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A Decade of Inaction at USDA on Non-O157 E. coli

In the wake of the horrible E. coli outbreak in Germany, many food safety advocates are calling on the U.S. Department of Agriculture (USDA) to get off the dime and expand required beef testing to strains beyond the standard O157:H7.

According to the Centers for Disease Control and Prevention (CDC) approximately 160,000 people in the United States are sickened each year by non-O157 E. coli. Six serotypes, known as the “Big Six” (E. coli O26, O45, O103, O111, O121, and O145) are currently under scrutiny.

Far from being a new issue, the evidence for why we need expanded testing has been available for at least 20 years, maybe even 30. According to the petition filed against USDA by the law firm Marler Clark (publisher of Food Safety News), as early as the 1980s, non-O157 strains were first identified globally.

The first outbreaks were reported in the U.S. in the 1990s. What has happened since? Quite a lot, but little of which can be called progress. Here’s a timeline:

2000: CDC requires non-O157 infections be reported

2000-2006: four-fold increase in number of non-O157 cases reported

2007: USDA’s alarming research and a meeting (both in October)

- USDA finds non-O157 strains at levels comparable to O157:H7

- USDA meeting on non-O157 strains with FDA and CDC

“The purpose of the meeting is to solicit input from academia, consumers, other public health and regulatory agencies and industry on the issue of whether non-O157:H7 STECs should be considered to be adulterants as E. coli O157:H7″

2008: Another USDA meeting, followed by a deadly outbreak

- April: USDA meeting: “Shiga Toxin-Producing E. coli: Addressing the Challenges, Moving Forward With Solutions”

- August: E. coli 0111 outbreak in Oklahoma, sickening more than 300 people, some with kidney failure, one young man dies

2009

With still no action from USDA (despite two meetings and a serious outbreak) in October 2009, Marler Clark files 470-page petition with USDA’s Food Safety and Inspection Service (FSIS) demanding expanded testing: “Recent studies have repeatedly shown that non-O157 STEC is a serious food safety hazard.” (Attorney Bill Marler vows to write FSIS every three months for updates.)

2010

January: FSIS responds to Marler Clark, approving the petition for expedited review and acknowledging the need to consider non-O157:H7 serotypes as adulterants.

February: Petition filed by Safe Tables Our Priority (now STOP Foodborne Illness) calling on USDA to declare six additional strains of E. coli adulterants in meat.

April of 2010 saw two non-O157 E. coli outbreaks: one in romaine lettuce (0145) with 19 confirmed cases in Michigan, New York, and Ohio, and the other (0111) in food served at a Colorado prison.

Also, in April 2010, U.S. Senator Kirsten Gillibrand (D-NY) sent a letter to USDA Secretary Tom Vilsack requesting an official response to the two filed petitions and reiterating the call for expanded testing of non-O157 strains.

Then, in perhaps the most surprising development to date, Wal-Mart announced its intention to start testing for non-O157 strains voluntarily.

May:

- CDC expressed concern over lack of testing in light of E. coli 0145 outbreak, predicting underreporting of such infections

- Marler Clark files supplemental petition based on CDC investigation of 0145 outbreak

- Sen. Gillibrand introduces a bill to amend the Federal Meat Inspection Act to revise the definition of “adulterated” to include contamination with E. coli strains that cause human illness

Meat lobby responds, eating its own E. coli-contaminated words

The American Meat Institute (AMI – representing 95 percent of the red meat industry) responded in June to the proposed bill with its trademark rhetoric: “We share Sen. Gillibrand’s desire to eradicate pathogenic bacteria, but we don’t believe that an act of Congress can make these bacteria disappear.”

Also in June, an AMI representative said boldly: “We do not believe declaring non-O157 STECS to be adulterants will enhance the food safety system.” (Never mind that declaring O157:H7 an adulterant back in 1994 has done exactly that.)

Then in August, AMI got more shameless, arguing in a letter to USDA Secretary Vilsack that expanded testing will “do more harm than good.” The letter also said that while outbreaks in “various foods” have been documented, no outbreak “has been confirmed to be directly linked to beef products.”

Ten days later, Cargill recalled 8,500 pounds of ground beef contaminated with E. coli 026 that had sickened at least three people in two states.

In September 2010, Elizabeth Hagen, the newly appointed USDA undersecretary for food safety, met with four advocates for expanded testing:

• Richard Raymond, MD (who formerly had Hagan’s job)

• Marler (food safety attorney whose law firm publishes Food Safety News)

• John Munsell of Montana (a meat packer whose plant was shut down after receiving contaminated beef from Cargill)

• Nancy Donley (mother of a boy who died of E. coli poisoning from eating a hamburger)

After the meeting, Marler predicted: “I’m convinced within the next six months, at least the CDC’s six top non-O157s will be regulated as an adulterant and the meat-eating public will be safer.” (This March would have been six months.)

