FDA Issues Revised Draft Guidance for Control of Listeria monocytogenes in Ready-To-Eat Foods
Friday, January 13, 2017

As our readership is well aware, Listeria monocytogenesis is a pathogen that causes the infection listeriosis and is the source of numerous food recalls.  See examples of recent recalls caused by Listeria monocytogenes contamination here and here.  Listeria monocytogenes can grow in various settings, including cold, refrigerated environments, and is particularly harmful to the elderly, pregnant women and/or their pregnancy, and those who are immunocompromised.

Today, the FDA released an updated draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods,” which supports ongoing efforts by industry and government agencies to reduce the risk of Listeria monocytogenesin in ready-to-eat (RTE) foods. The updated draft guidance has an emphasis on prevention, consistent with the FDA Food Safety Modernization Act (FSMA) and reflects the Agency’s current good manufacturing practice (CGMP) requirements, as well as new requirements for hazard analysis and risk-based preventive controls, including verification of preventive controls.  The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment, and sanitation, as well as for treatments that kill Listeria monocytogenes and formulations to prevent it from growing during storage of the food between production and consumption.

Of note, FDA has incorporated industry best practices and the “seek and destroy” approach used by USDA’s Food Safety and Inspection Service (FSIS) into its draft guidance. RTE facilities that produce foods that are regulated by both USDA/FSIS and FDA should benefit from a uniform federal approach to reducing the risk of environmental contamination with Listeria monocytogenesis.

FDA will be accepting public comments beginning on January 17, 2017.

 

 

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