Tice.us

In July 2010, CDC identified a nationwide sustained increase in the number of Salmonella Enteritidis isolates with PFGE pattern JEGX01.0004 uploaded to PulseNet, the national subtyping network made up of state and local public health laboratories and federal food regulatory laboratories that performs molecular surveillance of foodborne infections. This increase began in May 2010 and is evident in the epidemic curve, or epi curve. The number of reports increased substantially in July when the peak of the outbreak appears to have occured. From May 1 to August 31, 2010, a total of 2,508 illnesses were reported. However, some cases from this period have not been reported yet, and some of these cases may not be related to this outbreak. Based on the previous 5 years of reports to PulseNet, we would expect approximately 1,039 total illnesses during this same period. This means there are approximately 1,469 reported illnesses that are likely to be associated with this outbreak. Many states have reported increases of this pattern since May. Because of the large number of expected cases during this period, standard methods of molecular subtyping alone are not sufficient to determine which reported cases might be outbreak-associated. CDC is currently conducting testing using advanced molecular methodologies to help distinguish between outbreak-related cases and sporadic (or background) cases.

Illnesses that occurred after July 29, 2010 might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported. This takes an average of 2 to 3 weeks for Salmonella.

In July 2010, CDC identified a nationwide sustained increase in the number of Salmonella Enteritidis isolates with PFGE pattern JEGX01.0004 uploaded to PulseNet, the national subtyping network made up of state and local public health laboratories and federal food regulatory laboratories that performs molecular surveillance of foodborne infections. This increase began in May 2010 and is evident in the epidemic curve, or epi curve. The number of reports increased substantially in July when the peak of the outbreak appears to have occured. From May 1 to August 31, 2010, a total of 2,508 illnesses were reported. However, some cases from this period have not been reported yet, and some of these cases may not be related to this outbreak. Based on the previous 5 years of reports to PulseNet, we would expect approximately 1,039 total illnesses during this same period. This means there are approximately 1,469 reported illnesses that are likely to be associated with this outbreak. Many states have reported increases of this pattern since May. Because of the large number of expected cases during this period, standard methods of molecular subtyping alone are not sufficient to determine which reported cases might be outbreak-associated. CDC is currently conducting testing using advanced molecular methodologies to help distinguish between outbreak-related cases and sporadic (or background) cases.

Illnesses that occurred after July 29, 2010 might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported. This takes an average of 2 to 3 weeks for Salmonella.

William Neuman of the New York Times got Dr. Hagen on record this week in his article, “Beef Recall Heats Up Fight to Tighten Rules:”

Dr. Hagen has yet to say publicly what she plans to do. But in a written statement provided to The New York Times, she said, “In order to best prevent illnesses and deaths from dangerous E. coli in beef, our policies need to evolve to address a broader range of these pathogens, beyond E. coli O157:H7.” She added, “Our approach should ensure that public health and food safety policy keeps pace with the demonstrated advances in science and data about food-borne illness to best protect consumers.”

The agency has said that it is reluctant to make additional forms of toxic E. coli illegal in ground beef until it has developed a rapid test that can detect those strains in packing plants. Such tests are not expected to be ready until at least late next year.

The AP, picked up the same story and quote from the TImes. 

I do not want to sound like a broken record, but we can not wait yet another year or years for more tests to develop that might be more convenient for FSIS and the beef industry. The time has come to do the logical thing (at a minimum).  If E. coli O157:H7 is an adulterant because it can kill your child, then other non-O157 STECs (like O26, O45, 0103, O111, O121, and O145) that cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths in America each year, should be adulterants as well.

I think I pretty clearly set forth the rationale for FSIS action on these other six pathogens, "Non - E. coli O157:H7 EHEC (O26, O45, O111, O121, O145, and O103) should be "Adulterants"" and in the Pettion and Supplement 1 and Supplement 2, that we filed with the agency nearly one year ago.  As for testing - I have $500,000 reasons to say there are tests that already work.

Perhaps it is time for a Court to decide this?

We compiled a bit of data and some cool charts to try and see the differences between the last two years of the Bush administration and the first two years of the Obama term.  Download all the slides here - Obama v Bush

In less than two weeks (on September 14) the House of Representatives Committee on Energy and Commerce, headed by Representatives Dingell (D-MI), Waxman (D-CA), and Stupak (D-MI), will hold what has become an annual event--yet another hearing on the failings of the food industry to provide consumers safe food.

In 2007 the Committee held hearings on the 2006 E. coli outbreak from contaminated spinach that sickened 205 and killed 5. Shortly thereafter, the hearings were on Salmonella-contaminated peanut butter that sickened 714. In 2008 the Committee focused on the massive recall of some 143,000,000 pounds of meat. In 2009, it was peanut butter with Salmonella again, this time sickening hundreds and killing 9.

