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FSIS Responds to Marler Clark Petition

Prior to 1993, little was known about pathogenic E. coli. Although scientists identified the first harmful foodborne strain in 1982 (O157:H7), it took a deadly E. coli O157:H7 outbreak associated with Jack in the Box to snap public health agencies into action.

The “9/11 of the food industry,” as trial lawyer Bill Marler occasionally refers to the outbreak, launched a powerful torrent of media coverage, consumer outrage, litigation, and stricter federal regulations.

Following the outbreak, the United States Department of Agriculture (USDA) drastically shifted its stance on pathogens in raw meat, declaring E. coli O157:H7 to be an adulterant. Specifically, this gave the agency power to seek a recall of food contaminated with E. coli O157:H7; practically, it was used to spur the meat industry into increasing pathogen testing and preventing contamination.

Although the declaration was met with heavy resistance and a lawsuit from the meat industry, the United States District Court held in 1994 that the USDA had acted within its legal authority to declare E. coli O157:H7 an adulterant.

Since that time, E. coli has been under a microscope (both literally and figuratively). While experts have been long-aware of the dangers associated with O157:H7, the scientific and medical communities have recently recognized that O157:H7 is not the only deadly pathogen in the E. coli family.

The Centers for Disease Control and Prevention estimates that non-O157:H7 Shiga toxin-producing E. coli (STEC) causes 36,700 illnesses, 1,100 hospitalizations, and 30 deaths annually. The Food Safety and Inspection Service (FSIS) acknowledged this when, in 2007, the agency sponsored a meeting to consider the public health significance of non-O157:H7 STEC.

Despite the documented health risks, FSIS continues to hold that O157:H7 is the only E. coli strain that should be deemed an adulterant.

In an attempt to change FSIS policy, the law firm of Marler Clark submitted a petition to FSIS (pdf) on October 5, 2009 requesting the agency to issue an interpretive rule declaring six non-O157:H7 serotypes of E. coli adulterants.

In addition to a brief history of E. coli, the petition detailed the scientific and legal bases for the requested action, and perhaps most importantly, three severe human cases of non-O157:H7 STEC contamination. The petition also requested an expedited review process, as it is “intended to enhance public health by reducing food safety hazards.”

After months of waiting, and two weeks before Marler was set to file suit against FSIS for failing to respond to his petition, the agency finally replied.

In its response (pdf), dated January 27, 2010, FSIS approved Marler’s petition for expedited review, but not much else. While it did recognize the need to consider if non-O157:H7 STEC should be declared adulterants, the FSIS “also recognized the need to conduct research and otherwise develop the data the Agency needs to help address the outstanding issues,” including “the need to develop laboratory capacity to support policy decisions with respect to non-O157:H7 STEC.” In other words, the response said, the FSIS is not ready to declare any non-O157:H7 STEC adulterants.

Marler told Food Safety News he is preparing a letter to the FSIS response that will demonstrate the availability of the necessary “lab capacity.” In fact, he asserts that the U.S. Food and Drug Administration has a test specifically designed to detect non-O157:H7 STEC that was developed by its own Center for Food Safety and Applied Nutrition.  

Marler remembers the foot-dragging and industry resistance that occurred when FSIS first tried to declare O157:H7 an adulterant, and he hopes it doesn’t take another Jack in the Box-type outbreak to prompt action.

“The danger in waiting”, said Marler, “is that these outbreaks are increasing. Since reporting was implemented by the CDC in 2001, instances of non-O157 STEC have steadily increased year by year. This has become an issue that is too big to ignore any longer. If we trust science, and do our part to push government agencies, we can prevent further harm.”       

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