The bacteria-tainted apple that probably killed Shirlee Frey traveled hundreds of miles from an orchard to a packinghouse and then to a factory that coated it in caramel. It never came anywhere close to being examined or tested by a food-safety inspector.


The California woman died in December, about a month after she ate some of the Halloween treats she bought for her grandchildren. At the end, her brain was so swollen she couldn’t breathe on her own. Frey, 81, was one of seven fatalities in a listeria outbreak caused by caramel apples that spread to 12 states. Common bacteria such as listeria, salmonella and E. coli kill several thousand people each year and sicken some 48 million Americans. Brad Frey believes his mother and hundreds of others might still be alive if a sweeping law hailed as a complete revamp of the nation’s broken food-safety system had been put into action.

“This didn’t have to happen,” Frey said.

He may well be right.

According to a POLITICO investigation, the Obama administration and Congress have all but squandered an opportunity to give the anemic Food and Drug Administration, which is responsible for the safety of 80 percent of the nation’s food supply, a level of oversight the public long assumed it already had.

On paper, the law that Congress passed in late 2010 — known as the Food Safety Modernization Act — was bigger than anything since Teddy Roosevelt cleaned up the meatpacking industry. The law mandated more inspections and much tougher anti-contamination standards for everything from peaches to imported pesto sauce, and it placed more emphasis on preventing outbreaks than on chasing them down after people become sick.

But almost five years later, not one of the sweeping new rules has been implemented and funding is more than $276 million behind where it needs to be. A law that could have been legacy-defining for President Barack Obama instead represents a startling example of a broad and bipartisan policy initiative stymied by politics and the neglect of some of its strongest proponents.

The breakdown of food-safety reform is also a reminder of how quickly momentum can be lost without leadership. The White House has routinely put nutrition policy ahead of food safety, sat on key regulations for months and made only halfhearted attempts to fund the law, according to dozens of interviews with current and former government officials, industry leaders and consumer advocates. Congress, too, bears blame: With no real pressure from the White House or the public, Capitol Hill has given the FDA less than half of what the agency says it needs to actually enforce the new rules, once they take effect. And many of the industry lobbyists and advocates who once championed the measure have turned their attention to other, more pressing policy battles.

In the meantime, deadly outbreaks like the one that killed Shirlee Frey, and another earlier this year that resulted in the recall of Blue Bell Creameries’ entire ice cream inventory, keep happening. Since Obama signed the new law, outbreaks involving cantaloupes, salad greens, pomegranate seeds, sushi tuna and cilantro — to name a few of the more publicized incidents — have sickened thousands and killed several dozen people. And the threat posed by an increasingly exotic food system keeps growing: Two decades ago, the FDA oversaw 200,000 imports; last year there were 12 million, accounting for roughly 15 percent of the nation’s food supply.

Obama’s new budget calls for $109 million increase to implement the law next year. It’s a sudden reawakening of White House interest, more than four times what the administration requested last year, but still far short of what is needed to make the law work as intended, according to the Congressional Budget Office. Besides, Congress, dominated by Republicans focused on squeezing federal budgets, is not likely even to grant that much.

“You can’t do a new job without new resources,” said Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

“At this juncture,” he added, “FSMA either succeeds … or it falls off the rails.”

***

The American food-safety system was born out of crisis. At the turn of the 20th century, Harvey Washington Wiley, an intrepid government chemist, and Upton Sinclair, author of “The Jungle,” horrified the nation by uncovering widespread food fraud and grotesque conditions in Chicago meat plants. Congress responded by passing the first major safety laws: the 1906 Pure Food and Drug Act and Federal Meat Inspection Act.

In the years since, oversight of food has unfolded in a piecemeal and reactive fashion: President Franklin D. Roosevelt signed the Food, Drug, and Cosmetic Act in 1938 after 100 people died from a toxic quack medicine for strep throat. President Richard M. Nixon ordered a sweeping review of food additives when it was believed that saccharine caused cancer. President Bill Clinton cracked down on E. coli in meat after four children died from undercooked fast-food hamburgers. President George W. Bush mandated that food facilities register with the government in the wake of 9/11.

