Be Ready to Beat Listeria

There are three FSIS alternatives (Rule 430.4: Control of Listeria monocytogenes in post-lethality exposed ready-to-eat products).

Alternative 1 (use of post-lethality treatment and an antimicrobial agent/ process). This is the best alternative of the three. Using both intervention strategies means that the RTE processor’s sanitation program faces less of a verification burden than with the second and third alternatives.

Since 2003, many small to medium-sized plants have struggled with implementing this alternative because of plant design and internal resource issues, even though the types of products and their markets are amenable for both measures.

Alternative 2 (use of post-lethality treatment or an antimicrobial agent/ process and sanitation program requirements). As with alternative 1, post-lethality treatment must be in the HACCP plan and must be validated. But if the FSIS plant opts for the antimicrobial agent approach, the same parameters apply here as for alternative 1. In alternative 2, validation of the sanitation program is critical and requires:

• a microbial swab test of food contact surfaces;
• identification, holding, and testing of any positives for Listeria or indicator microbes;
• clear documentation of testing frequency; and
• clear identification of food and environmental contact sample sites and swab size.

This option puts much greater emphasis on sanitation validation and verification and can stress an RTE plant’s quality assurance, sanitation, production, and distribution personnel and resources. RTE plants opt for this alternative if their products, processes, or plant design are not conducive to using both post-lethality and antimicrobial processes. In most instances, RTE plants choose this alternative because their product and its process cannot support the introduction of an antimicrobial agent or other additive. In some instances, post-lethality intervention may not be effective for the product (e.g., products adhering to religious dietary law or U.S. organic product requirements). These and other mitigating factors may force the plant to use the third alternative.

Alternative 3 (use of sanitation measures only). An FSIS plant manufacturing any type of RTE and/or hot dog or deli-type product must have a sanitation program that adheres to a number of requirements. The FSIS will conduct much more verification testing in a plant that chooses this option than for an RTE plant using one of the first two alternatives. Sanitation rules for this option include those indicated in the second alternative, with the additional requirement that the plant must be able to support testing frequency. Also, plants that produce hot dogs and deli items must:

• verify corrective actions upon positive identification of food contact swabs;
• test and hold a product when a second positive is found; and
• sample and test lots to release or rework them to destroy Listeria monocytogenes.

With this high-maintenance alternative, the burden rests entirely upon the sanitation program. This may be the only option for some plants, however, especially if product type, process, and plant design make post-lethality and antimicrobial interventions awkward or impossible. Smaller processors have chosen this path for lack of resources. But, in many cases, adding a post-lethality intervention is not difficult and would be a far less stressful option than the third alternative.

Some plants that use this alternative may be using cooked product from another facility, then assembling and freezing meals. Or, these facilities may be composite plants, creating a variety of segregation and cross-contamination issues.

I have audited plants using all three alternatives for large, medium, and small RTE FSIS processors. Understandably, the small RTE processors with the most limited resources have had the most formidable task, but some have used the first alternative. Meanwhile, even some large RTE processors choose the second or third options.

Where to Begin

Deciding how to adhere to RTE regulations starts with verified, validated, evolving good manufacturing processes and sanitation programs that feature constant training for both new and veteran employees. This is mandated and is vital to surviving in the RTE FSIS marketplace.