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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 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 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

 

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