The patchwork response has created a regulatory monstrosity of a dozen poorly coordinated federal agencies that give the illusion of comprehensive coverage but in reality are woefully inadequate to the task of protecting the nation’s food supply. The Department of Agriculture oversees meat and poultry, and the FDA oversees just about everything else. But the lines of jurisdiction have been mocked for decades — cheese pizza falls under the FDA’s purview, but not pepperoni pizza. The same divide holds true for soups, sauces and other processed foods — if it has meat, it falls to the USDA – except for eggs. Eggs are regulated by the FDA, unless the egg is cracked and processed — then it’s the USDA’s job. Since 2007, the Government Accountability Office has rated the food-safety system one of the areas most in need of reform for being fragmented and ineffective, right up there with homeland security and the government’s patchy cyberdefense.

Anatomy of a food-borne illness outbreak A Halloween treat: Before Halloween, Shirlee Frey, 81, bought caramel apples to share with her four grandchildren. Several days later, Frey grew faint, hit her head and was airlifted to Stanford Medical Center in California for surgery to relieve brain bleeding. Doctors initially were optimistic, but days later, her condition worsened. On Thanksgiving, Frey became unresponsive. On Dec. 2, doctors determined she had listeriosis, a foodborne infection that can be dangerous for pregnant women and adults with weak immune systems. Frey died within hours of the diagnosis. “We figured we’d never really know what happened,” her son Brad Frey said. The listeria mystery: Federal and state public health officials knew there was a fatal outbreak of Listeria monocytogenes in multiple states, but they couldn’t figure out what food had caused it. It can take up to 70 days for a listeria-related illness to manifest. In this case, caramel apples were not a food, like poultry and soft cheese, that investigators typically asked about. In mid-December, a Texas epidemiologist noticed that two patients had mentioned caramel apples during their interviews. The California Department of Public Health called Brad Frey, asking if he still had any caramel apples. He did. A recall months later: Frey’s apples tested negative for listeria, but they weren’t the only ones his mom had bought from Safeway. By Christmas Eve, health officials had zeroed in on a caramel apple producer, Happy Apple of Washington, Missouri, which voluntarily recalled three months of its product, including the ones that Shirlee Frey had eaten. The apples had originated at an orchard in Shafter, California, owned by Bidart Brothers. Two other companies that bought fruit from Bidart recalled their caramel apples, as well. In January, Bidart recalled its entire crop for that season. Self-testing failure: In September, Bidart had voluntarily tested one set of samples for listeria — out of millions of apples — and the tests were negative. Testing just one sample is “worse than doing nothing because if it’s negative, it gives a false sense of security,” said Mansour Samadpour, a testing expert. The company was not required to monitor its plant for listeria, though it very likely would have been if rules required by the Food Safety Modernization Act had been in effect. Federal investigators visited the Bidart plant for the first time in late December. Apple season was over, but they were looking for the same strains of listeria that made people sick . Investigators found the pathogen on brushes used to clean apples, in drains near the packing line and inside apple bins. The aftermath: Scientists are still uncertain what caused the outbreak: Could the stick inside the caramel apple have pushed listeria inside the fruit? Are apples more at risk for listeria than previously thought? Bidart faces multiple lawsuits, including one from the Freys, as is Safeway and Happy Apple. In Shirlee Frey’s case, there are still questions: Did she fall because she was weak from listeriosis? Or did the brain surgery make her particularly vulnerable to infection? Her family is convinced she would still be alive if she hadn’t eaten the apples. Image credits: iStock, Getty and AP Photos

Obama’s food crisis was waiting for him as he took office in 2009: an unfolding salmonella outbreak that ultimately killed nine and sickened 714 across 46 states. The source was a filthy factory in Georgia that made peanut butter for everything from Clif bars to Keebler crackers. Thousands of products were recalled as hundreds of children fell ill, riveting the nation’s — and Congress’ — attention.

