Alliance for Listeriosis Prevention - Statement

December 17, 2003 - Statement on the Petition to Establish a Regulatory Limit for Listeria monocytogenes In Foods That Do Not Support Its Growth

The food industry is committed to public health. To that end, members of the Alliance for Listeriosis Prevention believe firmly that unsafe food should not be sold - period. On December 17, 2003, the Alliance for Listeriosis Prevention submitted a petition to the Food and Drug Administration (FDA) to establish a regulatory limit of 100 colony forming units per gram (cfu/g) for Listeria monocytogenes in foods that do not support growth of the microorganism. “Growth” of the organism has been substantiated by FDA as a major factor that affects consumer exposure to L. monocytogenes.

The proposed regulatory limit will establish a science-based standard for the regulation and control of L. monocytogenes. The proposal is based on new and emerging evidence that consumer protection is a function of the organism’s cell numbers in food, and not its mere presence. A regulatory limit will permit FDA and industry to distinguish products for which targeted attention is prudent from those for which greater attention will not yield a corresponding benefit to public health. Such an approach would, for example, encourage aggressive environmental sampling and application of interventions to minimize contamination, and facilitate development of new control measures to inhibit growth. Establishment of a regulatory limit is appropriate in light of the Food and Drug Administration/Food Safety and Inspection Service risk assessment document and the body of science on which it is based. Numerous scientific experts support a regulatory limit. The regulatory limit, if established by FDA, would equip government and the industry with public policy that is more appropriate for protecting public health. Specifically, the regulatory limit acknowledges that no-growth products present minimal risk of causing listeriosis, allocates regulatory resources accordingly, and facilitates industry efforts to develop products that control growth.

The foods that are the subject of this petition are prepared foods that have been demonstrated by scientific study to not support growth of L. monocytogenes. Included are prepared foods held at or below -1°C, prepared foods with pH values less than 4.4, and prepared foods with water activity (aw) less than 0.92. Also included are other prepared foods for which scientific evidence demonstrates that L. monocytogenes does not grow, such as foods to which microbial inhibitors have been added to prevent growth. For purposes of this petition and proposed regulatory limit, "prepared foods" are foods that can be consumed with no or minimal preparation (e.g., reheating) by the consumer. The term is intended to include both traditional "ready-to-eat" (RTE) foods that require no further preparation by the consumer, and products that are fully cooked but are reheated prior to consumption.

The food industry has engaged in unprecedented efforts to eradicate L. monocytogenes from the processing environment, and industry plans to continue to employ new technological advances toward this objective in the future. Despite continuing efforts, elimination of L. monocytogenes remains a constant challenge because the organism is ubiquitous. Members of organizations in the Alliance strive to use technological advances that will effectively control this bacterium in the food processing environment and all finished products. To more effectively target control efforts, a regulatory limit is requested to address the status of foods that do not support growth of L. monocytogenes , and that contain the bacterium at low, but unavoidable, levels that present minimal risk to public health.

By focusing scarce resources on microbial levels of public health significance, FDA and industry will be in a far better position to achieve or exceed public health goals related to L. monocytogenes -namely, a 50% reduction in cases of listeriosis, as called for in Healthy People 2010. Indeed, a quantitative risk assessment based on the most extensive survey to date of L. monocytogenes in RTE foods predicts that elimination of high concentrations of the organism in such foods could reduce listeriosis as much as 99.5%. This is further supported by the regulatory agencies’ own risk assessment. Accordingly, there is now a credible scientific basis upon which U.S. regulatory policies on L. monocytogenes can be reexamined.

Consumers can continue to reduce the risk of illness by:

  • Using a refrigerator thermometer to make sure that the refrigerator always stays at 40 degrees F or below.
  • Using perishable items that are precooked or ready-to-eat as soon as possible.
  • Washing hands and cleaning work surfaces often, and not allowing cross-contamination between raw and cooked foods.

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