In 2008, a deadly salmonella outbreak from contaminated peanut products killed nine and sickened over 700 people. In the aftermath, the peanut executives who poisoned people with food they knew was contaminated received decades-long prison sentences, an all-too-rare case of a corporate criminal being held responsible for the harm they caused. Contemporary public outrage also helped to fuel a push for more structural reform to the food safety regulatory system as a whole. Shortly after the outbreak, the Obama administration began whipping bipartisan congressional support for the Food Safety Modernization Act (FSMA), which sought to prevent future food safety crises by expanding and strengthening the Food and Drug Administration’s (FDA) authority over food. FSMA ultimately passed both the Senate and the House by wide margins and enjoyed broad public support when finally enacted in 2011.
FSMA mandated the nation’s first comprehensive, preventative food safety plan to be administered under the FDA’s food oversight authority. The legislation aimed to proactively prevent outbreaks instead of simply reacting to them by instituting mandatory inspection timetables and preventative control requirements as well as expanding the FDA’s recall and registration authorities in the event of outbreaks. It was a watershed moment in food safety legislation and, at least on paper, the most sweeping overhaul of food safety in the nation’s history.
As written, the law could have prevented the current infant formula crisis. Unfortunately, the reality of FSMA’s implementation is far removed from the vision that legislators put down on paper over a decade ago. FSMA ultimately failed to realize comprehensive change thanks to both Congress’ failure to fully fund the FDA to be able to implement its new mandate and because of the organizational negligence, and the broken infrastructure, that define the FDA’s food side. To clarify, the FDA’s ‘food side’ is an amorphous conglomeration of food sub agencies, offices, and staff that primarily includes Center for Food Safety and Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), Center for Veterinary Medicine (CVM), and the Office of Regulatory Affairs (ORA).
FSMA Implementation and Budget Stagnation
From the beginning stages of FSMA’s implementation, food safety champions like former Rep. John Dingell (D-MI) warned of the Obama administration’s plans to shortchange food safety: “It is imperative that we not compromise public safety in the name of being ‘penny-wise but pound foolish.’” By 2015, the FDA had received less than half of what the Congressional Budget Office (CBO) had established as critical to FSMA’s implementation. As Helena Bottemiller Evich at POLITICO reported, state-level agriculture and food offices did not have the necessary resources to fulfill food safety inspections. The state of funding for the legislation was so dismal that Florida’s (Republican) Agriculture Commissioner Adam Putnam called FSMA’s budget “a joke.” Michael Taylor, Obama’s FDA deputy commissioner for foods and veterinary medicine, stated the obvious: “You can’t do a new job without new resources.” Strategic defunding of federal agencies by Republicans during the Trump administration further devastated hopes of any real commitment to the FDA’s food-side budget and new oversight responsibilities.
The CBO estimated in 2010 that a comprehensive implementation of FSMA would require that the various sub agencies that make up the FDA’s food division would need a total budgetary increase of at least $1.4 billion between 2011 and 2015. But, less than a year after the FSMA’s enactment, then-President Obama signed the debt ceiling compromise known as the Budget Control Act of 2011. The compromise prompted an era of austerity measures, meaning broad federal spending cuts, a result of the ill-advised bipartisan budget sequestration agreement. Subsequently, the FDA’s desperately needed food budget increases, and FSMA’s implementation money, were cast aside in favor of years of austerity measures. As a result, despite the many new tasks required of the FDA’s food oversight divisions, the department never received the FSMA money it needed. Granted, the FDA failed to even ask for it. The FDA’s food budget did grow over the past decade, by a not-insignificant 42 percent, but these increases fell more than 33 percent short of CBO’s initial cost-estimate for FSMA – not taking into account the growing number of food facilities since 2011.
This stagnation in funding has assuredly contributed to the fact that even now, over a decade after its passage, FSMA still has yet to be fully implemented. Enforcement of certain proposed rules is set to begin as late as 2024 — 13 years after the legislation originally passed. Arguably the most critical preventative food safety measure, which should have been triggered by FSMA’s passage, remains forthcoming: agricultural water safety standards. Produce grown with infected water causes the majority of deadly food outbreaks, but the FDA has defaulted on deadlines for the rule stretching back years. Rulemaking for key provisions of FSMA has occurred so slowly that consumer advocacy group Center for Food Safety filed a lawsuit that resulted in a court-ordered schedule for rulemaking. However, even the rules that the agency finally managed to push through have not been effectively enforced. Due to growing concerns over our globalized food supply, FSMA required food safety inspections for imported goods conducted through a new Foreign Supplier Verification Program, but routine foreign inspections have not proceeded at a pace sufficient to keep up with FSMA’s mandate. Likewise, domestic high-risk facilities are required to be inspected at least once every three years and low-risk facilities are to be inspected once every five years. During FSMA’s first year (2011), the FDA inspected 10,641 food and cosmetics facilities, but inspections have steadily dropped to 7,242 facilities in 2019.
Between fiscal year 2018 and 2019, for example, food safety funding remained the same, but the level of inspections declined by 18 percent for domestic plants. 70 percent of the food program’s budget goes to the Office of Regulatory Affairs (ORA), but the subagency is responsible for far more than just food. ORA is responsible for all of FDA’s inspections, including those required for medical devices and drugs. In 2020 it had a staff of only 4,894 full-time equivalents (FTE), a drastic shortage that has devastated ORA’s inspection rates across all industries. In 2019, food funding allotted 2,179 food inspection staff specific to ORA, but the agency decided to only designate 785 positions for food safety compliance and inspections. This had drastic effects: the food system has 220,586 registered domestic and foreign food facilities, but only 2,850 facilities have been inspected so far this year. These staffing levels are far too low for an institution that is responsible for monitoring the safety of 80 percent of the nation’s food supply. Across the board, the FDA is failing on food, and the baby formula shortage is only the most recent example of its failure.
