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ManagementRegulatoryRecall/Crisis ManagementFDA

The Evolution of FDA CORE: Adaptive Response to Outbreak-Related Challenges

Since the CORE Network was established in 2011, its dedicated staff has worked to adapt to an ever-changing foodborne illness outbreak investigation landscape

By Stelios Viazis Ph.D., Christina K. Carstens Ph.D., M.S., Lindsay Walerstein, M.P.H., Marie Armstrong M.P.H., Angela Fields M.P.H., Tyann Blessington Ph.D., M.S., M.P.H., Cerisé Hardy M.P.H., Sharon Seelman M.S., M.B.A., Brett Weed M.P.H., M.S.

State and local partners, in collaboration with the Centers for Disease Control and Prevention (CDC), identify outbreaks of foodborne illness through public health surveillance and epidemiologic investigation. If a food product regulated by the U.S. Food and Drug Administration (FDA) is involved, then FDA collaborates with partners to conduct a traceback investigation and determine the origin of the identified food. State and local authorities, in collaboration with FDA, may use product and environmental sampling, as well as laboratory analyses, to further confirm the identified food as the outbreak source. Throughout the course of any given investigation, communication tools are also used to inform the public of outbreaks and provide information on how consumers can protect themselves from illness. To stop outbreaks and protect public health, FDA may use regulatory actions, such as recalls, import alerts, and others, informed by available investigational data to remove products from the market or to refuse entry of imports.

In 2011, the same year that FDA's Food Safety Modernization Act (FSMA) was signed into law, FDA established the Coordinated Outbreak Response and Evaluation (CORE) Network to serve as the agency's focal point for response coordination and evaluation of foodborne illness outbreaks.1,2 The primary role of FDA CORE is to conduct outbreak surveillance, manage the response efforts, and initiate post-outbreak activities related to incidents involving multiple illnesses linked to FDA-regulated human food, dietary supplements, and cosmetic products. CORE is comprised of the Signals and Surveillance Team (SST), multiple Response Teams (RT), the Outbreak Evaluation Team (OE), the Outbreak Analytics Team (OA), and the Communications Team. Between 2011 and 2022, CORE teams have coordinated surveillance activities for 1,042 illness clusters, responded to 274 outbreaks potentially linked to FDA-regulated products, identified a specific product in 109 outbreaks, and warned consumers to avoid those products through nearly 500 public notifications.

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