New FDA Guidance for Listeria Control

Posted in Food Regulatory Counsel

I have written often on the topic of FDA’s continuing efforts to overhaul the safety of the U.S. food supply. Over the past decade, the agency has used a numerous tools, including new regulations, new inspection policy, and new initiatives to encourage broader food safety compliance. Notably, a large focus of FDA’s most recent efforts has been directed at encouraging food companies to better control harmful pathogens in the ready-to-eat food processing environment.

To further this goal, the agency has now published “FDA’s Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods.”   The new draft FDA guidance, which eliminates any regulatory consequences for an initial positive Listeria spp. finding on a Zone 1 food contact surface, now provides food companies with substantially increased flexibility to strengthen their environmental monitoring programs. Click here to download a copy of the guidance.

In the guidance, FDA carefully outlines its recommendations to help food companies that process Ready-to-Eat (RTE) foods better control Listeria monocytogenes (Lm) in the RTE processing environment. The guidance details FDA’s recommendations for employee’s hands, gloves, footwear, and clothing, foamers and footbaths, design and construction of food facilities, and the construction and maintenance of food processing and related equipment. In addition, the guidance contains useful recommendations for cleaning and sanitizing equipment and drains, and for controlling for Lm in incoming raw materials. FDA’s guidance will be a valuable tool for any company interested in enhancing its existing controls.

As noted, the draft guidance also provides useful recommendations for the design and implementation of an effective environmental monitoring program, and provides recommended corrective actions that companies should take in the event they detect Listeria spp. in any of the following locations: (1) on non-food contact surfaces; (2) on Zone 1 food contact surfaces; or (3) in finished products.

Notably, FDA has changed its policy on the significance of a positive Listeria spp. test collected from a Zone 1 food contact surface. In the past, when a Zone 1 surface tested positive for Listeria spp. during production, FDA expected the food company to determine whether positive Zone 1 finding was Lm or a non-pathogenic strain of Listeria. If the positive was confirmed to be Lm, FDA would then expect any finished products that contacted the surface to be destroyed or recalled.

Under the draft guidance, however, FDA will no longer require food companies to test the initial positive Zone 1 food contact surface for Lm, and will instead allow a company to clean, sanitize and conduct intensified sampling of the affected area during the following production run. A company will only be required to hold and test finished product for the presence of Lm if the Zone 1 food contact surface tests positive for Listeria spp. for a second time in follow-up testing. The draft guidance also outlines additional corrective actions the agency recommends companies follow in the event of other positive environmental or finished product findings.

The core principles of FDA’s draft guidance reflect a significant change in FDA Listeria control policy. Companies will have more incentive test more aggressively, and more flexibility to respond to positive findings.