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| IKE Scenario 09-06: 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
ground beef.
You are assigned at a beef grinding plant that purchases
beef manufacturing trim from other establishments and grinds
the product for sale as ground beef at retail. You receive FSIS Notice 63-06.
As described in FSIS Notice 63-06, you perform a 03B01
procedure. As part of this procedure, you review the
establishment's microbiological testing records for
in-coming beef manufacturing trim, as part of the
prerequisite program, as well as the finished ground beef
product, as part of the HACCP plan, from December 1, 2005
through March 31, 2006. You find that no tests had been
performed in the in-coming product to verify the
effectiveness of the prerequisite program. However, the
percentage of O157 positives found by the establishment's
statistically-based sampling program for finished ground
beef for this period was 0.141%. You then review all of the
establishment's microbiological testing records from April
1, 2006 through September 30, 2006. Again, no tests were
conducted on the incoming product. However, you find that
the percentage of O157 positives found by the
establishment's statistically-based sampling program for
this finished ground beef product for this period was
0.189%.
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 0.141% on March
31, 2006 to 0.186% 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. The same suppliers and
the same prerequisite program requirements are in place for
both periods of time except that one new supplier of beef
manufacturing trim was added in June 2006. A review of the
written cold storage and handling procedures was conducted
and the 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.
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. The sampling procedures for ground
beef do not change during the high prevalence season (i.e.,
there is no enhanced testing, including more frequent
sampling). However, the written prerequisite program
procedures do specify that at least one sample of beef
manufacturing trim from each supplier will be conducted
weekly during the high prevalence season. No records appear
to be on file that demonstrate this enhanced testing of the
source materials was performed.
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
control procedures are met, you determine that the
establishment's total food safety system may not be
functioning as intended. You then contact your supervisor as
described in FSIS Directive 5,000.2 and FSIS Notice 63-06.
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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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