For starters, it is interesting to note the criminal prosecution of those responsible for serving contaminated food.   Note to Jack DeCoster and Stewart Parnell–don’t open new businesses north of the border.  Even under egregious circumstances, such prosecutions are apparently not sought here in the U.S.

In any case, The Standard newspaper reported that two Canadian individuals who operated the Yaman Restaurant in Ontario, were convicted of serving unfit food and fined:

The pair were convicted on five counts of selling unfit food, after a 2007 incident in which the water to the restaurant had been cut off due to a water-main break.  Asaad and Daoud kept their restaurant open and served food.  Several people who ate there later fell violently ill and tests confirmed they had contracted E. coli, with most contracting the same strain of the bacteria public health inspectors later found on chicken and a knife in the Yaman’s kitchen.

The trial judge apparently threw out two of the counts brought on behalf of people who reported falling ill within a day of eating at the restaurant, based on testimony from an expert at trial that the incubation period for E. coli O157:H7 is at least two days.  Another expert testified that it is possible for symptoms to occur after as little as a day, but the judge apparently did not factor this testimony in.

An incubation period of a single day is certainly possible.  According to the CDC:

The time between ingesting the STEC [the family of illness causing E. coli bacteria, like E. coli O157:H7]  bacteria and feeling sick is called the “incubation period.”  The incubation period is usually 3-4 days after the exposure, but may be as short as 1 day or as long as 10 days.

The defendants’ attorney is now attempting to have all the convictions thrown out.

This phenomenon is referred to as “secondary infection” and is very common.  Person-to-person transmission of foodborne pathogens is both common and exceedingly well-documented.[1,2] Secondary transmission cases are well understood in the scientific community to be an inevitable part of any foodborne illness outbreak.[3] Epidemiologists who have worked with us at Marler Clark have estimated to me that at least one in ten cases in an outbreak is likely to be a secondary infection.

What then are the legal consequences that flow from secondary infection?  The short answer is that the producers and sellers of contaminated food are no less liable to victims of secondary infection than they are to those who actually purchased and ate the food.

The first legal hurdle for a secondary infection victim was cleared nearly one hundred years ago, when the requirement of “privity” was removed from claims of injury from products.   Under the old privity requirements, only those who had a direct contractual relationship to the seller (i.e. the buyer) had the legal right to make claims.  Under such a requirement, even a consumer of contaminated food who was not the direct purchaser would have been without remedy.  Famed New York judge Benjamin Cardozo did away with this requirement in the case of MacPherson v. Buick Motor Co. (1916), involving a car’s defective wheel.  Judge Cardozo’s ruling only directly impacted New York law, but other states followed.   In Washington, the lack of a privity requirement is spelled out directly by statute.   “A claim may be asserted under this chapter even though the claimant did not buy the product from, or enter into any contractual relationship with, the product seller.” RCW 7.72.010(5).

More recently, manufacturers and sellers of contaminated food have attempted to argue that they cannot be held liable where the victim had no direct contact with the product.   In a case tried by the attorneys at Marler Clark, this argument was rejected on appeal by the Washington Courts.  The victim in the case was a four-year-old girl who suffered an E. coli O157:H7 infection (and developed hemolytic uremic syndrome).   The source of the E. coli O157:H7 outbreak was ground beef in a taco-meal, but the victim did not eat the meal.  Rather she had repeated contacts with two children who ate the meal, one of whom became infected.  The defendant argued to the appeals court that it could not be held liable where the injured party had no actual contact with the defective product (i.e. the taco meal).   The court disagreed.  The court likened the girl’s claim to a victim in a previous case that had been injured while assisting the victim of someone injured in an accident caused by a defective motorcycle.  The court explained the reasoning in allowing both claims under product liability law:

“There, as here, [the claimant] had no direct contact with the [product] . He was neither a driver nor a passenger. He was not struck by the [motorcycle]. The court nonetheless held there were no policy reasons demonstrating [the defendant’s] ‘liability should be cut off as a matter of law.’ Nor do we find any policy reasons to end the [defendant’s] liability here.  The [Product Liability] Act does not limit “claimants” to those who have direct contact with the product. Indeed, the Act broadly defines the class of persons who may bring a product liability claim.”   Almquist v. Finley Sch. Dist. No. 53, 114 Wn. App. 395 (Wash. Ct. App. 2002)

Defendants are likewise very unlikely to be successful with arguments based on the legal concept of “foreseeability.”   It is unlikely that the foreseeability of particular harm and injury can be a defense in a product liability claim.   Even if the defense is generally available, however, it would not be successful in the secondary infection context; as such outcomes are entirely predictable.  

Secondary infections are a predictable outcome of the sale of contaminated food.   A person sickened as the result of a secondary infection that can demonstrate the product source of the original illness has a claim that is well founded in both law and science.

References

1.  See e.g. K. Ludwig, “Outbreak of Escherichia coli O157:H7 Infection in a Large Family,” Eur. J. Clin. Microb. Infect. Dis. Vol. 16, at 238-41 (1997)

2.  P. Rowe, “Diarrhea in Close Contacts As a Risk Factor for Childhood Hemolytic Uremic Syndrome,” Epidem. Infect. 110:9-16 (1993).

3. See E. Belongia, et al., “Transmission of Escherichia coli O157:H7 Infection in Minnesota Child-Care Facilities,” JAMA, at 887 (Feb. 17, 1993) (describing the inevitable spread of illness from primary to secondary cases).

Safe barbecuing starts well before you fire up the grill. 

If you want to keep your family healthy, the commitment to safety has to start even before you walk out of the grocery store.  Separate raw meat and poultry from other items in the grocery cart–your first guard against cross-contamination between raw foods and ready to eat foods that will not be cooked.  After check-out, get your meat and poultry home and into the refrigerator.  FSIS says to refrigerate all perishable foods within 2 hours, 1 hour if the temperature outside has reached 90 F.  Any poultry or ground beef not to be used in the first 24 to 48 hours should be frozen.  Other meat should be frozen within 4 to 5 days.

