FDA Blueprint Sees Root Cause Analysis as Core Component of Food Safety

The Food and Drug Administration unveiled a blueprint July 13 for its plans to improve food safety over the next decade amid a host of challenges, among them recurring disease outbreaks linked to leafy greens and changes in the ways that food reaches consumers.

Titled “New Era of Smarter Food Safety,” the document emphasizes the central role of root cause analysis (RCA) in developing stronger systems to reduce contamination and human illness.

“Findings of root cause analyses can be an important step in helping industry modify practices to avoid identified risks and can provide more robust data for predictive analytics” that help detect potentially unsafe products, the agency said. Regular use of RCAs can help instill strong food safety cultures in businesses under FDA oversight, it noted.

Root cause analysis is a retrospective investigative method that has driven safety advances in transportation, medicine, and other industries. It can be applied to a wide range of events affecting food safety, especially problems of a recurring or unusual nature. However, businesses and regulators must train and plan appropriately to conduct effective RCAs, as The Pew Charitable Trusts explained in a March report.

According to the FDA blueprint, the agency aims to “invigorate” use of RCAs in food production settings through a range of activities in coming years. For example, it plans to collaborate with other public health authorities, industry and consumer representatives, and academic stakeholders to establish common protocols. Pew’s “Guide to Performing a Food Safety Root Cause Analysis” highlights the need to build capacity to perform these analyses before incidents occur by reviewing available staff and resources and preparing a multidisciplinary investigative team that can be mobilized quickly when needed.

To that end, FDA says it will work with local and state agencies on procedures to ensure that RCA teams are deployed rapidly when foodborne illness outbreaks are connected to particular sites in the food supply chain, such as produce farms or processing plants. The amount of time that elapses between a contamination event and investigators’ arrival on the scene can significantly affect prospects for learning what happened, a fact underscored by FDA’s probe of recent outbreaks tied to romaine lettuce.

The agency also will develop tools and processes to support clear and prompt communication of RCA findings to food businesses and trade organizations so that stakeholders understand the causes of past problems and corrective actions needed to prevent a recurrence. RCAs can generate wider food safety and public health only if their lessons are widely communicated and applied.

In addition, this information can be most effectively shared when it’s conveyed in simple, common language and through a variety of materials and communications channels tailored to people with different roles in food production and oversight. To support timely and candid discussion of RCA findings, Pew recommends that food industry groups and regulators establish a confidential, nonpunitive reporting system that encourages businesses to share what they have learned from internal investigations of food safety problems.

FDA’s blueprint recognizes the importance of RCAs to a prevention-based food safety system—and spells out some of the key obstacles to this method. Public health and consumer advocates, food producers, and state and local regulators should support the agency’s steps to make these analyses successful and to broadly communicate findings that can make Americans’ food safer.

Sandra Eskin directs The Pew Charitable Trusts’ work on food safety.