by Dr. Jim Gorny, PMA vice president of food safety and technology
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What food policies should be implemented to reduce the prevalence and subsequent adverse health effects of Listeria monocytogenes (Lm) in ready-to-eat (RTE) foods? Well, that’s a policy question the U.S. Food and Drug Administration (FDA) would like answers to as they develop new Lm food safety policy and guidance for industry and consumers.
Working toward that goal, the FDA Center for Food Safety and Applied Nutrition (CFSAN) Food Advisory Committee convened on Dec. 7-8, 2015, at FDA headquarters to provide expert opinion on FDA Lm policies. Excellent background materials regarding current FDA and the U.S. Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) regulatory policy were developed in advance of the meeting and are available here. Specifically, this FDA Food Advisory Committee was charged with providing expert opinion on the following questions:
- How to determine when a food is ready-to-eat (RTE)?
- Should FDA distinguish between RTE foods based on whether a food does or doesn't support the growth of Lm?
- What preventive controls are most effective to control Lm in RTE foods?
- What preventive controls should be used in produce packing houses?
- How should FDA prioritize FDA surveillance sampling for Lm?
- Should FDA amend recommendations regarding dietary guidance for Lm vulnerable populations
The detailed recommendations of the FDA CFSAN Food Advisory Committee that address these specific questions can be found in their entirety here.
The two overarching issues of critical importance to the food industry were discussion of aligning FDA Lm policy with that of USDA FSIS and how ready-to-eat foods should be appropriated regulated.
Unleash the food industry to seek and destroy listeria where it lives
In an earlier post, I opined that a regulatory environment that encourages aggressive environmental monitoring for Listeria indicators is what is needed to unleash the food industry’s use of science-based preventive control strategies to control Lm in ready-to-eat foods, such as fresh produce, without regulatory jeopardy. As a result, PMA has and will continue to advocate for sound FDA public policy that encourages food facilities to be able to proactively seek out and eliminate potential Lm harborages on food contact surfaces and non-product contact surfaces, without regulatory jeopardy.
Unfortunately, FDA’s 2008 draft Guidance for Industry “Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods”, recommends that industry determine whether or not an indicator organism (Listeria spp.) when detected on a food-contact surface is actually Lm, which discourages development of robust Listeria control programs. Changing this FDA recommendation and aligning it with USDA FSIS policy would go a long way toward unleashing industry efforts to seek out and destroy Listeria harborages in food processing and packing facilities—without undue regulatory jeopardy.
As a result, PMA recently submitted comments to the FDA Food Advisory Committee encouraging FDA to align their Lm policy with USDA FSIS, which allows for a single detection of transient Listeria spp. on food contact surfaces and does not require Listeria speciation on a single sample positive for Listeria spp. PMA has also been working in a broad coalition of food trade organizations called the Alliance for Listeriosis Prevention to share current knowledge, information, research findings and new developments regarding Listeriosis prevention and advocate for sound Lmregulatory policy.
Produce raw agricultural commodities as ready-to-eat foods
FDA’s recently published Food Safety Modernization Act (FSMA) Preventive Controls for Human Foods final rule states that “the terms RTE food and raw agricultural commodities are not mutually exclusive” and that “some raw agricultural commodities (such as lettuce, tomatoes, berries, and apples) are ready-to-eat, whereas other raw agricultural commodities (such as artichokes and potatoes) are not.” This designation by FDA of some produce items as a RTE food is important from regulatory perspective, especially when it comes to required implementation of preventive controls to prevent Listeriosis.
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