January 26, 2017

Draft listeria guidance issued for ready-to-eat foods

The U.S. Food and Drug Administration (FDA) is releasing an updated draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods,” which supports ongoing efforts by industry and government agencies to reduce the risk of Listeria monocytogenes (L. mono) in ready-to-eat (RTE) foods. L. mono, a pathogen that can grow even in cold, refrigerated environments, is particularly harmful to the elderly, pregnant women and/or their pregnancy, and those who are immunocompromised, according to FDA.

The emphasis on prevention in this draft guidance is consistent with the FDA Food Safety Modernization Act (FSMA) and reflects the FDA’s current good manufacturing practice (CGMP) requirements, as well as new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.

According to FDA, all food facilities that manufacture, process, pack, or hold RTE foods will benefit from clear guidance on measures to control L. mono in the food processing environment, regardless of whether the facility is subject to CGMPs, preventive controls, or both CGMPs and preventive controls.

Industry best practices and the “seek and destroy” approach used by the Food Safety and Inspection Service (FSIS) of the USDA have been incorporated into the draft guidance.

The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment, and sanitation, as well as for treatments that kill L. mono and formulations to prevent it from growing during storage of the food between production and consumption. The updated draft guidance does not change or alter what constitutes an RTE food.

The FDA began accepting public comments on Jan. 17. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2008-D-0096 in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2008-D-0096 on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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