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NewsRegulatoryFDA

FDA Publishes First CORE Annual Report Summarizing Foodborne Illness Outbreak Investigations

By Food Safety Magazine Editorial Team
enoki mushrooms fda logo overlay

Image credit: Ingeborg Korme via Unsplash

January 9, 2024

The U.S. Food and Drug Administration (FDA) has released the CORE 2022 Annual Report—the first report of its kind—summarizing the investigations of foodborne illness outbreaks and adverse events involving FDA-regulated foods conducted by the Coordinated Outbreak Response and Evaluation (CORE) Network.

Founded in 2011, the mission of CORE is to find, stop, and aid in the prevention of foodborne illness outbreaks, in collaboration with the U.S. Centers for Disease Control and Prevention (CDC) and state and local partners. The CORE Network provides a publicly available investigation table that is updated weekly and provides information about ongoing foodborne illness outbreak and adverse event investigations. CORE does not cover seafood-related illnesses or incidents related to animal feed or pet food, which are handled by different FDA departments.

In 2022, CORE evaluated, responded to, and issued advisories for 65, 28, and 11 incidents, respectively. This is a slight increase over 2021, which saw 59 evaluated incidents, 19 responses, and 11 advisories issued. However, 2022 saw the third lowest number of incidents evaluated in CORE’s ten years of operation.

Of the incident responses with identified products linked to illness, produce was associated with five incidents (37 percent), other or unknown commodities were associated with four incidents (31 percent), and nuts and seeds, fish, dairy, and multi-ingredient foods were linked to one incident each (8 percent each). Specific food products that were implicated include enoki mushrooms, alfalfa sprouts, cantaloupe, strawberries, romaine lettuce, ice cream, Brie and Camembert cheese, multiple types of fish, peanut better, plant-based crumbles, a meal replacement drink, powdered infant formula, and falafel.

FDA took several actions based on CORE investigations in 2022, the most notable being the commodity-specific prevention strategy for Cronobacter sakazakii contamination of powdered infant formula, following a prolific recall that led to a national shortage of formula. Aside from the prevention strategy, FDA issued 11 advisories, nine recall announcements, and one nationwide import alert.

Other noteworthy activity included two outbreaks linked to enoki mushrooms that took place in 2020 and 2022, resulting in more than 25 recalls due to potential Listeria monocytogenes contamination as of August 2023. The 2020 outbreak and subsequent increase in surveillance prompted the release of a commodity-specific prevention strategy for L. monocytogenes contamination of enoki and wood ear mushrooms. Additionally, after the 2022 outbreak, FDA added enoki mushrooms from China to an import alert that was originally established for enoki mushrooms imported from the Republic of Korea based on information gathered during and following the 2020 outbreak. The report highlights the importance of international genomic data sharing during outbreaks such as these.

Another important event was an August 2022 multistate outbreak of Salmonella Typhimurium linked to cantaloupe. The isolates in this cluster of illnesses were within seven alleles and 11 single-nucleotide polymorphisms (SNPs) of two FDA soil swab samples collected from a 2020 outbreak investigation in Indiana. Based on traceback information from the 2022 outbreak, FDA conducted investigations in Indiana at three farms, their common packinghouse, and nearby public lands. Salmonella-positive environmental samples were found at each location, but none of the resulting Salmonella isolates conclusively matched the outbreak strain by whole genome sequencing (WGS). The outbreak vehicle was confirmed after the outbreak ended. No cantaloupes were recalled, and no public warning was issued as the implicated products were no longer on the market. A feature article from the December 2023/January 2024 issue of Food Safety Magazine discusses at length several themes and conclusions related to the outbreak, such as how "business as usual" will continue to produce the same results.

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The last significant outbreak highlighted by FDA in the report is a multistate outbreak of Salmonella Senftenberg infections linked to certain peanut butter products, for which voluntary recalls and a warning letter were issued. FDA is preparing future communications to discuss findings and provide information to assist in future prevention efforts.

The report highlighted the use of the Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS), a way for consumers and healthcare providers to voluntarily submit complaints and data, which led to the investigation of four incidents involving powdered infant formula, a meal replacement drink, dry cereal, and frozen food. These types of investigations come with unique challenges, such as not always having all of the necessary data and lacking laboratory testing information.

Notably, the report mentions that in 2022, to handle the increasing workload of investigating outbreaks and adverse events, CORE established a permanent fourth Response Team with experts dedicated to solving and stopping outbreaks.

Finally, the report acknowledged the publications it issued during 2022 to communicate its activities, findings, and knowledge with the public. A total of 42 publications were put out in 2020–2022, tripling the average annual publication efforts during the 2012–2019 time period. Both of the trade press magazine articles published by CORE in 2022 were published with Food Safety Magazine, specifically, “The Incident Command System and Foodborne Illness Outbreak Investigations” in the October/November 2022 issue, and “Outbreak Investigations of Cyclospora cayetanensis Infections 2013–2020: Progress Made and Challenges Remaining” in the April/May 2022 issue.

KEYWORDS: CORE foodborne illness investigations report

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The Food Safety Magazine editorial team comprises Bailee Henderson, Digital Editor ✉; Adrienne Blume, M.A., Editorial Director; and Stacy Atchison, Publisher.

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