First of Three Parts
WASHINGTON (Sept. 28) -- For years, the U.S. Department of Agriculture has ignored burgeoning proof that several unregulated strains of E. coli contaminate America's meat supply.
"There is no indication that these strains are a health problem for anyone," a spokesman for the USDA, the federal agency responsible for the safety of meats, told AOL News last year and again earlier this year.
But a different message was conveyed in a second-story office in the Ag building overlooking the National Mall last week.
It was exactly a month and a day after Dr. Elisabeth Hagen was sworn in as the USDA's undersecretary for food safety. She quietly convened a meeting in her office with a physician, a lawyer, a Montana meat packer and the mother of a boy who died after eating at burger at a back yard cookout. The four, each in his or her own way, had worked passionately for years, prodding, cajoling and pleading that the agency demand that American meat producers ensure that they sold no beef containing six ignored strains of E. coli.
According to the visitors, Hagen told them she understood the danger of the unregulated pathogens and the harm they were doing. But it was also understood that it would be a difficult task because the meat industry would fight hard against the safety improvements, which would cost it dearly to deliver safer beef to consumers. Difficult fight or not, most left the meeting believing it was a battle that Hagen was willing to lead.
The USDA forbids the presence of the better-known E. coli 0157 in any meat sold in the market. The pathogen is considered an adulterant -- something harmful not allowed in meat -- and when found, it sparks instant and sometimes massive recalls.
But there are thousands of other strains of E. coli, including at least six that experts believe can be particularly harmful. And the agency has steadfastly refused calls from food safety authorities, members of Congress, citizen petitioners and some of its own senior experts to outlaw the presence of non-0157 E. coli in the meat consumers take home.
When asked if the American Meat Institute would sue, as it had done in the past, to block any USDA effort to outlaw additional E. coli pathogens from meat, the AMI's top spokeswoman, Janet Riley declined to comment, calling it "an unfounded rumor."
Hagen was not available to confirm what was said at the meeting, but her recent remarks seem to make her position clear.
"In order to best prevent illnesses and deaths from dangerous E. coli in beef, our policies need to evolve to address a broader range of these pathogens, beyond E. coli O157:H7," she said in her first speech as the USDA's top food-safety expert.
Many wonder how the USDA can justify not taking action already. Evidence shows that these unregulated strains cause disease, even death, and are present in cattle and found in grocery meat coolers.
Look at three facts:
* People are sick and dying -- Eleven years ago this month, Dr. Paul Mead, a medical epidemiologist with the Centers for Disease Control and Prevention's Foodborne and Diarrheal Diseases Branch, reported in Emerging Infectious Diseases that food-borne poisoning from exposure to E. coli non-O157 strains is responsible for at least 31,229 illnesses, 294 hospitalizations and 26 deaths each year.
* It is in cattle --- "It has been known for a long time that you can find non-O157 STEC in the feces of cattle and other animals and that you can find it without much difficulty in ground beef," Dr. Patricia Griffin, chief of the CDC's Enteric Diseases Epidemiology Branch, told AOL News last month.
* Tainted ground beef is being sold almost everywhere. Seattle-based food safety lawyer William Marler angered the meat industry and some in the USDA when he laid out $500,000 of his own money to have food safety scientist Mansour Samadpour and his nationwide chain of labs collect 5,000 samples of ground beef to document the scope of the contaminants. The research found about 2 percent of the meat tested positive. The number may seem insignificant, but food safety experts tell AOL News that considering the billions of pounds of ground meat being sold, at even 1 or 2 percent, you're talking about millions of pounds of contaminated meat.
"These strains are deadly. One percent is plenty of reason to be concerned, especially if it's yours or your loved ones' plate that the contaminated meat makes its way to," Nancy Donley, president of Safe Tables Our Priority, an advocacy group representing food-borne illness victims, told AOL News.
The Jargon and the Process
To understand this issue, we need to discuss some facts, acronyms, how the disease is caused and the ever-present result of the pathogen, bloody diarrhea.
First, E. coli is short for Escherichia coli, a bacteria that inhabits the gastrointestinal tract of humans and other warmblooded mammals. There are hundreds of strains of E. coli. Some are beneficial, part of the gut's normal flora. Many are harmless. But several, like E. coli 0157, can cause hemolytic-uremic syndrome, or HUS, which can produce the signature abnormal bleeding, kidney failure, central nervous system disruption, seizures, coma and death.
The ones that do harm are often tagged STEC (Shiga toxin-producing Escherichia coli), which was discovered more than a century ago by a Japanese microbiologist named Shiga. He documented the link between contact with feces and the dangerous pathogen.
Consider this uncomfortable reality: E. coli lives in the intestines of even healthy cattle, and so it's almost assured that most, if not all, cow feces carry the pathogens.