If you do freeze meat, it must be thawed properly.  Thaw meat fully to ensure even cooking.   Meat can be slowly thawed in the refrigerator, or in sealed packages in cold water.   Meat defrosted in the microwave needs to go straight to the grill.  

Many people marinate their meat to flavor and tenderize before grilling.   Marinating should be done in the refrigerator, not on the counter.   If you are going to use the same marinade on the cooked food, a portion must be reserved that does NOT come in contact with raw meat.   Marinade that comes into contact with raw meat can be re-used after it has been boiled to destroy any harmful bacteria.

Were still not on the grill yet, but there is still more to think about. 

Meat that is transported to a grill off site should be kept in an insulated cooler that keeps temperatures below 40 F.  Minimize the amount of time the lid is off the cooler, and keep it out of direct sunlight.

Next up is a critical and often overlooked step–avoiding cross-contamination.  All utensils and platters should be clean.  The utensils and platters used for raw meat cannot be allowed to come in contact with cooked meat.  Cross-contamination in this manner may undo all of the precautions you have taken to this point.  Also, remember that everyone preparing the food should properly wash their hands first with warm soap and water for at least 20 seconds.  Also, any person who has been sick with vomiting or diarrhea within the past 24 hours should not be preparing foods.

Finally, it’s time to cook.  

Everyone has a reliable food thermometer that they use every time they cook meat, right?  Temperature is the proper way to judge whether meat is safe to eat.   Color is not–meat and poultry cooked on the grill often brown quickly on the outside.  (See Ground Beef: Safe Handling and Cooking)  Here is the FSIS-approved internal temperature list for various meats:

Poultry–whole, breasts, or ground: 165 F
Hamburgers, beef: 160 F
Beef, veal, lamb- medium rare: 145 F, Medium: 160 F
Pork:  160 F
Any reheated meat:  165 F

Never partially grill meat or poultry and finish cooking later.

Avoid Cross-Contamination

Remember the cross-contamination rules when removing fully cooked meat from the grill.   Place that properly cooked hamburger on the platter that held the raw burgers–and you have the defeated the whole purpose of proper cooking.

Refrigerate

As with all perishable foods, leftovers should be promptly refrigerated.  (Within 2 hours, or within 1 hour in temperatures above 90 F.)  Any food left out more than 2 hours should be discarded.   

This may seem to be a lot to remember, but it really falls into a few basic categories:

1)    Avoid cross-contamination:  keep raw and cooked foods–and the items they come in contact with–separate.
    
2)    Store foods properly:  quickly refrigerate foods at proper temperatures.

3)    Cook thoroughly:  follow the guidelines and use a thermometer.

Have a safe and fun summer grilling season.

Food Safety in School Lunches

Concerns over the safety of school lunches, and in particular the potential for the presence of foodborne pathogens, have been well documented.  USA Today ran a series of articles detailing some of the problems, and stated that, “23,000 children were sickened by food they ate at school from 1998 through 2007.”  The paper’s investigation also revealed that approximately 26,000 schools had not had their mandatory twice-yearly inspections. http://content.usatoday.com/topics/topic/School+Lunch+Safety

In September of 2009, the Government Accountability Office (GAO) released a report, also calling into question the safety of school lunches.  The GAO report especially highlighted deficiencies of notifications to schools of the potential presence of recalled foods in school lunches, and other recall procedures.  As an example, it was estimated that 37 million of the 143 million pounds of meat recalled by Westland/Hallmark in 2008 made its way into school lunches.  More recently, schools had difficulty in assessing whether meat recalled in January, 2010 by Huntington Meats was in schools or not. 

In 2001, an outbreak of E. coli O157:H7 was traced to ground beef in a taco meal served at the Finley Elementary School in Finley, Washington.   The litigation that followed eventually made its way to the Washington State Supreme Court, where the $4.6 million dollar verdict on behalf of the sickened children was upheld. 

The new bill contains proposals aimed at eliminating or reducing these problems.  The act provides new direction to USDA to develop advance warning systems for schools when a food product is recalled.  In addition, new and additional training and qualification standards for school cafeteria staff would be put in place.  

Nutrition and School Lunches

To properly provide for the nation’s children, the school lunch program has to provide food that goes beyond being simply free of pathogens.  The Healthy, Hunger-Free Kids Act of 2010 also takes aim at this goal.  The bill has new nutrition standards, written by the USDA, to be based on recommendations from the Institute of Medicine (IOM). 

The IOM recommendations make the expanding child obesity crisis a focal point:  “Children in the United States are becoming more overweight and obese, putting them at risk for serious health concerns such as diabetes, cardiovascular disease, and elevated cholesterol and blood pressure levels.”

The IOM recommendations are based on 13 standards, which include:
 
Standard 1: Snacks, foods, and beverages meet the following criteria for dietary fat per portion as packaged:  No more than 35 percent of total calories from fat; less than 10 percent of total calories from saturated fats; and zero trans fat.

Standard 2: Snacks, foods, and beverages provide no more than 35 percent of calories from total sugars per portion as packaged. (With some exceptions for types of 100 percent juice and milk)

Standard 3: Snack items are 200 calories or less per portion.

Standard 4: Snack items meet a sodium content limit of 200 mg or less per portion as packaged or 480 mg or less per entrée portion.

Standard 5: Beverages containing nonnutritive sweeteners are only allowed in high schools after the end of the school day.

Standard 6: Foods and beverages are caffeine-free, with the exception of trace amounts of naturally occurring caffeine-related substances.

