The pathogen that changed it all – looking back to the monumental USDA decision to declare O157:H7 an adulterant in the wake of the 1993 Jack in the Box outbreak.
It was Sept. 29, 1994. Mike Taylor took the podium in San Francisco at the American Meat Institute’s annual convention to make his first, and most significant, speech as the top food safety official at the U.S. Department of Agriculture.
“I am here to talk about change,” began Taylor, who had just become administrator for the USDA’s Food Safety Inspection Service, as he looked out over his all-industry audience. “Change in what the public expects when it comes to food safety, change in how we at the Food Safety and Inspection Service (FSIS) are approaching our job, and change in the demands being placed on all those who produce, process and market meat and poultry for American consumers.”
Taylor explained his belief that the meat industry had an opportunity to move beyond the politics of food safety and find real solutions on the heels of the massive E. coli O157:H7 outbreak in the Pacific Northwest.
“You know from your daily experience that improving food safety serves us all.”
And then, Taylor uttered a few lines the industry may not have wanted to hear:
“In one critical respect, our inspection program at FSIS does not currently meet the public expectation. There is a gap in our system…”
“The fact is we do not deal directly enough and scientifically enough with the microbial pathogens that can make people sick,” he continued, before outlining some sweeping public health goals. And then he got very specific.
“To clarify an important legal point, we consider raw ground beef that is contaminated with E. coli O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act,” he added, explaining that he wanted to make USDA’s E. coli policy “crystal clear.”
“We are prepared to use the Act’s enforcement tools, as necessary, to exclude adulterated products from commerce.”
The audience of meatpackers responded with what those in attendance described as “polite applause.”
On the other side of the country, Mike Espy had learned all he knew about agriculture policy from serving on the Agriculture and Budget Committees in the House of Representatives.
After he failed to earn a spot on the Appropriations committee, he approached his friend and then President-elect, Bill Clinton, about serving as agriculture secretary in his cabinet. He wrote Clinton a note, on the back of an envelope, listing the reasons he should be considered for the job.
After getting a thumbs up from the transition team — and surviving the extensive vetting process — Espy’s nomination was announced, he was quickly confirmed and, at the age of 39, he became both the youngest and the first African-American to hold the position.
Two days after he was sworn into office, Espy headed to Camp David with the rest of the cabinet secretaries for a retreat. It wasn’t long before the Food Safety and Inspection Service at USDA called to brief him on a disaster unfolding in the Pacific Northwest. Jack in the Box restaurants had served undercooked hamburgers contaminated with E. coli O157:H7, a relatively unknown pathogen, and people were getting sick. Really sick. And most of them were children.
“The horrible news was that these small children, many of them had died or had gotten very, very ill. And that was brought to my attention while I was at Camp David,” recalls Espy in his oral history.
Espy remembers speaking directly to President Clinton about the outbreak.
“[I asked] to elevate this episode to the status of a Presidential inquiry, which allowed us to get off the mark maybe a little bit faster than would have normally been the case.” And then he headed to Seattle to investigate.
Espy wanted to personally conduct the investigation into what happened, in part because he “didn’t know much” about food safety issues. “And this was an excellent opportunity to learn and again to demonstrate to everyone that we took health matters very seriously.”
During his visit, he met with the families that had been directly impacted with serious illness or death. He testified before the Washington state Legislature and he got a crash course in meat safety.
This experience on the ground, as Espy describes it, became the “jump off point” for the major policy changes that were to come in the wake of the catastrophe.
“USDA will be making a decisive break from the past,” said Espy when President Clinton released his 1994 budget proposal, which aimed to strengthen meat inspection.
“In the future, USDA will not wait for pathogens to become a problem; nor will it be satisfied with holding the line against contamination: USDA will strive to reduce contamination from the farm to table,” he declared.
The Clinton administration initiated a wide variety of food safety changes, including hiring more meat inspectors, mandating safe food handling labels on raw meat and poultry products, improving recall notification, and reducing microbiological contamination in a variety of meat and poultry products.
The administration also succeeded in establishing the Office of the Under Secretary for Food Safety to increase visibility of food safety within the massive agriculture department. Food safety functions were also — logically — separated from marketing functions at the department.
All of these changes were, without a doubt, critical to improving food safety. But the real turning point was USDA’s decision to declare E. coli O1057:H7 illegal, and winning the legal battle that ensued.
The Jack in the Box outbreak, which garnered significant local and national media attention, was the catalyst.
