The U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS), and the U.S. Centers for Disease Control and Prevention (CDC) are working together to post foodborne illness outbreak data in an effort to improve outbreak investigation communications and transparency with the public. This collaboration addresses a goal in outbreak communications: sharing information quickly and accurately, even in the early stages of an outbreak investigation when significant details may be unknown. It gives consumers, food safety advocacy groups, and the food industry early awareness of developing multistate outbreaks.
FDA, CDC, and USDA-FSIS developed a coordinated approach through the efforts of the Interagency Foodborne Outbreak Response Collaboration (IFORC), a tri-agency collaboration chartered in 2013 to improve coordination of multistate outbreak investigations. IFORC develops and coordinates federal best practices for detection of foodborne outbreaks; generation and testing of hypotheses about outbreak causation, with input from industry partners; identification of food vehicles for outbreak-causing microbes; enhancement of data sharing and analyses; and development of interagency and public health communication strategies and processes. Each agency posts the data in slightly different though complementary formats.
CDC Active Investigation Table
CDC launched an Active Investigation Table that shares the number of open multistate investigations by pathogen, including links to any current Food Safety Alerts or Investigation Notices.
USDA-FSIS Outbreak Investigation Response Table
USDA-FSIS updated their Foodborne Outbreak Investigation: Response web page to include open investigations. The FSIS table, first launched in 2019, now lists outbreak investigations confirmed or suspected to be associated with FSIS-regulated products. The “References” column includes links to recall notices, public health alerts, and after-action review reports, as well as CDC outbreak notices for selected multistate foodborne outbreaks, which provide additional information.
FDA CORE Investigation Table
FDA launched the Coordinated Outbreak Response and Evaluation (CORE) Table on November 18, 2020. This new tool shares information on FDA foodborne illness outbreak investigations, even in their early stages and as soon as FDA begins its response to the outbreak. CORE, an office within FDA’s Center for Food Safety and Applied Nutrition, coordinates FDA’s foodborne illness outbreak investigations and developed the investigation table to publicly share the status of outbreak investigations.
Due to the recurring nature of outbreaks associated with leafy greens, FDA issued its commodity-specific Leafy Greens Shiga Toxin-producing E. coli (STEC) Action Plan in 2020. The plan called for actions to advance work in three areas: prevention, response, and addressing knowledge gaps. Within the area of outbreak response, the plan called for continuous improvements in recall and outbreak communications.
Specifically, the plan noted, “Communications during outbreaks are essential for spurring swift industry action and notifying consumers of potentially contaminated products. In addition, outbreak communications are important to inform industry of ongoing food safety issues within the leafy greens sector. Continuous improvements are needed to ensure that communication during outbreaks and recalls is effective in reaching industry and consumer stakeholders.”
FDA’s Leafy Greens STEC Action Plan calls for federal government partners to review and evaluate outbreak communication mechanisms and propose enhancements for continuous improvement.
Supplementing the Current Process
The CORE Investigation Table was designed to supplement the existing communication process by improving the availability of information about foodborne outbreaks. Outbreak investigations go through several stages. Some outbreak investigations will uncover enough information to develop specific recommendations for consumers, retailers, and industry. In these cases, FDA and CDC already have a process and tools laid out to communicate about these investigations.
When specific consumer guidance (such as recommendations to avoid a specific contaminated food item) can be developed, FDA will publish outbreak advisories communicating that advice. For example, a public health advisory is issued by FDA for outbreak investigations that result in specific, actionable steps for consumers to take to protect themselves.
Currently, FDA’s process remains the same. FDA will issue a public warning to alert consumers with actionable information to protect themselves, as in cases where a potentially contaminated product could or has reached consumers and they need to act to protect themselves from illness.
CORE is always monitoring newly emerging multistate outbreaks in collaboration with CDC to determine whether there is a common food item of interest. After CORE looks for signals that could be an early warning of an outbreak and then determines that an FDA-regulated food item is probably causing an outbreak, the outbreak is assigned to a CORE Response Team and added to the CORE Investigation Table.
Time is always of the essence when notifying the public about products that may present public health risks—that has not changed. FDA works with industry and state partners to publish press releases and other public notices about recalls, usually within 24 hours of identifying a specific cause. FDA provides companies with the opportunity to issue public notifications first. In fact, this ensures the recall happens faster because the company has instant access to their records and can more easily identify the scope of products that need to be recalled. This will allow customers to be notified, and stores and restaurants can remove products quickly.
FDA also issues its own notifications as part of its outbreak response. If a company refuses to recall a product, FDA can issue a notice to the public, warning against eating the specific food. Also, FDA notifications are important if the company notification does not sufficiently warn the public.
Some outbreak investigations, however, yield limited information, meaning detailed advice for consumers cannot be developed.
Under the new process, when a potential foodborne illness outbreak moves to an FDA CORE Response Team for coordination, information about that outbreak will post on the CORE Investigation Table. Only outbreaks that may relate to an FDA-regulated food, cosmetic, or dietary supplement that the CORE Response Teams are working on will be included on the table.
“Communicating in a timely manner is essential for the protection of public health, contributes to building and maintaining trust, and can prevent the development of rumors and misinformation,” Commander Kari Irvin, deputy director of FDA’s CORE Network states. “To be timely and transparent, we often need to communicate about uncertainties around the food safety risk and explain what’s being done to address the uncertainty. Our goal for the table was to do just that.”
