In 2015, Blue Bell Creameries, LP, was implicated in an outbreak of Listeria monocytogenes involving ice cream. The outbreak caused 10 known illnesses from 2010 through 2015. Of those, all 10 people were hospitalized, and three died. The Blue Bell outbreak investigation is an excellent example of the new paradigm of foodborne illness surveillance, one that significantly increases the legal risks that companies face. The events leading up to the outbreak, and the criminal prosecution that followed, also provide a look into the workings of the criminal justice system.
Foodborne Illness Surveillance
Historically, most foodborne illness outbreaks and recalls were linked to products produced during narrow, well-defined periods of time. Often, implicated products were limited to an individual lot or production date. In such cases, the contamination was typically attributed to a specific food safety failure, e.g., employee cross contamination or a single contaminated batch.
Advances in foodborne illness surveillance, genotyping, and networking have vastly improved our understanding of how foodborne illness propagates and fundamentally changed the landscape of outbreaks and recalls. The groundwork for this shift began the mid-1990s, following the 1993 Jack-in-the-Box E. coli outbreak. After Jack-in-the-Box, a public outcry led to the creation of a national foodborne illness surveillance program. CDC scientists and policy makers recognized that outbreaks could be detected and stopped sooner if public health laboratories employed a uniform standard of genetic subtyping and shared the results across a nationwide network of laboratories. This realization led to the creation of PulseNet.
PulseNet, subject to mandatory illness reporting rules, requires healthcare providers to report certain foodborne illnesses (such as L. monocytogenes, Salmonella or E. coli O157:H7) to public health officials. State laboratories conduct genetic subtyping on isolates collected from food samples or ill patients and then upload the isolates to PulseNet, allowing for rapid comparison to other isolates stored in the CDC database. Matching isolates often come from a common source, just as multiple crime scenes with the same fingerprints are likely the result of a single perpetrator. When a potential outbreak is identified, CDC shares information with federal, state, and local officials, who then collaborate to identify a source. Almost immediately after its inception, PulseNet began detecting a significant number of outbreaks, often with a small number of geographically diverse cases, that would have otherwise almost certainly gone undetected.
PulseNet has grown significantly over time. It now comprises 83 federal, regional, state, and local laboratories divided into seven regions. There is at least one PulseNet laboratory in every state, and the database now has more than a million isolates, which has enabled CDC and FDA to solve countless foodborne illness outbreaks.
And, just as surveillance has improved, so have the food safety programs at food companies. Yet, despite the extraordinary improvements over the last 25 years, which have undoubtedly made food safer, the number of recalls has continued to increase. This is likely because the fidelity of the surveillance is so keen that we are identifying outbreaks that we wouldn’t have before. Gone are the days when outbreaks were only identifiable if they caused many illnesses, in a short timeframe, over a limited geographic area. Today’s outbreaks are readily discoverable even if the contamination is caused by a niche organism in some dark, difficult-to-reach area of a facility. Such pathogens may only intermittently find their way into products before disappearing, only to reproliferate weeks, months, or years later. Then, as sporadic illnesses occur, the genetic isolates are uploaded into CDC’s database, where they remain indefinitely. This is what may have happened in the case of the Blue Bell outbreak.
The Blue Bell Outbreak
In May 2020, the federal government charged Paul Kruse, Blue Bell’s former president and CEO, with seven felony counts for his role in conspiring to conceal Listeria contamination from Blue Bell’s customers and regulators. By examining CDC’s outbreak investigation documents and the federal government’s prosecutorial materials, we can begin to understand how the outbreak happened and what missteps the company took.