Recent Listeria Outbreaks Hold Key Compliance Lessons
In this Law360 article, Kate Hardey, Olivia Kaufmann and Jessica Stoltz discuss the recent string of Listeria outbreaks and compliance considerations for food manufacturing facilities in the United States.
The recent Listeria monocytogenes outbreaks in ready-to-eat foods, such as deli meats, and the U.S. Department of Agriculture and U.S. Food and Drug Administration responses to these outbreaks, underscore the critical need for the FDA and USDA to bolster oversight of food safety measures to mitigate the risks posed by foodborne pathogens.
These recent outbreaks, notably involving Boar's Head Provisions Co. Inc., BrucePac and Ice Cream House LLC, have raised significant concerns regarding the integrity of food manufacturing practices, and the potential repercussions on public health and the food industry at large.
Food manufacturing facilities should take note of the series of events that ultimately led to one of Boar's Head's facilities being indefinitely closed in September, due to a severe Listeria outbreak.
The issues highlighted by these recent events should be closely evaluated from an overall compliance perspective, and during any transaction diligence process for food manufacturing facilities and retail food establishments, as diligence may help buyers understand potential risks and better manage them going forward.
USDA and FDA Regulatory Requirements
Listeria can cause fever, muscle aches and convulsions, among other symptoms. It can also cause more severe infections in pregnant women, people over 65 and those with weakened immune systems.[1] Symptoms can take up to 70 days to appear.[2]
The Centers for Disease Control and Prevention lists Listeria as the third leading cause of death linked to a foodborne illness, with an estimated 260 deaths a year.[3] For businesses, Listeria outbreaks may also lead to a significant loss in sales, recalls, food waste, lawsuits and other potentially negative consequences.
The USDA has a zero-tolerance policy for Listeria in ready-to-eat meats, as any amount of consumption can make a product unsafe. In 2003, what is commonly known as the Listeria Rule was enacted.[4] The Listeria Rule codified the required facility prevention and control measures to reduce the risk of contamination in ready-to-eat products.
In addition to USDA requirements, the FDA has a zero-tolerance limit for Listeria in food. The FDA's current good manufacturing practices for manufacturing, packing or holding human food set forth the requirements for the safe production of human food — including, among others, requirements for sanitary operations, facility sanitation, and production and process controls.[5]
The FDA inspects food manufacturing facilities, warehouses and distribution hubs as part of its food safety program.
Multiple Listeria Outbreaks: USDA and FDA Responses
Recent recalls initiated by Boar's Head and BrucePac involving millions of pounds of ready-to-eat meat and poultry products contaminated with Listeria have brought to light significant deficiencies and systemic weaknesses in food manufacturing surveillance mechanisms.
Delays between the production of contaminated products and their recall raise questions about the efficiency of current food surveillance and traceability systems within the food supply chain, from a USDA and FDA compliance perspective.
For example, in July, Boar's Head issued a recall for its ready-to-eat liverwurst product and other deli meats due to Listeria contamination. Subsequently, the company recalled an additional seven million pounds of ready-to-eat deli meats and poultry produced in the same facility as the liverwurst.
Boar's Head linked the outbreak to its manufacturing facility in Jarratt, Virginia.[6] The company discovered the outbreak after receiving a positive test for Listeria in their liverwurst product from the Maryland Department of Health. As of mid-September, the Listeria outbreak had led to significant adverse consumer health events and hospitalizations in 18 states.[7]
The Boar's Head Jarratt plant temporarily ceased operations in July when the company discovered the outbreak, and as of Sept. 13, the Jarratt facility determined it would indefinitely close.[8]
The closure came after federal inspectors cited dozens of violations at the facility over a number of years, including citations related to rusted equipment, mold and mildew buildup, and puddles of blood on the floor.[9] Despite these citations over the course of multiple inspections, the inspectors did not prevent the facilities from operating.
In October, on the heels of the Boar's Head outbreak, BrucePac recalled 11,765,285 pounds of ready-to-eat meat and poultry products produced from June through October due to potential Listeria contamination. This contamination was discovered during routine product testing by the USDA's Food Safety and Inspection Service, or FSIS.
Although no adverse events were reported, the discovery occurred after the products were shipped to restaurants and other institutions to be incorporated into consumer products, such as salads and sandwiches sold by popular national grocery chains.
As a result of these events, the USDA inspector general has launched an internal investigation into its handling of recent facility inspections, noting that the agency may have been complacent in allowing a manufacturing facility to continue operating despite a history of identified issues.
Notable food manufacturing, safety and operating deficiencies that may lead to Listeria contamination include the following:
- Inadequate sanitation practices: Deficient sanitation processes and procedures may not be effective at controlling the spread of Listeria.
- Failure to meet sanitation performance standards: A failure to maintain a sufficient written plan to guide employees moving within process lines may lead to cross-contamination and inadequate prevention of adulterated foods.
- Ineffective sanitation standard operating procedures: Facility sanitation processes and hazard analysis plan should be routinely evaluated for effectiveness to ensure there are adequate controls to prevent exposure to Listeria.
In addition to the cost and expense of product recalls and facility mitigation measures, companies with significant Listeria product contamination and recalls may also face potential lawsuits for failing to warn consumers of their contaminated products adequately.
