Processors should be aware of a revised FSIS directive regarding Listeria prevention.

It goes without saying that Listeria monocytogenes is a constant concern in ready-to-eat (RTE) food-production facilities. Because Listeria thrives in cold, moist environments, such as food-processing plants – and RTE foods don’t go through further cooking preparation that can be a failsafe to kill pathogens in raw products – US Dept. of Agriculture’s Food Safety Inspection Service (FSIS) has regulations in place to help processing facilities protect and monitor products.

As is the case with most government regulations, the FSIS directive regarding Listeria prevention is a work in progress. In early January, FSIS issued a directive (10240.4, Revision 3) “Verification Activities for the Lm Regulation & RTE Sampling Program”. The North American Meat Association (NAMA) held a Webinar in March designed to highlight the changes in the updated directive.

“Companies producing RTE products need to fully understand the changes and review their programs to ensure effectiveness, particularly when using approaches that differ from the FSIS Compliance Guideline,” said Jeremy Russell, director of communication and government relations for NAMA.

According to FSIS, the purpose of the revised directive was to provide inspection program personnel (IPP) with instructions to verify that meat and poultry establishments are complying with the regulatory requirements that are outlined in what’s referred to as the “Listeria Rule” (Regulation 9 CFR 430.4, “Control of Listeria monocytogenes (Lm) in Post-Lethality Exposed Ready-to-Eat (RTE) Products”).

While the revision does not contain major changes, processors should be aware of it to ensure compliance.

The key points of the revision include:

  • Verification of the establishment’s compliance with the Listeria Rule
  • Verification that establishment’s sampling and testing programs meet the requirements of the Listeria Rule
  • Collecting and submitting FSIS verification samples
  • Enforcement actions in response to a positive sample result

FSIS has revised this directive to incorporate and clarify previously issued instructions for:

  • Collecting samples under the RTEPROD sampling project
  • Verifying that establishments hold or control RTE products that FSIS has tested for pathogens, or that have passed over direct food-contact surfaces that FSIS has tested for pathogens, pending the results of FSIS testing.
  • Collecting samples in establishments that temporarily alter their routine practices.

The revision also provides new instructions for:

  • Submitting samples when interventions, such as high-pressure processing (HPP), are applied.
  • Verifying that establishments meet the requirements of the Listeria Rule when performing inspection tasks under the Public Health Information System (PHIS).
  • Taking action in response to a Listeria spp. positive result in the product when an establishment chooses to sample products as well as food contact surfaces.

‘Listeria Rule’

Understanding the revised directive involves understanding the basics of the initial regulation, including what’s called the “Listeria Rule”. This rule requires RTE processing establishments to control Lm through Hazard Analysis and Critical Control Point (HACCP) plans, Sanitation Standard Operating Procedure (SSOP) or prerequisite programs. The rule further explains that in order to “maintain the sanitary conditions necessary to meet this requirement, establishments must comply with the requirements for one of three Listeria alternatives (9 CFR 430.4(a) and (b)).”

Alternative 1: The establishment uses a post-lethality treatment (PLT) to reduce or eliminate Lm in the product and an antimicrobial agent or process (AMAP) to limit or suppress growth of Lm in the product – both of which must be outlined in its HACCP plan, and the effectiveness of both must be validated before used.

Alternative 2: The establishment uses a PLT to reduce or eliminate Lm in the product or the establishment uses an AMAP to limit or suppress growth of Lm in the product – again, both of which must be outlined in its HACCP plan, and the effectiveness of both must be validated before used.

Alternative 3: The establishment relies on sanitation alone to prevent Lm in the processing environment and on the product. The facility must then provide testing of food-contact surfaces on a regular basis to ensure that the surfaces are sanitary and free of Lm, and they must agree to test and hold product if any positive test occurs.

RTE sampling

Even best practices and standard operating procedures can’t guarantee safe, pathogen-free food products – contaminations can and do occur. Product sampling is one way to detect contamination. Wilmington, Del.-based DuPont Nutrition & Health offers a new fast, accurate test for Listeria monocytogenes. Food processors and service labs can use the latest DuPont BAX System assay, which combines shorter, simpler sample preparation and faster real-time processing. The BAX System is a quick and reliable method for detecting L. monocytogenes in a variety of products and has been validated on frankfurters, cooked shrimp, spinach, queso fresco and environmental surfaces.

Furthermore, the assay provides additional flexibility by allowing customers to test for L. monocytogenes, Listeria spp. and Salmonella in the same batch, with results for all organisms in a little over an hour.

According to the FSIS directive, if a RTE product or food contact surface test positive for Lm or another pathogen, then certain corrective actions must be taken. The Corrective Action/Preventative Action Program (CAPA) outlines both corrective actions which immediately reduce the risk at the positive site (such as intensified sanitation) and preventative actions which include long-term changes that permanently prevent contaminations to reoccur.

Processors with questions regarding the FSIS directive (10240, Revision 3) should direct them to the Risk, Innovations, and Management Staff (RIMS) through the following website: