| IKE Scenario 08-06: Verification Procedures Involving E. coli O157:H7 as
Described in FSIS Notice 63-06
Purpose: To remind inspection program
personnel how to assess information to ensure that the total
food safety system is functioning as intended. This IKE is
also intended to assist inspection program personnel in
verifying that the establishment is reacting appropriately
to the information generated for E. coli O157:H7 in raw
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 because the establishment's microbiological
testing program responds to the hazard analysis for the raw
not ground hazard analysis. 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. You find that the
percentage of O157 positives found by the establishment's
statistically-based sampling program for this period was
1.190%. You also notice that, for one week during August,
the rate of O157 positive results was much higher than for
any other one-week period during the high prevalence season.
You ask the HACCP coordinator if the establishment has any
records documenting that it has analyzed the microbiological
data for trends. You are told that it does not. In your
discussion with the HACCP coordinator, you inform him that
you noticed an upward trend in positive O157 results during
the high prevalence season of April through September. The
HACCP coordinator states that an upward trend during that
time of year is normal, and that therefore the establishment
did not feel it necessary to review trends during this
period. You also ask the HACCP coordinator whether the
establishment had implemented any corrective measures as a
result of the high percentage rate of positives at any time
during the high prevalence season, particularly for the one
week in August. The HACCP coordinator responds that
sometimes a spike occurs for periods of time, and therefore
no measures had been implemented.
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 do not believe that adulterated
product is in commerce because of the statistically based
sampling program is capable of detecting positive product.
You follow the instructions in FSIS Directive 5000.2 and
FSIS Notice 63-06 and contact the next level of supervision
of your findings.
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: November 16, 2006