All it takes to understand how feces contaminates beef heading to market is to spend just a few minutes in almost any of the 6,000 federally inspected slaughterhouses and meat processing plants in the United States.
There is a clipboard-carrying inspector, often in a blood smudged white coat and hardhat, from the USDA's Food Safety Inspection Services in every meat processing operation in America.
"But basically what they are doing is no different than what inspectors have been doing for 100 years. They are looking at stuff," attorney Marler said.
At the turn of the last century, when inspectors were first put in these plants, the things they were looking for were tumors, animals that were clearly tubercular.
"Nowadays, when 50 e. coli 0157 bacterium will kill and 100,000 would fit on the head of a pin, you could look at a carcass all day long and you can't tell whether it's contaminated or not," the lawyer said..
E. coli from the cow's intestines or fecal material on the hide is often spread throughout the beef-processing plants. The speed of mass production in the commercial slaughterhouse or high-speed butchering lines often overwhelms efforts to keep the operations clean.
The pathogen can be found on steaks and roasts, but this isn't a health problem, the industry says, because these solid cuts of beef don't provide bacteria access into the meat below the surface and can be rinsed with ammonia or other anti-bacterial treatment.
Ground beef is a completely different story.
The grinding of E. coli-tainted leftover trim from steaks and roasts -- and fat and unmarketable meat waste purchased from U.S. plants and foreign suppliers -- is almost a fail-proof technique for mixing E. coli through the soon-to-be-burgers.
This blend cannot be doused with bug-killing ammonia, and E. coli bacteria survive refrigerator and freezer temperatures. So all too often, a bacteria-laced product is on the way to your neighborhood store and, ultimately, your grill or skillet. With it comes the consumer warning from industry and the government: "If you're worried, cook the life out of your burgers."
Where Are the Bodies?
It is an axiom in much of the federal government that nothing happens until the bodies stack up. That was certainly the case with E. coli O157. Its presence in food was long known to cause disease, but for years the USDA completely accepted the meat industry's position that slaughterhouses and beef-processing plants were not accountable for pathogen contamination because consumers were expected to properly cook the product.
Ignoring the objections of its own health experts, the agency refused to do anything about O157 or any other pathogens in meat.
In January 1993, Washington state health officials announced that hundreds of people were being sickened by E. coli O157 from hamburgers at Jack in the Box restaurants in Seattle. Ultimately, 700 people fell ill to the pathogen in Washington State as well as Idaho, California and Nevada. Four children, three under the age of 3, died.
A year later, while some of the Jack in the Box victims were still recovering, Michael Taylor, who was then the USDA's food safety boss, stunned the meat industry when he stood in front of a meeting of the American Meat Institute and declared that O157 was an adulterant in beef.
Taylor's announcement was all it took to mandate that all slaughter and processing plants implement microbial test requirements and pathogen reduction standards for the meat industry, he explained at a food safety conference at MIT earlier this year. He is the Food and Drug Administration's new food czar.
A Reassuring Outcome
The four visitors who attended last week's meeting came away sounding almost enamored with Hagen, but, more important, they were convinced that progress in listing non-O157s as adulterants was not only possible but likely.
"Dr. Hagen clearly pointed out she is not going to wait until the bodies are stacking up," said Dr. Richard Raymond, who held the position that Hagen now fills from 2005 to 2008. None of us want to wait for another Jack in the Box."
Nancy Donley, whose son Alex died in 1993 after eating an E. coli-tainted burger in a backyard cookout, told AOL News she's convinced of Hagen's commitment to getting non-O157 into the regulatory arena.
"She fully understands the necessity for it, that it's in the meat supply and it can and does cause people to get sick and die," Donley said.
Seattle attorney Marler said, "Dr. Hagen is well aware that these pathogens cause human illness. She also reaffirmed that her agency the Food Safety Inspection Service's [FSIS] main mission is to protect public health."
He added, "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." Marler has been involved with almost every major food pathogen outbreak over the past 17 years.
John Munsell, the Montana meat packer, had concerns beyond the pathogens. His small mom-and-pop processing plant was shut down after he found and reported E. coli in the USDA-inspected meat he was grinding that had come from a massive ConAgra plant in Colorado.
He says the meat inspectors did nothing until a short time later when an Ohio woman died and three dozen others were sickened from E. coli-contaminated meat reportedly from the same Colorado ConAgra plant. ConAgra then recalled 19 million pounds of beef, according to the USDA.
For years, Munsell urged the FSIS to trace contaminated meat back to its source before people get sick, something it's refused to do with his reports.
Munsell said he was impressed with Hagen's thorough grasp of the health concerns raised in the meeting and the fact that she was not the least evasive.