Standard 9: Sports drinks are not available in the school setting, with limited exceptions for student athletes. 

These standards are aimed in large part at “trimming the excess from school foods and beverages.”   In particular, the guidelines are meant to reduce dietary fats; added sugars; “nonnutritive” sweeteners and soda; flavored, carbonated, and fortified waters; caffeine, and sports drinks.

The IOM also recommends that marketing of foods and beverages at schools should be limited as well.   This includes eliminating vending machines with corporate logos, or that suggest that the vended items have social or health benefits.  

Thankfully, the act provides at least some, albeit limited, financial resources for schools to meet these new goals.  The act provides that schools that implement the new rules would receive an additional 6 cents per meal added to the federal reimbursement rate. 

The bill overall provides $4.5 billion to child nutrition programs, short of the $10 billion increase that had been sought by the Obama administration.  Still, on paper, these appear to be excellent goals and well intentioned guidelines, provided with at least some financial support.  

According to NIDDK, “Chronic kidney disease affects approximately 23 million adults in the U.S. and is a major public health challenge. In 2007, almost 111,000 people in the U.S. began treatment for the most advanced stage of the disease, kidney failure. That year, treatment costs paid by Medicare totaled $23.9 billion — 5.8 percent of the Medicare budget.”

Kidney Health and Food Safety–HUS and E. coli O157:H7

There is a close connection between kidney health and food safety.  Hemolytic uremic syndrome (HUS), a potentially fatal complication of E. coli O157:H7 infection, is the most common cause of kidney failure in children.[1]  HUS is a frequent cause of long-term kidney injury in both children and adults.

Hemolytic uremic syndrome develops when the toxins from bacteria such as E. coli O157:H7, known as Shiga-like toxins (SLT), enter the bloodstream through the inflamed bowel wall.[2] SLT attach to receptors on the inside surface of blood vessel cells and initiate a chemical cascade that results in the formation of tiny thrombi (blood clots) within these vessels.[3] Several organs appear more susceptible to these clots, including the kidney.  Thus, when fully expressed, HUS presents with the triad of hemolytic anemia (destruction of red blood cells), thrombocytopenia (low platelet count), and renal failure (loss of kidney function).[4]  

There is no cure or effective treatment for HUS.[5]  Approximately half of the children who suffer HUS require dialysis to survive the acute stage of the illness.  Those who do survive almost invariably suffer irreversible damage to the kidneys.  The damage sustained in the short term then places the patient at risk for long-term kidney complications, including end stage renal disease (ESRD).  Five percent or more of those who survive have long-term kidney impairment.[6]

Hyperfiltration Injury

“Hyperfiltration injury” is a term used to describe chronic, progressive damage in kidneys that have already sustained significant damage during an HUS illness, resulting in the destruction of a substantial percentage of nephrons.  Nephrons are the functional units of the kidney and are comprised of glomeruli connected to kidney tubules.

Where hyperfiltration injury has occurred, the remaining healthy glomeruli attempt to adapt to their reduced number by enlarging (hypertrophy) and by hyper-filtrating.  In other words, 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.  The glomeruli, however, are being over-worked.  This overworking of glomeruli is manifested by the spillage of protein (albumin) in the urine.  This phenomenon is called proteinuria.

Over time, the hyperfiltration injury causes progressive loss of the remaining glomeruli due to the formation of scar tissue, or fibrosis.  Once the remaining functional nephron population drops below 10 percent, the person’s survival requires initiation of “renal replacement therapy”.

There are some medications that can help slow the need for renal replacement therapy.  The use of 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.

End Stage Renal Disease

Common problems associated with the development of ESRD include:

Reduced ability to excrete waste products and maintaining fluid and electrolyte balance:   As kidney function declines, waste products will accumulate.  The patient will experience uremic toxicity characterized by weakness, loss of appetite, nausea, and vomiting, and if not treated with dialysis, seizures, coma and death.  

Accumulation of body acid:  The patient will need to take a base such as sodium bicarbonate to neutralize remaining body acid.  Failure to do so results in poor appetite and weakened bones.

Anemia:  The patient may require hormone injections that would begin no later than the start of dialysis, and probably sooner.

Loss of bone density:  The patient is at high risk for bone pain and fractures.

High blood pressure: High blood pressure afflicts the majority of kidney failure patients.   Failure to maintain normal blood pressure increases the risk of heart failure, heart attack and stroke.

Once ESRD is reached there are two survival options:  long-term dialysis treatment or a kidney transplant.  Dialysis is a treatment designed to replace what damaged kidneys can no longer do. Treatments are usually 3-4 hours three times a week.  Receiving regular dialysis presents several challenges.  

At some point, kidney transplant may be preferable to dialysis or become necessary for survival.  The wait for a kidney is months to years, depending on the availability of a donor and the recipient’s blood type.  Since all kidneys except those from an identical twin are recognized as “foreign” by the recipient’s immune system, it will be necessary, for the rest of a transplant recipient’s life, to use immunosuppressive medications to reduce the risk of rejection.   Common complications of renal transplant include the following:

Acute rejection of the transplanted kidney.  This often requires a biopsy of the graft, and the use of very powerful medications (probably requiring hospital stays).

Infections (viral, fungal and bacterial) that can be life threatening.

Cancer due to the Epstein- Barr virus, and goes by the term of Post Transplant Lymphoproliferative Disease (PTLD).  

Osteopenia, an additional post-transplant risk is osteopenia (loss of bone calcium).

Premature coronary artery disease–coronary artery disease (including myocardial infarction) is the most common cause of death in the transplant population.

There is no known treatment to stop the progression of HUS–at either the acute stage or long-term.  Likewise, while not all those infected develop HUS, there is no way of preventing the development of HUS in a person infected with E. coli O157:H7.  As a result, there is only one avenue to reducing the impact of E. coli O157:H7 on kidney health–preventing food from becoming contaminated with E. coli O157:H7 in the first place.  

