FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses

WASHINGTON, D.C. — The following is a statement from Frank Yiannas, Deputy Commissioner for Food Policy and Response – Food and Drug Administration, and Stic Harris, D.V.M., Director – Office of Coordinated Outbreak Response and Evaluation Network – Center for Food Safety and Applied Nutrition (CFSAN):

“The U.S. Food and Drug Administration has a longstanding commitment to strengthening food safety and better protecting consumers, as part of its public health agenda… we are taking an important step to build on this commitment with the release of the Foodborne Outbreak Response Improvement Plan. This plan is designed to help the FDA and our partners enhance the speed, effectiveness, coordination and communication of foodborne outbreak investigations. We are confident that the actions outlined in this plan will in turn translate into activities focused on enhancing the prevention of outbreaks.

“As part of our work implementing the FDA Food Safety Modernization Act (FSMA) and our New Era of Smarter Food Safety initiative, we 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, state health officials, industry and consumer foodborne outbreak experts, along with the input of FDA leadership and staff, was key to the development of our 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… This report played an important role in the development of our new plan.

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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 smarter ways to digitize and routinely receive information needed to streamline the traceback process, which are the steps we use to pinpoint the source of contaminated foods during investigations. These tactics include obtaining more complete voluntarily provided consumer purchase data to better specify critical traceback information, facilitating and expediting how the FDA receives data, and employing more advanced analytical methods and computational approaches. We will work to harmonize our efforts with our federal, state, local and territorial counterparts, as well with 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 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, we will facilitate improvements to sharing of data with the CDC as well as other regulatory partners to further increase 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 better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities. The FDA is committed to using performance and outcome measures to assess 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.
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“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 U.S. food system is large and decentralized, with a broad array of widely distributed products, which we must adapt to in order to help ensure the safety of these products. 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.

“Our improvement plan sets out a clear pathway to achieving these important goals. We will continue to do everything we can to protect consumers from unsafe food. Adding the Outbreak Response Improvement Plan to our arsenal, which includes FSMA and the New Era of Smarter Food Safety, will ultimately prevent illnesses and save lives; and that is what this work is all about for us.”

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