Marler Blog - Providing commentary on food poisoning outbreaks & litigation

Study shows potential advance in fighting E. coli

Researchers have developed a new class of inhibitors that neutralize toxic bacteria produced by E. coli, the cause of most food poisoning outbreaks, according to a new study. The new inhibitor potentially represents an important advance over standard antibiotics, said the study published on Monday in the Proceedings of the National Academy of Sciences (PNAS). Used with customary therapeutics, the inhibitors could prove effective against numerous types of bacteria that release soluble toxins such as enterohemorrhagic E. coli, said David Bundle, principal author of the study. The inhibitor, called (S)-PolyBAIT, protected mice against the effects of a dose of the Shiga toxin that causes the hemolytic-uremic syndrome associated with E. coli food poisoning, according to the researchers. The inhibitors offer a more promising approach than antibiotics alone, which can destroy cells and release bacterial toxins into the bloodstream.

E. coli vaccine OK’d for cattle

A new E. coli vaccine for cattle given the green light by federal regulators is an encouraging development in food safety, but the threat posed by the deadly bacteria can never be eradicated, the lead investigator into the tainted water tragedy in Walkerton, Ont., said Monday. Bioniche Life Sciences Inc. announced Monday that the Canadian Food Inspection Agency has approved the vaccine Econiche to help reduce the proliferation of E. coli O157:H7 in cattle, in turn decreasing the risk of the bacteria spreading to humans.

Red meat, milk lovers more susceptible to E. coli

Lovers of red meat and milk may be more susceptible to a major strain of Escherichia coli (E. coli), which causes severe diarrhea, researchers in Australia said. In an article published in Nature, they said red meat and cow's milk contain a type of sugar that the Shiga toxigenic E. coli bacterium binds readily to, making people sick. "Frequent consumption of (red meat and milk) would allow incorporation of the sugar into our cells and when we eat meat infected with E. coli, it sensitizes our cells to attack by this toxin," said Travis Beddoe, a research fellow at the Protein Crystallography Unit of Australia's Monash University. Using human gut and kidney tissues, the researchers found that toxins from E. coli would only bind to tissues that were flushed with the sugar. "The toxins couldn't bind to human tissues in the absence of the sugar, but when we fed human cells with this (sugar) ... there was strong binding and increase in virulence and toxicity," Beddoe told Reuters in a telephone interview. The sugars can reside anywhere along the human digestive tract, although they tend to concentrate in the stomach and kidneys -- sometimes for up to a few days. "If we drink milk or have a lot of red meat intake we would be replenishing those sugars, they would be there all the time," Beddoe said. The Shiga toxigenic E. coli is a major pathogenic form of E. coli. The sugar, called N-glycolylneuraminic acid-containing saccharides, is abundant in cow's milk and red meat, but low or absent in poultry and fish.

Cases of confirmed E. coli contamination have authorities looking at a Pitt County petting zoo as a possible source.  The Pitt County Health Department tells WITN News that the petting zoo in question is located at Briley's Farms on Highway 264.  The Beaufort County Health Department says two children infected with E. coli visited the same zoo and the Pitt County health authorities shut down the that portion of Briley's as a precaution. The other parts of Briley's are not effected,  Beaufort County says it is working with health care providers to identify and test additional suspected cases.

This should not come as a surprise.  E. coli outbreaks have been linked to petting zoos for years.  See, Known Cases of Zoonotic Pathogen Outbreaks Associated with State and County Fairs, Petting Zoos, and Community Activities Involving Human-Animal Contact

After a day of mediation, we were able to resolve all 25 of the cases we represented in this litigation.  The mediator, Judge Epistein, did a masterful job getting the parties to resolve these cases.  As you might recall, in May 2007, the Centers for Disease Control and Prevention (CDC) begun a multi-state investigation in response to an increase in laboratory reports, first posted on the 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 were tested in twelve states. Salmonella sp. was isolated from thirteen bags of Veggie Booty. 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 tested positive for Salmonella Kentucky. CDC reported Salmonella Haifa and Salmonella Saint Paul were isolated from bags of Veggie Booty.

According to press reports, Hancock County Illinois Health Department learned from the Illinois Department of Public Health that lab results confirmed the existence of the E. coli O157:H7 bacteria in a case reported as "possible" last week. Confirmation of the case brings the tally of E. coli 0157:H7 cases in the area up to four, including two confirmed in Lee County last week and one confirmed in Des Moines County on Monday. The source of contamination, or whether the cases are connected, remains undetermined at this time.

With outbreaks in Washington, Vermont, Colorado, Michigan and Illinois in the past few weeks, my guess is that this Iowa/Illinois outbreak will be determined.

The first lawsuit stemming from the Snohomish county E. coli outbreak was filed today in the Superior Court for the State of Washington, County of Snohomish. The lawsuit was filed on behalf of the minor child of Alison and Ray Riojas of Snohomish County, against Ixtapa Family Mexican Restaurant, which has been identified as the source of the outbreak.