References

1.  Chinyu Su, MD & Lawrence J. Brandt, MD, Escherichia coli O157:H7 Infection in Humans, 123 Annals Intern.  Med. (Issue 9), 698-707.

2.  Amit X. Garg, MD, MA, et al.  Long-term Renal Prognosis of Diarrhea-Associated Hemolytic Uremic Syndrome: A Systematic Review, Meta-Analysis, and Meta-regression, 290 JAMA (No. 10) 1360, 1360 (Sept. 10, 2003).

3.  Richard L. Siegler, MD, The Hemolytic Uremic Syndrome, 42 Ped. Nephrology, 1505 (Dec. 1995), at 1509-11 (describing what Dr. Siegler refers to as the “pathogenic cascade” that results in the progression from colitis to HUS).

4.  Nasia Safdar, MD, et al.  Risk of Hemolytic Uremic Syndrome After Treatment of Escherichia coli O157:H7 Enteritis: A Meta-analysis, 288 JAMA (No. 8) 996, 996 (Aug. 28, 2002).  at 1360.  See also Su & Brandt, at 700.

5.  Id., at 996.  See also Siegler, supra note 3, at 1379.  (“There a
re no treatments of proven value, and care during the acute phase of the illness, which is merely supportive, has not changed substantially during the past 30 years.”)

6.  Safdar, supra note 4, at 996 (going on to conclude that administration of antibiotics to children with E. coli O157:H7 appeared to put them at higher risk for developing HUS).

There are currently federal regulations on the books regarding traceability.  It is not clear, however, that these regulations are sufficient, or that they are being adhered to.  A focus on improved traceability will benefit all stakeholders in the food safety discussion (isn’t that everyone?).  

Why is traceability a good thing?

Improving product traceback is an aspect of food safety reform that should receive near unanimous support, as it will result in improved outcomes for both consumers and the food service industry.  For consumers, better traceability can mean:

1.    Fewer outbreaks:  The ability to identify where food has gone downstream from a supplier can better allow a recall or removal from the marketplace before illnesses occur.  If testing or inspection uncovers a problem with a product, a corporation that knows exactly where its products have gone may be able to prevent them from even reaching consumers.

2.    Smaller outbreaks:  Even where a contaminated product makes it to market, traceability can greatly reduce the size of an outbreak.  Once again, this would be accomplished by more quickly removing the contaminated product from the market.  

3.    Protecting consumer choice and health:  When the scope of an outbreak cannot be immediately determined, health officials have no choice other than to err on the side of caution.  In September 2006, it became clear that a nationwide E. coli O157:H7 outbreak was linked to spinach consumption.  At the outset though, there was insufficient epidemiological data to be certain of the brand or brands involved.  In addition, even with a reasonably good identification of the brand, it could not be conclusively and quickly determined where the product had originated, and whether other brands might also have incorporated the same product.  Therefore, the FDA’s first pronouncement of the E. coli outbreak advised consumers nationwide to cease the consumption of “fresh spinach,” period, until a specific product could be identified as the source of the outbreak.  As a result, a healthy, popular food choice was removed from consumers’ menus. Only by avoiding all fresh spinach could consumers also avoid illness.

On the industry side, points one and two are plainly beneficial as well.  As a food producer, if it is your product that is contaminated, excluding or limiting consumer access to that product has obvious benefits.   Beyond that, there are more benefits:

1.    Differentiating your company’s brand from the recalled product:  Dovetailing with #3 on the consumer side above, the benefits of excluding your brand from a recall, with confidence, is very valuable.   During the early days of the Spinach outbreak, many ultimately unconnected brands of fresh spinach went unsold.

2.    Protecting the image of an entire product line.  In 2008 an outbreak of Salmonella Saintpaul sickened more than 1,200 people.  For weeks, public health officials struggled to identify the source.  Possibilities vacillated between different types of tomatoes, peppers, and other agricultural products.  Some of the problem in identifying the proper product was epidemiological–many sick people had eaten these products in tandem on more than once occasion.  But part of the problem is that produce distributors could not fully identify the entities upstream that had sold them suspect products.  Ultimately, different tomato products were pulled from the shelves, apparently in error.   This not only damaged sales in the short term, but it also could have damaged the long-term reputation of the product.

3.    Protecting a company in a legal setting:  It’s never good news if your company is implicated as a member of the chain of distribution of a contaminated product in an outbreak.   The legal battle that may ensue, however, can be much less threatening where the true “at fault” party can be determined.  Product liability laws vary from state to state.  Still, in many states, the current law offers full or partial protection for entities in the chain of distribution that are no more than “pass-throughs”.   

What are the current regulations on traceability?  Are they being followed?

Current regulations are applicable to traceability in the food industry.  Federal regulations stemming from the Public Health Security and Bioterrorism Preparedness Response Act of 2002 place certain obligations on those who “manufacture, process, pack, transport, distribute, receive, hold, or import food.”  See 21 CFR 1.326 et. seq.  As you can see from the list, the regulations are intended to apply very broadly to those throughout the chain of distribution.  Information that must be tracked includes dates of production, description of the food, quantity, manner of packaging, and lot numbers.  In addition, those shipping must have the contact information of the entity receiving the food.  Those downstream must have that same information for all food items received.   

It is not clear, unfortunately, that these potentially helpful regulations have been adhered to.  In March of this year, the Wall Street Journal (WSJ) reported that a survey of facilities covered by the regulations indicated that 60% were not keeping the records.  WSJ reported that a “watchdog agency also tried to trace 40 items such as fresh tomatoes, whole milk, oatmeal, and yogurt from retail stores to the farm where they were grown, but could do so for only five items.”  (See my earlier commentary, “Food Traceback in USA is Worthless.”)   

