FDA Issues Improvement Plan to Modernize Foodborne Illness Outbreak Responses

The U.S. Food and Drug Administration announced the release of the Foodborne Outbreak Response Improvement Plan, designed to help the FDA and its partners enhance the speed, effectiveness, coordination, and communication of foodborne outbreak investigations.

The FDA said they have collaborated with experts in both the public and private sectors for input on additional ways to strengthen the agency’s outbreak response. Input from the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) and the Centers for Disease Control and Prevention (CDC), state health officials, industry and consumer foodborne outbreak experts, along with the input of FDA leadership and staff, was key to the development of their new improvement plan.

“The agency also contracted with the University of Minnesota’s School of Public Health to assess the FDA’s capacity to support, join, or lead multistate outbreak investigations and to provide recommendations in an independent report, which we are also making public today. This report played an important role in the development of our new plan,” stated Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, and Stic Harris, D.V.M. director of the FDA’s Coordinated Outbreak Response and Evaluation Network.

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The Foodborne Outbreak Response Improvement Plan focuses on four specific priority areas in which improvements will have the most impact on outbreaks associated with human food.

  • Tech-enabled product traceback: Engaging more innovative ways to digitize and routinely receive the information needed to streamline the traceback process, which are the steps the FDA uses to pinpoint the source of contaminated foods during investigations. These tactics include obtaining complete voluntarily provided consumer purchase data to specify critical traceback information better, facilitating and expediting how the FDA receives data and employing more advanced analytical methods and computational approaches. The agency will harmonize its efforts with federal, state, local, and territorial counterparts and industry and others involved in traceback investigations.
  • Root-cause investigations (RCIs): Systematizing, expediting, and sharing FDA RCIs. The plan focuses on adapting and strengthening protocols and procedures for conducting timely RCIs of foodborne illness outbreaks, standardizing criteria for producing FDA RCI reports, and expediting the release of investigation findings to the industry and the public.
  • Strengthen analysis and dissemination of outbreak data: Working with the CDC, the USDA’s FSIS, and other partners to identify reoccurring, emerging, and persistent strains of pathogens. Specifically, the FDA will facilitate improvements to sharing data with the CDC and other regulatory partners to increase the transparency of outbreak investigations, increase public confidence in results, and facilitate improved collaboration on investigation activities.
  • Operational improvements: Building on performance measures across the FDA’s foods program to evaluate better the timeliness and effectiveness of outbreak and regulatory investigation activities. The FDA is committed to using performance and outcome measures to assess the progress of this improvement plan by updating stakeholders, posting updates on FDA.gov, and through a public webinar in early 2022 to discuss how regulatory partners, industry, and others can work together to achieve these goals.

“We know that the 21st century has brought new challenges in identifying, investigating, and controlling outbreaks of foodborne disease, but it has also brought new tools to meet those challenges. We also recognize that today’s U.S. food system is large and decentralized, with a broad array of widely distributed products, which we must adapt to help ensure the safety of these products,” said Yiannas and Harris.

“That is why we are taking steps through this improvement plan to evolve our outbreak investigations to meet modern-day needs using the most modern-day tools available. Our investigations must be faster, more streamlined, and more effective to identify, pinpoint and remove contaminated food from the market and identify root-cause factors in the food system to prevent similar outbreaks in the future,” the two FDA leaders added.