WASHINGTON — On a bright June day in 2018, one of the nation’s top regulators waved groceries in the air, quizzing the secretary of agriculture on which agency is charged with monitoring different types of food.
Scott Gottlieb, the commissioner of the Food and Drug Administration at the time, grinned widely as he held liquid egg whites and a carton of eggs. The former is under the U.S. Department of Agriculture’s food safety purview. The eggs, under the FDA’s. The mood was jovial, winkingly acknowledging the complexity, and at times absurdity, in the way the government regulates food.
But in times of crisis, the splintered U.S. food regulation system is far from amusing. With an outbreak of the H5N1 bird flu spreading among dairy cattle, experts say that the longtime fractured nature of the U.S. food regulation system could hamper the federal response.
STAT interviewed more than 20 former agency officials and independent experts, many of whom described the relationship between the USDA and the FDA as being punctuated by tense turf battles. Some cited the recent history as a basis for their concern now over H5N1. In the past, the fragmented responsibilities between the FDA and sub-agencies within the USDA led to inefficient investigations and stunted surveillance testing in cases involving E. coli, salmonella, and tuberculosis.
Because H5N1 is currently an animal disease, it’s clearly the USDA’s responsibility to test cattle and get a handle on the outbreak. But already, public health experts are concerned that the scope of that agency’s testing regime is too limited. The department is requiring farmers test only lactating cows before moving them across state lines.
“There needs to be a better understanding of the scope and scale of the problem,” said Stephen Ostroff, a former deputy commissioner in charge of food safety at the FDA. “This seems like it’s not necessarily going to be able to identify problems that could occur within a state.”
Some food safety experts believe the USDA has legal authority to conduct broader testing on farms, but so far it’s taken a voluntary approach whereby the agency is offering to pay farmers who choose to test their cows.
“I think [USDA] should be doing more,” Gottlieb told STAT. “I think we should be doing everything possible to isolate these outbreaks and prevent further spread.”
Neither the USDA nor the FDA responded to questions from STAT. The USDA’s secretary, Tom Vilsack, said on a call with reporters Friday that the agency doesn’t have authority to require tests of cows being moved within a state, but didn’t directly address whether the agency has authority to test cows on farms.
The FDA, meanwhile, tested pasteurized milk in grocery stores and confirmed the absence of live H5N1 virus. But if the agency wanted to enter farms to test livestock products and better understand how the disease might spread into human foods, it couldn’t. Neither could the Centers for Disease Control and Prevention.
It’s a glaring gap in the U.S. food regulatory system: No federal agency has the authority to go on farms to test for human diseases.
“It’s like if you go to put out a fire in an apartment building and the fire is coming from the apartment next door, but you’re not allowed in that apartment,” said Sarah Sorscher, the director of regulatory affairs at the Center for Science in the Public Interest.
Several experts and former federal officials argued that bringing food regulation under one agency would clearly improve public health, but industry interests and political power grabs make it a utopian, unlikely reality.
David Acheson, a food safety expert who has worked at both the FDA and USDA, warned, “With food safety, change doesn’t happen until people die.”
Historic FDA and USDA tension
Stuart Pape still has his government-issued green binder from when he worked in the FDA commissioner’s office in the late 1970s. He labeled it “FDA/USDA Turf Battle” to keep track of all the times the agencies clashed.
“Most of the time, FDA and USDA, in terms of food safety, get along just fine,” Pape, now a food regulatory lawyer at the firm Polsinelli, said. “But occasionally, they don’t.”
The missions are markedly different. While the USDA is in charge of regulating the country’s meat, poultry, and egg supplies, it also seeks to promote American agriculture. Abraham Lincoln founded the agency in 1862 to support the farmers supplying Union troops with food. The FDA, on the other hand, was founded in 1906 and is exclusively focused on food and drug safety. It’s part of the Department of Health and Human Services, which is charged with protecting human health.
“USDA has a conflicted mission,” said Thomas Gremillion, the director of food policy at the Consumer Federation of America. “It’s promoting these industries, but at the same time, it’s gonna regulate the safety of their products.”