How can traceability be improved?

One obvious step to improved traceability is for the entities involved to comply with existing regulations.  Again, following these regulations offers numerous benefits, not simply the burdens ordinarily associated with regulatory compliance.  Beyond this, new food safety legislation also takes aim at traceability issues.  For example, Senate Bill 510, the FDA Food Safety Modernization Act, would require the following, aimed specifically at traceability in produce:

• The establishment of a pilot project in coordination with the produce industry to explore and evaluate methods for effectively tracking and tracing fruits and vegetables that are raw agricultural commodities.
• This program is to include at least three types of fruits or vegetables that have been the subject of outbreaks during the past five years.
• The creation of standards for the type of information, format, and timeframe for persons to submit records to aid in effectively and rapidly tracking raw fruits and vegetables in the event of an outbreak.

S. 510 passed out of committee, but is still awaiting a vote on the Senate floor.  Hopefully, such a vote will come shortly.

Where are we now?

Traceability shouldn’t be a controversial part of our country’s food safety scheme.  Improved traceability is good for consumers and industry.  Its focus is on prevention of illness in the first place, but it also is a useful tool in defining and understanding problems when they arise.  Food industry businesses ought to be making a full commitment to traceability of all of their products notwithstanding any addition, or lack thereof, to the existing legislation.

The show was open from January 10 to 25, 2009.   The common denominator among all cases of E. coli O157:H7 in the outbreak was attendance at the show.  It appears that the exposures occurred at the “feed the animals” exhibit.  

Depending on counting method and reporting variances, the number of outbreaks at animal exhibits exceeds two dozen.

It doesn’t have to be this way.  

The CDC has been publishing guidelines designed to prevent or greatly reduce the likelihood of outbreaks in these settings since 2001 when high profile E. coli O157 outbreaks in Pennsylvania and Ohio prompted legislation designed to institute changes in animal exhibits in Pennsylvania.  In the summer of 2004, the National Association of State Public Health Veterinarians and CDC issued an updated set of guidelines and provided specific instructions on how to prevent the spread of zoonotic disease (i.e. disease spread from animals to humans).  Among these:

• Educate vendors about the risk of the spread of zoonotic disease, and methods of prevention.
• Educate fairgoers, in multiple formats, of the same risks and methods of prevention.
• Make special effort to reduce risk among vulnerable populations, especially children.
• Provide adequate hand-washing facilities;
• Design animal exhibits to reduce and control human/animal interaction;
• Closely supervise animal/human interaction, again with special attention to children;

Despite the presence and widespread dissemination of these guidelines, October of 2004 brought one of the most devastating petting zoo E. coli O157:H7 outbreaks yet.  The outbreak at the 2004 North Carolina State Fair led to 108 cases.   Of these, forty-one were laboratory confirmed with E. coli O157:H7.   The ill were almost entirely children, with a number of very severe cases of hemolytic uremic syndrome (HUS).  

The investigation of the outbreak eventually led to the release of a report by the Duke University Institute for Public Policy.  The recommendations in the Duke report were well conceived and well supported.  Still, there was really nothing new about the North Carolina outbreak that informed those recommendations.  The North Carolina outbreak resulted from the failure and/or refusal of those who ran the fair and its exhibits to implement CDC-endorsed guidelines to address a well-documented risk.

Still, there was more to come.  Just months after the North Carolina outbreak a string of E. coli O157:H7 outbreaks linked to a common vendor plagued animal exhibits in Florida.  The AgVenture Farms E. coli O157:H7 outbreak was first recognized after two separate HUS case reports were posted to the Florida Department of Health in March 2005.  The fairs ultimately implicated were the Florida State Fair, the Central Florida Fair and the Florida Strawberry Festival, all in 2005.  A total of 22 confirmed, 45 suspect and 6 secondary cases from 20 Florida counties were identified as victims of this outbreak.  Most cases were infected at either the Central Florida Fair or the Florida Strawberry Festival. Three cases were associated with the Florida State Fair.  Twelve cases developed HUS.

Since that time, the CDC has made updated recommendations for animal exhibitors available, but the tide of outbreaks does not appear to be stemmed.  Another petting zoo in Florida was linked to an E. coli O157:H7 outbreak in 2007.  More recently, a number of children were sickened in the UK in an E. coli O157:H7 outbreak linked to the Godstone farm. 

The saddest part is that these outbreaks can likely be greatly curtailed, if not eliminated.   The guidelines are not only available, but feasible.  Hopefully, those operating these events will get the message soon.

Unfortunately, this glaring lack of concern for the safety of food in the school lunch program is nothing new.   In our work at Marler Clark, we have litigated cases arising out of an array of food safety failures.   The facts surrounding the outbreak of illnesses amongst students at the Laraway Elementary School in Joliet, Illinois in 2002 may well be the most shocking and unconscionable.

In 2001, the USDA supplied the State of Illinois with commodity bulk chicken for the National School Lunch Program (NSLP).  The chicken was processed into “tenders” by a commercial chicken producer and retailer.  Illinois also contracted with Lanter Company to store and deliver the tenders to schools in Illinois.  Lanter stored the tenders at a frozen food storage facility in St. Louis, Missouri, operated by Gateway Cold Storage, (Gateway).

On November 18, 2001, there was a large anhydrous ammonia leak at the Gateway facility.    At the time of the leak, a USDA compliance officer was on site, and aware of the leak.  According to the various health agencies that later became involved, the USDA did not notify any other agency of the leak.  Likewise, the USDA apparently took no steps to curtail or stop shipping of foods from the facility, despite the leak.  