At a 2009 oversight hearing on the outbreak, Rep. Diana DeGette (D-Colo.) was exasperated. Congress had held hearing after hearing on food safety, she said, but hadn’t passed meaningful reform. “How many sick kids does it really take for us to finally act?”

Obama’s tone was equally as urgent when he appeared on the “Today” show and spoke about the government’s obligations to ensure food safety. “At a bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter,” he said, referring to his youngest daughter: “That’s what Sasha eats for lunch.”

But the part of the government responsible for keeping kids’ peanut butter safe was a chronically understaffed unit of the FDA called the Office of Regulatory Affairs.

In 2009, ORA had fewer than 700 food inspectors (calculated in full-time employees) to cover hundreds of thousands of food facilities. By comparison, at the Department of Agriculture, which oversees all meat processing, the ratio is flipped: There’s more than one inspector for every one of the 6,200 facilities, and they’re on site around the clock. That level of scrutiny is a vestige of Teddy Roosevelt’s reforms: Meat companies by law aren’t allowed to operate without an inspector on hand. The FDA has had no similar mandate, so its workforce never kept pace.

For decades, the ORA’s inspection force has been dwarfed by the number of companies the agency oversees. And as the food system has become increasingly globalized, the gap between the FDA’s capacity and its vast jurisdiction has grown exponentially. U.S. food companies might get inspected every four to five years, and the overwhelming majority of foreign producers never get inspected at all. The ORA now has about 1,100 food-safety inspectors — a seemingly large increase since 2009 but still a tiny force compared with the 377,000 domestic and foreign facilities it is nominally in charge of monitoring.

The FDA’s foods program also has significantly lagged in funding over the years. In the 1970s, close to half the agency’s budget was spent on food safety and nutrition. Today, it’s closer to one-fifth. Spending on drugs and medical device programs has boomed — a trend fueled largely by industry user fees. Drug and device companies have an economic incentive to keep FDA well-staffed to speed product approvals, but there is no such incentive for food-safety inspections.

The consequence of ORA’s understaffing was on full display in the 2009 peanut butter disaster. At the time of the outbreak, federal officials hadn’t inspected the Peanut Corporation of America’s Blakely, Georgia, plant since 2001, years before the company had started making peanut butter. State inspectors, under contract with the FDA, had visited the plant in 2007 and 2008 and found numerous sanitation problems that the company committed to correcting. But no tests for salmonella were done.

Faces of food safety reform Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, the leader of the effort to implement the Food Safety Modernization Act. David Acheson, a food industry consultant and proponent of food safety reform who served as associate commissioner for foods under the George W. Bush administration. Melinda Plaisier, associate commissioner for regulatory affairs, the current head of the FDA's Office of Regulatory Affairs, which oversees food and drug safety inspections.

Food-safety experts recognize that there will never be enough resources, or FDA inspectors, to have the same level of coverage that the USDA has over meat plants, but food-safety inspections are seen as critical to ensuring that food companies are actually following the new food safety rules. ORA declined interview requests about staffing levels and the food-safety law, citing the fact that the final regulations have not been issued.

“You could double the workforce and it would not cover the industry all that well, either,” said a former FDA official. Even if the agency could multiply its inspection force so it could pop into a food facility twice a year, it would still just be “a spot check” because that plant might be operating three shifts a day, 365 days a year. Nevertheless, the official said, “The spot checks are still important,” just like “it’s important for a cop car to sit on the side of the road to deter speeding.”

When federal investigators finally set foot in the Georgia peanut butter plant in 2009 — four months after people began getting sick — they discovered evidence of roaches and a leaky roof that, a company employee later said, had allowed bird feces to drop into the plant. Officials also discovered that the company had been testing its products for salmonella, but it had disregarded positive results and shipped products anyway.

