dark overlay
nav button USDA Logo

FSIS

Web Content Viewer (JSR 286)

Actions
Loading...

Web Content Viewer (JSR 286)

Actions
Loading...

Web Content Viewer (JSR 286)

Actions
Loading...

Web Content Viewer (JSR 286)

Actions
Loading...

Web Content Viewer (JSR 286)

Actions
Loading...

Purpose:

Online References
IKE Scenario 09-06: 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 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.
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