CORE 2023 Annual Report

In November 2022, FDA issued a final rule on food traceability designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, with the ultimate goal of reducing the number of foodborne illnesses and/or deaths. The final rule aligns with current industry best practices and covers domestic, as well as foreign firms producing food for U.S. consumption.

Members from CORE played a central role in establishing the new rule by helping develop resources, supporting memos, and educating stakeholders on the rule’s requirements. CORE staff also played a role in the development of the Food Traceability List providing data from foodborne outbreak investigations which helped to determine what foods should be included in a Risk-Ranking Model for Food Tracing. Many of the foods on the list include suspect vehicles that CORE investigates each year but has difficulty tracing back to the source for a variety of reasons, such as lack of records and harmonized data elements during the movement of certain food items through the supply chain. This often increases the amount of time it takes to solve a foodborne outbreak and remove contaminated food items from the market. When there is an outbreak of foodborne illness, CORE needs to rapidly trace the contaminated food through the supply chain, identify the source, and remove that product from the market before more people get sick. The Food Traceability Rule will help CORE find the source of those foods on the Food Traceability List more quickly and will help investigators identify the root cause of the contamination to ultimately prevent it from happening again.

Approximately one third of all FDA-regulated human food is imported into the United States from Mexico. The FDA and Mexico’s food safety regulators, under the Produce Safety Partnership, have been working collaboratively on fresh produce safety since 2014. In September 2020, the Food Safety Partnership (FSP) was established between the FDA, Mexico’s National Service of Agro-Alimentary Public Health Safety and Quality (SENASICA), and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) with the continued goal of better protections for public health and to ensure the safety of food for consumers in both countries. The FSP expands the scope of collaboration included in the Produce Safety Partnership from fresh produce to all food traded between the countries.

The FSP Outbreak Response Workgroup includes representatives from FDA, SENASICA and COFEPRIS and is tasked with enhancing the effective and timely response for the identification of outbreaks associated with human foods traded between both countries. The FSP streamlines the exchange of outbreak information between the three agencies via the Binational Outbreak Notification Protocol. In 2023, the Binational Outbreak Notification Protocol was initiated for four CORE responses including the hepatitis A outbreak linked to imported frozen strawberries, the Salmonella outbreak linked to imported cantaloupes, the Cryptosporidium parvum outbreak potentially associated with cilantro and onions, and a Cyclospora outbreak linked to imported leafy greens. In 2023, the FSP Outbreak Response Workgroup and FDA’s Latin America Office (LAO) facilitated FDA’s participation in accompanied, unannounced inspections in Mexico; one with SENASICA in response to the hepatitis A outbreak, and another with COFEPRIS at a broccoli producer in Puebla. Mexico is the only country that has a procedure in place with the FDA to conduct these types of inspections.

FDA has a research program aimed at enhancing FDA’s communications on foodborne illness outbreaks and food recalls. Office of Surveillance Strategy and Risk Prioritization (previously called Office Analytics and Outreach) staff, including social scientists in the Behavioral and Social Sciences Branch (previously called Consumer Studies Branch) and statisticians in the Signal Detection and Bioinformatics Branch (previously called Bioinformatics Branch), work closely with CORE to evaluate the effectiveness of FDA’s communications during foodborne illness outbreaks and food recalls. In 2023, four studies were conducted under this research program.

A focus group study with a total of eight focus groups (four to six U.S. consumers in each group) in June 2023 tested CORE’s updated outbreak advisory template (the template was updated based on a one-on-one interview study with U.S. consumers conducted in 2021). FDA used the findings from the focus groups and further strengthened its outbreak advisory messaging by streamlining the formatting and reinforcing the use of plain language whenever possible to make the message more digestible for the reader. Additionally, the focus groups also emphasized the importance of leveraging different tools to reach target populations, such as using social media, listservs, and conducting outreach to news outlets.

Additionally, three quick-turnaround consumer surveys were conducted during three major food recalls in 2023: the first in March on a frozen strawberry recall associated with a hepatitis A outbreak (N=1,235), the second in May on a flour recall associated with a Salmonella outbreak (N=1,208), and the third in November on the cinnamon applesauce pouches recall associated with elevated lead levels (N=1,543). Consumer awareness of these recalls varied (34% - 46%) depending on the recalled food product. For both the frozen strawberry and flour recalls, consumers with higher education, those who had consumed the products associated with the recalls, and those who had the products in their homes were more likely to have heard about the recalls. For the cinnamon applesauce pouches recall, parents and primary caregivers of young children were more likely to have heard about the recall (58%) than others (43%).  

