You are a Consumer Safety Inspector (CSI) in a small beef slaughter and processing establishment that bones beef carcasses into primal and subprimal parts. As a result of this boning process they produce beef trimmings for sale to their customers.

Today you are performing procedure 06D01 verifying sanitary operations in the processing and packaging area in the fabrication department. As you proceed through the packaging area you observe that the establishment employees are attaching a pressure sensitive label that states “For Cooking Only” onto the boxes of beef trim produced during the boning process today. You question the packaging room supervisor about the label and are informed that the establishment just started using the label on all beef trimmings produced by the boning process. The supervisor is unable to provide information concerning the label approval or if there is related information in the establishment’s hazard analysis.

You go to the Quality Assurance (QA) office, where the approved label file is maintained, to see if the establishment has an approved label on file for the label being applied to the boxes of beef trim. You see that it is approved by the Label and Consumer Protection Staff of FSIS as a “Sketch Approval” and that the establishment gave the label a final approval. Based on the sketch approval the establishment met the labeling requirements of the beef trim.

You remember from reviewing FSIS Directive 10,010.1, Rev. 1, that while performing the HACCP 01 or 02 procedure, you are to verify that the instructional statement does not serve as a control or CCP to address E. coli O157:H7 or to justify that E. coli O157:H7 is NOT a hazard reasonably likely to occur in their production of product. You are also to verify that the use of the instructional statements is reflected in the establishment’s decisionmaking documents, per 9 CFR 417.5, or hazard analysis, per 9 CFR 417.2(a)(1).

As you continue to verify the instructional statement, you perform the appropriate HACCP 01 procedure to see if the establishment has decisionmaking documents, in reference to the statement, or relevant information contained in their hazard analysis. Since these records are also maintained in the QA office you request to see the establishment’s hazard analysis and supporting/decisionmaking documents. Upon review of the hazard analysis and decisionmaking documents you see that there is no mention of the instructional statement being applied to the beef trim. You discuss this issue with the QA manager and plant manager who indicate that they are not aware that they need to address the instructional statement in the hazard analysis or through decisionmaking documents. You notify them that you will be issuing a Noncompliance Record (NR) since this instructional statement is implying special preparation and handling is needed to ensure that a food safety hazard E. coli O157:H7, is eliminated or reduced to an undetectable level, and the use of labeling is not reflected in the hazard analysis and decision making documents as required in 9 CFR 417.5. You proceed back to your office and document the noncompliance on an NR as described in FSIS Directive 5000.1, Revision 1, Chapter IV using the HACCP 01 procedure code, marking the recordkeeping trend indicator, and citing 9 CFR 417.5.