Listeria was top of the news in 2024, not only causing consumer illness and industry recalls, but also wreaking havoc for both U.S. and Canadian food regulatory bodies.
What is going wrong?
While the Canadian Food Inspection Agency is undergoing fire for it risk-based inspection “algorithm” (which sounds ominously like FDA’s focus) and third-party inspections, the USDA faced a Congressional inquiry on its handling of the deli meat Listeria recall of July. And FDA is not safe from the spotlight as there have been nearly 20 recalls in the fourth quarter alone for potential Listeria contamination in FDA-regulated foods.
The risk-based inspection system followed by both CFIA and FDA means that facilities that are considered to be at higher risk are prioritized for inspections. So, this immediately raises the question of whether the risk algorithms are correct or, if they are correct, does the inspection actually reduce or, preferably, prevent the risks?
Due to the number of facilities vs. the number of inspectors, it means that some facilities are rarely, or never, inspected. Such was the case with a plant-based milk facility to which a Listeriosis outbreak was linked, which sickened at least 20, three of whom died. As detailed in the Globe and Mail, “no CFIA inspector had visited the site to ensure federal food-safety policies were being followed under the terms of its licence, to test for Listeria, or to conduct an on-site verification of the company’s paperwork or procedures” since 2019 – when the agency was at the plant for “an unrelated matter that involved no checking on Listeria protocols.” However, because the Listeria strain was then connected, through genome sequencing, with two cases of listeriosis reported almost a year earlier, there had likely been issues in the plant at least that long.
While the major FDA recalls of 2024 involved Salmonella and E. coli, the same critique can be waged against FDA, as the basis of its current FSMA regulations focus on risk-based prevention and inspection. In fact, the Act specifically mandates an inspection frequency of at least once every three years for domestic high-risk facilities and at least once every five years for non-high-risk facilities. But with nearly 95,000 registered food facilities in the U.S., the numbers don’t add up, as FDA conducted only 2,499 surveillance inspections and 454 for-cause inspections in FY 2023.
Although USDA is required to have an inspector onsite at all times a facility is operating, it doesn’t always prevent issues. As in the deli meat recall, which led to more than 60 illnesses and 10 deaths, USDA received a Congressional Letter rebuking its handling of the facility. With reports that USDA inspectors were warned of conditions in plants posing an “imminent threat to public health” as early as 2022, and additional records showing the alarming conditions continued in the years that followed. The letter stated, “It is painfully clear that by choosing not to aggressively ensure that safety standards were being followed, the USDA failed to uphold its congressional mandate….Years of inadequate response have led to safety conditions within the plant that are impossible to remedy easily.”
Additionally, the food agencies from both the U.S. and Canada have been criticized for their reliance on third-party inspections, which are seen as having too much variance due to auditor competence, company payment for the audits, and lack of, or limited, unannounced visits. CFIA is particularly under fire because it factors third-party audits into its risk-based algorithm.
On the positive side, the agencies are taking steps to reform their approaches. The ongoing restructuring of FDA has been well-documented, and the USDA recently announced measures to strengthen its Listeria contamination oversight with key measures including:
- All samples of ready-to-eat product, environmental and food contact surfaces are to be tested for Listeria species, beginning in January 2025 to provide more information about the effectiveness of a facility’s sanitation program and signal to FSIS if follow up is needed.
- The inspection workforce is being equipped to recognize and highlight systemic problems in a standardized way, aimed at Listeria spp controls.
- In-depth Food Safety Assessments will be conducted at facilities that use sanitation as the primary method of control for Listeria monocytogenes (Lm).
- FSIS will verify specific Lm-related risk factors at ready-to-eat facilities weekly.
With all three agencies under the gun related to Listeria, you can expect that there will be continued, and likely heightened, attention to and regulation on Listeria as we move forward in 2025. Currently, FDA and USDA have a zero-tolerance policy for Listeria in ready-to-eat foods, with CFIA having a limit of 100 CFUs in foods that don’t support growth; and you can expect that these will be even more stringently sampled and cited.
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