Few members of Congress expressed as much anger over the incident as Rep. Greg Walden (R-Ore.), who had several constituents fall ill during the outbreak. During one hearing, he dared Stewart Parnell, PCA’s chief executive, to eat recalled products he had brought in a large jar wrapped in yellow caution tape. Parnell declined (and refused to testify, invoking his right against self-incrimination.)

That bipartisan outrage was sustained by a powerful alliance of consumer groups and the much deeper-pocketed food industry, which had become increasingly anxious about eroding consumer confidence and the staggering costs to businesses. Given the historic lack of a powerful constituency pushing for stronger oversight of the nation’s food supply, the breadth of the coalition was unique and effective.

“This legislation means that parents who tell their kids to eat their spinach can be assured it won’t make them sick,” declared Sen. Tom Harkin in December 2010. The Iowa Democrat had worked closely with Sen. Mike Enzi, a Wyoming Republican, to bring the law to the finish line. The Senate cleared the bill 73-25.

***

The January 2011 signing ceremony for the landmark Food Safety Modernization Act should have been the first clue something was amiss.

There wasn’t one. No kids. No media photo ops. The president signed the bill alone.

The Democrats, and therefore the White House, had just endured a thrashing in the 2010 midterm elections and food safety was not a priority.

Despite the lack of fanfare, the White House appeared committed to funding the new law. The Congressional Budget Office had estimated that the FDA would need $583 million added to its less than $4 billion base over five years — or an increase of roughly $116 million each year — to boost the agency’s capacity to prevent outbreaks. The administration’s fiscal 2012 request for a $183 million increase far exceeded that — a big ask considering the House had flipped to conservative control. Congress ultimately gave the FDA a $46 million bump, just less than 40 percent of what CBO said was needed.

The following year, the administration capitulated, seeking a minuscule $6 million increase and relied instead on the idea that new industry fees could fund the difference. The White House proposed more than $240 million in fees that year, a politically toxic and unrealistic approach that drew scorn from industry groups, which argued that registration and inspection fees would be an unfair tax on food. Congress granted FDA a $37 million increase that year.

It was the beginning of a worrisome trend. Each year, the White House asked Congress for far less than what FDA needed and Congress more or less agreed. All the while, the administration continued to float the unpalatable idea of industry fees. In 2015, the White House asked for such a small increase ($24 million) that Congress again exceeded the president’s request by several million dollars.

The funding for the new law was way behind, but so were the new rules that were at the heart of the reform.

As soon as Obama signed the law, the clock started ticking to get the four biggest rules out within the year. By the end of 2011, the FDA had drafted a rule requiring food makers to limit potential hazards, whether through better cleaning or simply keeping rodents out. The agency drew up a similar rule to keep contamination from spreading in animal feed and pet food. FDA also drafted tough new rules for food importers and produce growers.

The rules were sent to the White House Office of Management and Budget for review. They weren’t seen again for more than a year. Most people figured the rules had gotten stuck in the administration’s do-no-harm reelection strategy that, in practice, meant no major regulations were issued in 2012. The food-safety rules stalled alongside a bevy of other major regulations, including silica exposure limits for workers and pollution standards for industrial plants.

Administration officials deny they stalled for political reasons. “OMB works as expeditiously as possible to review rules,” said Emily Cain, a spokeswoman. “The administration is committed to a regulatory strategy that maintains a balance between protecting the health, welfare and safety of Americans and promoting economic growth, job creation, competitiveness and innovation.”

Once Obama was reelected, OMB released the rules in January 2013. But they weren’t the rules that observers were expecting. The OMB review had stripped out key requirements for product and environmental testing and added a year to some of the deadlines for businesses to comply with the new rules.

Food-safety advocates were furious. David Plunkett, a senior attorney at the Center for Science in the Public Interest, accused the administration of “protecting corporate bottom lines at the expense of protection for public health.”

Why were all the changes made? “Undoubtedly election-year politics,” Marion Nestle, a food politics expert at New York University, said at the time.