Of course, during that same three-year period, dozens of other outbreaks--some just as bad or worse--happened with little notice by anyone other than the victims and their families. And if the CDC is to be believed, during those three years of Committee work 228,000,000 Americans were sickened by food consumption, 975,000 were hospitalized, and 15,000 died.

I attended each of the Committee hearings in 2007, 2008, and 2009. In 2007 and 2009 I went to support clients who were attending to tell their story of a tragically sickened child or parent, or the pain at the death of a loved one--because they ate food. In 2008, I asked the Committee to move on food safety legislation to “put me out of business” as a lawyer representing these people.

The theater of the committee hearings tends to fit a pattern. Grave congress members chastise food manufacturing executives for poisoning consumers (and voters) and belittle federal officials for not preventing the incident (although they have no budget to do so) in the first place. My favorite is when one of the congress members asks a victim--a mom whose two-year-old nearly died from eating E. coli-contaminated spinach or the son of a triple Purple Heart winner who died after consuming Salmonella-contaminated peanut butter, “What do you think we should do to prevent this?”

Almost as entertaining as congress members’ questions is the audience. Most of those who sit for the three hours are paid to do so. For the most part, they are the herds of lawyers for the companies being questioned, lobbyists representing the particular company or industry under fire, and of course, the obligatory consumer groups.

What is absent from the mix is an audience filled with consumers who have been impacted directly by the poisoned product du jour. This gave me an idea. Food Safety News will provide travel expenses, up to $25,000 total, for those who have been linked to the recent Salmonella Enteriditis egg outbreak. For those in the Pacific Time Zone, $1,500 per person is available, for the Mountain Time Zone $1,200, for the Central Time Zone, $1,000 and for the Eastern Time Zone, $500. Anyone interested should email Bill Marler at mail@foodsafetynews.com this week to make arrangements.

My hope would be that replacing lobbyists and lawyers present with people who have suffered from foodborne illness recently would give the Committee a flavor for what is real outside the Washington Beltway.

The CDC estimates that "non-O157 STECs (like O26, O45, 0103, O111, O121, and O145) cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths in America each year.” And, with the outbreak of E. coli O26 in Cargill hamburger that was announced last weekend, I frankly fail to see what more needs to be said to convince the USDA and FSIS to label these bugs as adulterants.

It is time for the USDA and FSIS to respond to my "Petition for an Interpretive Rule Declaring all enterohemorrhagic Shiga Toxin-producing Serotypes of Escherichia coli (E. coli), Including Non-0157 Serotypes, to be Adulterants Within the Meaning of 21 U.S.C. § 601(m)(1)" (See attached, Petition Supplemental) that I mailed today.

At the PulseNet conference here in Chicago there was a lot of discussion as to what happened to Stewart Parnell, the CEO of the Peanut Corporation of America (PCA), who was responsible for 714 ill and nine deaths, which until this DeCoster Egg recall, was one of the larger Salmonella outbreaks in recent memory. Nearly two years after the PCA outbreak Stewart Parnell does not sit behind bars where many think he should reside.

Now, Mary Clare Jalonick of AP and Philip Brasher of the Des Moines Register both reported this morning that Wright County Egg and Hillandale Farms, the two Iowa farms at the center of a salmonella outbreak and massive egg recall, have been visited by federal agents - again. It is unclear whether this new investigation is the first step in a criminal probe.

The FDA has jurisdiction to investigate crimes involving adulterated food, coordinating with the Justice Department. The 483 reports released this week by the FDA show sources of contamination at both farms, including rodent, bug and wild bird infestation, uncontained manure, holes in walls and other problems that could have led to the outbreak. Positive samples of the type of salmonella linked to the illnesses have been found at both farms.

So, will the egg man DeCoster join Parnell the peanut man in the big house? Frankly, I highly doubt it given the government’s failure to prosecute Parnell.  However, if they did, here are the laws that they would have to work with.

The Federal Food, Drug, and Cosmetic Act was passed by Congress in 1938 in reaction to the growing public safety demands. The primary goal of the Act is 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, inter alia, 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. If, however, the “poisonous or deleterious” substance is not an added substance, the food is not considered adulterated if the quantity of the substance in the particular food item does not ordinarily render the food injurious to health.

The Act authorizes factory inspections and added injunctions to the enforcement tools at the Food and Drug Administration's (FDA) disposal. Following hearings in the early 1950s, a series of laws addressing pesticide residues (1954), food additives (1958), and color additives (1960) gave the FDA much tighter control over the growing list of chemicals entering the food supply, putting the onus on manufacturers to establish their safety. The Act stands today as one of the primary means by which the federal government enforces food and pharmaceutical safety standards.

