagues have proposed the legislation in response to a number of recent outbreaks of food poisoning linked to Salmonella, E. coli O157:H7, Campylobacter, and other pathogens.  Among other things, the legislation would give the FDA broader authority to inspect food processing establishments. 

From Senator Durbin's website:

The recent recalls of tainted peanut butter, spinach, seafood, and pet food are only the latest examples of today's broken food safety system. Authority for regulating our nation's food supply is split among more than ten federal agencies. Most of these agencies lack the resources necessary to ensure the integrity of the food we consume.

I am working to secure increased resources for the Food and Drug Administration (FDA) food safety program, and I am the lead sponsor of several pieces of legislation designed to improve our food safety system. Among these bills is the Safe Food Act, which would streamline our food safety structure, improving coordination by combining the disparate food safety functions spread across the federal government into a single agency based on scientific principles. We also need to establish a robust system for overseeing the safety of imported food. I introduced legislation to strengthen the FDA's ability to monitor and inspect goods that enter the U.S. from abroad by imposing a fee on companies and countries exporting food products to the U.S. Consumers often take for granted that the food they purchase will be safe whether it originated in the U.S. or was imported, but the standards of other countries and the lack of U.S. food inspectors monitoring imported food too often proves them wrong.

Time for everybody to call your Senators, no matter which party you, he, or she belongs to.  The safety of the food supply is way too important an issue, and the regulatory problems way too complex, to sideline this important legislation.  S 510 is not the entire solution to many of the food poisoning problems that we currently face, but its a good first step.  

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It is a fact of life that little kids get sick.  As any parent knows, there will be days when clean-up is job one.   A good parent also knows how important thorough and proper clean-up and sanitation is for preventing the spread of illness from one child to another.

Sanitiation is particularly important in daycare settings.   In August, 2000, an E. coli O157:H7 outbreak was linked to the Kindercare facility in Folsom, California. An investigation revealed that the outbreak began when the probable “index case” – a child who unknowingly brought the bacteria into the facility – experienced “explosive diarrhea at the daycare on August 3.  It was the failure to deal properly with this event that led to four additional illnesses.

The four other children that attended the daycare became infected with E. coli O157:H7 on successive days, the 6th, 7th, 8th and 9th of August.  According to the Facility Evaluation Report by the Department of Social Services dated November 7, 2000, “the cause of the  outbreak was the use of  a sponge for both for wiping down a [diaper] changing table and wiping down a table used for serving meals."

Children are particularly susceptible to severe outcomes when infected with E. coli O157:H7, as well as other pathogens.  Those who care for children must take thorough precautions and follow all sanitation guidelines in order to limit the spread of illness.

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The Oregonian reported today that four Clark County children have been hospitalized (3 released) in an outbreak of E. coli O157:H7 possibly linked to a daycare.  The Oregonian reports:

"We don't see a whole lot of this but it can occur," said Dr. Alan Melnick, Clark County's public health officer. He said the health department investigates an average of 8 cases of E. coli O157:H7 infection in Clark County each year.

In the current outbreak, Melnick said the health department learned of the first hospitalization on March 19. Soon after, three other children required hospitalization. Melnick said investigators tested stool samples from 22 children and four adult caregivers at the day care and found six carrying the O157:H7 strain but not showing symptoms.

To reduce the risk of further spread, Melnick said the health department decided to close the day care on April 2. One of the four sick children remains hospitalized, Melnick said. So far, none of the other day-care children or staff have become sick. Symptoms can take up to 10 days to appear after exposure, Melnick said, so the health department each day is checking with staff and the families of the children who attended the day care, which is state-licensed.

The day care will remain closed until the affected staff show no presence of the bacteria on two consecutive tests conducted at least a day apart, Melnick said. Children who tested positive have to meet the same criteria before being allowed to attend any daycare or school.

It is not clear whether any of the children developed hemolytic uremic syndrome.  E. coli O157:H7, and other frequent foodborne pathogens, are a recognized risk in daycare, as well as foodservice, settings.  It is a risk that needs to be addressed and controlled for by chld care workers. 

Frequently, though certainly not always, it is not the food that ends of causing illness in daycares, but the general sanitation of the facility that serves as the vector by which bacteria passes to children or staff.  In May 2010, this is exactly what happened in Joplin, Missouri at Kids Korner Daycare. 

Kids Korner Outbreak Summary:

On May 10, 2004, the Jasper County Health Department (JCHD) received a report from St. Johns Regional Medical Center that two 2-year-old children had been hospitalized with hemolytic uremic syndrome (HUS) at Children’s Mercy Hospital in Kansas City, Missouri. The children, one boy and one girl, were residents of Carthage Missouri. Five of the girl’s family members soon developed symptoms of E. coli infection, and one later tested positive for E. coli O157:H7.

JCHD began investigating the apparent E. coli outbreak, and learned that the hospitalized girl and one of her siblings attended daycare at Kid’s Korner daycare in Joplin, Missouri. JCHD investigators visited the daycare facility on May 11. They did not note any major hand washing or diapering violations, and discussed the importance of excluding children with diarrheal illness from the daycare with daycare operators and employees.

On May 24, JCHD was notified that a 4-year-old girl who attended daycare at Kid’s Korner had become ill with symptoms of E. coli infection on May 14 and was being transferred from a Joplin hospital to Children’s Mercy in Kansas City with HUS.

JCHD inspectors returned to Kid’s Korner on May 25, and instructed the daycare to distribute a letter explaining the incidence of E. coli at the daycare and the signs and symptoms of illness to parents. During this inspection, JCHD investigators noted deficiencies conducive to the spread of disease and instructed Kid’s Korner employees on methods of hygiene and sanitation effective to prevent the further spread of E. coli.

By May 26, JCHD had received two additional reports of illness in children who attended Kid’s Korner. One of the children had had bloody diarrhea on May 11; the child’s sibling fell ill on May 26 and was later hospitalized with HUS. Despite their earlier assurances that no children at the daycare had been symptomatic during the month of May, Kid’s Korner then produced a list of nine children who had exhibited symptoms of E. coli infection to JCHD investigators.

On May 27, JCHD inspectors returned to the daycare center and noted handwashing lapses. They also learned that Kid’s Korner had failed to distribute the May 25 letter regarding possible E. coli exposure and symptoms to 32 percent of the families with children in attendance at Kid’s Korner.

Marler Clark represented the family of a two-year-old boy and his eight-month-old sister who both attended Kids’ Korner and became ill with E. coli infections. The two-year-old boy developed HUS and was hospitalized for nearly three weeks. He endured a full week of dialysis, seven transfusions, three surgeries, and a severe case of pancreatitis. The family’s claim was resolved in 2006.

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KITV.com reports that Peppa's Korean BBQ in Honolulu has reopened after several E. coli O157:H7 illnesses were linked to the restaurant.  The station reports that "the State Health Department said they found no signs of E. coli in an investigation of the Peppa's Restaurant on South King Street," and as a result, gave the restaurant clearance to reopen, which the restaurant did for lunch today. 

The good news is that the clearance to reopen is an indication that the health department believes there is no further risk of disease spreading from the restaurant--i.e. the place is clean and free of environmental contamination.  This is good news for anybody who has recently eaten at the restaurant.  There are a wide number of possibilities as to how the food became contaminated, sickening the several people that it did, but if the health department is allowing the restaurant to reopen, it must be comfortable that there is no longer a contaminated ingredient at the restaurant.

This stands in stark contrast to some restaurant outbreaks, which are particularly prone as retail establishments serving finished products to large-scale outbreaks as a result of employee illness and/or environmental contamination.  Such was precisely the case in the recent Shigella outbreak linked to a Subway restaurant in Lombard, Illinois, which I believe still remains closed after being shuttered now for about a month in the wake of an outbreak that has caused at least 116 people to suffer culture-confirmed infections.  It is known that employees at the restaurant were sick, and it is almost a certainty that the restaurant was widely contaminated, given the extent of the outbreak and long period of closure. 

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The Billings Gazette reported today that Montana senator Jon Tester plans to introduce a bill in Congress to Modify the Federal Meat Inspection Act.  Interestingly, Senator Tester is not new to the beef slaughtering business.  He operated a small-scale slaughtering establishment on his family farm--he took over his father's business--until he began his first senate run.  According to the Gazette, at issue in Senator Tester's bill:

is the way the U.S. government tracks E. coli- and salmonella-contaminated meat in cases of food-borne illness.

Investigations currently stop at butcher shops and packing plants, but Tester said the real contamination takes place in slaughterhouses, where animals are cut open and fecal bacteria from intestines and hides can come in contact with meat. For decades, rules for required testing have made it impossible to trace contamination back to slaughterhouses.

Tester said he will introduce a bill today to amend the Meat Inspection Act, changing those rules and get to the source of a food illnesses like E. coli. Roughly 73,000 Americans are sickened annually by E. coli, 2,000 are hospitalized and 60 are killed, according to the Centers for Disease Control and Prevention. Medical costs associated with E. coli exceed $405 million a year.

E. coli O157:H7 is a major public health concern.  It maims people, kills people, and causes millions of dollars in medical costs every single year in this country.  A lucky victim typically is sick enough to require professional medical help. 

Senator Tester's bill may or may not be a good part of the solution.  I have not yet seen the bill, but anything that increases scrutiny of slaughterhouse practices must be considered a positive step.  5.7 million pounds of beef products have been recalled this year alone, and it's not even Easter.  But the reality is that better inspection and traceback alone will not fix the problems with our beef supply.

Another potential solution is irradiation, which is a process of exposing food products to electromagnetic energy, thus providing a "kill step" (i.e. a step taken to kill bacteria prior to consumption) for the meat.  Despite its unfortunate name, which conjures images of Chernobyl quicker than it does safe food, irradiation affects neither the taste nor the healthful quality of meat, or any food for that matter.  In an interview with Themeatingplace.com, Marler Clark partner Denis Stearns said:

“We’ve talked a lot about irradiation at the firm,” Stearns told The Meatingplace.com “We expect to see more irradiated food being served to more vulnerable segments of the population. I wouldn’t be surprised—if it hasn’t already occurred—to start seeing hospitals and school lunch programs using irradiated meat. People [there] are typically much more susceptible to food-borne illness.”

Notably, some meat companies, such as Omaha Steaks, have already taken steps to sell only irradiated product.  More companies need to take this step, and the federal government needs to consider requiring irradiation of all meat. 

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Hemolytic uremic syndrome (HUS) is a potentially fatal complication of E. coli O157:H7 infection, most common in children. At Marler Clark, we too often have to explain HUS to the lawyers and insurers for companies that have sold contaminated food.

Acute renal failure is one of the signature elements of HUS. Many of those who develop HUS must receive dialysis to survive. Most of those that survive the acute phase of HUS regain enough renal function to abandon dialysis, at least for a time.

One of the most disheartening aspects of the syndrome, however, is the irreversible damage done to the kidneys during the acute stage. The damage sustained in the short term then places the patient at risk for long term renal complications, including end stage renal disease (ESRD). That damage to the kidney is referred to as a "hyperfiltration injury."

Hyperfiltration injury is a term used to describe chronic, progressive damage in kidneys that have already sustained a severe acute injury (such as in HUS) that results in the destruction of a substantial percentage of nephrons.   Nephrons are the functional units of the kidney and are comprised of glomeruli connected to renal tubules.

The remaining functional glomeruli attempt to adapt to their reduced number by enlarging (hypertrophy) and by hyper- filtrating (i.e., the remaining glomeruli work extra hard) in an attempt to meet the needs of the body. For a time, they are usually able to compensate, but they are being “over worked”, and their “cry for help” is manifested by the spillage of protein (albumin) in the urine (proteinuria).

As time passes, the hyperfiltration injury causes progressive loss of the remaining glomeruli due to fibrosis (scar tissue formation). And, in time, once the remaining functional nephron population drops below 10 percent, the person’s survival requires initiation of “renal replacement therapy”.

The use of an angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) is usually helpful in slowing the fibrotic process, but no known treatment can stop it. ESRD, also known as stage 5 kidney disease, eventually occurs.

Once ESRD is reached there are two survival options, neither enticing. The patient must then receive long-term dialysis treatment or a renal transplant.

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Over the last several years, there have been multiple outbreaks linked to, and recalls of, various kinds of spices. From white pepper, to red pepper, to black pepper and beyond, spices are a potentially ideal vehicle for the transmission of foodborne disease. More and more people are becoming ill from contaminated spices, and more and more recalls are occurring. So is this problem merely an emerging threat? Or is it a problem that food producers must confront here and now, finding ways to better ensure the safety of the consumers they profit from.

Spice outbreaks in recent history:

1. Veggie Booty

In May 2007, the Centers for Disease Control and Prevention (CDC) began a multi-state investigation in response to an increase in laboratory reports, first posted on PulseNet on April 2, 2007, of Salmonella Wandsworth. Salmonella Wandsworth is a very rare serotype that was never before implicated in a U.S. outbreak. As of September 6, 2007, there were 69 reported cases of Salmonella Wandsworth in 23 states and 14 cases of Salmonella Typhimurium in six states who became ill after consuming Veggie Booty, a puffed vegetable snack food with a raw, dried vegetable coating. A total of 61 bags of Veggie Booty were ultimately tested in twelve states. Salmonella was isolated from thirteen of them. Eleven of the thirteen bags were positive for the outbreak strain of Salmonella Wandsworth, and one bag was positive for Salmonella Typhimurium and Enterobacter sakazakii. One bag also tested positive for Salmonella Kentucky, and Salmonella Haifa and Saintpaul were isolated from other bags.

2. Union International

The Union International Food outbreak sickened more than 79 people in Western states between December 2008 and April 2009; the majority of the illnesses were in California. Public health officials traced the outbreak to white pepper manufactured by Union International and sold under the brand names Uncle Chen and Lian How. Ultimately the company recalled more than 50 products, including spices, oils, and sauces, due to potential contamination with Salmonella.

3. Wholesome Spice Company and Overseas Spice

This outbreak and recall is, of course, still going on.  According to the CDC just days ago, 238 individuals infected with the outbreak strain of Salmonella Montevideo, which displays either of two closely related pulsed-field gel electrophoresis (PFGE) patterns, have been reported from 44 states and District of Columbia since July 1, 2009.  Epidemiological investigation showed that these 238 sick people all ate Daniele Inc salami products contaminated by salmonella.  Daniele used salmonella-contaminated pepper in the production of the various kinds of recalled salami. 

4. Today’s recall of Johnny’s brand French dip au jus powder?

Will the Johnny’s recall, announced today out of Tacoma, Washington, be another recall or outbreak to add to this list? The ingredient list for the recalled prodcut states that it contains: 'MSG, Wheat, Soy & Milk; Hydrolyzed vegetable protein (corn, soy, wheat), yeast extract, salt, rice flour, monosodium glutamate, partially hydrogenated vegetable oil (soy & cottonseed), caramel color, whey solids, non-fat milk solids, mono & diglycerides."  Only time will tell, hopefully, what happened at Johnny's to prompt today's recall.  Spices?  Certainly possible.

The historical trend:

These kinds of events naturally prompt the question why are we suddenly seeing outbreaks and recalls linked to pepper and other spices. Is this truly a new phenomenon; a new species of failure by food importers and producers? 
 

The combination of Google and about 5 spare minutes will show you that spice problems are, by no means, a new phenomenon. As stated in a 2006 Journal of Food Protection article (“Journal article”): "We reviewed spice recalls that took place in the United States from fiscal years 1970 to 2003. During the study period, the FDA monitored 21 recalls involving 12 spice types contaminated with bacterial pathogens."  See Journal of Food Protection, Vol. 69, No. 1, 2006, Pages 233–237(Recalls of Spices Due to Bacterial Contamination Monitored by the U.S. Food and Drug Administration: The Predominance of Salmonellae). See article at: http://www.cdc.gov/enterics/publications/381_vij.pdf.

Indeed, as the name of the Journal article suggests, the problem of spice contamination has long been known. And not only that, it has long been known to be predominantly one of Salmonella contamination specifically.

Defining the problem:

Lest we delude ourselves into believing that the risk is not that great, it is clear that spice outbreaks are on the rise. The Journal article further states that “Although five of these recalls transpired during the preceding 30 years (one each in 1971, 1983, 1989, 1995, and 1996), the remaining 16 (76%) occurred during fiscal years 2001 to 2004.” And the other outbreaks described above (i.e. Veggie Booty, Union International, Wholesome/Overseas, and possibly Johnny’s) are too recent to have been included in the Journal article’s study.

But to add even further concern, it is evident that counting recalls and outbreaks may only partially define the problem. The Journal article further notes that, of the 105,440 spice brands imported at the time into the US, 258 were coded as "refusals" and were thus prevented access to US markets:

178 (69%) were refused because the manufacturer had a history of shipping Salmonella-contaminated spices. In 131 (74%) of these 178 refusals, the importer chose not to challenge the refusal; in 44 (25%) instances, Salmonella was shown to be present by laboratory analysis. In the remaining three (1%) instances, the spices were refused because of the presence of mold or filth.

Thus, upon inspection, there were an additional 258 refusals of spice products during the one year period analyzed, thereby preventing those contaminated spices from being included in the Journal article’s analysis. Admittedly, some were refused entry only because of past problems associated with the exporter, and some due to contamination by mold or other filth, but 44 were refused entry because they were, in fact, contaminated.

Where do all these contaminated spices come from? Again, the Journal article:

The country of origin of the spice was known for 15 recalls: 12 involved imported spices (India [three recalls], Spain [three recalls], Turkey [two recalls], and one recall each from Egypt, Jamaica, Mexico, and Taiwan), and the remaining three involved domestically produced spices (two recalls due to Salmonella and one recall due to L. monocytogenes).

Further:

Overall, there were 6,112 unique spice manufacturers in the 129 nations from which the United States imported spices; the three countries with the leading numbers of spice manufacturers were India (629 manufacturers), China (547), and Mexico (441). During fiscal year 2003, there were 9,911 unique spice consignees in the United States who purchased imported spices. Approximately 85% of the spices imported in fiscal year 2003 were produced in China, and the next four leading spice exporters to the United States—Honduras, Mexico, Lebanon, and Peru—contributed an additional 13%.

Further defining the problem:

As we know from past experience with food products, certain items are more susceptible to contamination, or to causing higher rates of infection and illness, due to their very nature. For instance, ground beef is a risky food because of the oftentimes preventable contamination that is so rampant in the production process. And lettuce and other leafy greens are susceptible to contamination because they are grown in an environment particularly capable of causing the contamination. 

Spices have numerous “performance characteristics” that make them a ready vehicle for contamination and illness. First, they are generally a dried product that have a long shelf-life . . . even for those of us who do not have spices still on our shelves for the 1990s. Second, they are ubiquitous and widely-sold; everybody has them, and everybody eats them, from the very healthy to the young and old, and all people in between. Third, the Salmonella bacteria, which is far and away the most prevalent contaminant of spices, is a hearty bug capable of surviving for long periods in a dry environment (e.g. a container of spices). As the Journal article notes, in a 1993 spice outbreak in Germany, testing 8 months after the contaminated product was identified produced positive results for viable Salmonella bacteria.

And the threats from a public health and surveillance standpoint? Long shelf-life frustrates the efforts of investigating health authorities to detect outbreaks and stop them.  Also, again, everybody eats these spices, which works to the detriment of public health in investigating spice outbreaks because investigators are not necessarily able to hone in on the suspect product as easily. Even though everybody buys them and uses them, people may use many different brands on their shelves and would not be able to retrospectively identify which particular brand they used days, weeks, or months ago.  And finally, spices are often a post-cooking flavoring ingredient, and thus there is often no kill step.

So what are we to do?

Certainly, the solution does not lie in not using the product. Very few, even among those who truly know the scope of the problem, will stop using spices altogether. And nor does the solution lie in preventing US food companies from using imported spices. These solutions are both totally unrealistic, forcing the bottom line conclusion that the food companies themselves must act as a buffer against the purchase, manufacture, and distribution of contaminated spices.

With respect to spices, the buck stops with the industry. It is time for the process of irradiation to gain a stronger foothold in the United States with respect to all products, and most definitely with respect to those food products that carry the greatest risk.

But irradiation is not the only answer. The Journal article describes others as well:

A number of methods exist to reduce or eliminate pathogens from spices (e.g., the use ethylene oxide, heat treatment, or irradiation [UV, infrared, or gamma]). Ethylene oxide is highly diffusive; is simple to use; does not significantly alter either the aromatic or flavor components of spices (unlike heat treatment, which can destroy the aromatic and flavor components of spices as well as their color (12)); and is effective in destroying microorganisms (18). However, the effect of ethylene oxide on spores is not as great as it is for vegetative cells (12). The FDA has established a maximum tolerance of 50 ppm for residues of ethylene oxide in ground spices (2). On the other hand, at least one study has suggested that irradiation represents the most effective and safe method of treatment of spices, and it is a process that yields no toxic by-products (17). For the microbial disinfection of spices, the FDA has established that, when irradiation is used, the maximum dose should not exceed 30 kilogray (3 Mrad) (3).

And yet another solution is good old fashioned hard work by food companies. Do your job better by instituting and following rigorous standards in the import, production, distribution, and sale of your products. This involves knowing your suppliers, and their track-record with respect to food safety; don’t simply look at cost as the sole conclusive factor in deciding who to buy spice products from. Also, take all necessary precautions to avoid contaminating your production environment. This was certainly a factor in the Union International outbreak, and possibly one in the Daniele salami outbreak linked to black and red pepper. And finally, as is the case in any outbreak of foodborne illness, act quickly and proactively in informing the public and investigating health authorities about the probability and scope of a contamination problem with your products. Media exposure, and the resulting business loss, that occurs in the wake of outbreaks and recalls is only worse when more people get sick; and hiding the ball is certainly a good way to make more people sick.
 

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The Huffington Post today announced its list of the ten worst product recalls of all time.  The food recalls include melamine-tainted milk, worm-infested chocolates, and of course the September 2006 E. coli O157:H7 (and other serotypes) outbreak linked to Dole baby spinach.  The spinach outbreak was among the most devastating outbreaks ever to occur in this country. 

2006 Spinach Outbreak:  a short summary:

Official word of the spinach outbreak broke with the FDA’s announcement, on September 14, 2006, that a number of E. coli O157:H7 illnesses across the country “may be associated with the consumption of produce.” “Preliminary epidemiological evidence suggests,” the statement continued, “that bagged fresh spinach may be a possible cause of this outbreak.” By the date of the announcement, fifty cases had been reported to the CDC, including eight cases of hemolytic uremic syndrome (HUS) and one death. States reporting illness included Connecticut, Idaho, Indiana, Michigan, New Mexico, Oregon, Utah, and Wisconsin.

The much-publicized outbreak grew substantially over the next several days. By September 15, the FDA had confirmed 94 cases of illness, including fourteen cases of HUS and, sadly, one death. Recognizing the lethality of the developing outbreak, the FDA’s September 15 release warned people should “not eat fresh spinach or fresh spinach containing products.” 

Press Releases over the ensuing days announced steady growth in the number of people sickened, hospitalized, and with HUS as a result of the outbreak—109 cases from nineteen states by September 17, and 131 cases from twenty-one states just two days later. The latter statistic included 66 hospitalizations and twenty cases of HUS.

Meanwhile, the FDA and CDC, in conjunction with local and state health agencies from across the country, worked feverishly to figure out the brand names associated with illness. Early statistical analysis suggested that many brands were implicated, but the spinach sold under the several brand names had all come from the Natural Selection Foods processing center in San Juan Batista, California. Accordingly, Natural Selection recalled all of its spinach products with “use by” dates from August 17 to October 1, 2006. The recall, of course, included Dole brand spinach. But further data and study ultimately narrowed the possible sources of the outbreak down to one brand of packaged greens: Dole.

Though epidemiological evidence had already strongly linked Dole to the outbreak, the FDA found the proverbial “smoking gun” on September 20. The bag of Dole baby spinach had been purchased and consumed by an Albuquerque, New Mexico woman, and testing by the New Mexico State Health Department had confirmed that the product was contaminated with E. coli O157:H7 bearing the same genetic marker as the outbreak strain. The FDA announced the critical finding on September 21, 2006—also disclosing the “best by” date on the positive Dole bag of August 30—thereby giving a worried public a bit more information on what spinach products to eat, if any, and what to avoid.

By the date of the FDA’s September 21 announcement, the number of confirmed cases had swelled to 157 people from twenty-three states. Ultimately, the FDA confirmed 204 outbreak-related cases, with 102 hospitalizations, thirty-one cases of HUS, and three deaths, though the actual number of people affected by the outbreak was certainly much larger. In addition to an elderly Wisconsin resident, the FDA stated that the outbreak had claimed the lives of two-year-old Kyle Algood, from Chubbuck, Idaho, and also 81-year-old Ruby Trautz, from Bellevue, Nebraska. A Maryland woman named June Dunning, and a Washington woman named Betty Howard, ultimately died as a result of their illnesses as well. The tragedy of this outbreak can hardly be overstated.

Epidemiological and laboratory evidence, which had already proved the link to Natural Selection and Dole, soon revealed that the contaminated spinach had been grown at Paicines Ranch in San Benito County, California. More specifically, investigators had traced the source of the contaminated spinach to one field on the ranch that had been leased by Mission Organics.

Once identified as the likely source for the outbreak, Mission Organics became host to health officials looking for the outbreak strain of E. coli O157:H7. State and federal investigators took hundreds of environmental samples and swabs from the vicinity of the implicated spinach field, which was fifty acres in size, including from a nearby cattle pasture and water source. Investigators also sampled the intestinal lining of feral pigs that had been killed as part of the investigation. Samples from a variety of sources, including the pigs, the water, and cattle feces, tested positive for the same strain of E. coli O157:H7 that had now been isolated in over 200 people nationally. Finally, the outbreak strain of E. coli O157:H7 has been isolated in at least thirteen separate bags of Dole baby spinach.
 

