IKE Scenario 07-03 Performing 03J01 & 03J02 Procedures for the Determination Compliance with the Food Safety Standard for Fecal Material, Ingesta and Milk on Livestock Carcasses During Slaughter Operations.

This IKE scenario is the third of three that are designed to illustrate the procedures used in accordance with FSIS Directive 6420.1, Livestock Post-Mortem Inspection Activities – Enforcing the Zero Tolerances for Fecal material, Ingesta and Milk, dated 12/17/98. This directive provides instructions to inspection personnel that are similar to FSIS Directive 6150.1, Rev. 1, Poultry Post-Mortem Inspection and Reinspection – Enforcement of Zero Tolerance for Visible Fecal Material, dated 6/19/98

You are a Veterinary Medical Officer (VMO) in the same young, fat cattle slaughter facility described in IKE s 05-03 and 06-03. Your duties include performing an overall analysis of the establishment’s food safety system and assessing its adequacy in preventing issues of public health concern. This includes verifying the adequacy of the establishment’s response to food safety defects, such as contamination with feces, ingesta or milk.  In doing so, your analysis takes into account the on-going implementation, effectiveness, and maintenance of the establishment’s food safety and other-consumer-protection controls.

During the past week, in-plant inspection personnel have identified and documented several incidences of the establishment failing to meet the Agency’s food safety standard of removing fecal contamination, ingesta, and/or milk. The resulting non-compliance reports (NRs) have all been linked due to the fact that the non-compliances were determined to be from the same cause; the fact that the establishment has not been implementing the corrective actions as presented in their response to the non-compliances. (For more information, please refer to IKE s 05-03 and 06-03.)  

The CSI comes to you several hours after start-up on Thursday and informs you that the on-line inspector has informed him of a higher-than-normal occurrence of fecal contamination on the carcasses presented at the final rail.

As a critical thinker, what do you think the next actions should be by the on-site FSIS in-plant team assigned to the establishment?

·        You, as the IIC, perform an 03J02, including verification of the previously proffered corrective actions. (Note: you decide to perform an 03J02 rather than an 03J01 because you are assessing the entire system at this point.) You go to the live production area and observe that the establishment is again not consistently monitoring the live cattle for excessive contamination, nor are they removing any contamination prior to the cattle entering the establishment.  

·        Also as part of the 03J02, you perform a “hands-on” verification by observing carcasses at a point after the final rail as described in FSIS Directive 6420.1.  You observe two of the eleven carcasses are contaminated with fecal material contamination.  

·        You realize that there are two options that you have open to you:

1.     You can determine to continue to document the failure using an NR specifically describing the failure related to corrective actions as well as the fecal findings and link it to the previous related NR. You also discuss at the next weekly PBIS meeting your concerns that the plant is not willing or able to control fecal contamination and that continued failure will result in action under the Rules of Practice. You document what you have discussed with the plant on a memo that you place on file and send an email to the Frontline Supervisor (FLS) making them aware of these concerns.

2.     You can determine the need to implement the Rules of Practice, 9 CFR 500.4(a). You document an NR describing the failure related to corrective actions as well as the fecal findings, and also indicate that you are recommending suspension with prior notification based on the recurring noncompliance. You contact the DO (and ensure that the FLS is informed) and provide the data to support your recommendation. The DO will follow the Administrative Enforcement Report (AER) process, including documentation of the NOIE to send to the plant. (Note: The AER process is a new method to ensure that the proper case support files and documents are in place when an enforcement action is taken. A key component of this case file is any documentation performed by the in-plant team. This means that properly documented NRs and memos of pertinent plant meetings, conversations, etc. are vital, as they are an important part of this report.)  

·        At this point in time, your analysis of the system, as it is currently being implemented, is that it is ineffective in preventing adulteration of product and that there is also a potential public health concern. It is apparent to you that the establishment is unable or unwilling to implement effective corrective actions as required by 9 CFR 417.3(a). You decide to recommend a suspension with prior notification to the DO.  

·        You immediately contact your Frontline Supervisor who has been performing IPPS reviews, is aware of the situation, and is confident in your verification procedures and decision making. You then contact the DO and apprise them of the situation. After reviewing your support they issue an NOIE to the establishment based on your information.  

·        Once the DO receives an adequate response to the NOIE, a verification plan will be developed with input from the FLS and yourself.  You, the IIC will be responsible for using the verification plan to ensure verification of the plant’s corrective actions.   

This IKE scenario is an example that clearly demonstrates the importance of all members of the district food safety inspection team. While the post-mortem inspector has responsibility for inspecting carcass by carcass, they work closely with the off-line inspection team when they question that the process may be out of control. The off-line team has the responsibility of analyzing the system and working with other district personnel when it becomes apparent that the establishment is not consistently controlling their food safety system.

For IKE related questions, send mail to ike@fsis.usda.gov. For all other general questions, send to Tech Center address listed below.