The Riojas family ate at the Ixtapa Restaurant in Lake Stevens on or about October 11. One of their daughters began to feel ill on October 13, and on the 14th was sent home from school. She began to experience diarrhea, which soon turned bloody. On October 16, Mrs. Riojas took her daughter to the pediatrician, where she was advised to go to the Children’s Hospital Emergency Room. At the ER, the child was treated for dehydration and released. Over that day, her symptoms continued to worsen. In severe pain, she was returned to the ER, where she was treated with pain medication and allowed to go home. That night, the child was taken to the ER for a third time, where she began to vomit blood. She was admitted, and a stool sample revealed that she was infected with E. coli O157:H7. The genetic pattern of her E. coli would later match others in the developing outbreak tied to the Ixtapa Restaurant.
The Riojas child has returned home where she continues to recover from her illness. She lost 9 pounds and is too weak to walk; if she has to move, her parents carry her.

News Coverage:

Lawsuit filed in E. coli outbreak tied to Lake Stevens restaurant

Lawsuit filed in Snohomish County E. coli outbreak

Lake Stevens eatery reopens as E. coli suit filed

Family files suit in Lake Stevens E. coli sickness

A restaurant in Lake Stevens is the likely source of 13 of 17 cases of E. coli, the Snohomish Health District announced today.  The people were likely exposed to the illness at the Ixtapa restaurant, according to health officials who say they interviewed and compared notes from the sick people.  Health officials need to still interview one more person.  Three of the ill did not eat at the restaurant.

A University of Michigan student has filed a lawsuit against Detroit-based Aunt Mid's Produce in connection with a statewide E. coli outbreak last month.  The lawsuit -- the second against Aunt Mid's since the outbreak -- was filed Monday in Washtenaw County Circuit Court on behalf of a U-M senior who alleges she was sickened in the outbreak, which has been linked to Aunt Mid's.  At least 38 people were sickened in Michigan last month by an E. coli strain linked to industrial-size packages of iceberg lettuce distributed by Aunt Mid's to restaurants and institutions. In her complaint, the student says she consumed the contaminated lettuce in mid-September, and by Sept. 19, she began to experience abdominal cramps, vomiting, and bloody diarrhea.  She sought treatment at the University of Michigan Health Service Clinic. An MSU student has also sued Aunt Mid's in connection with the E. coli outbreak.

Since June of 2007 I have been blogging about the increase in E. coli illnesses and recalls after years of decreases. Those increase have continued well into 2008. It now seems every day there is another outbreak. Colorado, Vermont, Michigan, Iowa have all seen outbreaks in the last few days.

Minnesota Public Radio Mark Steil reporter reported on Friday what many have long suspected, and that a USDA study confirms, that there is link between ethanol by-product and E. coli.  A U.S. Agriculture Department study shows a significant increase of potentially harmful E. coli bacteria in cattle that are fed an ethanol by-product known as distiller's grain. Distillers grain is a common ingredient in cattle feed. But researchers say it's too soon to know whether cattle producers should change the amount of distiller's grain they feed to their herds. See the full story – “USDA study confirms link between ethanol by-product and E. coli.”

In December of 2007 I wrote about one of the causes I suspected in this E. coli uptick:

High oil prices: They get blamed for everything else, so why not food-poisoning? The theory is that $3 gas has fueled the growth of ethanol plants. Those plants tend to be built next to feedlots, because the plants produce a byproduct called distiller’s grains, which serves as an excellent feed for livestock. Problem is, according to research at Kansas State University, the distillers grain also increases the incidence of E. coli in the hindguts of cattle.

As I wrote in January of this year:

There are as many theories as there are authorities, researchers, and meat packers. Some of my thoughts from December 2007 surfaced again in Phil Brasher’s article, “Scientists study possible link between ethanol byproduct and E. coli.” A nationwide surge in beef recalls has pointed the finger at an unlikely culprit - the nation's fuel ethanol industry. Studies at two universities suggest that feeding cattle a byproduct of ethanol production known as distillers grains may increase levels of a deadly form of E. coli bacteria.

It seems to be about saving or making a buck. According to the Iowa Cattlemen's Association, cattlemen pay $35 a ton for distillers grains, the equivalent of $2.85 a bushel for corn. In Iowa corn has been selling for more than $4 a bushel. It takes about 33 bushels to make a ton. It takes the equivalent of 70 bushels of corn to fatten a steer. So if I did my math correct, if you feed a steer corn, it costs about $132 to fatten it; if distillers grain is used, $75. Hmmmm, I wonder if that has anything to do with it. It will be interesting to see the cattlemen explain that to a jury in an E. coli case.

I found some interesting quotes about the price of steers and how the costs of inputs like, corn vs distillers grain, might drive risky decisions - “In The Cattle Markets” - A weekly newsletter jointly produced by Kansas State University, University of Nebraska and Utah State University.

“Feedlots seem to be signaling that they would prefer to place feeders at heavier weights and avoid feeding that high priced corn. Fed cattle weights have also been declining since November of last year and are now below the 5-year average. That decline may also reflect a dislike for feeding high priced corn…. Packer margins have likely improved in the last few weeks but feedlots are probably losing over $100 per head on most sale lots…. Lower returns and increased risk is the current state of the industry.”

So, what are industry and the Government going to do about it? Another study? Watch more people get sick? Send more clients to my office? For an industry and a Government that claims to not like lawyers, they sure are keeping me busy.

Contaminated ground beef that sickened at least 10 people in Vermont has been traced to the Vermont Livestock, Slaughter and Processing Co. in Ferrisburgh, the U.S. Department of Agriculture said Thursday. The USDA has recalled more than a ton of ground beef processed at the plant and distributed to restaurants, food services and institutions in Vermont and Plattsburgh, N.Y., the USDA said.

