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

What is a Class I recall?

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

What is E. coli O157:H7?

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

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

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

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

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

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

On February 5, 2004, the FDA wrote a letter to the lettuce and tomato industries to voice its concern about the frequent outbreaks linked to those products. In the letter, the FDA counted 14 such outbreaks since 1996 that it had investigated. Among other things, the letter stated:

In view of continuing outbreaks associated with fresh lettuce and fresh tomatoes, we strongly encourage firms in your industries to review their current operations in light of the agency’s guidance for minimizing microbial food safety hazards in fresh lettuce and fresh tomatoes, as well as other available information regarding pathogen reduction or elimination on fresh produce. We further encourage these firms to consider modifying their operations accordingly, to ensure that they are taking the appropriate measures to provide a safe product to the consumer. Since the available information concerning some of the recent outbreaks does not definitively identify the point of origin of the contamination, we recommend that firms from the farm level through the distribution level undertake these steps.

On September 30, 2005, a year and a half after the FDA’s 2004 letter to the lettuce industry, the Minnesota Department of Health issued a press release stating that 11 Minnesota residents had been infected by E. coli O157:H7 from contaminated Dole romaine lettuce. Two days later, the FDA issued a nationwide public health alert regarding Dole pre-packaged salads. Further investigation indicated that 22,321 cases of potentially contaminated Dole romaine lettuce had been sent to market from a processing facility in central California. Ultimately, at least 32 people were sickened in the outbreak.Continue Reading Salinas Valley, Leafy Green Vegetables, and E. coli

The Washington State Department of Health issued a press release today on its continuing investigation into the Salmonella Montevideo outbreak associated with salami manufactured by Daniele International.  The salami has since been recalled and a list of retailers that may have received the implicated product can be found HERE.

Thus far,  the infections of

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

Friday’s recall:  (from FSIS press release)

Daniele International Inc., an establishment with operations in Pascoag and Mapleville, R.I., is recalling approximately 1,240,000 pounds of ready-to-eat (RTE)

We hear about them so often these days–recalls of all kinds of products, from foods, to medications, to kids toys–that "recall" has become a working concept in everybody’s vocabulary.  But what is a recall?  Who has the legal obligation to announce them?  And what legal ramifications are there ot being involved in one?  

First, despite not having the legal authority to actually recall products, the FDA and USDA are frequently involved.  In fact, the USDA’s Food Safety and Inspection Service (the agency arm responsible for ensuring the safety of meat, poultry, and eggs) sets the standards for when, and what kind of, a recall is required.  

The FSIS defines three kinds of recall actions that can fairly be included under the same umbrella.  A "Class I recall" should occur in "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."  (Editor’s note: "should" is italicized because sometimes food product manufacturers do not issue class I recalls even when circumstances require it.)  Under this definition, a Class I recall should occur any time a food product is known or suspected to be contaminated with any foodborne pathogen, whether bacterial or viral.  The reason:  bacteria and viruses make people sick, and as a result, food contaminated by them will make people sick.

A "Class II recall" should occur in "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."  This is a little less clear than the definition of a Class I recall, but I certainly believe that the consequences of foodborne disease are simply too extreme for food companies to play fast and loose under these definitions.  A Class I recall should occur every time a food manufacturer knows, or has reason to know, that a product it has produced is or may be contaminated with a foodborne pathogen.  Every time.

Finally, a "market withdrawal"

occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

A "market withdrawal" has no place in the world of food contamination.  Again, salmonella and e. coli and campylobacter and hepatitis and every other foodborne pathogen are simply too dangerous for companies to try to avoid their obligations by calling what should be a recall a "market withdrawal"–something done purely to avoid the media ramifications of saying that you’re product has been recalled.  This has been done before under circumstances where a Class I recall was surely warranted. Continue Reading Recall basics for food products

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

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

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