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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Purpose:

Online References
IKE Scenario 07-06: Verification Procedures Involving E. coli O157:H7 as Described in FSIS Notice 63-06
To remind inspection program personnel how to assess information to ensure that the total food safety system is functioning as intended. This is to also assist inspection program personnel in verifying that the establishment is reacting appropriately to the information generated for E. coli O157:H7 in raw beef manufacturing trim intended for use as ground beef.
You are assigned at a beef slaughter/processing combination plant. The establishment slaughters and produces beef trim for raw ground beef. You receive FSIS Notice 63-06.

As described in FSIS Notice 63-06, you perform a 03C01 procedure. As part of this procedure, you review the establishment's microbiological testing records for trim from February 1, 2006 through March 31, 2006. You find that the percentage of O157 positives found by the establishment's statistically-based sampling program for this period was 0.410%. You then review all of the establishment's microbiological testing records from April 1, 2006 through September 30, 2006, the period known to be a higher prevalence season for this pathogen. You find that the percentage of O157 positives found by the establishment's statistically-based sampling program for this period was 0.890%.

You review the establishment's trend analysis records to determine if the establishment recognized the upward trend in positive O157:H7 results and what actions were taken if the trend was recognized. The following entry was made by the HACCP coordinator on the on August 15, 2006 on the trend analysis record.

A review of the microbiological testing records revealed an upward trend in O157 positive results from 0.41% on March 31, 2006 to 0.86% on August 15, 2006. A review of the data from the same time periods during the past 2 years indicated that this upward trend is consistent with the percent positives recorded for those years. A review of sanitary dressing procedures was conducted and the sanitary dressing procedures were being followed. A review of the critical control points revealed that all of the parameters of the validation for the critical limits were being followed. The monitoring results were being recorded at the frequency specified in the HACCP plan and no deviations from the critical limits had occurred. The records also indicated that the establishment had implemented their written procedures during the high prevalence season which is to identify an additional employee specially trained to assess for and remove fecal contamination during the hide removal and evisceration process. The records further stated this employee had been added to both shifts. The establishment increases its sampling frequency from five combo bins groupings to three combo bin groupings during the high prevalence season as a precautionary measure. None of these enhanced procedures applicable to the high prevalence season were improperly applied.

A review of the zero tolerance records was conducted and one fecal contamination finding had occurred on July 12, 2006. A review of the corrective action records for this entry were reviewed and the corrective actions taken met the regulatory requirements of 9 CFR 417.3(a). A review of the microbiological testing records were performed and it was determined that the statistically-designed testing program was being implemented as designed and is adequate to prevent adulterated product from entering commerce.

You realize that even though you are performing a 03B01 procedure, that you need to verify requirements in the slaughter process as well to ensure that the total food safety system is functioning as intended in the control of O157. After reviewing the trend analysis record for percent positive O157 and the corrective action record for the zero tolerance deviation from the critical limit, you verify that the sanitary dressing procedures. You find that the enhanced sanitary dressing procedures for the high prevalence season were documented as being followed. You also review the monitoring records for the CCPs and find that the monitoring activities are being performed and recorded at the frequency specified in the HACCP plan.

What determination did you make based on the information gathered while performing this procedure?

After reviewing the microbiological testing data, the trend analysis record, and the corrective action record, the monitoring records at the CCPs, and verifying that the sanitary dressing procedure requirements are met, you determine that even though there is an upward trend in the percent positive O157 results, the establishment's total food safety system is functioning as intended and therefore no further action is required.
For IKE related questions, send e-mail to Ike@fsis.usda.gov. For technical or regulatory questions, send e-mail to TechCenter@fsis.usda.gov.
Last Modified May 19, 2013