A recent conversation with officials from the U.S. Food and Drug Administration (FDA) explained to stakeholders how the agency handles foodborne illness outbreaks and other adverse food safety events, as well as the ways in which FDA plans to improve its processes. Highlighted throughout the conversation was the importance of data in foodborne illness outbreak investigations; FDA expressed its intent to continually explore ways to enhance the agency’s data streams.
FDA also released a supplementary, informational video that illustrates the agency's process in responding to foodborne illness outbreaks. The video describes the complex web of steps taken by FDA—along with the U.S. Centers for Disease Control and Prevention (CDC) and local, state, and international public health authorities—to respond to foodborne illness outbreaks associated with FDA-regulated goods. The video explores how CDC works with public health authorities to learn more about what could be sickening consumers, and if an FDA-regulated food product is identified, how FDA investigates the cause of the outbreak and works with industry to remove any potentially contaminated product from the market.
The present conversation and supplementary video follows a recent Food Safety Matters podcast episode with Kimberly Livsey, a Senior Emergency Response Coordinator in FDA’s Office of Regulatory Affairs (ORA), as well as a Food Safety Magazine article by various FDA officials. Both the podcast episode and article explore, in great detail, FDA’s use of the Incident Command System (ICS), which is an aspect of how the agency responds to food safety incidents.
FDA’s Processes: CORE, CFSAN, ORA
FDA representatives who took part in the conversation include Stic Harris, D.V.M, M.P.H., Director of FDA’s CORE Network; Conrad Choiniere, Ph.D., Director of the Office of Analytics and Outreach at FDA’s Center for Food Safety and Applied Nutrition (CFSAN), who was also a recent guest on the Food Safety Matters podcast; and Michael Rogers, M.S., Assistant Commissioner for Human and Animal Food Operations in FDA’s ORA. The CORE Network, CFSAN, and ORA respectively tackle different aspects of FDA’s food safety work: foodborne illness outbreak investigations, consumer complaints and reports of potential hazards associated with FDA-regulated commodities, and inspection and enforcement.
CFSAN and ORA receive consumer complaints and adverse event reports through two voluntary channels: the CFSAN Adverse Event Reporting System (CAERS) and ORA’s consumer complaint coordinators located in FDA field offices across the U.S. When necessary, FDA will follow up on complaints with inspections, sampling, recalls or import alerts, a 72-hour food history investigation, and other actions.
Dr. Choiniere and Mr. Rogers explained how four consumer complaints with commonalities led to the recent, prolific investigation of Abbott Nutrition’s Sturgis, Michigan facility that was producing powdered infant formula contaminated with Cronobacter sakazakii. However, there were several factors that made it difficult for FDA to link cases of infant illnesses to the infant formula in question. Notably, since Cronobacter is not a nationally notifiable disease, the agency had to rely solely on consumer complaints for its investigation rather than receiving information from public health partners. Whole genome sequencing (WGS) is also rarely performed on the pathogen, so the available genomic data was limited.
FDA’s response to foodborne illness outbreaks through the CORE Network differs greatly from the agency’s investigations into consumer complaint reports. The CORE Network is typically made aware of potential multistate foodborne illness outbreaks by CDC and state health departments after case patients have been tested by a doctor and had their results reported to public health authorities. If public health authorities are notified of a patient that has been sickened by a nationally notifiable disease, the case will be added to CDC’s National Notifiable Diseases Surveillance System (NNDSS); however, the list of diseases that are required to be reported by doctors and laboratories varies by state. The Council of State and Territorial Epidemiologists (CSTE) has developed a list of recommended notifiable diseases that includes problematic pathogens like Escherichia coli, Listeria monocytogenes, and Salmonella, but other notable pathogens, such as Cronobacter sakazakii, are not on the list.
Using the PulseNet database, WGS analysis will reveal to CDC the genetic relatedness between isolates from case patients. When it is apparent that isolates are genetically related and a food item may have been the vehicle for the pathogen, state and local public health authorities will conduct interviews to determine the exact source, if possible. If an FDA-regulated product is identified, CORE will take on the foodborne illness outbreak investigation by gathering supply chain data in search of a common point where contamination may have occurred, and will collaborate with ORA to take samples and review operational practices in farms or facilities.
The conversation highlighted efforts that FDA is making to improve its processes for responding to foodborne illness outbreaks and adverse food safety events. At present, CFSAN is developing a new online reporting form to collect consumer complaints through CAERS. The new platform will allow FDA to streamline its response and allows for the collection of more comprehensive data with the submission of product pictures.
In December 2021, the CORE Network released its Foodborne Outbreak Response Improvement Plan, which identifies steps that the FDA is taking to enhance the speed, effectiveness, coordination, and communication of outbreak investigations. The improvement plan builds upon the pillars of FDA's New Era of Smarter Food Safety Blueprint. The plan will focus on tech-enabled traceability, root cause analysis, outbreak data, and operational improvements.
ORA recently revised its internal consumer complaint procedure to better define when certain consumer complaints need to be escalated to senior officials, including when FDA field offices receive a complaint that has the potential to seriously impact public health or involves a whistleblower. ORA also streamlined its initial review process for when complaints are received so that submissions can be responded to more quickly. Additionally, investigators have been provided with updated information about reviewing complaints and adverse event reports prior to and during an inspection to better inform their observations.
Finally, ORA is continually updating its investigator trainings, including lessons learned from recent inspections. For example, the office is now educating its investigators about infant formula regulations and the unique characteristics of and manufacturing processes for different types of infant formula, including liquid, powder, milk, soy, and other varieties. FDA also updated its trainings on inspections for facilities that produce dairy products, make low-acid canned foods, or use aseptic processing and packaging, because such manufacturing processes impact infant formula production.
Update, October 26, 2022: The article was edited slightly to include information about a newly released FDA video that supplements the agency's explanation of its response to foodborne illness outbreaks.