The 2,758 pounds of ground beef subject to the recall was shipped in 5-pound packages labeled VT BURGER CO GROUND BEEF. They carry the number EST 9558 inside the USDA mark of inspection and a lot code of 090508A, 090808A, 091208A, 091908A or 092208A. The products were shipped two packages per box and were produced on Sept. 5, 8, 12, 19 and 22. The problem was discovered through a joint investigation with the USDA's Food Safety and Inspection Service and the state Health Department.

Is there a link to this outbreak in Canada?  Vermont is certainly not that far away.

Up to 93 possible E. coli cases in Ontario linked to Harvey's as outbreak spreads

As I said in a press release today:

"In the last year and a half, the American meat industry has been in a spiral of recalls," said food safety advocate and attorney William Marler. "More than 40 million pounds of meat tainted with E. coli O157:H7 has been publicly recalled, up by a factor of two hundred from the 2006 amount of 181,900 pounds. This is a very dangerous and completely unacceptable level of contaminated beef making its way to consumers."

In more than thirty recalls ranging from a few hundred to millions of pounds, the Food Safety Inspection Service (FSIS) has deemed E. coli contaminated meat a class one health hazard to consumers. (A class I recall involves a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death.)

"There are many theories as to why there has been such an unprecedented jump in E. coli," said Marler. "It could be regulatory complacency, better reporting, or immigration sweeps that have left slaughterhouses empty of skilled workers. Global warming may be spreading fecal dust and/or high oil prices may have led to an E. coli-producing diet for cattle. The microbe itself may even be evolving to elude capture. These ideas need investigation and research, so that real change can begin."

According to Vermont Press reports, the number of E. coli cases in Vermont has reached nine, with a 10th case suspected. In a Press Release the Vermont Department of Health officials offered little specific information on the outbreak, saying only that it had been linked to ground beef served at three Vermont (UNNAMED) restaurants and most of the people infected lived in Chittenden County. 

“Our laboratory results tell us that each person became ill from the same source,” said Deputy State Epidemiologist Susan Schoenfeld. “And our epidemiology investigation has found that source to be ground beef that was contaminated before it was distributed to, prepared, and served at a few restaurants in Vermont.” 

While people are sickened in Vermont another restaurant E. coli outbreak hits in Canada.  The Globe and Mail reports – “More will fall ill in E. coli outbreak, officials warn, after more than 50 customers sickened, health officials close fast-food outlet.”  This E. coli outbreak may have sickened more than 50 people who ate at an Ontario Harvey's restaurant.  Fourteen people were confirmed to have fallen ill from E. coli O157:H7 bacteria after eating at a North Bay Harvey's franchise.  Another 38 illnesses linked to the same restaurant are under investigation to determine whether they are the result of E. coli contamination.  But health officials fear that number could climb significantly because it can take several days for people to feel ill after coming in contact with E. coli.

Are these two outbreaks linked?

I would like to give a "shout-out" to our gun-totting, Caribou Barbie, Governor from our somewhat neighboring state (they can see Russia - we can only see Canada) that she is needed back North with gun in hand.  The Anchorage Daily News reported that federal public health officials have confirmed a link between peas grown on a Palmer farm this summer with a bacterial outbreak that made 99 people sick.  Laboratory findings from the Centers for Disease Control and Prevention in Atlanta determined that the outbreak of Campylobacter diarrhea can be traced to eating uncooked peas that came from a field frequented by sandhill cranes.  Droppings from the cranes most likely contaminated the peas, said Dr. Tracie Gardner, an epidemiologist with the Alaska Division of Public Health.  These cranes have clearly been "palin' around with terrorists" and need to be shot.  I'll "betcha" you can shoot them from a plane.

I am humbled to see Chinese lawyers standing up for the victims of this melamine tragedy despite being pressured to walk away.

The family of a baby whose death has been blamed on toxic milk filed suit against one of China's largest dairies, while another dairy ensnared in the scandal said it was a victim of unscrupulous subcontractors. The lawsuit filed Monday against Shijiazhuang Sanlu Group Co. was over the May 1 death of 6-month-old Yi Kaixuan in the northwestern city of Lanzhou, the family's lawyer said. It is the first to be filed over a child who died from drinking the tainted milk and asks for almost US$160,000 in damages.

The Yi family's lawyer, Dong Junming, said he turned the lawsuit in at Lanzhou's No. 2 Intermediate People's Court where clerks told him they would notify him Tuesday as to whether it would be accepted. At least two other lawsuits have been filed against Sanlu - the company at the center of the uproar - in recent weeks by parents of children suffering from kidney stones. It is not clear if courts will allow these suits to progress.

Wesley Medical Center has confirmed two kids have died at the hospital due to E. coli contamination in the last few days.  No connection or sad coincidence?

Recently, the mayor of Liberal, Kansas said that 18-month-old Tanner Strickland, died last week. His brother was also contaminated, but has been released.  The medical centart announced that the other child, from Matfield Green in Chase County, has  died from E. coli over the weekend.

According to the CDC, E. coli is a common kind of bacteria that lives in the intestines of animals and people. There are many strains of E. coli. Most are harmless. However, one dangerous strain is called E. coli O157:H7. It produces a powerful poison. You can become very sick if it gets into your food or water.