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

* 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 three years imprisonment.

* 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 up to one year imprisonment or a $1000 fine.

The Act also includes provisions for individual liability, specifically. Individuals who are responsible for criminal behavior are normally named as defendants along with corporate entities through which crimes are committed. A corporate defendant's willingness to enter a plea of guilty is accordingly not a basis for dismissal of charges against an individual. Individual defendants are generally the highest ranking officials in a firm who made decisions that violated the law, along with others who actively participated in fraudulent activity. Thus, presidents of corporations and managers of facilities where violations take place are often appropriate defendants.

References

1. Carol Benjamin and Betsy J. Floman, Federal Food and Drug Act Violations, 31 Am. Crim. L. Rev. 629 (1994).

2. 21 U.S.C. §331.

3. 21 U.S.C. §333(a)(2).

4. See United States v. Park, 421 U.S. 658, 674-77 (1975); United States v. Dotterweich, 320 U.S. 277, 280-81 (1943).

5. See United States v. Marcus, 82 F.3d 606 (4th Cir. 1996) (President/CEO of generic drug manufacturing firm prosecuted for altering heart medication formula without adequate testing or FDA approval); United States v. James V. Mays, 77 F.3d 906 (6th Cir. 1996); United States v. Samuel and Patsy Mays, 69 F.3d 116 (6th Cir. 1995), cert. denied, 116 S. Ct. 2504 (1996) (President, Secretary/Treasurer, and Operations Manager of juice concentrate company prosecuted for secretly adding 20,000,000 pounds of sugar to product sold as pure 100% orange concentrate).

Our fourth food poisoning lawsuit was filed today in the enormous egg recall and Salmonella outbreak tied to two Iowa egg farms. The lawsuit was filed against Quality Egg (doing business as Wright County Egg) in the Northern District Court of Iowa, Western Division just as the FDA released its report on Wright County Egg and Hillandale Farms.

“It’s almost a given that these kind of unhygienic conditions would produce contamination and illness. I hoped I had seen the last of this kind of disregard for public safety after the peanut butter outbreak, but this manages to be even worse.”

The plaintiff, a California mother of two young children, ate a custard dessert at a graduation banquet in May 2010. A few days later, she began to suffer from severe gastrointestinal symptoms including abdominal cramps and diarrhea. Her symptoms continued to worsen, and she was admitted to the hospital, where she remained for 4 days. She was released but had to be readmitted at the end of June for another 5 days. While hospitalized, she tested positive for the outbreak strain of Salmonella enteritidis. The California Department of Health confirmed that the eggs used to make the dessert she consumed came from Wright County Egg.

“The FDA report on these farms details appalling conditions,” said food safety attorney Bill Marler. “It’s almost a given that these kind of unhygienic conditions would produce contamination and illness. I hoped I had seen the last of this kind of disregard for public safety after the peanut butter outbreak, but this manages to be even worse.”

In August 2010, Wright County Egg and Hillandale Farms together recalled 550,000,000 eggs due to contamination with Salmonella. To date, 2,403 illnesses have been confirmed in Alaska, California, Colorado, Iowa, Minnesota, Nebraska, North Carolina, Nevada, South Dakota, Texas, and Wisconsin.

And, our investigators have confirmed that the FBI has been in and around the Wright County Egg and Hillandale Farms egg factories.

As I was boarding a plane to Chicago, my inbox filled up with Wright County Egg's and Hillandale Farm's first every FDA inspection - the so called 483.  Here are the highlights (more like lowlights) of Wright County Egg. Frankly, it was hard to read this one.  I'll leave Hillandale's for another day.  If you want to read them in full, head over to the FDA Website.

• Chicken manure located in the manure pits below the egg laying operations was observed to be approximately 4 feet high to 8 feet high at the following locations: Layer 1 – House 1; Layer 3 – Houses 2, 7, 17, and 18. The outside access doors to the manure pits at these locations had been pushed out by the weight of the manure, leaving open access to wildlife or domesticated animals.

• Un-baited, unsealed holes appearing to be rodent burrows located along the second floor baseboards were observed inside Layer 1 – Houses 1-9 and 11-13; Layer 2 – Houses 7 and 11; Layer 3 – Houses 1, 3, 4, 5, and 6; Layer 4 – House 3.

• Dark liquid which appeared to be manure was observed seeping through the concrete foundation to the outside of the laying houses at the following locations: Layer 1 – Houses 1, 2, 3, 4, 5, 8, 11, 12, and 14; and Layer 3 – Houses 1, 8, 13, and 17.

