This guidance is intended for those persons (“you”) who are subject to our regulation, in 21 CFR part 117 (part 117), entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and who manufacture, process, pack, or hold ready-to-eat (RTE) foods. This guidance is intended for you regardless of whether you are only subject to the current good manufacturing practice requirements for human food of part 117 (CGMP requirements), the requirements for hazard analysis and risk-based preventive controls for human food in part 117 (PCHF), or both the CGMP requirements and the PCHF requirements. See section II.A of this guidance for additional information about the CGMP and PCHF requirements. This guidance is intended to help you comply with the CGMP and PCHF requirements of part 117 with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes.
This guidance is not directed to processors of RTE foods that receive a listericidal control measure applied to the food in the final package, or applied to the food just prior to packaging in a system that adequately shields the product and food contact surfaces of the packaging from contamination from the food processing environment.
This guidance also is not intended for food establishments that are not subject to part 117, such as farms.
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