In the days following the leak, and prior to notification of any health agency other than the USDA, Gateway shipped products to the Illinois State Board of Education (ISBE).  St. Louis Health officials appear to have first learned of the leak from cafeteria employees’ reports of harsh-smelling potato wedges.   

Because Gateway and Lanter continued shipping products involved in the ammonia leak, ISBE began receiving reports from schools that they had been shipped commodities with a strong ammonia odor on November 27, 2001.  The products that led to the complaints were potato wedges, with a product code of A174.  Amazingly, it was these products that were later confirmed to have been “directly below the ammonia leak.”  Despite the fact that these products had been directly exposed to the leak, Lanter and Gateway had gone ahead and shipped them to Illinois schools without notifying to the schools.  The potato wedges were part of more than 800,000 pounds of products that were shipped from the facility with the USDA present, and without involvement from any other health agency.  

After the ISBE learned of the contaminated potato wedges, it contacted Gateway and Lanter. Only at this point did Gateway and Lanter advise ISBE of the leak.   At this point, shipment of food exposed to the ammonia finally ceased.  
    
Believe it or not, this was not the end of the story, not even close.  Instead of disposing of the various foods exposed in the leak, the various health agencies involved, now including the FDA, came up with a plan to salvage much of the food involved.  

On December 6, 2001, a consulting firm sent an industrial hygienist to Gateway to take ambient samples of food products to determine if ammonia had saturated food product.   Still, it does not appear that any of the exposed chicken products were ever tested.  

The USDA refused to release most of its documents concerning the incident when requested through the Freedom of Information Act.  Still, it is clear that at some point in early 2002 Gateway and Lanter once again began shipping products from the St. Louis facility to schools in Illinois.  Complaints to the ISBE regarding the food began almost immediately.  

By January 2002, schools began complaining about beef patties that stunk of ammonia.  As schools continued to complain to the ISBE and to reject shipments from Lanter and Gateway, the USDA was apparently notified.  

Throughout the remainder of the school year, schools complained about various foods that arrived reeking of ammonia.  Individual schools were allowed to reject product and receive replacement – but no move was made to stop the shipments.  

The chicken tenders in question were not sent immediately after shipping re-commenced.  The boxes of chicken tenders had been so inundated with ammonia that the majority of the boxes had been saturated to the point that the ammonia smell could not be dissipated, or to the point that the boxes themselves were destroyed.  Nonetheless, the corporations, in conjunction with the USDA, pressed forward with a plan to salvage the product.

A letter from Gateway to ISBE dated February 21, 2002, stated that Gateway’s planned repackaging of the chicken product would take 2 days to 2 weeks.  There were 361 boxes of the chicken, each with 20-22 pounds of product in 5 individual bags.  According to the letter, “[Gateway has] contacted the FSIS [Food Safety Inspection Service, a branch of USDA] and the USDA and have made arrangements for an inspector to oversee our repackaging process.”  

For unknown reasons, the repackaging of the chicken did not take place for several more months.  There is significant confusion, in part due to the lack of USDA documents, as to the exact date of the re-packaging.  The repackaging of the chicken was apparently done by Lanter employees in late June or late July of 2002, purportedly under the supervision of the USDA St. Louis Branch.   

Before the 2002 school year had begun, and prior to the shipping of the chicken, at least two dozen schools complained of products with a strong ammonia smell.   Nevertheless, the shipments continued.  On August 15, 2002, the first day of deliveries for the 2002 school year, schools were again complaining of ammonia smell, at this time connected with beef patties.  

In October 2002, cafeteria workers at Illinois schools began complaining to ISBE about the chicken tenders either smelling or arriving in damaged or unfamiliar boxes.  On October 15, 2002, the Chicago Heights school rejected chicken due to ammonia smell.  On October 23 and 24, 2002, three more schools complained.  Still, none of the other schools that had received the products as part of their participation in USDA’s National School Lunch Program were notified or warned.

As schools continued to complain, it appears that no one tested the chicken, or made an effort to remove the remaining chicken from storage at other schools.  Rather, individual shipments were returned to Lanter.  

More than a month after all of these warnings, the chicken was still sitting at Laraway Elementary School, in Joliet, Illinois.   On November 25, the chicken tenders were served as part of the National School Lunch Program.  The tenders were also served at Oak Valley Elementary, also in Joliet, on that day.

Within minutes of ingesting the contaminated chicken, students and teachers began to fall ill.  The children’s illnesses were characterized by nausea, vomiting, headache, and burning sensations in the mouth, nose, and throat.  Students ran from their classrooms, vomiting.   The sudden outbreak led to eighteen ambulances bringing forty-four children to five local hospital emergency rooms.  As the ambulances, police and media personnel descended on the school, frightened students and teachers had no idea what was going on, or why the students had fallen ill.  Of course, it was later determined that the students were victims of ammonia poisoning.   
On December 2, 200
2, the USDA verified very high ammonia levels in leftover re-boxed chicken through its own laboratory analysis.  This verified testing conducted by an independent laboratory at the behest of IDPH.  The testing showed contamination of the tenders with ammonia at 500-2,000 parts per million (ppm).  The legal limit for ammonia is 15 ppm.   

Thankfully, it does not appear that any of the children affected suffered any permanent physical harm.  Acute ammonia poisoning, however, can be fatal.  Perhaps most remarkable about this situation was the large number of people and agencies who had multiple opportunities to prevent the outcome.  The recent article in USA Today only serves to emphasize that protection against similar future occurrences is still lacking. 

If you wouldn’t, don’t eat with the decision makers from the FDA.   In a letter to the Corn Refiners Association in July 2003, FDA “Product Evaluation and Labeling Team” Supervisor Geraldine June told manufacturers of high-fructose corn syrup that product in that manner could be labeled as “natural.”  Interestingly, although the term “natural” is affixed to a great many products on the shelves in grocery stores today, it is not precisely defined outside of the context of food coloring and flavoring.  In a preamble to a rule making in the Federal Register, the FDA describes natural as meaning “nothing artificial or synthetic has been added to a food that would not normally be expected to be in the food.”  (58 Fed. Reg. 2302, 2407).