• Standing water approximately 3 inches deep was observed at the southeast corner of the manure pit located inside Layer 1 – House 13.

• Un-caged birds (chickens having escaped) were observed in the egg laying operations in contact with the egg laying birds at Layer 3 – Houses 9 and 16. The un-caged birds were using the manure, which was approximately 8 feet high, to access the egg laying area.

• Layer 3 – House 11, the house entrance door to access both House 11 and 12 was blocked with excessive amounts of manure in the manure pits.

• There were between 2 to 5 live mice observed inside the egg laying Houses 1, 2, 3, 5, 7, 9, 10, 11, and 14.

• Live and dead flies too numerous to count were observed at the following locations inside the egg laying houses: Layer 1 – Houses 3, 4, 6, 8, 9, 11, and 12; Layer 2 – Houses 7 and 11; Layer 3 – Houses 3, 4, 4, 5, 7, 8, 15, 16, 17, and 18. The live flies were on and around egg belts, feed, shell eggs and walkways in the different sections of each egg laying area. In addition, live and dead maggots too numerous to count were observed on the manure pit floor located in Layer 2 – House 7.

You get the picture, read on if you wish:

• You did not document washing and disinfecting of your dead hen truck and manure equipment prior to moving from farm to farm.

• You did not maintain records documenting the washing and disinfection of the trailers used for the movement of pullets to laying houses

• Birds were observed roosting and flying, chicks heard chirping in the storage and milking facilities. In addition, nesting material was observed in the feed mill closed mixing system, ingredient storage and truck filling areas.

• Outdoor whole kernel corn grain bins 4 and 6 observed to have the topside doors/lids open to the environment and pigeons were observed entering and leaving these openings. Birds were also observed sitting/flying around and over the openings.

• Samples collected during the course of this inspection and tested by an FDA laboratory revealed the following positive analytical results for Salmonella Enteritidis:

o On 8/13/2010, an environmental sample was collected from Layer 2, house 7 manure swab from row 1 – left side.

o On 8/16/2010, an environmental sample was collected from Layer 2, house 11 at manure scraper blade from row 3 – right side.

o On 8/13/2010, an environmental sample was collected from Layer 4, house 3 at walkway 1 – right side and walkway 3 – right side.

o On 8/14/2010, a sample of meat and bone meal was collected from ingredient bin 7 located at your feed mill.

o On 8/17/2010, a sample of finished feed “Developer” pullet feed was collected from the feed mill.

o On 8/16/2010, an environmental sample was collected from the roof level covered ingredient bin chute 8; Second Floor ingredient bin cover 19 (ingredient bin 19 holds ground corn) located at your feed mill.

I am heading to Chicago to attend two E. coli O157:H7 mediations and the annual CDC PulseNet conference, and just got the chance to read Mr. Schneider’s “USDA Lax on E. Coli Strain Linked to Beef Recall.”

I would urge all to do so.

In a letter to USDA Secretary Vilsack on August 18, 2010, J. Patrick Boyle, President and CEO of AMI stated “outbreaks associated with non-O157:H7 STECs in various foods have been documented, but no reported outbreak in the U.S. has been confirmed to be directly linked to beef products.”

Really J. Pat?

Interestingly, The CDC estimates that "non-O157 STECs (like O26, O45, 0103, O111, O121, and O145) cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths in America each year." In speaking about the May E. coli O145 outbreak linked to romaine lettuce, Patricia M. Griffin, chief of CDC's Enteric Diseases Epidemiology branch, said it is likely that E. coli O145 [and others have] caused previous food poisonings but has gone undetected because only about 5 percent of clinical laboratories are able to detect it. "The fact that we found it now doesn't mean it wasn't there before," she said. "The ability to look for the organism in ill people and in outbreaks and food has been increasing. We're gradually finding more of these organisms."

She also attached a memo outlining a number of animal contact outbreaks AND an E. coli O111 outbreak in North Dakota with ground beef in 2007.

Perhaps J. Pat did not read the memo?

Although I am not much of a conspiracy theorist, you have to wonder why J. Pat did not get the heads up from FSIS that a non-O157:H7 outbreak and recall [the recent E. coli O26] were brewing before he wrote his August 18th letter?  According to last Friday night’s press release: “FSIS became aware of the problem [E. coli O26 outbreak] on August 5, 2010 when the agency was notified by the Maine Department of Agriculture, Food and Rural Resources of an E. coli O26 cluster of illnesses.”

I will leave it up to the FSIS to explain why they waited from August the 5th until midnight last Friday to inform the public (and J. Pat) of the outbreak that AMI seems to have been waiting for.

