Scenario 20-02: Microbial Sampling of RTE Products for FSIS Verification Testing Programs:  December 9, 2002

FSIS Directive 10240.3 Microbial Sampling of Ready-To-Eat (RTE) Products for the FSIS Verification Testing Program was signed and became effective December 9, 2002. The following IKE is to facilitate FSIS program personnel’s understanding of this new directive.

You are a GS-9 inspector assigned to a large establishment that produces various ready-to-eat (RTE) products including sliced luncheon meat and hot dogs. Neither deli-type or the hot-dog type product is formulated or produced to prevent growth of Listeria monocytogenes (L. monocytogenes or Lm) however, the establishment does have a post packaging pasteurization process step within their process. This places the products into the low risk category (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 noncompliances documenting insanitary conditions (01B, 01C and 06D).

The establishment has science-based programs in place to control Listeria monocytogenes (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) procedures to test product contact surfaces for Lm, and a prerequisite program that includes environmental testing of indirect and non-contact surfaces. The establishment 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. Consequently this places these low risk products into the low risk operation category (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 (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 (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 establishment into the FSIS Low-Targeted Verification Testing Program.

While performing PBIS scheduled procedure 01C01, operational Sanitation SOP records verification, you also review the results of their environmental testing program for indirect and non-food contact surfaces from their prerequisite program. From the review of the environmental testing program records you observe that the establishment had a positive Listeria spp finding from a floor drain in the Ready-to-Eat (RTE) product packaging room. Upon further review of the establishment records you discover that the establishment performed corrective action as stated in their prerequisite program. The corrective actions included additional cleaning and sanitizing in that part of the facility and additional indirect/non-food contact surface testing which resulted in a positive Lm finding on a non-food contact surface. You further look into what other actions the establishment has conducted and find that they reviewed their procedures for the cleaning of floor drains in that production related area and have decided to increase the frequency of that cleaning from once per week to twice per week. Additionally they are increasing the testing of product contact surfaces to determine if the Sanitation SOP is functioning as intended and based on those results may modify their Sanitation SOP program. A review of establishment records for their environmental product contact surface testing program showed no positive findings for Lm.

How should you proceed?

Since the establishments testing program for product contact surfaces indicated that there were no positive findings of Lm it cannot be determined that adulterated product was produced. Findings of Lm on a non-contact surface, such as in a drain, does not indicate that the establishments’ process or systems, i.e. HACCP plan, Sanitation SOP or prerequisite programs, are inadequate. The establishment reacted to the positive finding and instituted additional procedures to control the incidence of Lm in their facility. Therefore no other action would need to be taken and you would document that the ISP code 01C01 was performed on FSIS form 5400.3.

For IKE related questions, send mail to For all other general questions, send to Tech Center address listed below.