The OMB review is opaque, but stakeholders came to the conclusion that the administration was worried about the price tag of the rules — the changes made dropped the estimated cost to industry by hundreds of millions of dollars.

“Obviously — and it’s understandable — the White House did not want proposals with sort of horrific price tags coming out during an election year,” said Stuart Pape, a former FDA official who now leads the food practice at Polsinelli, a law and lobbying firm that represents the industry.

Last year, the FDA restored some teeth to the rules when it released amendments that included testing requirements, but the entire ordeal slowed down the reforms, and the FDA missed many of its statutory deadlines.

“The White House has only, frankly, been more of an interference than a help on food safety,” said Bill Marler, an attorney specializing in the subject who represents the Frey family. “That’s the way it’s been for six years.”

The Obama administration contends it has remained committed to implementing the reforms.

“Continuing to improve the safety of the nation’s food is a top priority of the president and the administration, as shown by the historic food-safety bill signed into law, the investments in the president’s budget request to help make the law more sustainable and effective in the long run,” said Jessica Santillo, a White House spokeswoman.

***

Earlier this year, elderly hospital patients in Kansas became gravely ill and three died. They had all eaten ice cream manufactured by Blue Bell Creameries, a regional company with a devoted customer base. It turned out that the ice cream was contaminated with listeria that was present in two of Blue Bell’s plants — one in Texas, where the company is based, and one in Oklahoma. The Centers for Disease Control and Prevention has now linked 10 illnesses, going back to 2010, to the company’s ice cream.

The company, FDA discovered in March, had known for two years that it had an issue with listeria in its Oklahoma plant, but it wasn’t required to report its findings to the agency because of a technicality about how close to the food the bacteria was found. And though state inspectors in Texas had visited the plant roughly every six weeks, they reported “very few issues … no penalties, no enforcement actions.” But the inspectors never tested for listeria.

These blind spots were due in part to a lack of knowledge about food-borne bacteria. Until very recently, it was commonly believed that listeria could not thrive in frozen ice cream, but two other ice cream companies have had to issue recalls in the past year because of listeria. It also was believed that listeria could not survive on the skin of an uncut apple. Bidart Bros., the California company that packed and distributed the apple that is thought to have killed Shirlee Frey, was never inspected by FDA or state health officials. The three caramel apple companies to which it shipped its apples hadn’t had much contact with food-safety inspectors, either. Happy Apple, which made the caramel apples that Frey ate, had a visit from California state inspectors in 2013, but they did not test for listeria.

Later this summer and fall, the rules engendered by FSMA that had languished so long at the White House, will be finalized. Once that happens, the FDA’s Office of Regulatory Affairs will have reams of new safety regulations they are expected to enforce, along with greater access to records and mandatory recall authority. It’s all long overdue for food-safety advocates, who sued the FDA in 2013 because the regulations were so delayed and got a federal court to set deadlines for the agency.

Produce growers, for the first time, will have to comply with federal food-safety standards, including mandated water testing and training for workers in the fields. Food manufacturers will have to identify and control for anything that could potentially make consumers sick. They will have to verify that their systems are working, keep food-safety records, which the FDA now has more power to inspect, and scrutinize their ingredient suppliers. The new law also requires that FDA inspectors visit “high-risk” facilities at least every three years.

But the FDA remains about $276 million short of its estimated need. The agency says it needs more money to improve its oversight of the flood of imported foods, including at least 50 more staff to help enforce the coming final rules for food importers. The agency wants to increase its workforce in the field by 100 next year, though officials declined to specify how many would be inspectors. It wants to train many of the inspectors it already has to specialize in food safety (currently, most are also doing medical device and drug inspections). It has plans to dole out more than $30 million to states to help with inspections. The agency also wants funds for training and technical assistance for the thousands of farms and small businesses – most of which have been largely unregulated – that will need to learn how to comply with the new rules.

