Listeria monocytogenes (L. monocytogenes) is an environmental pathogen that can contaminate foods and cause a mild, non-invasive illness (listerial gastroenteritis) or a severe, invasive illness (listeriosis). Although the number of outbreaks and illnesses from this pathogen are not high compared with other pathogenic organisms, such as Salmonella, listeriosis is considered to be a significant foodborne pathogen since the illness outcome is severe and the fatality rate is high.
In light of recent notable outbreak incidents with foods such as caramel apples and ice cream, the publication of FDA’s draft guidance for L. monocytogenes in ready-to-eat (RTE) foods is timely. Control of the process environment is important to minimize potential cross contamination of RTE foods by this environmental pathogen. This draft guidance provides a comprehensive tool to help protect public health and reduce the incidence of listeriosis. The construct of the document is thorough and well laid-out. It is intended for the food manufacturer that is subject to the Food Safety Modernization Act (FSMA) and is required to follow current good manufacturing practices for human food of part 117 (CGMP – Subpart B) and/or the requirements for the hazard analysis and risk-based Preventive Controls for Human Food (PCHF) in 21 CFR 117 (PCHF).
The guidance identifies several examples of measures that could significantly minimize or prevent the contamination of RTE food with L. monocytogenes. This guidance is not intended for the food manufacturer of RTE food that receives a listericidal control measure applied in the final package or before packaging.