When foodborne illnesses are linked to products regulated by the Food and Drug Administration, the agency’s top priority is limiting harm to consumers with swift removal of unsafe items from the market. But FDA’s work doesn’t end there. The agency increasingly uses an investigative approach called root cause analysis (RCA) to identify how and why dangerous bacteria or other pathogens contaminated specific products and what steps could help businesses prevent a recurrence of these problems. The FDA publicly shares findings and recommended corrective actions from each RCA so that food growers and manufacturers across an industry can apply them to their food safety systems.
Frank Yiannas, deputy commissioner for food policy and response, heads FDA’s efforts to reduce food contamination risks and respond to foodborne outbreaks. He spoke with The Pew Charitable Trusts about the importance of RCA in this work and cited a new Pew report that offers guidance for effective analyses to food companies and government agencies. His responses have been edited for clarity and length.
Q: How can root cause analyses make our food safer?
A: Root cause analysis in food safety is critical to preventing foodborne illnesses. We know that identifying the food vehicle responsible for illnesses isn’t enough to prevent similar outbreaks from happening. That’s why it’s important to go beyond routine food safety assessments and investigate, in a disciplined manner, not only what went wrong but what contributing factors and root causes allowed contamination to occur in the first place.
Conducting a proper RCA allows us to better understand where the contamination actually originated and the corrective actions that are needed to prevent the problem from occurring again. And the learnings from an RCA—whether conducted after an outbreak or a near miss on one farm or a single food production facility—can be shared with others, strengthening an entire industry and further protecting consumers.
Q: Can you give an example of food safety improvements based on root cause analyses?
A: The FDA has prioritized investigations that dig deep to find the true root causes of a foodborne illness outbreak or a food contamination event. Summaries of each analysis are posted online, and FDA provides recommendations to the farm, facility, or industry, including measures to prevent similar contamination in the future.
For example, FDA’s environmental assessment of a 2011 outbreak linked to cantaloupe led to widespread awareness regarding the listeriosis risk associated with produce sold raw or with minimal processing. This led to the incorporation of specific provisions for equipment, tools, buildings, and sanitation in the Preventive Controls for Human Foods Rule and Produce Safety Rule, which are two crucial regulations established under the FDA Food Safety Modernization Act. The assessment also informed workshops for growers and industry guidelines for the safety of cantaloupe and other melons and the monitoring and controlling of listeria.
Q: How does root cause analysis fit into FDA’s food safety strategy?
A: Last spring, FDA announced an initiative called the New Era of Smarter Food Safety, designed to leverage the use of new technologies and approaches in addressing some of the food system’s greatest safety challenges. Among the goals is to invigorate the use of RCAs.
FDA sought public input on its plan, and details about the agency’s blueprint for the initiative are coming soon. However, it is clear that we need to advance, standardize, and socialize root cause analysis protocols to move the ball forward and enhance food safety. Pew’s RCA guide helps accomplish these goals by helping to standardize RCA concepts, criteria, and formats to enhance the use of this important safety tool and ultimately prevent future contamination events. The guide also acknowledges the need to quickly and transparently relay lessons and outcomes from RCAs so that everyone with a stake in food safety can learn from them.
Q: FDA continues to investigate root causes of recent E. coli outbreaks linked to romaine lettuce. How have the agency’s past analyses informed ongoing and future investigations?
A: For some outbreaks, like those associated with fresh leafy greens and other seasonally available products, RCAs should ideally be performed as soon as possible. Unfortunately, due to the long time it takes until illnesses are detected, reported, and ultimately traced to a source, investigations following the romaine outbreaks have been challenging.
As part of our New Era of Smarter Food Safety initiative, we plan to work with federal and state partners to accelerate foodborne illness reporting and tracing of contaminated produce back to its source. Once this is achieved, RCAs conducted on farms will be even more meaningful.
That said, RCAs still hold value once an outbreak has ended. Each has been a learning experience as to what worked and what didn’t work in identifying likely root causes. They’ve also been useful in advancing what we know.
For example, RCAs have helped develop better, faster, and more sensitive means of sampling and testing the environment when hunting for sources and routes of contamination. Federal investigators have recently deployed new high-volume water sampling techniques to look for human pathogens in produce farm environments. These have helped investigators detect small amounts of human pathogens from agricultural water reservoirs linked to outbreaks, even months after a contamination event occurred. This deployment of new technologies during RCAs helped us understand specific routes of contamination in the farm environment and led to further study of the basic biology of human pathogens on farms.
While ongoing romaine-related RCAs haven’t yet answered all questions about how the contamination occurred, they have helped to identify pathogens in water and sediments as potential contributing factors. And they’ve been helpful in formulating relevant investigational and research questions that could help strengthen future prevention efforts.
Q: How can the root cause analysis guide help food businesses and public agencies routinely and effectively conduct these analyses?
A: Conducting a thorough RCA after an incident is a common practice in other disciplines, such as manufacturing and occupational safety and health, and the benefits of these approaches are well documented.
The time has come for the field of food safety to further advance this approach. The Pew guide is a significant contribution, as it provides a standardized lexicon so everyone can understand what RCAs are and how to effectively and efficiently implement them. The guide provides not only the mechanics of an RCA but emphasizes the importance of broadly communicating and sharing findings so the entire food industry as well as consumers can benefit.
I encourage public health agencies and food producers everywhere to review the guide, train their staffs on the principles in it, and put it into practice—not only for outbreaks, but also for near misses. If we do, I’m convinced we’ll learn from previous mistakes, advance food safety, and protect consumers from foodborne illnesses.
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