IKE Scenario 03-04 Performing 03B01 & 03B02 Procedures for Determining Compliance with the Food Safety Standard for Raw Product-Ground.
This IKE scenario is designed to illustrate the procedures used in accordance with FSIS Directive 10.010.1 Revision 1, Part VII – Establishments testing of Product for E. coli O157:H7.
You are a Consumer Safety Inspector (CSI) in a beef slaughter facility that produces raw ground beef from beef trimmings. In addition to grinding their own trimmings, the facility receives and grinds beef trimmings from three other beef slaughter facilities. Your duties include verification of HACCP, SSOP, and other regulatory requirements related to the production of ground beef products.
You are assigned to perform the procedure 03B02. According to FSIS Directive 5000.1 Revision 1, you will verify that all product in a particular production lot meets the critical limits at all CCPs, and that the preshipment review is signed as required by 9 CFR 417.5(c). You will verify that all HACCP monitoring, corrective actions, verification, recordkeeping, and reassessment requirements are met. You understand that the 02 procedure is performed to verify that the HACCP system is functioning as intended. In this scenario, you use the HACCP recordkeeping component to perform the 03B02 procedure.
The establishment uses a prerequisite program to support the decision in their hazard analysis that E. coli O157:H7 is a food safety hazard not reasonably likely to occur. The prerequisite program has two components. First, they have product purchase specifications and only purchase beef trimmings from plants with a validated intervention for the control of E. coli O157:H7 on raw beef. Second, they test all beef trimmings for E. coli O157:H7 at receiving. They maintain records to support the prerequisite program, as well as the decision made in the hazard analysis. Plant records include supplier letters concerning the purchase specifications and E. coli test results performed by the receiving plant for all lots of beef trimmings received into the establishment. These documents are available upon request.
You review the HACCP records for all ground beef produced yesterday on your shift. You observe that the critical limits were met for all products and that the preshipment review was signed. Next, you review the test results for the beef trimmings used to produce this product. You find one positive result for a load that was returned to supplier and a note to see corrective action record.
Since the beef trim on the refused load was intended for use as ground beef, and tested positive for E. coli 0157:H7, it is adulterated. Part VII of FSIS Directive 10,010.1 Revision 1 describes inspection program personnel responsibilities related to an establishment’s testing of product for E. coli 0157:H7.
You request the corrective action record from the HACCP manager related to the load of E. coli O157:H7-positive beef trimmings. The plant addresses E. coli O157:H7 in a prerequisite program rather than as a CCP, but are still required to meet all parts of 417.3(b). You ask to see the corrective action records.
In the corrective record, you observe a notation that the truck with the refused product was sealed with company seal #33624. A copy of a letter to the supplier of that product is also included with the records. The letter notifies the supplier that their product tested positive, and that they should investigate to determine the effectiveness of the interventions and report back in writing in order to continue supplying product to the grinding plant. Additionally, there is a letter from the supplier verifying receipt of a load of sealed beef trimmings. The letter states the E. coli O157:H7-contaminated beef trim will be cooked within their establishment and will be worked into the production schedule. The entire lot will be cooked within 2-3 days and at that time documentation attesting to this fact will be provided.
Also included is a statement about reassessment of the hazard analysis and HACCP plan at the grinding establishment, signed by the HACCP Manager. She states that she reassessed the hazard analysis and HACCP plan yesterday afternoon after taking corrective actions. She feels the prerequisite program is effective in preventing E. coli O157:H7 –adulterated trimmings from entering the grinding plant. She feels decisions made in the hazard analysis are supportable, and the prerequisite program and HACCP plan do not require changes at this time.
At this time, you e-mail the contact person in your District Office with the following information: name of the supplying establishment, point of contact (name, title, e-mail address, and fax number), supplier lot number, production date, name of supplied material, and any additional information that will clearly identify this shipment of beef trimmings. Your District Office will pass this information on to the District Office of the supplying plant, if they are different. The inspector at the supplying plant will be notified to perform a 02 procedure on the lot of affected product.
As a critical thinker, what do you think the next actions should be by the on-site FSIS in-plant inspector assigned to the establishment?
At this point, you can’t complete the 03B02 procedure until the establishment can verify that all product within the effected lot has been cooked. However, you are satisfied that the establishment has taken the appropriate measures in reassessing the HACCP plan and controlling the movement of the E. coli O157:H7-contaminated product. You plan to check the records in 2-3 days for confirmation that the product has been cooked. At that time, you will be able to complete your 03B02 task.