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Late yesterday, a Bellingham, Washington company called Jackie's Jersey Milk recalled raw milk product due to possible contamination by E. coli O157:H7.  The contamination was detected during routine sampling and testing of the company's products by the Washington State Department of Agriculture. 

Products subject to the recall include all Jackie's Jersey Raw Jersey Cow Milk with a "use by" date through March 4, 2010.  The half-gallon containers are sold in retail grocery stores in Whatcom, Skagit, Snohomish and King counties, so anybody with any raw milk in their refrigerators from South King County to the Canadian border would be well advised to find out exactly where their raw milk came from before consuming it themselves, or more importantly giving it to any small children. 

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Yesterday, the USDA and FDA released a joint statement on their intent to coordinate efforts to achieve better produce safety.  See Salinas Valley, Leafy Green Vegetables, and E. coli for a description and summary of the problem.  The joint statement reads as follows:

The U.S. Department of Agriculture (USDA) and the Food and Drug Administration are working together to achieve the goals of enhancing the safety and quality of fresh produce in ways that take into account the wide diversity of farming operations. We are committed to leveraging the expertise of our partner agencies and working together to ensure that our current produce safety and quality activities are complementary and consistent. While USDA’s Agricultural Marketing Service (AMS) is in the midst of evaluating a proposed marketing agreement for the leafy green industry, the FDA is currently developing a proposed produce safety regulation. It is our expectation that these products will take into account the diverse nature of farming operations and that any marketing agreement would conform to any regulations that may be promulgated by FDA.

The success of these efforts depends on the feedback and comments we receive from growers and other produce safety stakeholders. AMS will continue to review the comments that have been submitted to USDA on the proposed marketing agreement. To further inform its planned rulemaking, the FDA is announcing today the establishment of a docket to receive information about current practices and conditions for the production and packing of fresh produce and practical approaches to improving produce safety. The FDA will work with AMS to have the testimony from the AMS hearings placed in the FDA docket for consideration by the FDA. The FDA encourages all interested persons to submit information they believe will inform the development of safety standards for fresh produce at the farm and packing house, as well as strategies and cooperative efforts to ensure compliance with those standards.

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On February 12, 2010, Huntington Meat Packing, Inc., expanded its January 18, 2010 beef recall to include approximately 4.9 million pounds of beef and veal products that it produced in 2009 and the first few days of this year. This expanded recall brings the grand total of beef products recalled since November 2009 (just 3 and a half months) to 5,672,000 pounds. 

The expansion of the Huntington Meat recall is remarkable for both its size and the fact that it occurred based on evidence gathered during an ongoing criminal investigation being conducted by the Office of the Inspector General (OIG) with assistance from FSIS. This evidence shows that the products subject to this recall expansion were produced in a manner that did not follow the establishment's Hazard Analysis and Critical Control Points (HACCP) plan. A HACCP plan describes the process controls an establishment must take to prevent food safety hazards and create a safe and wholesome product. The investigation has uncovered evidence to show that the food safety records of the establishment cannot be relied upon to document compliance with the requirements.

This recall expansion continues the disturbing trend of major meat recalls over the last several months.  On February 4, West MissourI Beef, LLC, a Rockville, Missouri beef company, recalled 14,000 pounds of boneless beef products due to potential E. coli O157:H7 contamination. 

On January 11, 2010, Adams Farm Slaughterhouse, LLC., an Athol, Mass., stablishment, recalled approximately 2,574 pounds of beef products due to potential E. coli O157:H7 contamination. The recall occurred in the wake of an epidemiological investigation into the E. coli illness of at least one Massachusetts resident.

On Christmas Eve 2009, National Steak and Poultry recalled at least 124 tons of mechanically tenderized beef products. The National Steak and Poultry outbreak caused at least 21 E. coli O157:H7 illness in 16 states, including nine hospitalizations and one case of HUS.

And in November 2009, ground beef from a New York ground beef company called Fairbank Farms was recalled due to E. coli O157:H7 contamination. That outbreak caused resulted in 26 E. coli O157:H7 illnesses, nineteen hospitalizations, and five who developed hemolytic uremic syndrome (HUS).

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Marler Clark filed a lawsuit today on behalf of Alice Smith against Fairbank Farms in Federal District Court in Maine.   Ms. Smith, 88 years old, was hospitalized for weeks with an E. coli O157:H7 infection after consuming ground beef contaminated with the bacteria produced by Fairbank.

In late October 2009, Fairbank Farms recalled 545,699 pounds of ground beef contaminated with toxic E. coli O157:H7. A joint investigation between the Centers for Disease Control (CDC), the Food Safety and Inspection Service (FSIS), and several state health departments determined that the contaminated meat was responsible for 2 deaths and at least 25 E. coli illnesses in 10 states, most of them in New England.

Ms. Smith was hospitalized for several weeks, during which time she suffered from renal failure.  She has not returned to her prior state of health.  

Marler Clark previously filed lawsuits in Maine and Massachusetts on behalf of other victims of the Fairbank Farm outbreak.

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West Missouri Beef, LLC has voluntarily recalled 14,000 pounds of boneless beef products due to potential contamination by E. coli O157:H7.  USDA's Food Safety and Inspection Service (FSIS) announced the Class I recall in a press release last night.  It is the third Class I recall this year, and the fifth since November, adding up to 1,636,000 pounds of beef products that have been recalled due to potential E. coli O157:H7 contamination in the last 3+ months.

What is a Class I recall?

A Class I recall, according to FDA definitions, should occur when "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."  Class II and III recalls are appropriate only when there is a significantly lesser, or remote, risk of adverse health consequences, or when the health consequences are minor.  Due to its lethal capacity, E. coli O157:H7 is a bacteria that always requires a Class I recall.

What is E. coli O157:H7?

Escherichia coli (E. coli) are members of a large group of bacterial germs that inhabit the intestinal tract of humans and other warm blooded animals (mammals, birds). Newborns have a sterile alimentary tract which within two days becomes colonized with E. coli.

More than 700 serotypes of E. coli have been identified. The different E. coli serotypes are distinguished by their “O” and “H” antigens on their bodies and flagella, respectively. The E. coli serotypes that are responsible for the numerous reports of contaminated foods and beverages are those that produce Shiga toxin (Stx), so called because the toxin is virtually identical to that produced by another bacteria known as Shigella dysenteria type 1 (that also causes bloody diarrhea and hemolytic uremic syndrome [HUS] in emerging countries like Bangladesh) (Griffin & Tauxe, 1991, p. 60, 73). The best known and most notorious Stx-producing E. coli is E. coli O157:H7. It is important to remember that most kinds of E. coli bacteria do not cause disease in humans, indeed, some are beneficial, and some cause infections other than gastrointestinal infections, such urinary tract infections. This section deals specifically with Stx-producing E. coli, including specifically E. coli O157:H7.

Shiga toxin is one of the most potent toxins known to man, so much so that the Centers for Disease Control and Prevention (CDC) lists it as a potential bioterrorist agent (CDC, n.d.). It seems likely that DNA from Shiga toxin-producing Shigella bacteria was transferred by a bacteriophage (a virus that infects bacteria) to otherwise harmless E. coli bacteria, thereby providing them with the genetic material to produce Shiga toxin.

Although E. coli O157:H7 is responsible for the majority of human illnesses attributed to E. coli, there are additional Stx-producing E. coli (e.g., E. coli O121:H19) that can also cause hemorrhagic colitis and post-diarrheal hemolytic uremic syndrome (D+HUS). HUS is a syndrome that is defined by the trilogy of hemolytic anemia (destruction of red blood cells), thrombocytopenia (low platelet count), and acute kidney failure.

Stx-producing E. coli organisms have several characteristics that make them so dangerous. They are hardy organisms that can survive several weeks on surfaces such as counter tops, and up to a year in some materials like compost. They have a very low infectious dose meaning that only a relatively small number of bacteria, less than 50, are needed “to set-up housekeeping” in a victim’s intestinal tract and cause infection.

The Centers for Disease Control and Prevention (CDC) estimates that every year at least 2000 Americans are hospitalized, and about 60 die as a direct result of E. coli infections and its complications. A recent study estimated the annual cost of E. coli O157:H7 illnesses to be $405 million (in 2003 dollars) which included $370 million for premature deaths, $30 million for medical care, and $5 million for lost productivity (Frenzen, Drake, and Angulo, 2005).
 

What is Hemolytic Uremic Syndrome?

Post-diarrheal Hemolytic Uremic Syndrome (D+HUS) is a severe, life-threatening complication that occurs in about 10% of those infected with E. coli O157:H7 or other Shiga toxin (Stx) producing E. coli. D+HUS was first described in 1955, but was not known to be secondary to E. coli infections until 1982. It is now recognized as the most common cause of acute kidney failure in infants and young children. Adolescents and adults are also susceptible, as are the elderly who often succumb to the disease.

How did these otherwise harmless E. coli become such killers? It seems likely that DNA from a Shiga toxin producing bacterium known as Shigella dysenteriae type 1 was transferred by a bacteriophage (bacteria infected with a virus) to harmless E. coli bacteria, thereby providing them with the genes to produce one of the most potent toxins known to man. So potent, that the Department of Homeland Security lists it as a potential bioterrorist agent. Although E. coli O157:H7 are responsible for the majority of cases in America, there are many additional Stx producing E. coli that can cause D+ HUS.

The chain of events leading to HUS begins with ingestion of Stx producing E. coli (e.g., E. coli O157: H7) in contaminated food, beverages or through person to person transmission. These E. coli rapidly multiply in the intestines causing colitis (diarrhea), and tightly bind to cells that line the large intestine. This snug attachment facilitates absorption of the toxin into the circulation where it becomes attached to weak receptors on white blood cells (WBC) thus allowing the toxin to “ride piggyback” to the kidneys where it is transferred to numerous avid (strong) Gb3 receptors that grasp and hold on to the toxin. Organ injury is primarily a function of Gb3 receptor location and density. Receptors are probably heterogeneously distributed in the major body organs, and this may explain why some patients develop injury in other organs (e.g., brain, pancreas).

Once Stx attaches to receptors, it moves into the cell’s cytoplasm where it shuts down the cells’ protein machinery resulting in cellular injury and/or death. This cellular injury activates blood platelets and the coagulation cascade which results in the formation of clots in the very small vessels of the kidney resulting in acute kidney injury and failure. The red blood cells are hemolyized (destroyed) by Stx and/or damaged as they attempt to pass through partially obstructed microvessels. Blood platelets (required for normal blood clotting), are trapped in the tiny blood clots or are damaged and destroyed by the spleen.
 

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The unfortunate trend for E. coli and beef in late 2009 and 2010 continues.  This evening, West MissourI Beef, LLC, a Rockville, Missouri beef company, recalled 14,000 pounds of boneless beef products due to potential E. coli O157:H7 contamination.  Today's recall brings the tally for recalled beef due to E. coli contamination to 1,636,000 pounds of beef products in the last three months. 

On January 18, 2010, the USDA's food inspection branch (FSIS) announced the recall of 846,000 pounds of ground beef products produced by a California company called Huntington Meat Packing, Inc., due to potential contamination by E. coli O157:H7.

On January 11, 2010, Adams Farm Slaughterhouse, LLC., an Athol, Mass., stablishment, recalled approximately 2,574 pounds of beef products due to potential E. coli O157:H7 contamination. The recall occurred in the wake of an epidemiological investigation into the E. coli illness of at least one Massachusetts resident.

In November 2009, ground beef from a New York ground beef company called Fairbank Farms was recalled due to E. coli O157:H7 contamination. That outbreak caused resulted in 26 E. coli O157:H7 illnesses, nineteen hospitalizations, and five who developed hemolytic uremic syndrome (HUS).

And on Christmas Eve 2009, National Steak and Poultry recalled at least 124 tons of mechanically tenderized beef products. The National Steak and Poultry outbreak caused at least 21 E. coli O157:H7 illness in 16 states, including nine hospitalizations and one case of HUS.

Together, the recalls and outbreaks linked to beef from Adams Farm, National Steak and Poultry, Fairbank Farms, and now West Missouri Beef have caused at least 48 illnesses nationally. At least 1,636,000 pounds of beef have been recalled in total in the five recalls. .
 

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West Missouri Beef, LLC, a Rockville, Missouri establishment, is recalling approximately 14,000 pounds of fresh boneless beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. 

The following products are subject to recall:

One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as “75 1-M,” produced on October 26, 2009.  

One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as “90 3-D,” produced on November 25, 2009.  

One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as “90 5-D,” produced on November 27, 2009. Combo bins containing approximately 2,000 pounds of fresh boneless beef identified as “90 2-P,” “90 2-R” or “90 2-V,” produced on December 8, 2009. 

One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as “90 3-E,” produced on January 13, 2010. Each container is marked with the establishment number “EST. 5821” inside the USDA mark of inspection.  

The fresh boneless beef products were distributed to wholesalers in the Chicago, Ill., area. 

The problem was discovered by FSIS during a verification review performed at the establishment.

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Counting Friday's sausage recall by Daniele International, Inc., food companies have recalled at least 2,880,000 pounds of meat products since November 2009 due to contamination by E. coli or Salmonella. 

Friday's recall:  (from FSIS press release)

Daniele International Inc., an establishment with operations in Pascoag and Mapleville, R.I., is recalling approximately 1,240,000 pounds of ready-to-eat (RTE) varieties of Italian sausage products, including salami/salame, in commerce and potentially available to customers in retail locations because they may be contaminated with Salmonella, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The Daniele Inc. sausage outbreak, due to contamination by Salmonella Montevideo, has caused at least 184 illnesses in residents of 38 states. 

On January 18, 2010, the USDA's food inspection branch (FSIS) announced the recall of 846,000 pounds of ground beef products produced by a California company called Huntington Meat Packing, Inc., due to potential contamination by E. coli O157:H7.

On January 11, 2010, Adams Farm Slaughterhouse, LLC., an Athol, Mass., establishment, recalled approximately 2,574 pounds of beef products that was potentially contaminated with E. coli O157:H7.  The beef was the cause of infection in at least one Massachusetts resident. 

On December 24, 2009 (The Christmas Eve sneak), an Oklahoma company called National Steak and Poultry recalled 248,000 pounds of tenderized beef products due to contamination by E. coli O157:H7.  The outbreak is known to have sickened at least 21 people in 16 states.  Last week, Marler Clark filed the first lawsuit arising from the outbreak on behalf of a Utah resident.

And in November 2009, A New York company called Fairbank Farms recalled 545,699 pounds of ground beef due to E. coli O157:H7 contamination. The outbreak caused resulted in 26 E. coli O157:H7 illnesses, nineteen hospitalizations, and five who developed hemolytic uremic syndrome (HUS). 

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Virtually every time an E. coli O157:H7 outbreak occurs, the most severely injured people develop a condition called hemolytic uremic syndrome (HUS).  The cluster being investigated by health officials in Belgium, Wisconsin is no exception.  At least one of the cases, believed to be a child, developed HUS and spent multiple weeks hospitalized at Children's Hospital of Wisconsin.

What is HUS?

Post-diarrheal Hemolytic Uremic Syndrome (D+HUS) is a severe, life-threatening complication that occurs in about 10% of those infected with E. coli O157:H7 or other Shiga toxin (Stx) producing E. coli. D+HUS was first described in 1955, but was not known to be secondary to E. coli infections until 1982. It is now recognized as the most common cause of acute kidney failure in infants and young children. Adolescents and adults are also susceptible, as are the elderly who often succumb to the disease.

How did these otherwise harmless E. coli become such killers?

It seems likely that DNA from a Shiga toxin producing bacterium known as Shigella dysenteriae type 1 was transferred by a bacteriophage (bacteria infected with a virus) to harmless E. coli bacteria, thereby providing them with the genes to produce one of the most potent toxins known to man. So potent, that the Department of Homeland Security lists it as a potential bioterrorist agent. Although E. coli O157:H7 are responsible for the majority of cases in America, there are many additional Stx producing E. coli that can cause D+ HUS.

From Diarrhea to Dialysis

The chain of events leading to HUS begins with ingestion of Stx producing E. coli (e.g., E. coli O157: H7) in contaminated food, beverages or through person to person transmission. These E. coli rapidly multiply in the intestines causing colitis (diarrhea), and tightly bind to cells that line the large intestine. This snug attachment facilitates absorption of the toxin into the circulation where it becomes attached to weak receptors on white blood cells (WBC) thus allowing the toxin to “ride piggyback” to the kidneys where it is transferred to numerous avid (strong) Gb3 receptors that grasp and hold on to the toxin. Organ injury is primarily a function of Gb3 receptor location and density. Receptors are probably heterogeneously distributed in the major body organs, and this may explain why some patients develop injury in other organs (e.g., brain, pancreas).

Once Stx attaches to receptors, it moves into the cell’s cytoplasm where it shuts down the cells’ protein machinery resulting in cellular injury and/or death. This cellular injury activates blood platelets and the coagulation cascade which results in the formation of clots in the very small vessels of the kidney resulting in acute kidney injury and failure. The red blood cells are hemolyized (destroyed) by Stx and/or damaged as they attempt to pass through partially obstructed microvessels. Blood platelets (required for normal blood clotting), are trapped in the tiny blood clots or are damaged and destroyed by the spleen.

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The E. coli O157:H7 outbreak in Belgium, Wisconsin has sickened at least 6 kids (one who developed HUS) seems to have several well-defined epidemiological circumstances that may help the State of Wisconsin Health Department identify a source.  The victims seem to all be kids, the kids all come from the same relatively small part of the town, and the kids apparently do not interact socially.  

Whatever the ultimate significance of these circumstances, another highly interesting epidemiological point in the outbreak is the apparent presence of Cryptosporidium and Clostridium difficile infection among the outbreak cases. 

Clostridium difficile

Clostridium difficile (C. difficile) is a spore-forming, gram-positive anaerobic bacillus that produces two toxins: toxin A and toxin B. These toxins typically cause gastrointestinal disease, often with severe complications. In rare cases, C. difficile-associated disease can be fatal. Although C. difficile bacteria can be present in human intestinal tracts and cause no clinical symptoms (a condition called colonization), some individuals with C. difficile colonization are at increased risk of becoming ill. The most common risk factor for C. difficile-associated disease is exposure to antibiotics, especially those with broad-spectrum activity. Although less common, exposure to agents that suppress the immune system may also increase the risk of illness. Advanced age, severe underlying illness, gastrointestinal surgery, use of nasogastric tubes, and gastrointestinal medications (such as gastrointestinal stimulants or antacids) have also been associated with an increased risk of colonization. Most cases are acquired in hospitals or nursing homes, but an increased incidence of community–acquired C. difficile has been reported as well. Recent studies indicate that C. difficile can also be found in food products, thus raising a significant question: Can C. difficile cause foodborne illness?

Sources and Transmission

C. difficile is shed in feces. Any material, device, or surface that becomes contaminated with feces—such as toilets or bathing tubs—may serve as a reservoir for C. difficile spores. The ability of C. difficile to form spores is thought to be a key feature that enables the bacteria to persist in patients and the physical environment for long periods of time, thereby facilitating its transmission.

The spores are transferred to patients in healthcare settings mainly through the hands of healthcare personnel who have touched a contaminated surface or item. Some evidence suggests that C. difficile may be brought into healthcare environments by asymptomatic carriers—otherwise healthy individuals with no apparent symptoms. Virulent strains, which cause severe disease in populations at high risk, might also cause more frequent, severe disease in populations previously at low risk—that is, in otherwise healthy persons with little or no exposure to health-care settings or antimicrobial use. Certain emerging features of C. difficile illness, such as close-contact transmission, high recurrence rate, young patient age, bloody diarrhea, and lack of antimicrobial exposure, might indicate that the illness and its effects are changing.

C. difficile has also been linked to illness in livestock. Studies have revealed high infection rates of C. difficile among neonatal pigs. Similarly, C. difficile has been implicated as a cause of diarrhea in calves. Livestock contamination raises concerns that the bacteria may make its way into retail food products. Indeed, C. difficile has been identified in raw meat intended for pet consumption in Canada, retail ground beef in Canada, and uncooked and ready-to-eat meats in retail markets in a U.S. metropolitan area.

Symptoms

The incubation period from ingestion of C. difficile to the development of symptoms has not been established. Among patients taking antibiotics, symptoms can appear immediately after beginning treatment or may not develop until several weeks after it is completed.

Most often, C. difficile-associated disease includes symptoms of mild to moderate non-bloody diarrhea, sometimes accompanied by lower abdominal cramping. Systemic symptoms, such as fever, are typically absent; mild abdominal tenderness is usually the only finding on physical exam.

In more severe cases, colitis develops, with symptoms of profuse watery diarrhea and abdominal pain and distention; bloody stools are rare. Fever, nausea, and dehydration are also often present in severe cases. Furthermore, a characteristic membrane with adherent yellow plaques can be found in the colon. Patients with severe colitis are at increased risk of developing paralytic ileus (blocked colon due to lack of peristalsis―the normal rhythmic contraction of the colon muscles) and toxic megacolon (dilated colon). These conditions may lead to a decrease in diarrhea. Severe cases may also include fulminant colitis―a rapid downhill clinical course that occurs among 1% to 3% of patients. Patients may have an acute abdomen and systemic symptoms, such as fever and tachycardia, and may require surgery.

Mortality rates associated with C. difficile-related disease in the U.S. increased nearly three-fold from 1999 to 2002. A recent study, which included C. difficile-related cases where C. difficile infection was present but not listed as the underlying cause of death, demonstrated an increase in deaths from 5.7 per million population in 1999 to 23.7 per million in 2004. It is possible that the increased rates were due to the emergence of a highly virulent strain of C. difficile.

Detection

Stool cultures are the most sensitive means available to detect C. difficile, however, they are also the test most often associated with false-positive results, due to presence of non-toxigenic bacterial strains. C. difficile stool cultures are also labor intensive and require the appropriate culture environment to grow anaerobic microorganisms. Results are available within 48 to 96 hours of the test.

Antigen detection tests for C. difficile have a very fast turn around time (less than one hour); these tests detect the presence of C. difficile antigen by latex agglutination or immunochromatographic assays. Antigen tests must be combined with toxin testing to verify diagnosis. One type of antigen test, enzyme immunoassay, detects toxin A, toxin B, or both A and B. It is a same-day assay but is less sensitive than the tissue culture cytotoxicity assay. The tissue culture cytotoxicity assay detects toxin B only. This assay requires technical expertise, is costly, and requires 24 to 48 hours for a final result. It does, however, provide specific and sensitive results for C. difficile-associated disease.

It is important to note that C. difficile toxin is very unstable. The toxin degrades at room temperature and may be undetectable within two hours after collection of a stool specimen. False-negative results occur when specimens are not promptly tested or kept refrigerated until testing can be completed.

Treatment

C. difficile-associated disease will resolve in one-quarter of antibiotic-related cases within two to three days of discontinuing the problematic antibiotic. The infection can usually be treated with an appropriate course (about ten days) of antibiotics, including metronidazole or vancomycin (administered orally). Following treatment, repeat testing is not recommended if the individual’s symptoms have resolved, due to the fact that many patients remain colonized. In high risk individuals, recurrence of infection or relapse may occur after treatment. 

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Sheboyganpress.com reports that the six children living in a well-defined, relatively small corner of Belgium, Wisconsin who were infected with E. coli O157:H7 had related infections with other dangerous bugs, including Cryptosporidium and Clostridium difficile. 

Cryptosporidium parvum (also known as "Crypto") is a parasite that is too small to be seen with the naked eye. It is found in water and food sources contaminated with the feces of infected humans, cattle, and other mammals. The infectious form of the parasite, known as an "oocyst," is highly resistant to the levels of chlorine normally found in drinking water and swimming pools.

Symptoms of Cryptosporidium

Cryptosporidiosis, the infection caused by ingestion of the Cryptosporidium parasite, causes painful abdominal cramping and profuse, watery diarrhea. In addition to diarrhea, symptoms of infection are fatigue, fever, nausea, vomiting, and loss of appetite.

Symptoms of Cryptosporidiosis appear an average of seven days after oocysts are swallowed, and normally last for two weeks or less in healthy adults. People with compromised immune systems (those with diabetes, receiving cancer treatments, who have received organ transplants, or are infected with HIV/AIDS), the elderly, pregnant women, and small children are more likely to become infected, and will suffer more severe illnesses than healthy adults. In some cases, Cryptosporidiosis can be life-threatening, especially when those infected become dehydrated.

Detection and Treatment of Cryptosporidium

Infection with Cryptosporidium parvum typically occurs after a person swallows contaminated water, eats contaminated food, or comes into direct contact with contaminated feces. Since 1988, health departments have documented more than ten outbreaks traced to contaminated water sources, including water parks and swimming pools in the U.S. Thousands have become ill.

The number of Cryptosporidium oocysts needed to cause human infection is relatively low -- ingestion of as few as two to ten oocysts can cause illness. When infectious, a person can pass millions of oocysts per day in his or her stool; even after symptoms resolve, a person can remain infectious for a number of weeks. Therefore, it is important that individuals experiencing symptoms of diarrheal illness do not participate in activities that could lead to the contamination of water (i.e. swimming in pools, playing in spray-or waterparks).

Cryptosporidium may remain infectious for 2-6 months in moist environments outside the body.

Prevention of Cryptosporidium

Reported outbreaks of Cryptosporidium are small in number, but it is believed that as physicians and other health care providers increase their testing of patients with diarrheal illness for crypto that reported incidence will increase. Once a pool is contaminated by fecal accident or by rinsing a diaper in the water, it can remain a source of infection for significant periods of time since Cryptosporidium is resistant to treatment with Chlorine.

In addition to its resistance to treatment with Chlorine, Cryptosporidium is difficult to filter out of water sources because the oocysts are microscopic in size. Oocysts can pass through pool sand filters and most cartridge filters relatively easily; however, a diatomaceous earth filter can capture most oocysts.