"She is one sharp cookie, well versed, yet cordial in her behavior. She has my vote," the Montanan said.
The Power of the Meat Lobby
Ask anyone involved with food safety issues what has kept the USDA from demanding that meat suppliers eliminate the dangerous strains of E. coli and the answer is almost always the agency's all-too-cozy relationship with the industry.
"The meat industry, in particular the American Meat Institute, is extremely powerful, and they play a major role setting public policy at USDA," said Tony Corbo, a food safety specialist for Food and Water Watch. "For the agency to institute any rules that ensure or increase the safety of meat, they first must overcome efforts from [the meat lobby] to block them."
AMI launched its preventive strike two days before Hagen was sworn in.The lobby group's president, Patrick Boyle, wrote to Agriculture Secretary Tom Vilsack, saying that "AMI is concerned that the designation of non-O157:H7 STECs as adulterants will result in a misdirected regulatory program that will cause more harm than good."
The letter said that "no reported outbreak in the U.S. has been confirmed to be directly linked to beef products."
Ten days later, Cargill Meat Solutions Corp. in Wyalusing, Pa., recalled approximately 8,500 pounds of ground beef products contaminated with E. coli O26. Three people in two states were sickened, health officials said.
Boyle insisted in his letter that "technologies we currently have in place are effective against various strains of E. coli." He listed eight things that the USDA should do, including the formation of a commission to study non-O157 E. coli and another to "determine the impact on international beef trade that would result from declaring non-O157:H7 STECs an adulterant on beef products."
The reaction to the AMI's letter among many in the public health community was similar to what Hagen's predecessor, Dr. Richard Raymond, told AOL News. "The AMI list of eight things that must be done before protecting American lives is laughable at best. Like we need to determine if our trading partners would like this or not? Come on," he said.
Donley, whose organization was formed initially by survivors and the Jack in the Box victims' next of kin, said the USDA has been pressured by industry lobbyists for years about not moving forward on these safety changes. And, from the industry perspective, money is the driving issue.
"The industry stands to lose substantial money if they have to test for [the pathogens], and when positives are found, they either divert the product for cooking, which fetches a cheaper price, or destroy it," she said last week.
But the AMI still opposes adding the six non-O157s to the inspection requirements.
"We have measures in place for 0157 that are equally effective against all strains. Declaring another strain an adulterant will not make the pathogen go away. If it could, we would be the first ones to seek such a change," Riley, the AMI's spokeswoman, told AOL News. "Changing a bacteria's legal status won't make it disappear."
The Elusive Test
Raymond, who served as undersecretary for food safety at the USDA between 2005 and 2008, lists three reasons why the agency -- including when he was top gun -- didn't moved forward on regulating the other six E. coli strains. "I think the primary reason is the lack of readily available validated testing for these pathogens. No large outbreaks have ever occurred linked to beef, unlike the Jack in the Box episode, and these [non-O157] illnesses are generally milder."
There has been testing available for decades, and the FDA has been using it since 2002.
"It is bizarre to me that the USDA would be saying there are no tests available when the FDA is saying yes there are and we use them. And I know FDA uses them because we did when I was there," former FDA Assistant Commissioner David Acheson said.
In fact, 20-plus years ago, while Acheson was researching food-borne pathogens at Boston's Tufts-New England Medical Center, he was a key player in developing a test that could identify a broad range of Shiga-toxin-producing E. coli, thus avoiding the need to analyze biological samples from food poisoning victims strain by strain. That test has been sold commercially since the mid-'90s.
Acheson's research was not a secret. What he was finding was published in professional food safety journals.
"USDA leadership has to carefully weigh public health needs against the impact on the industry," Raymond said. "Without available tests that can be counted on for accurate but rapid results, the agency could be faced with having the industry being told to hold a million pounds of fresh ground beef for five days waiting for tests to come back, and that's a horrible problem for them to have to deal with."
But, he added, "at the meeting, Dr. Hagen told us that they've got the test for four of the six [non-O157 strains] ready to go, and the remaining two are in the pipeline."
A Helpless Feeling
Last week, in her first public speech as USDA's top doc, Hagen told the National Food Policy Conference that her agency will focus on preventing food-borne illnesses.
She also said that when she was practicing medicine she cared for many patients with food-borne illness. And she recalled one, a World War II veteran, who had been infected with E. coli O157. And how she sat in the ICU explaining to the man's wife of 60 years how that single-celled organism could cause this disaster.
"How this big strong man, who survived D-Day, had raised four children and nine grandchildren, and built his own business from the ground up; how he probably wasn't going to survive this. This happened because he ate contaminated food. Food -- a fundamental necessity of life," Hagen told the audience.
"I have never felt more helpless than I did in that moment."