In 1999 it was estimated that about 73,000 people in the U.S. got sick each year from E. coli. About 60 died. It’s believed that the number of illnesses and deaths has been dropping since then.  Little solace for two grieving families.

Better late than never:

This letter is intended to ensure that members of the United States food manufacturing industry are aware of the Food and Drug Administration's (FDA's) serious concern about the possibility that foods or food ingredients produced in China and exported to the United States may be contaminated with melamine or its analogues. FDA has information indicating that melamine and its analogues have been added to milk produced in China and that milk contaminated in such a fashion has been used to manufacture infant formulas and other dairy-based products. As of this writing, Chinese authorities are reporting that in China approximately 53,000 infants have suffered illnesses, with 13,000 hospitalizations and four deaths. Approximately 158 of the victims thus far have suffered acute kidney failure. Chinese authorities have disclosed that, in addition to discovering contaminated infant formulas, melamine has been discovered in 24 of 1202 samples of milk and yogurt. There is little information at this stage to determine when the contamination might have begun or how widespread the contamination might be. However, Chinese authorities report that melamine was found in infant formula, milk, yogurt, and ice cream manufactured by 22 companies in China. The Chinese investigation into this matter is ongoing.

Milk and milk products that could originate from China include condensed, dried, and non-fat milk, condensed and dried whey, lactose powder, permeate powder, demineralized and partially demineralized whey powders, caseins, yogurt, ice cream, cheese, whey protein concentrate, and milk protein concentrate.

In light of current circumstances, there are several useful steps to help protect the public health available to manufacturers of products containing milk-derived ingredients, including the following:

* Know the precise origin of each milk-derived ingredient. For example, milk-derived ingredients that are sourced from countries other than China could actually originate from China.

* Determine that milk-derived ingredients originating from China are free of melamine and its analogues prior to usage.

* For food manufactured in the last twelve months which might still be on the shelf at retail or in stock elsewhere, determine whether the food might contain any milk-derived ingredients from China. If any such foods exist, verify that they do not contain melamine or its analogues.

In addition, it would be useful for manufacturers to be alert to the possibility that non-milk-derived ingredients from China that are or may be sold on the basis of protein content, such as soy protein, also could be contaminated with melamine.

Should firms decide to recall any of their products because of the presence of melamine, please follow FDA's guidelines in 21 CFR Part 7 Subpart C. We encourage you to communicate any concerns to your local FDA district office.

A gas chromatography-mass spectrometry (GC-MS) as well as a liquid chromatograph-tandem mass spectrometry (LC-MS/MS) method for determining melamine and its analogues is available at the following link to the FDA website:  http://www.fda.gov/oc/opacom/hottopics/melamine.html#testing.

If you have any questions regarding this letter, you may contact John F. Sheehan, J.D. at (301)436-2367 or Benson M. Silverman, M.D. (301)436-1459.

Although the financial bailout may hit $1 trillion and the market is kissing 8,000, RBC Capital Markets quietly rolled out a $185 million loan yesterday that backs the leveraged buyout of Earthbound Farm, a San Juan Bautista, Calif.-based organic produce company, by private equity firm Lindsay Goldberg, according to sources.  Terms of the buyout and financing package have not circulated widely. Bank of America has committed to the deal, along with BMO Capital Markets.  The BMO ticket has some conditions attached to it, sources note.  Earthbound Farm was the first company to successfully launch pre-washed bagged salads packaged for retail sale in 1986.  The company sells more than 100 varieties of organic salads, fruits and vegetables across 75% of supermarkets nationwide, according to Earthbound. Its main farms are located in California, Arizona, and Mexico.  The company also grows organic produce in Colorado, Washington, Oregon, Canada, Chile, and New Zealand.

Why is this important? Earthbound Farms is the parent company of Natural Selection Foods Inc., which manufactured the Dole Baby Spinach that sickened 205 in an E. coli outbreak in 2006.  To date we have settled nearly 100 cases, but have 5 more to resolve through settlement or trial.  It is good to see they are setting aside some cash for the victims of this tragedy.

The first lawsuit stemming from a recent lettuce-borne E. coli outbreak was filed today in the Circuit Court for Ingham County, Michigan against Aunt Mid’s Produce. The petition was filed on behalf of Michigan State University (MSU) student and East Lansing resident Samantha Steffen.  In September 2008, at least 34 people were sickened by the virulent E. coli strain O157:H7. The ill were concentrated in Michigan, and included students at MSU Lansing as well as inmates at a Michigan jail. The outbreak was traced to contaminated lettuce distributed by Aunt Mid’s Produce of Detroit, Michigan.

Samantha Steffen consumed lettuce on campus in early September, and by September 13, she began to experience nausea, abdominal cramps, and frequent bouts of diarrhea. In the next couple of days, her diarrhea turned bloody, and she asked a friend to take her to the emergency room where she was treated for severe dehydration. A stool sample taken there revealed that she was infected with E. coli O157:H7. After her release from the ER, Ms. Steffen continued to experience painful cramps, nausea, and bloody diarrhea. She has yet to fully recover from her illness.