Now, J. Pat - Why does the AMI not want bacteria that can kill you to be considered “adulterants?”

FYI - I am putting this Press Release out at 6:00 AM Eastern Time Monday - "E. coli O26 Outbreak and Recall Illustrate Urgent Need for Change."  By the way, I like J. Pat.  in 1999 he actually asked me to speak before the AMI Board of Directors (I spoke just after they all agreed to become "Pioneers" for George W. Bush - $200,000 a pop), but they have never invited me back.  Also, J. Pat and I had a civil debate about E. coli and death on Larry King Live a few months ago.

I know realistically that raising a few chickens for eggs in my backyard (presently in the guest room shower) will not change what happened over the last few weeks with the US Egg Industry.  And, I know that the eggs are not necessarily safer, but I felt I needed to do something other than sue some corporation for poisoning 1,400 people.  Plus, my 11-year-old was bugging me all last week about getting some.

The chicks were not that expensive, nor the feed.  Right now they are housed in an old Hamster cage. However, once the designer coop and the fence are built to keep out raccoons and eagles - well, I do not want to think about how much the eggs will be per dozen.

Update:

The CDC and FDA released FDA's Form 483 reports on Hillandale Farms and Quality Egg LLC (Wright County Egg) Monday. The 483 is a standard form that FDA’s field investigators use to note what they have observed during an inspection. The form does not include the final Agency determination of the company’s compliance with the Federal Food, Drug, and Cosmetic Act, but rather, it details the observations made during the inspection by the inspection team.

Hillandale Farms, New Hampton, IA, 483 Issued 8/26/2010

Quality Egg LLC (Wright County Egg), Galt, IA, 483 Issued 8/30/2010

In light of this weekends recall by Cargill Meat Solutions of approximately 8,500 pounds of ground beef products that may be contaminated with E. coli O26, and the sickening of three people, it is time for the United States Department of Agriculture (USDA) and Food Safety and Inspection Service (FSIS) to deem another six “enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of Escherichia coli (E. coli) strains - O26, O45, O111, O121, O145, and O103 – “adulterants.”

Non-E. coli O157:H7 EHEC as “Adulterants.”

According to the CDC, E. coli O157:H7 causes 73,000 illnesses and 50 deaths every year in the United States. Another six E. coli strains - O26, O45, O111, O121, O145, and O103 - are considered less pervasive, sickening “only” an estimated 37,000 people a year and killing nearly 30. E. coli O157:H7 is considered an adulterant in beef by the USDA (particularly ground beef), the other six strains are not.

Under 21 U.S.C. § 601 … (m), the Federal Meat Inspection Act (FMIA), the term “adulterated:”

shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances: (1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; ...

It is hard to read the above and not think that the word “adulterated” does not apply to all E. coli. Presently, industry does not test for it because the USDA and FSIS does not require it – because they are not considered “adulterants.” In addition, only five percent of labs in the U.S. routinely test for these other E. coli leaving a gap in our food safety network and the true level of illness unknown.

Non-E. coli O157:H7 EHEC have been found in ground beef.

In 2008 Marler Clark hired a private lab to conduct a large-scale, nationwide study of ground beef, a key vector in E. coli O157:H7 cases. During the past year and a half, that lab has tested 5,000 samples from a variety of manufacturers. IEH Laboratories found that about 1 percent of the samples were tainted by E. coli O26, O45, O111, O121, O145, and O103. The results and the testing methodology have been shared with USDA and FSIS and the beef industry.

A history of E. coli O157:H7 as an “Adulterant” and why other EHEC’s should be too.

It seems that any serious discussion of E. coli O157:H7 always has to start with one event: the 1993 outbreak associated with the Jack in the Box restaurant chain. This, of course, is with good reason. That outbreak left over 650 persons ill (many with life-long complications) and 4 children dead. The “9/11 for the food industry,” precipitated a whirlwind of events including media coverage, consumer outrage, lawsuits, and stricter federal regulations regarding meat safety. Though the swell of emotion that spiraled out of the Jack in the Box disaster dulls somewhat with each passing year, the federal regulations that sprung up in its wake continue to generate more questions.

To understand the significance of these regulations, a little background information is useful. The FSIS stated mission renders it “responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.” FSIS operates as part of the USDA. To promote its mission, FSIS has the power under the FMIA to, among other things, seek the recall of products that have been deemed “adulterated.” FSIS drastically shifted how it interpreted and enforced the FMIA in 1994 when, following the Jack in the Box outbreak, the agency declared E. coli O157:H7 to be an “adulterant.” This marked a dramatic change from its previous stance that pathogens in raw meat were not “adulterants.”

