IKE Scenario 21-02: Microbial Testing Under Conditions That Have Been Historically Associated With Findings Of LM

You are a GS-9 CSI assigned to a large processing facility that manufactures fully cooked luncheon meats and hot dogs. Neither deli-type or the hot-dog type product is formulated or produced to prevent growth of Listeria monocytogenes (Lm) however, the establishment does have a post packaging pasteurization process step within their process. This identifies the products as low risk (see Flowchart of previous IKE in the Lm series.).

The firm has a good compliance history in maintaining sanitation and has no history of multiple or recurring non-compliances documenting insanitary conditions (01B, 01C and 06D) in the ready-to-eat (RTE) production area.

The establishment has science-based programs in place to control Lm in the product, on food contact surfaces, and in the environment to support their decisions made in the hazard analysis of their HACCP Plan. The programs include their Sanitation Standard Operating Procedures (Sanitation SOP) to test product contact surfaces for Listeria spp., and a prerequisite program that includes environmental testing of indirect and non-contact surfaces. The establishment also has included controls for Lm in their HACCP plan through a CCP for the post-packaging pasteurization process step as well as CCPs for lethality and stabilization. (Due to this validated post-packaging pasteurization step the plant normally only tests product contact surfaces once per quarter and enumerates the number of organisms present because their post-packaging pasteurization step is validated to achieve a specific reduction in the number of organisms.) Based on all of the above, the operation is categorized as low risk (see Flowchart of previous IKE in the Lm series.)

Plant management shares all product contact test results with FSIS by having the testing results within the establishment’s Sanitation SOP records (9 CFR 416.16) In addition, all records for the testing of indirect and non-contact surfaces are available to FSIS inspection personnel through the pre-requisite programs. (Note: Because these programs and records support decisions in the HACCP plan hazard analysis, they are available to FSIS inspection program personnel through record keeping requirements defined under 9 CFR 417.5(a)(1)). These factors place the establishment into the FSIS Low-Targeted Verification Testing Program.

You conduct your weekly exit meeting with plant management each Friday and during this week's meeting, the plant maintenance supervisor informs you that the company will be initiating a renovation to two of the existing production rooms:

They will be removing the wall between the raw product storage cooler and the cooked product slicing room so that they can expand the existing slicing operation. This will be conducted over the next two weekends, along with the installation of several overhead water, air and electrical lines.

They will be installing a new shingle stack slicing/packaging machine in the newly enlarged ready-to-eat product packaging room.

Modifications will be made to a floor drain in order to install a new hand wash sink as well as the installation of a drain line adjacent to the new slicing machine. In addition, they will be making corrections to the water leak in the ceiling that you had documented on an NR, at the same time they install the sink.

Finally, a hydraulic oil line will need to be installed to accommodate the new slicing/packaging machine.

Because of the extent of the changes, the entire area will be out of use until the renovation is completed. Entrances to the effected rooms will be sealed with plastic sheets and the QC supervisor will monitor traffic in and out of the area.

The sanitation supervisor advises you that, when the renovations are complete, a special crew will be responsible to ensure that the new equipment, and the entire RTE product packaging room, will be thoroughly cleaned. The QC department will perform microbial swabbing of the affected equipment and environment to further ensure its cleanliness. (Note: The plant has elected to perform additional product contact testing outside of their normal quarterly testing frequency, to ensure the effectiveness of their special clean-up).

The area is scheduled to be ready for use in two weeks, at the beginning of business on Tuesday morning after the holiday.

Based on this information, after the holiday weekend, you decide to conduct an unscheduled pre-operational sanitation inspection 01B02 procedure at the facility on Tuesday morning. When you arrive in the RTE production room you notice that there is an area, in close proximity to an existing wall, that has plastic placed from the floor to the ceiling that resembled a temporary wall. You question the sanitation foreman about the plastic and are informed that all the work was not completed as intended so they put up a temporary wall to create a barrier between the production area and the area that the construction crew was completing work on. He indicated that this work included covering up the area where the old existing wall was located as well as some electrical and plumbing work, which they projected to have completed in a week or so. You also notice that there is a small area where the plastic is loose towards the top, which he indicated was needed for ventilation back to the work area. In addition there was an area along the bottom that was folded back, which he stated was to allow access for the construction workers since there was no other access to that area from the outside. The construction workers access the work area in the RTE room along a roped off area next to the wall.

