FDA Issues First Annual CORE Report Summarizing FDA Investigations Into Foodborne Outbreaks

The FDA issued the first CORE (Coordinated Outbreak Response & Evaluation Network) annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year.

"The FDA’s CORE Network was established in 2011 with the mission to find, stop, and aid in the prevention of foodborne illness outbreaks. This is accomplished through disease surveillance, outbreak response, post-response activities, and collaboration with CDC and state and local public health agencies. Every year, CORE evaluates and responds to numerous foodborne outbreaks related to FDA-regulated products."

"In 2022, CORE evaluated 65 incidents, responded to 28, and issued advisories for 11. These numbers show a slight increase in the number of incidents evaluated in recent years, with 59 incidents evaluated, 19 responses, and 10 advisories issued in 2021. The investigations in 2022 included E. coli, Cronobacter, hepatitis A virus, Listeria monocytogenes, and Salmonella which were linked to a variety of products, including produce, dairy, and fish."

The 2022 annual report highlights a few noteworthy outbreaks from 2022: Listeria monocytogenes linked to enoki mushrooms, Salmonella linked to cantaloupe, and Salmonella linked to peanut butter.

In our reporting, we summarized the FDA findings of these noteworthy outbreaks: 

Salmonella in Cantaloupe (August 2022) - The investigation did not find a definitive source for the Salmonella strain found in the outbreak, although a common  packinghouse was identified.  The report does give some broad recommendations that packing houses, as well as farms, should be following.   Key among these, from my perspective, developing written procedures (SOPs) for the operation based upon reducing risk and then following these procedures with documentation.  It seems that this was the biggest knock against the firm in this investigation.

Salmonella in Peanut Butter (May 2022)  Inspectors found "found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation" and "failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule"  The biggest issue was related to positive tests in the facility and the corrective action that was taken,  FDA finished the report stating the concern that Salmonella may be a resident contaminate within the facility and that broader measures are needed.

FDA published a strategy summary to prevent Listeria from Enoki mushrooms. 

The report provides links to the other FDA actions related to outbreaks.

LINK to report.

https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-core-2022-annual-report-investigations-foodborne-outbreaks-and-adverse-events-fda
FDA Releases the CORE 2022 Annual Report: Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods

Constituent Update

Today, the U.S. Food and Drug Administration (FDA) Coordinated Outbreak Response & Evaluation (CORE) Network released its first annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year.

The FDA’s CORE Network was established in 2011 with the mission to find, stop, and aid in the prevention of foodborne illness outbreaks. This is accomplished through disease surveillance, outbreak response, post-response activities, and collaboration with CDC and state and local public health agencies. Every year, CORE evaluates and responds to numerous foodborne outbreaks related to FDA-regulated products.

In 2022, CORE evaluated 65 incidents, responded to 28, and issued advisories for 11. These numbers show a slight increase in the number of incidents evaluated in recent years, with 59 incidents evaluated, 19 responses, and 10 advisories issued in 2021. The investigations in 2022 included E. coli, Cronobacter, hepatitis A virus, Listeria monocytogenes, and Salmonella which were linked to a variety of products, including produce, dairy, and fish.

CORE investigations also resulted in numerous public health actions, including recalls, public health advisories, Warning Letters, FDA prevention strategies, a country-wide Import Alert, and a Consent Decree. These are further described in the report.

The 2022 annual report highlights a few noteworthy outbreaks from 2022: Listeria monocytogenes linked to enoki mushrooms, Salmonella linked to cantaloupe, and Salmonella linked to peanut butter.

Up-to-date information on outbreak-related activities and investigations can always be found on the CORE Investigation Table, FDA’s Public Health Advisories, Outbreak Investigation Reports, and Publications.