By Melanie Neumann, J.D., M.S., Neumann Risk Services
The FDA recently released draft guidance (the “Guidance”) on controlling Listeria monocytogenes (LM) and ready-to-eat foods (RTE) in conjunction with the final rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF rule). Any FDA-regulated facility that manufacturers, processes, packs, or holds RTE foods needs to take the time to read this new draft Guidance. Why? For three reasons. First, as we all know, draft guidance can often take years before it turns to final guidance, and in the interim, FDA inspectors still rely on it as gospel. Second, whether it’s considered draft or final by the FDA, we all know the reality is guidance is often treated like directive, which in turn is often treated just like regulation. If we don’t follow it, we have a lot of explaining to do. Third, there are a few waves contained in this guidance that we, as an industry, all need to be aware of now!
The guidance is closely aligned with PCHF requirements and places. A notable expectation on conducting a hazard analysis and implementing risk-based preventive controls, including verification of preventive controls — notably for the prevention of LM as this is the primary focus of the new guidance.