Thank you for that kind introduction. And thank you to the Advisory Board and organizers of the American Food Manufacturing and Safety Summit for inviting me to speak to you today.
I am an outlier among the distinguished speakers from whom you’re hearing. I am not in the food and beverage industry. I’m a lawyer for the federal government. I know you don’t often hear from lawyers. I imagine that some of you wouldn’t mind keeping it that way. But I appreciate the opportunity to speak with you precisely because I think engagement and dialogue between government and industry is vitally important to bridging the gaps between our worlds. And I will try my best to avoid legal jargon, although I am sure that I will fail.
I have spent the past six and a half years at the Department of Justice and the past three years overseeing much of the department’s work related to issues of food safety – first as the head of the Civil Division and now as the department’s number three official. The core of the Justice Department’s mission is to protect the American people. That means fighting terrorism and cybercrime and violent gangs. It means preserving our financial security by fighting fraud.
And it means ensuring the safety of the food we eat, the medicines we take and the medical devices we use.
This basic message – that food, drug and medical device safety should be taken no less seriously than any other risk facing the American people – is a critical one. And it is a message that, during my time at the Department of Justice, I have had too many opportunities to repeat. It is a message I conveyed when we responded to the deadly salmonella outbreak that ultimately led to the criminal convictions or guilty pleas of four officials of the Peanut Corporation of America. It is a message I delivered after fungus in a purportedly sterile injectable steroid caused a nationwide meningitis outbreak – an outbreak that, according to the Centers for Disease Control and Prevention, killed over 70 people and sickened hundreds more. And it is a message that I have repeated in announcing dozens of actions we have taken to ensure that unsafe manufacturers clean up their practices before they can result in the next outbreak.
But this is the first chance I have had to speak directly to you – the leaders in food safety and manufacturing in the United States, the people who have dedicated their careers to bringing safe and healthy food to consumers across the country and around the world. You are the people who ensure that we have confidence in what we eat – that when our families sit down together at the dinner table, or when our kids head to lunch at the school cafeteria, we can know that food and drinks we are enjoying are safe. So I’m glad for the chance to speak to you about an issue – food safety – that I and the Department of Justice care deeply about.
Over the next few minutes, I would like to talk about some of the legal duties manufacturers and distributors have to ensure that the food they sell is safe. And I want to talk about the ways in which the federal government and industry share a common interest in promoting consumer confidence after incidents of foodborne disease. But before I do that, I want to start by talking briefly about why I see food safety as such a key priority for the Justice Department.
As parents, we can make sure that our kids look both ways before they cross street. We can buckle their seat belts when we’re in the car and make sure they wear helmets when they ride their bikes.
But we have to rely on you – on the companies who manufacture and distribute food – to ensure that the food we buy for our children is safe. That is not something we can do on our own.
Now, the overwhelming majority of food produced and consumed in the United States is safe. America’s incidence of foodborne illness is below the average in other developed countries, and it continues to drop. Every day, the vast majority of Americans buy and eat food with total confidence in its quality. That confidence is a testament to you and your companies.
That said, foodborne illness still imposes a significant public health burden on the American people. About 48 million Americans, or one out of every six people, get sick each year from food. For many of those people, the problem isn’t just a stomach ache. It can cause life-long chronic diseases, like arthritis and kidney failure. The Centers for Disease Control and Prevention (CDC) estimate that 3,000 people die each year from foodborne illness and 128,000 people are hospitalized.
Among the government’s highest obligations is to protect citizens when they cannot protect themselves. That is what the Food, Drug and Cosmetic Act and other food safety laws are designed to do. That is why the CDC, the Food and Drug Administration (FDA) and the Department of Agriculture continue to do groundbreaking work to identify the causes that contribute to foodborne illness and to promote conditions that minimize them. And it is why the Justice Department works closely with our federal agency partners to ensure that our enforcement efforts are making a positive difference to food safety and quality. We rely on their technical expertise, their investigative support and their deep knowledge of the industries they regulate as keys to building cases.
Against that backdrop, I want to describe some of the laws that protect the integrity of our food – and how those laws are being used.
