When an outbreak of E. coli makes the news, typically any illnesses reported are related to the strain O157:H7. But Seattle-based foodborne illness attorney Bill Marler is petitioning the USDA to declare six more serotypes of the bacteria as adulterants.
He's giving USDA 90 days to respond to the petition or face a lawsuit.
These six serotypes — O26, O111, O103, O121, O45 and O145 — have been found in food products in the U.S. and have caused both illnesses and death, Marler states in his 472-page petition, which was hand-delivered to USDA Secretary Tom Vilsack on Oct. 6. The problem is, USDA inspectors are not required to test for these pathogens and, even if they were found on raw beef products, the products would not be subject to an immediate recall, he says.
By declaring these serotypes as adulterants, like O157:H7, it would be illegal for companies to release into commerce any product that tested positive for the pathogens, in the same way that products carrying O157:H7 are immediately recalled and destroyed now.
Jack in the Box put O157 on the map
It was an outbreak linked to contaminated hamburgers served at Jack in the Box restaurants in the Pacific Northwest in 1994 that largely put E. coli O157:H7 on the map. As many as 600 people became ill and four children died, leading then-Food Safety and Inspection Service Administrator-turned-Acting Undersecretary for Food Safety Mike Taylor to declare the pathogen an adulterant, which means any product found to contain E. coli O157:H7 can not be sold.
Taylor pointed then to a provision in the Federal Meat Inspection Act that says a carcass or meat product is adulterated if it "bears or contains any poisonous or deleterious substance which may render it injurious to health."
The meat industry pushed back, saying USDA needed to follow a standard rulemaking procedure to make a decision that would require plants to test for the pathogen and conduct a recall if products were determined to be contaminated by it. But a judge in the U.S. District Court for the Western District of Texas, in Austin, sided with Taylor, saying it was within the jurisdiction of the USDA to make such a declaration. According to the Administrative Procedures Act, the agency may issue "interpretive rules, general statements of policy, or rules of agency organization, procedure or practice."
Because USDA used this regulation in declaring O157:H7 an adulterant in 1994, Marler argues in his petition, the same step could be taken by the agency now to declare the six other serotypes adulterants as well. If the serotypes cause the same symptoms in people as O157:H7, the agency should be testing for them, Marler says.
One mean family of bacteria
In his petition, Marler names two victims and the family of one victim who fell ill after eating food tainted with a strain of E. coli that was not O157:H7.
June Dunning, a Maryland resident who ate spinach contaminated with E. coli O146:H21 in August 2006, was hospitalized for a week. Her kidneys failed, and she needed surgery to remove some of her colon after suffering seizures. She died six days later.
Megan Richards became ill in June 2006, 10 days after she ate a hamburger from a fast-food chain that contained E. coli O121. She suffered renal failure caused by hemolytic uremic syndrome (HUS) and suffered seizures but was sent home after two months and may need a kidney transplant later in life.
Shiloh Johnson fell ill with E. coli O111 after eating at the Country Cottage restaurant in Oklahoma in August 2008. She, too, eventually became well enough to be released from the hospital, but may also need a kidney transplant later in life.
In his petition, Marler also sites a number of studies that indicate non-O157:H7 serotypes of E. coli "are prevalent in beef production systems at rates as high as 70.1%," and includes information from a USDA study that indicates "non-O157:H7 [Shiga-toxin E. coli] have been found in ground beef and on cattle hides at levels comparable to E. coli O157:H7."
Additionally, "European studies indicate that non-O157:H7 STEC infections occur more frequently than E. coli O157:H7 infections" in some nations.
"With such a ubiquitous presence, the potential risk for harm caused by non-O157:H7 STEC may be on par with, or even greater than, the risk created" by O157:H7, Marler writes.
According to data from the Centers for Disease Control and Prevention, less than one illness per 100,000 were caused by E. coli serotypes other than O157:H7 in 2007 and 2008, which lists an incident rate of 0.59 in 2007 and 0.45 in 2008. During those same years, O157:H7 had an illness rate of 1.19 illnesses and 1.12 illnesses per 100,000 people, based on information last updated in March 2009.
USDA's position
While multiple attempts were made to get a response from the USDA about Marler's petition, no information was provided to FCN by press time.
However, a few months ago, Elisabeth Hagen, then-executive associate for public health at USDA's Office of Public Health Science, told FCN that O111 and the other serotypes Marler wants declared adulterants, were becoming a top priority for the agency (see FCN Feb. 23, Page 21). She said OPHS was collaborating with USDA's Agriculture Research Service to develop better testing methods to identify all six serotypes, but with so much funding and attention directed toward O157:H7 in the past, no tests have been developed to find them in food. She admitted that USDA has found these other serotypes in food, and agreed that they could be responsible for up to 80% of all E. coli illnesses not linked to O157:H7, but said only that the other serotypes could only be individually identified.
"We have a better capacity for detecting these strains than we did 10 years ago," Hagen said at the time, but the tests that are available can only indicate that the pathogen is present in a sample.
Marler points out that there wasn't a test for O157:H7 when the Jack in the Box outbreak occurred, but USDA found a way to create one when the pathogen was declared an adulterant and companies were forced to test for it.
"We're trying to take a reasonable and rational approach to this," Marler says. "USDA doesn't have an argument for why they won't do it, but if they decide [to declare the other six serotypes as adulterants], the industry will go nuts."
Advocates applaud petition
The American Meat Institute and the National Cattlemen's Beef Association told FCN that they would need more time to read Marler's petition before responding last week. Bill Bullard, CEO of R-CALF, said he hadn't heard about the petition and "didn't know the science behind E. coli" enough to comment. FCN was not able to reach a source with the National Meat Association before going to press.
However, while the meat industry and USDA may not be talking about the petition, consumer advocates are.
Safe Tables Our Priority filed a similar petition with USDA years ago, says Donna Rosenbaum, the organization's executive director, but never received any response.
"We've studied this issue for a long time and we belief that if there was a demand for more testing, companies would clamor to invest in a rapid-test kit for industry" due to the new testing demands, she says.
In response to challenges Marler might face from both industry and USDA, Marler should "get his legal team ready for a tough fight," says Stan Painter, chair of the National Joint Council of Food Inspection Locals, the union that represents thousands of FSIS inspectors.
Painter notes that in 2008, USDA had a meeting of advocates, inspectors and industry to discuss the problems posed by E. coli in its many forms. When all three parties agreed to do more testing and look for more strains of the pathogen, it was "one of those rare times when we inspectors agreed with the agency," he says. "Speaking on behalf of the union, I'd welcome a broader spectrum" of testing for other strains of E. coli.
Now, however, he's not so sure USDA will be willing to take any kind of action. "The agency won't do anything the industry doesn't want them to do," he tells FCN.
Marler's petition, which includes more than 400 pages of attachments and court documents, can be found on Marlerblog.