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TradingMarkets.com reports another development in the food industry's fight against E. coli contamination:

Strategic Diagnostics Inc., a leading provider of biotechnology-based detection solutions for food safety and life science applications, today announced that its recently improved RapidChek(R) E. coli O157 (including H7) System has earned Performance-Tested Methods(SM) certification from the AOAC Research Institute (License Number # 070801) for testing composite samples of raw beef including ground beef and boneless beef trim.

Tim Lawruk, SDI Food Safety Marketing Manager, said about the test method:

"With the recent announcements of E. coli O157:H7 contamination in beef products, SDI has been working with leaders in the beef industry and regulatory agencies to understand testing requirements based on new sampling practices and industry testing concerns. The newly improved AOAC-certified RapidChek E. coli O157 test system, which includes improved materials and reagents, is designed to offer several advantages over competitive testing methods, including greater accuracy, faster results, reduced testing costs, and increased confidence in test results. This certification also confirms SDI's commitment to provide the food market with superior, complete pathogen testing solutions that provide rapid and accurate results."

Good timing for progress.  This announcement comes right on the heels of yesterday's announcement by the State of Wisconsin that the state is investigating a cluster of six E. coli O157:H7 illness in Belgium, Wisconsin. 

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Fox 6 News in Milwaukee reported today that the state of Wisconsin, with the aid of local health authorities, is investigating 6 E. coli O157:H7 illnesses in Belgium, Wisconsin.  Wisconsin has been hit hard by E. coli before.  Why is it that some states--Minnesota, Utah, and a list of 3 or 4 others--seem to be involved in many major E. coli O157:H7 outbreaks?

Forty-nine Wisconsin residents were sickened in the infamous spinach E. coli O157:H7 (and other serotypes) outbreak in August/September 2006.  (Actually, it was a call from the mother, in the second week of September, of TWO kids infected in the outbreak that helped us figure out exactly what was happening), as were multiple Minnesota residents.  In the Cargill E. coli O157:H7 outbreak in 2007, many Minnesota residents were sickened including Stephanie Smith.  And in the JBS E. coli O157:H7 outbreak in summer 2009, at least six Wisconsin residents were infected, including Joshua Rosploch, who developed HUS.  This is just a short list, but these several states (most prominently Wisconsin and Minnesota) truly have been at the epicenter of surveillance and detection of multiple major national outbreaks. 

Why?  Unlucky distribution of the implicated products?  Wisconsin and Minnesota residents eat more beef and bad produce? 

Many would say that the real reason doesn't have anything to do with plain old nebulous bad luck.  Instead, it happens because these states have surveillance, microbiological, and sanitation personnel who are among the most talented anywhere.  It is not mere coincidence that these states figure prominently in many outbreaks of foodborne disease.  

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Today, the USDA's food inspection branch (FSIS) announced the recall of 846,000 pounds of ground beef products produced by a California company called Huntington Meat Packing, Inc., due, of course, to potential contamination by E. coli O157:H7.  In addition to ground beef produced early this month (Jan 2010), the recall includes ground beef products produced as far back as February 19 to May 15, 2008, due to the concern that some of these products may still be frozen in consumers' homes.  For anybody keeping a running tally, with the addition of today's large recall, beef companies have recalled 1,640,000 pounds of beef products since November.  Its a little scary to think where this number may end up come December 2010. 

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FSIS reported today that Huntington Meat Packing Inc., a Montebello, Calif. establishment, is recalling approximately 864,000 pounds of beef products that may be contaminated with E. coli O157:H7.  Although the recall is Class I--i.e. associated with a very high risk to consumer health--there are no illnesses currently known to be associated with the potentially contaminated meat.  The recalled ground beef was produced between January 5, 2010, and January 15, 2010, and was shipped to distribution centers, restaurants, and hotels within the State of California.

The following products, consisting of all ground beef products produced by the plant from January 5, 2010 to January 15, 2010, are subject to recall:

40 lb. boxes of “Huntington Meats Ground Beef”
40 lb. boxes of “ HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING”
40 lb. boxes of “BEEF BURRITO FILLING MIX”
10 lb. boxes of “IMPERIAL MEAT CO. GROUND BEEF PATTY”
20 lb. boxes of “IMPERIAL MEAT CO. GROUND BEEF PATTY”
10 lb. boxes of “El Rancho MEAT & PROVISION ALL BEEF PATTIES”

Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on a label.

Interestingly, though, these are not the only products subject to the large recall.  FSIS investigation at Huntington Meat Packing, Inc., must have turned up some serious violations because the company is also recalling meat produced in 2008.  FSIS determined that the 2008 meat was adulterated because the ground beef products produced from February 19, 2008 to May 15, 2008 may have been contaminated with E. coli O157:H7.

As a result, the following products produced from February 19, 2008 to May 15, 2008, are subject to recall:

40 lb. boxes of “Huntington Meats Ground Beef”
40 lb. boxes of “ HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING”
40 lb. boxes of “BEEF BURRITO FILLING MIX”
10 lb. boxes of “IMPERIAL MEAT CO. GROUND BEEF PATTY”
20 lb. boxes of “IMPERIAL MEAT CO. GROUND BEEF PATTY”
10 lb. boxes of “El Rancho MEAT & PROVISION ALL BEEF PATTIES”

Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on a label.

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 Adams Farm Slaughterhouse, LLC., an Athol, Mass., establishment, is recalling approximately 2,574 pounds of beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.  A sample of the recalled ground beef tested positive for E. coli O157:H7 in the wake of an epidemiological investigation initiated by Massachusetts into the illness of one resident.  Are there more illnesses?  

This is the second ground time in the last several months that Massachusetts citizens have been caught in the midst of a ground beef recall.  In November, ground beef from a New York ground beef company called Fairbank Farms was recalled due to E. coli O157:H7 contamination.  That outbreak caused at least 8 people in the Commonwealth of Massachusetts to become infected with E. coli O157:H7.    

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The Meat Trade News Daily misses only a couple major food safety issues (i.e. outbreaks) in yesterdays summary of ten major food stories in 2009.  In the blog post, titled "USA - Food Safety a Bloody Disgrace," MTND includes: 

1.  Stephanie Smith's E. coli O157:H7 and HUS illness from eating a contaminated Cargill ground beef patty.  Stephanie has sued Cargill for $100,000,000.

2.  Linda Rivera's E. coli O157:H7 and HUS illness from eating contaminated Nestle cookie dough.

3.  Peanut Corporation of America's Salmonella Typhimurium outbreak, remarkable for a lot of things, not least of which the depth of its seemingly utter disdain for the wellbeing of consumers.

4.  The Salmonella Newport (an antibiotic resistant strain) outbreak linked to Cargill ground beef.

5.  President Obama's failure to nominate somebody, despite having served for almost a year--a year marked by, well, see above and below--for the position of Undersecretary of Food Safety at the USDA.

6.  The Milan, Illinois McDonald's Hepatitis A outbreak, lacking only an ounce of intent in its comarability to the actions of PCA and Stewart Parnell.

7.  The Organic Pastures E. coli O157:H7 outbreak linked to raw milk.

8.  The E. coli O157:H7 outbreak linked to JBS beef.

9.  A Chinese court's acceptance of the first lawsuit to arise from the 2008 melamine scandal linked to tainted milk, which killed 6 babies and sickened about 300,000.

10.  The "food fight" sparked by the Center for Science in the Public Interest's report on the ten riskiest foods regulated by the FDA.

A good list.  I would add many more if there was room in a list of ten, but two are certainly worthy of emphasis:

1.  The E. coli O157:H7 outbreak, announced in a Christmas Eve press release, linked to tenderized beef products produced by National Steak and Poultry.

2.  The large Salmonella Saintpaul outbreak from January through April linked to contaminated sprouts.  Ultimately, at least 228 people were sickened in the outbreak from 13 states.

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Urinary tract infections (UTI) are a serious health problem affecting millions of people each year.  In fact, they are the second most common type of bodily infection, accounting for about 8.3 million doctor visits annually.  Escherichia coli--a family of bacteria that includes E. coli O157 and other shiga-toxin producing strains, as well as certain generic strains that can reside quite peacefully in the human colon--is the most common cause of urinary tract infections.  New research suggests that, even for strains associated with UTI rather than gastrointestinal disease, meat may be the ultimate reservoir. 

Researchers from Denmark conducted the study, and will soon publish the results in the publication "Foodborne Pathogens and Disease."  In the study, abstract available here, researchers studied the serogroups and antimicrobial resistance characteristics of E. coli isolates (pure bacteria examined for genetic characteristics and uniqueness) from various sources, including community-dwelling humans, broiler chicken meat, broiler chickens, pork, and pigs.

A total of 964 geographically and temporally matched E. coli isolates from UTI patients (n=102), community-dwelling humans (n=109), Danish (n=197) and imported broiler chicken meat (n=86), Danish broiler chickens (n=138), Danish (n=177) and imported pork (n=10), and Danish pigs (n=145) were tested for phylogroups (A, B1, B2, D, and nontypeable [NT] isolates) and antimicrobial susceptibility. Phylogroup A, B1, B2, D, and NT isolates were detected among all groups of isolates except for imported pork isolates. Antimicrobial resistance to three (for B2 isolates) or five antimicrobial agents (for A, B1, D, and NT isolates) was shared among isolates regardless of origin.

Using cluster analysis to investigate antimicrobial resistance data, the researchers found that UTI isolates always grouped with isolates from meat and/or animals. Researchers detected B2 and D isolates, that are associated to UTI, among isolates from broiler chicken meat, broiler chickens, pork, and pigs. Although B2 isolates were found in low prevalences in animals and meat, these sources could still pose a risk for acquiring uropathogenic E. coli. Further, E. coli from animals and meat were very similar to UTI isolates with respect to their antimicrobial resistance phenotype. The researchers believe that the study provides support for the hypothesis that a food animal and meat reservoir might exist for UTI-causing E. coli.

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In 1999, the USDA-FSIS asked the National Advisory Comittee for Microbiological for Foods whether tenderized beef presented increased risks of contamination by E. coli O157:H7.  The answer, of course, was that it does, and that risks to consumer health increased correspondingly.  See Recommendations. 

This is not surprising, of course, nor is it particularly newsworthy in and of itself given the recent outbreak linked to tenderized beef from National Steak and Poultry.  In other words, we already knew that.  What i am interested in at this point is what questions we need to ask of National Steak and Poultry in upcoming litigation over the outbreak.  Essentially, what did National Steak and Poultry, and the industry at large, know about the risks of tenderized beef, and what did they do in order to reduce these risks and make a safer product. 

FSIS recommended several such steps, which certainly do not exhaust the list of things that manufacturers of tenderized beef need to do, but are good first steps at least:

First, the FSIS asked each plant operater that mechanically tenderizes beef to specifically consider in their annual reassessment of their HACCP (hazard analysis and critical control points) plan the significance of E. coli outbreaks linked to tenderized beef as a hazard that is reasonably likely to occur. 

Second, FSIS asked that each of these processors implement purchase specifications requiring the incoming product to be treated to reduce or eliminate E. coli to an undetectable level or apply an approved antimicrobial treatment to the meat.  See yesterday's post on this subject.

Third, though not really a recommendaiton, FSIS was "considering" a requirement that raw, mechanically tenderized beef be labeled to show that it had undergone mechanical tenderization.  (A brilliant idea, and one that all state legislatures should consider independently of any FSIS commandment on the subject; consumers should, at the very least, know whether the meat they are about to consume has undergone a tenderization process that may require a different cooking approach to make the product safe to eat)

Further, in light of the FSIS research and recommendations, the Dairy and Food Protection Branch (Division of Environmental Health, Department of Environmental and Natural Resources) issued the following additional recommendations:

1.  All beef not labeled as intact and without buyer specifications to show that it is intact must be assumed to be a non-intact beef product based on the standard meat processing industry practices of pinning, tenderizing or injecting these products. This also includes comminuted beef steak (chopped, flaked, ground, minced, restructured or reformulated).

2. Cook non-intact beef products to a temperature of 155°F as measured by a properly calibrated food thermometer as required by the FDA Food Code.

3. If you currently tenderize beef steaks or other beef products in your restaurant kitchen, please stop this practice.

4. Educate your staff about the identified risks of mechanically tenderized (non-intact) beef products.

5. When possible, notify consumers about the risk of getting E. coli from mechanically tenderized (nonintact) beef steaks and roasts

I wholeheartedly agree, particularly with any recommendation aimed at achieving elimination of bacterial contamination by the slaughterhouses, as well as with any recommendation that aims to educate the consumer about the risks he or she faces by consuming tenderized beef.  National Steak and Poultry, which of these steps were you actively taking at the time of the outbreak?

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Every time an E. coli O157:H7 outbreak occurs, we get yet another reminder how devastating the bacteria can be, particularly when it causes hemolytic uremic syndrome (HUS).  See www.about-hus.com..  And every time we represent a young child with HUS, I am reminded of the story of Regan Erickson, who was sickened in the spinach E. coli outbreak in September 2006 (We represented over 100 victims, including nearly 30 who suffered kidney failure and hemolytic uremic syndrome). 

Tiffany and Russ Erickson were just like most Americans until September 2006. Their four-year-old son Regan (pronounced "Ree-gun") was one of many young kids whose future was unalterably and forever changed by spinach. What appears below is Regan's story. It is a little long, but that must be forgiven. Regan's illness very nearly cost him his life.

ONSET OF ILLNESS:

Regan's mother, Tiffany, and his sister, Emma, were both sickened during the Spinach outbreak as well. Tiffany actually fell ill first, on August 28. It felt like cruel timing, given that it was only three days before Emma’s birthday and little more than a week since discovering that she was pregnant with her third child, Maggie, but Tiffany took everything in stride. She had no reason to suspect that she was dealing with anything more than a run-of-the-mill flu, and her primary concern was with the health of her unborn child.

After twenty-four hours or so, however, thoughts began to change about the nature of Tiffany’s illness. Her bouts of diarrhea had grown more frequent and severe, and her abdomen was beset by cramps more severe than labor pains. Then, the evening of August 29, after a particularly painful bout of diarrhea, Tiffany noticed that the toilet bowl was streaked with blood. Up until this point, Tiffany had endured everything with resolute confidence, but this symptom suggested something that she had never before reckoned with.

Tiffany soon underwent a diagnostic procedure called an endoscopy to shed light on what was wrong. Of his wife’s illness, before his thoughts turned to Regan alone, Russ recalls:

We left the urgent care facility and gave the drugs some time to work, but the pain continued to be unbearable. As my concern shifted from the baby to Tiffany I couldn’t stand seeing her in that much pain, tired from lack of sleep, and not able to get comfortable.

Meanwhile, Regan had begun to develop symptoms, and Emma soon would. “We didn’t realize that the illnesses could be related,” Russ recalls, “since Regan couldn’t express his pain as well as Tiffany. He just knew his ‘tummy’ hurt and he began having diarrhea.” Emma’s symptoms began the very next day, September 1.

Russ recalls:

Everyone in the family was sick, tired, and the children being so young, not knowing how to tell or deal with the symptoms like diarrhea, I was continually cleaning, comforting, and helping where I could, all without Tiffany’s help who is usually the stalwart caregiver. We knew that we had some kind of ‘bug’ but not how severe yet. It presented a lot like flu symptoms, but we began to know it was more serious as the kids, just as Tiffany, began to have blood in their stool, and then blood instead of stool. That is a scary, unnerving experience to see blood when your 3 and 4 year olds are using the bathroom.

Compared to four year-old Regan, the illnesses that Tiffany and Emma Erickson suffered were nothing more than a small current in a raging sea. Nevertheless, to hear Russ describe what his wife and daughter endured is to fully comprehend the aggressive nature of this virulent pathogen. Emma endured many days of an illness more acutely painful than anything her parents had ever seen. But as sick as she was, her older brother was fast-becoming critically ill, and her parents thoughts and attention soon went solely and exclusively to Regan.

REGAN'S ILLNESS:

During an appointment with his pediatrician on September 4, Tiffany reported that Regan had had twenty bouts of bloody diarrhea that day, prompting endless complaints of a sore stomach. Regan been unable to eat or drink for days, and had developed redness and inflammation in the rectal area due to the frequency and severity of the diarrhea. These seemingly benign signs were immediately concerning to the pediatrician, who immediately sent Regan and his parents to Mckay Dee Hospital's emergency department. Tiffany and Russ rushed to the ER and carried their son in, having no concept of the road that lay ahead.

Regan remained hospitalized at Mckay Dee for the next two days. Gradually, blood tests showed that he was becoming anemic and losing platelets, and he was also not urinating normally. Soon, stool tests showed exactly why. Regan had been infected by E. coli O157:H7, and he was developing HUS. Doctors at Mckay Dee knew that Regan was critically ill, and they transferred him by Ambulance to Primary Children's Medical Center (PCMC) in Salt Lake City on September 6.

Meanwhile, Tiffany and Russ had begun the painful process of contacting friends and relatives. Russ’s mother dropped everything and, leaving at 4:00 AM, drove to Salt Lake City from Las Vegas. She recalls:

I arrived at Primary Children’s just after the ambulance arrived. They had just gotten Regan in his room. It was a flurry of activity, doctors and nurses in and out of the room. I was taken aback by his appearance. The last time I had seen him was on the 4th of July. He was playing with all his cousins, excited with all the fireworks, eating bar-b-que, and being a normal kid. Today he was pretty much unresponsive; he didn’t even know I was there. So pale and vulnerable, it broke my heart to see him in that condition. I was also taken aback by the appearance of Russell and Tiffany. It was obvious that Tiffany was still not well. She looked pale and tired. As if she was just barely making sense of the whole bizarre turn of events. Russell looked like he hadn’t slept in days . . . come to find out he hadn’t. He had been holding his little family together for over a week now. The only one of them not affected, the burden of care had been fully placed upon his shoulders. And they sagged at the weight of it all. He was tired; with worry in his eyes, fear in his voice and faith in his heart he told me that they were in the best hospital, with the best doctors and that Regan would be okay.

Regan had a difficult night his first night at PCMC. He had run a fever consistently; he had been nauseated despite Zofran; and he had vomited and suffered from painful abdominal distention all night long. Perhaps more significantly, he had had little to no urinary output all night, his face was swollen, and there were signs that his pancreas had already been affected, in addition to his kidneys, by the shiga-toxins released by the E. coli O157:H7 bacteria in his gastrointestinal tract. Regan's nephrologist planned to begin dialysis immediately if the Lasix, a diuretic, did not stimulate more urine production.

Tiffany placed a call to her mother, Tonya Peterson, the afternoon of September 7. Tonya remembers:

Tiffany told me that his pancreas and kidneys had shut down. I couldn’t believe it. I sat at work at my desk, crying for several hours, unable to concentrate on my work. I thought that Regan might not make it. I called my dad and asked him to take me to see Regan. I knew I wouldn’t be able to drive to the hospital in my condition. I was too distraught at the thought of losing Regan. He was such a sweet, innocent little boy. He called me “Ma-mah,” his version of “grandma.”

Regan continued his descent toward total kidney failure that night. He had stopped producing urine completely, and his nephrologist ordered that Regan be prepped for peritoneal dialysis. Accordingly, Regan was transported to the operating room on Friday morning, September 8, where doctors placed a spiral peritoneal catheter for dialysis. He also placed a PICC (peripherally inserted central catheter) line in Regan’s right arm to facilitate infusion of blood products, medicine, and IV nutrition. Then dialysis began.

September 9-13

Regan ran a fever all night on September 8 and vomited five times. He produced no urine and continued to suffer bouts of bloody diarrhea, producing 76 ml of mostly blood before 11:00 AM on September 9. Attendants administered morphine to ease the little boy’s immense discomfort. And because he continued to suffer from nausea and vomiting, doctors began Regan on total parenteral nutrition. Dialysis continued with hourly exchanges.

Over the next two days, Regan remained critically ill. He continued to have no renal function, and his hematocrit continued to drop, which indicated progressive anemia. In addition, Regan had consistently elevated blood pressure readings and was overloaded, in fact bloated, from fluid retention because he was unable to urinate.

Russ recently recalled his sense of devastation and total helplessness during this time:

Together with the surgeries, dialysis, and transfusions was a lot of heartache and a lot of pain. As I watched Regan suffering, I felt helpless. He wasn’t comforted by me and there wasn’t anything I could do to fix the situation. I could just watch, wait, and hope that he would pull through this illness.
***
I also had Emma and Tiffany to worry about. Emma was still having trouble adjusting to what was going on, and she was still regaining strength from her own illness. She couldn’t understand why Regan had to stay at the hospital and have tubes coming out of him all over the place when she had been sick and gotten better without any of that. Tiffany was still recovering, ragged from stress, and she was in a difficult first trimester with all the ailments that come along with that. I was very worried about what I could do to help my family, and it didn’t feel like much.

Regan’s hematocrit continued to drop on September 12, indicating progressing anemia. Doctors ordered that a transfusion of leukocyte filtered packed red blood cells be administered as soon as possible. Regan’s bloody diarrhea continued, but seemed to be improving, and his WBC count dropped as well. Nonetheless, Regan continued to be anuric, leaving his nephrologists little choice but to continue peritoneal dialysis.

September 14-16

By Thursday, September 14, Regan’s medical picture continued to be dire. He continued to be medicated for nausea, hypertension, fevers, to stimulate red blood cell production, and he continued to receive a bronchodilator. He also remained positive, by stool culture, for E. coli O157:H7, and consequently remained under strict quarantine.

Russ’s mother stayed at the hospital, alternating with Tiffany and Russ, at least one of whom was always at Regan’s bedside. She says of Regan’s first week:

The chair made into a bed of sorts and the nurses brought me blankets and pillows. We realized very quickly that the hour drive to PCMC every day was not only costly for the kids but most inconvenient. One of Russell’s cousins lived in the area of the hospital and invited Russell and Tiffany to stay at their house. The Ronald McDonald House had a distance rule that they missed qualification for by just 7 miles. They decided that as long as I could stay with Regan at night, they would go home to sleep in their own bed and then when I had to leave they would go to Russell’s cousin’s house and take turns staying at the hospital at night with their boy.

Throughout the week Regan was so sick that I still wondered if he even knew who I was. He progressed somewhat with the dialysis and his lab tests improved at a snail’s pace. Toward the end of the week they declared him E. coli free and he was allowed to ride in the little red wagon and get out of that tiny room for a minute. Up until that time not only was he confined to the room but his sister, Emma, wasn’t allowed in the play room and his family had strong precautions they were to take to insure that the E. coli would stay contained.

Regan remained very irritable and uncommunicative on Saturday, September 16, prompting an examining physician to describe him as an irritable young lad who had pulled the blanket over his head and his knees up to his abdomen during the examination attempt. Nevertheless, no new symptoms had arisen, and Regan’s hemolytic anemia and thrombocytopenia had begun to improve. Peritoneal dialysis, however, continued just as before.

September 18-23

By September 18, Regan had begun to pass a small amount of urine, and his stools had firmed up. He nevertheless remained extremely irritable and very uncooperative, evidently suffering significant discomfort from his ongoing symptoms. He had begun to moan during the drainage cycle of his ongoing peritoneal dialysis, which had been further reduced to twelve hours per day. But despite the encouraging sign of modest urine production, Regan’s kidney labs had not improved; BUN and creatinine levels remained very high at 62 and 6.1.

Over the next several days, Regan’s kidney lab values continued to fluctuate, so doctors ordered an increase to seventeen hours per day on September 20 due to an unexpected increase in creatinine to 6.7. And on September 22, in fact, Regan again could muster no urine at all. He was anemic and symptomatic with weakness, fatigue, and shortness of breath—all of which convinced his medical team that another transfusion was in order. Dialysis continued as well.

Dr. Sherbotie evaluated Regan the morning of September 23, noting that Regan’s appetite was “clearly” improving with only occasional vomiting. Regan was also able to produce a “substantial amount” of urine that morning. Nevertheless, his lab values indicated ongoing renal dysfunction, and peritoneal dialysis continued with a decrease in the number of hours.

September 25-26

Regan's nephrologist noted significant improvements during his initial assessment on September 26. Generally speaking, Regan appeared well and “was quiet but interactive.” He had lost weight—significant to the clinical picture because it suggested a reduction in fluid retention—and he continued to produce more urine. Nevertheless, he remained on dialysis.

September 27-28

On Wednesday, Regan’s urinary output continued to increase. He produced 641 ml (3 ml/kg/hr) with 550 ml intake. His appetite also continued to improve and, though still cranky, he was more playful than he had been previously. Additionally, his hematocrit, WBC, platelets, sodium, potassium, and glucose were all within normal range, and his BUN and creatinine were trending down with values of 56 and 5.4. With this positive news, Regan’s nephrology team ordered that peritoneal dialysis be stopped for the first time since September 8.

The order to stop dialysis did not, however, mean that the dialysis catheter could be removed. Labs on September 28 indicated another increase in BUN and creatinine, to 60 and 5.9, which values had remained elevated since dialysis was discontinued the day before. Regan’s blood pressure was stable but high at 118-122 over 70-90. Accordingly, Amlodipine continued for Regan’s hypertension.

September 29

On Friday morning, Regan was doing well overall. He continued to be anxious, but seemed to be less cranky, and he was able to eat and drink more and had further increase in urinary output. His facial edema had also improved, but Regan was considered to be generally mildly edematous. He also continued to have elevated but stable blood pressures.

Later in the day, Regan again went to the operating room—this time, however, to have his dialysis catheter removed. Tiffany recalls:

This was a surgery that wasn’t quite as scary to send him in to. He’s laughing because the anesthesiologist put some type of goofy medicine in his PICC line that just made him into a hoot and a half. I was still quite nervous but it felt better to send a laughing child into surgery than a sickly one.