Recent lawsuits related to these issues generally allege that the product labeling is deceptive or misleading, or that such food-related recalls deliberately prevent most consumers from receiving a refund, because that would require keeping the contaminated food.
FDA Warning Letter for Listeria Contamination
In July 2023, a widespread outbreak of Listeria was connected to ice cream products manufactured by Ice Cream House, a kosher ready-to-eat food company.
Several individuals were hospitalized because of a Listeria infection that was traced back to this outbreak. An analysis of ice cream samples prompted a recall of all dairy and nondairy (parve) frozen products bearing the Ice Cream House logo on Aug. 30, 2023.
The FDA inspected the Ice Cream House manufacturing facility in Brooklyn, New York, in September 2023, and conducted a follow-up inspection from February through March of this year. On Sept. 24, the FDA sent a warning letter to Ice Cream House.
According to the warning letter, Ice Cream House's facility was contaminated with Listeria found on food-contact surfaces in production areas, which is indicative of inadequate sanitation protocols — a frequent theme in food safety breaches.
The warning letter focuses on four key food manufacturing safety practices in hazard analysis and risk-based preventative controls:
- Inadequate preventive controls: The facility didn't have proper controls to minimize or prevent hazards, which could lead to unsafe food.
- Environmental pathogen contamination: The facility's ice cream products were at risk of being contaminated with Listeria, an environmental pathogen. Even though the facility identified this as a hazard, the warning letter maintains that it didn't have effective sanitation controls to address it.
- Recurring contamination with Listeria: Listeria was found in the facility during multiple inspections, indicating potential ongoing contamination despite cleaning efforts.
- Lack of effective pathogen control: The facility did not have effective control of Listeria, showing a need for better hygiene practices and pathogen control methods.
These recent incidents involving various food products collectively reveal a troubling trend of Listeria as a persistent challenge in food manufacturing and food safety practices, and emphasize the importance of conducting due diligence to help mitigate these occurrences.
Looking Ahead: Preventative Measures and Regulatory Guidance
Given the recent Listeria outbreaks, facilities should consider implementing rigorous internal food safety management systems that include an analysis of potential systemic vulnerabilities.
They should also enact stringent preventive strategies, consisting of routine internal audits, continuous employee training on hygiene and safety practices, and a culture that prioritizes food safety. Such measures may also include:
- Ensuring employees wash their hands when working with food;
- Following the USDA FSIS best practice guidance and directives to control Listeria in ready-to-eat meat and poultry products, and other USDA regulatory education videos that address food safety, where applicable;[10]
- Using the FSIS' guidance for controlling Listeria in post-lethality exposed ready-to-eat meat and poultry products, which sets forth step-by-step instructions for compliance with the Listeria Rule, descriptions of and technical information on control alternatives, and training programs for implementing the Listeria Rule;[11]
- Implementing the FDA guidance to control Listeria in ready-to-eat foods, to ensure the facility complies with the recommended regulatory framework for different types of operations;[12]
- Reviewing the FDA's public list of outbreaks and investigations due to foodborne illnesses, to see how active investigations may affect operations;[13] and
- Investing in advanced testing and detection methods for pathogens like Listeria within the facility to further mitigate risks, ensuring any presence of pathogens is quickly identified and addressed before products leave the facility.
Additionally, investors in this area should conduct thorough due diligence on a target's food safety management processes. Investors should consider whether food manufacturing and facility suppliers equally value and adhere to high safety standards.
Investors may also consider engaging third-party auditors who can provide an objective review of a company's food safety practices, offering an additional layer of assurance that protocols are both followed and effective.
Kate Hardey is a partner, and Olivia Kaufmann and Jessica Stoltz are associates, at Kirkland & Ellis LLP.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of their employer, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
[1] See https://www.cdc.gov/listeria/outbreaks/delimeats-7-24.html; see also https://www.fda.gov/food/foodborne-pathogens/listeria-listeriosis.
[2] Id.
[3] https://www.cdc.gov/listeria/hcp/clinical-overview/index.html.
[4] See 9 C.F.R. §430.4; see also USDA FSIS Directive, Listeria Rule Verification Activities (10,240.4, Rev. 4) (March 2022).
[5] See 21 C.F.R. Part 100 & 21 CFR Part 117.
[7] https://www.cdc.gov/media/releases/2024/s0828-listeria-outbreak-deli-meats.html.
[8] https://boarshead.com/products-recall-2024.
[9] See Boars Head Non-Compliance Reports 11/2022 – 8/2-2024 available at https://www.fsis.usda.gov/sites/default/files/media_file/documents/Non-Compliance_Reports_112022-To-812024.pdf.
[10] See USDA FSIS Guidance, available at https://www.fsis.usda.gov/policy/fsis-guidelines?keywords=LIsteria; and Regulatory Education Videos, available at https://www.fsis.usda.gov/inspection/inspection-training-videos/regulatory-education-video-seminars.
[11] See FSIS-GD-2014-001 (Jan. 2014), available at https://www.fsis.usda.gov/guidelines/2014-0001. FSIS directives are available at https://www.fsis.usda.gov/policy/directives-notices-guidelines/fsis-directives.
[12] See Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry (Jan. 2017), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-control-listeria-monocytogenes-ready-eat-foods.