“Lettuce from Aunt Mid’s Produce has been positively identified as the source of this outbreak,” said Ms. Steffen’s attorney William Marler. “Despite calls to reveal the source of the tainted lettuce—a pivotal step toward ensuring that there is no additional tainted product in the supply chain—Aunt Mid’s has refused to do so. Food distributors are responsible only to their direct consumers but also to the food supply system as a whole. By withholding information about a contamination event, Aunt Mid’s Produce is not doing their part to keep food safe for everyone.”

Although E. coli outbreaks are often associated with meat, produce-borne outbreaks have become more frequent in recent years. The Center for Science in the Public Interest noted that fully 25 percent of E. coli outbreaks from 1990-1998 were traced to produce. Data from the Centers for Disease Control show that over the last 12 years, twenty-two E. coli outbreaks have been traced specifically to leafy greens, including the spinach outbreak in 2006, which made more than 200 ill and caused four deaths.

E. coli Victim Sues Lettuce Supplier

MSU student sues Detroit produce supplier following E. coli illness

Lettuce that Sickened 37 in Michigan Linked to California

Student Sues for E. coli Damages

News outlets report that the toll of Chinese children ill from toxic milk formula may have nearly doubled since the Health Ministry's last public count.  That number now may be over 94,000 children sickened.  Beijing is now struggling with the political, business and moral fallout from the adulteration of milk with the industrial chemical melamine.

Like the alcoholic, China needs at least several of Alcoholics Anonymous Twelve-Step Program’s guiding principles for "recovery from addiction, compulsion, or other behavioral problems."  Dr. Bob - one of AA’s co-founders - has characterized the process of twelve-step recovery as "trust God, clean house, help others". 

OK, so God may not be a moving force in China, but it really is time to “clean house and help others.”  As summarized by the American Psychological Association, and adapted by me, China’s process must involve at least the following:

*  Admitting that the Chinese government cannot control its addiction or compulsion for money and power;

*  Recognizing a greater power that can give strength – The Party leaders need to go back and read and understand Confucius, Mao and Sun Tzu;

*  Examining past errors with the help of a sponsor - I’m available;

*  Making amends for these errors – It is time to take care of the children that you have allowed to be poisoned;

*  Learning to live a new life with a new code of behavior – it is time for a free press and a functioning civil legal system;

*  Helping others that suffer from the same addictions or compulsions – Every country can do better – China, that has developed so much over a proud history, can help us all.  It just needs to first admit that it has a problem.

I am sitting at the 3rd International Conference for Food Safety and Quality (I already did my Keynote speech) listening to a microbiologist explain some new bacterial test.  It made me recall that I took a picture of the meal that someone I had dinner with last night:

Yes, that is actually Steak Tartare.  And, No, I did not eat any.  I had a well done steak.  And, No, I would not represent this normally very bright person if they become ill.

OK, perhaps, this is not what Mao was actually thinking when he said:

"If we have shortcomings, we are not afraid to have them pointed out and criticized, because we serve the people.  Anyone, no matter who, may point out our shortcomings.  If he is right, we will correct them. I f what he proposes will benefit the people, we will act upon it.”

Mao, China's food safety system is a mess.  If you do not fix it quick, "Made in China" will mean that it is likely poisoned.  If you want market share in the US and EU, people should not have to worry about the candy they eat or the milk their kid's drink.  My guess is that you would not have tolerated this melamine mess.  Perhaps, it is time for a "Great leap Forward" in food safety. 

I got it, you need to appoint me as Food Safety Czar (È£üÂìÅÂÆâÂÖ®Ê≤ôÁöá) since the Obama folks are still "vetting" me to even give them advice, and McCain, well, that will not happen - my guess is that I fail in the "maverick" department - although, from Seattle, I can almost see Russia.  Anyway, Mao, I am available.  That would be William "Maoler."

好吧，也许，这不是什么毛泽东思想，实际上他说：

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I provided the 2008 HACCP Conference organizers with my presentation weeks ago, but since then we have seen, more raw milk, red meat and lettuce outbreaks.  We have also seen the China Melamine disaster and an E. coli O111 outbreak that sickened over 300 in Oklahoma.  It is hard to stay current.

Just click on the below and download the entire report:

Introduction

This is the second part of a series on Food Safety and irradiation.  Here was the first installlment.  The new FDA rule approves the use of ionizing radiation (also termed irradiation, irradiation pasteurization, cold pasteurization) of fresh iceberg lettuce and fresh spinach for control of foodborne pathogens, and extension of shelf-life. Molins (2001) and other experts agree that food irradiation fits the definition of a “critical control point” in a comprehensive farm-to-table approach (e.g., HACCP) to prevent foodborne illnesses and outbreaks. But, implementing irradiation into fresh lettuce and spinach processing poses some challenges. In the second part of this series, the pros and cons (advantages and limitations) of irradiation relative to food safety are reviewed.

The Problem of Foodborne Pathogens in Fresh Lettuce and Spinach

Before embracing a potentially expensive and controversial new control method in processing such as irradiation, it is imperative to consider the scope of the problem being addressed. Consumer confidence in the safety of fresh fruits and vegetables has been shaken in recent years due to high-profile and sometimes deadly outbreaks linked to produce contaminated with foodborne pathogens. Experts in nutrition agree unanimously that fresh produce is an important component of a healthy diet; therefore, production of safe produce free of harmful pathogens is critical.