“That really was a critical event in the history of food safety in this country and certainly for the Administration it was absolutely galvanizing because it came to public attention during the first week of the Administration,” recalls Taylor, in his oral history.
“Brand new secretary, brand new President, brand new vice president confronted with a really significant public health event and also an event that really began to shed light on some gaps, some problems in the meat inspection system.”
Taylor believed the event was the result of a flawed system and he set out to fix it.
When the Jack in the Box outbreak struck headlines, Taylor was the deputy commissioner for policy at the U.S. Food and Drug Administration, where he had served since 1991. He worked on nutritional labeling and developing HACCP regulations for seafood.
Secretary Espy interviewed him to head food safety at USDA in the spring of 1994.
“[I] had a terrific interview with him,” recalls Taylor. “He was so clearly, personally committed to solving this problem, frustrated by the difficulty of solving it and looking for help.”
Taylor says the Jack in the Box tragedy fueled his efforts.
“If you need motivation to work on a problem like this, just meet with the people who’ve been directly affected.”
When Taylor finally arrived at FSIS — after a few months of wrangling with the White House Personnel Office — he found an agency ready for change.
“People recognized there was a need for change in the system, they were the victims however of a lot of very harsh press criticism, there was a great sense that some
thing needed to be done to sort of get it off the dime.”
As he saw it, USDA needed a paradigm shift when it came to meat safety. For 90 years, the USDA mark of inspection had been placed on products “without regard to the presence of pathogenic bacteria.”
That was all about to change. Taylor wanted pathogen controls, and accountability. And he first took aim at E. coli O157:H7.
He talked to the FSIS field force, the leadership of the field force, the compliance people, and the lawyers.
“It was evident that the agency, as it properly should have, was, whenever it encountered a quantity of ground beef that was adulterated, through whatever means … they would remove it from commerce,” explains Taylor. “So the question I asked was well, if that’s what we’re doing anyway and if this is a dangerous product, why don’t we simply deem it to be an adulterant? Why don’t we back up what you’re doing as a practical matter with the legal tool so that companies are required and have a responsibility coming from the law to avoid that contamination and to not ship product adulterated with O157 into commerce.”
Weeks of meetings with agency lawyers and scientists followed as Taylor’s team tried to assess whether they could make the case that O157 in ground beef “would in fact violate one or more of the adulteration provisions of the statute.”
“We decided it would, we decided that henceforth in enforcement situations we, if we encountered a contaminated lot, we would invoke that authority,” recalls Taylor.
Soon thereafter, Taylor was invited to the AMI convention and decided he would send a message to the industry.
“I wanted to lay out [the] whole strategy and so I have a speech that laid that out and then a kind ‘oh, by the way’ I just want to clarify our position on O157. I announced henceforth that we could deem the pathogen in ground beef to be an adulterant.”
Calm before the storm
According to Taylor, there was silence immediately following his announcement on E. coli O157:H7 at the AMI convention.
“There was a lull for a day or two before I heard much,” he recalls. “And then the industry’s lawyers began to focus and the industry was on edge, shall we say.”
“They kind of started making phone calls and fly ins and see you to tomorrow['s] [in a] ‘why you’ve just upset civilization in a fundamental way.’ “
The meat industry decided to sue the department over the decision.
That litigation, as Taylor puts it, actually worked out “extremely well” because the the Federal District Court in Texas upheld USDA’s decision with a “resounding, firm opinion” that upheld our finding of adulteration and the process by which we reached the finding.
“It was all down hill from there,” says Taylor. “It changed everything.”
The legal win backed up the government’s ruling and with it, E. coli O157:H7, the tiny pathogen that had wreaked so much havoc on both lives and consumer confidence, officially became an adulterant, making it illegal in raw meat products.
“There’s a lot of internal stuff that you work through whenever you’re doing anything like this,” concludes Taylor. “But … having the opportunity to make that policy change on O157 and seeing what that meant to people whose lives had been [affected] by the old policy…it was just moving and deeply satisfying.”
According to the Centers for Disease Control and Prevention, the rate of E. coli illnesses has been reduced by nearly 50 percent since 1997.
A special thanks to the research assistants at the Clinton Presidential Library for their assistance in digging up food safety records and oral histories from before the age of the Internet.
FDA Photo of Michael R. Taylor, deputy commissioner for Foods, U.S. Food and Drug Administration© Food Safety News