Scenario 19-02 :  Microbial Sampling of RTE Products for FSIS Verification Testing Programs: December 5, 2002

On December 9, 2002, FSIS Directive 10,240.3, Microbial Sampling of Ready-To-Eat (RTE) Products for the FSIS Verification Testing Program will be signed and effective. This issuance will cancel FSIS Directive 10,240.2 and outlines new verification steps that FSIS will take in establishments to ensure control of pathogens or toxins of public health concern: Listeria monocytogenes, Escherichia coli 0157:H7, Salmonella, and Staphylococcal enterotoxin.

The following series of scenarios are informational exercises meant to facilitate FSIS program personnelís understanding in advance of this upcoming new issuance which will be issued on December 9, 2002:

You are a GS-12 SVMO assigned to a large slaughter/processing establishment that produces various ready-to-eat (RTE) products including sliced luncheon meats, non-sliced luncheon meats intended to sliced at delis, and a variety of hotdog-type products. Neither the deli-type nor the hot dog-type product is formulated or produced to prevent growth of Listeria monocytogenes (L. monocytogenes or Lm). These conditions place the deli-type and hot dog-type products and their operation into the high/medium-risk category (See the attached Flowchart: Determining Risk of Product and Operations).

For the deli-type and hot dog-type product, the establishment has science-based programs in place to control for L. monocytogenes in the product, on food contact surfaces, and in the environment. These programs form the basis for decisions made in the hazard analysis of the establishmentís HACCP plan. The programs include: Sanitation Standard Operating Procedures (Sanitation SOP) procedures to test product contact surfaces for indicator organisms (in this case Listeria species) and a prerequisite program that includes environmental testing of indirect and non-contact surfaces, also for indicator organism. The HACCP plan includes critical control points (CCPs) for lethality and stabilization.

All product contact testing results can be found within the establishmentís Sanitation SOP records (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 program (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 417.5(a)(1). These factors place the establishmentís deli-type and hot dog-type products into the FSIS Targeted Verification Testing Program. (See the Flowchart: Determining Testing Verification Program, provided in the first scenario of this series).

While performing the 01C01 record verification procedure, you observe that a food contact surface (slicer blade) resulted in a positive for the plantís indicator organism (Listeria species). What actions do you take?

  1. You verify (through records and/or direct observation) that the establishment has followed the corrective actions outlined in its SSOPs. Verification activity would include:
The plant reviews past sample data and determines there are no positives for product or food contact surfaces in the past several months.
They also inform the sanitation foreman of the positive samples, who ensures that special care is taken that night in cleaning and sanitizing the positive areas. This includes breaking down the complex machinery for thorough cleaning and placing equipment in the smokehouse for heat application of 170 degrees.
The plant takes additional food contact surface samples as defined in their SSOP after completing their pre-operational sanitation. Samples are also taken before the broken down machinery is reassembled (see above).
  1. You review past sample data in both the Sanitation SOP and prerequisite program records to determine if any trends exist. You determine there are no positive samples for product or for food contact surface samples in the past several months.
  2. You review past NRís to determine if any past sanitation pre-operational and/or operational sanitation deficiencies have been documented on the slicer.
  3. You verify all product and food contact surface samples come back negative and you determine that no further FSIS action is necessary. Thus, you document that ISP code 01C01 was performed on FSIS form 5400-3.

Flowchart: Determining Risk of Product and Operation

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