In 2010, two producers recalled more than half a billion eggs after regulators traced an outbreak of salmonella to unsanitary conditions at two Iowa farms. It was the largest egg recall in history, ultimately sickening nearly 2,000 people and garnering national headlines.
Investigators eventually reported a wide array of safety violations, from live rodents in the henhouses to manure oozing out of the buildings. In a congressional hearing about a month after the recall, lawmakers asked regulators why they hadn’t noticed the conditions earlier. One of the farms had a history of safety violations. How could they have missed it?
At first, this looked like an embarrassing lapse. A failure at this scale suggested that the federal food safety system — which officials often credit for the world’s safest food supply — had somehow missed problems even though millions of the eggs were packed in cartons stamped with a U.S. Department of Agriculture grade for quality.
But in fact, regulators hadn’t missed it. A 2012 report from the Department of Agriculture’s inspector general discovered that officials from the Animal Plant Health Inspection Service (APHIS) “were aware that the company’s egg-laying barns had tested positive for [salmonella] over 4 months before the recall was issued.” An inspector from another agency, the Agricultural Marketing Service (AMS), had visited the farm two weeks before the recall and “he observed some of the same sanitation issues (e.g., rodent activity and high bird manure levels) that FDA later reported [after the outbreak was discovered].”
The problem wasn’t that inspectors weren’t aware. The problem was that the agencies that discovered the health hazards weren’t responsible for overseeing that part of the food safety system. They simply had not passed on what they knew to the agencies that had the authority.
“On an issue that’s so important and sickened so many people — by your estimation, 100,000 cases a year — and it’s a high-risk food, why wouldn’t there be a tendency for cross-communication between a federal agency under the USDA and the Food and Drug Administration?” said Rep. Michael Burgess (R-Texas) at the hearing that September.
What emerges, if you get to the heart of the reports about the outbreak in Iowa, is a bewildering division of responsibilities within the federal government over the job of regulating eggs. The Food and Drug Administration, part of the Department of Health and Human Services, has jurisdiction over eggs in their shells, while the Food Safety Inspection Service (FSIS), at USDA, is responsible for eggs processed into egg products. The Agricultural Marketing Service sets quality and grade standards of shell eggs, while APHIS helps ensure that laying hens do not have salmonella. The feed the hens eat? That’s the FDA again.
“That’s madness,” Rep. Rosa DeLauro (D-Conn.) told POLITICO.
It’s not just eggs, of course. The modern U.S. food safety system is the responsibility of a patchwork of 15 federal agencies, plus many more at the state and local level. The FDA, for instance, is responsible for regulating cheese pizzas, but pepperoni pizzas fall under the purview of FSIS. The multitude of food safety regulations are a point of pride, proof that the country has come a long way since the days when rats swarmed over mountains of rancid meat that became the next morning’s breakfast sausage. But critics have long seized on the sheer complexity of that system as one of its signal flaws. Complexity doesn’t create errors, necessarily, but as the Iowa egg farms outbreak showed, it can create obstacles to safeguarding public health.
“We’re the only developed country in the world that doesn’t have a single food agency,” said Glenn Morris, director of the Emerging Pathogens Institute at the University of Florida. “It is crazy.”
At its core, then, this is an argument about the ultimate goals of the U.S. food safety system. Is it acceptable that 128,000 Americans are hospitalized and 3,000 die each year from food-borne illnesses? Is it worth blowing up the current system and going through a disruptive transition to a streamlined agency, without any results guaranteed?
“People need to know what's going on. Food-borne illness is preventable, and we lose 3,000 people every year,” said DeLauro, who supports a single food agency. “They die.”
THE MODERN U.S. food safety system dates back to a book that nauseated a nation. In 1905, Upton Sinclair published “The Jungle,” a scathing indictment of Chicago’s filthy meatpacking factories. The ensuing uproar over unsanitary food led President Theodore Roosevelt a year later to sign two bills, which for the first time provided a national policy toward regulating food in America.
The Federal Meat Inspection Act established sanitary standards at meat processing plants and mandated that officials at the Department of Agriculture inspect all carcasses at those plants — basically to look for dirt and other obvious contaminants. “We didn’t even know what bacteria was back then,” said Bill Marler, a Seattle-based food safety attorney. “We didn’t understand germ theory the way we do today.”
The Pure Food and Drug Act set standards for food and drug labels and led to the creation of the FDA. Both laws were limited to regulating foods moving in interstate commerce to ensure that the laws were constitutional.
Those two laws from 1906 still shape how the nation’s food safety system works. The country’s main meat regulator, FSIS, was established in 1977 and requires that all meat- and poultry-processing facilities have an inspector on site at all times. The FDA, which took on its current name in 1930, is responsible for monitoring virtually all of the remaining 80 percent of the food supply. But over time, the two agencies have developed vastly different cultures, thanks in part to their different operational responsibilities. FDA inspectors, for instance, are required to have a college degree, while FSIS inspectors are not.
