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Publisher’s Platform

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Last week I spoke at the National Environmental Health Association annual convention.  My talk was entitled “What has Changed Since Upton Sinclair?   A Contemporary View of Food Safety.”  As I told the audience at 7:30 a.m., to put things in context, in 1906 the U.S. population was only 85,450,000 and today it hit 309,388,000.  Per capita beef consumption was 71.1 pounds in 1906, today about 60.0 pounds.  Things have changed at least a bit.

hamburgers-grill-featured.jpgIn January 2007, I wrote in an Op-ed piece “The Jungle Revisited, 100 Years Later,” where I actually agreed in part with the President and Chief Executive of the American Meat Institute when he said, “Since 1999, the incidence of E. coli O157:H7 in ground beef samples tested by the Agriculture Department has declined by 80 percent to a fraction of a percent, a level once thought impossible.”  In fact, E. coli illnesses, outbreaks and recalls where falling and falling fast.  Less than a half decade earlier most of my clients had been sickened by contaminated meat. Between 1993 and 2002 I took over $250 million from the meat industry in verdicts and settlements on behalf of my clients, mostly children with kidney failure caused from consuming E. coli-contaminated hamburger.  In the summer of 2003 I expected the normal flood of calls from parents of kid’s stricken with Hemolytic Uremic Syndrome–they did not come.  They did not come in 2004, 2005 nor in 2006.

What changed from Jack in the Box until 2003?  To turn that mess around we needed somebody like Michael Taylor, who was head of The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) in the mid-1990s, when undercooked hamburgers from Jack in the Box sickened 650 people and killed four children. In the wake of that epidemic, Taylor stood before the American Meat Institute and announced, “We consider raw ground beef that is contaminated with E. coli O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act.” Taylor was warning the industry “things were going to be different and there was going to be accountability.”  Things changed.  Was it because E. coli O157:H7 was now an adulterant?  Was it because of HACCP?  Did the Industry step up?  I do not know the answers for sure, but for a few years there were fewer recalls or illnesses tied to ground beef.  I touted the meat industry as a model of what an industry could do that was right to protect consumers.

But then it changed again. Since April of 2007, 50 million pounds of red meat, mostly ground beef products, has been recalled. To put that in perspective, that is enough red meat to make 200 million hamburgers.  E. coli illnesses once on a downturn spiked.  Kids were getting sick, seriously sick, again–nearly 100 since April 2007. Topps Meat Company expanded its 300,000-pound recall to include 21 million pounds of ground beef. This recall tops the ConAgra recall of 19 million pounds in 2002 that sickened over forty and killed one and is just under the 25 million pounds recalled by now-bankrupt Hudson Foods in 1997.

And was the governmental response?  The then Under Secretary for Food Safety at the USDA/FSIS told us: “our meat supply is the safest in the world.”  This when Topps, a company in operation for nearly 70 years, closes its doors and recalls 21 million pounds of ground meat after sickening 30, and Cargill, one of the largest food producers in the U.S., recalls hamburger after sickening 4 children in Minnesota and a dozen others in several states. “The U.S. beef supply is safe?”  Tell that to Stephanie Smith.

One would think that with hundreds of Americans poisoned that the Secretary would not be acting as the “cheerleader in chief” for the beef industry, but would be asking one simple question–”What is going on?”   I called on Congress to act.  I said that it was time for Congress to accept a leadership role and call hearings on “How safe is our meat supply, really?” Hearings need to not only explore the reasons for the past months’ outbreaks, but also to help prevent the next one. Congress must reach out to all facets of the meat industry, from “farm to fork,” to consumers who bear the burden of illnesses, and to academics and regulators to find reasonable, workable solutions to prevent the next meat-related illnesses. More regulation may not help. Testing all products may not be feasible. More funding for the CDC and USDA may not be enough. And, more research at universities may not find all of the answers.  But, getting everyone concerned to the same table is a start.

The American Meat Institute’s Patrick Boyle was quoted recently: “We are selling a raw product, however, and raw products by their nature may contain harmful bacteria. That’s why we are committed to providing consumers the information that they need to handle and cook ground beef safely.”  I like Patrick.  I frankly thought our discussion on Larry King a few months ago was the best part of the show.  But, Patrick, since 1994 E. coli O157:H7 has been considered to be an adulterant in hamburger by the government–it is not supposed to be there. What you should be “committed” to is keeping cow shit out of “consumers’” meat.

Where do we go from here?  Marler’s Baker’s Dozen:

1. Tattoo on a body part–one that you use every day–FSIS’s Mission Statement:  The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

2. Push for tax credits for workable food safety innovations for small, medium, and large producers and support small and medium sized agriculture by growing local and regional markets for meat.

3. Meet with all major purchasers of meat, poultry, and eggs (governments, ‘big box’ stores, fast food chains, and retailers) and develop product specifications that mandate food safety and sustainability at a fair price.

4. Visit victims of foodborne illness outbreaks and bring along key FSIS staffers and industry leaders.

5. Develop uniform cooking, handling, and labeling instructions that actually provide helpful guidance to the public (in contrast, for example, the suggestion to “cook thoroughly”).

6. Enforce a real zero-tolerance policy for E. coli O157:H7, non-O157 Enterohemorrhagic E. coli strains and all other antibiotic resistant bacteria on all meats.

7. Conduct meaningful sampling and surveillance at farms, slaughter facilities, and retail to determine the real prevalence of all pathogens and provide that data to the public.

8. Post all Non-compliance Reports (NR’s), product test results, and other enforcement documents at manufacturing operations online in real-time (like restaurant health inspections are).

9. Create manufacturer quality certifications to aid consumers in making safe choices, and allow companies to capture price premiums for higher quality.

10. Increase food inspections. While domestic production has continued to be a problem, imports pose an increasing risk, especially if terrorists were to get into the act. Points of export and entry are a logical place to step up monitoring. We need more inspectors–domestically and abroad.

11. Make better use of our technology to ensure traceability of all food so that when an outbreak occurs authorities can quickly identify the source and limit the spread of the contamination and stop the disruption to the economy.

12. Improve surveillance of bacterial and viral diseases; First responders–ER physicians and local doctors–need to be encouraged to test for pathogens and report findings directly to local and state health departments and the CDC promptly.

13. Fire any FSIS employee that would believe and/or be quoted as saying anything like:  “I have to look at the entire industry, not just what is best for public health.”

I am sure there are other ideas and even better ideas–email them to the President’s nomination for Undersecretary for Food Safety: Elisabeth.Hagen@fsis.usda.gov.


Publisher’s Platform

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Has the nail been driven into the coffin of the conventional wisdom that grass-fed beef is safer than grain-fed beef?

In 2008 I posted “Grass-Fed vs Grain-Fed Beef and the Holy Grail: A Literature Review,” in which I raised the question if grass-fed beef is safer that grain-fed, on my blog.  My concern was, as I said, that quotes like these were becoming more common on the Internet and recent media reports:

“Products from grass-fed animals are safer than food from conventionally-raised animals.” Eatwild, 2008

“Research has shown that the strains of E. coli most devastating to humans are the product of feedlots, not cows. This is due to the animals being forced to eat an unnatural diet, and not their natural choice, grass.” Grass-Fed Beef: Safer and Healthier, Animal Welfare Approved, June 15, 2008

My conclusion of the literature review was: In summary, the scientific evidence at this time does not support a broad conclusion that grass feeding significantly reduces the risk of E. coli O157:H7 or other dangerous foodborne pathogens from entering the food chain. However, more research is needed to better understand the influence of diet, especially the use of different types of grains in animal feed.

Now a recent abstract entitled, “Contamination Rates and Antimicrobial Resistance in Bacteria Isolated from “Grass-Fed” Labeled Beef Products” by Jiayi Zhang, Samantha K. Wall, Li Xu, Paul D. Ebner in Foodborne Pathogens and Disease, once again puts into question the conventional wisdom that somehow grass-fed cows are safer than grain-fed cows. Here is the abstract in part:

“Grass-fed and organic beef products make up a growing share of the beef market in the United States. While processing, animal handling, and farm management play large roles in determining the safety of final beef products, grass-fed beef products are often marketed as safer alternatives to grain-finished beef products based on the potential effects of all-forage diets on host microbiota.

“We conducted a series of experiments examining bacterial contamination rates in 50 beef products labeled as “grass-fed” versus 50 conventionally raised retail beef products.

“Coliform concentrations did not differ between conventional and grass-fed beef (conventional: 2.6 log10 CFU/mL rinsate; grass-fed: 2.7 log10 CFU/mL rinsate). The percentages of Escherichia coli positive samples did not differ between the two groups (44% vs. 44%). Enterococcus spp., were frequently isolated from both grass-fed beef products (44%) and conventional beef products (62%; p = 0.07). No Salmonella or E. coli O157:H7 isolates were recovered from any of the meat samples. Enterococcus spp. isolates from conventional beef were more frequently resistant to daptomycin and linezolid (p < 0.05). Resistance to some antimicrobials (e.g., chloramphenicol, erythromycin, flavomycin, penicillin, and tetracyline) was high in Enterococcus spp. isolated from both conventional and grass-fed beef.

“There were no differences in the percentages of antimicrobial resistant E. coli isolates between the two groups. Taken together, these data indicate that there are no clear food safety advantages to grass-fed beef products over conventional beef products.”