Jerold Mande, who has served as deputy undersecretary for food safety at the USDA and in the commissioner’s office at the FDA, said farmers see the USDA as less threatening.
“USDA comes on the farm … and they’re seen as friends,” Mande said. “You see USDA as in your corner fighting for you everyday, versus FDA where this is a police officer just showing up on your property. They may be armed and could bring criminal charges against you.”
As evidenced by Pape’s binder held together by 40-year-old Scotch tape, the agencies have bickered for decades. Though the two share the goal of maintaining a safe, thriving food supply, complicated power dynamics can easily impede that purpose.
Tensions have bubbled up in several high-profile instances, including a fight during George H.W. Bush’s administration over food labeling. Don’t even get an FDA regulator started on catfish, a food category that fell to the USDA in 2014 after political pressure from catfish farmers. Southern farmers wanted to squash foreign competition by leveraging the USDA’s tough scrutiny of imported animals, and Thad Cochran, then a U.S. senator, became their champion. Studies by a government watchdog have shown splitting seafood between the agencies causes $14 million in duplicative spending every year.
“An unbelievable waste of money, resources, time,” Acheson said. “FDA fought to keep catfish but failed because it was coming under congressional pressure to move it.” The USDA made a “grab” for all seafood, Acheson said, and it got ugly.
In an interview, Gottlieb said the FDA and the USDA jockeyed for control over cell-cultured meat during his tenure as commissioner — an area the agencies recently decided to jointly oversee. But he noticed the deeper, cultural differences as well. USDA officials think the FDA is insensitive to the commercial concerns of farmers, which Gottlieb said can sometimes be a legitimate gripe. On the flip side, FDA officials feel the USDA doesn’t act quickly enough during outbreaks.
“I felt and I still do feel that some of the agricultural regulators aren’t aggressive enough early enough and risks percolate for too long,” Gottlieb said.
A former USDA official called friction between the two agencies a constant, and described the FDA’s attitude toward the USDA as condescending. The former official also said the FDA weighs input from health advocacy groups more heavily, while the USDA is more likely to balance that input with information from industry.
“These M.D.s and Ph.D.s believe that we are all uneducated rednecks and that we don’t know what we’re doing, and because we listen to different constituencies we can’t get it right,” said the former official, speaking on condition of anonymity to describe the dynamics more candidly.
Some experts said the agencies communicate more frequently and efficiently during urgent situations. But the jurisdictional divide can also get in the way of conducting thorough surveillance during public health emergencies.
A noteworthy example is the 2018 E. coli outbreak in romaine lettuce that sickened more than 200 people and killed five. While FDA investigators quickly rooted out romaine as the source, they struggled to confirm their theory that the disease originated from a livestock feedlot located near an irrigation canal used by lettuce growers. The FDA could test the canal, but did not have the authority to test the cattle.
Ostroff, the FDA food safety lead at the time, said the agency eventually gained access to the facility after long discussions. But months had passed since the initial outbreak, and he said agency personnel tested only a few dozen animals out of more than 100,000.
The FDA had encountered a similar issue a few years earlier, in 2015, when pig farmers blocked investigators from their property during a salmonella outbreak that sickened almost 200 people.
And at the FDA in 2005, Acheson had witnessed the dysfunction while handling a bovine tuberculosis outbreak spreading through cheese. The cheese came from infected cattle, and Acheson’s team believed people were illegally importing the product from Mexico. He asked members of the USDA’s animal protection team if they could set up import controls to prevent infected animals from crossing the border.
But because the tuberculosis was making people sick and not animals, the USDA said its hands were tied.
“That was an absolute roadblock and jurisdictional breakdown,” Acheson said. “Clearly, there was not an adult in the room who could say, look, we’ve got people dying from TB, it’s coming from cheese and sick animals, we need to work collaboratively to figure out how to stop this.”
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How the breakdown could impact H5N1 response
The U.S. government is in a better position to investigate the H5N1 bird flu spread than past outbreaks, but only if the USDA uses its powers.
