FDA sets sights on reducing Listeria risk in RTE food


The US Food and Drug Administration (FDA) has updated draft guidance to reduce the risk of Listeria monocytogenes (L. mono) in ready-to-eat (RTE) foods.

It incorporates industry best practice and the “seek and destroy” approach of the US Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS).

Facilities that produce food regulated by USDA/FSIS and FDA will also benefit from a uniform approach to reducing the risk of environmental contamination with L. mono, said FDA.

It is not binding and alternative approaches can be used if they satisfy requirements of the applicable regulations.

Electronic or written comments on the guidance can be submitted until July 26.

Prevention emphasis

The pathogen can grow in cold, refrigerated environments and is particularly harmful to the elderly, pregnant women and the immunocompromised.

Listeriosis is characterized by a high mortality rate compared to illnesses caused by other pathogens.

The emphasis on prevention is consistent with the Food Safety Modernization Act (FSMA) and reflects current good manufacturing practice (CGMP) requirements, as well as demands for hazard analysis and risk-based preventive controls, including verification of these.

FDA said facilities that manufacture, process, pack or hold RTE foods will benefit from guidance on measures to control L. mono in the processing environment, regardless of whether they are subject to CGMPs, preventive controls or both.

Some RTE foods have characteristics (such as pH and water activity) that support the growth of L. mono.

Example guidance

The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment and sanitation.

It also outlines treatments that kill L. mono and formulations to prevent it from growing during storage of food between production and consumption.

Sorbic acid can be added to prevent the growth of L. mono in cheese and a combination of sorbic and benzoic acid is commonly added to prevent growth in deli-type salads.

The guidance recommends people who enter an area where RTE foods are processed or exposed to the environment thoroughly wash their hands.

“We recommend that personnel use suitable utensils (such as spatulas or tongs), or wear gloves, when touching exposed RTE foods, food-contact surfaces (FCSs), and packaging materials, and not touch exposed RTE foods, FCSs, and packaging with bare hands.

“We recommend that gloves and footwear worn by personnel who handle RTE foods, or who work in areas where RTE foods are processed or exposed, be made of impermeable material, be in good repair and be easily cleanable or disposable.”

It also contains advice on sanitizers, clothing, plant design/construction, equipment maintenance, sanitation, drainage, raw material controls and transportation.

Meanwhile, the FDA is to hold a public hearing on February 14-15 in College Park, Maryland, regarding partnerships to enhance the safety of imported food. Registration ends February 8.

The agency said it recognizes the importance of strengthening existing collaborations among food safety regulators (federal, state, local, territorial, tribal and foreign) to achieve public health goals.

The Food Safety Modernization Act (FSMA) has provided authority to ensure imported foods meet the same standards as those produced domestically.

The hearing will focus on partnerships that incorporate information from private entities and foreign authorities to inform risk-based decision making and those that recognize commodity-specific export programs.

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