The Details: The Food and Drug Administration (“FDA”) recently published draft guidance articulating recommended practices to control Listeria monocytogenes (“L. mono”) in Ready-to-Eat Foods (“RTE Foods”) manufactured in food facilities. The guidance applies to food facilities that are subject to current good manufacturing practices requirements (“CGMP”) and/or the hazard analysis and risk-based preventive controls requirements (“PCHF”) finalized in part 117 of the Code of Federal Regulations as part of FDA’s implementation of the Food Safety Modernization Act.
FDA intends the guidance to assist food facilities in “complying with the CGMP and the PCHF requirements … with respect to L. mono 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. mono) that would significantly minimize L. mono.” The guidance addresses a range of topics, including:
- personnel practices;
- the design, construction, and operation of a food facility;
- the design, construction and maintenance of equipment;
- sanitation practices;
- raw materials and other ingredients;
- storage practices;
- environmental monitoring;
- sampling and testing of RTE Foods;
- training; and
FDA is seeking comment from the food industry on the draft guidance. For example, what did the FDA get right on this? Did the FDA forget to include practices that would help control L. mono in food facilities?
Although FDA guidance is not binding on the food industry, it does provide a guide to how the agency thinks about and will enforce the regulations under part 117. It is important, then, for FDA to hear from the food industry about the draft guidance. Food facilities that are subject to CGMP and/or PCHF requirements can submit their comments starting today, January 17, 2017; the comment period closes on July 17, 2017.