Perhaps more research is still needed.  The sample size of this recent study was small.  Perhaps Food Safety News should do a larger one?

Publishers Platform

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I received this email this weekend in response to an interview I gave recently about raw milk to “Food Manufacturing” online:

Farm fresh? All the rage? natural food craze? certified organic is a buzzword? You make the lifestyle of eating pure, unpesticide treated, unindustrialized, unprocessed food seem like a generational fad like acid washed denim or cabbage patch dolls.  Those use words like you in your ridiculous article are afraid of the truth and just don’t want to know about it. So keep eating your corn feed beef, your pesticide-salads and your oreo cookies, you industrial eaters because you seem to not care about your bodies or your kids health or the future of the earth.

Actually, I get more than a few emails like this.  Most do a bit better at spelling and punctuation, but nearly all are from raw milk proponents, producers, or consumers (although there are a few from the anti-S. 510 cabal).  Some, but not all, have a level of passion that borders on violence.  Perhaps not directed at me, but generally in the “do not tread on me”–”tea party” shouting that we have been subjected to over the last year.

Frankly, I was perplexed at the “yell fest” that passed for discussion of whether we should expand health care to the 40 million of our fellow citizens without health insurance.  I am shocked at how we scream at each other via email or blog comments about raw milk or honest differences about how food safety legislation should be modeled.  It is like screaming at and belittling each other at the dinner table–albeit, a very large table.

What is with all this anger over food?  I mean, honestly, it seems like there are bigger fish to fry.  What about the wars?  Global warming?  Energy policy?

But, folks are angry about their view of food–especially the proponents of raw milk (affectionately, “raw milkies”) and the anti-S. 510 folks (affectionately, “organic tea baggers”).  Both groups view themselves as victims of big government and big business bent on reducing them to servitude or extinction.  They cannot see that perhaps, just perhaps, people who see the dangers of raw milk or the value of S. 510, might simply have an honest disagreement with those that see raw milk as the nectar of the gods or S. 510 as more than a method of lining the pockets of Monsanto.  But, hey, that is just me.

So, do the yelling, threats and belittling of the anti raw milk/pro S. 510 crowd actually work?  Are some convinced that those that yell the loudest have the best arguments?  Or, do some simply shy away from their positions after being the target of a nasty blog post or scathing email or comment?  I think some do.  I know I have been tempted to simply focus on other pressing issues surrounding food safety–there are many–and let folks guzzle raw milk to their heart’s content and let S. 510 die a lingering death.

But, that is not my style.  Even as a child when told to do A I usually did B.  When the raw milk party calls me a tool of big dairy or an ambulance chaser, I come back with reasoned pros and cons of raw milk consumption, videos of raw milk consumers sickened, and a website–Real Raw Milk Facts–dedicated to having a reasoned discussion about raw milk.  I am also beginning to work on a raw milk retail sampling project to test its safety.

As for S. 510, the nastier the emails from small producers who want little or no food safety regulation, the more money I donate to political campaigns, the more trips I take to DC, and the more often I fund victim visits to their favorite senator.

And, to do the above, I hardly raise my voice.  Well, once in awhile I do.

Publisher’s Platform

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The House and Senate Agriculture and U.S. Food and Drug Administration Oversight Committees should hold joint hearings on the Salmonella egg fiasco.

As I said to the Associate Press yesterday, “The history of ignoring the law makes the sickening of 1,300 and the forced recall of 550 million eggs shockingly understandable.”  I was talking about the owner of the largest egg farm at the center of this massive recall and outbreak of Salmonella Enteriditis.   As the AP found, the owner, Austin “Jack” DeCoster, is no stranger to controversy in his food and farm operations:

-  In 1997, DeCoster Egg Farms agreed to pay $2 million in fines to settle citations brought in 1996 for health and safety violations at DeCoster’s farm in Turner, Maine. Then-Labor Secretary Robert Reich said conditions were “as dangerous and oppressive as any sweatshop.” He cited unguarded machinery, electrical hazards, exposure to harmful bacteria, and other unsanitary conditions.

-  In 2000, Iowa designated DeCoster a “habitual violator” of environmental regulations for problems that included hog manure runoff into waterways. The label made him subject to increased penalties and prohibited him from building new farms.

-  In 2002, the federal Equal Employment Opportunity Commission announced a more than $1.5 million settlement of an employment discrimination lawsuit against DeCoster Farms on behalf of Mexican women who reported they were subjected to sexual harassment, including rape, abuse, and retaliation by some supervisory workers at DeCoster’s Wright County plants.

-  In 2007, 51 workers were arrested during an immigration raid at six DeCoster egg farms. The farm had been the subject of at least three previous raids.

-  In June 2010, Maine Contract Farming, the successor company to DeCoster Egg Farms, agreed in state court to pay $25,000 in penalties and to make a one-time payment of $100,000 to the Maine Department of Agriculture over animal cruelty allegations that were spurred by a hidden camera investigation by an animal welfare organization.

Yesterday, according to the Washington Post, Rosa DeLauro (D-CT), announced plans to ask the Food and Drug Administration and Agriculture Department about DeCoster.  DeLauro’s questions are aimed at getting more information about how much federal regulators knew about DeCoster’s poor compliance record and what steps were taken to ensure safety at DeCoster’s facilities.

I think questions should be asked.  Actually–a lot of questions.  However, in addition to Congresswoman DeLauro’s, I would ask the FDA and U.S. Department of Agriculture’s Food Safety and Inspection Service together (hence the joint hearing), who was in charge of what in inspecting the DeCoster farms prior to the beginning of the Salmonella outbreak in late May?  Will that jurisdiction change now that the ìEgg Ruleî (also known as ìFederal Register Final Rule (July 9, 2009, 74 FR 33030): Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportationî) is in effect?  Is this apparent ìjoint jurisdictionî between FDA and FSIS the best way of assuring the public that eggs will be safer?  Are resources sufficient to assure the public that the most is being done to protect them and prevent a similar debachle from happening?

For good measure, I would ask DeCoster to come and explain (under oath) to the Committee if his farms were complying with the spirit and/or letter of the ìEgg Ruleî before the recall and outbreak.  Here are the highlights of the Rule:

• Buy chicks and young hens only from suppliers who monitor for Salmonella bacteria;

• Establish rodent, pest control, and biosecurity measures to prevent the spread of bacteria throughout the farm by people and equipment;

• Conduct testing in the poultry house for Salmonella Enteritidis. If the tests find the bacterium, a representative sample of the eggs must be tested over an eight-week time period (four tests at two-week intervals); if any of the four egg tests is positive, the producer must further process the eggs to destroy the bacteria, or divert the eggs to a non-food use;

• Clean and disinfect poultry houses that have tested positive for Salmonella Enteritidis;

• Refrigerate eggs at 45 degrees F during storage and transportation no later than 36 hours after the eggs are laid (this requirement also applies to egg producers whose eggs receive a treatment, such as pasteurization);

• Environmental Testing for Salmonella Enteritidis.  There are specific requirements on when and how to test for the pathogen and coordination with pullet testing; and,

• Egg Testing for Salmonella Enteritidis.  Whenever you have reason to know/suspect of presence of Salmonella Enteritidis. Two week intervals in positive poultry houses.

The FDA said that if DeCoster had been following the ìEgg Ruleî this outbreak would not have happened.  Really?  His farms really were not trying to follow the common sense ideas above before this happened?  If he was following the Rule, where was the error made?  Or, is there something wrong with the Rule?

Much to talk about, much to learn.

Publisher’s Platform: A Meal from Hell

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It is time to pass S. 510 BEFORE this is on the Senate Dining Room Menu:

Next week I will be co-chairing the ACI Foodborne Illness Litigation Conference in Chicago and co-hosting an evening meal for speakers. I had to approve the dinner menu, which got me thinking (after nearly 20 years) about what a Marler Clark Potluck would look like.  Then I started thinking about what if this was on the Senate Dining Room Menu on the day that it was “Take a child or grandchild to lunch day.” 

Here is the menu for the meal from hell:

Appetizers

Soft Cheese Plate with Celery, Cantaloupe and Hummus

Salad

Spinach Salad with Peanut Dressing, Tomatoes and Sprouts, topped with Pistachios

Caesar Salad topped with slices of Beef Tri-Tip

Main Course

Orange Shredded Chicken with White and Black Pepper Sauce

Bison Burgers with Jalapenos and Green Onions

Canned Chili with Parsley

Chicken Pot Pies with an Egg Wash

Dessert

Raw Milk Ice Cream with Shredded Raw Almonds

Cookie Dough Ice Cream with Raw Milk Chocolate Colostum Topping

Beverage

Seasonal Beer from a Recently Cleaned Tap

Imported Water from Colorado

Frankly, I could go on and on. You can make up your own menu by visiting nearly 20 years of foodborne illness litigation at Marler Clark.

Publisher’s Platform: What is a Food Crime?

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Do you remember Domino’s Pizza employees Kristy Hammonds and Michael Setzer, who made a video of Setzer, 32, putting cheese up his nose before putting it on a sandwich, passing gas on a piece of salami and sneezing on an order of cheese sticks, then hiding the mucus under the cheese before boxing the order?  