Many of the laws we enforce are laws of general applicability – laws that govern conduct in all industries, not just the food industry, such as the laws prohibiting mail and wire fraud. But perhaps the most important law to the protection of food safety is one designed to address the unique interests at stake in the production of food and medicine. The Food, Drug and Cosmetic Act provides for criminal penalties and civil relief against those who introduce adulterated foods into interstate commerce. A food is considered adulterated if, among other things, it is contaminated with a substance that may make someone sick or if it was prepared, packed, or held under insanitary conditions. Congress has made the prohibition on introducing adulterated food into interstate commerce a strict liability offense, meaning a company violates the law when it distributes adulterated food whether or not it intended to do so. But if there is a proven intent to defraud or to mislead – either to defraud or mislead customers or the FDA, or both – a defendant can face felony charges.
These requirements are not new. The Food, Drug and Cosmetic Act was enacted in 1938. It was strengthened in 2011, when Congress provided the FDA with greater authority to regulate food facilities, establish standards for safe produce, recall contaminated foods, oversee imported foods and require improvements in surveillance and response to outbreaks, and when Congress also asked the CDC to extend its surveillance and outbreak response. Those changes have enhanced our ability to identify violations and bring cases against those breaking the law. But the basic legal obligations that the Act imposes on food manufacturers, distributors, and retailers go back over 75 years.
And the fundamental concept of an affirmative legal duty to ensure that the food we produce and sell is safe goes back even further – to 1906, when a Chicago journalist named Upton Sinclair published The Jungle. Sinclair’s novel told a story that could have come from the nightmares of many of the people in this room. After spending seven weeks working incognito in the meatpacking plants of the Chicago stockyards, Sinclair depicted a world marked not only by deep working class poverty, but also by pervasive health violations and unsanitary practices in the meatpacking industry. The first five publishing houses to which Sinclair submitted his manuscript rejected it; an employee at Macmillan, for example, wrote: “I advise without hesitation and unreservedly against the publication of this book, which is gloom and horror unrelieved.”
But the horrors The Jungle recounted were, for the most part, based on true facts. Independent investigators commissioned by President Theodore Roosevelt came back with similar findings of filthy facilities producing unsafe food. The President, in forwarding the investigators’ report to Congress, described the conditions as “revolting,” and said that, “It is imperatively necessary in the interest of health and of decency that they should be radically changed.”
The results were the first two modern federal food safety laws – the Pure Food and Drug Act and the Meat Inspection Act. Those laws, for the first time, established a legal obligation to ensure that food is produced under safe conditions and that it is free from dangerous pathogens. They recognized the reality that the person best positioned to guarantee the safety of the food production process is the manufacturer – not the consumer, or even a government inspector. And they recognized the special importance of food to our society – the special, sacred trust we put in the farmers and packers, the processors and distributors who ensure that we can get nourishment and enjoyment from food that we can rely on to be safe.
Those principles of trust and responsibility continue to underscore our enforcement efforts now, 109 years after President Roosevelt first argued so forcefully for them.
Often, our enforcement actions take the form of civil cases, designed to prevent the distribution of adulterated food. When we see evidence of unlawful practices or conditions, we may ask a court to order the seizure of potentially unsafe products or to temporarily prevent a facility from operating until sanitary conditions are established. In these cases, we routinely seek measures that require companies to institute new health and safety procedures, including independent monitoring programs. Often, rather than requiring a court to impose requirements, we are able to resolve these actions through a negotiated agreement that promotes a safe production environment.
For example, we brought suit in New York after FDA inspections uncovered that a Brooklyn fish processor was consistently missing steps necessary to prevent listeria contamination. Last year, a court ordered that the processor be prohibited from operating its facility until an independent laboratory and an independent sanitation expert developed a satisfactory Listeria Monitoring Program and until the processor could establish that it will fully comply with that program on an ongoing basis. The facility cannot begin operating again until the processor has cleaned and sanitized it and laboratory testing confirms that the listeria bacteria is no longer present.
We have brought similar actions in other instances, such as requiring a Michigan manufacturer of soy products to implement sanitation control programs and Pennsylvania-based dairy firms to adopt a record-keeping system for every animal receiving drugs to prevent drug levels from exceeding what is allowed by law.
In each of these cases, our top priority is safety. We hope to ensure that, when a facility that has produced adulterated food in the past reopens, its operators have taken all of the steps necessary to prevent a recurrence.
Now, the civil remedies available under the Food, Drug and Cosmetic Act are important and civil cases make up the majority of the food safety actions we bring. But many of the headlines about the Justice Department’s increasing focus on food safety have highlighted the criminal prosecutions we have brought. These prosecutions have targeted not only companies but also individuals who have been responsible for putting consumers at risk.
