A Look at FDA’s Foodborne Outbreak Response Improvement Plan

Because foodborne disease is a significant public health issue in the United States, FDA recently developed the Foodborne Outbreak Response Improvement Plan (FORIP) to help the agency and its partners enhance the speed, effectiveness, coordination, and communication of outbreak investigations. “Tackling foodborne illnesses faster and revealing their root cause is essential to the prevention of future outbreaks,” says Frank Yiannas, FDA’s deputy commissioner for food policy and response. “We are confident that these actions outlined in the plan will contribute to bending the curve of foodborne illness in this country by helping to prevent future outbreaks.”

The plan is a necessary component of the agency’s strategy to ensure that the most effective tools and procedures are being used to streamline outbreak investigations and alleviate the effects of foodborne illness.

Key Areas of the Outbreak Response Plan

FORIP focuses on four specific priority areas in which improvements will have the most impact on outbreaks associated with human food:

1. Tech-enabled product traceback,
2. Root cause investigations (RCIs);
3. Analysis and dissemination of outbreak data; and
4. Operational improvements within the agency.

Yiannas notes that the plan focuses specifically on reducing the time needed to identify contaminated product; gathering and sharing critical investigational findings and recommendations to prevent future outbreaks more quickly and fully; more rapidly identifying a source and providing earlier and more open communications with government partners, industry, and the public; and measuring, streamlining, and continuously improving FDA’s performance.

David Goldman, MD, MPH, chief medical officer in FDA’s Office of Food Policy and Response, notes that FDA learns something new with each outbreak that occurs and then tries to incorporate that knowledge into its response. “Metrics are being addressed across the entire foods program,” he says. “We’re looking at a combination of operational and public health metrics—which, together, we intend to translate into faster response, earlier action, and secondary prevention—that are preventing further illnesses during an outbreak.”

Craig W. Hedberg, PhD, professor in the division of environmental health sciences at the University of Minnesota in Minneapolis, who conducted an independent review of FDA’s foodborne outbreak response processes, notes that FORIP was necessary to address new food safety challenges that continue to emerge and to take better advantage of new developments in public health surveillance methods. “In particular, the development of whole-genome sequencing for bacterial pathogens such as Salmonella, Shigatoxin-producing E. coli, and Listeria provides more information to better identify outbreaks with small numbers of cases, to link cases to food or environmental isolates, and to identify recurring patterns over time that highlight persisting problems that may not have been adequately addressed,” he says.

Being able to rapidly assemble records for shipment of food products through the distribution system to the point of service will greatly increase the speed and reliability of traceback efforts and make it more feasible to incorporate traceback data into the epidemiologic investigations.—Craig W. Hedberg, PhD

Liz Sertl, senior director of community engagement for GS1 US, a nonprofit standards organization, notes that FORIP is an extension of the work that FDA already has in place with the Food Safety Modernization Act and its New Era of Smarter Food Safety. “FORIP is focused on multi-state outbreaks that require significant engagement coordinated by FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network,” she says. “The plan seeks to enhance the speed, effectiveness, coordination, and communication of those outbreak investigations. Ultimately, the plan is intended to complement two of the blueprint’s core elements, “Tech-Enabled Traceability” and “Smarter Tools and Approaches for Prevention and Outbreak Response.”

The positive impact of this work is made possible, she adds, by using smarter ways of digitizing information to help get to the root cause of foodborne illness more quickly due to the speed of information available. “Data that’s identified, captured, and shared in a standardized, digitized manner is key for FORIP, as this enables trading partner collaboration and systems interoperability, and can help members meet the requirements of FDA regulations,” Sertl adds.