Thankfully, widespread national furor over the baby formula shortage has prompted Congress to take action. Last month, the House passed a bill that would finally pad the FDA’s depleted food budget with an additional $28 million in support for the FDA’s salaries and expenses. The measure passed despite 192 out of 208 GOP representatives voting against it. Instead of investing in the basic stability of the nation’s food supply, nearly 200 House Republicans continue to use the infant formula crisis as an opportunity to attack Biden and federal regulators while intentionally stripping the funds that could solve this crisis and help prevent the next one.
To be clear, the crisis at the FDA has been decades in the making and is a problem President Biden inherited but did not create. While bad-faith Republican attacks have sought to politically profiteer on the crisis through a broad demonization of government and Biden himself, these convenient taglines ignore the fact that these failures are fundamentally a result of the GOP deregulatory agenda that devalues human lives in favor of corporate convenience. Republicans are defunding safe food enforcers. However, the political case for safe food and healthy babies requiries federal agents to make sure corporations aren’t killing us. The politics of public safety will not make itself. Biden can only be a winner if he makes it in a direct and confrontational manner.
Organizational Breakdown and Regulatory Negligence
The FDA needs additional funds to support it in finally establishing the crucial food-safety infrastructure laid out in FSMA. However, the agency also can and must do better with the resources it already has. Decades of bureaucratic disorganization, a defined culture of apathy, and institutional disregard for food safety have resulted in an FDA that holds little institutional knowledge of food issues and which has continuously proven itself too slow to respond to urgent food crises when they arise.
The food side has long suffered from a lack of clear leadership structures that have left the few food officials at the FDA without a clear idea regarding their authorities and obligations, particularly as compared to other food officials. While this problem has long defined the food side of the FDA, it worsened considerably under the Trump administration, when consulting giant McKinsey (a villain in an astounding number of tales) was ushered in to further fracture the agency’s food leadership. After McKinsey got through with the food division, the organization was divided along arbitrary and administratively tedious lines. Department’s top officials, including Susan Mayne, the leader of CFSAN, and Frank Yiannis, the deputy commissioner for food policy, were left with unclear reporting and authority pathways. This fracturing continues to prevent coordinated food safety implementation from the department because it remains unclear which leaders are responsible for each part of the food safety system.
When asked a simple question at the Congressional Oversight hearing on the baby formula crisis, “Who is responsible for food safety at the FDA?,” Commissioner Califf and Deputy Commissioner Mayne failed to pinpoint a single individual.
As such, one of the easiest ways that the FDA can begin investing in our collective food safety, without further Congressional action, is through a simple, common sense, reorganization of the food division. The agency needs clearly defined, articulable, and straightforward institutional leadership hierarchies to govern and oversee the food side. The FDA alsoneeds these leaders to bring relevant experience from food safety backgrounds. While the food division has long been treated as something of a patronage system for people with pharmaceutical backgrounds, this can no longer be tolerated for officials intended to preside over a system as sprawling and critical as the global and domestic food supply.
Commissioner Robert Califf, whose background is in pharma, has floated the idea of installing veteran physician Janet Woodcock as a de facto head of the food division. Not only has Woodcock prioritized corporate profitability over clinical efficacy and played a central role in the FDA’s deplorable response to the ongoing opioid crisis, she has no real food policy experience. Big Pharma complicit officials have no insight on how to fix the food deficiencies at the FDA, and Califf’s recommendation in the midst of this crisis only further underscores the agency’s gross lack of critical thought regarding the issue. Even worse, Woodcock was also one of the FDA officials who received a copy of the whistleblower report regarding the safety violations at the Abbott Sturgis plant, which led to today’s formula shortage crisis. Neither Woodcock nor the multiple other officials who were sent the files (and email follow-ups) did anything to investigate or meaningfully intervene for months. This delay is indicative of Woodcock’s, and leadership across the FDA’s, sweeping unwillingness to take food safety seriously even when a crisis is clearly, desperately, presented to them.
Fundamentally, the FDA must invest in forming clear divisions of power and authority for food safety governance and must elevate food safety experts to populate these positions. Advocates and the Government Accountability Office (GAO) have also repeatedly pushed for a single food agency, separate and distinct from the FDA, that has full, consolidated control over the food system. If FDA leadership remains unwilling to challenge the apathy which has thus far allowed food crises to arise, the creation of a distinct food regulatory agency should be once again seriously considered.
We Deserve Safe Food
The Obama administration’s passage of the FSMA, catalyzed by a deadly peanut outbreak, never achieved its goal to protect one of our most basic needs. This history of government negligence has resulted in a hollowed-out FDA failing to prevent the deadly food outbreaks that kill 3,000 people a year. To put this number in perspective, the FDA’s failure to protect the food we eat kills the same number of people as died in 9/11, every single year. The public deserves better. People across the country should be able to go to the grocery store and buy food that they know is safe, not that they simply hope to be. FSMA provided a blueprint for greater food safety enforcement and oversight at the FDA, but the underfunded, disorganized, apathetic agency never fulfilled the goals of the legislation. Will it take another crisis for the government to take its approach to food safety seriously?
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“The Federal Drug Administration (FDA)” is licensed under Title 17, Chapter 1, §§ 105 and 106 of the U.S. Code.