New FDA report reinforces transparency, reveals reactive reality of foodborne outbreak responses
A new FDA report showcases a refined dedication to risk communication, but its CORE Network’s response to foodborne illness outbreaks still may be somewhat reactive.
At a Glance
- FDA’s CORE Network released a report summarizing investigation findings and actions from 2022.
- In 2022, CORE Network collaborated with CDC and local agencies to evaluate 65 incidents and issue 11 advisories.
- Despite improvements to communication and prevention strategies, similar contaminations continue to occur.
FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network released a report, “Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods,” which summarizes investigations performed and actions taken for outbreaks related to FDA-regulated products during 2022.
While this report shows that FDA is working to improve transparency and risk communication, it also reveals limitations in the outbreak response process, which may still be more reactive than preventive.
A CORE purpose
Founded in 2011, CORE Network collaborates with CDC, FDA field offices, and state and local public health agencies to detect and respond to foodborne disease outbreaks.
In 2022, CORE evaluated 65 foodborne outbreaks and adverse events, transferring 28 to a Response team and issuing advisories for 11. This represents a slight increase from 59 incidents evaluated in 2021, but a larger decrease compared to the 10-year average of 103.9 incidents per year. It’s unclear whether this data underlines a reduction in the overall number of incidents or simply in those reported or discovered.
“It is difficult to draw conclusions about slight changes in the number of incidents reported from year to year,” Sheila Alaghemand, a health communications specialist at the CORE Network, said. “We see that across the past 11 years there is quite a bit of variation in the number of incidents evaluated and responded to, and the number of incidents reported will fluctuate depending on the number of multistate outbreaks occurring and being detected annually.”
Alaghemand claimed this information contributes to the development of targeted prevention strategies for specific foods, which can be found on FDA’s prevention strategies web page.
“The CORE Outbreak Evaluation and Outbreak Analytics teams look at all aspects of the outbreak, from ingredient sourcing to production and distribution,” she explained. “The teams conduct data analyses to recommend ways to integrate preventative measures in food safety activities, including sharing CORE’s outbreak investigations and analytic summaries with internal and external stakeholders through publications and presentations.”
Response to outbreaks
According to the report, CORE Network collaborates with stakeholders to:
Detect possible outbreaks. The CORE Signals and Surveillance team works with relevant parties to determine possible outbreaks by analyzing disease surveillance trends and reviewing data from food firms and previous incidents for possible similarities.
Notify a CORE Response team. If the CORE Signals and Surveillance team determines that an outbreak may have been caused by an FDA-regulated food, it sends this information to a CORE Response team. (Information from outbreaks that have already ended or that were linked to non-FDA products are sent instead to appropriate stakeholders outside FDA, such as USDA.)
Take action. The CORE Response team may issue public health advisories, request that companies recall affected products or pursue compliance actions such as a mandatory recall.
CORE investigations have already resulted in several such actions, along with the development of prevention strategies targeting specific foods. For example, a Listeria monocytogenes outbreak linked to enoki mushrooms (Flammulina filiformis) resulted in a countrywide import alert, which involved detaining mushrooms from the Republic of Korea and China without physical examination. This response may have sped up the process of controlling the outbreak.
Outbreaks versus contamination
Another noteworthy investigation from 2022 was a Cronobacter sakazakii contamination of powdered formula manufactured by Abbott Nutrition in Sturgis, MI, which was linked to four cases of infant illness or death. This incident eventually led to an FDA reorganization and the creation of a powdered infant formula strategy. Despite these efforts, however, a similar incident involving Cronobacter in baby formula recently occurred.
Alaghemand asserted that the recent incident is simply a recall rather than a full-blown outbreak, with no illnesses yet reported. At the beginning of the incident, the Israeli Ministry of Health notified FDA of a positive test during routine sampling. CORE reviewed the results and recommended a recall, which manufacturer Reckitt/Mead Johnson Nutrition initiated voluntarily. FDA then conducted a for-cause inspection and additional sampling.
“FDA has taken numerous steps to enhance the safety of powdered infant formula through the development of a Cronobacter prevention strategy, issuance of the updated infant formula compliance program, enhanced inspectional activities, increased engagement with the infant formula industry and by pursuing regulatory actions when appropriate,” Alaghemand explained. FDA has also called on industry to enhance oversight of infant formula and help identify and remove contaminated product before consumers become ill.
The CORE network plans to release future reports for each calendar year. It’s also working to further speed up risk communications through its investigation table and public health advisories, both of which provide more up-to-date information about developing outbreaks.
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