The CDC estimates that 48 million people get sick, 128,000 are hospitalized, and 3000 people die from foodborne illness each year in the United States. Major known pathogens account for approximately 9 million of these cases, but it is extremely difficult to link an individual illness to a particular food except during an extreme outbreak. Consider the problem faced by food safety institutions. The average American eats nearly 2000 pounds (1 ton) of total food each year. That figure includes about 630 pounds of dairy (milk, yogurt, cheese, and ice cream), about 185 pounds of meat and poultry, nearly 275 pounds of fruit, and 415 pounds of vegetables. Produce accounts for about half of all illnesses, most often caused by norovirus. Within this category, it was leafy vegetables that cause nearly half. Most fatal illnesses are caused by Salmonella and Listeria passed to humans by meat and poultry. Meat and poultry account for fewer illnesses, but more deaths (29%). America imports about 15 percent of the U.S. food supply, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood. Americans consume twice as much fruit, and three times as many vegetables, from both Mexico and Canada as they did two decades ago. Between foreign and domestic production, distribution, preparation, and sale of foods, the food safety challenge is immense. Roughly, these challenges might be grouped into three classes. First, food that is contaminated, diseased, or contains harmful materials that are not detected or remedied. Second, faulty storage, handling, or processing, which might either introduce risks or fail to detect risks. Third, the intentional introduction of harmful materials into the food supply including toxins, food additives, chemicals, pesticides, drugs, packaging materials, or poisons. See generally Richard A. Merrill & Jeffrey K. Francer, Organizing Federal Food Safety Regulation, 31 Seton Hall L. Rev. 61 (2000); Institute of Medicine, Ensuring Safe Food: From Product to Consumption (1998). For many years, there was remarkable little in the way of federal food safety legislation. In 1906, Upton Sinclair published his famous novel The Jungle, a socialist screed aimed at revealing the plight of immigrants the working poor in advanced industrial capitalism. The book, however, had a much larger impact on food safety law than on anti-capitalist sentiments. Sinclair revealed the inner workings of the Chicago slaughterhouses and meatpacking plants. The result was none too pretty. His portrait of not just unsanitary, but downright disgusting conditions and practices caused a justifiable outcry among the American public and politicians. Contemporaneous reports documented “meat shoveled from filthy wooden floors, piled on tables rarely washed, pushed from room to room in rotten box carts.” Upton Sinclair, What Life Means to Me, Cosmopolitan Mag. (Oct. 1906). What resulted politically was the Pure Food and Drug Act of 1906 (PFDA), 34 Stat. 768 and the Federal Meat Inspection Act (FMIA), 34 Stat. 1260 (1907). The goal of the FMIA was to protect consumers “by ensuring that meat and meat food products are wholesome, not adulterated, and properly marked labeled, and packaged.” The Act’s method was to establish sanitary standards and mandate continuous inspection of cattle, sheep, goats, and equines before, during, and after slaughter. That is, a federal inspector (or inspectors) was placed in each facility to monitor the entire production process from start to finish. Consider how much staffing would be necessary to comprehensively and effectively inspect every piece of meat sold in the United States. The PFDA, by contrast, mandated nothing like continuous inspection for non-meat products. Rather, the PFDA simply forbid the “adulteration” of foods in interstate commerce. Yet, because the statute did not set standards for what a particular “food” was, it was extremely difficult to prove that a given food was “adulterated.” After several decades of struggling with the inadequacies of the PFDA, the FDA recommended that Congress enact new legislation in the 1930s. In a remarkable bout of administrative agency activism, the FDA developed an exhibit and ultimately a book known as the Chamber of Horrors in 1936. Chamber of horrors was published by Ruth deforest Lamb, FDA’s chief educational officer. It was the historical equivalent of an expose on the food industry, revealing a range of unpalatable industry practices. Although Chamber of Horrors did not have quite the impact of The Jungle, the book, together with the death of 107 people from unknowingly consumed the drug elixir of sulfanilamide, helped prompt the enact of the Food, Drug, and Cosmetic Act of 1938, that today remains the overarching framework for the federal regulation of food, drugs, and cosmetics. The FDCA expanded FDA authority to inspect food manufacturing and processing facilities, prohibited the sale of food prepared in unasanitary conditions, defined adulteration to include bacteria and chemicals that are potentially harmful, and created new authorization for the FDA to set mandatory standards for food. Although amended over the years to address particular concerns---like pesticide residue in foods (see the Miller Pesticides Amendment of 1954), the FDCA’s basic structure has proven remarkably durable. By the turn of the century, however, the country was overdue for a food safety law update. The Food Safety and Modernization Act of 2011 (FSMA) was heralded as a complete overhaul of our approach to food safety regulation. Once again, the Act was passed after a series of foodborne illness outbreaks from products as diverse as bagged spinach, peanut butter, cookie dough, and pot pies. Coupled with a growing concern about the safety of imported food in an age of globalization and terrorism, FSMA sought to develop a new comprehensive approach to the food safety problem. At the core of FSMA is a commitment to prevention. Under the prior regime, FDA’s understaffed inspectors would collect data for warning letters and enforcement actions against food producers. If inspectors found evidence of adulteration, for example, an enforcement action might be commenced. In the new regime, FDA would work with producers to ensure that everyone in the food system had an adequate plan to identify points in the production process most likely to result in unsafe food and put in place a plan to manage those risks. The statute required new FDA regulations for Hazard Analysis and Preventative Controls, the establishment of minimum standards for safe production and harvesting of fruits and vegetables, new sanitary transportation rules, and the establishment of a new Foreign Supplier Verification program to ensure that all foreign suppliers of food could ensure that imported food is safe.