Circumstances have long been ripe for calling all shiga-toxin producing strains of Escherichia coli (E. coli) “adulterants” in our food supply. The USDA’s Food Safety and Inspection Service, which is the entity that has the regulatory capacity to do just this, currently has in its possession two citizen petitions to take this action.  In our petition, we state:

Despite strong scientific evidence that many strains of non-O157 STEC are as pathogenic as E. coli O157:H7, FSIS has thus far failed to include all STEC as adulterants under the FMIA.  Recent studies have repeatedly shown that non-O157 STEC is a serious food safety hazard. According to one study, non-O157 STEC are prevalent in beef production systems at rates as high as 70.1%.5 A United States Department of Agriculture (USDA) study states that non-O157 STEC have been found in ground beef and on cattle hides and feces at levels comparable to E.coli O157:H7.6 Furthermore, European studies indicate that non-O157 STEC infections occur more frequently than E. coli O157:H7 infections.7 With such a ubiquitous presence, the potential risk for harm caused by non-O157 STEC may be on par with, or even greater than, the risk created by E. coli O157:H7. Indeed, another study concluded that “non-O157 STEC can cause severe illness that is comparable to the illness caused by STEC O157.”

Our petition has recently received the support of Senator Kirsten Gillibrand (D-NY). FSIS’s response, to date, is that they are considering the petition. Also currently on the federal government’s to-do list is a Senate vote on S 510 "The Food Safety Modernization Act."  The Food Safety Modernization Act would amend the Food Drug and Cosmetic Act by giving the Food and Drug Administration better authority and ability to monitor the safety of our food supply, and take quicker and more effective action for food companies that don’t adequately protect against foodpoisoning risks.

Readers may ask why these regulatory and legislative measures are ripe for action.

1.  Stephanie Smith

2.  Linda Rivera

3.  252 illnesses nationally linked to salami, black pepper, and red pepper

4.  Millions and millions of pounds of meat products recalled.

5.  HVP recall, which, although it caused no known illnesses, resulted in one of the largest food product recals in history.

6.  About 76,000,000 other reasons every year.

As for the regulatory action that has really got our eye, particularly in the wake of multiple outbreaks linked to non-O157 strains of E. coli. Currently, at least 60 people recently fell ill in Michigan, Ohio, and New York due to infection by E. coli O145. Also last month, at least11 inmates at a correctional institution in Colorado fell ill due to infection by E. coli O111. Word of exactly what food products were contaminated in the Michigan, Ohio, and New York E. coli O145 outbreak has not yet come.

To understand the significance of regulating non-O157 strains of E. coli, a little background information is useful. FSIS’s 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.” To promote its mission, FSIS has the power—under the Federal Meat Inspection Act (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.

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 enterohemorrhagic 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).

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

The USDA is conducting testing on tater tots that were distributed to schools in Nebraska after several children who ate the tater tots complained of upset stomachs, according to the Associated Press.  A recall of 25,000 pounds of tater tots that were distributed to schools and day care centers was initiated following the complaints of illness.  The Lincoln Journal-Star reported on the recall: 

State health official Todd Landry says the department sent out 840 cases of the potatoes through its Food Distribution Program. The state learned Thursday morning that the product was being recalled and notified 345 schools and daycare centers, some of which were preparing the tater tots for lunch.

The U.S. Department of Agriculture says the potatoes had an odd taste and odor, and that some children who ate them later complained of upset stomachs. In Nebraska, three schools reported sick students.

In 2002, a food poisoning outbreak at an Illinois school was traced back to chicken tenders that had been exposed to ammonia.

The Associated Press reported today that Castleberry’s, the plant that was the source of a botulism outbreak traced to several hot dog chili products, has closed its doors. out of Dallas/Fort Worth carried the AP story, "Castleberry’s shuts plant over botulism outbreak." 

Over the weekend, 16 cans of chili produced at the Castleberry’s Georgia plant tested positive for botulism, and company officials have confirmed that the canned products were not cooked to high enough temperatures to kill Clostridium botulinum, the bacterium that causes botulism food poisoning.  AP reported:

So far, four cases of botulism have been reported — two from Indiana and two from Texas. All four people consumed Hot Dog Chili Sauce Original, a product made by Castleberry’s.

On Saturday, Castleberry’s expanded its recall of canned meat products that may be connected to a botulism outbreak. It recalled more than 80 types of canned chili, beef stew, corned beef hash and other meat products in addition to the 10 brands it had recalled Thursday.

The latest FDA and USDA recall announcements can be found here:

Washington Beef, a Toppenish, Washington firm, recalled over 82,000 pounds of beef products on Friday.  The recall was initiated after the Washington State Department of Health determined that the products were likely produced using non-potable water.  According to a recall release by the United States Department of Agriculture’s Food Safety and Inspection Service:

The beef products subject to recall were shipped in bulk for further processing and may have been sold under different retail brand names in the affected states. Consumers should check with their local retailer to determine whether they may have purchased any of the products subject to recall.

The list of recalled products can be accessed on the FSIS Web site here:

The Cattle Network posted a brief analysis of a study conducted by Harris Interactive between April 10 and April 16 – weeks before a number of E. coli outbreaks caused the recall of millions of pounds of ground beef.  The study showed that of 79 percent of consumers surveyed online, 86 percent are aware of food product recalls, and 29 percent believe that food product recalls are a serious concern. 

The poll also demonstrated that consumers especially attuned to recalls attributed to health or safety concerns, with 55 percent saying they would at least temporarily purchase another brand and 15 percent saying they would permanently switch brands.

Also noteworthy were consumers’ varying levels of familiarity with six product recalls that occurred in the past 8 months that were measured in the study. Along with varying familiarity levels, the actual number of consumers able to name the brands involved in the recalls drops considerably.

For example, only 20 percent indicated they were familiar with a nationwide recall of chicken contaminated by Listeria monocytogenes. And of those familiar with the recall, only two percent were able to name the correct brand involved. Meantime, 17 percent named other industry brands not associated with the chicken recall.