In May 2023, per request from the Montana Gallatin City-County Health Department and the Montana Department of Public Health and Human Services (DPHHS), the FDA and CDC assisted with an investigation of illnesses at a single restaurant in Montana. The investigation identified a total of 51 illnesses in people who ate at the restaurant. There were three hospitalizations and two deaths associated with this incident.  

Epidemiological evidence indicated that morel mushrooms consumed at the restaurant were likely the cause of illnesses; however, mushroom poisonings can be difficult to diagnose as the exact chemical nature of some toxins found in wild-type mushrooms are currently unknown. This was the first time CORE investigated illnesses related to mushroom toxins and it presented unique challenges because morel mushrooms are generally considered safe to eat. The toxins in morel mushrooms that may cause illness are not fully understood but using proper preparation procedures, such as thorough cooking, can help to reduce toxin levels.

The morel mushrooms served at the restaurant where the ill customers ate were either prepared raw or lightly cooked, depending on the date served. FDA and state partners conducted traceback on the morel mushrooms received by the restaurant in Montana and identified other restaurants that also received morel mushrooms from the same importer. These restaurants reported various forms of cooking or thorough heating of morel mushrooms, but no significant findings or reports of illnesses were associated with morel mushrooms served by other restaurants. 

In October of 2023, FDA was made aware of a developing investigation by the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) regarding four children with elevated blood lead levels, indicating potential acute lead toxicity. NCDHHS analyzed multiple lots of WanaBana cinnamon applesauce pouches, detecting extremely high concentrations of lead. The FDA reviewed and supported NCDHHS’s analytical findings and found that analytical results at this level could result in acute toxicity. The FDA shared the results with the firm whose representatives agreed to voluntarily recall all WanaBana cinnamon applesauce pouches within expiry. This investigation was quickly transferred to CORE response for further investigation and follow-up. Shortly after their initial recall, WanaBana LLC later expanded their recall to include Schnucks and Weis-brand cinnamon applesauce pouches.  

FDA initiated an onsite inspection at WanaBana, LLC’s manufacturer, Austrofood, located in Ecuador. FDA collected and tested samples of cinnamon from Austrofood and identified elevated levels of lead and chromium.  

Unique to this investigation, and unlike outbreaks of foodborne illnesses that are genetically linked to pathogens, lead exposure in an individual can result from several sources. The FDA relied on self-reported information submitted by healthcare providers, consumers, and some state partners who submitted adverse event reports to FDA to identify new cases and to determine if a product is a shared source of exposure amongst complainants. In total, CORE reviewed 90 confirmed complaints/reports of adverse events potentially linked to recalled product.  

The agency is now focused on post-incident response actions and activities, which may include additional surveillance as well as prevention and compliance activities. Future updates on lead-related actions and activities can be found at FDA Post- Incident Response Activities. 

The FDA and CDC, in collaboration with state and local partners, investigated an outbreak of Listeria monocytogenes infections linked to Soft Serve On The Go cups distributed by Real Kosher Ice Cream of Brooklyn, NY.  

This investigation is noteworthy due to the speed at which the FDA and CDC, in collaboration with state and local partners, were able to solve the outbreak with only two ill people included in the outbreak. Based on epidemiological data provided by CDC, both sick people reported eating Soft Serve On The Go Vanilla Chocolate ice cream before getting sick. The Pennsylvania Department of Agriculture collected an unopened sample of Soft Serve On The Go from an ill person’s home. Whole Genome Sequencing (WGS) analysis confirmed that the strain of Listeria found in the sample from the patient’s home matched the strain of Listeria causing illnesses in this outbreak. In response to the analysis, Real Kosher Ice Cream voluntarily recalled all flavors of Soft Serve On The Go 8-oz cups.

As part of this investigation, product sampling was conducted by the New York State Department of Agriculture and Markets at Ice Cream House, LLC located in Brooklyn, NY. Ice Cream House, LLC is the manufacturer for Real Kosher Ice Cream Soft Serve On The Go cups and also manufactures products under their own Ice Cream House brand. Five finished product samples of Soft Serve On The Go Vanilla Chocolate ice cream were reported as positive for Listeria monocytogenes. WGS analysis confirmed that the strain of Listeria found in these products matched the outbreak strain. In response to this investigation, Ice Cream House of Brooklyn, NY voluntarily recalled all dairy and non-dairy products bearing the Ice Cream House logo that were manufactured in the Brooklyn, NY facility.