Health Law

Lawyer Battles FSIS on Non-O157 E. coli

By Dan Flynn and Suzanna Schreck

Before the 1993 Jack in the Box outbreak, little was known about pathogenic E. coli.  Since that time, however, E. coli has become nearly universally recognized as a deadly bacterium most commonly found in ground beef.

What many people don't know, though, is that different strains of E. coli can be found almost everywhere in our environment. In fact, humans excrete between 100 billion and 10 trillion E. coli bacteria daily. Moreover, E. coli can be a digestive aid, and it even provides vitamins, like K and B-complex.

Unfortunately, many strains of virulent E. coli that produce toxins, such as O157:H7, the strain that sickened hundreds in the Jack in the Box outbreak.  Because of its lethality, O157:H7 was declared an adulterant by the Food Safety and Inspection Service (FSIS) in 1994, which allowed the agency to test food for the bacterium and seek a recall if food is found contaminated with E. coli O157:H7.

Meanwhile, other deadly strains of E. coli--O26, O111, O103--were left unclassified. Recognizing the danger posed by this loophole, the food safety law firm Marler Clark submitted a petition to FSIS on October 5, 2009, requesting the agency to issue an interpretive rule declaring non-O157:H7 serotypes of E. coli as adulterants.

After more than four months, Phil Derfler, an assistant administrator with FSIS, finally responded to the firm's petition.

The response, dated January 27, 2010, approved the petition for expedited review and acknowledged the need to further consider non-O157:H7 serotypes as adulterants.

"FSIS recognized the need to conduct research and otherwise develop the data the Agency needs to help address the outstanding issues," Mr. Derfler said.  This includes "the need to develop laboratory capacity to support policy decisions with respect to non-O157:H7 STEC (Shiga toxin-producing E. coli)."

Bill Marler, the managing partner of Marler Clark and author of the petition, took issue with Derfler's lab capacity claim.

"It is worth noting that your sister agency, the FDA, has already developed and implemented a method to identify isolates that belong to six prevalent [E. coli] serotypes," he replied in a letter on February 22, 2010. "With these recent developments, detection has become more feasible than ever before.  As you know, we used methods in our own study on retail ground beef in 2008." 

In addition, Marler promised to write FSIS every 3 months to stay informed on the progress of work on the petition.

True to his word, Marler followed up with FSIS on April 1, 2010. "I would like to know if the agency has made any progress in its study to determine laboratory-testing capacity," he asked. "If you need any additional materials from me to aid in this study, I will gladly do my best to provide them."

Derfler, whom Marler now playfully calls his "pen pal," responded on April 8, 2010.

"When FSIS has an appropriate laboratory method for conducting regulatory sampling for non-O157:H7 STEC, and has developed a plan for how it intends to address this issue," he wrote, "it will make the plan available to the public for comment. At that time, the Agency will also issue a final response to your petition."

Marler remains determined to demonstrate the danger of non-O157:H7 STEC. To prove his point, he recently hired a private laboratory to test grocery store ground beef around the country. So far, 4,700 samples have been tested, and 1.9 percent of them have tested positive for non-O157:H7 E. coli.  

For Marler, the numbers reinforce the need for more regulation. "Prompt action regarding this petition continues to be of the utmost importance," he told Food Safety News. Citing Dana Boner, a mother who lost her child to E. coli O111 in 2007, Marler affirmed the danger of allowing non-O157:H7 serotypes to remain outside the classification of adulterant. "Indeed, more deaths are inevitable if the USDA does not change its policies."                  

Full post as published by Food Safety News on April 26, 2010 (boomark / email).