For example, many of you likely have heard about the criminal trial and convictions of the former CEO and two other officials associated with the Peanut Corporation of America, or PCA. PCA products were tied to a salmonella outbreak that, according to the CDC, led to over 700 reported infections and nine deaths. Using epidemiological projections, the CDC estimates that over 22,000 individuals may have been affected by salmonella.
The human toll of an outbreak on this scale is heartbreaking, but the actions that caused it make it all the more horrifying. The evidence the Justice Department introduced at the trial showed that the officials misled PCA’s customers about what they had done to test their products and covered up the fact that some of the products had tested positive for salmonella. For example, they fabricated certificates of analysis accompanying various shipments of peanut products so that the certificates stated that the food in the packages was free of pathogens. In fact, there had been no testing of the food – or, even worse, tests had revealed that the food was contaminated.
After a seven week trial, a federal jury found the officials guilty of FDCA violations, conspiracy, mail fraud and wire fraud, as well as obstruction of justice for making false and misleading statements to FDA investigators responding to the outbreak. They are waiting to hear what their sentences will be.
It is easy to hear these allegations – to hear about company officials deciding to ship peanut butter to stores around the country knowing that it is contaminated with salmonella – and to dismiss them as an anomaly. It is easy to think, “That could never happen at my company.” It is easy to think, “That could never be me.”
And in many ways, that’s right. The overwhelming majority of the food produced in America is not tainted with pathogens. The overwhelming majority of people in the food manufacturing business do the right thing, day in and day out, diligently working to ensure that the processes they use are appropriate and the products they sell are safe. But in an industry that occupies a critical position of public trust, even a tiny minority can cause grave harm. Even a single decision to cut corners can have deadly consequences. The criminal prosecutions we bring should stand as a stark reminder of the potential consequences of disregarding danger to one’s customers in the name of getting a shipment out on time – of sacrificing what is right for what is expedient.
Now, when we are talking about enforcement – when the focus is on a specific investigations, whether criminal or civil – it is easy to think of government and industry as adversaries. But when the goal is ensuring that Americans can trust the food they eat, government and industry are on the same side. We are both working to assure people across the country that, regardless of the problems at PCA, regardless of the highly publicized contamination of eggs and dairy products and cantaloupe, their food is safer than it ever has been. And we are both working to create the conditions and incentives to ensure that progress toward the safest possible food supply continues into the future. So I want to close by talking about some of the common interests that the Justice Department shares with you and your companies.
First, we have a common interest in promoting an ethical corporate culture – in creating an environment where everyone from the CEO to a compliance manager to a production processor is empowered to respond if he or she sees misconduct. A common thread in many of the cases we have pursued is that multiple people within an organization saw red flags of unsafe practices and chose not to act. It is no easy thing to question how things are being done, but speaking out can be vital to protecting not just the safety of customers but the security of the company as well.
Second, we have a common interest in being transparent about the conduct we investigate. When we enforce the food safety laws, we want not only to hold accountable a particular violator of the law but also to encourage compliance by others – supporting the great work that the FDA, the Department of Agriculture and others are doing. Effectively encouraging compliance can only happen if people like you across the industry know about and understand what we are doing and why.
Third, we have a common interest in ensuring that producing safe food is not just a legal obligation, but a prudent business decision. A company that is trying to do the right thing might not stay in business long if its competitors can gain market share and make higher profits by cutting corners. Aggressive enforcement creates an environment in which that kind of corner-cutting does not pay – in which taking the steps necessary to assure the production of safe, high-quality food is the right call for a company to make.
I know that you all are committed, just as we at the Department of Justice are committed, to ensuring the safety of our food supply. In fact, the very theme of this year’s Summit – identifying strategies for future food manufacturing and safety success – resoundingly affirms this. As a consumer and as a parent, I thank you for the work that you have done and the work that I know you will continue to do. I greatly appreciate the chance to speak to you about how and why we are placing such emphasis on food safety issues – and the chance to see those issues from your point of view as well. Events like this enhance our respective practices and our understanding of our respective positions. They allow all of us to consider new ideas and varying perspectives. And they allow us to explore new ways to work together to enhance Americans’ trust in the food they eat and beverages they drink. I hope that today can be part of broader dialogue between the food industry and the Justice Department and look forward to being part of that conversation going forward.