September 30—Discharge from PCMC

On Saturday, September 30, 2006, after four weeks in the hospital and countless dialysis treatments, Regan Erickson was discharged home. His discharge diagnoses included HUS; pancreatitis; acute renal failure requiring peritoneal dialysis from September 8 to 26; placement of PICC on September 8 and removal on September 26; placement of peritoneal dialysis catheter on September 8 and removal on September 29; anemia requiring blood transfusions and ongoing Darbopoetin infusion; emesis requiring Prevacid and Erythromycin Ethylsuccinate (anti-infective); hyperphosphatemia requiring calcium carbonate with meals and phosphate restriction; hypocalcemia status post calcium supplements between meals and IV Calcium chloride x 2; and reactive airway disease.

REGAN'S PRESENT CONDITION AND PROGNOSIS:

Sadly, a child's HUS illness doesn't really end when he is discharged from the hospital. Regan is a perfect example of this. He remained on blood pressure medications after discharge, and he continued to suffer physical and emotional problems related to his prolapsed rectum and the trauma of going through an illness as severe as his was.

Tiffany recalls:

A couple of months after Regan's hospitalization, we made a decision, which hindsight tells us was a bad one, to go to Las Vegas with my husband for a conference he had. His parents live there so we thought it would be a nice cheap vacation. We drove down. The morning after we arrived Regan's prolapse came back out but this time we couldn't get it back in the entire day. I had been speaking over the phone to a pediatrician throughout the day. By the time the prolapse had been out for 12 hours we were advised to take him to the ER in Las Vegas. He was hospitalized.

When we got home I took Regan to a local surgeon and then to a pediatric GI doctor. We decided to allow Regan to use a pullup and stay off the toilet for several months. Regan had a hard time with the toilet because it really scared him when the prolapse would appear. We bought a box of rubber gloves and made sure we had plenty packets of lubricating gel.

Regan is one of many people, mostly children, sickened in the Spinach outbreak whose lives have permanently changed as a result of their illnesses. He is forecast by several of the country's leading pediatric nephrologists to require multiple kidney transplants due to the severity of the kidney injury that he suffered in the Spinach outbreak. Lifetime medical costs will run into the millions of dollars.

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 The Washington State Departments of Health and Agriculture today released information linking recent E. coli illnesses in Washington State to raw milk produced by the Dungeness Valley Creamery in Sequim, WA.  See www.marlerblog.com.  I will point out up front that the Dungeness Valley Creamery, which appears to be where the milk was produced, is a dairy properly licensed in Washington to sell raw milk.  I would ban the sale of raw milk from any dairy in the country, personally, whether licensed or not, but that is not the point of this post.  Every time a raw milk outbreak happens, which is relatively frequently, it causes me to think how many options there really are for people who are looking to purchase the product . . . even in states that otherwise ban it.  

I talked recently in an article on foodsafetynews.com about the deceptive, transparent efforts of many unlicensed dairies to sell raw milk under the guise of cow-share agreements.  Read the article here.  First of all, these arrangements are patently illegal in most states, including Washington, and even states where the Legislature has not specifically condemned them.  Read Washington State Dept of Agriculture's views on cow-share agreements for a perfect example.  And second, it's really a little scary to think that, because these dairies are selling raw milk without having to meet state licensure requirements, some of them produce their product under some terrible conditions. 

 Dee Creek Farm in Woodland Washington was a prime example. Prior to the December 2005 outbreak, Washington State Department of Agriculture (WSDA) had learned of Dee Creek Farm’s cow-share program, and had ordered the farm to cease the dispensing, giving, trading, or selling of milk or to meet requirements for selling milk that had been laid out by WSDA. The letter was sent in August, 2005, and WSDA received a response from Dee Creek Farm in September, 2005, stating that the farm was not selling milk but that the farm’s owners intended to meet requirements for a milk producer and retail raw milk processor in the future.

During the December investigation into the E. coli outbreak, WSDA noted several milk processing violations that would have been addressed during the licensing process had Dee Creek applied for the license. Among the violations were the following:

1. No animal health testing documentation for brucellosis and tuberculosis or health permits
2. Beef cattle contact with wild elk
3. No water or waste water system available at milk barn for milking operations or cleaning
4. No hand washing sinks available for cleaning and sanitizing
5. No bacteriological test results available for the farm’s well-water system
6. Mud/manure with standing water at the entrance to the milk barn parlor
7. Milking bucket in direct contact with unclean surfaces during milk production
8. Multiple instances providing for the opportunity for cross-contamination
9. No separate milk processing area from domestic kitchen
10. No raw milk warning label provided on containers

In addition, sample testing confirmed the presence of E. coli O157:H7 in two milk samples provided by Dee Creek Farm and in five environmental samples taken from Dee Creek Farm milk-barn areas by investigators.

When its investigation was completed, WSDA had identified eighteen people who had consumed raw milk purchased from Dee Creek Farm through the cow-share program and developed symptoms consistent with E. coli infection. Five Clark County, Washington, children were hospitalized, with two developing hemolytic uremic syndrome and requiring critical care and life support for kidney failure as a result of their E. coli infections.

Maybe none of these illnesses would have been prevented had the dairy met the licensing requirements of the state. But maybe the entire outbreak wouldn't have happened. Had Dee Creek become properly licensed before the outbreak, many of the violations noted above would have been far less likely to have occurred.

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Tomorrow morning, we will file a lawsuit on behalf of Kelly and Matthew Cobb.  Kelly was one of at least ten people infected with E. coli O157:H7 in May 2008 after eating contaminated lettuce.  Kelly ultimately developed hemolytic uremic syndrome as a result of her infection, and she had to be hospitalized for two weeks.  Of course, a big part of Kelly's story is that her husband, Matt, was fighting with the marines in Iraq at the time she became ill, leaving Kelly home alone to care for their two children. 

The lawsuit tomorrow will be filed against multiple entities, all of whom played a role in manufacturing the lettuce that made Kelly sick.  The companies, all from California, are as follows:  Church Brothers, LLC; Premium Fresh Farms, LLC; True Leaf Farms, LLC; Andrew Smith Company; and Paul's Pak, Inc.

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The CDC again amended its case-count in the Fairbank Farms ground beef E. coli O157:H7 outbreak.  Secondary DNA tests (surely MLVA) have helped the CDC whittle the number of cases down from 28 in 12 states on November 2, to 26 in 11 states on November 3, to 25 in 10 states today.  These changing case-counts got me thinking about an important aspect of every outbreak of foodborne disease:  that the number of "confirmed cases" is rarely, if ever, an accurate count of the number of actual victims in any outbreak situation. 

The reality of these outbreaks (whether E. coli O157, Salmonella, or anything else) is that the number of people who are actually ill, as opposed to the number who have a stool sample that tests positive, is much bigger than the reports would indicate.  In fact, one of the leading studies on the subject suggests that the number of actual victims in a given outbreak, as opposed to merely those with positive stool samples, is as much as 38 times the number of stool sample confirmed individuals. 

There are several primary reasons why this is the case. First, as noted by Mead et al. in the classic epidemiological study on the subject, underreporting of foodborne disease is common. “Surveillance of foodborne illness is complicated by several factors. The first is underreporting. Although foodborne illnesses can be severe or even fatal, milder cases are often not detected through routine surveillance.” See Mead et al., Emerging Infectious Disease, Vol. 5, No. 5, September-October 1999.  It is frequently the case that only the more severe illnesses come to the attention of health department officials. The less severe illnesses in any given outbreak often require less medical treatment, and the possibility that the causative agent will be identified decreases as well.

Many cases of foodborne illness are not reported because the ill person does not seek medical care, the health-care provider does not obtain a specimen for diagnosis, the laboratory does not perform the necessary diagnostic test, or the illness or laboratory findings are not communicated to public health officials. See Mead at 609.

Also, frequently in the setting of cantagious foodborne diseases, there is a significant likelihood of secondary transmission of disease. As stated in the Mead Article, “many pathogens transmitted through food are also spread through water or from person to person, thus obscuring the role of foodborne transmission.” See Mead at 607. In other words, it is common in outbreak situations for people who became infected by contaminated food to thereafter sicken co-workers or family members by unwitting transmission of a small amount of bacteria.

Thus, for many reasons, publicized case-counts in outbreaks are only indicators of how many people were actually affected. Turning back to the Fairbank Farms outbreak and recall, its a little frightening to apply the Mead formula: 38 X 25 = A lot of sick people, and way too many kids laying in hospital beds connected to dialysis machines.
 

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 The CDC did not provide any updated statistics today about the number of people sickened in the ongoing E. coli O157:H7 outbreaks linked to ground beef (still 26 illness in 11 states, with 2 deaths and 3 HUS), but the Food Safety and Inspection Service (FSIS) did update the list of retail stores who may have received contaminated ground beef.  The list is long and comprehensive and, to me at least, suggests that the number of people who may be involved in at least the Fairbank Farms outbreak may continue to grow.  See the FSIS update here.

 Here is the short version:  

Shaws in Connecticut, Maine, Massachussetts, Rhode Island, New Hampshire and Vermont

Price Chopper in Connecticut, Pennsylvania, Rhode Island, and Vermont

Acme in Delaware, Maryland, New Jersey, and Pennsylvania

Giant in Pennsylvania

Pathmark in Delaware, New Jersey, New York, and Pennsylvania

Food Lion in North Carolina, South Carolina, Virginia and West Virginia

Trader Joe in Connecticut, Delaware, Maryland, Massachussetts, New Jersey, New York, and North Carolina

BJ in New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Virginia

Martins in Maryland, Pennsylvania, Virginia, and West Virginia

Great American in New York

IGA in Maine, New York, and Vermont

Surefresh in Delaware, Maryland, and Pennsylvania

Grand Union in Connecticut and New York

A&P in New Jersey and New York

Waldbaum in New York

C&S in Vermont

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 The CDC reports today that there are currently only 26 illnesses in 11 states that are linked to the Fairbank Farms E. coli O157:H7 ground beef outbreak and recall.  This represents a reduction in the number of cases attributed to the outbreak by two.  

Here is the outbreak rundown:

On October 31, 2009, FSIS issued a notice about a recall of over 500,000 pounds of beef products from Fairbank Farms that may be contaminated with E. coli O157:H7. Health officials in several states who were investigating a cluster of E. coli O157:H7 illnesses, with isolates that match by “DNA fingerprinting” analyses, found that most ill persons had consumed ground beef, with several purchasing the same or similar product from a common retail chain. At least some of the illnesses appear to be associated with products subject to these recalls. A sample from an opened package of ground beef recovered from a patient's home was tested by the Massachusetts Department of Health and yielded an E. coli O157:H7 isolate that matched the patient isolates by DNA analysis.

The cluster includes 26 persons from 11 states infected with matching strains of E. coli O157:H7. The number of ill persons identified in each state is as follows: California (1), Connecticut (4), Massachusetts (8), Maryland (1), Maine (2), Minnesota (1), New Hampshire (4), New Jersey (1), New York (1), Pennsylvania (2), and Vermont (1). Of these, the genetic association of 13 human isolates and the product isolate have been confirmed by an advanced secondary DNA test; secondary tests are pending on others. Depending on the results of continuing laboratory testing and ongoing case finding, the number of persons determined to be in this cluster may increase or decrease.

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The latest CDC summary on the ongoing E. coli O157:H7 outbreak linked to Fairbank Farms ground beef says that there are 28 confirmed cases in 12 states.  The USDA-FSIS's latest outbreak summary, which is where you would expect to find information on the retailers who have received recalled product, seems a little slow on the uptake.  As we posted yesterday, the FSIS statement is limited to Price Chopper and Shaws' stores in just 8 states.  So what about the other 4 states with sick people in them?  Isn't there some missing information here?

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Recently, certain sectors have argued that the incidence of E. coli O157:H7, and other shiga-toxin producing strains of E. coli, in ground beef has dropped precipitously, and that our food safety system is, as a result, working very well.  At Marler Clark, over the last several years—in fact, beginning with the infamous Dole baby spinach outbreak in September 2006—fully 90% of the people we have represented have been victims of severe E. coli O157:H7 infections, sometimes resulting in hemolytic uremic syndrome; and aside from approximately 100 spinach victims, 95% of these folks were sickened by contaminated ground beef.  In fact, with the recent, virtually simultaneous recalls of about 546,000 pounds of ground beef by South Shore Meats and Fairbank Farms, 45,000,000 pounds of ground beef have been recalled in the last two years.  These statistics sure don’t jibe well with any optimism about our food safety system, as a whole, or ground beef more specifically. 

As recently as the beginning of 2007, the beef industry touted that the incidence of E. coli O157 in meat had plummeted since the 1990s, dropping nearly 80%. The rate of actual illnesses in people, it was said, was also way down. It appeared, by both statistics and the profiles of our clients at Marler Clark, that the meat industry had indeed cleaned up its act—that big beef finally would put Bill Marler's firm in Seattle out of business.

If the first several years of this millennium showed progress by the beef industry, 2007, 2008, and 2009 are years that it would rather forget. Beef companies recalled over twenty-nine million pounds of meat in 2007. 2008 saw at least sixteen recalls of beef products, totaling at least 2,361,295 pounds of meat. And to date in 2009, beef companies have recalled close to two million pounds of product, if not more. True enough, these are just bare numbers—courtesy of the USDA website—but a simple contrast with the first five or six years of this millennium are illustrative. Progress? Optimism? I don’t see it.

Ultimately, these numbers may serve the opposing perspective directly: more recalls may mean more testing, but it does not necessarily mean more illness. To that, all we can really say is that, well, we’ve sure as heck seen a lot more sick people in the last three years than we did the six previous ones. Indeed, there are more than a few families that I can think of around the country who would be shocked—probably even dismayed—to learn that our “food-safety system is working, even though the number of recalls is rising.”

Let me make a different assessment; perhaps it will be a better platform from which to build a national, and international, food-safety system that’s more in keeping with what consumers expect: no, we are not making good enough progress; and no, I don’t agree that the increased number of food recalls (ground beef in particular) is just because of better testing, and more surveillance within the public health community. Take it for what you will, but we have represented more victims of foodborne disease in the last three years alone that we did in the entirety of this firm’s first decade of existence.

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 Tuesday morning, we will be filing lawsuits on behalf of the families of two children sickened in the ongoing, likely developing, outbreaks of E. coli O157:H7 linked to ground beef.  The lawsuits will be filed in Plymouth County Superior Court for the Commonwealth of Massachussetts against Brockton, Mass.-based Crocetti-Oakdale Packing, Inc., doing business as South Shore Meats Inc., and Ashville, NY-based Fairbank Farms, Inc. Both companies recalled meat last week after their products were identified as the source of a national E. coli outbreak.

The medical complications associated with E. coli O157:H7 infection are many.  Most infections are characterized by 7-10 days of diarrhea, frequently bloody, severe abdominal cramps, and a host of other painful symptoms.  Infection by this dangerous pathogen frequently results in hospitalization, and kills with frightening efficiency and regularity.  Those who are acutely susceptible to severe infection whether by age or immuno-compromisation frequently have dangerously severe medical courses.  

Far and away the most frightening medical complication associated with infection by E. coli O157:H7, however, is hemolytic uremic syndrome, or HUS.  The chain of events leading to HUS begins with ingestion of Stx producing E. coli (e.g., E. coli 0157: H7) in contaminated food, beverages or through person to person transmission. These E. coli rapidly multiply in the intestines causing colitis (diarrhea), and tightly bind to cells that line the large intestine. This snug attachment facilitates absorption of the toxin into the circulation where it becomes attached to weak receptors on white blood cells (WBC) thus allowing the toxin to “ride piggyback” to the kidneys where it is transferred to numerous avid (strong) Gb3 receptors that grasp and hold on to the toxin. Organ injury is primarily a function of Gb3 receptor location and density. Receptors are probably heterogeneously distributed in the major body organs, and this may explain why some patients develop injury in other organs (e.g., brain, pancreas).

Once Stx attaches to receptors, it moves into the cell’s cytoplasm where it shuts down the cells’ protein machinery resulting in cellular injury and/or death. This cellular injury activates blood platelets and the coagulation cascade which results in the formation of clots in the very small vessels of the kidney resulting in acute kidney injury and failure. The red blood cells are hemolyized (destroyed) by Stx and/or damaged as they attempt to pass through partially obstructed microvessels. Blood platelets (required for normal blood clotting), are trapped in the tiny blood clots or are damaged and destroyed by the spleen.

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FSIS today released the identities of retail stores that may have received E. coli O157:H7-contaminated ground beef involved in the current recall by Fairbank Farm.  All Shaw's stores in Connecticut, Maine, New Hampshire, Rhode Island, Massachussets, and Vermont may have received contaminated meat; and all Price Chopper stores in Connecticut, Pennsylvania, New York and Vermont may have received contaminated meat.  The CDC now reports that 2 deaths and 26 illnesses may be linked to the Fairbank Farm recall, with the majority of illnesses coming from New England residents.  Fairbank Farm has recalled approximately 546,000 pounds of fresh ground beef. 

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Senator Gillibrand of New  York has unveiled new legislation, entitled the "E. coli Eradication Act" according to this report from the North Country Gazette.  The legislation is aimed at eliminating E. coli O157:H7 from the U.S. food system.  In previous years, outbreaks linked to lettuce, spinach, ground beef and even cookie dough have called the safety of U.S. food into question.  Senator Gillibrand is a member of the Senate Agriculture Committee.  Gillibrand is quoted as saying:

“In America, in 2009, it is unconscionable that food is still going straight to our kitchens, school cafeterias and restaurants without being properly tested to ensure its safety. It’s spreading too many diseases and costing too many lives. We need to do a better job of catching contaminated food before it ever comes close to a kitchen table. My plan addresses the gaps in the inspection process and improves recalls and public education, so parents have the information to keep their families safe.”

Key aspects of the proposed legislation include:

• Improve Testing of Ground Beef, including mandatory testing for E. coli O157:H7.
• Improve Regulation Of All Other Food
• Focus on Prevention, requiring all facilities to establish preventive plans to address hazards upfront, prevent adulteration, and give the FDA access to all of these plans and procedures.
• Expand Access to Records, giving the FDA access to the records of all food processing facilities.
• Establish Oversight of High Quality Testing Laboratories, by granting the FDA authority to check the credibility of the laboratories testing the safety of food, requiring the labs to report all of their findings to the FDA, and certify that foreign food facilities comply with U.S. food safety standards.
• Improve Detection, by increasing inspections at all food facilities, including annual inspections of high-risk facilities, and inspections of all facilities once every four years.
• Enhance U.S. Food Defense Capabilities by helping food companies protect their products from intentional contamination, and commence a national strategy to protect our food supply from terrorist threats, and rapidly respond to food emergencies.
• Increase FDA Resources, increasing federal investments to give the FDA all the resources it needs to implement comprehensive food safety improvements.
• Improve Recall Response, especially for school lunches.   Make recalls of contaminated food mandatory.
• Improve Public Education 

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The CDC estimates that foodborne pathogens cause 76 million cases of gastrointestinal illness every year.  325,000 of these illnesses require hospitalization, and about 5,000 people die annually.  (See Paul S. Mead, et al., Food-Related Illness and Death in the United States, 5 Emerging Infect. Dis. (No. 5) 607, 614 (1999)).  It is estimated that the five most common foodborne pathogens alone cause a loss of $6.9 billion annually in medical expenditures, productivity losses, and the costs of premature death.  (See Crutchfield, S.R. and T. Roberts, “Food Safety Efforts Accelerate in the 1990s,” FOOD REVIEW, 23,3:44-49,(2000))  But what these staggering statistics don't account for are the personal economic costs and physical losses that some victims of foodborne disease (i.e., the permanently injured) face in the future.  These losses can be astronomical, both economically and personally.

In those cases of severe foodborne disease that don't end in death, likely the most costly condition that we regularly see is hemolytic uremic syndrome (HUS).  Post-diarrheal Hemolytic Uremic Syndrome (D+HUS) is a severe, life-threatening complication that occurs in about 10% of those infected with E. coli O157:H7 or other Shiga toxin (Stx) producing E. coli. It is now recognized as the most common cause of acute kidney failure in infants and young children.

In a significant subset of HUS victims, the spectrum of long-term kidney complications runs from fairly benign conditions to end stage renal disease (ESRD), an inexorable process by which the kidneys lose their filtering capacity until the patient requires dialysis or kidney transplantation to survive.  Many such victims will suffer from myriad physical complications before, during, and after kidney transplantation, including:  (1) alterations in calcium and phosphate balance, known as renal osteodystrophy, that cause the bones to become weak and soft, resulting in bone pain and susceptibility to fracture; (2) anemia —which is characterized by a low red blood cell count and consequent lack of energy; (3) growth failure caused by the damaged kidney’s inability to properly regulate the calcium necessary for bone growth; and (4) high blood pressure, which, among other things, stresses the heart and can lead to coronary artery disease, heart attack, and stroke.

Following transplantation, the victim will require immunosuppressive medications for the rest of her life to prevent rejection of the transplanted kidney. Medications used to prevent rejection have considerable side effects. Corticosteroids are commonly used following transplantation. The side effects of corticosteroids are Cushingnoid features (fat deposition around the cheeks and abdomen and back), weight gain, emotional instability, cataracts, decreased growth, osteomalacia and osteonecrosis (softening of the bones and bone pain), hypertension, acne, and difficulty in controlling glucose levels. The steroid side effects, particularly the effects on appearance, are difficult for children, particularly teenagers, and non-compliance with the treatment regimen is a problem with teenagers due to unsightly side effects.

Clearly, the physical impediments to leading a normal life for victims of severe HUS are many.  The economic losses that frequently result in such cases are correspondingly staggering.  We have represented many people, mostly children, in these unfortunate circumstances.  A brief review of three such cases selected at random reveals an average cost of $5,776,352 for medical care and future income losses. 

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 The 2000 movie called “The Perfect Storm” loosely chronicled the destruction of an Atlantic nor’easter that formed due to the random convergence of several destructive weather patterns. Twelve people died in the storm, including six sword fishermen aboard the Andrea Gail (captained by George Clooney’s in the movie). Today is September 14, 2009, marking three years since the convergence of another set of tragic circumstances, ending in hundreds of millions of dollars in damages, many lives lost, and many more lives changed forever:  the 2006 Spinach E. coli outbreak.

Though there were no rough-hewn sword fishermen dying in the Grand Banks, perhaps more than any other outbreak of foodborne disease that we have seen, the spinach outbreak in September 2006 really was the perfect storm. The vehicle, Dole baby spinach, was a nationally-distributed, high-volume product eaten raw by people in every age group, including the young and the old. Contamination on the product was widespread, as is apparent from the severity and number of illnesses caused. And the strains of shiga-toxin producing E. coli involved, again as judged by the severity and number of illnesses caused, were simply more virulent than the strains we typically see.

But just like George Clooney’s movie, the spinach outbreak is truly memorable because of the suffering it caused. Ultimately, the outbreak cost the leafy greens industry over $175 million, maybe more, ruining a brand name; and more importantly, over 200 people were sickened, 102 were hospitalized, and at least thirty-one people developed HUS, five of whom died. Among the five who passed away were Betty Howard, Ruby Trautz, and June Dunning. All three were beloved mothers and grandmothers, and all three died undeservedly shameful, protracted deaths.

The deaths of these three women have been described often enough, however. So it is thus in tribute to Betty, Ruby, and June, and their families, on this third anniversary of the spinach outbreak, that we remind everybody just briefly about these wonderful ladies’ lives.

Betty Howard was born on September 14, 1923 in Sharon Springs, Kansas. She graduated high school in Salina, Kansas in 1941. Like others of the GI Generation, during World War II Betty did her part by working in a gunpowder plant in Oklahoma. After the war, she moved to Yakima, Washington, where she met John W. Howard. The striking young couple married on February 26, 1947.

John and Betty Howard raised four sons: Kim, Paul, Brian, and Darryl. Kim, the Howard’s first son, died in 1998. Paul, Brian, and Darryl are independent, successful men with families of their own. And to a man, each reflects on his childhood, and his mother more specifically, as idyllic in both appearance and reality.

The Howard boys’ mother left an indelible impression on each from day one, most significantly the way in which she lived and conducted her life. Darryl Howard eulogized his mother on February 1, 2007. He stated:

As I thought back this morning, it reminded me of the movie Second Hand Lions.

Two uncles raise a son of a relative. They tell him of their unbelievable adventures. Adventures in the Foreign Legion, tales of saving a girl, and wittingly getting a reward of gold offered for their own heads from a Saudi Prince.

In the end after the two 90-year old uncles pass away by flying their bi-plane into a barn, the boy returns to the farm and this helicopter lands. There is the son of the Saudi Prince with his son. They had heard of the uncles’ passing. The Prince looks over at a large yacht in a small pond and comments: “I see they spent my father’s money well.” Hearing this, the Prince’s son exclaims “So the stories grandfather told of the men are true, they really lived.” To which the boy who the uncles raised, now a man, says: “Yeah, they really lived, boy how they lived.”

My mom and dad really lived.

June Dunning was born on June 20, 1920 in Catford, England. She met her future husband, Arthur Gordon Dunning, a US citizen born to British parents, some years later while working in London. Arthur was then working at Scotland Yard. June and Arthur married in Sussex, England on April 24, 1943.

Arthur thereafter joined the U.S. Army, and he and June spent the majority of the next 20 years living in and around Europe. Their army life resulted in frequent moves, and June held numerous jobs over the years at various Army Base stores. They were eventually transferred to Fort Ritchie, Maryland, where Arthur retired. June and Arthur moved to Hagerstown, Maryland in the mid seventies.

For the last seven years of her life, June lived in Hagerstown, Maryland with her daughter, Corinne Swartz, and her son-in-law, Warren Swartz. Corinne recalls her mother as “a proper British lady that loved her tea, meticulously cared for her flowers and plants and adored our Yorkshire Terrier ”Roxie” whom she walked almost every day until the day she became ill. Neighbors often commented on how they enjoyed watching her walk around the neighborhood with the Yorkie by her side."