Not everyone agrees with the FDA that high fructose corn syrup fits this definition.   In 2007, a class action lawsuit on behalf of consumers was filed in Federal District Court in New Jersey against the beverage manufacturer Snapple.   The suit alleged that the claim the beverage was “all natural,” as indicated on packaging was misleading.  Snapple based its defense on the legal doctrine of preemption.  (Snapple now produces its product without high fructose corn syrup.)

Preemption is a legal doctrine based in Article VI, Section 2 of the U.S. Constitution that holds that federal law is the supreme law of the land.  Under the doctrine, state laws deemed to be in conflict with federal regulation cannot be upheld.   The class action complaint by the consumers was based on fraud, defined by state law in New Jersey.  Thus, if U.S. law regarding labeling rules was deemed to be in conflict with New Jersey laws on fraud, the U.S. law would negate or preempt an action based upon the state law.

There are generally two types of preemption.  The first is express preemption, which is found where a federal law explicitly states that any state regulation on a subject is intended to preempt any existing state laws.   More common is implied preemption, where a litigant argues that preemption of state law is implied in the federal regulatory scheme.  There are, in turn, two types of implied pre-emption–conflict preemption and field preemption.  The term conflict preemption is used where the federal and state law are perceived to be at odds.  In such a case, of course, the federal law trumps.  In field preemption, the federal government is found to have so pervasively regulated an area as to preempt any state regulation in the area.

Snapple defended the fraud claims, arguing all three types of preemption.   Largely though, the argument focused on implied preemption, based on the FDA’s 2003 letter allowing the “natural” claim.  As such, a state law ruling to the contrary would be in conflict with the federal regulation, and thus preempted.  

The District Court agreed, finding that the FDA letter constituted a formal definition of the word natural, and then also finding that FDA regulated the area so fully as to trigger “field” preemption of state claims.   

The plaintiff class members appealed to the Third Circuit.  There, the judges reversed the District Court’s ruling.   See, Holk v. Snapple, 575 F. 3d 329 (3rd Cir. 2009).  The Appeals Court rejected the claim of field preemption, finding that the FDA was aware of and allowed state regulation in the area.  The Court also rejected the idea of conflict preemption.   In doing so, it held that the letter from the FDA did not rise to the level of an official federal regulation, and that only such an official regulation could hold the power to preempt state law.  With those holdings, the case has been remanded to the District Court for further proceedings.

In the meantime, a similar suit was filed in California in August of this year.   Without clear guidance from the FDA as to the meaning of the term “natural” on food labels, such litigation is likely to continue.   Food industry marketers clearly place some value on being able to make such a claim on their product.  The question is, how much does that claim signify to consumers?  

All sarcasm aside, the importance of safe food handling practices for healthcare workers is likely underrated.  While safe food is important to all of us, healthcare food service workers serve a particularly vulnerable population.  The elderly, in particular, are foremost among that vulnerable population.

The Increased Risks Posed by Foodborne Pathogens to the Elderly

One group of persons served by healthcare foodservice workers is the elderly.  Morbidity and mortality in the elderly from infectious disease is far greater than in other populations.  For instance, death rates for infectious diarrheal disease alone are five times higher in people over 74 years of age than in the next highest group, children under four years of age, and fifteen times higher than the rates seen in younger adults.  Published studies attribute the elderly’s heightened risks, both of infection and mortality due to enteric infectious disease, to several factors:  (1) the aging of the gastrointestinal tract (reduced gastric acidity/reduced gastric mobility); (2) a higher prevalence of underlying medical disorders (co-morbidity factors); and (3) malnutrition and a decline in the immune response that leaves the host less able to defend itself against infectious agents.

1.    Aging of the Gastrointestinal Tract–An Invitation to Infection

Inflammation and shrinkage of the gastric mucosa increase with age.  These changes lead to low gastric acidity.  Because stomach acids play an important role in limiting the number of bacteria that enter the small intestine, low gastric acidity increases the likelihood of infection if a pathogen is ingested with food or water.

Gastrointestinal mobility also decreases with age, meaning that life-threatening pathogens are removed from the body more slowly.  This delay contributes substantially to the increased prevalence and severity of infection in the elderly.  When the pathogen is E. coli O157:H7, decreased gastrointestinal mobility allows the bacteria to multiply and produce more of the toxin that is absorbed in the gastrointestinal tract and leads to a higher likelihood of complications.

2.    A Higher Prevalence of Underlying Medical Conditions–
Co-Morbidity Factors

Underlying medical conditions or disease (co-morbid factors) also contribute to the morbidity and mortality of infection in the elderly.  Among hospitalized patients, those older than 65 develop pneumonia twice as often as younger patients. Pneumonia is the leading infectious cause of death in the elderly.  

When an infectious microorganism, regardless of source, gains access to the bloodstream, the patient may develop systemic sepsis, also known as bacteremia.   Bacteremia is most common in people who are already affected by, or are being treated for, some other medical problem (co-morbid disease); conversely, people in good health with strong immune systems rarely develop bacteremia.  The main sources of bacteremia in elderly patients are the urinary tract, gastrointestinal tract, respiratory tract, and the skin.  Other potential sources include surgical wounds, invasive tubes and catheters, intravenous lines–virtually any site where an invasive medical procedure has occurred.  Bacterial organisms most likely to cause bacteremia include members of the Staphylococcus, Streptococcus, and Escherichia coli genera.  

