IKE Scenario 07-04: Updated information included in the October, 2004 version of the Compliance Guidelines to Control Listeria monocytogenes in Post-lethality Exposed Ready-to-Eat (RTE) Meat and Poultry Products.

 FSIS Directive 10240.4, Verification Procedures for the Listeria monocytogenes Regulations and Microbial Sampling of Ready-to-Eat (RTE) Products for the FSIS Verification Testing Program states that RTE product is adulterated if it contains Listeria monocytogenes or if it comes into direct contact with a food contact surface (FCS) that is contaminated with Listeria monocytogenes.

You are a Consumer Safety Inspector (CSI) in a Ready-to-Eat meat processing establishment that has chosen Alternative 2 with use of a post-lethality treatment to control Listeria monocytogenes (Lm) in the post-lethality processing environment.  The post-lethality treatment is a post-packaging pasteurization process CCP that utilizes hot water which results in more than a 2 log reduction of Lm.  The establishment also tests food contact surfaces to ensure that adequate sanitation performance is maintained in the post-lethality processing environment. This testing is through a pre-requisite program that includes follow-up action when a food contact surface tests positive.

On Wednesday, you are assigned to perform procedure 03G02.  According to FSIS Directive 5000.1 Revision 1, you will verify that all regulatory requirements are met for a specific production lot, and that the pre-shipment review is signed and dated as required by 9 CFR 417.5(c).

You review the HACCP monitoring records and find that the critical limits have been met at all the Critical Control Points (CCP’s).  You review the HACCP verification records and pre-shipment review and find that a recent food contact surface test report showed an Lm positive finding on the slicer.


With the available information, how do you proceed?

·      You know FSIS considers an RTE product to be adulterated if a food contact surface such as a surface of equipment used in the production of the product tests positive for Listeria monocytogenes. 

·      You have already reviewed all the HACCP monitoring records and find the critical limits have been met at all CCP’s.

You review the establishment’s corrective action records. The corrective actions records are complete and address all parts of 9 CFR 417.3(a).  (417.3(a) would be the appropriate corrective action requirements that should be met because Lm has been determined to be a food safety hazard likely to occur).

o       The establishment performed a review of their HACCP plan, HACCP monitoring and verification records, and pre-shipment review to determine the acceptability of the affected product for distribution into commerce (final disposition). 

o       Since the product had received a second lethality (post-packaging hot water pasteurization) after packaging that is documented in the HACCP plan has been validated, and the HACCP monitoring records showed that all critical limits for this CCP for the production days in question were in compliance, the establishment has concluded that the affected product has met an adequate lethality to eliminate Lm from the surface of the product to achieve food safety.  In addition they have implemented follow-up procedures outlined within their pre-requisite program.

·      You have read the updated FSIS Compliance Guidelines for the Control of Listeria monocytogenes in the post-lethality environment for Ready-to-Eat Meat and Poultry Products (Oct., 2004) and conclude that the establishment’s final disposition to release the product into commerce is based on their validated hot water post-packaging pasteurization process that has been documented in their HACCP plan, which shows that the potentially adulterated product has been exposed to a second lethality step that reduces or eliminates Lm to safe levels.

As a critical thinker, what is your next course of action?

Because you have found that the establishment’s HACCP system is functioning as it is intended, and you determine that no noncompliance exists; and therefore no Noncompliance Record (NR) is warranted.