Hammonds, 31 at the time, narrates the videos, laughing and making encouraging comments. Hammonds and Setzer were charged with felony adulteration of food. Hammonds pleaded guilty to a lesser charge. She received a 45-day suspended sentence and 18 months probation. During her probation, Hammonds cannot work at any establishment that prepares or serves food or beverages. Hammonds also must complete 200 hours of community service and pay for her attorney fees, which amounted to $1,125. Setzer pleaded guilty, taking an Alford plea. This admits the evidence against him is strong enough to produce a guilty plea but admits no wrongdoing.  Setzer was given a six-month suspended sentence, 24 months supervised probation and he was ordered to have no contact with Hammonds or Domino’s.

And, Peanut Corporation of America President Stewart Parnell (who sickened over 700 and killed 9 in a Salmonella Outbreak in 2009) and Wright County Eggman Jack DeCoster (who sickened over 1,600 in a Salmonella Outbreak in 2010) have been charged with no crimes at all.

What the hell is with that?

Publisher’s Platform: Who is a Food Safety Hero?

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We started Food Safety News nearly three years to the day the U.S. Food and Drug Administration announced that a nationwide E. coli O157:H7 outbreak had been traced to spinach. I had filed suit against Dole several hours earlier, and it was several days later that the FDA and Centers for Disease Control and Prevention announced that the spinach responsible for the outbreak was Dole brand baby spinach.

In the end, 205 people became ill with E. coli and 5 died during the 2006 spinach E. coli outbreak – an outbreak which was perhaps second only to the 1993 Jack in the Box E. coli O157:H7 outbreak which resulted in over 650 E. coli cases and 5 deaths. 

What the spinach outbreak again underscored was the vulnerability of “the safest food supply in the world,” and how food that sustains us can also cause tragic illness with lasting consequences.

Of course, there have been many other foodborne illness outbreaks that have shaken the confidence of consumers. Too many of my clients’ stories have been seared in my memory – like the unnecessary death of a young child who drank Odwalla apple juice; the tragic death of Kevin Kowalcyk (10 years ago), Abby Fenstermaker’s life cut short at age 6; the dancing legs and quick wit of 20-year-old Stephanie Smith taken from her; the 2-year hospitalization of Linda Rivera, a mother of 6; and the last breath of a 2-year-old as a mother and father removed her from life support.

These were the tragedies, where are the heroes?
 
Without a doubt, the heroes have been in part the victims and their families. They have lived, or died, because of the simple act of eating or drinking. Those that were left are left facing consequences that no one could have imagined.

But, what control did they have over the losses? Don’t we expect that the food that we order at a restaurant or drop in our shopping cart will not be poisoned?

We learned in the last week, with the recall of 36 million pounds of ground turkey contaminated with antibiotic-resistant Salmonella that caused one death and at least 107 illnesses, and the recall of local strawberries sold at farmers markets, that we place much of our trust in the people that grow, manufacturer, ship, sell and prepare our food.
 
Readers, I want to ask you a favor, please.  If you were able to pick a food safety hero, who would it be?  Who is that someone who has tried to make our food supply safer?  What do you think they did of merit?
 
I ask you to think large.  Think not only of victims who taught us something through their tragedy, but also of the family members that make us all remember. Think also about the farmer, the broker, the shipper, the manufacturer or retailer, who thought more of their customers than their bottom line.  What about the academic?  What about the public servant? 

Who has tried to move food safety forward?  And, please, don’t think just like me – what bacteria or virus – can kill you in the short run; think also about sustainability, fairness toward labor and healthfulness.
 
Email the names to me at bmarler@marlerclark.com and tell me briefly why they are your heroes.  What the staff of Food Safety news will do over the next years is to profile the most suggested and glean from them something that can make our food supply safer.
 
Thank you for your help.

Publisher’s Platform: Should Brothers Ryan and Eric Jensen Face Criminal Charges

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Will producers of Listeria-tainted cantaloupe be fined or jailed?

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

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

So, now we know that a total of 147 persons infected with any of the five and possibly six outbreak-associated strains of Listeria monocytogenes were reported to CDC from 28 states.  The number of infected persons identified in each state was as follows:

Alabama (1), Arkansas (1), California (4), Colorado (40), Idaho (2), Illinois (4), Indiana (3), Iowa (1), Kansas (11), Louisiana (2), Maryland (1), Missouri (7), Montana (2), Nebraska (6), Nevada (1), New Mexico (15), New York (2), North Dakota (2), Oklahoma (12), Oregon (1), Pennsylvania (1), South Dakota (1), Texas (18), Utah (1), Virginia (1), West Virginia (1), Wisconsin (2), and Wyoming (4).

Deaths were scattered in Colorado, Indiana, Kansas, Louisiana, Maryland, Missouri, Montana, Nebraska, New Mexico, New York, Oklahoma, Texas, and Wyoming.

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

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

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

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

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

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

The FDA’s Investigation at Jensen Farms

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

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

Among other things, the report notes:

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

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

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

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

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

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

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

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

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

Those failures, several of which draw from the FDA’s Environmental Assessment Report, included:

- Condensation from cooling systems draining directly onto the floor;

- Poor drainage resulting in water pooling around the food processing equipment;

- Inappropriate food processing equipment which was difficult to clean (i.e., Listeria found on the felt roller brushes);

- No antimicrobial solution, such as chlorine, in the water used to wash the cantaloupes; and

- No equipment to remove field heat from the cantaloupes before they were placed into cold storage.

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

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

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


Publisher’s Platform: MMWR – Food for Thought

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Several years ago I started following the CDC’s Morbidity and Mortality Weekly Report (MMWR).  It used to come weekly in the mail (perhaps it still does), but it is a bit easier to see it online and it can be quickly downloaded.

Given my profession, I tend to quickly pass over some of the other notifiable diseases like Babesiosis and Psittacosis, but several others perk my interest.  Here is this week’s MMWR summary in the USA of those things generally food related:

Botulism – Luckily none this week and only seven this year.  There were twenty-four in 2011.

Listeria – Nine this week and 287 this year.  There were 870 in 2011 (we all recall cantaloupe).

Hepatitis A – Eleven this week and 755 this year.  There were 739 in 2011 (we should all get vaccines).

Salmonella – 582 this week and 20,371 this year.  There were 24,366 in 2011.

Shiga Toxin E. coli – Fifty-four this week and 2,295 this year.  There were 2,842 in 2011.

Hemolytic Uremic Syndrome (HUS) was seen three times this week and seventy-five times so far this year.  There were 290 cases in 2011 (a good trend this year).

Shigella – 142 this week and 6,619 this year.  There were 6,424 in 2011 (not on pace for a positive 2012).

Say, CDC, what about Campylobacter, Norovirus?

For more information on Food Safety, keep current at Food Safety News. If you want to know too much about food poisoning, see Foodborne Illness dot com. And for complications, see Guillain-Barré Syndrome, Irritable Bowel Syndrome and Reactive Arthritis.

Publisher’s Platform: Ode to the Microbiological Data Program

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I was going to take a weekend off from Publisher’s Platform. It has been a long couple of weeks of long days, and more than a few late nights, working on putting the cases together of the 22 injured people and the families of 20 who died in the 2011 Listeria cantaloupe outbreak that I represent.

We have a court imposed deadline of September 14 (which, coincidentally, is one year to the date of the recall) to present every client’s story. Every person and family has a story – all of them quite horrible and heroic. If we told them one by one, they would take up every page of Food Safety News through the end of the year.

But, let my tell you one fact: these families collectively have incurred to date over $8,000,000 in medical bills.  If you count in future medical bills and lost wages, you are now well into eight figures.  If you then add in the pain of the loss of a spouse or living your life with the after effects of Listeria meningitis, you are talking much, much more.  And, that is only 42 of the 147 the CDC counted.

After 20 years of doing this kind of work, it is easy for me to estimate that this one tragedy will ultimately cost business, government and the victims well over $100,000,000.

So, I really was going to take the weekend off and then Food Safety News reporter Helena Bottemiller (a.k.a. Lois Lane) wrote a story early Saturday morning about this summer’s cantaloupe, and now honeydew recall prompted by the Microbiological Data Program (MDP).

Burch Equipment LLC in North Carolina is expanding its recent recall of nearly 189,000 cantaloupes to now include all of this growing season’s cantaloupes and honeydew melons distributed in 18 states because they may be contaminated with Listeria monocytogenes.

In the U.S. Food and Drug Administration update, issued very early Saturday morning, the agency noted that here have been no illnesses reported to date — the recall expansion is based on FDA’s recent finding of Listeria monocytogenes on a honeydew melon grown and packed by Burch Farms.

The original recall of cantaloupes was initiated on July 28 after a MDP in New York found contaminated cantaloupe. Two days later, the recall was greatly expanded and the FDA warned the public to not eat the recalled melons after agency officials reported unsanitary conditions at the company’s packing shed.

Now, more than 10 days later, the company and FDA are casting a wider net on the potentially-contaminated melons, including honeydew, which were not previously part of the recall. Earlier this week, the company clarified that although it had originally identified Athena cantaloupes as the variety it was recalling, it was actually recalling Caribbean Gold variety.

So as Food Safety News Editor, Dan Flynn, put it a few months ago, let us thank the United Fresh Produce Association for:

-Killing the nation’s only (real) produce surveillance program (it is on life support until the years end and FDA has a small program).

-Turning Congress against the only (real) program to collect data on the prevalence of foodborne pathogens in domestic and imported produce.

-Leaving the Food and Drug Administration (FDA), federal Centers for Disease Control and Prevention (CDC), and state health departments in the dark about the incidence of pathogens in fresh produce commodities.

-Keeping tainting products in the marketplace – MDP testing has been responsible for 23 produce recalls during 2010 and 2011 alone, and 15 of these involved human illnesses.

Did I mention that MDP costs us taxpayers less than $5,000,000 per year?

Publisher’s Platform: Tracking Cantaloupe Outbreaks

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The Outbreak Database has come in handy to track just how often cantaloupes – and other foods – have caused problems.  Here is a sample platter of outbreaks linked to cantaloupe with links to citations:

Marler Clark is proud to sponsor both the Outbreak Database and underwrite Food Safety News.

Publisher’s Platform: All About Hepatitis A

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In a continuing effort to keep current on those bugs that are bad for us, we have updated www.about-hepatitis.com.

Exposure to the hepatitis A virus can cause an acute infection of the liver that is typically mild and resolves on its own. The symptoms and duration of illness vary a great deal, with many persons showing no symptoms at all. Fever and jaundice are two of the symptoms most commonly associated with a hepatitis A infection.

It has been written that the “earliest accounts of contagious jaundice are found in ancient China.”

According to the CDC:

The first descriptions of hepatitis (epidemic jaundice) are generally attributed to Hippocrates. Outbreaks of jaundice, probably hepatitis A, were reported in the 17th and 18th centuries, particularly in association with military campaigns. Hepatitis A (formerly called infectious hepatitis) was first differentiated epidemiologically from hepatitis B, which has a long incubation period, in the 1940s. Development of serologic tests allowed definitive diagnosis of hepatitis B. In the 1970s, identification of the virus, and development of serologic tests helped differentiate hepatitis A from other types of non-B hepatitis.

Until 2004, hepatitis A was the most frequently reported type of hepatitis in the United States. In the pre-vaccine era, the primary methods used for preventing hepatitis A were hygienic measures and passive protection with immune globulin (IG). Hepatitis A vaccines were licensed in 1995 and 1996. These vaccines provide long-term protection against hepatitis A virus (HAV) infection.

Consequently, hepatitis A is the only common vaccine-preventable foodborne disease in the United States. This virus is one of five human hepatitis viruses that primarily infect the human liver and cause human illness. Unlike hepatitis B and C, hepatitis A does not develop into chronic hepatitis or cirrhosis, which are both potentially fatal conditions. Nonetheless, infection with the hepatitis A virus (HAV) can lead to acute liver failure and death.

This puts it in perspective: Real Life Impacts:  The Story of Richard Miller.

More about Hepatitis A:

An Introduction to Hepatitis A

The Incidence of Hepatitis A Infections

Transmission of and Infection with Hepatitis A

Symptoms of Hepatitis A Infection

Complications of Hepatitis A Infection

Diagnosis of Hepatitis A Infection

Treatment of Hepatitis A Infection

Real Life Impacts of Hepatitis A Infection

Preventing Hepatitis A Infection

Outbreaks of Hepatitis A

Consumer Resources for Hepatitis A

References

Publisher’s Platform: Perhaps No Need for Private A.G?

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This is somewhat of a reprint of an Op-ed of a few years ago.  However, in light of this week’s 76-count indictment of Stewart Parnell and four others, I thought a reprint was in order.

Everyone seems to hate government nowadays. From being afraid the FDA “food police” will try to steal your seeds, to trying to privatize Social Security, government is perceived as both overbearing and incompetent (at the same time). Some want to gut the EPA and abolish the Department of Education. Some see the “private sector” as a panacea for all our ills — that somehow an unregulated, or nearly so, economy will magically produce good wage jobs, a clean environment and smart, well-mannered children. Be that as it may, I have not seen anyone yet suggest that we privatize the office of the Attorney General, in full or in part.  Might I be so bold as to suggest at least a small subcontract to “Marler Clark, Food Safety Prosecutors?” I would be willing to put people in jail for poisoning people, and I would do it on the cheap – perhaps for the fun of it. Here is how it would work.

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

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

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce. Any person who commits a prohibited act violates the FDCA. A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Make note, a conviction DOES NOT require intent!

Similar laws deal with the meat side of the equation over at USDA/FSIS.

So, in the near two decades of being involved in every major foodborne illness outbreak in the United States, I have seen more than a few outbreaks that, if I had the authority, I would have prosecuted — some as felonies and some as misdemeanors.  Either way, I would have sought fines and jail time for the executives responsible for food safety.  Here is a “sample platter” by “bug:”

Botulism

Castleberry – In July of 2007, the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and public health officials in Texas and Indiana joined to investigate a botulism outbreak.  Four outbreak victims — siblings from Texas and a married couple from Indiana — had been hospitalized with botulism after eating Castleberry’s hot dog chili sauce.

On July 18, FDA issued a consumer advisory regarding the presence of botulinum toxin in Castleberry’s brand chili products and Castleberry’s Food Company issued a voluntary recall that included a limited number of production dates of Castleberry’s Hot Dog Chili Sauce Original, Castleberry’s Austex Hot Dog Chili Sauce Original, and Kroger Hot Dog Chili Sauce. The recall was expanded on July 21 to include all production dates for 91 types of canned chili sauce, chili, other meat products, chicken products, and dog food that were manufactured in the same set of cookers, or “retorts” as the hot dog chili sauce at the Castleberry’s facility in Augusta, Georgia.

By August 24, eight cases of botulism had been reported to the CDC.  In addition to the Indiana couple, the mother of the children in Texas had developed symptoms of botulism, which brought the total number of Castleberry-associated cases in Texas to three.  There were also three unrelated residents of Ohio who had developed botulism after consuming Castleberry’s hot dog chili sauce.  Botulinum toxin was identified in leftover chili sauce collected from the refrigerator belonging to one of the Ohio cases.

On July 18 and 19, a team of FDA investigators was sent to the firm’s warehouse to collect samples of Castleberry’s products for testing. Of 17 swollen cans obtained from the Castleberry’s facility, 16 tested positive for Clostridium botulinum (C. botulinum) toxin.  Several other tests revealed C. botulinum toxin in additional cans of Castleberry’s chili products.

FDA inspectors conducted testing at the Castleberry plant and observed several food safety violations.  After its inspection, FDA cited Castleberry’s for “failure to maintain fixtures in repair sufficient to prevent food from becoming adulterated.”

Campylobacter

Raw Milk – In the summer of 2008, an outbreak of Campylobacter jejuni in Del Norte County, California (near the Oregon border) that sickened 16 people and left one paralyzed was traced to Alexandre EcoDairy Farm raw milk.  Fifteen of the people who were infected with Campylobacter consumed the milk; the 16th was an employee of the dairy.  The consumers were part of an illegal “cow-leasing” program that gave them access to the milk.

E. coli

Odwalla – On October 31, 1996, the Food and Drug Administration (FDA) announced that Odwalla was recalling all of the company’s juice products that contained unpasteurized apple juice. The recall was initiated in response to 13 reported cases of E. coli O157:H7 illness that had been linked to the company’s unpasteurized apple juice by the Seattle-King County Department of Public Health.

During the course of the public health investigation into the outbreak, a genetically indistinguishable strain of E. coli O157:H7 that had been isolated from case patients was found in a bottle of unpasteurized Odwalla apple juice.  Investigators from FDA found numerous violations of health and safety codes at the Odwalla manufacturing plant, including lack of proper sanitizing procedures and poor employee hygiene. The FDA also found that the plant accepted decayed fruit from suppliers.

When the outbreak was over, one child was dead from complications arising from her E. coli O157:H7 infection, and more than 65 individuals were confirmed infected with the bacteria in the western U.S. and British Columbia. Of these reported cases, more than a dozen developed hemolytic uremic syndrome (HUS), a life-threatening condition that causes the body’s major organs – particularly the kidneys – to fail.

In 1998, Odwalla was indicted and held criminally liable not for the 1996 E. coli outbreak, but for selling juice packed with fructose.  The company plead guilty to 16 federal criminal charges and agreed to pay a $1.5 million fine.

Jack in the Box – On January 13, 1993, the Washington Department of Health (WDOH) was notified that a cluster of children suffering hemolytic uremic syndrome (HUS) secondary to E. coli infection was being treated in a Seattle-area hospital and that there had been an increase in emergency room visits from patients with bloody diarrhea. &nb
sp;In response to the apparent outbreak, WDOH began interviewing case-patients for an epidemiologic investigation and learned that nearly all patients had consumed hamburgers purchased from Jack in the Box restaurants in the days before becoming ill.

Since the ground beef identified as the source of the outbreak had been distributed to Jack in the Box restaurants in Washington, Idaho, California, and Nevada, all states investigated cases of bloody diarrhea that had been reported since November 15, 1992 to determine whether patients had eaten hamburgers from Jack in the Box in the days before becoming ill.  By the end of February 1993, the states had reported the following:

- Washington reported 602 patients with bloody diarrhea or HUS.  477 Washingtonians were culture-confirmed with E. coli infections, with illness onset peaking between January 17 and January 20, 1993.  144 people were hospitalized; 30 developed HUS, and three died.

- Idaho reported 14 culture-confirmed E. coli O157:H7 cases with illness onset dates between December 11, 1992 and February 16, 1993.  Four people were hospitalized; one developed HUS

- California reported six culture-confirmed cases, with 34 patients meeting the outbreak-case definition with illness onset dates between November 15 1992 and January 31, 1993.  Fourteen people were hospitalized; seven developed HUS, and one child died.

- Nevada reported only one culture-confirmed case, with 58 other patients meeting the outbreak-case definition with illness onset dates between December 1, 1992 and February 7, 1993.  Nine people were hospitalized; three developed HUS.

Over the course of the outbreak investigation and the litigation that followed, documents from Foodmaker, the San Diego-based parent company of Jack in the Box, revealed that the company had been warned by local health departments and by their own employees that they were undercooking their hamburgers prior to the outbreak, but the company had decided that cooking beef to 155 degrees, the standard set by WDOH, made the meat too tough.

Cargill - On October 6, 2007, Cargill Meat Solutions Corporation announced that it was recalling approximately 845,000 pounds of frozen ground beef patties for possible E. coli O157:H7 contamination. The recall was initiated after three people in Minnesota tested positive for E. coli and a joint investigation by the Minnesota Department of Health and Minnesota Department of Agriculture identified the Cargill hamburger patties as the source of the illnesses.  Forty-seven people would be part of the outbreak.

The Cargill products were sold at retail establishments and to restaurants and other institutions. Sam’s Club announced that it was pulling the potentially E. coli-contaminated ground beef patties produced by Cargill from its store shelves nationwide on October 5.

The most grievously sickened victim was Stephanie Smith, who developed HUS and spent months in a medically induced coma. The former dance instructor was paralyzed from the waist down, and both her kidney function and cognitive abilities were impaired.

Dole – In late September of 2005, the Minnesota Department of Health (MDH) received several reports of E. coli O157:H7 illness among Minnesota residents and began conducting laboratory testing to determine whether the cases were related. Through pulsed field gel electrophoresis (PFGE) testing, commonly called DNA “fingerprinting” of the E. coli bacteria isolated from patients, public health investigators identified a single strain of E. coli O157:H7 that was causing illness and recognized that an E. coli O157:H7 outbreak was underway in Minnesota.  MDH ultimately counted 23 laboratory-confirmed cases of E. coli O157:H7 and seven epidemiologically linked cases.  Two cases developed hemolytic uremic syndrome (HUS).  Oregon and Wisconsin reported one case each. The manufacturer of the lettuce was Dole.

Dole – On September 14, 2006, the Food and Drug Administration (FDA) announced that a nationwide E. coli outbreak had been associated with the consumption of bagged baby spinach. For fear of E. coli contamination, all bagged spinach was recalled nationwide, and on September 19, 2006, the FDA announced that all spinach implicated in the outbreak had been traced back to Natural Selection Foods, a company located in California’s Salinas Valley that was marketed under the Dole brand.

FDA and the Centers for Disease Control and Prevention (CDC) confirmed 205 E. coli illnesses associated with the spinach E. coli outbreak, including thirty-one cases of hemolytic uremic syndrome, 104 hospitalizations, and four deaths. Victims of the E. coli outbreak were identified in 26 states: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Michigan, Minnesota, Nebraska, Nevada, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. Wisconsin was the state hardest-hit in the outbreak, with 49 confirmed cases of E. coli. Canada reported one confirmed case.

A joint trace-back by FDA and the State of California revealed that four spinach fields were the possible source of the E. coli contamination. The outbreak strain of E. coli was isolated from cattle fields nearby the implicated spinach fields, as well as from a wild boar that was killed in one of the fields.

Nebraska Beef – In late July and early August of 2006, the Minnesota Department of Health (MDH) received notification that three people, all residents of or visitors to Longville, Minnesota, had tested positive for E. coli O157:H7.  At the same time, MDH learned that many members of the Salem Lutheran Church in Longville had become ill with a gastrointestinal illness after eating meals served at the church on July 10 and 19.

MDH conducted epidemiologic and environmental health investigations into the confirmed illnesses and the church outbreak to determine whether they were related.  MDH’s epidemiologic investigation revealed seventeen illnesses that met the case definition. Three people developed hemolytic uremic syndrome (HUS) and one person died. Attendance at the church’s July 19 dinner was significantly associated with illness.

MDA conducted a traceback of the ground beef purchased at the Supervalu and learned that Interstate Meat distributed the ground beef in question to Supervalu. Further traceback of the meat revealed that the “most possible” source of the meat delivered to the Supervalu store was the Nebraska Beef processing plant. In addition to this, the USDA reported that a sample of beef trimmings collected on June 14, 2006 at a processing plant cultured positive for a genetically indistinguishable strain of E. coli O157:H7 as the outbreak strain.

Nebraska Beef – In late June of 2008, public health officials in Michigan and Ohio began investigating several cases of E. coli O157:H7.  An epidemiological investigation by officials at the Michigan and Ohio departments of agriculture determined that the source of the E. coli outbreak was ground beef purchased at Kroger stores.

Kroger stores recalled an undetermined amount of ground beef, which was ultimately linked to 42 illnesses of E. coli O157:H7– 21 in Michigan and 20 in Ohio. In its recall announcement, Kroger identified stores that had sold the contaminated meat, including Fred Meyer, QFC, Kroger, Fry’s, Ralph’s, Smith’s, Baker’s, King Soopers, City Market, Hilander, Owen’s, Pay Less, Scott’s, Dillons, and Gerbes.

Nebraska Beef also issued a massive recall of ground beef, which was eventually expanded to include a total of 5.3 million pounds of meat intended for use in ground beef production.

On July 18, 2008 the CDC announced that 49 confirmed E. coli O157:H7 cases had been linked both epidemiologically and by molecular fingerprinting to the consumption of ground beef products produced with Nebraska Beef meat.  States with confirmed cases included Georgia, Indiana, Kentucky, Michigan, New York, Ohio, and Utah. Twenty-seven people were hospitalized, and one patient was known to have developed a type of kidney failure called hemolytic uremic syndrome (HUS). No deaths were reported.

Later that year, in August of 2008, Nebraska Beef recalled an additional 1.2 million pounds of meat for potential E. coli contamination after a cluster of Boston illnesses was traced to Whole Foods, whose processor, Coleman Natural Meats, purchased the meat from Nebraska Beef.  As many as 30 E. coli cases were reported in California, Colorado, Connecticut, Idaho, Illinois, Massachusetts, New Jersey, New Mexico, Pennsylvania, Virginia, and Canada in association with the August recall. On August 14, Nebraska Beef expanded its recall to include 160,000 pounds of meat, bringing the total meat recalled in August to 1.36 million more pounds.

Hepatitis A

Chi-Chi’s – In late October of 2003, Pennsylvania health officials learned of a potential hepatitis A outbreak from emergency room doctors treating patients in Beaver County. The Beaver County Health Department (BCHD) and Pennsylvania Department of Health (PDOH) began investigating the apparent outbreak, and learned through interviews that all case patients had eaten at the Chi Chi’s restaurant at the Beaver Valley Mall in the weeks before becoming ill.

On November 3, PDOH issued a hepatitis A advisory, encouraging anyone who had eaten at the Beaver Valley Mall Chi-Chi’s restaurant within the past 14 days to receive an Immune globulin (Ig) shot to prevent becoming ill with the hepatitis A virus. Ig is only effective in preventing infection with hepatitis A if it is administered within 14 days of exposure to the virus. PDOH scheduled Ig immunization clinics at several locations over the following days.

By November 7, PDOH had identified 130 people who had contracted hepatitis A as part of the outbreak.  The number had grown to 240 cases by November 11, and kept climbing.  By November 14, three people had died due to liver failure caused by hepatitis A, and the number of ill people had risen to 500.

PDOH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), conducted an epidemiological study of the outbreak, and determined that green onions imported from Mexico were the source of the outbreak. The FDA issued a statement dated December 9, 2003, affirming that this outbreak was associated with eating raw or undercooked green onions.

Ultimately, over 650 confirmed cases of hepatitis A, both primary and secondary, were linked to consumption of green onions at the Beaver Valley Mall Chi-Chi’s. The victims included at least 13 employees of the restaurant, and numerous residents of six other states. Four people died as a consequence of their hepatitis A illness.  In addition, more than 9,000 people who had eaten at the restaurant during the period of potential exposure, or who had been exposed to ill Chi-Chi’s customers, obtained immune globulin shots to prevent hepatitis A infection.

Salmonella

Wright County Egg – In August 2010, Wright County Egg of Galt, Iowa recalled 380 million shell eggs due to contamination with Salmonella. The recalled eggs were distributed nationwide under many different brand names, in 6, 12, and 18 pack cartons, as well as 15-carton cases. Hillandale, another Iowa egg producer, recalled 170 million eggs bringing the total to 550 million nationwide. The CDC has now reported over 2,000 cases of Salmonella Enteritidis (SE) tied to the contaminated eggs.

On August 31, the FDA issued a report of their investigation at the two egg farms, revealing massive violations. At Congressional hearings into Wright County Egg and Hillandale Farms on September 22, 2010, it was revealed that the egg producers had long-term Salmonella problems as well as a history of making people sick.

Shigella

Gate Gourmet – In September of 2004, health agencies from many U.S. state and international health agencies began receiving reports that travelers who had recently traveled by air from Honolulu, Hawaii in late August of 2004 had tested positive for Shigella sonnei infections. An epidemiologic investigation commenced, and investigators soon determined that food served on several flights from the Honolulu airport was the source of the travelers’ illness.

Further investigation revealed that food produced by Gate Gourmet, an
airline caterer, and served on several different airlines’ flights was the source of the outbreak.  As a result, in February of 2005, the Food and Drug Administration (FDA) inspected the Gate Gourmet, Inc., facility located at 324 Rodgers Boulevard, Honolulu, Hawaii, which provides food and beverage service to various airlines at Honolulu Airport.

In a letter to Gate Gourmet headquarters, FDA noted:  ”The observations made during the inspection revealed that your facility is in violation of the Public Health Service Act and the Interstate Conveyance Sanitation regulations.”  During the inspection, Gate Gourmet was cited for holding foods at improper temperatures, pest and vermin violations, equipment maintenance and cleanliness violations, and bare-hand contact with ready-to-serve items.

Listeria

Jensen Farms - the CDC had increased the numbers of those considered to be culture-confirmed cases from the 2011 cantaloupe Listeria outbreak from 146 to 147 and confirmed that the death toll now stands at 33.  Of course, the death toll is in fact much larger — likely as high as 37 or 38 — and, there may well be many more that were sickened by the tainted cantaloupe who are not officially counted as part of the outbreak.  So, now we know that a total of 147 persons infected with any of the five and possibly six outbreak-associated strains of Listeria monocytogenes were reported to CDC from 28 states.  The number of infected persons identified in each state was as follows:  Alabama (1), Arkansas (1), California (4), Colorado (40), Idaho (2), Illinois (4), Indiana (3), Iowa (1), Kansas (11), Louisiana (2), Maryland (1), Missouri (7), Montana (2), Nebraska (6), Nevada (1), New Mexico (15), New York (2), North Dakota (2), Oklahoma (12), Oregon (1), Pennsylvania (1), South Dakota (1), Texas (18), Utah (1), Virginia (1), West Virginia (1), Wisconsin (2), and Wyoming (4).  Deaths were scattered in Colorado, Indiana, Kansas, Louisiana, Maryland, Missouri, Montana, Nebraska, New Mexico, New York, Oklahoma, Texas, and Wyoming.

 The FDA’s Investigation at Jensen Farms

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

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

Among other things, the report notes:

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

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

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

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

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

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

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

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

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

Those failures, several of which draw from the FDA’s Environmental Assessment Report, included:

- Condensation from cooling systems draining directly onto the floor;

- Poor drainage resulting in water pooling around the food processing equipment;

- Inappropriate food processing equipment which was difficult to clean (i.e., Listeria found on the felt roller brushes);

- No antimicrobial solution, such as chlorine, in the water used to wash the cantaloupes; and

- No equipment to remove field heat from the cantaloupes before they were placed into cold storage.

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

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

Some of the above causes of the above outbreaks could well have been considered for felony prosecution. All, however, could have been prosecuted as misdemeanors. Under either scenario a CEO may well have faced both a fine and jail time.  Consider for a moment how a CEO might well think twice about pushing food safety to the side ahead of increased sales and profits.  My bet is that if I had prosecuted some of the above cases, as the crimes they were, many of the others would never have happened. CEOs now might risk poisoning people because an insurance company will pick up the tab, but they would not risk personal fines and jail time.  But, perhaps we are seeing a new day in prosecutions of those who poison?

Publisher’s Platform: McDonald’s and E. coli, 30 Years Later

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A few weeks ago I was giving a talk at the Association of Health Care Journalists conference in Boston.  My talk was primarily an overview of where food safety has come since the Jack in the Box E. coli O157:H7 outbreak in 1993.  At one point I introduced an article I found in 1993 at the beginning of the Jack in the Box litigation.

The article, “Hemorrhagic colitis associated with a rare Escherichia coli serotype.” New England Journal of Medicine, 1983 Mar 24; 308 (12): 681-5., was the report of two outbreaks of an unusual gastrointestinal illness that affected at least 47 people in Oregon and Michigan in the first half of 1982. The illness was characterized by severe, crampy abdominal pain, initially watery diarrhea followed by grossly bloody diarrhea, and little or no fever. It was associated with eating at restaurants belonging to the same fast-food restaurant chain in Oregon and Michigan. This report described a clinically distinctive gastrointestinal illness associated with E. coli O157:H7, apparently transmitted by undercooked meat.

I made the point in my talk that I learned that “the same fast-food restaurant chain” was in fact McDonald’s and that I was not aware that the outbreak had been publicized at all at the time.  Apparently, making such a statement in a room full of journalists was the right thing to do, as someone promptly “tweeted” me the March 23, 1983 article by the now-retired Daniel Q. Haney of the Associated Press.  Haney had written “Fast Food Illness Traced To Rare Bacteria,” in March 1983, and I had missed it in my 1993 research. Apparently, so it appears, did everyone else. Or, worse yet, it was simply ignored.

Reading the article 30 years later makes me wonder how often we miss the important things:

A mysterious intestinal ailment that first struck diners at a fast-food chain is a newfound disease caused by rare bacteria, and it has spread across the United States, researchers say.

The first major outbreak appeared last year among 47 people who ate at McDonald’s restaurants in Michigan and Oregon.

A report on their inquiry into the disease, directed by Dr. Lee W. Riley, was published in Thursday’s New England Journal of Medicine.

From the patients’ stool samples, doctors isolated a very rare form of bacteria called E. coli O157:H7. Then they found the same bacteria in a frozen hamburger patty stored at a processing plant. The meat had been kept from a batch that was shipped to the Michigan restaurants.

Steve Leroy, a McDonald’s spokesman, declined to comment on the federal report.

“It’s hard to predict what’s going to happen,” Riley said. “If it’s like any other food-borne illness, if the original source is not immediately eliminated, then it’s possible that it will stay in the food cycle for a long time to come.”

I decided to reach our to both Dr. Riley and Mr. Haney.  I found Dr. Riley at Berkley and Mr. Haney on Facebook, through a reporter I met on Twitter.  Both Dr. Riley and Mr. Haney were kind enough to answer a few questions.

In 1983 Dr. Riley was a CDC epidemiologist sent to investigate the E. coli outbreak in Oregon.  He was the lead author of the NEJM article.

At that time, Mr. Haney was a general assignment reporter for AP in Boston with a special interest in science and medicine, so he would cover interesting reports from the NEJM.

Dr. Riley recalls that “we at CDC at the time were very ‘excited’ about this E. coli because up to that time, we knew of only three classes of E. coli that caused diarrhea and none of them caused bloody diarrhea or HUS [Hemolytic Uremic Syndrome, a kidney disease brought on by severe E. coli infection].”  Dr. Riley also said he believed that “this strain of E. coli had always been around but it was not recognized until the U.S. entered the era of mass production and distribution of hamburger meat to be served at fast-food restaurants — a lot of hamburger patties needed to be consumed to generate a recognizable outbreak.”

Mr. Haney recalled that he wrote two versions of the story – one for the morning publication and one for the evening.  He recalled thinking at the time that this bug had the potential to create future harm — that the bacteria “could settle in the nation’s food chain if the source of the organism was not found soon.”

Ten years later, in Boston, Mr. Haney looked on as the Jack in the Box E. coli outbreak garnered national attention.  Dr. Riley recalled thinking that the E. coli problem was not going to disappear anytime soon.  He felt that “this E. coli strain had become entrenched in the food animal reservoir and that the increasing animal husbandry practice of producing meat from cattle raised in concentrated animal feeding operations (CAFOs) had only exacerbated the problem.”

For me, I still wonder how much more could have been done to prevent the explosion that was the Jack in the Box outbreak.  Had Dr. Riley’s NEJM article been publicized more widely would more have been done in the intervening decade?  What if other reporters had covered E. coli more in depth in the 1980s?

Clearly, at least as it relates to ground beef, the beef industry, restaurants and government have made great strides in preventing E. coli illnesses and outbreaks.  As I have said before, in the decade after Jack in the Box, 90 percent of  my law firm’s revenue came from E. coli cases linked to hamburger. That percentage in now near zero.  Interventions at slaughter and increased cook temperatures and times, along with E. coli O157:H7 being considered an adulterant by the USDA/FSIS, have all helped.

But, E. coli has now found its way into foods as varied as spinach, lettuce, cookie dough, apple juice and cheese, and it has become an ever-increasing problem at water parks and petting zoos.  And, unfortunately, those cases have become a bigger and bigger part of what I do each day.

Publisher’s Platform: Townsend Farms Class Letter

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I know lawyers suffer from an image problem. Most people think we spend our weekend on fancy golf courses or driving jet boats around tropical isles. I actually like driving jet boats at high speed. I had one once. But I don’t have any time anymore, especially in the aftermath of each of these continued outbreaks.

So what did I spend my weekend doing? Writing letters to the people my clients have or may sue is always part of the job. I thought it would be good to share my work to give Food Safety News readers a better understanding of how we approach obtaining justice for victims, and other, of foodborne illness.

The letter that follows is to Mr. Townsend at Townsend Farms in Oregon, the company that produced the frozen berry product that gave their consumers the troubling liver disease we call hepatitis A.

Dear Mr. Townsend:

As you are aware, the Centers for Disease Control and Prevention (CDC) has linked 79 hepatitis A illnesses in 8 states to the consumption of Townsend Farms Frozen Organic Antioxidant Blend products. This number is expected to continue to rise.