In cases like salmonella and E. coli, the USDA was hamstrung from doing testing on farms because the bacteria weren’t making animals sick. But H5N1 is making dairy cows sick, which qualifies it as an animal disease.
The secretary of agriculture “may carry out operations and measures to detect, control, or eradicate any pest or disease of livestock (including the drawing of blood and diagnostic testing of animals), including animals at a slaughterhouse, stockyard, or other point of concentration,” the statute reads.
So far, the USDA is only requiring testing of dairy cows being moved between states. The agency is doing some testing at slaughterhouses. It’s “urging dairy cattle producers and those who work in or with the industry to share epidemiological information from affected farms,” per its website.
But the agency has made it abundantly clear that it’s choosing not to do mandatory surveillance testing on farms.
“Are there plans to expand mandatory testing to all cattle, not just dairy cattle moving interstate?” reads a theoretical question on one of the agency’s question and answer documents. “Not at this time,” the agency says.
Several experts have questioned whether that approach is sufficient to measure the spread of a virus that does not necessarily lead infected animals to exhibit symptoms.
“They have a lot of authority. They could be going and demanding much more testing than what they are,” said Gremillion of the Consumer Federation of America.
Ostroff, the former FDA deputy commissioner for foods and veterinary medicine, said it’s in the best interest of the dairy industry, the beef industry, and the USDA to understand the scope of the problem as soon as possible.
“You can’t do that by simply hoping that people will cooperate. Sometimes they don’t,” he said.
Other experts are suggesting more testing may be helpful, too.
“It’s always good to have more information about how infectious disease is spreading. And, in particular, to know both how it’s moving between the farms, and then also, whether it’s spreading to the milk,” Sorscher of the Center for Science in the Public Interest said.
Industry groups, however, are not so enthusiastic about the prospect of mandatory surveillance testing.
Stephanie McBath, public policy director at the National Association of State Departments of Agriculture, said states are happy with the USDA’s response thus far. While the group is open to coordinating with other agencies, state agriculture departments are most comfortable with the USDA.
And Ed Maltby, executive director of the Northeast Organic Dairy Producers Alliance, said the outbreak hasn’t reached the stage where the USDA should be doing involuntary testing on farms.
“That would just upset too many people,” he said.
Instead of doing mandatory testing, the USDA on Friday announced a program to pay farmers to get veterinarians to test on their farms and ship the tests to labs, and compensate producers for loss of milk production.
The USDA has processed positive samples, but it took a while for the agency to catch on to the spread. Its own analysis shows that H5N1 may have spilled over from birds into dairy cows four months before it was detected.
The delay follows a large infusion of cash into the USDA to help the agency track disease outbreaks among animals following the Covid-19 pandemic. In a Covid relief law passed in March 2021, the division at the USDA in charge of leading the H5N1 response received $300 million to conduct surveillance of Covid in animals and to build an early-warning system “to alert public health partners to take steps sooner to potentially prevent or limit the next zoonotic disease outbreak or the next global pandemic,” according to a six-page document produced by the USDA in February 2022.
That cash infusion was more than 13 times larger than the normal budget the USDA gets to monitor zoonotic diseases, which has been $22 million for each of the past three years.
“I would say the biggest problem is we don’t have a national active monitoring system for pandemic potential diseases, and it’s kind of crazy that we don’t after Covid,” said Steven Roach, who directs the safe and healthy food program at the Food Animal Concerns Trust.
Caitlin Rivers, an epidemiologist and senior scholar at the Johns Hopkins Center for Health Security, said she would be curious to know how many negative samples the USDA has obtained to give more context to the positive results the agency is reporting.
The best publicly available estimate about the prevalence of the virus has come through the FDA’s decision to test a national sample of retail milk. That testing found traces of the virus in around 1 in 5 samples. The studies have shown so far that pasteurization appears to make the milk safe to drink.