CORE will use this new Investigation Table to communicate about outbreaks from beginning to end. This table will be updated weekly, on Wednesdays, and will include all outbreaks for which a CORE Response Team is coordinating an active investigation. This table has been rolled out as a 6-month pilot, during which FDA will consider feedback and after which the agency may adjust the table, if needed. Comments on the table can be sent to CORE Communications.
The CORE Investigation Table is intended to notify the public of outbreaks at the start of a response, when there is little information and the source of the outbreak is unknown. This FDA table will also serve to augment CDC’s Investigation Notices.
Elements of the CORE Investigation Table
The CORE Investigation Table currently includes the following information:
- Date Posted on the Table (when it has been determined that the outbreak may involve an FDA-regulated food)
- Reference Number (FDA-assigned number used to identify an outbreak for reference by stakeholders)
- Product(s) Linked to Illnesses (if any)
- Case Count
- Investigation Status
- Outbreak Status
- Recall Initiated
- Traceback Initiated
- On-Site Inspection Initiated
- Collection and Analysis of Sampling
The foodborne outbreak investigation process is comprehensive. It involves coordinated efforts by federal, state, and local authorities. The results of each investigation depend on the information uncovered during the various phases of the investigation process. This process includes the collection of epidemiological information, traceback information, and information through laboratory analysis. Each of these processes takes time, and there are no guarantees that the information available to investigators will demonstrate a link between illnesses and foods. However, FDA is providing this table to communicate what the agency is doing to find that link and share updates on the investigation along the way.
“This table shares up-to-date, preliminary information on any outbreaks to which we are responding,” Dr. Stic Harris, CORE director, notes. “It gives the public a look into where we are with each investigation and links to available information you can use to educate and protect yourself from foodborne illness.
“Most commonly, we work on multistate outbreaks of Salmonella, STEC [Shiga toxin-producing Escherichia coli], or Listeria infections,” continues Harris. “Though any outbreak we respond to will be reflected on the table. Typically, that’s about 25 investigations annually, though with improved technologies such as whole-genome sequencing [WGS], that number may continue to grow in the future.” WGS is a cutting-edge technology that protects consumers from foodborne illness. WGS reveals the complete DNA makeup of an organism, enabling us to better understand variations both within and between species.
Each column in the table reports significant information about the status of the outbreak or about the major actions being taken during an outbreak investigation. Each of the reported actions being taken comprises several steps.
For example, in a combined effort, CORE, FDA field offices, and state and local agencies track down leads and trace product distribution. Additionally, sample collection occurs when investigators go into a facility or farm of interest and collect samples of suspected foods or sample surfaces or the environment that may have come into contact with a food item. Samples can also be taken from food found in grocery stores, from other locations in the distribution chain such as warehouses or processors, or even from food found in someone’s home if they make such samples available. Laboratory analysis is then conducted on the collected samples to determine whether the sample shows the presence of a pathogen and whether that pathogen is making people sick based on their common DNA sequences.
Notably, in the column “Product(s) Linked to Illnesses (if any),” a commodity or specific food could be named. Although if the entry in the column reads “Not Yet Identified,” the investigation has not yet uncovered sufficient evidence to determine what specific food is making people sick at this stage. The investigations on the table will be at many different stages, and when FDA and investigational partners have narrowed the field enough to identify a likely food as the source of the outbreak, the investigating agencies will report that information publicly.
It is also important to note that before a specific food is definitively linked to an outbreak, the investigation of a commodity or a specific food by the USDA-FSIS, FDA, CDC, and state and local partners does not mean the food is the cause of an outbreak. In many cases, the investigation is also looking to rule out specific foods even as it works to identify the food linked to an outbreak. If there is evidence that a specific food is linked to illnesses, health authorities will warn the public about that food. In the meantime, FDA always recommends that consumers follow general food safety guidelines.
The purpose of the “Total Case Count” column is to give the public general awareness of the size of an outbreak. The case numbers reported on this table are preliminary and subject to change. In the early stages of an investigation before a specific food is linked to an outbreak, the goal is to provide early awareness and transparency to the public.
Outbreaks will remain on this table for one calendar year and will then be placed on an archived table for that calendar year. For example, 2020 outbreaks for which investigations have been closed out will be archived, and a new 2021 table will be created at the start of the year.
This new approach to sharing information about outbreaks in the early stages of the investigation is a demonstration of the FDA commitment to more real-time and transparent communication with stakeholders and consumers about outbreaks.
“This new forward-leaning posture on transparency regarding foodborne outbreaks is just the beginning,” says Frank Yiannas, deputy commissioner for food policy and response at the FDA. “This pilot tool allows FDA to share what we know when we know it, even when there isn’t an identified food vehicle. It demonstrates FDA’s commitment to open communication.”
Douglas Karas, M.A., is the team leader of the FDA’s CORE Network Communications Team. He oversees the issuance of public warnings about foodborne illness outbreaks. He has 25 years of experience in communications, including risk and emergency communications and media relations.
Lindsay Walerstein, M.P.H., is a member of FDA’s CORE Network as a health communications specialist for the CORE Communications Team. She writes and issues public warnings and other educational content related to foodborne illness outbreaks.
This article was originally published in the April/May 2021 issue of Food Safety Magazine.