The Marler Clark law firm represents over two dozen of these people, and their families, who are suffering from, or recovering from, their acute hepatitis A illnesses. Two individual personal injury lawsuits have been filed – in California and Arizona to date. We expect to file more.

Costco indicates that it sold at least 330,000 bags of your product across the country. In addition, Harris Teeter stores sold your product under a different label but have so far not been linked to hepatitis A illnesses. Since the hepatitis A outbreak was announced on May 31, 2013, and the recall of your product was announced on June 3, 2013, it is likely that tens of thousands of individuals have either received blood tests to determine whether they were infected by hepatitis A, or received hepatitis A vaccination or immune globulin injections.

On behalf of several putative class representatives, Marler Clark has filed, or will file, class actions in Arizona, California, Colorado, Hawaii, Idaho, New Mexico, Nevada, Utah, and Washington. These class actions seek to recover damages on behalf of people who have had blood testing, or received vaccinations or injections to prevent the onset of symptoms.  We intend to file a similar class action in Oregon, under theories including strict product liability, breach of express and implied warranties, negligence and negligence per se.

Before filing the enclosed complaint, however, on behalf of putative class representatives in Oregon, and pursuant to the notice requirement of Civil Rule 32H, specifically sections 1(A) and 1(B), we are required to send you this notification letter to demand relief before filing suit. We ask that Townsend Farms do the following:

  1. Admit that Townsend Farms Frozen Organic Antioxidant Blend Products are the source of the hepatitis A outbreak reported by the CDC;
  2. Pay the amount of any bill or cost charged to any person who has had blood tested for the presence of hepatitis A, or to any person who has been vaccinated or received an immune globulin injection,due to his or her consumption of your product and/or exposure to another person who consumed your product.  Also, to the same group of people, pay the amount of all other general, special, incidental and consequential damages incurred as the direct and proximate result of their consumption of your product;
  3. Reimburse Costco for any and all costs expended by it to ensure that people exposed to your product, either directly or secondarily, have received necessary blood testing to determine the presence of hepatitis A virus, or received vaccination or immune globulin injection;
  4. Reimburse any state, local, or federal health organization for all costs expended to ensure that people exposed to your product, either directly or secondarily, have received necessary blood testing to determine the presence of hepatitis A virus, or received vaccination or immune globulin injection;
  5. Reimburse any state, local, or federal health organization for all costs expended in the investigation of the hepatitis A outbreak;
  6. Revise the labeling on the Townsend Farms Frozen Organic Antioxidant Blend Products to more clearly inform the consumer that it may contain component parts that are not grown in the United States, and;
  7. Donate $50,000 to Stop Foodborne Illness to assist in food safety education.

We look forward to your prompt response.

 


Publisher’s Platform: It is Time for a Sarbanes-Oxley Act for Food Safety

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Food safety programs are the crazy uncles of corporate food production – everyone has one, but no one really wants to talk about it.

Corporate management on average is far more interested in sales and profits and would just as soon ignore those people who talk incessantly about a “culture of food safety,” or “food safety from farm to fork.”

Management is most interested in getting food from the farm to your grocery cart in exchange for as much cash as possible and for as little corporate cost as necessary. Food safety is overhead, as are the audits that slow the chain of distribution from revealing bad food safety behavior.

True, safe food becomes important when a foodborne illness outbreak happens and the corporate brand is put at risk.  However, on a day-to-day basis, food safety is, at best — and most often — simply ignored.

That is why food – most produced here in the U.S. – sickens 48 million, hospitalizes 125,000 and kills 3,000 of us yearly.

What if the corporate management of a food manufacturer or retailer was required to personally certify to the public that he or she had established “internal controls” over food safety, and in fact the food produced and sold was safe?

What if an auditor was required to “issue an opinion” as to the accuracy of those controls over food safety, and that in fact the audit was truthful?

Stunning ideas? Not really!

There is a somewhat recent and apt model for increasing corporate and auditing responsibility that would work quite well to focus attention on good food safety behavior.

Fact — good food safety behavior in the long-run protects consumers, which protects the corporate brand. Not poisoning your customers is actually good for business.

The Sarbanes-Oxley Act, known as the “Corporate and Auditing Accountability and Responsibility Act,” has set increased standards for all corporate management and auditing firms.  The bill was enacted in 2002 in reaction to corporate and auditing scandals in the 1990′s, which cost investors billions of dollars when share prices of public companies collapsed.

As a result of Sarbanes-Oxley, top corporate management must now personally certify the accuracy of financial information. Management must certify that they are “responsible for establishing and maintaining internal controls” and “have designed such internal controls to ensure that material information relating to the company” is made known.

Sarbanes-Oxley has also increased the responsibility of outside auditors who review the accuracy of corporate financial data. External auditors are now required to issue an opinion on whether management maintained effective internal control over financial reporting and that the financial statements are in fact accurate.

How can the Sarbanes-Oxley Act relate to safer food?

Can you imagine if the president of a food company was actually required to sign off yearly on the company’s food safety “internal controls?” If that were the case, perhaps food safety would have a direct line of communications to corporate leadership instead of lagging behind marketing and short-term profits.

It would be truly revolutionary to have a food company focused on producing and selling safe food as its core mission. That would be a “culture of food safety.”

And, what about audits? What if an auditor had to sign his or her name that the audit was in fact truthful and was not simply a mechanism to move product speedily, not necessarily safely, along the chain of distribution?

An honest audit would be “food safety from farm to fork.”

Does it not seem at least equally important that the food manufacturers or retailers ask our children to put in their bodies have some of the safeguards that investors have in the same corporation?

Publisher’s Platform: Will Whole Genome Sequencing Solve More Outbreaks?

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“No illnesses have been reported to date.”

How many times have we read a food recall notice posted on either the FDA or FSIS websites and written by the companies recalling the product who use that self-serving statement?  I would say most of the time.

In the past few months the CDC has reported three outbreaks – one Salmonella outbreak and two Listeria outbreaks that have used whole-genome sequencing to connect ill people to tainted product. Perhaps “No illnesses have been reported to date” is a statement of the past trumped by science.

So, what is the science?

State and CDC public health investigators have used the PulseNet system to identify cases of illness that were part of an outbreak for nearly two decades.  PulseNet, the national subtyping network of public health and food regulatory agency laboratories coordinated by CDC, receives from state laboratories DNA “fingerprints” of bacteria obtained through diagnostic testing using Pulsed-field Gel Electrophoresis (PFGE).

Multiple Locus Variable-number Tandem Repeat Analysis (MLVA) is another technique used by scientists to generate a DNA fingerprint for a bacterial isolate. Scientists usually perform MLVA after PFGE to find out more specific details about the type of bacteria that may be causing an outbreak.

Whole Genome Sequencing, is a newer, more highly discriminatory subtyping method, that has been used to define the following outbreaks:

  • Oasis Brands Inc., Cheese Recalls and Investigation of Human Listeriosis Cases – One person became ill in September 2013 and two persons became ill in June and August 2014. These three ill persons were reported from three states: New York (1), Tennessee (1), and Texas (1).  All ill persons were hospitalized. One death was reported in Tennessee. One illness was related to a pregnancy and was diagnosed in a newborn.

“No illnesses have been reported to date,” may well be a statement of the past.

Publisher’s Platform: Time to Discard That Wire Brush?

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Internal injuries from ingestion of wire grill-cleaning bristles are well documented.  In a single hospital system, 12 patients with injuries due to ingestion of wire bristles were reported between July 2009 and June 2012. The severity of injury ranged from puncture of the soft tissues of the neck, causing severe pain on swallowing, to perforation of the gastrointestinal tract requiring emergency surgery.[1]

On May 29, 2012, U.S. Senator Charles E. Schumer, joined by Chuck Bell, programs director at Consumers Union, called on the Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) to determine whether metal bristle grill brushes are safe for consumer use.[2] Two men from New Jersey and Washington state had also been recently hospitalized and underwent emergency surgery after accidentally swallowing a metal bristle that had broken off their grill brushes and become attached to their food. Schumer called on the CPSC and the FDA to launch a review of whether the bristles are safe and to issue warnings to consumers about the dangers of ingesting metal grill bristles.

The Centers for Disease Control and Prevention (CDC) recommends actions to prevent these injuries by increasing awareness among consumers, manufacturers, retailers and medical professionals to promote prevention, timely diagnosis and appropriate treatment.  In an editorial published in the Morbidity and Mortality Weekly Report (MMWR), the agency suggests that awareness on the part of manufacturers and retailers of the risk of ingesting wire bristles might encourage alteration of current products or development of safer ones.  The CDC recommends those in the food services industry “examine whether their patrons are at risk for this injury” and advises the “use of alternative grill-cleaning methods or products.”[3]

Recently, on the evening of Friday, September 19, 2014, Diane Norman bought pizzas at Domino’s Pizza located at 2800 Milton Way in Milton, Washington.  She took the pizzas home for her family to consume.  Michael Norman chose two slices of Canadian bacon and pineapple pizza and took a bite of one slice.  He swallowed and immediately felt something sharp in his throat.  He started to choke and dashed to the sink to drink water to help clear his throat.  At this point he felt a sharp tearing at his throat and drank a glass of cranberry juice.  His throat felt scratched and to relieve his pain he ate a slice of bread.  Although this action eliminated the feeling that food was lodged in his throat, Michael felt a dull pain in his stomach.  Since he no longer felt hungry, he did not eat any more pizza.  Diane Norman froze the remaining leftover pizza.  Sometime later she examined the frozen pizza slices and found a wire in a piece of the pizza she had saved.

