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Listeria: A Global Issue with Varied Regulatory Controls

One of the top pathogens of concern in the U.S. for food adulteration is Listeria, for which the FDA developed draft guidance for Control of Listeria monocytogenes in Ready-To-Eat Foods in 2017. But Listeria has no recognition of country borders; in fact, it is widespread in nature, can grow at refrigeration temperatures and can survive in food processing plants for months to years, thus its control is essential for the food industry of all countries.

In comparison to some other countries – such as Canada, the U.S. was actually a bit late to the game.

Health Canada just recently completed an update of its “Policy on Listeria monocytogenes in Ready-to-Eat Foods,” but that version supersedes a 2011 version (set to expire October 1, 2023), which, itself, superseded a 2004 version.

So, what’s new with Canada’s 2023 Update? And what does it mean for U.S. manufacturers?

A key aspect of Health Canada’s updated Listeria monocytogenes (Lm) control policy is its emphasis on environmental sampling in post-process areas where ready-to-eat (RTE) foods are exposed to the environment prior to packaging. The overarching goals of the policy are to enable early identification of persistent Listeria species in the food processing environment; allow for the assessment of the effectiveness of control measures; and ensure that RTE foods are safe for consumption.

In comparison with the 2011 version (which remains in effect until October), the 2023 update focuses on:

  • Presentation of concepts, including the legislative context of the Listeria policy, in a new order for better readability and refined for improved clarity.
  • The current outcome-based regulatory landscape for domestic manufacturers, importers, and exporters of RTE foods.
  • Updates and increased detail on specific food businesses, activities, and foods for which the Listeria policy does not apply.
  • A decision tree, with a series of questions to help determine the categorization of ready-to-eat foods that are subject to the policy, to facilitate the industry’s categorization of RTE foods.
  • Modification of the definition of RTE foods with certain refrigerated or frozen processed foods labeled on the package with validated cooking instructions now excluded from the Listeria policy. However, additional recommendations for vulnerable individuals should be taken into account, as they have an increased susceptibility.
  • More detail on foods specifically produced for consumption by vulnerable populations.

A key difference between the USFDA and Health Canada policy, of which U.S. exporters need to be aware, is that of the categorization of foods, based on their potential to support Lm growth.

  • Category 1: Those which support the growth of Lm under reasonably foreseeable conditions of distribution, storage and stated shelf-life. As such, process monitoring, environmental sampling and end-product testing should be conducted more frequently, and Lm detection in sampling and testing may trigger a serious “Health Risk 1” concern, requiring risk management actions.
  • Category 2 contains 2 subgroups, for which validation may be necessary to demonstrate that control measures are effective to limit or prevent Lm growth.
  • 2A Foods. RTE foods in which the growth of L. monocytogenes may be limited to levels not exceeding 100 CFU/g under reasonably foreseeable conditions of distribution, storage and use throughout the stated shelf-life. 
  • 2B Foods. RTE foods in which Lm growth will not occur under reasonably foreseeable conditions of distribution, storage and use throughout the stated shelf-life.
  • If there is uncertainty regarding the categorization of a RTE food, the relevant regulatory authority should be contacted.

Regardless of the food category, the Listeria policy takes into account the potential for Lm growth as well as the presence or levels of Lm in RTE foods as factors to determine the health concern that such foods pose to consumers. The intended consumers of the RTE foods (for example, vulnerable populations) are also considered in determining the health concern.

Although the number of cases of listeriosis is small, the high death rate associated with Lm makes it a global issue. However, the policies and regulations to control Lm in foods can vary significantly across countries. So, it is critical that food processors and suppliers understand the policies in which they manufacture or into which they export food.


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