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| IKE Scenario 07-06: Verification Procedures Involving E. coli
O157:H7 as Described in FSIS Notice 63-06
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Purpose: 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.
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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.
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Last Modified: November 16, 2006 |
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