3.    A Weakened Immune System–An Inability to Fight Off Infection

With advancing age come progressive weakness, decline, and dysfunction of the immune system.  Many of the body’s natural physiologic responses to infection are therefore blunted in the elderly; and the intensity of many clinical signs and symptoms in an elderly patient with an infectious process are muted when compared to those in a younger person.  This age-related decline contributes significantly to the increased risk of severe illness and mortality in elderly persons with infectious disease.  The effect of a weakened immune response on the health of an elderly person often manifests most apparently during periods of intense stress (e.g., surgery, sepsis, multiple organ failure, malnutrition, dehydration).

Prior Foodborne Illness Outbreaks in Healthcare Settings

2005 E. coli O157:H7 Outbreak, King County, Washington

In late September 2005, Pubic Health Seattle and King County (PHSKC) and the State of Washington Department of Health (WDOH) began investigating a cluster of E. coli O157:H7 illnesses in King County.  The agencies eventually concluded that an outbreak consisting of 14 cases of E. coli O157:H7 (4 laboratory confirmed cases, and 10 probable cases) was tied to consumption of food served at a senior living facility in Bellevue, Washington.   One of the members of the outbreak, an 83-year-old woman, who was culture confirmed with E. coli O157:H7, died as the result of her infection.  PHSKC determined that the source of illness was traced to ready-to-eat foods prepared at the facility–likely a garnish.  PHSKC investigators conducted an on-site inspection of the kitchen, and found food-handling errors, that supported the conclusion that the ready-to-eat foods had been cross-contaminated through contact with raw meat products.  

2003 E. coli O157:H7 Outbreak, San Mateo County, California

In 2003, the San Mateo County Health Services Agency investigated an outbreak of E. coli O157:H7 and determined that sixteen confirmed and probable E. coli O157:H7 cases were linked to spinach served by Sodexho at an upscale retirement facility in Portola Valley.  The spinach, which was pre-packaged before it reached the facility, was never washed by Sodexho staff in the kitchen prior to serving.  As with the 2005 outbreak in Washington state, one of the residents of the facility died as the result of her infection.  

Conclusion

As the tragic examples above demonstrate, healthcare foodservice workers have a lot at stake when preparing food for their patients and clients.  Those with compromised immune systems, including the elderly, are at great risk for severe complications of foodborne illness.  

National Healthcare Foodservice Workers Week is being promoted by the American Society for Healthcare Food Service Administrators.

First, MDA’s tips for the hungry football fan:

• “Wash hands with warm, soapy water for at least 20 seconds before, during and after handling food. Hand sanitizing gels kill the bacteria, but don’t remove dirt and dead bacteria.”  Hand washing is the forever under-appreciated tenet of food safety.  A review of surveillance data for U.S. foodborne disease outbreaks over a five-year period by the CDC in 1435 foodborne illness outbreaks, that poor personal hygiene was a contributing factor in over a third (514) of them.  Hand washing is important for both the person preparing the food, and those eating it.  In group-meal and buffet-meal settings, the importance of hand washing for food consumers may be magnified.
• “Defrost meat in the microwave or refrigerator, not on the counter at room temperature or outside near the barbeque.”  The danger zone for most foods and pathogens is between 40° and 140°F.   Defrosting foods improperly leaves them in this danger zone for too long, increasing the likelihood of pathogen growth and transmission.
• “Undercooked meats pose a risk for E. coli infection, which can lead to kidney failure or death.” Kudos to MDA for providing the proper cook temperatures for the various meats:  “Veal, lamb, and pork to an internal temperature of 160 degrees; ground poultry to 165 degrees; and steaks to at least 145 degrees (medium-rare). Whole poultry should reach 180 degrees in the thigh and breast meat to 170 degrees.”  It is remarkable that a Google search will still lead you to articles giving advice on the “done-ness” of meats based on color.   It has been shown repeatedly that color is not a safe indicator of meat’s internal temperature–a point that is demonstrated in this site’s article, “Ground Beef: The Importance of Safe Handling Practices and Accurate Final Product Temperature.”
• “Wash all plates, utensils and surfaces that come into contact with raw meat before using them again.”  This one might seem like a no-brainer, but cross-contamination can be overlooked as a possible culprit for foodborne illness.  Properly cooking raw meats is not enough to prevent illness if ready-to-eat foods are allowed to come in contact with the surfaces that touched raw meat.
• “Keep cold dishes cold and hot dishes hot. Do not leave perishable food out for more than two hours, or no longer than one hour if the temperature exceeds 80 degrees.”  This gets back to the guideline on defrosting above.   It is essential to keep foods from reaching internal temperatures in the “danger zone” between 40° and 140° F.

Food safety is especially important for school children.   Younger people are at increased risk for severe complications associated with foodborne illness, including a greatly heightened risk for developing hemolytic uremic syndrome (HUS).  HUS is a potentially fatal complication of E. coli O157:H7 infection.  Not surprisingly, the MDA tips for packing school lunches mirror those associated with tailgating.   Thus, one very important goal for school lunches is to keep foods out of the previously mentioned temperature “danger zone” between 40° and 140°F.   MDA had these ideas for keeping foods out of this range:

• Put something cold in the lunch box.   This can be a frozen juicebox, or an icepack from the fridge.
• Freeze sandwiches.  Ok, I’ll admit, I am not sure my kid will eat his PBJ frozen, but he does like ice-cream sandwiches….
• Use a thermos to keep milk or juice cold until lunchtime.
• Store lunches in a cool place.  A refrigerator is best is one is available.   

The other big hint for kids and food safety is the same as it is for adults – wash hands.
Representing so many children with devastating foodborne illnesses has helped push me to really make this an issue in my home.   It is such a simple thing that can really make a difference, so make a full household commitment to washing hands.

Here’s hoping that you follow these tips and keep all of your little ones, and football fans of all sizes, eating safe this fall.