Over the next few days Michael continued to feel a dull pain in his abdomen.  His doctor ordered x-rays, which showed two metallic objects inside his abdomen.  A CT scan revealed that one of the metal objects had punctured his small intestine.  After a failed attempt to remove the metal objects via endoscopy, Michael was rushed into surgery on September 27.  It was then that surgeons removed two wires from Michael Norman’s intestines.

On September 30 Michael Norman filed a complaint with the Tacoma Pierce County Health Department.  In response to his complaint, TPCHD environmental health specialist, Christina Sherman, conducted an on-site investigation at the Domino’s in Milton.  Ms. Sherman reviewed the pizza making process with Domino’s employee, James Tyler.  She noted that a wire brush was used to clean a wire rack inside the oven at the end of each day.  Ms. Sherman also observed wear on some of the brush bristles.  This wear was evident in photos of the brush taken by Ms. Sherman.

On October 8 Michael Johnson at TPCHD conducted a second on-site visit to Domino’s.  Mr. Johnson wrote in the inspection report:

Observed a wire brush with food debris between the wires.  Wires on the brush were bent and pointing in different directions and did not maintain its original design.  Employee stated they had another brush that was used to clean the oven but was discarded last week.  Person in charge stated the outside of the oven is cleaned every night and the inside of the oven is cleaned once a month using the brush.

Ms. Johnson advised that”equipment and utensils must be designed and construction to be durable and to retain their characteristic qualities under normal use conditions.”

The wire brush was discarded.

Perhaps that is what all of us should do?  Michael has the scars to prove it.



[1] Grand DJ, Egglin TK, Mayo-Smith WW. et al. Injuries from ingesting wire bristles dislodged from grill-cleaning brushes – Providence, Rhode Island, 2009-2012. J. Safety Res. 2012 Dec. 43(5-6):413-5.)

[3] Centers for Disease Control and Prevention, Injuries from ingestion of wire bristles from grill-cleaning brushes – Providence, Rhode Island, March 2011-June 2012.  MMWR Morb Mortal Wkly Rep 2012 Jul 6;61(26):490-492.)

Publisher’s Platform: A Reasonable Proposal for Safer Meat

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http://www.dreamstime.com/royalty-free-stock-image-fast-food-hamburger-image12143746New York Senator Kirsten Gillibrand has once again proposed a law that would give the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) the ability that it does not believe it already has to recall meat tainted with the pathogenic Salmonella bacteria. The law, in essence, would prompt FSIS to label Salmonella for what it really is — an adulterant that should not be on the meat on our tables.

In our convoluted food safety system, FSIS generally oversees beef, chicken, pork and lamb production, and the Food and Drug Administration (FDA) regulates all other manufactured food products. FDA already bans Salmonella from all food; FSIS, not at all.

Salmonella is a fecal bacteria that the Centers for Disease Control and Prevention (CDC) estimates sickens 1.4 million annually in the United States, hospitalizing 15,000 and killing 400. The economic loss is just as staggering. The USDA’s own Economic Research Service reports Salmonella illnesses and deaths cost $3.6 billion yearly in medical costs, wage loss and premature death.

The junior senator from New York properly recognizes the long-standing dysfunction at FSIS. Despite an 18-month Salmonella outbreak during 2013 and 2014, which sickened more than 600 people — 40 percent who were hospitalized — and linked to one chicken supplier, this supposed public health agency felt powerless to close the plants or recall the chicken because, notwithstanding the illnesses linked to the chicken, FSIS presently does not consider Salmonella an adulterant, regardless of what commonsense might otherwise tell you.

As long as FSIS maintains that Salmonella is not an adulterant, it will continue to claim it lacks authority to protect public safety by recalling the tainted meat and shuttering the offending plants. This is why the senator’s proposal has merit.

FSIS’ decades-long position is as perplexing as it is wrong-headed — especially in light of a history of its own success with another fecal bacterial pathogen, E. coli O157:H7.

In 1993, as a new president was being inaugurated, a deadly E. coli outbreak was being linked to hamburgers. Four kids were dead, dozens suffered kidney failure, and hundreds were hospitalized. Hamburger sales dropped.

The beef industry was on its knees, and the public wanted answers. Haltingly at first, the Clinton administration found its backbone when FSIS Administrator Michael Taylor (now FDA’s Deputy Commissioner for Foods) stood before the American Meat Institute and proclaimed a so-called “Zero Tolerance Rule.” The deadly E. coli bacteria would no longer be tolerated in hamburgers; it would now be considered an adulterant.

At first, the beef industry balked — even litigated against the new rule — arguing that consumers should just cook the bacteria out of the meat. However, over time, industry and government found that with E. coli banned, the numbers of outbreaks and recalls linked to hamburgers fell from commonplace to infrequent. And, as a lawyer whose firm benefited from the commonplace, I was pleasantly stunned to see the flow of new clients — mainly children — slow to a trickle.

It is hard to underestimate what the success that setting the E. coli bar low (with ongoing plant inspections by FSIS inspectors) has meant for consumers and the industry. All the fears of hamburger being regulated out of existence, or that the cost of production would be so high that hamburger would no longer be an American staple, never came to be. And it had the added success of fewer people sickened by E. coli-tainted hamburger, resulting in fewer lawsuits.

The senator’s proposal gives us a great opportunity to learn from the hamburger/E. coli experience. We can do more to move the needle down on the 48 million sickened, 125,000 hospitalized, and 3,000 deaths per year by food, which costs our economy more than $15 billion annually.

I once penned an op-ed urging action during the middle of an E. coli outbreak linked to hamburger centered in Colorado that sickened 50, killed one, and caused a half-dozen children to suffer acute kidney failure. Banking on the reality that trial lawyers are only slightly more popular than members of Congress, I suggested that something be done to “put me out of business.”

As it relates to hamburger, the plea has worked. And, a few months ago, I had my first hamburger in 22 years.

The senator’s proposal gives FSIS the tools it feels it needs to keep the public a bit safer. Safer food should be non-partisan. Republicans and Democrats eat and drink, and they have parents, kids, grandkids, and constituents who are some of the most vulnerable to foodborne illness. We can do something to make our food just a bit safer. The senator’s proposal is a step in the right direction.

Publisher’s Platform: 75 sproutbreaks later, fresh raw sprouts still not safe

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axx-sprout2-13-16_9Thanks to my friends at Barfblog for keeping track of the Sproutbreaks over the last couple of decades. These outbreaks have been some of the largest and most deadly in the world.

Now we are seeing two being reported in the United States in the last few weeks.

  • A total of nine people infected with the outbreak strain of E. coli O157 have been reported from two states: Minnesota has seven sick and Wisconsin two. Illnesses started on dates ranging from Jan. 17 to Feb. 8. Ill people range in age from 17 years to 84, with a median age of 28. Sixty-six percent of ill people are female. Two ill people have been hospitalized. Collaborative investigative efforts of state, local, and federal public health and regulatory officials indicate that alfalfa sprouts produced by Jack & The Green Sprouts of River Falls, Wisconsin are a likely source of this outbreak.
  • A total of 13 people infected with the outbreak strain of Salmonella Muenchen have been reported from four states: Kansas has five, Missouri three, Oklahoma three and Pennsylvania two. Illnesses started on dates ranging from Dec.1, 2015, to Jan. 21 this year. Ill people range in age from 18 years to 73, with a median age of 51. Ninety-two percent of ill people are female. Among 13 ill people with available information, five reported being hospitalized. , No deaths have been reported. Collaborative investigative efforts of state, local, and federal public health and regulatory officials indicate that alfalfa sprouts produced by Sweetwater Farms of Inman, KS, are a likely source of this outbreak.

As far back as September 1998, the FDA issued a warning against sprouts urging:

Children, pregnant women and the elderly should not eat alfalfa sprouts until growers find a way to reduce the risk of a potentially deadly bacteria that infects some sprouts, the Food and Drug Administration said this week. The FDA, which is investigating sprout industry practices, said children, the elderly and people with weakened immune systems should avoid eating sprouts. The agency’s statement, issued Monday, repeated similar but little-noticed advice the U.S. Centers for Disease Control gave to doctors and researchers a year ago.

Here is the CDC warning :

Sprouts Not Healthy Food for Everyone

Children, the elderly, and persons whose immune systems are not functioning well should not eat raw sprouts, because current treatments of seeds and sprouts cannot get rid of all bacteria present.

Persons who are at high risk for complications from foodborne illness should probably not eat raw sprouts, according to an article in the current issue of Emerging Infectious Diseases, CDC’s peer-reviewed journal, which tracks new and reemerging infectious diseases worldwide.

Although sprouts are often considered a “health food,” the warm, humid conditions needed for growing sprouts from seeds are also ideal for bacteria to flourish. Salmonella, E. coli, and other bacteria can grow to high levels without affecting the appearance of the sprouts.

Researchers have treated both seeds and sprouts with heat or washed them in solutions of chlorine, alcohol, and other chemicals. Some of these disinfectants reduced the levels of bacteria, but a potential hazard remained, especially for persons with weak immune systems. High temperatures that would kill the bacteria on the seeds would also keep them from sprouting. Until an effective way is found to prevent illness from sprouts, they should be eaten with caution, if at all.

Need I say more?

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