June remained independent to the last. She enjoyed heading into town on her own. In fact, Corinne and Warren purchased their home at its location in part due to its proximity to a Hagerstown bus stop. This allowed June to pack a bag for the day, scurry to the bus stop, make a transfer in the downtown square and then ride a second bus to the Mall for a day of shopping, or for an evening of Bingo.
“She never complained about anything,” Corinne recalls, “unless it was raining. The rain always made her mad because she would probably not go out that day. She was an avid shopper. I’m sure the department stores at the Mall have felt the effects of the sudden lack of sales. Finding bargains was a favorite past-time of hers. She often came home after riding the bus from the mall with her arms full of the day’s ‘good buys’.”

Ruby LaFon Trautz was born in the back seat of a car on February 2, 1925 in Manzanar, California. She was the second of four girls born to working class parents, Maude and Paul LaFon. Typical of the era, Maude was a homemaker and Paul, Ruby’s much-beloved father, worked construction.

Ruby and her sisters lived their formative years in a home on Settle Avenue in San Jose, California. The girls sprouted from their humble origins to become cultured, ambitious young women. The personal history of each is remarkable; and Ruby’s, in particular, shows an early bent toward the vibrant and confident persona that she carried throughout her life.

Characteristically, Ruby was not enamored with many of the “social constraints” extant during her adolescent and early adult years. She was, and so remained until the day she died, determined to shape her own life. Thus, she was consistently employed from her adolescent years, through high school, and, after a respite of fifteen years to care for her two girls, consistently until retirement at age 65. Most of her early jobs were military in some fashion, or related to the war effort at least, and she quickly found her calling in the nursing field.

Ruby began training for her nursing career at Santa Clara County Hospital in 1943. She would remain there until 1946, when she transferred to a program at Queen of Angels Hospital in Los Angeles, where she worked in obstetrics and orthopedics. The picture below is of Ruby shortly after graduation from nursing school. Afterward, she returned to Santa Clara County Hospital, where she worked in surgery until commissioned as a 1st Lieutenant in the Air Force in 1950.

It was in her capacity as an Air Force Lieutenant that Ruby served as a flight nurse aboard planes flying wounded Korean War soldiers from base to base—a role that Ruby considered the single-most important of her distinguished medical career. By chance, or perhaps provenance, Ruby’s thoughts about the time she spent in that critical role are memorialized. Students from Conestoga School District in Murray, Nebraska recorded them in an interview several years ago about female war veterans:

Ruby’s job was to help the wounded [] soldiers get on the planes and to help medically while they were transported back to a hospital closest to their homes to continue their medical care or to die. The soldiers would come in on Navy planes to Travis AFB, CA and the nurses would fly on Navy or Air Force planes to get them closer to homes.

The nurses were very much in charge once the patients were on the plane. . . . Nurses essentially had power over the pilots because they could request that the pilots find an airfield to land at anytime if they felt a patient needed to be at a hospital or with a doctor. She requested a plane be taken down to Ft. Knox, KY.

Ruby would often sign in at 3 a.m. and take off at 7 a.m. Her days were typically 12-14 hours. They would land in 7-8 places a day. Sometimes nurses were left at the last stop and it might take 2-3 days to hitch a ride on another plane home. . . .

I asked Ruby what the injury types were. She said it was very sad, they were young kids. They usually had bad injuries like amputations, gun shot wounds, and schizophrenia caused by the war.

Many who knew Ruby Trautz would say that she remained vibrant until she was sickened in the spinach outbreak. Confident, independent, and informed are other adjectives not unfamiliar to Ruby’s description—some might even say feisty. To a person, however, no matter the adjective used, everybody who knew Ruby Trautz agrees that, even at age 81, she remained the dominant force in her own life. As Polly Costello, one of Ruby’s two daughters stated, “my mom was living her life, not waiting for death.”

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The Wisconsin State Journal recently published an excerpt from an interview on the increased number of food recalls we have seen in the last few years.  In the interview, Dr. Kathleen Glass of the Food Research Institute at UW-Madison concluded, in part at least, "That the food-safety system is working, even though the number of recalls is rising."  This inspired me to respond with a slightly different take on the safety of our food safety system as a whole.

Over the last several years—in fact, beginning with the infamous Dole baby spinach outbreak in September 2006—fully 90% of the people we, at Marler Clark, have represented have been victims of severe E. coli O157:H7 infections, sometimes resulting in hemolytic uremic syndrome. And aside from approximately 100 spinach victims, close to 95% of these folks were sickened by contaminated ground beef. This may be nothing more than a real world application of non-scientific fact. Whatever the case, it sure doesn’t jibe well with Dr. Glass’s optimism about our food safety system, as a whole, or ground beef more specifically.

Certain sectors expressed sentiments similar to Dr. Glass’s as recently as the beginning of 2007, touting that the incidence of E. coli O157 in meat had plummeted since the 1990s, dropping nearly 80%. The rate of actual illnesses in people, it was said, was also way down. It appeared, by both statistics and the profiles of our clients, that the meat industry had indeed cleaned up its act—that big beef finally would put Bill Marler and his firm in Seattle out of business.

If the first several years of this millennium showed progress by the beef industry, 2007, 2008, and 2009 are years that it would rather forget. Beef companies recalled over twenty-nine million pounds of meat in 2007. 2008 saw at least sixteen recalls of beef products, totaling at least 2,361,295 pounds of meat. And to date in 2009, beef companies have recalled close to one million pounds of product, including the recent recall of 825,000 pounds due to possible Salmonella contamination. True enough, these are just bare numbers—courtesy of the USDA website—but a simple contrast with the first five or six years of this millennium is illustrative. Progress? Optimism? I don’t see it.

Ultimately, these numbers may serve Dr. Glass’s points directly: more recalls may mean more testing, but it does not necessarily mean more illness. To that, all we can really say is that, well, we’ve sure as heck seen a lot more sick people in the last three years than we did the six previous ones. Indeed, there are more than a few families that I can think of around the country who would be shocked—probably even dismayed—to learn that our “food-safety system is working, even though the number of recalls is rising.”

Let me make a different assessment; perhaps it will be a better platform from which to build a national, and international, food-safety system that’s more in keeping with what consumers expect: no, we are not making good enough progress; and no, I don’t agree that the increased number of food recalls (ground beef in particular) is just because of better testing, and more surveillance within the public health community. Take it for what you will, but we have represented more victims of foodborne disease in the last three years alone that we did in the entirety of this firm’s first decade of existence. 

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According to a CDC update on the multistate outbreak of E. coli O157:H7 linked to Nestle cookie dough, the agency is working with public health officials in several states and collaborating with the FDA and FSIS to investigate the outbreak.

Preliminary results of the investigation “indicate a strong association with eating raw prepackaged cookie dough,” though the agency is still trying to figure out the exact cause of the contamination. In late June, the FDA announced that it found a strain of E. coli O157:H7 in a sample of the recalled cookie dough, but the culture did not match the outbreak strain.

At last count, 80 persons from 31 states have been sickened. Of those cases, 70 have been confirmed by advanced DNA testing as having the outbreak strain, 35 have been hospitalized, and 10 developed hemolytic uremic syndrome. In response to the outbreak, Nestle recalled 3.6 million packages of cookie dough.

The Danville Nestle cookie dough plant linked to the outbreak received clearance to restart manufacturing cookie dough July 9 and shipped out its first shipment of cookie dough since the outbreak last week.

The agency continues to recommend that consumers not eat any variety of the recalled dough. Of Nestle cookie dough packages have a “new batch” label then they were not a part of the outbreak. The agency also reminds consumers that they should not eat raw products that are meant to be cooked or baked before consumption.

Here is the CDC’s updated map:

The number of ill persons identified in each state is as follows: Arizona (2), California (5), Colorado (6), Connecticut (1), Delaware (1), Georgia (2), Iowa (2), Idaho (1), Illinois (7), Kentucky (2), Massachusetts (4), Maryland (2), Maine (3), Minnesota (8), Missouri (1), Montana (1), North Carolina (2), New Hampshire (2), New Jersey (1), Nevada (2), New York (1), Ohio (3), Oklahoma (1), Oregon (1), Pennsylvania (2), South Carolina (1), Texas (3), Utah (4), Virginia (2), Washington (6), and Wisconsin (1).

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Today the USDA Food Safety and Inspection Service (FSIS) announced a recall of ground beef products due to possible Salmonella contamination. According to the press release, “Beef Packers, Inc. [BPI]…is recalling approximately 825,769 pounds of ground beef products that may be linked to an outbreak of salmonellosis.” The link between confirmed Salmonella infections and consumption of BPI ground beef products was first discovered by the Colorado Department of Public Health, and a subsequent traceback investigation conducted by FSIS.

This recall was, for me, surprising news—and also inexplicable given the USDA’s long-held position that Salmonella is not an adulterant per se in raw meat, and the meat industry’s prior success in getting a court to invalidate Salmonella performance standards that the USDA had tried to implement as part of its Pathogen Reduction, HACCP regulations adopted in 1996. So when I read about this recall, my first thought was to wonder why BPI agreed to the recall. (Remember: FSIS lacks the statutory authority to compel a recall.) And my second thought was: I wonder if the meat industry is going to sue the USDA to try and prevent the Agency from seeking a second recall in the future based on possible Salmonella contamination.

I obviously cannot answer either of these questions. But I can provide some useful background information about why this particular recall is so surprising, and so inexplicable. (And, by the way, by inexplicable I mean that it is nearly impossible to explain how FSIS could take this action in light of 25 years worth of policy and court decisions that would appear to suggest that the Agency has no authority to do what it did. The recall is certainly NOT inexplicable from a public health and safety perspective, which is certainly ironic given the fact that the FSIS has the term “safety” in its name, and doing something in favor of safety should not be inexplicable.)

And so now onto some history:

In 1971 the American Public Health Association (APHA) sued the USDA on the grounds that its mark of inspection (“USDA inspected for wholesomeness”) was misleading because, even though the USDA had put its stamp of approval on meat—literally—it did not, for example, test the meat for bacteria. Moreover, APHA argued that raw meat was commonly contaminated with Salmonella, which posed a risk to the public health. According to APHA, the USDA should instead require that meat carry both a warning label and cooking instructions. The USDA opposed the APHA, helped ably (and predictably) by the meat industry. As quoted by Marion Nestle in her great book, Safe Food, the USDA’s position was that, given how many foods are contaminated with Salmonella, “it would be unjustified to single out the meat industry and ask that the [USDA] require it to identify its raw products as being hazardous to health.” Nestle at 66. (Note to Reader: No, I am really not making this up.)

In 1974, the DC Circuit Court of Appeals upheld the position of the USDA and the meat industry, doing so in a way that was as nonsensical as it was sexist. The court stated that: “The presence of salmonellae on meat does not constitute adulteration within this definition [of ‘adulterated,’ provided in 21 U.S.C. § 601 (m)]….As it said in its letter of August 18, 1971 ‘the American consumer knows that raw meat and poultry are not sterile and, if handled improperly, perhaps could cause illness." In other words, American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.’” APHA v. Butz, 511 F.2d 331, 334 (1974).

This remained the position of the USDA and the meat industry until 1994 when, in an act of both common-sense and bravado, Michael Taylor, then FSIS Administrator, announced that E. coli O157:H7 would be deemed an adulterant in raw ground beef. The Agency did not, however, change its tune with regard to any other pathogens, especially Salmonella. Indeed, in 1999, when FSIS announced it inane distinction between E. coli O157:H7 in “intact” meat versus “non-intact” meat, the Agency continued to focus on how a given meat was “customarily cooked” as a chief determinant of whether it must be treated as an adulterant. Thus, for example, because it decided that “intact steaks and roasts are customarily cooked in a manner that ensures that these products are not contaminated with E. coli O157:H7,” there was no need to treat this deadly pathogen as an adulterant on intact cuts of meat. Of course, this FSIS policy is also one that appears to have been silently jettisoned by the Agency of late. (For more on this, see my prior post “More Doubletalk from the USDA on E. coli and Swift Meat Recall,” at  www.foodpoisonjournal.com/2009/07/articles/food-policy-regulation/more-doubletalk-from-usda-on-e-coli-and-swift-meat-recall/)

The Agency’s position on Salmonella and meat came back to haunt it in a big way when FSIS tried to shut down Supreme Beef Processors, Inc. for repeatedly failing Salmonella performance standards that, according to the Agency, was proof that the ground beef being made there was being processed under “insanitary conditions.” Supreme Beef sued the USDA and not only won an injunction, but it succeeded in having the Salmonella regulations struck down as being “beyond the authority granted the Secretary [of the USDA] by the Federal Meat Inspection Act.” Supreme Beef  v. USDA, 275 F.3d 432, 434 (5th Cir. 2001). Explaining its holding, the Court wrote:

The difficulty in this case arises, in part, because Salmonella, present in a substantial proportion of meat and poultry products, is not an adulterant per se, 21 meaning its presence does not require the USDA to refuse to stamp such meat "inspected and passed." 22 This is because normal cooking practices for meat and poultry destroy the Salmonella organism, 23 and therefore the presence of Salmonella in meat products does not render them "injurious to health" 24 for purposes of § 601(m)(1). Salmonella-infected beef is thus routinely labeled "inspected and passed" by USDA inspectors and is legal to sell to the consumer.

Supreme Beef, 275 F.2d at 438-39. And, of course, not surprisingly, the court in this case was quick to cite the decision in APHA v. Butz, and to note that even now the “USDA agrees that Salmonella is not an adulterant per se.” Id. at 439 n. 21.

In my view the Supreme Beef decision is poorly reasoned and ill-informed. (For example, could not someone at the Court figure out that it is impossible for meat to be “infected” with Salmonella, and the proper term here is “contaminated”?) But the real lesson of Supreme Beef is that the USDA was, and continues to be, an Agency that is unable to decide whose side it is on. Sometimes it puts on its public safety hat, and sometimes—actually, most often—it puts on its pro-meat industry hat. And, unfortunately, these roles are too often contradictory. That is why USDA policy when it comes to meat safety is also too often contradictory.

So how does the USDA square today’s recall of Salmonella-contaminated meat with the last 25 years of Agency policy on meat adulteration standards? It cannot. But let us hope that if the meat industry decides to sue to scuttle what appears to be a new and better policy on Salmonella in meat that this time the USDA decides to stand with the public on the side of meat safety.

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     Blatantly (and self-servingly) rewriting history, in Friday’s Wall Street Journal, the USDA is reported as stating the following:

The USDA has been considering for more than a year a policy change that would allow whole beef cuts to be considered "adulterated" -- and thus subject to recall -- even if they aren't "intended for use in ground beef," according to Daniel Engeljohn, a deputy assistant administrator for USDA's Food Safety and Inspection Service, or FSIS.
The policy change is still under consideration, he said.

See Bill Tomson, U.S. Beef Safety Plan Languishes Amid New Illnesses, Wall Street Journal, July 10, 2009, see: online.wsj.com/article/SB124725846273124757.html

     Despite the fact that it has been pressed on the problem for over eight years, the USDA is now trying to act as if the serious risk of E. coli O157:H7 contamination of primal and subprimals, so-called intact cuts of meat, is a recent problem that is currently subject to ongoing policy review. This, to put it mildly (and aptly), is a bunch of cow-sh*t. Confusion has reigned since the FSIS E. coli O157:H7 policy on intact vs. non-intact meat was first announced on January 19, 1999. See 64 Fed. Reg. No. 11, 2803-05, see ftp.resource.org/gpo.gov/register/1999/1999_2805.pdf (hereinafter “Intact Meat Policy Statement)”.

For a complete and accurate history of how long this issue has been before the USDA, without it taking any action to address the risk, please click on the Continue Reading link.

    Following Texas Food Industry v. Espy, which upheld the USDA decision to treat E. coli O157:H7 as an adulterant in raw meat “in light of the common cooking practices of most Americans,” the Agency stated in its Non-Intact Meat Policy Statement, published in the Federal Register on January 19, 1999, that it "believes the status under Federal Meat Inspection Act (FMIA) of beef products contaminated with E. coli O157:H7 must depend on whether there is adequate assurance that subsequent handling of the product will result in food that is not contaminated when consumed." Intact Meat Policy Statement at 2803.

   In its policy statement, the Agency provided no statutory basis for its authority to define adulteration on a product-specific basis. Nor did the Agency expressly state that E. coli O157:H7 was no longer an adulterant per se. Instead, it stated that:

[USDA] believes that with the exception of beef products that are intact cuts of muscle that are to be distributed for consumption as intact cuts, an E. coli O157:H7-contaminated beef product must not be distributed until it has been processed into a ready-to-eat product—i.e., a food product that may be consumed safely without any further cooking or other preparation. Id at 2804.

Accordingly, based on the input it received, the Agency announced that it would consider expanding its sampling and testing program to include non-intact beef products or intact cuts of meat that are to be further processed into non-intact cuts. Id.

   The corollary of the Agency’s position was that, while it would treat non-intact meat as “adulterated” if contaminated with E. coli O157:H7, it would not treat intact meat as “adulterated” if it was identically contaminated. Id. (“such intact products that are to be distributed for consumption as intact cuts are not deemed adulterated.”) Essentially, the Agency had therefore created an exception to its E. coli O157:H7 policy for an entire product-category—intact meat. The Agency defined the category by exclusion as “cuts of muscle include steaks, roast, and other intact cuts (e.g., briskets, stew beef, and beef ‘cubes for stew’, as well as thin-sliced strips of beef for stir-frying) in which the meat interior remains protected from pathogens migrating below the exterior surface.” Id.

   The definition of “intact meat” is explicit in its reliance on the deliberations of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and the work it did for FDA and USDA in their joint development of the 1999 Food Code. One such task was to determine the “appropriate cooking temperatures for, among other things, intact beef steaks for the control of vegetative enteric pathogens.” As stated in the Non-Intact Meat Policy Statement regarding intact product:

Due to a low probability of pathogenic bacteria being present in or migrating from the external surface to the interior of beef muscle, cuts of intact muscle (steaks) should be safe if external surfaces are exposed to temperatures sufficient to effect a cooked color change. In addition, the cut (exposed) surfaces must receive heat to effect a complete sear across the cut surfaces . . . . The Committee’s definition of “Intact Beef Steak” limited the applicability of this conclusion to “[a] cut of whole muscle[s] that has not been injected, mechanically tenderized, or reconstructed.”Id. at 2803-04. See also 1999 Model Food Code, 3-201.11(E), at vm.cfsan.fda.gov/~dms/fc99-3.html (defining “whole-muscle intact beef steaks” as those “that are intended for consumption in an undercooked form without a consumer advisory”).

Therefore, intact meat is any meat that is not non-intact, and vice versa.

   Recognizing the utility of excluding entire product-categories from the USDA’s E. coli O157:H7 policy, the meat industry soon began to press the Agency to also exclude mechanically-tenderized meat from the policy. The meat industry sponsored research intended to show the safety of this second category of meat products. Wendy Warren, Characterization of E. coli O157:H7 on Subprimal Beef Cuts Prior to Mechanical Tenderization: Project Summary (Aug. 2002), at www.beef.org/uDocs/E.%20coli%20Mech%20Tenderization_Warren_6_6_03.pdf (stating on title page “Funded by America’s Beef Producers”).

   In response to meat industry lobbying, the Agency asked NACMCF to “answer several questions with regard to E. coli O157:H7 in blade-tenderized, non-intact beef.” E. Coli O157:H7 Contamination of Beef Products, 67 Fed. Reg. 62,325, 62,333 (Oct. 7, 2002). For its part, “NACMCF concluded that non-intact, blade tenderized beef steaks could potentially contain an infective dose of E. coli O157:H7 in their interior.” Id. As a result, on October 7, 2002, USDA announced in a policy statement that:

FSIS is reviewing the NACMCF report and its draft risk assessment for E. coli O157:H7 in intact and non-intact (blade tenderized) steaks and will consider NACMCF’s conclusions and the conclusions from the risk assessment with regard to the policy announced for non-intact products in the January 19, 1999 Federal Register . . . . At this time, FSIS believes that the public health hazard presented by E. coli O157:H7 and the prevalence of E. coli O157:H7 in these products continues to support application of the policy announced in the January 19, 1999, Federal Register. There is a lack of data on industry and consumer practices for cooking pinned, needled, and blade tenderized steaks (e.g., grilling, oven broiling, or frying) and a lack of data on the proportion of [meat] industry outlets and consumers that prepare these products according to each of these different methods. If FSIS obtains substantial and reliable data showing that [meat] industry and consumers customarily cook pinned, needled, and blade tenderized products in a manner that destroys E. coli O157:H7, FSIS would consider modifications to its policy . . . in these products. Id. at 62,334.

   As a result, the focus continued to be placed upon cooking and nothing else. The extremely low infectious-dose made cross-contamination as big a risk as undercooking. At least in the case of cross-contamination risk, the Agency remained steadfast in its position.

   Two years later an outbreak of E. coli O157:H7 infections was linked to non-intact blade tenderized steaks. Ellen Swanson Laine et al., Outbreak of Escherichia coli O157:H7 Infections Associated with Nonintact Blade-Tenderized Frozen Steaks Sold by Door-to-Door Vendors, 68 J. Food Protection (No. 6) 1198, 1200, 1202 (2005) (describing an outbreak in which one 52 year-old HUS victim was hospitalized for 25 days and suffered permanent brain injury, and concluding that the “USDA should consider reevaluating the microbiologic hazards of technologies used in the production of nonintact steaks”). Nevertheless, the Agency continued to consider further narrowing the products subject to its E. coli O157:H7 per se adulteration standard. After having first set forth a zero-tolerance policy for this deadly pathogen, the Agency proceeded with an approach designed to satisfy the meat industry rather than protect the public from a known risk.

   This risk became even better known in 2000 when, in Milwaukee, there were over 62 lab-confirmed E. coli O157:H7 infections linked to a Sizzler restaurant where cross-contamination from intact cuts of meat caused other ready-to-eat food items to turn deadly. Tragically, one young child, Brianne Kriefall died as a result of her infection.

Wisconsin health investigators later concluded Brianna Kriefall died from eating watermelon that Sizzler workers had inadvertently splattered with juices from tainted sirloin tips. The meat came from a Colorado slaughterhouse where beef repeatedly had been contaminated with feces, [E. coli]'s favorite breeding ground. Federal inspectors had known of the problems at the plant and had documented them dozens of times. But ultimately they were unable to fix them.).

Joby Warrick, An Outbreak Waiting to Happen: Beef-Inspection Failures Let In a Deadly Microbe, Wash. Post, Apr. 9, 2001, at A1.

   In the resulting litigation, the defendant meat company, Excel Meat Corporation, a subsidiary of Cargill, argued that it could not be held legally liable for the injuries because the USDA authorized it to sell intact cuts of meat contaminated with E. coli O157:H7, citing the Intact Meat Policy Statement discussed above. The trial court agreed and dismissed all claims, but the Court of Appeals reversed, finding, among other things, that the USDA had no jurisdiction to treat E. coli O157:H7 as an adulterant on some meat but not others. The court also found that the actual policy of the USDA was a zero-tolerance one, notwithstanding the Agency’s conflicting statements regarding enforcement policy to the contrary. Estate of Kriefall ex rel. Kriefall v. Sizzler USA Franchise, Inc., 671 N.W.2d 849 (Wis. 2003) (denying petition for review); Excel Corp. v. Estate of Kriefall, 541 U.S. 956 (2004) (denying Excel’s petition for writ of certiorari).

   While the litigation and appeals were pending, I filed a petition with the USDA seeking a clarification of its policy on intact meat and E. coli O157:H7. A copy of that Petition can be found here: www.fsis.usda.gov/OPPDE/Comments/02-022N/00-022N-12.pdf Among the many points made in the Petition is one in which I emphasized that substantial amounts of intact meat end up being used to make ground beef at retail. This, I argued, was contrary to the Agency’s own stated position that the policy was to allow the pathogen to be present only if the meat was to be distributed for consumption as an intact cut. This was plainly not the case, however, with intact cuts sold to restaurants and grocery stores.

    In response to my Petition, the USDA simply punted, stating that “because the issues raised in your petition are related to the matters discussed in the October 7, 2002 notice [67 FR 62325], the Agency will consider your petition in conjunction with the comments received in response to that document.” And that was over five years ago.

   The final bit of history that gives lie to Mr. Englejohn’s statements concerning supposedly ongoing policy review is the fact that the FSIS issued a draft risk assessment report on E. coli O157:H7 and ground beef, titled Preliminary Pathways and Data for a Risk Assessment of E. coli O157:H7 in Beef, on October 28, 1998—over ten years ago. See www.fsis.usda.gov/Ophs/ecolrisk/prelim.htm  It then submitted the draft for scientific peer-review to the National Academy of Sciences. This review found numerous shortcomings, including, not surprisingly, the complete failure to take into account the risk of cross-contamination as a vehicle of infection. See, e.g. National Academy of Science, Escherichia coli O157:H7 in Ground Beef: Review of a Draft Risk Assessment, Executive Summary, at 7 (noting that the lack of data concerning the impact of cross-contamination of E. coli O157:H7 during food preparation was a flaw in the Agency’s risk-assessment), available at www.nap.edu/books/0309086272/html/

   Then, as announced in October 7, 2002 notice (the one cited in response to my Petition), the USDA noted that, “On November 5, 2001, FSIS announced the availability of and requested comments on its draft risk assessment for E. coli O157:H7 in ground beef (66 FR 55912).” There it also stated that “FSIS believes that the availability of certain scientific data on E. coli O157:H7 constitutes a change that could affect an establishment's hazard analysis or alter its HACCP plans for raw beef products.” See E. coli O157:H7 Contamination of Beef Products, 67 Fed. Reg. 62325, at www.fsis.usda.gov/oppde/rdad/frpubs/00-022n.htm Here, tellingly, again over five years ago, in 2002, the USDA stated:

The Agency stated that if non-intact products or intact products that are to be further processed into non-intact product prior to distribution for consumption are found to be contaminated with E. coli O157:H7, they must be processed into ready-to-eat product, or they would be deemed to be adulterated (64 FR 2804). FSIS explained that pathogens, including E. coli O157:H7, may be introduced below the surfaces of non-intact products as the result of the processes by which they are made. As a result, customary cooking of these products may not be adequate to kill the pathogens. In contrast, the meat interior of intact products remains protected from pathogens migrating below the exterior. Consequently, customary cooking of these products will destroy any E. coli O157:H7. Finally, in this Federal Register notice, FSIS requested comments and recommendations relevant to the Agency's policy and to any regulatory requirements that might be appropriate to prevent the distribution of beef products adulterated with this pathogen.
Id. at 62326 (emphases added).