Outbreaks associated with fresh leafy green vegetables including iceberg lettuce and spinach are increasing. Herman (2008) presented data at the International Conference on Emerging Infectious Diseases showing a 9% increase in consumption of leafy green vegetables from 1996-2005, compared with a 38.6% increase in leafy green-associated outbreaks during the same time period. These results suggest that the proportion of foodborne disease outbreaks due to leafy greens cannot be explained by increases in consumption alone. Unfortunately, there is evidence that consumers may be at risk from produce that is contaminated prior to purchase, and recommendations to “wash” their fruits and vegetables before consumption may not always be adequate to prevent foodborne illness. In a study of E. coli O157:H7 outbreaks from 1982-2002, the authors estimated that half of the produce-associated outbreaks were due to produce already contaminated with E. coli O157 before purchase by the retail store or consumer (Rangel et al, 2005).

Examples of foodborne disease outbreaks and recent recalls linked to salad greens are shown in the Table below. The table includes only outbreaks/recalls believed to be due to contamination before the produce reached the retail level (e.g., grocery store, restaurant, kitchen). The fact that lettuce, spinach and other raw or minimally-processed produce can be contaminated with foodborne pathogens on the farm, or during harvest, transportation, or processing is a daunting problem for public health and industry. The risk is increased because fresh lettuce, and often spinach, is not subjected to a “kill” step such as cooking prior to consumption. Other unique challenges with microbial contamination of lettuce and spinach have been documented in the literature.

• The purpose of sanitizers used to wash leafy greens (for example, chlorine solutions) is to eliminate microbial contamination of the wash water, not the plant leaves. Many studies have shown the limitations of routine protocols for chemical washing of lettuce and other leafy greens in reducing pathogen levels. The low infectious dose (very few bacteria) of pathogens such as E. coli O157:H7, other STECs, and Shigella increase the threat.
• Researchers have found that plant lesions (such as those caused by harvesting and processing, including “fresh-cut” processing) can promote the rapid multiplication of E. coli O157:H7 (Brandl, 2008)
• Bacteria may internalize into the plant tissue and be protected from chemical sanitizers. Giron from the University of Arizona described preliminary results from high-resolution electron microscopy showing E. coli O157 internalized within the “stomata” of spinach leaves, and the bacteria were not destroyed by chlorine wash solutions

See Table of Outbreaks from 1995 to present.

The Pros (Advantages) of Food Irradiation for Fresh Lettuce and Spinach

Could any of these outbreaks or recalls have been prevented by use of irradiation as a control step during processing in the US and other countries?

An analysis by Tauxe (2001) suggests that the answer to this question would be “yes.” He analyzed the potential benefit of irradiated meat and poultry and estimated that 900,000 cases of infection, 8,500 hospitalizations, over 6,000 catastrophic illnesses, and 350 deaths could have been prevented each year. A similar analysis of the potential impact of irradiation in preventing illnesses due to contamination of lettuce, spinach, and other leafy greens would be interesting. Nine of the outbreaks and 1 recall (Table) were from contaminated fresh iceberg lettuce or spinach. Additionally, several outbreaks involved institutional settings such as hospitals, children’s camp, and nursing homes, which serve populations that are especially vulnerable to severe illness or death from foodborne pathogens.

Notably, the pathogens most commonly implicated in leafy green-related outbreaks and recalls are bacteria and parasites; these organisms are also the most susceptible to control using medium (1-10 kGy) dosage of irradiation. For example, research indicates that Campylobacter, Cyclospora, E. coli O157/STECs, Listeria, Salmonella, and Shigella are reduced by 3-5 logs. Additionally, raw or “minimally processed” fresh-cut, pre-washed leafy greens have unique risks that irradiation as a control step could potentially address. Specifically, an advantage of irradiation is its ability to penetrate the leaf tissue and reach bacteria internalized in the lettuce or spinach tissue. For example, Niemira (2007) showed that “ionizing radiation but not chemical sanitizers effectively reduced viable E. coli O157:H7 cells internalized in leafy green vegetables.”

The Cons (Limitations) of Food Irradiation for Fresh Lettuce and Spinach

The irradiation dose (up to 4 kGy) approved by FDA is not meant to sterilize (kill all living organisms) iceberg lettuce or spinach. Thus, irradiation is not a replacement for good agricultural practices and management practices on the farm and during harvest, transportation, and processing. Use of irradiation also does not prevent post-processing contamination during transport or by the retailer or consumer during food preparation and handling. Murano summarizes the issue in her chapter on microbiology of irradiated foods:

“Irradiation, however, should not be used to make “dirty” products (those heavily contaminated with microorganisms) clean again. To attempt to do so would require doses much higher than those needed to eliminate normal background levels. This would result in significant damage to the quality of the product, and in high costs to the processor in terms of energy.”

Additionally, at the approved dose for iceberg lettuce and spinach, irradiation may not effectively reduce viruses (e.g., norovirus, hepatitis A), spore forming bacteria such as Clostridium botulinum, and it does not eliminate toxins. However, it is worth noting that these causes of foodborne illness and intoxication are rarely linked to fresh lettuce and spinach. All forms of food processing including ionizing radiation may introduce “resistance” into the microbial pathogen. Likewise, processing techniques may lead to mutations in bacteria. There is a theoretical risk of irradiation-induced mutations leading to increased virulence in a bacterial population, but no evidence of this phenomenon with food irradiation could be found in the literature.