The declaration of E. coli O157:H7 as an “adulterant” was met with strong opposition from the meat industry. In a lawsuit filed soon after the 1994 declaration, the industry accused the FSIS of not following proper rulemaking procedures and of acting in an arbitrary and capricious manner beyond its legal authority. The United States District Court held, however, that the FSIS was allowed to interpret the FMIA and that the FSIS has the power to declare substances to be “adulterants” with the intended purpose of spurring the meat industry to create and implement preventative measures.

During the early part of this decade, however, it became readily apparent that E. coli O157:H7 was not the only deadly pathogen in E. coli family - in fact, far from it. The Centers for Disease Control (CDC) recognized this fact when, in 2000, the agency made all EHEC’s nationally notifiable. The CDC subsequently referred to non-O157 EHEC’s as emerging pathogens that pose a significant health threat, with more strains reported every year.

Still, FSIS remained steadfast in its stance that O157:H7 is the only EHEC that should be deemed to be an adulterant. So what’s wrong with FSIS’s position regarding E. coli O157:H7? The simple answer is this: the people of this nation do not deserve another Jack in the Box-sized catastrophe as a pre-requisite for currently needed agency action.

The scientific and medical communities have recognized the dangers of all EHEC’s, not just O157:H7. Nearly three years ago, on October 17, 2007, the CDC, FDA and FSIS even went so far as to hold a public meeting to consider the public health significance of non-O157 EHEC’s. In the Notice of the meeting, FSIS referred to the “growing awareness that EHEC’s other than E. coli O157:H7 cause sporadic and outbreak-associated illnesses.” Nevertheless, following the meeting, FSIS failed to re-interpret its policies.

It is time for the USDA and FSIS to deem another six EHEC strains - O26, O45, O111, O121, O145, and O103 – “adulterants.”

This brings us to today. We’re nearing the end of 2010, closing in on eighteen years since the Jack in the Box outbreak. Millions of Americans have suffered foodborne illnesses, injuries, and deaths in that time, thousands of them likely due to EHEC’s other than E. coli O157:H7.

It was on behalf of those persons that the law firm of Marler Clark has authored a petition to FSIS requesting the agency to issue an interpretive rule declaring all EHEC’s to be adulterants within the meaning of the FMIA. The petition details the scientific and legal bases for the requested action, but perhaps more importantly it details the suffering that food contaminated with non-O157:H7 E. coli inflicted upon three individuals: June Dunning, Megan Richards, and Shiloh Johnson.

Ms. Dunning, whose infection was caused by E. coli O146:H21, unfortunately succumbed to her illness, passing in 2006. Ms. Richards and Ms. Johnson endured lengthy hospitalizations, kidney failure, and will both endure a lifetime of medical complications as a result of their E. coli O121:H19 and E. coli O111 infections (respectively).

It would be naïve to assume that a change to FSIS policy will immediately rid the world of all foodborne E. coli infections. It has been unequivocally proven, however, that all EHEC’s are potentially lethal pathogens that we must fight tooth and nail to keep out of this nation’s food supply. If we trust science, and do our part to push government agencies to enact regulations to require better monitoring, we can no doubt begin to prevent further harm. In the end, after all, the requisite wading through the mess of bureaucracy required to change federal regulation is all worth it, so long as the outcome prevents at least one more case like that of June Dunning, Megan Richards, or Shiloh Johnson.

In another late Friday night press release, FSIS announced that Cargill Meat Solutions Corp., a Wyalusing, Pa. establishment, is recalling approximately 8,500 pounds of ground beef products that may be contaminated with E. coli O26.

FSIS became aware of the problem on August 5, 2010 when the agency was notified by the Maine Department of Agriculture, Food and Rural Resources of an E. coli O26 cluster of illnesses. In conjunction with the Maine Department of Health and Human Services, Maine Department of Agriculture, Food and Rural Resources, the New York State Department of Health, and New York State Department of Agriculture & Markets, two (2) case-patients have been identified in Maine, as well as one (1) case-patient in New York with a rare, indistinguishable PFGE pattern as determined by PFGE subtyping in PulseNet. PulseNet is a national network of public health and food regulatory agency laboratories coordinated by the Centers for Disease Control and Prevention (CDC). Illness onset dates range from June 24, 2010, through July 16, 2010.

* 42-pound cases of "GROUND BEEF FINE 90/10," containing three (3) - approximately 14 pound chubs each. These products have a "use/freeze by" date of "07/01/10," and an identifying product code of "W69032."

The products subject to recall bears the establishment number "EST. 9400" inside the USDA mark of inspection. These products were produced on June 11, 2010, and were shipped to distribution centers in Connecticut and Maryland for further distribution. It is important to note that the above listed products were repackaged into consumer-size packages and sold under different retail brand names.