Thus, it seems plain as day, that the FSIS policy has always been, at most, that intact cuts distributed FOR CONSUMPTION as intact cuts might reasonably be treated as not adulterated, but nothing else. There is no, and has been no, rational basis for FSIS to somehow claim that intact cuts that are destined for purposes other than consumption AS INTACT CUTS.

   Of course, all of this ignores why the USDA thinks it has the authority to pick and choose what meat it considers to be adulterated when it comes to E. coli O157:H7. To-date, the only court that has been asked to answer that question has ruled that the USDA lacks the authority for this very policy. Perhaps it is time to put this question to the test in a declaratory action against the USDA. Maybe that will get more of a response that my petition did many years ago.

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Michigan is no stranger to outbreaks of E. coli O157:H7 . . . particularly over the course of the last year.  The CDC reports six culture-confirmed, PFGE matched cases in the JBS Swift outbreak and recall.  Michigan also counted many of its residents as victims in the E. coli outbreak linked to lettuce sold by Aunt Mid's and Santa Barbara Farms last September/October. 

Among the Michigan victims of the Aunt Mid's/Santa Barbara Farms lettuce outbreak is Lindsey Jennings, a then 21-year-old pre-med student at the University of Michigan in Ann Arbor.  In fall 2008, Lindsey suffered an E. coli O157:H7 infection and illness the likes of which we don't often see . . . at least not in somebody so undeniably healthy and vibrant. Lindsey was hospitalized for 12 days with a gastrointestinal illness so severe that she required replacement nutrition (total parenteral nutrition) because her gastrointestinal tract was too injured to process food or fluid. She did not eat solid food for over a month, and actually had to continue to receive this nutrition through a tube (peripherally inserted central catheter--PICC) even after she was discharged from the hospital.

Lindsey has continued to recover from her illness in 2009, but she has chosen not to forget about the experience of being so ill. Along with several other Marler Clark clients, Lindsey recently spoke to members of Congress about food safety issues and the need for more vigorous legislation and regulation of the food supply. Afterward, in an interview with Elizabeth Rackover of The Oakland Press, Lindsey stated, “It’s made me much more interested in the political side of things.” “No one should have to go through what we’ve gone through. There are approximately 5,000 people who die every year from foodborne illnesses and almost all of it is preventable.”
 

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   Yesterday, the USDA Food Safety and Inspection Service issued a largely useless, but still widely published, news release entitled “Independence Day: Drills for the Grill.” See News Release, www.fsis.usda.gov/News_&_Events/NR_062909_01/index.asp While notable for a cheery and reassuring tone, the information provided is, at best, unhelpful, and, at worst, is dangerously misleading. In addition to providing little in the way of substantive food safety information about how to “safely” grill a burger, the FSIS news release deceitfully soft-pedals the real risks posed by ground beef, generally, and outdoor grilling in particular. For example, the new release clumps together hamburgers, steak, chicken, hot dogs, and ribs as if all can be treated in the same way, and pose the same relative risk—which is blatantly false. And also, how can anyone at FSIS expect to educate the public about safely grilling ground beef (the real risk here) without once mentioning E. coli O157:H7, the primary risk?

  Take, for example, the introductory quote from FSIS Administrator, Alfred V. Almanza, who states: “Safe food handling is always important, but during the warm summer months — peak grilling season — there is an increased need for awareness of safe food handling practices.” Well, Mr. Almanza, why is that? Could it be because numerous research studies have shown that the incidence of E. coli O157:H7 in cattle rises significantly during the spring, and peaks during the summer months? See, e.g., Edrington, et al, 2006. Seasonal shedding of Escherichia coli O157:H7 in ruminants: a new hypothesis. Foodborne Pathog Dis 3:413-21; Hancock, et al., 1994. The prevalence of Escherichia coli O157.H7 in dairy and beef cattle in Washington State. Epidemiol Infect 113:199-207; Hancock, et al., 1997. A longitudinal study of Escherichia coli O157 in fourteen cattle herds. Epidemiol Infect 118:193-5; and Hussein, et al., 2005. Prevalence of Shiga toxin-producing Escherichia coli in beef cattle. J Food Prot 68:2224-41.  Why not level with the public and tell them that ground beef simply tends to be more dangerous in the summer, and that is when a higher than average percentage of E. coli O157:H7 infections occur?  Of course, that might make the USDA look bad, and could further depress the sales of ground beef.

(Please click on Continue Reading to view the rest of this article.)

Another reason the safe grilling practices are particularly important is because grilling burgers on a barbecue grill is an exceedingly risky practice that is almost certain to result in burgers not consistently reaching an internal temperature of 160 degrees Fahrenheit? Snyder, O. P. 2005. Cooking hamburgers on a Weber outdoor grill. HITM. St. Paul, MN.: http://www.hi-tm.com/Documents2005/hamb-cook-webgrill-6-4-05.pdf  And the USDA spent years and years telling people to rely on color as an indication of doneness when cooking hamburger patties, but then switched in June 1997 and started recommending the use of thermometers to determine doneness. See FSIS Technical Publication, Color of Cooked Ground Beef as it Relates to Doneness, available www.fsis.usda.gov/oa/pubs/colortech.htm (citing the studies that prompted the changed recommendation). Or because once the USDA started to recommend the use of a thermometer use, it was inappropriate and inaccurate bi-metallic coil thermometer (the one that appears on the USDA safe-handling instructions on all meat) that was consistently suggested. See, e.g. O. Peter Snyder, Ph.D., The Dangerous Bi-Metallic Thermometer, available at www.hi-tm.com/Documents2001/hamburger-temp.pdf (“USDA-recommended bimetallic coil thermometer is an inaccurate, awkward, and complicated device for measuring the temperature of highly contaminated, government-inspected and improved raw foods that cooks must pasteurize”).

Notably, yesterday’s press-release recommends the “use of an instant-read thermometer,” which is an excellent recommendation. But few consumers even own this kind of thermometer, let alone use one. McCurdy, et al., 2004. Availability, accuracy and response time of instant-read food thermometers for consumer use. Food Prot. Trends. 24(12):961-968. A 2006 food safety survey conducted by—you guessed it—the USDA (and FDA) found that only 13% of consumers always or often use a thermometer, of any kind, when cooking hamburgers. Lando and Verril, 2008. 2006 USDA/FDA Food Safety Survey, www.cfsan.fda.gov/~comm/crnu-tri7.html And there is also the significant risk that the temperature measured in one place on the hamburger will be different than the temperature elsewhere. Berry, B. W., and Bigner-George, M.E. 2001. Postcooking temperature changes in beef patties. J. Food Prot. 64(9):1405-1411.

And then there is the low infectious dose of E. coli O157:H7, and its virulence. Patricia M. Griffin, et al., Large Outbreak of Escherichia coli O157:H7 Infections in the Western United States: The Big Picture, in RECENT ADVANCES IN VEROCYTOTOXIN-PRODUCING ESCHERICHIA COLI INFECTIONS, at 7 (M.A. Karmali & A. G. Goglio eds. 1994) (“The most probable number of E. coli O157:H7 was less than 20 organisms per gram.”) Patricia M. Griffin & Robert V. Tauxe, The Epidemiology of Infections Caused by Escherichia coli O157:H7, Other Enterohemorrhagic E. coli, and the Associated Hemolytic Uremic Syndrome, 13 Epidemiologic Reviews 60, 73 (1991) (“an organism that can be transmitted by exposure to extremely few organisms.”) Indeed, the USDA has repeatedly noted that a primary reason behind the decision to treat E. coli O157:H7 as an adulterant per se is “the low infectious dose of E. coli O157:H7 associated with foodborne disease outbreaks and the very severe consequences of an E. coli O157:H7 infection.” See  Beef Products Contaminated with Escherichia coli O157:H7, 64 Fed. Reg. 2803, at 2804 (Jan. 19, 1999).

Finally, there is the issue of the cooking instructions that appear on the packages of frozen ground beef patties, one of the most popular products purchased for purposes of outdoor grilling. By law, the USDA is supposed to approves the labels of meat and poultry products, which includes any cooking instructions. But a recently published study compared the cooking instructions on 37 retail packages and found a huge variation in suggested cook times (from 1.5 to 8 minutes per side), and inconsistent advice on whether to use a thermometer or rely on the color of the patty to determine doneness. S. McCurdy, et al., Label Instructions and Cooking Times for Retail Frozen Ground Beef Patties, Food Prot. Trends, 29 (6, 335-41 (June 2009). The study found many cooking instructions “are inadequate to produce a safely cooked patty.” And these are instructions supposedly approved by the USDA.

So if consumers cannot even rely on the USDA-approved cooking instructions printed on the box of frozen ground beef patties, how can they be expected to take seriously a new release about the “food safety ‘drills of the grill’”? I certainly wouldn’t.

(Oh, and by the way, if you do want to grill burgers, I would suggest that you cook all hamburger patties on a cooking rack in your oven set at 350 degrees. After cooking for 15-20 minutes, check the temperature of each patty in multiple locations with a digital read thermometer. If all readings are above 150 degrees, remove the patties from the cooking rack to a warm platter. Now take those patties out to the barbecue grill so you can put grill marks on them. Happy cooking!)

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The recent (and still unfolding) E. coli O157:H7 outbreak linked to contaminated Toll House cookie dough manufactured by Nestle has no shortage of lessons to teach, including the reminder that this deadly pathogen can find its way into nearly any food product if sufficient care is not taken during its manufacture. But this sad outbreak is also a case study in the ridiculously complicated, and too-often ineffective, state of food safety inspection in the United States. What makes the outbreak such an excellent case-study is the fact that the Nestle plant located in Danville, Virginia was not only manufacturing Toll House cookie dough products, but also a variety of Buitoni flat and stuffed pastas, and pasta sauces. This made the plant what is called a “dual jurisdiction establishment” that fell under the regulatory authority of both the FDA and the USDA. And to make things even more interesting, Virginia Department of Agriculture and Consumer Services (VDACS) was performing routine plant inspections under contract with the FDA. So how come with all these agencies involved no one prevented the outbreak?

By way of background, the FDA has jurisdiction over all domestic and imported food products, except meat, poultry, or processed egg products, which fall under the jurisdiction of the USDA. But not all food products fall neatly on one side of the jurisdiction line or the other. For example, the products that Nestle manufactured for its Buitoni-brand fell on both sides of the line, with a few falling almost on the line. Meat-flavored pasta sauce would be inspected by the FDA, while meat sauce containing 3% or more of meat would be inspected by the USDA. The ravioli stuffed with cheese would be the responsibility of the FDA, while those stuffed with pork or prosciutto would be the responsibility of the USDA. Thus, if you look at the FDA Inspection Report from September 11 and 12, 2006, you will see that the inspector takes note of fettuccini and linguine being manufactured (FDA products), and chicken tortellini being manufactured (USDA product). Only the Toll House cookie dough products feel solely within the jurisdiction of the FDA. Nonetheless, the FDA plainly took note of all products being manufactured, without, however, making mention of whether or how what was found would be communicated to the USDA. Of course, since the USDA had an inspector onsite, and the FDA showed up in the plant only every year or so, it is the USDA that presumably knew much more about the plant.

Given the presence of the USDA in the plant on a daily basis, the obvious question then is what did the USDA know, and when did it know it? Another obvious question is: Could the USDA have prevented this outbreak from occurring? And, indeed, was it potentially in a better position to prevent this outbreak. (NOTE: As part of my firm’s investigation into this outbreak we are currently attempting to obtain the USDA inspection records for this plant.)

For more, please click on the Continue Reading link.

The ineffectiveness of the FDA and USDA in these dual jurisdiction establishments was noted years ago. According to a March 2005 report by the General Accounting Office, there are 1,451 dual jurisdiction establishments in the United States—that is, plants that product food regulated by both the USDA and the FDA. (Other agencies that can have overlapping authority include the Environmental Protection Agency and the National Marine Fisheries Services.)

In analyzing how such dual jurisdiction work in practice, the GAO found that it imposes significant and unjustified burdens on the plants, failed to adequately coordinate inspection activities, and wasted large amounts of money through duplicative training programs for inspectors, and overlapping efforts that could and should be reduced. See GAO Report, www.gao.gov/new.items/d05213.pdf  Indeed, the GAO specifically noted that the 2002 Bioterrorism Act granted the FDA authority to allow USDA inspectors to alone inspect the dual jurisdiction establishments, but that the FDA has never taken any action in this regard. Finally, the GAO reminded that it had for quite some time promoted the creation of a single food safety agency with jurisdiction over all food production in the United States, stating “that improvements short of reorganizing the food safety system can be made to reduce overlaps and duplication, and to leverage existing resources.” GAO Report at 7.

Plainly effective coordination did not occur at the Nestle plant. The FDA personnel inspected the Nestle plant only every year or so (on 9/06, 9/05, and 7/04). The VDACS had inspected the plant on March 12, 2009, finding “no unsanitary conditions,” but noting “observed GMP deficiencies” on a state inspection report. (This is another report we are attempting to obtain.) The VDACS also inspected the plant twice in 2007, again under contract to the FDA. Whether the state of Virginia also had jurisdiction over the plant is right now unclear, but it appears to have also been inspecting the plant pursuant to its own jurisdiction.

Finally, as already noted, the USDA had an inspector onsite in the plant, but presumably the inspector stayed away from the part of the plant where the cookie dough was manufactured. This presumption is based on an USDA-FSIS Directive that states:

A. FSIS inspection program personnel are not to routinely enter or inspect an area of the establishment in which nothing that is subject to FSIS jurisdiction occurs. Inspection program personnel are to focus inspection toward the USDA regulated products. There may be situations where an FDA product is processed in close proximity to or on the same line as a FSIS regulated product, and, therefore, inspection personnel may be in the same area. In meat and poultry establishments the inspected facility is defined in the grant of inspection, and in egg products establishments the entire premises includes all buildings on the property.
B. If conditions in the area of the establishment that is only under FDA’s jurisdiction may lead to, or are creating, insanitary conditions in the FSIS inspected areas of the establishment as described in 9 CFR 416.2, Establishment grounds and facilities, or in 9 CFR 590,
1. Inspection program personnel in meat and poultry establishments are to:

a. take the appropriate action with respect to FSIS regulated products as set forth in FSIS Directive 5000.1, Revision 1, Chapter I, Sanitation and Chapter IV, Enforcement , and
b. notify the District Office of the situation through supervisory channels.

See FSIS Directive 5730.1, www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/5730.1.pdf The Directive also makes clear that the agencies are supposed to communicate with each other when “foods produced in a DJE are implicated in outbreaks of foodborne illness,” but so far there has been no word yet whether such communication has taken place with regard to the Nestle Toll House cookie dough outbreak. It is also unclear what FDA policy is with regard to inter-agency communications related to an outbreak like this one.

In light of the foregoing, it is hard not to think of the story of the blind men and the elephant, with each inspecting only a part of the elephant, but none of them able to determine what it was they were inspecting, or reach any other conclusions. See “Blind Men and an Elephant, Wikipedia, en.wikipedia.org/wiki/Blind_Men_and_an_Elephant Because each blind man knew only part of the truth, none of them were able to come to agreement as to the whole truth, even after they compared notes.

In thinking about our current story, the one where cookie dough made by Nestle poisoned dozens, I can’t help but think of the FDA, USDA, and VDACS as three blind men inspecting an elephant. And perhaps the moral of our story is that it is long past time to have our food plants inspected by a single person, and one who is not blind.
 

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We have already heard from several families whose children have developed hemolytic uremic syndrome (HUS) after contracting E. coli O157:H7 from Nestle cookie dough.  Most often, though we certainly see cases where the pathalogic process described below affects other organs, HUS affects the kidneys.  Here is a short explanation of what HUS is, and why it is so lethal. 

The toxins that are released by E. coli O157:H7 bacteria (called shiga-toxins) are so potent, in fact lethal, that the Department of Homeland Security lists it as a potential bioterrorist agent. (Although E. coli O157:H7 are responsible for the majority of cases in America, there are many additional shiga-toxin producing E. coli that can cause HUS. 

The chain of events leading to HUS begins with ingestion of E. coli 0157: H7 bacteria in contaminated food. These E. coli rapidly multiply in the intestines causing colitis (diarrhea), and tightly bind to cells that line the large intestine. This snug attachment facilitates absorption of the toxin into the circulation where it becomes attached to weak receptors on white blood cells (WBC) thus allowing the toxin to “ride piggyback” to the kidneys, or other organs, where it is transferred to numerous avid (strong) Gb3 receptors that grasp and hold on to the toxin. Organ injury is primarily a function of Gb3 receptor location and density. Receptors are probably heterogeneously distributed in the major body organs, and this may explain why some patients develop injury in other organs (e.g., brain, pancreas).

Once shiga-toxin attaches to receptors, it moves into the cell’s cytoplasm where it shuts down the cells’ protein machinery resulting in cellular injury and/or death. This cellular injury activates blood platelets and the coagulation cascade which results in the formation of clots in the very small vessels of the kidney resulting in acute kidney injury and failure. The red blood cells are hemolyized (destroyed) by shiga-toxins and/or damaged as they attempt to pass through partially obstructed microvessels. Blood platelets (required for normal blood clotting), are trapped in the tiny blood clots or are damaged and destroyed by the spleen.
 

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Although not really a good defense in the arenas of law or common sense, I was struck by how quickly Nestle suggested that the consumers sickened by eating their contaminated cookie dough were themselves at fault for ignoring the recommendation on the label that the cookies be “bake before consuming.” What most struck me as most odd (and indefensible) about Nestle’s suggestion that the consumer was to blame, is how incongruous it is for Nestle to say that its product was too dangerous to be eaten raw when it manufactures its cookie dough with pasteurized eggs. Prior to this outbreak, few (if any) would have argued that the risk of eating raw cookie dough, to the extent that it was risky at all, came from anything other than the risk of Salmonella poisoning due to the presence of raw eggs. But Nestle had plainly chosen to eliminate that risk. And my guess is that they did so specifically because they knew (and encouraged) people to eat the cookie dough while it was raw, a guilty pleasure of lots and lots of people.

With this in mind I decided to look at some of the research on the consumption of raw cookie dough. Not surprising (to me), the perception of raw cookie dough as being unsafe is not only based primarily on the presence of raw eggs, and thus Salmonella, that is the SOLE basis for the perceived risk. Look at this question posed as part of a survey of school children that attempted to determine the knowledge of food safety risks:

TRUE or FALSE:
It is okay to eat raw cookie dough—(1) Anytime. The raw eggs will not hurt you. (2) Only if the cookie dough is store bought. (3) Only if the cookie dough is homemade. (4) Never. Raw cookie dough puts you at risk for Salmonellosis.

(See Richards 2008, below). Plainly, this question presupposes not only that Salmonella is the primary risk created by cookie dough, but that raw eggs solely creates the risk. Thus, no doubt, the food safety educators who did this survey would have been thrilled if the students vowed to only eat raw cookie dough so long as it was made with pasteurized eggs.

The other thing that is odd (and indefensible) about Nestle’s stated defense is that most people of relatively good health, who are not too young or old, and with a non-compromised immune system, eat raw cookie dough, even if made with unpasteurized eggs, and not face a significant risk of illness—certainly not a serious one. That is why, if you look at many of the studies that I have included in bibliography below, it will become quickly apparent that the food safety education that is being aimed at the elderly and immune-compromised is solely aimed at avoiding the risk of a Salmonella infection caused by exposure to raw eggs in cookie dough.  These citations also ably demonstrate that no one would have previously said that a person eating raw cookie dough faced a risk of being infected with a pathogen as deadly as E. coli O157:H7.  For Nestle  to suggest otherwise is like someone saying that you should wear a seatbelt when driving because meteor might crash into your car. 

Consequently, I think Nestle probably should restate its position, that is, if it wants to appear anything else but insensitive and oblivious. The presence of E. coli O157:H7 in raw cookie dough was never the risk that the recommendation of “bake before consuming” was intended to prevent. If Nestle had wanted to warn against that risk, the recommendation should have been: Danger: This Product May Kill You If Not Handled With Extraordinary Care.

Partial Bibliography for the Discussion Above:

Julie Albrecht, Food Safety Knowledge and Practices of Consumers in the U.S.A., Int’l Jnl. of Consumer Studies, 19(2), pp. 119-34 (2007) (documenting that a low percentage of people perceived eating cookie dough as a health risk, and that those that did perceive it as a risk did so because of presence of raw eggs in the dough).

Julie A. Albrecht & Alice Henneman, Handling Eggs Safely at Home, Nebraska Cooperative Extension Publication, NF91-33 (1991) (warning that “Eggs in cookie dough and cake batter are raw and dough and batter should not be eaten”)

Marcus Comer, Food Safety for Healthy Families: Evaluation of Program Effectiveness, 40(4) (Aug. 2002) (discussing a “heated debate” among students as to whether eating cake batter or cookie dough was dangerous, and finding that students “held to the belief that eating [it] would not make a person sick and stated that they would continue the practice”).

Cynthia Dols, et al., Preventing Food and Water-borne Illnesses, American Jnl. of Nursing, 101(6), 24AA-24KK (June 2001) (stating that the teaching of immune-compromised patients about food safety risks should include a warning that “during preparation, foods should not be tasted until they are thoroughly cooked (including raw cookie dough)” because of the presence of raw eggs).

Joye Gordon, et al., Risk Perception, Attitudes, Knowledge and Safe Food Handling Behavior Among Those 65 Years and Older, Proceedings of the 20th Annual Conference of Association for International Agricultural Extension Education, Ireland,(2004) 20, 724-734,

I. Hapala & C. Probart, Food Safety Knowledge, Perceptions, and Behaviors Among Middle School Students, Journal of Nutrition Education and Behavior, 36 (2), 71-76 (study finding that, among middle school students surveyed, only 46% reported not seldom eating food items containing raw eggs, with raw cookie dough being used as the example).

Katherine MacComas, Psychological Factors Influencing People’s Reactions to Risk Information, Joint Institute for Food Safety and Applied Nutrition, Food Safety Risk Analysis Clearinghouse, Presentation, (1999) (making point that “When deciding whether to eat raw cookie dough, an individual may choose between the pleasure of eating the dough versus the risks of contracting salmonella poisoning), at http://www.foodrisk.org/exclusives/RC_tutorials/

Jennifer Richards, et al., Validation of an Interdisciplinary Food Safety Curriculum Targeted at Middle School Students and Correlated to State Educational Standards, Jnl. of Food Science Education, 7(3), 54-61 (2008) (study that analyzed self-reported food behaviors of middle school students, including asking them if: “It is okay to eat raw cookie dough,” with the choices of answers being—anytime. The raw eggs will not hurt you; only if the cookie dough is store bought; only if the cookie dough is homemade; never. Raw cookie dough puts you at risk for salmonellosis.”).

Tionni Wennrich, et al., Food Safety Knowledge and Practices of Low Income Adults in Pennsylvania, Food Protection Trends, 23(4), 326, at 332 (2003) (documenting that the “foods prepared with raw eggs, such as raw cookie dough, were the most commonly eaten high-risk food by survey respondents”).

Mary Wilson, et al., Survey of Food Safety Behaviour in Nevada Child Caregivers, Int’l Jnl. of Food Safety, Nutrition and Public Health, 1(2), 116-26 (2008) (finding that people from two rural regions had a higher preference, by 11 and 16%, for eating raw cookie dough, compared to people from two other regions).

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The Washington State Department of Health has just released further details on the five confirmed Washington E. coli O157:H7 cases connected to the emerging nationwide Nestle cookie dough outbreak:

-- May 6, Grays Harbor County woman,

-- May 12, Thurston County teenage girl, hospitalized,

-- May 15, Pierce County girl,

-- May 20, King County boy,

-- May 21, King County girl, hospitalized.

Beyond the voluntary recall, the response from Nestle has thus far been little more than an apology for the "inconvenience" this outbreak has caused.  Click here for more details.

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According to local news channel Komo 4, the Washington State Department of Health announced this morning that five people in Washington state are believed to have been sickened by the E. coli O157:H7-contaminated Nestle cookie dough. Two of those sickened were hospitalized.

As a reminder, the products currently being recalled due to E. coli O157:H7-contamination include:

Cookie & brownie dough bar
- Chocolate Chip bar 16.5oz
- Chocolate Chip bar 16.5oz
- Chocolate Chunk bar 16.5oz
- Walnut Chocolate Chip bar 16.5oz
- Jumbo Chocolate Chip bar 16.5oz
- Oatmeal Raisin bar 16.5oz
- Sugar Cookies bar 16.5oz
- Sugar Cookies bar 16.5oz
- Mini Chocolate Chip bar 16.5oz
- Mini Chocolate Chip bar 16.5oz
- Mini Brownie Bites bar 16oz
- Fudgy Brownie With Peanut Butter Filling 19oz

Cookie Dough Tub
- Chocolate Chip tub 40oz
- Chocolate Chip tub 80oz (5 lb)
- Sugar tub 40oz.
- Gingerbread tub 40oz
- Peanut Butter tub 40oz

Tube Dough
- Chocolate Chip tube 16.5oz
- Chocolate Chip tube 32oz

Ultimates Cookie Bar Dough
- Ultimates Peanut Butter Cups, Chips & Chocolate
- Chunks bar 16oz
- Ultimates White Chip Macadamia Nut bar 16oz
- Ultimates Chocolate Chip & Chunks with Pecans bar 16oz
- Ultimates Chocolate Chip Lovers 16oz
- Ultimates Turtles bar 16oz
- Ultimates Peanut Butter Lovers bar 16oz
- Ultimates Chocolate Chip with Caramel Filling bar 16oz
- Ultimates Chocolate Chip with Chocolate Filling bar 16oz

Seasonal Cookie & Brownie Dough
- Valentine Hearts Sugar Cookie Shapes 15.5oz
- Valentine Swirled Chocolate Chip bar 16oz
- Fudgy Brownies With Raspberry Filling 19oz
- Easter Eggs Sugar Cookie Shapes 15.5oz
- Easter Swirled Chocolate Chip bar 16oz
- Easter Swirled Mini Brownie Bites bar 18 oz
- Red, White & Blue Swirled Choc Chip bar 16oz
- Halloween Pumpkin Pals Sugar Cookies 13.5oz
- Halloween Swirled Chocolate Chip bar 16oz
- Halloween Swirled Fudgy Brownies bar 18oz
- Christmas Shapes Sugar Cookies 15.5oz
- Christmas Swirled Chocolate Chip bar 16oz
- Christmas Swirled Fudgy Brownies bar 18oz
- Limited Edition Mint Swirled Chocolate Chip 16oz

Discounted Varieties
- Valentine Hearts Sugar Cookies 13.5oz
- Easter Brownie Bar 18oz
- Easter Bunnies Sugar Cookies 13.5oz
- Halloween Sugar Shapes 15.5oz
- Christmas Sugar Cookie Tube 16oz
- Oatmeal Cranberry Cookie Tub 48 oz.

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 Today's recall of Nestle cookie dough got me thinking about other E. coli O157:H7 cases that we've recently handled.  John McDonald was a 5-year-old boy who we represented in a ground beef outbreak that occurred in 2007.  Unfortunately, John's illness was about as bad as an illness can get without causing a death.  (it is unbelievable how many times I find myself saying that about our clients) 

John was hospitalized at East Tennessee Children's Hospital from October 4 through 12, then was transferred to the University of Tennessee Medical Center where he remained until October 29.  During his hospitalization, John's kidneys failed requiring extensive dialysis to cleanse his blood, and he became badly anemic requiring many blood transfusions.

But these conditions, though in and of themselves potentially lethal, were just the beginning.  What truly separates John's illness from most of the hemolytic uremic syndrome illnesses that we see was the extent of injury to his gastrointestinal tract. 

Jim McDonald, John's father, was present at the moment it became apparent just how severe John's illness was.  It occurred in the early morning hours of Thursday, October 11, 2007.  He recalls: 

As usual, I got up to help as much as possible when the nurses came in and woke us up. When we opened his diaper, I got excited since it looked like he had had dark brown diarrhea, which told me that his digestive system was finally starting to kick in again. Realizing how liquidy the diaper was, we turned on an extra light to help us while changing him.

I will never forget what I saw. To my dismay, the diaper was not full of a bowel movement like I had desperately hoped. It was full of blood. An entire bowel movement of blood. Maybe an entire cup of blood. I got light-headed and almost passed out. I immediately sat down and grasped my head, apologizing to the nurses and telling them that I could no longer help them treat my son. This was the first of five grossly bloody stools that day.

Now bloody diarrhea is typical in the setting of an E. coli O157:H7 illness.  But this was another animal altogether.  John was losing blood from his gastrointestinal tract like he was bleeding from an opened artery.  In fact, over the course of the day on October 11, John was given two transfusions of packed red blood cells to address the significant blood loss he had suffered.  John was transferred to The University of Tennessee Medical Center the next day, where he endured, hopefully, the fight of his life. 

After transfer to UT, it became apparent that John was suffering from an infection somewhere in his body.  Coupled with the fact that he was bleeding heavily from his rectum and was constantly complaining of severe abdominal pain, doctors began to suspect that the infection was in his abdomen.  Heavy duty antibiotics were administered, but with no effect.  John continued for several days to exhibit signs of severe infection. 

The afternoon of October 16, 2007, doctors began to suspect that John had suffered a perforation (e.g. a puncture) somewhere in his gastrointestinal tract.  Besides the immense pain, the concern was that the contents of John's gastrointestinal tract, including the shiga-toxin producing E. coli O157:H7 bacteria, would escape and cause severe, potentially lethal infection elsewhere in his body. 

At around 8:00 PM on October 16, John was rushed to the Operating Room for an emergency exploratory laparotomy—i.e., an incision through the abdominal wall to gain access to the abdominal cavity. What the pediatric surgeon found inside was a mess of fecal material and grossly swollen bowel loops. The surgeon also found a portion of John’s rectum to be necrotic (i.e. diseased and dead) and there he located the perforation through the rectal wall that had allowed the contents of John’s bowel to spill into his abdomen, thus causing the severe infection in his peritoneal cavity.  

Ultimately, the surgeon decided that the necrotic and damaged portions of John’s colon and rectum stood no chance of recovery or survival, and so he removed about five inches of John's colon and rectum. After cutting and removing the damaged tissues, the surgeon washed John’s peritoneum copiously with normal saline. He then took a portion of John's colon outside of the peritoneal cavity and formed a pouch out of John's own tissue.  This pouch was then connected a colostomy bag to drain feces from John's abdominal cavity. 

It goes without saying that John's illness was severe.  After his surgery to remove part of his colon, John had to be sedated and kept on mechanical ventilation for many days.  He was hardly able to walk at discharge on October 29, 2007.  About John's discharge, his father recalls:

October 29, 2007: John got to come home today. He came home to a new house. He still couldn’t walk, but was trying to very hard. It was difficult for him (like Michaela) to rebuild his strength in his atrophied and skinny legs. We carried him when he couldn’t crawl. Nonetheless, everybody, including John, was thrilled that he was home. There were many tears of joy shed by all.
 

John's recovery is still ongoing.  He has done well since discharge, and has proved to be an extremely tough little customer.  We were honored to represent him and his family (by the way, his younger sister Michaela had HUS too), and have truly been inspired by his story. 

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Valley Meats LLC recently recalled nearly 96,000 pounds of ground beef due to potential contamination by E. coli O157:H7.  Now, SP Provisions of Portland, Oregon has recalled almost 40,000 pounds of ground beef due to positive sampling of its ground beef during production.   Hamburger E. coli season appears to be getting underway.

John McDonald was a victim of E. coli O157:H7 in hamburger almost two years ago now.  We represented John and his family in a ground beef outbreak that occurred in 2007.  The following summary tells you a bit about John's very sad case.

John was hospitalized at East Tennessee Children's Hospital from October 4 through 12, then was transferred to the University of Tennessee Medical Center where he remained until October 29.  During his hospitalization, John's kidneys failed requiring extensive dialysis to cleanse his blood, and he became badly anemic requiring many blood transfusions.

But these conditions, though in and of themselves potentially lethal, were just the beginning.  What truly separates John's illness from most of the hemolytic uremic syndrome illnesses that we see was the extent of injury to his gastrointestinal tract. 

Jim McDonald, John's father, was present at the moment it became apparent just how severe John's illness was.  It occurred in the early morning hours of Thursday, October 11, 2007.  He recalls: 

As usual, I got up to help as much as possible when the nurses came in and woke us up. When we opened his diaper, I got excited since it looked like he had had dark brown diarrhea, which told me that his digestive system was finally starting to kick in again. Realizing how liquidy the diaper was, we turned on an extra light to help us while changing him.

I will never forget what I saw. To my dismay, the diaper was not full of a bowel movement like I had desperately hoped. It was full of blood. An entire bowel movement of blood. Maybe an entire cup of blood. I got light-headed and almost passed out. I immediately sat down and grasped my head, apologizing to the nurses and telling them that I could no longer help them treat my son. This was the first of five grossly bloody stools that day.

Now bloody diarrhea is typical in the setting of an E. coli O157:H7 illness.  But this was another animal altogether.  John was losing blood from his gastrointestinal tract like he was bleeding from an opened artery.  In fact, over the course of the day on October 11, John was given two transfusions of packed red blood cells to address the significant blood loss he had suffered.  John was transferred to The University of Tennessee Medical Center the next day, where he endured, hopefully, the fight of his life. 

After transfer to UT, it became apparent that John was suffering from an infection somewhere in his body.  Coupled with the fact that he was bleeding heavily from his rectum and was constantly complaining of severe abdominal pain, doctors began to suspect that the infection was in his abdomen.  Heavy duty antibiotics were administered, but with no effect.  John continued for several days to exhibit signs of severe infection. 

The afternoon of October 16, 2007, doctors began to suspect that John had suffered a perforation (e.g. a puncture) somewhere in his gastrointestinal tract.  Besides the immense pain, the concern was that the contents of John's gastrointestinal tract, including the shiga-toxin producing E. coli O157:H7 bacteria, would escape and cause severe, potentially lethal infection elsewhere in his body. 

At around 8:00 PM on October 16, John was rushed to the Operating Room for an emergency exploratory laparotomy—i.e., an incision through the abdominal wall to gain access to the abdominal cavity. What the pediatric surgeon found inside was a mess of fecal material and grossly swollen bowel loops. The surgeon also found a portion of John’s rectum to be necrotic (i.e. diseased and dead) and there he located the perforation through the rectal wall that had allowed the contents of John’s bowel to spill into his abdomen, thus causing the severe infection in his peritoneal cavity.  

Ultimately, the surgeon decided that the necrotic and damaged portions of John’s colon and rectum stood no chance of recovery or survival, and so he removed about five inches of John's colon and rectum. After cutting and removing the damaged tissues, the surgeon washed John’s peritoneum copiously with normal saline. He then took a portion of John's colon outside of the peritoneal cavity and formed a pouch out of John's own tissue.  This pouch was then connected a colostomy bag to drain feces from John's abdominal cavity. 

It goes without saying that John's illness was severe.  After his surgery to remove part of his colon, John had to be sedated and kept on mechanical ventilation for many days.  He was hardly able to walk at discharge on October 29, 2007.  About John's discharge, his father recalls:

October 29, 2007: John got to come home today. He came home to a new house. He still couldn’t walk, but was trying to very hard. It was difficult for him (like Michaela) to rebuild his strength in his atrophied and skinny legs. We carried him when he couldn’t crawl. Nonetheless, everybody, including John, was thrilled that he was home. There were many tears of joy shed by all.
 

John's recovery is still ongoing.  He has done well since discharge, and has proved to be an extremely tough little customer.  We were honored to represent him and his family (by the way, his younger sister Michaela had HUS too), and have truly been inspired by his story.

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As I noted in an earlier post on a different blog about the USDA’s decision to, in a matter of speaking, take its head out of the sand and recognize that E. coli O157:H7 is a problem that starts (and someday will hopefully end) with the slaughter and dressing process, the agency is finally appearing to take a more reality-based (which is to say, less industry-biased) approach to ensuring food safety.  For the earlier post, see here:www.foodpoisonblog.com/2009/05/food-policy-regulation/usda-sees-the-light-on-e-coli-o157h7-and-meat/#comments

Specifically, the only way that meat gets contaminated is because insufficient care was taken during slaughter and feces or ingesta cross-contaminates the previously uncontaminated carcass. Knowledge that this cross-contamination is commonplace is what has given rise over the years to post-slaughter “interventions” like steam-pasteurization and organic acid washes. Put bluntly, there is no need to try to remove the poop on the meat if it does not end up there in the first place.

Since the Pathogen Reduction; HACCP Final Rule was issued in 1996, it has been the stated policy of the USDA that E. coli O157:H7 be reduced to an "undetectable level." This is the so-called zero-tolerance policy for this deadly pathogen, which is based on the irrefutable fact that if the “presence [of E. coli O157:H7] can be prevented, no amount of temperature abuse, mishandling, or undercooking can lead to foodborne illness.” See HACCP Final Rule, 62 Fed. Reg. at 38,962. Now, seemingly more intent at make zero-tolerance a reality, USDA yesterday issued notice that it was mandating an increase in the frequency of its in-plant testing for E. coli O157:H7 in raw ground beef. While this is an improvement, it is but a baby step, since the most frequent testing that will occur under this policy is 4 times per month, and this is only at plants that produce volumes of ground beef greater than 250,000 pounds PER DAY.

For more on this change in policy, please click on CONTINUE READING.
 

As the agency noted in FSIS Directive 6410.1, "it considers an acceptable reduction of E. coli O157:H7 to be a reduction to an undetectable level." It thus announced that it was going to start increasingly demand that plants reassess their Slaughter HACCP plans when a sample tests confirmed-positive for E. coli O157:H7. This policy change is now being buttressed by an increase in the frequency of the testing that the USDA performs in each plant producing ground beef, with such frequency determined by each plant’s daily production amount. While this is certainly improvement, the increased testing is in large part symbolic, as the USDA has come close to admitting when it defended the chosen frequency by stating:

The number of samples that you would need to collect to have some statistical confidence that if it was contaminated you would find it is in the hundreds," he said. "I mean, it is a lot of samples that need to be collected. At $20 to $100 a sample, you have to make some decisions as to what you can afford.

For the full article from which this quote was taken, see: abcnews.go.com/Health/Wellness/story
 

Although I applaud any increase in testing, it seems to me that the American public deserves a testing-frequency that achieves statistical significance. Furthermore, it is time for the USDA to implement a meaningful testing program at retail, and stop using the American public as guinea pigs to determine how much E. coli O157:H7 is not eliminated in the plant.

The one final step that the FSIS needs to take to make this new and much improved approach really work is to eliminate, once and for all, the absurd fiction that a presumptive positive is not a "real" positive test result. Confirmatory testing should be required of all presumptive positive test results. Or, in the alternative, if the plant objects to the expense of doing confirmatory testing, then the presumptive results should be presumed to be confirmed positives for purposes of prompting further corrective actions and enforcement efforts.

It is time for the FSIS to enfore a true zero-tolerance for E.coli O157:H7; and with this new Directive, the agency has taken a great step in the right direction.

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The spinach E. coli outbreak in September 2006 was perhaps the most devastating outbreak of foodborne disease since the Jack in the Box E. coli outbreak in 1993.  Over two hundred people suffered confirmed illnesses in the spinach outbreak, with 102 hospitalizations, and at least four deaths.  We represented over 100 victims, including nearly 30 who suffered kidney failure and hemolytic uremic syndrome  (HUS).  The outbreak caused spinach, and produce companies generally, to lose hundreds of millions of dollars.  But this is all just numbers and words, things that are no closer, or more real, to most of the 300 million Americans than a successful missile launch by North Korea or Iran.  It happens, and its a little scary, but do we do anything different in our daily lives because of it?  

Tiffany and Russ Erickson were just like most Americans until September 2006.  Their four-year-old son Regan (pronounced "Ree-gun") was one of many young kids whose future was unalterably and forever changed by spinach.  What appears below is Regan's story.  It is a little long, but that must be forgiven.  Regan's illness very nearly cost him his life.

ONSET OF ILLNESS:

Regan's mother, Tiffany, and his sister, Emma, were both sickened during the Spinach outbreak as well.  Tiffany actually fell ill first, on August 28. It felt like cruel timing, given that it was only three days before Emma’s birthday and little more than a week since discovering that she was pregnant with her third child, Maggie, but Tiffany took everything in stride. She had no reason to suspect that she was dealing with anything more than a run-of-the-mill flu, and her primary concern was with the health of her unborn child.

After twenty-four hours or so, however, thoughts began to change about the nature of Tiffany’s illness. Her bouts of diarrhea had grown more frequent and severe, and her abdomen was beset by cramps more severe than labor pains. Then, the evening of August 29, after a particularly painful bout of diarrhea, Tiffany noticed that the toilet bowl was streaked with blood. Up until this point, Tiffany had endured everything with resolute confidence, but this symptom suggested something that she had never before reckoned with.

Tiffany soon underwent a diagnostic procedure called an endoscopy to shed light on what was wrong.  Of his wife’s illness, before his thoughts turned to Regan alone, Russ recalls:

We left the urgent care facility and gave the drugs some time to work, but the pain continued to be unbearable. As my concern shifted from the baby to Tiffany I couldn’t stand seeing her in that much pain, tired from lack of sleep, and not able to get comfortable.

Meanwhile, Regan had begun to develop symptoms, and Emma soon would. “We didn’t realize that the illnesses could be related,” Russ recalls, “since Regan couldn’t express his pain as well as Tiffany. He just knew his ‘tummy’ hurt and he began having diarrhea.” Emma’s symptoms began the very next day, September 1.

Russ recalls:

Everyone in the family was sick, tired, and the children being so young, not knowing how to tell or deal with the symptoms like diarrhea, I was continually cleaning, comforting, and helping where I could, all without Tiffany’s help who is usually the stalwart caregiver. We knew that we had some kind of ‘bug’ but not how severe yet. It presented a lot like flu symptoms, but we began to know it was more serious as the kids, just as Tiffany, began to have blood in their stool, and then blood instead of stool. That is a scary, unnerving experience to see blood when your 3 and 4 year olds are using the bathroom.

Compared to four year-old Regan, the illnesses that Tiffany and Emma Erickson suffered were nothing more than a small current in a raging sea. Nevertheless, to hear Russ describe what his wife and daughter endured is to fully comprehend the aggressive nature of this virulent pathogen. Emma endured many days of an illness more acutely painful than anything her parents had ever seen. But as sick as she was, her older brother was fast-becoming critically ill, and her parents thoughts and attention soon went solely and exclusively to Regan.

REGAN'S ILLNESS:

During an appointment with his pediatrician on September 4, Tiffany reported that Regan had had twenty bouts of bloody diarrhea that day, prompting endless complaints of a sore stomach. Regan been unable to eat or drink for days, and had developed redness and inflammation in the rectal area due to the frequency and severity of the diarrhea. These seemingly benign signs were immediately concerning to the pediatrician, who immediately sent Regan and his parents to Mckay Dee Hospital's emergency department.  Tiffany and Russ rushed to the ER and carried their son in, having no concept of the road that lay ahead.
 

Regan remained hospitalized at Mckay Dee for the next two days.  Gradually, blood tests showed that he was becoming anemic and losing platelets, and he was also not urinating normally.  Soon, stool tests showed exactly why.  Regan had been infected by E. coli O157:H7, and he was developing HUS.  Doctors at Mckay Dee knew that Regan was critically ill, and they transferred him by Ambulance to Primary Children's Medical Center (PCMC) in Salt Lake City on September 6.

Meanwhile, Tiffany and Russ had begun the painful process of contacting friends and relatives. Russ’s mother dropped everything and, leaving at 4:00 AM, drove to Salt Lake City from Las Vegas. She recalls:

I arrived at Primary Children’s just after the ambulance arrived. They had just gotten Regan in his room. It was a flurry of activity, doctors and nurses in and out of the room. I was taken aback by his appearance. The last time I had seen him was on the 4th of July. He was playing with all his cousins, excited with all the fireworks, eating bar-b-que, and being a normal kid. Today he was pretty much unresponsive; he didn’t even know I was there. So pale and vulnerable, it broke my heart to see him in that condition. I was also taken aback by the appearance of Russell and Tiffany. It was obvious that Tiffany was still not well. She looked pale and tired. As if she was just barely making sense of the whole bizarre turn of events. Russell looked like he hadn’t slept in days . . . come to find out he hadn’t. He had been holding his little family together for over a week now. The only one of them not affected, the burden of care had been fully placed upon his shoulders. And they sagged at the weight of it all. He was tired; with worry in his eyes, fear in his voice and faith in his heart he told me that they were in the best hospital, with the best doctors and that Regan would be okay.

Regan had a difficult night his first night at PCMC. He had run a fever consistently; he had been nauseated despite Zofran; and he had vomited and suffered from painful abdominal distention all night long. Perhaps more significantly, he had had little to no urinary output all night, his face was swollen, and there were signs that his pancreas had already been affected, in addition to his kidneys, by the shiga-toxins released by the E. coli O157:H7 bacteria in his gastrointestinal tract.  Regan's nephrologist planned to begin dialysis immediately if the Lasix, a diuretic, did not stimulate more urine production. 

Tiffany placed a call to her mother, Tonya Peterson, the afternoon of September 7. Tonya remembers:

Tiffany told me that his pancreas and kidneys had shut down. I couldn’t believe it. I sat at work at my desk, crying for several hours, unable to concentrate on my work. I thought that Regan might not make it. I called my dad and asked him to take me to see Regan. I knew I wouldn’t be able to drive to the hospital in my condition. I was too distraught at the thought of losing Regan. He was such a sweet, innocent little boy. He called me “Ma-mah,” his version of “grandma.”

Regan continued his descent toward total kidney failure that night. He had stopped producing urine completely, and his nephrologist ordered that Regan be prepped for peritoneal dialysis. Accordingly, Regan was transported to the operating room on Friday morning, September 8, where doctors placed a spiral peritoneal catheter for dialysis. He also placed a PICC (peripherally inserted central catheter) line in Regan’s right arm to facilitate infusion of blood products, medicine, and IV nutrition.  Then dialysis began.

September 9-13

Regan ran a fever all night on September 8 and vomited five times. He produced no urine and continued to suffer bouts of bloody diarrhea, producing 76 ml of mostly blood before 11:00 AM on September 9. Attendants administered morphine to ease the little boy’s immense discomfort. And because he continued to suffer from nausea and vomiting, doctors began Regan on total parenteral nutrition. Dialysis continued with hourly exchanges.

Over the next two days, Regan remained critically ill. He continued to have no renal function, and his hematocrit continued to drop, which indicated progressive anemia. In addition, Regan had consistently elevated blood pressure readings and was overloaded, in fact bloated, from fluid retention because he was unable to urinate. 

Russ recently recalled his sense of devastation and total helplessness during this time:

Together with the surgeries, dialysis, and transfusions was a lot of heartache and a lot of pain. As I watched Regan suffering, I felt helpless. He wasn’t comforted by me and there wasn’t anything I could do to fix the situation. I could just watch, wait, and hope that he would pull through this illness.
***
I also had Emma and Tiffany to worry about. Emma was still having trouble adjusting to what was going on, and she was still regaining strength from her own illness. She couldn’t understand why Regan had to stay at the hospital and have tubes coming out of him all over the place when she had been sick and gotten better without any of that. Tiffany was still recovering, ragged from stress, and she was in a difficult first trimester with all the ailments that come along with that. I was very worried about what I could do to help my family, and it didn’t feel like much.

Regan’s hematocrit continued to drop on September 12, indicating progressing anemia. Doctors ordered that a transfusion of leukocyte filtered packed red blood cells be administered as soon as possible. Regan’s bloody diarrhea continued, but seemed to be improving, and his WBC count dropped as well. Nonetheless, Regan continued to be anuric, leaving his nephrologists little choice but to continue peritoneal dialysis.

September 14-16

By Thursday, September 14, Regan’s medical picture continued to be dire. He continued to be medicated for nausea, hypertension, fevers, to stimulate red blood cell production, and he continued to receive a bronchodilator. He also remained positive, by stool culture, for E. coli O157:H7, and consequently remained under strict quarantine.

Russ’s mother stayed at the hospital, alternating with Tiffany and Russ, at least one of whom was always at Regan’s bedside. She says of Regan’s first week:

The chair made into a bed of sorts and the nurses brought me blankets and pillows. We realized very quickly that the hour drive to PCMC every day was not only costly for the kids but most inconvenient. One of Russell’s cousins lived in the area of the hospital and invited Russell and Tiffany to stay at their house. The Ronald McDonald House had a distance rule that they missed qualification for by just 7 miles. They decided that as long as I could stay with Regan at night, they would go home to sleep in their own bed and then when I had to leave they would go to Russell’s cousin’s house and take turns staying at the hospital at night with their boy.

Throughout the week Regan was so sick that I still wondered if he even knew who I was. He progressed somewhat with the dialysis and his lab tests improved at a snail’s pace. Toward the end of the week they declared him E. coli free and he was allowed to ride in the little red wagon and get out of that tiny room for a minute. Up until that time not only was he confined to the room but his sister, Emma, wasn’t allowed in the play room and his family had strong precautions they were to take to insure that the E. coli would stay contained.

Regan remained very irritable and uncommunicative on Saturday, September 16, prompting an examining physician to describe him as an irritable young lad who had pulled the blanket over his head and his knees up to his abdomen during the examination attempt. Nevertheless, no new symptoms had arisen, and Regan’s hemolytic anemia and thrombocytopenia had begun to improve. Peritoneal dialysis, however, continued just as before.

September 18-23

By September 18, Regan had begun to pass a small amount of urine, and his stools had firmed up. He nevertheless remained extremely irritable and very uncooperative, evidently suffering significant discomfort from his ongoing symptoms. He had begun to moan during the drainage cycle of his ongoing peritoneal dialysis, which had been further reduced to twelve hours per day. But despite the encouraging sign of modest urine production, Regan’s kidney labs had not improved; BUN and creatinine levels remained very high at 62 and 6.1.

Over the next several days, Regan’s kidney lab values continued to fluctuate, so doctors ordered an increase to seventeen hours per day on September 20 due to an unexpected increase in creatinine to 6.7. And on September 22, in fact, Regan again could muster no urine at all. He was anemic and symptomatic with weakness, fatigue, and shortness of breath—all of which convinced his medical team that another transfusion was in order. Dialysis continued as well.

