By Donna Garren, executive vice president of science and policy, and Sanjay Gummalla, senior vice president of scientific affairs, both of the American Frozen Food Institute

America’s food industry deserves a scientific and risk-based regulatory framework from the U.S. Food & Drug Administration. That’s why the American Frozen Food Institute (AFFI), which represents frozen food and beverage makers and ingredient suppliers, calls upon FDA to turn to our neighbors to the north as the agency reviews its existing Compliance Policy Guide (CPG) regarding the presence of Listeria monocytogenes in food products. Health Canada, the department of the government of Canada responsible for national health policy, released its updated policy for Listeria monocytogenes in ready-to-eat (RTE) foods recently. The new policy recognizes and clearly delineates a risk-based approach that reflects current science and sets an important precedent as the U.S. FDA responds to calls for substantive regulatory, structural and cultural reform. 

Reiterating Globally Recognized Risk Principles 
Health Canada’s policy applies the globally accepted categorization of RTE foods based on their potential to support the growth of Listeria monocytogenes. Consequently, the policy separates RTE foods that support growth of the pathogen from those in which the growth is limited to levels not exceeding 100 CFU/g or in which growth will not occur throughout the food’s stated shelf-life (i.e., low risk). This approach is similar to the Codex Alimentarius Commission, Food Standards Australia and New Zealand, and the Commission of European Communities policies addressing Lm in RTE foods.  

Canada’s Listeria monocytogenes policy also clearly defines RTE foods as those that are normally eaten in the same condition as they are purchased. It also identifies foods that are excluded from the policy. This clarity is significant as it describes the foods subject to this policy, effectively allowing food and beverage processors to direct and apply the right resources and effort where risk is the highest. For example, RTE foods subject to the Listeria monocytogenes policy often require refrigeration (that is, labelled “Keep Refrigerated” on the package) or freezing (that is, labelled “Keep Frozen” on the package) for their preservation until the time of consumption. RTE products may include raw fresh-cut produce items that have been pre-peeled or cut and are intended to be consumed in the same condition in which they are purchased. Frozen fruits that are labeled “Keep Frozen” are also considered as RTE foods. As frozen foods do not support growth, the policy stipulates a less than 100 CFU/g level of Listeria monocytogenes in these foods. On the other hand, frozen vegetables that include validated cooking instructions on packaging for consumers to follow and ensure safe consumption would be treated as not-ready-to-eat (NRTE) foods. These would not be subject to the Listeria monocytogenes policy. 

Under this policy, Health Canada manages the public health implications of the presence of Listeria monocytogenes, through shared responsibility between industry (food processors, importers, exporters), government, consumers and care providers in ensuring safe food production and consumption as well as reducing the prevalence of Listeria monocytogenes in foods and the incidence of foodborne listeriosis. Health Canada’s policy underscores the relevance of Listeria monocytogenes in foods that are specifically produced for vulnerable populations, which have an increased susceptibility to listeriosis infection. At the same time, Health Canada recognizes that “in all likelihood, Canadians consume foods that may contain low levels of Listeria monocytogenes on a regular basis,” but “the incidence of listeriosis remains relatively low.” The risk-based policy approach and its implementation relies on process review, environmental sampling and end-product testing.

A Listeria Approach Grounded in Science
AFFI has been at the forefront of promoting research to better understand the management of Listeria monocytogeney in food processing and related public health implications. Health Canada’s latest policy is consistent with the scientific consensus across the global research community and in particular the recommendations of AFFI’s 2020 Listeria Global Expert Panel that brought together scientists from Cornell University, University of Georgia, Rutgers University, Wageningen University, University of Guelph, University of Vermont and University of Minnesota. Their work provided renewed scientific thinking on addressing risks associated with the prevalence of Lm in the food supply and identified that applying a risk-based regulatory approach provides the greatest public health benefit. Their research, published in the scientific journal Food Control, determined the relevance of providing a distinction between foods that support the growth of Listeria monocytogenes and foods that do not support growth (low-risk foods). As Dr. Jeffrey Farber, former director of microbial food safety at Health Canada and a facilitator for the expert panel stated, such an approach provides a practical regulatory and industry framework to prevent and control Listeria monocytogenes in foods that do not support growth of the pathogen, particularly in the context of the broader food supply chain, while also potentially reducing incidences of listeriosis associated with low-risk foods. 

Additional research at the University of Minnesota, published in the International Journal of Food Microbiology in 2022, demonstrates progress on reducing Listeria monocytogenes prevalence in our foods and in reducing listeriosis incidence in the recent five years. Co-author Dr. Craig Hedberg, professor in the School of Public Health with the University of Minnesota, indicated that given the current science on Listeria monocytogenes prevalence and exposure from foods, a regulatory tolerance for the pathogen in low-risk foods would be more protective of public health due to the operational benefits it offers industry in controlling the persistence of Listeria monocytogenes in production facilities. 

Implications for FDA Policy
The U.S. FDA  plans to update this year a 2008 Compliance Policy Guide on Listeria monocytogenes, “Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff.” AFFI and a range of food industry stakeholders (including the International Dairy Foods Association, National Fisheries Institute, American Bakers Association, Consumer Brands Association and FMI – The Food Industry Association) have long called for FDA to produce a risk-based regulatory approach for an action level of Listeria monocytogenes in a manner consistent with Health Canada’s latest policy update. The default alternative, a zero-tolerance approach across all food categories, irrespective of public health risk, would ignore the latest available science and fail to pursue a risk-based food safety approach as mandated by Congress in the Food Safety Modernization Act. Congress has been vocal in encouraging FDA to incorporate the latest science and has included language in the last four Agriculture Appropriations reports which asked the agency to pursue a modern, prevention-focused and risk-based approach to regulating Listeria monocytogenes. The FDA has yet to take action on these requests. 

In 2022, an independent review of the U.S. FDA conducted by the Reagan-Udall Foundation identified challenges with the structure, leadership, culture, transparency and accountability within the agency’s foods program. If FDA leadership seeks to make a good-faith effort for substantive reform and support of public health, it is essential to listen to feedback from stakeholders and the scientific community regarding the benefits of a Listeria monocytogenes regulatory action level greater than zero for low-risk foods. The science and data indicate that FDA guidance and policy founded on a risk-based approach to regulating Lm will better drive positive public health outcomes. This is an opportunity for FDA to lead a science-based and risk-based approach to update its much-needed U.S. Listeria monocytogenes policy and harmonize with Canada and other global public health agencies.

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