According to the CDC - non-O157 E. coli STECs (like O26, O45, 0103, O111, O121, and O145) cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths in America each year.  And, tell me why our government has not agreed to adopt my "Petition for an Interpretive Rule Declaring all enterohemorrhagic Shiga Toxin-producing Serotypes of Escherichia coli (E. coli), Including Non-O157 Serotypes, to be Adulterants Within the Meaning of 21 U.S.C. sec. 601(m)(1)?"

For those interested in a bit more background, look at these links:

Marler's Response to the American Meat Institute Statement on New Bill to Declare Additional Strains of E. coli as Adulterants

Supplemental Reasons Why Non-O157's - like O145 - Should be Adulterants

It is Time (past time) for the FSIS to deem both Shiga-Toxin E. coli and Antibiotic Resistant Salmonella Adulterants

Also, I put my money were my mouth was and funded a $500,000 testing project to both test for non-O157 prevalence and to see if testing was practical.

I was visting my clients, Linda and Richard Rivera, in San Francisco today where Linda is in her 15th month of hospitalization from an E. coli O157:H7 infection.  She has become, in my mind at least, the reason that S. 510 must pass and the President must sign sweeping food safety legislation now.  

We talked for hours about their hopes and fears for themselves and their children, and how they wanted to give back to the High School where Linda worked and their kids went to school.  I offered to help.  

We will be setting up a Linda Rivera/Marler Clark Scholarship to be split between the wrestling program, the special education program and a scholarship for students interested in science - E. coli preferable.

I did get a bracelet out of it (GWTOY - means - "Guess who's thinking of you?")

Fruiti Pops, Inc. of Santa Fe Springs has recalled its mamey frozen fruit bars because of a possible link to a rare U.S. outbreak of typhoid fever.  The company said Thursday that the fruit bars were distributed in California, Arizona and Texas since May 2009.

Fruiti Pops says retail stores, ice cream trucks and vending machines sold the frozen fruit bars, which have the UPC number 763734000097.

The company says the frozen fruit bars were made from contaminated mamey pulp that Goya Foods, Inc. voluntarily recalled on Aug. 12, after it was linked to a typhoid fever outbreak in California and Nevada. So far no illnesses have been reported from the mamey fruit bars.

The other morning when I was prepping in another studio to talk with another cable channel about yet another food crisis—this time the recall of a half of a billion Salmonella-tainted eggs that had already sickened at least 1,400—I was asked by a young producer, “Attorney Marler, if you had a magic wand, what would you do to make food safer?”

My first thought (to myself) was, “How the hell do I know, I’m just an ambulance chasing barracuda looking to destroy some poor helpless food manufacturing corporation that just poisoned a bunch of people, cost retail chains hundreds of millions of dollars in recall costs, and damaged its entire sector’s image and sales?”

But then I thought some more. I thought about my nearly eighteen years spent dismantling those helpless corporations to secure medical expenses and lost wages for clients whose lives were destroyed, or ended, because they did something we all do about three times a day: they ate food. I thought about the ICU’s I had been in and witnessed the panic in a parent’s eye as a doctor coldly explained the need for kidney dialysis, or the reasons to stop life support because their child’s brain had stopped functioning. I thought about the heroic struggles in rehab as a brain-injured client learned to brush her hair and teeth, or learn to walk again as the family looked hopefully on. I thought about the fear that these families have as they wonder how they will cope with a disabled future without the resources to pay for it.

And, then I thought, “Give me the damn wand!”

First, I would increase criminal sanctions for poisoning your customers. If a CEO of a food manufacturer takes unreasonable risks with the public’s health, and people get severely sick or die, that CEO should spend time in jail. For goodness sake, we make kids do hard time for smoking dope, yet we do nothing to a CEO who sickens several hundred and kills nine by knowingly shipping Salmonella-tainted peanut butter (Yes, Mr. Parnell, I am thinking of you).

Second, I would financially-incentivize food manufacturers and retailers to produce and buy safer food. I would give them tax breaks for food safety interventions that have been proven to make our food both safer and healthier.

Third, I would encourage transparency in food safety; consumers need to know who produces and sells the safest and healthiest food, not just who produces and sells the cheapest food. Quality needs to replace quantity in the American diet.

Fourth, I would assure that our food regulations were even and flexible for all players—small and large, foreign and domestic. Safety would be paramount, but innovation—especially, those focused on energy consumption, environmental concerns and sustainability—must be encouraged.

Fifth, give local, state and federal inspectors the resources to enforce the regulations fairly and as frequently as necessary to assure compliance. Make all inspections – especially product test – transparent. Manufacturers and retailers need to work in virtual glass houses. Food production and food safety needs to be seen by all.