You conduct the pre-operational inspection and determine that the product contact surfaces of the new machine are visibly clean and that throughout the entire RTE production room no non-compliances were found. You observe the company's quality control (QC) technician collecting samples to be tested, among other things, for Listeria species. The technician takes swabs from both food contact surfaces on the new slicing machine and from non-food contact surfaces of the floor drain.

On Thursday afternoon of the following week, you are reviewing the company's Sanitation SOP records. Additionally, you review the test results of their environmental and special product contact surface testing from the previous week. The records indicate:

The establishment had a positive Listeria spp. finding from a floor drain in the RTE product packaging room.

A positive Listeria spp. finding on a product contact surface of a slicing machine in the RTE product packaging room on that same day.

The plant had followed the corrective actions stated in their prerequisite program, which included additional cleaning and sanitizing in that production area with additional indirect/non-food contact surface testing, to include testing for Lm due to the Listeria spp. finding.

The plant decides to follow the same procedure for the positive finding on the food contact surface, since they have no written procedures to follow.

As you continue your review of the records you discover:

Two days later the establishment had a positive Lm finding on another product contact surface of a slicing machine in the RTE product packaging room. The records showed no other positive sample results, either for Lm or Listeria spp., for that same day.

The establishment again performed additional cleaning and sanitizing in that production area, as well as additional product contact and environmental indirect/non-food contact testing in an attempt to determine the cause of the positive findings.

In addition, the establishment elected to collect a product sample from that day’s production to test for Lm past their post-packaging lethality step. They held the affected product lot, pending the results of the testing, even though they were certain that their validated post-packaging pasteurization step would control any potential Lm.

The records further indicate that this product sample tested positive for Lm. Since the production lot was held, the plant did not initiate a product recall and the establishment decided to reprocess this product by placing it back through the smokehouse to provide a further lethality step.

The plant is continuing to perform additional cleaning and sanitizing of the RTE production area, as indicated by their records, as well as additional environmental indirect/non-product contact and product testing, however those results are not available as yet.

Based on what you are seeing how should you proceed?

You know from having been the IIC assigned to this establishment for the past 6 months that the establishment has not had any previous product positives for Lm. You also don’t recall that they have had anymore than one or two positive Listeria spp. results from their environmental testing program for indirect/non-product contact surfaces. However, you look at the past records to confirm that this is the case.

The positive samples seem to have started after the establishment started their construction process and they had installed the new equipment in the RTE production room, yet plant management has not reassessed nor made adjustments to their Sanitation SOP, HACCP plan or prerequisite program.

You know that per 9 CFR 417.4(a)(3) and FSIS expectations that when there are changes that could affect an establishments hazard analysis, i.e. changes in slaughter or processing methods or system (construction/equipment), an establishment shall reassess the adequacy of the HACCP plan.

Although plant management took several appropriate actions they seemed to only take the effectiveness of the initial cleaning of the area and equipment into account in their thought process. They do not appear to have taken into account any possible new process steps introduced by the construction and new equipment or to have considered their long-term effect(s) in the hazard analysis, such as the introduction of new hazards. They also apparently did not take into account the traffic flow of people, product or airflow.

Their insufficient thought process becomes even more obvious when you determine that the plant did not reevaluate the validation of their post-packaging pasteurization step after they had an Lm positive sample past this step, indicating that the construction process had potentially affected the validation.

The only documented actions currently being taken by the plant is that they continue to repeat their previous cleaning regimen as described in their Sanitation SOP and prerequisite program without further evaluation or modification of any of their science-based programs based on the sampling results.

You take the appropriate action as set out in FSIS Directive 5000.1, FSIS Directive 5400.5 and FSIS Notice 29-02:

You document a Noncompliance Record (NR) under the appropriate HACCP 03 procedure using the “Verification” trend indicator and reference 417.4(a)(3) as the regulatory citation.

You notify the District Office of the situation and based on the establishment response to the NR you request a withholding action be taken per 9 CFR 500.4, Rules of Practice.



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