Food Irradiation and Toxicology

Considerable debate about the safety of irradiated food products in terms of potential “side effects” has ensued since the inception of this technology. The primary concerns raised include: 1) potential for “radioactivity” of the food or packaging, and 2) production of toxic elements or “unique radiolytic products” in the food or packaging that may have long-term health consequences for consumers such as cancer or reproductive problems.

An extensive review of the literature revealed no significant health risks for consumers at the irradiation doses approved for food processing. Indeed, the research by preeminent scientists in the fields of physics, biology, nutrition, and medicine overwhelmingly provide data that refutes concerns about food irradiation leading to long-term negative health outcomes. Additionally, respected public health organizations worldwide have reviewed the data, and every major group has stated that food irradiation is a potential tool to protect the public health. In addition to FDA, these groups include but are not limited to: American Academy of Pediatrics, American Dietetics Association, American Medical Association, Centers for Disease Control and Prevention, and the World Health Organization.

Given the massive amount of work by experts already dedicated to addressing the two questions above, only a brief summary and selected citations are provided in this review.

First, it is physically impossible to create radioactivity in food or packaging at the approved food irradiation dosages using gamma ray technology; as discussed in the previous part of this series, gamma rays are the only food irradiation technique that require a radioactive substance (Cobalt 60). X-ray and electronic beam (E-beam) technology do not use radioactive substances, and therefore cannot create “radioactivity” in food or packaging.

The second concern about potential toxic substances created by irradiation, and subsequent effects on human health, has been the subject of intense research for four decades. A few preliminary studies suggested possible risks that prompted more research; the original findings could not be reproduced in later studies, which lead experts to conclude that food irradiation is safe.

One substance is worth mentioning as it is the only chemical described as a potential “unique radiolytic product” in food following irradiation: 2-alkylcyclobutanones (2-ACBs). Scientific evidence indicates that 2-ACBs do not pose a health risk for consumers. The substance is created by a chemical reaction with lipids (fats), and most research has focused on food with fat content (e.g., meat, poultry). Since iceberg lettuce and spinach contain virtually no fat content, 2-ACBs are not relevant in the discussion of food safety and use of irradiation to reduce foodborne pathogens..

In summary, food irradiation is not a “silver bullet” for food safety. However, the increasing problem of illnesses and deaths associated with consumption of fresh produce, including lettuce and spinach, emphasizes the need for an intervention. It is critical that scientists, policy makers, industry, and the public consider carefully the implications of this technology, and its potential role in food safety.

In the next part of this series, the effect of food irradiation on food quality, including sensory and nutritional properties, will be explored.

References

It is getting harder to keep up with the outbreaks of E. coli O157:H7 linked to raw milk.  Now, a third person has been diagnosed with an E. coli bacteria infection, and Vermont state health officials suspect raw milk was the source.  Patsy Kelso, an epidemiologist for the state Health Department, says raw milk is the only link between the three cases in Orleans County, but that officials can't be sure since they didn't test any of the product.  Two of the three people ate ice cream made from raw milk at a picnic, and the third drank raw milk from the same producer.  In Vermont, farmers are allowed to sell small quantities of raw milk and raw milk products, but only on the farm. State health officials and the state Agency of Agriculture recommend that raw milk not be consumed.  Here is a link, complements of Barf Blog, of past raw milk outbreaks.  Looks like I am going to have to keep updating this slide:

At least 40 confirmed cases of the infection with the highly toxic pathogen E. coli O157:H7 have been linked to commercial bagged lettuce distributed by Aunt Mid’s Produce, but the Detroit-based company refuses to name the supplier of the contaminated product. Thirty of the illnesses are in Michigan; the others have been documented in Illinois, Ohio, New York, and Oregon.

“Food borne illnesses are often difficult to trace, as we saw this summer with the tomato-pepper Salmonella outbreak,” said food safety advocate and attorney William Marler. “You want to get to the source as quickly as possible in order to stop the flow of contaminated produce and alert those who might have it in hand to discard or return it. In this case, we have a trail leading directly to the door of the distributor—Aunt Mid’s Produce—and they’re blocking the trail there. Not revealing the source of the contaminated lettuce means that there could be other contamination—in fields or in the supply chain—which is not being stopped. It’s completely irresponsible and should be illegal.”

E. coli O157:H7 outbreaks associated with leafy greens are not a new phenomenon. The FDA has reported that in the last 12 years, twenty-two E. coli O157:H7 outbreaks linked to consumption of contaminated leafy greens have made more than 700 consumers ill. Marler recently released a history of leafy greens and E. coli documenting the outbreaks.

“It’s bad enough that they refuse to name their source,” continued Marler. “But on their website, they go so far as to say that no contamination has been found in their products. This claim is disingenuous at best, reflecting tests done on other product in hand. The link to Aunt Mid’s is clear, and so is their responsibility to the consumer—to reveal where the tainted lettuce originated, so that testing can pinpoint the source, and it can be stopped. Lettuce is highly perishable; every day that passes means information lost.”

Melamine-tainted milk powder has contaminated products world-wide, from infant formula, cookies, tea, and candies.  The contamination has been blamed for the deaths of four children and kidney ailments among 54,000 others.  More than 13,000 children have been hospitalized, over 1,400 with kidney failure.  There have been four deaths.  And guess what?  The tainted powder can be found in food on store shelves in the US.  No recall?