Dr. Sherbotie evaluated Regan the morning of September 23, noting that Regan’s appetite was “clearly” improving with only occasional vomiting. Regan was also able to produce a “substantial amount” of urine that morning. Nevertheless, his lab values indicated ongoing renal dysfunction, and peritoneal dialysis continued with a decrease in the number of hours.

September 25-26

Regan's nephrologist noted significant improvements during his initial assessment on September 26. Generally speaking, Regan appeared well and “was quiet but interactive.” He had lost weight—significant to the clinical picture because it suggested a reduction in fluid retention—and he continued to produce more urine.  Nevertheless, he remained on dialysis.

September 27-28

On Wednesday, Regan’s urinary output continued to increase. He produced 641 ml (3 ml/kg/hr) with 550 ml intake. His appetite also continued to improve and, though still cranky, he was more playful than he had been previously. Additionally, his hematocrit, WBC, platelets, sodium, potassium, and glucose were all within normal range, and his BUN and creatinine were trending down with values of 56 and 5.4. With this positive news, Regan’s nephrology team ordered that peritoneal dialysis be stopped for the first time since September 8.

The order to stop dialysis did not, however, mean that the dialysis catheter could be removed. Labs on September 28 indicated another increase in BUN and creatinine, to 60 and 5.9, which values had remained elevated since dialysis was discontinued the day before. Regan’s blood pressure was stable but high at 118-122 over 70-90. Accordingly, Amlodipine continued for Regan’s hypertension.

September 29

On Friday morning, Regan was doing well overall. He continued to be anxious, but seemed to be less cranky, and he was able to eat and drink more and had further increase in urinary output. His facial edema had also improved, but Regan was considered to be generally mildly edematous. He also continued to have elevated but stable blood pressures.

Later in the day, Regan again went to the operating room—this time, however, to have his dialysis catheter removed. Tiffany recalls:

This was a surgery that wasn’t quite as scary to send him in to. He’s laughing because the anesthesiologist put some type of goofy medicine in his PICC line that just made him into a hoot and a half. I was still quite nervous but it felt better to send a laughing child into surgery than a sickly one.

September 30—Discharge from PCMC

On Saturday, September 30, 2006, after four weeks in the hospital and countless dialysis treatments, Regan Erickson was discharged home.  His discharge diagnoses included HUS; pancreatitis; acute renal failure requiring peritoneal dialysis from September 8 to 26; placement of PICC on September 8 and removal on September 26; placement of peritoneal dialysis catheter on September 8 and removal on September 29; anemia requiring blood transfusions and ongoing Darbopoetin infusion; emesis requiring Prevacid and Erythromycin Ethylsuccinate (anti-infective); hyperphosphatemia requiring calcium carbonate with meals and phosphate restriction; hypocalcemia status post calcium supplements between meals and IV Calcium chloride x 2; and reactive airway disease.

REGAN'S PRESENT CONDITION AND PROGNOSIS:

Sadly, a child's HUS illness doesn't really end when he is discharged from the hospital.  Regan is a perfect example of this.  He remained on blood pressure medications after discharge, and he continued to suffer physical and emotional problems related to his prolapsed rectum and the trauma of going through an illness as severe as his was.  

Tiffany recalls:

A couple of months after Regan's hospitalization, we made a decision, which hindsight tells us was a bad one, to go to Las Vegas with my husband for a conference he had. His parents live there so we thought it would be a nice cheap vacation. We drove down. The morning after we arrived Regan's prolapse came back out but this time we couldn't get it back in the entire day. I had been speaking over the phone to a pediatrician throughout the day. By the time the prolapse had been out for 12 hours we were advised to take him to the ER in Las Vegas. He was hospitalized.

When we got home I took Regan to a local surgeon and then to a pediatric GI doctor. We decided to allow Regan to use a pullup and stay off the toilet for several months. Regan had a hard time with the toilet because it really scared him when the prolapse would appear. We bought a box of rubber gloves and made sure we had plenty packets of lubricating gel.

Regan is one of many people, mostly children, sickened in the Spinach outbreak whose lives have permanently changed as a result of their illnesses.  He is forecast by several of the country's leading pediatric nephrologists to require multiple kidney transplants due to the severity of the kidney injury that he suffered in the Spinach outbreak.  Lifetime medical costs will run into the millions of dollars.

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Bill Marler and the other attorneys at Marler Clark have been litigating E. coli O157:H7 cases for sixteen years.  I have done it now for six.  Collectively, we have seen E. coli illnesses ranging from a few days of diarrhea to some of the most agonizing deaths imaginable . . . and everything in between.  It doesn't matter how it happens--at least not to the parents of the kids getting sick.  Whether its lettuce, hamburgers, stagnant pond water, or contaminated venison, the results can be tragic.

Many of the saddest cases we have been involved came from California produce.  Ruby Trautz is a perfect example.  She was a beloved mother and grandmother who lived in Bellevue, Nebraska.  Ruby died a death more befitting of a capital murderer . . . and only because she ate contaminated spinach.  Read more about Ruby's E. coli O157:H7 illness here.

Kelly Cobb is yet another example.  Kelly was also infected by California produce, though her illness arose from a different outbreak than Ruby Trautz.  Kelly was more fortunate than Ruby, but only because her younger body was more capable of fighting the severe infection than Ruby's was. 

Nonetheless, Kelly's E. coli O157:H7 infection also resulted in hemolytic uremic syndrome.  See www.about-hus.com.  Here is the story of Kelly's illness:

In the early morning hours of May 16, 2008, Kelly was roused from sleep, at first by a strange bloated feeling and then a bad bout of diarrhea. It seemed as if there was a rock under her rib cage causing an overwhelming feeling of nausea, yet she did not vomit. This was followed by crampy pain in the upper part of her stomach, with sharper spasms of pain coursing through her torso every ten minutes or so. With the pain came diarrhea, which by 5:00 AM had turned to blood.

Kelly was seen in the emergency room of Good Samaritan Hospital in Tacoma, Washington from 6:00 AM until 11:00 AM. She described to the doctors the surprisingly severe, sudden onset of the nausea, abdominal cramping and bloody diarrhea. The history taken by the triage nurse revealed nothing out of the ordinary: Kelly had been in good health, she was not pregnant, her children had not been sick.

But blood tests showed an elevated number of white blood cells, the sign of a bacterial infection. The presence of gallstones was picked up by an abdominal ultrasound, yet there was no evidence that Kelly had cholecystitis, an active gallbladder attack. A watery stool was guaiac positive—in other words, there was blood in it. This was sent to be cultured and also for Clostridium difficile toxin-testing. Kelly was initially given intravenous fluids and pain medication, then sent home with prescriptions for the antibiotic Ciproflaxin, as well as oral pain and anti-nausea medications. She was told to see her primary care physician in a day or two, or return to the emergency room if other problems arose.

Other problems did crop up, almost immediately. Kelly could not drink or eat anything, including her prescribed medications, without vomiting. The diarrhea was unrelenting, and the watery rectal discharge was mostly bright red with blood. She was also suffering from intense pain. Kelly returned to the Good Samaritan Hospital emergency room on May 17, and this time she was admitted to the hospital for treatment. She was severely dehydrated, with depressed levels of serum electrolytes, blood urea nitrogen and creatinine. She was started on IV fluids and given something for the pain.

A colonoscopy performed on May 18 showed pancolitis, a form of severe, ulcerative colitis that is manifested by an irritation throughout the length of the colon and that typically is the result of an infection. The pathologist suspected that the source was likely E. coli O157:H7, but could not rule out the possibility of ulcerative colitis. Bowel tissue biopsies showed inflammatory pseudomembranes. These findings were nonspecific, so still did not explain the cause of the problem.

On May 19, the doctor noted that Kelly’s abdominal pain was relatively better, and that she no longer felt nauseated and was not vomiting. Her pancolitis was improving and there was no blood in her stool. The plan was to take her off intravenous medications, switch her to oral treatments and then let her go home.

On the morning of May 20, the mystery of Kelly’s symptoms was solved. A stool sample collected on May 16 had grown out E. coli O157:H7 bacteria. The Ciproflaxin was discontinued. Kelly still rated her abdominal pain as a seven on a scale of one to ten, and she was nauseated again. But doctors were encouraged that she could finally keep down food and water and that there had been no bouts of bloody diarrhea overnight, so they discharged her to go home around midday.

The following day, May 21, Kelly’s symptoms returned worse than ever. She had awakened overnight feeling quite ill and began to vomit again repeatedly. She was absolutely unable to keep any fluids down. Her family took her back to the hospital on May 22 after she had been up the whole night with awful nausea and vomiting.

Laboratory tests now indicated that she was anemic. Since her discharge May 20, her hematocrit and platelet counts had decreased significantly, while her BUN and creatinine levels had increased since her recent discharge. These were ominous signs that Kelly’s kidneys were beginning to lose filter function and that she appeared to be developing hemolytic uremic syndrome (HUS), the dire complication of an E. coli O157:H7 infection. Kelly was told her kidney function was at 50 percent of normal.

Kelly was once again admitted to the hospital, where a catheter was inserted so she could receive intravenous fluids and for blood draws. She was tired and miserable. Whenever she opened her eyes she felt dizzy and sick to her stomach.

By May 23, the doctors agreed that plasmapheresis, or plasma exchange, would be necessary as soon as possible to remove waste products from the blood that were accumulating as Kelly’s kidney function diminished. Plasmapheresis involves withdrawing whole blood from the patient, removing the plasma from the blood cells through a cell separator, and then returning the blood cells to the patient while replacing the plasma with donor plasma.

Over the next eight days, Kelly would undergo eight total plasmapheresis sessions, receiving 81 units of fresh, frozen plasma through these procedures. In addition, four units of packed red blood cells were administered to Kelly between May 23 and May 27. Her hemoglobin, hematocrit and platelet counts bottomed out from May 24 to 26, but then began to slowly respond to the treatment. On May 25, her BUN and creatinine levels peaked and then began to decline as her kidney function improved. To help rebuild red blood cells, she was given ongoing folate, iron and B12 replacements. Kelly recalls that throughout the two weeks in the hospital, she endured more than 50 blood draws, two ultrasound examinations, a CAT scan, a colonoscopy, seven IVs and had a central line inserted in her neck.

On May 23, when Kelly first learned that she would need phasmapheresis treatments, she began to question whether she would survive. She recalls thinking that she needed to talk to her mom to let her know what she wanted for her kids if she died.

I remember getting my meds before my plasma exchange and having such a bad reaction that I had intense chest pain and blacking out. At that point I remember holding my husband’s grandmother’s hand and thinking that’s how I was going to die, in that hospital bed and wasn’t able to say goodbye to my husband and kids. Thinking that my kids would grow up without me, with that thought I made myself open my eyes and listen to what the nurses were saying to me.

All of these procedures were done while Kelly was enduring intense, debilitating pain that continued despite ongoing pain medication. But the physical pain does not begin to describe her emotional trauma. Already worried about her husband and father being in harm’s way in the Middle East, Kelly now had to inform them that she, too, faced a potentially life-threatening ordeal. The message to her husband had to be sent via the Red Cross; her father was told during one of his phone calls home. Kelly was terrified that Matt’s concern for her might distract him to the point where he or one of his men could be hurt.

Prior to her hospitalization for her E. coli O157:H7 infection, Kelly had been away from Liberty only once before, and then only briefly—for two nights when her son Matthew was born. Matthew had never before been separated from his mother. The children stayed with Kelly’s mother, who had to wake at 4:00 AM every day, an hour and one half before her regular routine, so that she could take Liberty and Matthew to their other grandmother’s home. After work each day, Kelly’s mother picked up the children and brought them to the hospital to see Kelly.

Kelly recalls that was the best part of her day—seeing her babies—although saying good-bye to them each night was beyond heart-breaking. Liberty asked every day when Kelly would come home to take care of her. Matthew cried inconsolably every night as his grandmother pulled him away from Kelly to go home. Kelly worried constantly that she was putting too much of a burden on her mother and mother-in-law. Always at the back of her mind was the dreaded thought that she was not going to make it and that she might not see her children again, that she might not live to see them grow up.

Kelly is a capable and tough woman, used to the responsibility of being a single mother while Matt was in Iraq and managing the worry of not knowing whether her husband and father are safe each day. But her hospitalization took her to the breaking point:

My hospital stay was pure hell. I’ve never had a harder two weeks in my life. The pain that I felt was unbelievable. For the first few days I really wasn’t sure what was going on. Most days were spent by myself, with nurses coming in and out of my room. I remember being so swollen at one point that I couldn’t even bend my fingers. I went from 140lbs to 180lbs. It hurt to get out of bed because I was so swollen. During my plasma exchange I would sleep to help the time go by faster; there was just something about the blood being cycled out of me that was hard for me to handle. I remember the floor I was on lost four people the first four days I was there, and I can remember thinking, “Why did they put me here, everyone around me is dying?” I couldn’t shower for eight days because of the central line in my neck; I could only take sponge baths. My hair was so dirty when I left the hospital that I went to a hairdresser to have her wash my hair. When it came time to have my central line out I had to lay on my back for 30 minutes and when the nurse pulled it out it felt like I was giving birth out of my neck.

Kelly’s E. coli infection has changed her. She no longer eats any produce she cannot wash herself. She cannot even watch someone eat a salad—it makes her sick to think about. She now has to get blood draws every six months to monitor her kidney function. She has been told that if she gets pregnant she should be seen immediately because of the potential health effects from her infection. She now suffers from chronic heartburn. And she is angry that her husband had the additional burden of serving in Iraq while wondering if his wife was going to make it through a life-threatening illness and who was taking care of his kids.

And Kelly hopes lessons have been learned by those involved in bringing her contaminated lettuce.

I want the party at fault to know that they took a stay at home mother away from her children for two weeks. That because of them I went through pain that no person should ever have to go through. I would rather have a baby with no meds than have the pain of E. coli again. I would ask them to really think about changing their policies. And to think about how they would feel if it was their mother, father, daughter, son, husband or wife that was lying in that same bed as me, with all the tubes and wires that I had. That it could have just as easily been one of my children who ate that salad, that a small child could have been just as sick, if not worse, than me because of a mistake they made.

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E. coli O157:H7 outbreaks associated with lettuce or spinach, specifically “pre-washed” and “ready-to-eat” varieties, are by no means a new phenomenon. By way of illustration:

- in October 2003, thirteen residents of a California retirement home were sickened, and two people died, after eating E. coli-contaminated, pre-washed spinach;

- in September 2003, nearly forty patrons of a California restaurant chain fell ill after eating salads prepared with bagged, pre-washed lettuce; and

 - in July 2002, over fifty young women fell ill with E. coli O157:H7 at a dance camp after eating “pre-washed” lettuce, leaving several hospitalized and one with life-long kidney damage.

Here are a few more examples:

• Aug. 1993--E. coli O157:H7 outbreak linked to a salad bar; 53 reported cases in Washington State
• July 1995 Lettuce (leafy green; red; romaine) E. coli O157:H7; 70 reported cases in Montana
• Sept. 1995 Lettuce (romaine) E. coli O157:H7; 20 reported cases in Idaho
• Sept. 1995 Lettuce (iceberg) E. coli O157:H7; 30 reported cases in Maine
• Oct. 1995 Lettuce (iceberg; unconfirmed) E. coli O157:H7; 11 reported cases in Ohio
• May-June 1996 Lettuce (mesclun; red leaf) E. coli O157:H7; 61 reported cases in Connecticut, Illinois, and New York
• May 1998 Salad E. coli O157:H7; two reported cases in California
• Feb.-Mar. 1999 Lettuce (iceberg) E. coli O157:H7; 72 reported cases in Nebraska
• July-Aug. 2002 Lettuce (romaine) E. coli O157:H7; 29 reported cases in Washington and Idaho
• Oct. 2003-May 2004 Lettuce (mixed salad) E. coli O157:H7; 57 reported cases in California
• Apr. 2004 Spinach E. coli O157:H7; 16 reported cases in California
• Sep. 2005 Lettuce (romaine) E. coli O157:H7; 32 reported cases in Minnesota, Wisconsin, and Oregon

But we all know that the list does not end there.  E. coli O21:H19 nearly killed two women at a Wendy's in Utah.  Who can forget the September 2006 outbreak associated with Dole Baby Spinach?  Click here to see how the Spinach outbreak unfolded, and what all the epidemiological and other scientific evidence revealed.  Also Taco Bell and Taco John's in late 2006.  2008 saw E. coli outbreaks linked to lettuce in Michigan and the State of Washington - Spinach too in Oregon.  And, there have been may others sickened in produce-related outbreaks of E. coli O157:H7, Salmonella, and other dangerous bugs.

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During the Bush administration, and its do-anything-help-big-business approach, agencies were required to insert "preemption" language into all regulations, rules, and policies that  the agencies promulgated.  This was intended as an attempt to "protect" corporations from state laws and regulations that had the effect of imposing stricter requirements, especially with regard to product safety.  One big "win" for this approach was the U.S. Supreme Court decision in Reigel v. Medtronic, which held that people injured by a medical device "pre-approved" by the FDA could not file a lawsuit claiming that the device was defective as a matter of state law.  A not so successful attempt to use preemption for food cases was that tried by the Excel Corporation in litigation arising from an E. coli O157:H7 outbreak linked to a Milwaukee-area Sizzler restaurant. In those cases, Excel argued that its admittedly contamianted meat was neither defective nor unsafe because USDA policy at the time only prohibited this deadly pathogen from being in ground beef. (For an op-ed piece I wrote about this USDA policy, see Who does the USDA Really Protect, which can be found here: www.marlerblog.com/2008/08/articles/lawyer-oped/who-does-the-usda-really-protect-when-it-comes-to-deadly-e-coli/)

But now most of the arguments in favor of preempting state law in favor of "uniform" federal regulations are going to be undercut by a just-issued Executive Order that declares a new (or renewed) era of states rights.  The introductory paragraph of the Order is telling and compelling:

From our Nation's founding, the American constitutional order has been a Federal system, ensuring a strong role for both the national Government and the States. The Federal Government's role in promoting the general welfare and guarding individual liberties is critical, but State law and national law often operate concurrently to provide independent safeguards for the public. Throughout our history, State and local governments have frequently protected health, safety, and the environment more aggressively than has the national Government.

Not only does this Order announce a new direction, it requires the heads of all federal agencies to "review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law," and to remove them.  So once more the role of the state in protecting its citizens from unsafe food and other products is restored to its rightful place.  More importantly, the next time that a big food company argues that the USDA said it was okay to poison people, it will likely get laughed out of court. Or at least we can hope so.

To read the full text of the Executive Order, please click on the Continue Reading link.

THE WHITE HOUSE
Office of the Press Secretary
 

For Immediate Release May 20, 2009
May 20, 2009
 

MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES
SUBJECT: Preemption
 

From our Nation's founding, the American constitutional order has been a Federal system, ensuring a strong role for both the national Government and the States. The Federal Government's role in promoting the general welfare and guarding individual liberties is critical, but State law and national law often operate concurrently to provide independent safeguards for the public. Throughout our history, State and local governments have frequently protected health, safety, and the environment more aggressively than has the national Government.

An understanding of the important role of State governments in our Federal system is reflected in longstanding practices by executive departments and agencies, which have shown respect for the traditional prerogatives of the States. In recent years, however, notwithstanding Executive Order 13132 of August 4, 1999 (Federalism), executive departments and agencies have sometimes announced that their regulations preempt State law, including State common law, without explicit preemption by the Congress or an otherwise sufficient basis under applicable legal principles.
 

The purpose of this memorandum is to state the general policy of my Administration that preemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption. Executive departments and agencies should be mindful that in our Federal system, the citizens of the several States have distinctive circumstances and values, and that in many instances it is appropriate for them to apply to themselves rules and principles that reflect these circumstances and values. As Justice Brandeis explained more than 70 years ago, "[i]t is one of the happy incidents of the federal system that a single courageous state may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country."
 

To ensure that executive departments and agencies include statements of preemption in regulations only when such statements have a sufficient legal basis:
 

1. Heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation.
 

2. Heads of departments and agencies should not include preemption provisions in codified regulations except where such provisions would be justified under legal principles governing preemption, including the principles outlined in Executive Order 13132.
 

3. Heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.
 

Executive departments and agencies shall carry out the provisions of this memorandum to the extent permitted by law and consistent with their statutory authorities. Heads of departments and agencies should consult as necessary with the Attorney General and the Office of Management and Budget's Office of Information and Regulatory Affairs to determine how the requirements of this memorandum apply to particular situations.
 

This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
 

The Director of the Office of Management and Budget is authorized and directed to publish this memorandum in the Federal Register.
 

BARACK OBAMA

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In April, The Oklahoma State Health Department (OHD) published its final report on a massive outbreak of E. coli 0111 linked to the Country Cottage restaurant in Locust Grove, Oklahoma.    E. coli O111, one of the family of E. coli bacteria, is classified as an STEC, a shiga toxin producing escherichia coli.  In other words, it is, like E. coli O157:H7, pathogenic to humans and carries the potential to cause hemolytic uremic syndrome (HUS). 

The findings of the report also help illustrate an important legal point about the work we do at Marler Clark.   Despite a thorough investigation, OHD was not able to pinpoint the particular food source or sources that caused the 341 documented cases of E. coli O111.   "It could not be conclusively determined how E. coli O111 was introduced into the restaurant."   The OHD looked at a number of possibilities for the "original" source of the contamination - tainted well water; an infected food worker; contaminated food. 

From a legal standpoint, not being able to identify the "original" source of the infection is irrelevant to the customers claims against the restaurant.  Following a doctrine called "strict liabilty"  an injured customer simply has to prove that a restaurant meal caused his or her illness.  It is not necessary that the claimant be able to trace an illness to the mashed potatoes as opposed to the gravy.  In Oklahoma, the rule of "strict liability" is laid out in the case of Kirkland v. Gen. Motors, Corp (1974), but for all intents and purposes, the rule would apply anywhere in the U.S. 

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Towns in Oklahoma, Texas, and Wisconsin are taking steps to prevent illness in residents using public water after positive tests for  E. coli.  Officials in Hollis, Oklahoma were distributing bottled water after positive tests in the public water system.

In Baytown, Texas, officials announced a boil order after positive E. coli tests. 

And finally, residents in Janesville, Wisconsin were also under a boil order, again after positive tests for E. coli.

The term E.coli referst to family of baceria that includes the dangerous E. coli O157:H7 bacteria.  A positive, general,  test for E. coli does not necessarily indicate the presence of E. coli O157:H7.  Likewise, it does not rule out its presence.

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For years, the USDA Food Safety and Inspection Service (FSIS) has allowed meat plants to divert meat that has tested positive for E. coli O157:H7 (or some other pathogen) to a further-processing facility where it is cooked for a time and at a temperature sufficient to kill the pathogens.  What FSIS has not done, however, is require immediate corrective action of the plant's slaughter and sanitary dressing procedures so as to determine how the meat came to be contaminated in the first place.  Because, let us be clear: ground beef, trimmings, an intact cuts of meat do not get contaminated with E. coli O157:H7 unless the carcass is contaminated, or cross-contaminated, druing the slaughter or carcass-dressing process.  Bottom-line: Meat is not contaminated but for the manner of its slaughter and dressing. 

So lax has been the FSIS focus on and oversight of the slaughter and dressing process that it has routinely allowed plants to send meat that has tested presumptively positive for E. coli O157:H7 to be sent for further-processing without requiring that confrimatory testing be done.  This give the plant a free pass by avoiding a confirmed positive test result for E. coli O157:H7, something that would be higly likely to prompt a comprehenisve assessment at the plant, and the requirement that the plant's HACCP plan be re-assessed and re-validated.  This also allows both the plant and FSIS to pretend that the Slaughter HACCP plan has not failed for not reduciing E. coli O157:H7 to an "undetectable level"--something that FSIS policy has required since October 7, 2002.

Now, if in reading the above the image of an ostrich with its head in the sand came to mind, then you are definitely grasping the gist of my criticism here.  But, that said, I am happy to report that FSIS finally seems to have pulled its proverbial head out of the sand and seen the light. 

Yesterday the agency issued FSIS Directive 6410.1, and it is a very good thing indeed.  For more on this, please hit the CONTINUED READING link.

For the first time, the agency has explicitly announced its recognition that E. coli O157:H7 is a problem that starts (and someday hopefully ends) with the slaughter and dressing process.  As a result, from this point forward, FSIS is going to take note:

of the increased number of E. coli O157:H7 positive samples of ground beef and trim collected by FSIS and an increased number of recalls associated with E. coli O157:H7, including those specificall initiated as a consequent of human illness. These increases can be attributed, in part, to ineffective sanitary dressing and process control procedures that create insanitary conditions during slaughter.  Effective sanitary dressing annd process control procedures are crucial to an establishment's ability to produce clean, safe, and wholesome product.

The importance of this shift in FSIS enforcement efforts cannot be overstated, and hopefully it represents a sea-change that will lead to a reduction in death and serious injury.  In particular, this may put to an end the inane argument, incessantly advanced by the meat industry, that deadly pathogens are somehow inherent to meat, and thus it must fall to consumers to make meat safe to eat by cooking it "safely." As the agency noted in this recent directive, "it considers an acceptable reduction of E. coli O157:H7 to be a reduction to an undetectable level." In other words, it is not supposed to be there in or on meat at all, and, if it is, the meat is adulterated.

The one final step that the FSIS needs to take to make this new and much improved approach really work is to eliminate, once and for all, the absurd fiction that a presumptive positive is not a "real" positive test result.  Confirmatory testing should be required of all presumptive positive test results.  Or, in the alternative, if  the plant objects to the expense of doing confirmatory testing, then the presumptive results should be presumed to be confirmed positives for purposes of prompting further corrective actions and enforcement efforts. 

It is time for the FSIS to enfore a true zero-tolerance for E.coli O157:H7; and with this new Directive, the agency has taken a great step in the right direction.

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