“I give them credit that they went out and sampled milk retail … that they didn’t just restrict it to the states, where the affected herds are. They did a national sample, which is the proper thing to do,” said Michael Hansen, a senior staff scientist at Consumer Reports.
However, given the way milk is processed, with product from many different farms mixed together, the sampling isn’t a very efficient way of pinpointing where the virus may be coming from, experts said. It also doesn’t indicate how many farms might be affected.
“Testing the milk is a backdoor way to do on-farm testing,” Gottlieb said. “They should be testing directly on the farms. They can’t do it, so they’re testing the milk. … They’re not being allowed to do it, and USDA is not doing it aggressively enough.”
The CDC is more focused on tracking the virus in humans, particularly farmworkers who may be exposed to infected livestock. The agency doesn’t have direct authority to test workers, and has to work in tandem with state and local health departments to track cases. The agency is also tracking the prevalence of the virus in wastewater.
Most experts don’t think there’s reason for serious concern in humans yet given the current situation. But that forecast could worsen quickly depending on whether the virus spreads to species like pigs, where it could change and become more harmful.
“With the [highly pathogenic avian influenza] strains, it’s kind of every epidemiologist’s nightmare, but it’s also completely unknown whether it’s going to become a big problem. And what that means is that we need to track and monitor,” said former CDC Director Tom Frieden.
Combining forces: a food safety fantasy
In an ideal world, the government would have one point agency during a food-related infectious disease outbreak.
The idea of creating a single food safety agency is not new; in fact, it’s been around so long that bringing it up might elicit a groan from food regulatory experts. Even those in favor are cynical about the pitch ever coming to fruition.
“Every president, at least going back to Clinton, has actually recommended this or endorsed this idea in one way or another,” said Michael Taylor, who held food safety leadership positions in both agencies. “The Clinton administration actually worked very hard internally but it couldn’t convince its own HHS secretary to go along with it and then it got killed.”
Both the FDA and the USDA’s food safety programs have their own problems. FDA food staffers have frequently complained about a lack of resources compared to their colleagues on the medical products side, an issue that exacerbated the FDA’s slow response to a 2022 baby formula contamination and shortage. The agency is in the process of reorganizing its food office.
The USDA, meanwhile, sends thousands of regulators to slaughterhouses each day — a practice that originated in the days of Upton Sinclair’s “The Jungle,” which uncovered horrific conditions in the meatpacking industry in 1905. These days, some argue that microbial pathogens in food pose a greater risk than slaughterhouse conditions, and that the USDA should redistribute resources accordingly.
Taylor thinks both agencies should be modernized and combined.
“If you want to get the most public health bang for the buck in food safety, you merge the agencies with a common, risk-based, modern prevention regulatory framework,” he said.
Combining the two would not only require rewriting the law, it could require congressional committees to give up some of their power. Because authority over policy issues often leads to campaign donations and political clout, lawmakers are generally loath to give up any sliver of their authority. Industry is accustomed to the current system and would likely lobby against it.
“Many people, myself included, have advocated for single food safety agencies,” Acheson said. “It sounds good. It would require a statutory rewrite, and who the heck’s got the energy to do that?”
A bill led by Rosa DeLauro (Conn.), the ranking Democrat on the House Appropriations Committee, and Sen. Cory Booker (D-N.J.) could be a more targeted patch, if a larger overhaul of the food regulation system is out of reach.
The legislation, called the Expanded Food Safety Investigation Act, would give the FDA authority to conduct testing for diseases that make humans sick on livestock feedlots and farms for public health reasons. Right now, neither the USDA nor the FDA has that authority.
That missing link could have provided the FDA with more authority to investigate outbreaks of E. coli and salmonella that make humans sick, but could also give the agency more options in an outbreak like H5N1.
The bill hasn’t gone far. “You don’t get a whole lot of accolades for advancing a piece of legislation like this, but you do piss off a bunch of industry lobbyists,” former DeLauro aide Christian Lovell said.
Absent congressional input, the agencies must overcome their differences themselves. As the H5N1 virus makes its way through cattle at a rapid clip, figuring out the right level of oversight will be crucial.