As our government spends $700,000,000,000 on Wall Street, I guess it simply does not have the time nor the money to protect us from an industrial chemical blamed for sickening thousands of infants in China? Go figure.  Where is the FDA and our famous “food czar?”  My guess is they are all watching the stock market and their government retirements flush down the food safety toilet.

Were governments world-wide are pulling products containing the milk powder, the FDA could not be bothered.   Leave it to our new Superhero, “Eddie, the Haphazard Gourmet Girl” to swing into action when the FDA could not be bothered (lycra suit?).   She and her photographer did what the FDA seems incapable to do – take this stuff of store shelves before children eat it.   She first blogged about it a few days ago and then she made made FOX TV 11 in Los Angeles (click here or on picture on right).  FDA, where are you?

For those who forget, melamine, which is high in nitrogen, is used to make plastics and fertilizers and experts say some amount of the chemical may be transferred from the environment during food processing.  But in China's case, suppliers trying to boost output are believed to have diluted their milk, adding melamine because its nitrogen content can fool tests aimed at verifying protein content.  And remember this:

December 2007 - Sanlu Fonterra had first received complaints about its powdered baby formula.

March 2008 - Sanlu Fonterra had hired private companies to test its milk powder for contaminants.  Sanlu Fonterra never issued any public warnings and never stopped promoting its products.

May 18 - After the devastating earthquake in Sichuan Province, the Sanlu Fonterra made a much-publicized donation of $1.25 million worth of baby formula for infants orphaned or displaced by the catastrophe.

June 30 - A mother in Hunan Province had written a detailed letter pleading for help from the food quality agency, the General Administration of Quality Supervision, Inspection and Quarantine (organization that sponsored the Food Safety Conference I attended).  The letter, posted on the agency’s Web site, described rising numbers of infants at a local children’s hospital who were suffering from kidney stones after drinking powdered formula made by Sanlu Fonterra.  The watchdog agency's director, Li Changjiang, and several Communist Party officials in Hebei province, where Sanlu Fonterra is based, lost their jobs.

August 2 - Sanlu Fonterra officials informed the board about the melamine problem.

September - The New Zealand government, after discussions with Fonterra executives, contacted authorities in Beijing.  Beijing officials say they knew nothing about the scandal until September, though a Fonterra company spokesman said the company believed the central government knew in August.

September 9 – Recall announced.

September 29 - FDA does nothing, but the Haphazard Gourmet Girl swings into action.

Local Virginia News reported that a family of a 10-year-old Boy Scout who got sick after eating hamburger tainted with E. coli bacteria is suing the company that supplied the meat.  The lawsuit filed by Jansen Saunders and his parents against S&S Foods alleges 84 people were sickened by tainted meat at the Boy Scout camp near Goshen, and the company should assist affected families.  The suit filed Friday in Rockbridge County Circuit Court says Jansen became ill July 25 and tested positive for E. coli infection while hospitalized.

This is the first part of a multi-part series on the Pros and Cons of Commercial Irradiation of Fresh Iceberg Lettuce and Fresh Spinach.  Given the recent outbreaks, hopefully this is timely.

On August 22, 2008, FDA published a final rule for the safe use of ionizing radiation (also termed irradiation, irradiation pasteurization, cold pasteurization) of fresh iceberg lettuce and fresh spinach for control of foodborne pathogens, and extension of shelf-life. A few weeks later, the US Government Accountability Office (GAO) released a report entitled, “Improvements Needed in FDA Oversight of Fresh Produce.” This report states that FDA’s intervention efforts for reducing the risk of contamination during the processing of fresh-cut produce have been limited. Interestingly, the GAO reviewers only briefly mention irradiation, and brought little context to the implications of introducing irradiation as a potential control (“kill”) step during produce processing.

Currently, a serious outbreak of E. coli O157:H7, possibly linked to iceberg lettuce, is unfolding in Michigan and other parts of the United States. Since 1995, the FDA has documented at least 22 other E. coli O157:H7 outbreaks traced to leafy greens likely contaminated before retail distribution, including a number of outbreaks involving fresh iceberg lettuce and spinach. Clearly, there is a need for improved methods to prevent contamination of produce before it reaches the consumer.

Most food safety experts would agree that there is no silver bullet (defined by Webster’s dictionary as “a magical weapon ; especially : one that instantly solves a long-standing problem”) to guarantee protection of any food from contamination. The use of comprehensive “farm-to-table” approaches is well accepted as the best way to combat the complex problems in food safety.

Where does irradiation of food fit into this evolving continuum including the new rule in the United States for lettuce and spinach?

Irradiation is probably the most studied, and the most controversial, food processing method in history. Several years ago, two renowned food safety leaders, Drs. Robert Tauxe (2001) and Michael Osterholm (2004), published elegant summaries describing the role of irradiation in food safety and protecting the public health. They did not promote irradiation as a silver bullet, but their commentaries suggested the process is one tool in the toolbox, and may be a silver lining (defined as “a hopeful side of an otherwise desperate or unhappy situation”) in the burgeoning problem of foodborne disease.

To better understand the implications of FDA’s new rule, I hit the books with the goal to examine the “pros and cons,” (perhaps more appropriately described as “advantages and limitations”) of using irradiation as a control step during fresh lettuce and spinach processing. The following is the first in a series summarizing the findings.

Part I. Historical Perspective and Definitions