Also in September 2010, for good measure and in light of recent outbreaks, Marler Clark files a second supplement to its FSIS petition.

2011

In January, USDA (apparently) submits request to the White House Office of Management and Budget (OMB) for approval of a rulemaking on “Shiga Toxin-Producing E. coli (STEC) in Certain Raw Beef Products.”

In March, test results released from USDA showed the presence of non-O157 E. coli strains “that may be considered a significant food safety threat.”

In April, results of tests (paid for by Bill Marler) and reported at the “7th International Symposium on Shiga Toxin Producing E. coli” found non-O157 STECs in 1.9 percent of 5,000 samples, or one out of every 50 packages.

May and June: horrible outbreaks, scary data, and inexplicable delays

May saw one E. coli outbreak in Japan (0111), sickening nearly 100, 23 with kidney disease, killing four. (And they all ate steak, not ground beef.) The other was in Germany (0104 – not one of the Big Six), from spouts, the source of which is still unknown. That outbreak (the deadliest on record) has thus far killed 48 and sickened thousands, hundreds with potential life-long kidney disease.

Meanwhile, back at home, a May report from the U.S. Government Accountability Office confirmed that USDA has had tests for non-O157 E. coli strains ready to go as of February of this year, so why the delay?

We learned in early June that apparently the White House OMB is stalling approval of the FSIS petition. Who knows why? (See my recent interview with Dr. Richard Raymond, ex-head of FSIS at USDA for why — of course it’s politics.)

Also in June, to further drive home the need for action, a study from Texas Tech showed that 5.9 percent of all beef was contaminated with non-O157 strains, an alarming amount. And if that weren’t scary enough, the CDC recently released data showing (for the first time) that the number of people infected with various strains of non-O157 E. coli in 2010 exceeded those sickened by O157.

At least someone in Congress is listening. Undeterred by Big Meat lobbying, in June, Senator Gillibrand introduced yet another bill and sent yet another letter to USDA. The new legislation, “would target all high-risk pathogens and all currently unregulated strains of E. coli found in the meat supply that have been proven to cause food-borne illnesses.” The senator’s letter reminded Secretary Vilsack that she wrote to him in April of 2010. (In case someone at AMI made him forget?)

Speaking of AMI, their arguments appear to be getting more desperate. Despite ample evidence (from the feds themselves) that testing is now available, the trade group now claims that FSIS testing is “a work in progress.” And anyway, AMI, argues, who needs more testing? “Common interventions in U.S. meat plants work against all strains of E. coli.” (Not sure what that means either.)

Bringing us up to date, Marler Clark recently sent a letter to USDA, threatening to sue the agency if it takes no action on the firm’s petition before the pending September 2011 deadline. And finally, Congresswoman Rosa DeLauro (D-CT) just sent a letter to OMB also urging action; she was disturbed by the delay considering the “devastating health consequences” of E. coli infection.

DeLauro also (understatedly) expressed concern that OMB “may be working to indefinitely delay consideration or fundamentally change the proposal at the urging of those who argue that the action is a threat to financial interests.”

Financial interests? Indefinite delay? This timeline is already too long.

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

    Man, time flies. I hope that FSIS moves on this by September 1, 2011. I would hate to see the Court force this issue. However, at this point, not moving on declaring non-O157 E. colis adulterants is beyond arbitrary – it is stupid. Just look at what is going on in Germany, France, Sweden and Denmark.

  • dangermaus

    And after that detail of food safety is managed, which detail are you going to get indignant about next? And then which one? That kind of thinking is regulating the country into the ground.
    The fundamental problem is the way that beef is raised in this country, and the fact that American consumers don’t give a damn how it’s produced and processed. If we all ate locally, we’d face more price fluctuations, and probably eat less beef, but E. coli outbreaks would have been far smaller, and far easier to track down.

  • dangermaus

    I should say “raised, processed and distributed”

  • Minkpuppy

    Sorry Bill, In my experience, nothing happens in September in the government. Too close to the end of the fiscal year (Sept. 30) when everyone is “out of money”.
    The budget will be the excuse for not acting on this especially in the current climate in DC. They’ll cite the extra costs of initiating the sampling, blah blah blah. I’ve heard it dozens of times over my career and that dog doesn’t hunt for me anymore.