In this scenario we will be relating the Rules of Practice in Part 500 to the SSOP and Sanitation Performance Standards (SPS) agency verification requirements.

You are the GS-9 IIC assigned to a small establishment that slaughters beef and processes miscellaneous beef cuts, ground beef and cooked sausages. Over the last three months, you and relief inspection personnel have issued NRs for multiple and recurring noncompliances identified for failure of the SSOP to prevent direct product contamination and failure to maintain sanitary conditions as required in the SPS. You have issued three more NRs since the Relief Inspector’s last visit for heavily beaded condensation found in multiple non-production areas. You have kept your Circuit Supervisor informed of the recurring nature of the situation and also discussed this with plant management during the weekly joint meetings. You then decide that it is time to recommend that the District Manager issue a Notice of Intended Enforcement (NOIE) letter to this establishment. This decision is based on the insanitary conditions and/or practices prevailing at this establishment.

Your recommendation to the District Manager includes details of the multiple and recurring noncompliances identified for SSOP and SPS failures and the corrective actions that were either not effective or not implemented by the establishment as was verified and documented by FSIS. You list the relevant NRs as follows:

The original NR written on rodent activity.

A NR issued for condensation leading to direct product contamination.

A NR issued for condensation leading to direct product contamination.

A NR issued for holes in walls around pipes behind the smokehouse.

A NR issued for a door with gaps leading to the outside and a hole in the processing room wall leading to the outside.

A NR issued for rodent droppings in the boiler room.

A NR issued for insanitary conditions due to rodents and contamination of product by insanitary conditions.

A NR issued for condensation in a production area without direct product contamination.

A NR issued for condensation in a non-production area without direct product contamination.

A NR issued for condensation in a non-production area without direct product contamination.

A NR issued for condensation in a non-production area without direct product contamination.

Your review of the records leads you to believe that there are two root causes for the above NRs. One is the failure to prevent rodent harborage and entry into the establishment.(NR 1, 4, 5, 6 and 7). A second root cause is a lack of adequate ventilation or airflow, resulting in condensation from overhead structures.(NR 2, 3, 8, 9,10 and 11). The establishment responses indicate that corrective actions and preventive measures have been identified and implemented for each non-compliance. FSIS verification and documentation shows that these actions were either not implemented or not effective. You conclude that these failures within the food safety system do not pose an imminent threat to public health, but based upon the Rules of Practice you feel the situation warrants action with prior notification (9 CFR 500.4(b)&(c)). You recommend issuing an NOIE letter to the establishment.

The District Manager agrees with your recommendation and an NOIE letter is issued to the establishment. The establishment will need to respond to the NOIE and provide the District Manager information about the corrective actions that they believe will take care of the noncompliance issues.

In response to the NOIE received concerning the SSOP and Sanitation Performance Standard noncompliance’s in the recent weeks, we have taken the following actions:

First, as we indicated in the response to a NR, we have sealed the outside door leading into the boiler room and repaired the holes in the wall. In addition, we have identified other points in the outside walls of the basement under the boiler room that could allow entrance into the facility and up into the boiler room. All new openings have been sealed.

We have also hired a new extermination company with a certified pest control operator to perform a monthly service. They have inspected the outside grounds and inside areas of the plant. Tomorrow they will be installing additional bait stations outside of the boiler room and new traps in the basement and boiler room.

We have re-evaluated our SSOP program and have determined that modification of the program was needed. We are modifying it to include a procedure for pest and rodent control in our operational sanitation SSOP. We have assigned a production person to make a daily rodent and pest check. QC will be monitoring the procedure daily and recording the results on the SSOP form.

Since the installation of the ceiling fans has been insufficient to eliminate the condensation, we have hired an Environmental Engineer who is to visit the plant tomorrow to determine the best way of preventing the condensation from forming.

We will be adding a procedure to the SSOP program for condensation. We have assigned a production person to identify and to remove condensation on an hourly basis, until our consulting engineer has determined what actions are needed for a permanent solution. The condensation procedure will be monitored by our QC personnel two times per day. If they identify condensation over product areas or in product and employee traffic areas, production will be stopped in that area until the problem has been corrected and further preventive actions have been determined and implemented. We will also take immediate actions and further planned actions for condensation found in the non-production areas by tagging the affected area until the problem has been corrected and further preventive actions have been determined and implemented.

The District Manager opts to defer an enforcement decision due to a belief that the establishment’s proposed corrective and preventive action may be adequate to eliminate the noncompliance but lacks the substantive and supporting evidence that is needed to make a definite decision. The District Manager will make a decision on the adequacy of the preventive action as soon as sufficient information becomes available.

The next IKE Scenario will specifically deal with FSIS verification of the establishment’s action plan.