Sixth, I would elevate public health to the height it deserves. We need to encourage cooperation between all levels of public health in charge of educating the public on safe food handling. We also need to encourage coordination to those charged with surveillance of foodborne and bioterrorism events. We need to stop outbreaks earlier and prevent the spread of disease.

Damn, my wand arm is tired. I know I missed some things, and likely emphasized ideas that others would not, but I am tired now and still have an ambulance to chase.

When lawyers talk about “the smoking gun,” we are usually talking documents, not finding genetically matching Salmonella Enteriditis samples at Wright County Egg and in its chicken feed – but that will work too.

So, where are we? The FDA and Wright County Egg Recall number is still 550,000,000, which was announced August 15. And, newer numbers on those ill are now at least 1,500 according to the CDC. However, we still have very little information on the actual spread of those illnesses on a state-by-state basis.

Now in addition to the questions raised on how this Salmonella Enteriditis outbreak happened, are questions about when Wright County Egg and local, state and federal officials knew that the public was at risk. Someone who I have a great deal of respect for, Jeff Farrar, DVM, PhD, MPH, associate commissioner of food safety at FDA, has defended the government's response to the contamination, which has been criticized by others as too slow.

"We have to strike a balance between being timely and being accurate," he said, noting that the FDA requested that Wright County Egg and Hillandale Farms initiate the recall before lab results had confirmed that the companies' eggs were the source of the outbreak.

It is hard to argue with Jeff. However, because of the litigation we have filed, we received public health records today from the County of Kenosha (WI) Department of Human Services, as part of our ongoing investigation of the nationwide Salmonella Enteritidis outbreak. A partial selection of the records can be viewed here: County of Kenosha (WI) Department of Human Services Records

Among some of the interesting notes:

• An email on August 6, 2010, showing the connection between the Baker Street restaurant outbreak and the larger outbreak: "we were able to link the eggs from Baker Street to a large egg farm in Iowa."

• References to an egg distributor from Milwaukee, Reinhardt, as a common source of eggs to implicated restaurants, and the statement that Reinhardt "receives their eggs directly from Wright County Egg."

• Discussion of clusters of illnesses with a matching strain in Minnesota, as well as "additional restaurant outbreaks in Iowa and Colorado."

• Implication of illnesses in California on August 4, "We have firmly implicated shell eggs as the source in two outbreaks and traceback of shell eggs in our most recent outbreak appears to match egg traceback California has conducted."

• A description of the four restaurant clusters in Minnesota sharing the outbreak strain.

Obviously, we are in the dark (perhaps less so that others) on the particulars at this point, but the first mention of a national outbreak and recall to the public was August 15 (we heard rumblings a few days before that). So, what happened between August 6, or earlier, and August 15? 

Rodent feces are the usual source

Test results from environmental samples at Wright County Egg - one of two related companies believed to have supplied Salmonella - contaminated eggs now under nationwide recall - showed strains of the bacteria with the same DNA fingerprint seen in clinical isolates. Chicken feed at facilities supplying Iowa-based Wright County Egg and Hillandale Farms also tested positive for Salmonella enteritidis with the same genetic fingerprint as 1,300 ill people across the U.S.

In the legal context, any possible defenses that Wright County Egg might have been able to raise are "up in smoke."

According to press reports, late yesterday afternoon a federal judge recommended approval of a $12 million settlement for those sickened or killed in last year's salmonella outbreak tied to a Virginia-based peanut processor.  This includes nearly 50 families represented by Marler Clark.  

U.S. Magistrate Judge Michael Urbanski issued his recommendation late Wednesday for the payments for the more than 120 personal injury claims related to the outbreak. The settlement must now be approved by a bankruptcy court judge.  The outbreak traced to Lynchburg-based Peanut Corp. of America's plants in Georgia and Texas was linked to the illnesses of about 700 people and the deaths of at least nine.  Peanut Corp. filed for Chapter 7 bankruptcy to dissolve amid fallout from the outbreak.  The money provided by the company's insurers will be distributed based on the extent of victims' illnesses.

The settlements reached involved only 125 or of the 714 culture-confirmed cases. It did include all nine of the death claims. Frankly, I am not sure where the near 600 others went. That would be interesting study to see why they did not come forward. The awards to the 125 were partially funded by PCA’s 12M and partially by Kellogg. The amounts on all the claims were based upon prior verdicts and settlements in Salmonella cases with a view to the law of where the claimant resided (some states allow compensation for one thing, but not another). I thought the awards were fair.

And, Stewart Parnell is still not in Jail.