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OMB Stalls Move to Make Non-O157 STEC Adulterants

Germany’s catastrophic foodborne illness outbreak, caused by a rare but virulent strain of E. coli, raises new concerns about whether federal regulators are adequately addressing similar emerging pathogens in the U.S.

The USDA’s Food Safety and Inspection Service was petitioned last year to declare additional disease-causing strains of E. coli — beyond the well-known E. coli O157:H7 — as adulterants, a move that would trigger more testing and make the pathogens illegal in meat products. The notice for rulemaking is now languishing in review at the Office of Management and Budget (OMB), though it is unclear what the remaining issues are.

Regulators at USDA confirmed in a recent Government Accountability Office report that FSIS has developed tests for the six Shiga-toxin producing E. coli (STEC) of most concern to the Centers for Disease Control and Prevention. The CDC estimates that the six STECs under consideration cause approximately 113,000 illnesses and 300 hospitalizations annually in the United States.

According to the OMB regulatory portal, the notice is not considered “economically significant,” and “has not been published in a Unified Agenda.”

A USDA official familiar with the process declined to comment on what might be holding up the issue, citing its “pre-decisional” status.

“OMB has basically approached this and said ‘where are the bodies?,’ ” says Monsour Samadpour, a microbiologist and leading food safety expert who believes the government is dragging its feet. “The position we have taken is this: the entire group is pathogenic. It’s like a hand grenade. It can go off at anytime so it shouldn’t be in food.”

Labeling one STEC an adulterant and not another is like “saying a magenta hand grenade is dangerous, but a blue one is not,” adds Samadpour, who is intimately familiar with STECs and the food supply.

Samadpour’s company, IEH Laboratories, was recently commissioned by Marler Clark, publisher of Food Safety News, to detect the prevalence of non-O157 STECs in retail ground beef. In 5,070 samples, IEH found 301 presumptive positives and 96 confirmed non-O157 positives, 30 of which fall within the six strains of most concern to CDC. The study detected one positive for E. coli 0104:H7, which is in the same family as the strain currently wreaking havoc in Europe.

“We are obviously very concerned about this outbreak and are always on the lookout for emerging pathogens,” a USDA official told Food Safety News Wednesday. “We currently test for and have a zero tolerance of E. coli O157:H7.  We have developed a method to test for other strains of E. coli identified as the greatest public health concerns.  In the wake of this current outbreak, we have to examine how we can best protect consumers from this and other emerging pathogens.”

The foodborne illness chaos in Germany also comes on the heels of an E. coli O111 outbreak last month in Japan. That outbreak — which sickened 90 people, left 23 with hemolytic uremic syndrome, and killed four — was tied to raw beef dish called yukhoe, similar to tartare, popular at barbecue restaurants.

“The tragedies in Germany and Japan should serve as a wakeup call to governments and businesses worldwide. The U.S. is seeing more and more E. coli outbreaks from non-O157 strains,” said Bill Marler, managing partner at Marler Clark, in a release Wednesday. Marler’s firm originally petitioned FSIS on STECs in October 2009.

© Food Safety News
  • http://www.marlerblog.com bill marler

    Here is a post from early April of this year from my blog:
    In October 2009 that we filed a “Petition for an Interpretive Rule Declaring enterohemorrhagic Shiga Toxin-producing Serotypes of Escherichia coli, Including Non-O157 Serotypes, to be Adulterants Within the Meaning of 21 U.S.C. § 601(m)(1)” with the Food Safety Inspection Service (FSIS). Since I filed the Petition, I have also filed two supplements (See, First and Second) and provided the FSIS with my private test results.
    When I filed the Petition, Mead, et. al., estimated that non-O157 STECs (like O26, O45, 0103, O111, O121, and O145) caused 36,000 illnesses, 1,000 hospitalizations and 30 deaths in America each year. Now, admittedly, not all, or most of these illnesses and deaths were caused by vectors overseen by FSIS, but clearly some have. However, the CDC new estimates of illnesses caused by non-O157 STECs have risen to over 160,000 ill yearly. Hospitalizations and deaths are lower because many non-O157 STECs do not cause severe illness, but O26, O45, 0103, O111, O121, and O145 certainly do.
    Today the USDA/FSIS posted this press release:
    Almost everyone knows about Escherichia coli O157:H7, the culprit behind many headline-making outbreaks of foodborne illness in the United States. But the lesser-known relatives of this pathogenic microbe are increasingly of concern to food safety scientists.
    That’s according to U.S. Department of Agriculture (USDA) microbiologist and research leader Pina M. Fratamico. Researchers such as Fratamico, along with food safety regulators, public health officials and food producers in the United States and abroad, want to know more about these less-studied pathogens.
    In the past few years, a half-dozen of these emerging E. coli species, also called “serogroups,” have come to be known among food safety specialists as “the Big Six,” namely E. coli O26, O45, O103, O111, O121, and O145.
    Fratamico and her colleagues are sorting out “who’s who” among these related pathogens so that the microbes can be identified and detected quickly and reliably. The researchers are doing that by uncovering telltale clues in the microbes’ genetic makeup.
    Building upon this work, Fratamico and her Agricultural Research Service (ARS), university, and industry collaborators have developed gene-based PCR (polymerase chain reaction) assays for each of the Big Six. With further work, the assays might be presented as user-friendly test kits for use by regulatory agencies and others. Foodmakers, for example, might be able to use such kits for in-house quality control, while public health agencies might rely on them when processing specimens from patients hospitalized with foodborne illness.
    Analyses of test results might help researchers determine whether certain strains of Big Six E. coli species cause more illness than E. coli O157:H7 does, and if so, why.
    The USDA/FSIS has been studying this issue for years while people continue to become ill. Tests that work have been available for years – I have $500,000 worth of examples. The USDA/FSIS has the authority to deem at least the “the Big Six” adulterants despite some in the industry desire to not do so. It is time to – past time – to act.
    Go here to see links to Petition and other documents:
    http://www.marlerblog.com/lawyer-oped/it-is-past-time-for-the-usdafsis-to-deem-the-big-six-e-coli-as-adulterants/