AP photo / Data: FDA, CDC

It’s a long and ambitious wish list, keeping with the bold mandate that Congress gave the agency to keep more Americans from getting sick. They’re the kind of improvements recommended by food-safety experts who know what the public doesn’t. That, for example, the United States imports 80 percent of its seafood and roughly half of its fruits and vegetables but inspects less than 2 percent of that and tests even less. But whatever appetite for change might have existed in that fleeting moment of bipartisan consensus five years ago, it has long been swallowed up by a predictable budget battle.

House appropriators last month proposed a $40 million increase for food safety at FDA, less than half of Obama’s request. Connecticut Democratic Rep. Rosa DeLauro, a key backer of food-safety reform in the House, protested at the committee markup: “We need to get [FSMA] up and running,” she said, arguing that less than half “won’t do the job.” The Senate has not yet proposed a figure, but Sen. Jerry Moran, chairman of the appropriations subcommittee with jurisdiction over FDA, has called the president’s ask “a difficult number to accomplish.”

Pew Charitable Trusts, which provided much of the money and organizing prowess needed to get FSMA passed, has continued to press for funding, but the sweeping coalition that got the law through Congress has withered.

“The amount provided in the [House] bill falls far short of what FDA needs,” said Sandra Eskin, director of food safety at Pew. “The longer it takes to get the food-safety regulations up and running, the more people will get sick with preventable food-borne illnesses.”

Interestingly, there are food industry representatives who say they would be happy to lobby for more money for this law if the White House would stop pushing for user fees, which the administration has since cut back but not abandoned. Even the most ardent supporters of FSMA have become fed up with the administration’s stubbornness. “User fees are not the way to get there,” DeLauro said earlier this year.

Emily Cain, a spokeswoman for OMB, said the president’s latest budget request responds to that point. “We listened to feedback from Congress and increased the FDA’s budget authority by $109 million to further support food-safety efforts,” she said.

Pew got several of the country’s largest food companies to sign letters to Congress, saying they support more funding, but the fact is industry groups and companies have focused their political power on the Hill to address more pressing concerns, like trying to influence the new dietary guidelines and beating back the groundswell of state labeling laws for genetically modified foods.

“I wish the consumer groups who have beaten the crap out of the FDA to meet the deadlines went on the Hill and beat the crap out of Congress on the funding,” said David Acheson, a food industry consultant who served as associate commissioner for foods during the George W. Bush administration.

Some in the industry are also less than enthusiastic about going to bat for the FDA’s funding boost right as the agency takes a more aggressive stance on nutrition issues, like the controversial move to nearly ban the use of trans fat and an unpopular proposal to mandate that all added sugars be listed on nutrition labels.

The final FSMA rules have also not yet been released, which makes skeptical lawmakers even less inclined to bump the spending, since some in industry remain nervous about what the final regulations might look like. Legislative aides have also been frustrated that FDA has not given more detail on how exactly it would spend the money.

“Before we give them more fuel,” said a senior GOP appropriations aide, “we want to see where they’re driving.”

***

Brad Frey believes his mother and hundreds of others might still be alive if a sweeping law hailed as a complete revamp of the nation’s broken food safety system had been put into action. | Nic Coury for Politico

Last month, Brad Frey was in Washington, on a trip funded by Pew, to share his story about his mother’s death. He met with the offices of Sens. Barbara Boxer and Dianne Feinstein, who is on the Appropriations Committee. The senators were receptive to his call to fund the law, he said, but they also quickly noted that Republicans are in charge.

Frey’s most powerful moment, however, came during a mundane FDA stakeholder meeting on FSMA held in the basement of a Marriott Hotel downtown. The room was full of hundreds of food industry leaders, public health advocates and academics and Frey had a chance to address FDA officials during a question-and-answer session.

“I just think it’s important that we put faces to this because it’s real,” he said as the room fell silent. He told them it was disheartening that standards that could have prevented his mother’s death have not yet been put in place.

“I realize it’s a daunting task,” he says. “But people are dying.”