Along with FDA and FSIS, 13 other agencies are involved in the food safety system. For instance, Customs and Border Protection is responsible for inspecting imports of food products, plants and live animals. The Environmental Protection Agency regulates pesticide residues in food. The Centers for Disease Control and Prevention tracks outbreaks of food-borne illnesses and assists with data management. The Grain Inspection, Packers and Stockyards Administration establishes quality standards and inspection practices for grain and related agricultural products.
Countless state and local agencies, which are often closest to the actual food production process, play key roles in the food safety system. But their relationships with their federal colleagues are uneven at best. FDA works closely with many state departments of agriculture, for instance. FSIS, on the other hand, largely works by itself in the states.
“FDA has authority to inspect facilities that we inspect,” said Jamie Adams, director of the Michigan Department of Agriculture. “If they don’t include us in what they are working on, we may be veering off in a different direction.”
This fragmentation creates some very odd divisions of duties. Adding pepperoni to a pizza moves the regulatory oversight from the FDA, which handles cheese and grain, to FSIS, which regulates meats. An open-faced, pre-packaged sandwich with meat on it is FSIS’ responsibility, but add a second slice of bread to make it a closed-face sandwich and FDA has jurisdiction. FDA is responsible for seafood — except for catfish, which falls under FSIS’ jurisdiction. Why? Who knows?
This split of responsibilities frustrates businesses that must comply with multiple sets of regulations and even confuses the regulators themselves. But not everyone sees the strange and incomprehensible rules as a significant safety problem. “That’s a great rhetorical point,” Stuart Pape, head of the FDA practice at the law firm Polsinelli, said about the oft-cited pizza example. “It doesn’t prove very much to me about the system and the inadequacies of the system.”
Even some proponents of a single food agency say Pape has a point. They argue that coordination issues such as happened in the 2010 salmonella outbreak are not the ultimate problem with the fragmented system. Instead, the problem is subtler, and much broader: With so many agencies collecting data, it’s nearly impossible to integrate all that information in useful ways to trace food-borne illnesses. “You have multiple agencies collecting the data, frequently at cross-purposes,” Morris said.
Morris compared the U.S. food safety system to that of the Netherlands, which is fully integrated and allows regulators to monitor both human and animal microorganisms and then match them together to trace an outbreak to its source. He points out that in the United States, one agency collects samples of human microorganisms and another agency collects samples of chicken and farm animal microorganisms. “[But] there is not a unified system that pulls those data streams together and is able to take full advantage of the fact that we have both types of data available,” he said.
In a sense, America has a food safety system that would be far more effective if it figured out a way to operate as one system.
IN RESPONSE TO this fragmented system, food safety agencies have hatched what must seem to outsiders like an only-in-Washington scheme: They’ve created a set of entirely new organizations just to help coordinate with one another. The Foodborne Diseases Active Surveillance Network — FoodNet, for short — is a collaboration of CDC, FDA, FSIS and 10 state health departments. The IFORC (Interagency Foodborne Outbreak Response Collaboration) involves CDC, FDA and FSIS to coordinate their investigations into food-borne-illness outbreaks. EPA, FDA, FSIS and other agencies work together within another umbrella organization called the IRCG (Interagency Residue Control Group) to address chemical residue issues. Got that?
In 2011, FDA, FSIS and CDC formed an interagency working group, known as the Interagency Food Safety Analytics Collaboration (IFSAC), to better share data and develop strategies to attribute food-borne illnesses to certain pathogens. This was the first concerted effort among the three agencies to share information and coordinate their approaches to determining the source of food-borne illnesses.
These task forces are an improvement, but only because a few years ago there was really no coordination at all. Still, the fragmented system limits IFSAC's effectiveness. The collaboration that is happening, for instance, is focused on individual topics — salmonella, for instance — which means the food safety system is basically adding a second patchwork to its first patchwork. In its most recent report on federal food safety oversight, the Government Accountability Office determined that “these mechanisms do not provide for broad-based, centralized collaboration that would allow FDA, FSIS and other agencies to look across their individual food safety programs and determine how they all contribute to federal food safety goals.” Since 2007, GAO has released numerous reports recommending that Congress consolidate the food safety programs into a single agency.
So what might such an agency look like? In 2010, more than a dozen experts produced a report for the National Academies of Sciences, Engineering and Medicine titled “Enhancing Food Safety” that analyzed the current food safety system and offered recommendations for how to move to an integrated system. The 588-page report advised the government to consolidate food safety responsibilities in a single agency and to reform the inspection process to move to a risk-based system where resources are devoted to high-risk producers and away from low-risk ones. Furthermore, the integration must happen both among agencies at the federal level and across state and local departments as well.
In January 2011, President Barack Obama signed into law the Food Safety Modernization Act, the most sweeping changes to the FDA in more than half a century. FSMA followed the recommendations of that massive report, moving the FDA toward more of a risk-based system. Food facilities that were deemed high-risk to public health would now face an inspection every three years, while low-risk ones might only see an inspector every five years. The law also strengthened the FDA’s authority, but on the crucial issue of coordination between agencies, it really didn’t do much. It has also been plagued by funding shortfalls and neglect from key officials. Regulators have yet to finalize key regulations, and consumer advocates are disappointed with the pace of implementation.
Yet, moving to a risk-based system, even within a single food agency, may be easier said than done. Consider the USDA’s recent attempt to update its IT systems so that FSIS inspectors could develop a database of real-time information that would indicate which attributes of a plant pose the greatest risk to consumers.
But the effort has not gone as planned. After spending nearly $100 million on the project, inspectors found the devices cumbersome to use, and many plants did not have connectivity. Last August, the USDA inspector general criticized the program and said FSIS needs to reassess whether the system will actually help the agency. The inability to collect such data makes it difficult to move to a perfectly risk-based system.
“FSIS has got major, major issues,” said Tony Korbo, the senior lobbyist for the food campaign at Food & Water Watch. “I’ll be as blunt as I can: They tried to shine shit, and they can’t get away with it.”
IF THE U.S. food safety system is so obviously fragmented, and independent observers such as GAO have been calling for a more unified approach, why haven’t lawmakers addressed it? Inertia, of course, is one big reason.
“At the state level, we always say if you were starting from scratch, would you build it how it looks today? Probably not, and probably not at the federal,” said Katy Coba, director of the Oregon Department of Agriculture. “But the fact of the matter is we’re not starting from scratch.”
In Washington, everything comes down to jurisdiction, and the modern food safety system has the misfortune of being split up among different committees. FDA and its $4.9 billion budget (about $1 billion of which goes to food safety) are overseen by the Health, Education, Labor and Pensions Committee in the Senate and the Energy and Commerce Committee in the House. FSIS and its $900 million budget are overseen by the Agriculture committees in both chambers. Combining the two agencies into a unified single food agency would require one committee to give up jurisdiction and the budgetary power that comes with it. That’s a difficult sell in Washington.
“Nobody wants to give up turf in Washington,” DeLauro said.
DeLauro has introduced legislation over the years to create a single food safety agency, and Dick Durbin, the No. 2 Democrat in the Senate, introduced a companion bill in the Senate. That legislation has never gone anywhere. In his 2016 budget, Obama proposed a new “Food Safety Administration” that would have jurisdiction over the entire food supply and would be housed in HHS. “The new agency would be charged with pursuing a modern, science based food safety regulatory regime drawing on best practices of both agencies,” the White House explained.
It received some mixed reviews among food policy experts, even those who support the idea of a single food agency. The proposal also fell flat on Capitol Hill, and, in this year’s budget, the president dropped the idea.
It’s not about jurisdiction, say the opponents. It’s about disruption that would do more harm than good. Mike Gruber, vice president of federal affairs for the Grocery Manufacturers Association, argues that consolidating food oversight responsibilities should not be considered until lawmakers have time to see the results of the Food Safety Modernization Act.
“It’s like going through a massive remodeling of a home, and then before all is said and done, before the switches have been put in place and new locks have put on the brand new doors — do we need to go through another overhaul?” he said.
Other critics of the proposal point to the Department of Homeland Security as an example of consolidation gone awry. What seemed like a good idea, putting 22 agencies under one roof, turned out to be an exercise in duplicating efforts and wasting resources.
“My least favorite idea,” Pape said about a single food agency. He added: “People are unavoidably trying to spend a lot of time figuring out what is the new order, how do you get anything done, who do you report to, as opposed to doing your job.”
This fear is shared by many supporters of a single food agency, who believe the transition would be rocky but ultimately worth it. They see two big food-inspection cultures that, right now, are very different, with fundamentally different ideas about what monitoring even looks like, and the costs of trying to merge them would be significant. But those obstacles, while real, can be overcome, they say.
An intermediate idea has also emerged. The Enhancing Food Safety report suggested that an independent risk analysis and data management center would help improve coordination between the agencies and separate the responsibilities for identifying and inspecting the risks. Food experts consider the latter policy particularly important, as there is an inherent conflict of interest between identifying risks and inspecting them.
“If you created a single risk-assessment center and left FDA to do the risk management of the foods they regulate and USDA to do the risk management of the foods they regulate, that might work, and you might not need to actually create a single food agency,” said Barbara Kowalcyk, a research analyst at RTI International who contributed to the report.
This intermediate approach would create yet another food agency, but it would avoid the disruptive task of trying to integrate two agencies with very different cultures and instead look to solve the data management issues while retaining the current structure.
In the end, the answer from food policy experts on whether to move to a single food agency often seems to rest on a single question: Is the current food safety system working? Depends on what your expectation is, or your threshold for food-borne illness.
“This system is failing,” DeLauro said, adding, “American consumers are being sickened, they're being hospitalized and sometimes killed by deficiencies in our food safety system.”
Adams, of the Michigan Department of Agriculture, said a country that has one of the safest food supplies in the world doesn’t need radical change.
“We have the safest and most abundant food supply in the entire world and for that Americans are very fortunate,” Adams said. “That being said, that doesn't mean we can't be better. But we will never have a system where you have absolutely no risk.”