Unwrapping FDA’s Draft Guidance for Control of Listeria Monocytogenes in Ready-To-Eat Foods

In January, the FDA released an updated draft guidance document on “Control of Listeria monocytogenes in ready-to-eat foods". According to the FDA, the guidance is intended for those subject to 21 CFR part 117: 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. The guidance supports ongoing efforts by industry and federal government agencies to reduce the risk of L. monocytogenes in RTE food products. 

Listeria monocytogenes is a pathogenic bacteria that is commonly present in the environment, raw food products, and food processing facilities. It causes listeriosis, a serious infectious disease caused by eating contaminated food. This guidance document is in accordance with the FDA’s Food Safety Modernization Act (FSMA) and reflects current good manufacturing practices (CGMPs), as well as new requirements for hazard analysis and risk-based preventive controls, including verification of preventive controls. The guidance is intended to help food industries 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 assuring food safety. 

As nearly half of the guidance document is devoted to implementing an effective environmental monitoring program, it is clearly an area of special concern for the FDA. It is very clear that the FDA is more focused on implementing an effective environmental monitoring program than ever before. This guidance document provides FDA’s current thinking and recommendations on environmental monitoring programs and the active search for L. monocytogenes in a facility. Additionally, this new draft guidance document provides recommendations on food industry best practices for the control of L. monocytogenes in relation to personal practices, plant design, equipment, sanitation, raw materials and ingredients, process control based on formulation, listericidal process control, storage practices, time/temperature controls, and transportation.

This guidance does not apply 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
  • Food establishments that are not subject to part 117, such as farms. 

FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance describes the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The FDA will accept public comments on the Control of Listeria monocytogenes in Ready-to-Eat Foods Draft Guidance through July 17, 2017.

Read more about AIB's key takeaways from the FDA guidance document in our newest free download.