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Expansion of FSIS Non-O157 Toxin-producing Escherichia Coli (STEC) Testing to Additional Raw Beef Products

FSIS Notice 06-23
Issue Date Jan 27, 2023
Expiration Date Feb 01, 2024
Full Notice
FSIS Notice 06-23

DO NOT IMPLEMENT THIS NOTICE UNTIL FEBRUARY 1, 2023.

  1. PURPOSE
    This notice informs inspection program personnel (IPP) at official establishments and official import inspection establishments about the expansion of routine verification testing for six non-O157 Shiga toxin- producing Escherichia coli (STEC) that are adulterants. Currently, FSIS only tests beef manufacturing trimmings for non-O157 STEC. This testing will be expanded to ground beef, bench trim, and other raw ground beef components. FSIS is also merging the individual E. coli O157 and non-O157 STEC reported results into a single "Shiga Toxin-Producing E. coli" reported result. There are no changes to the sample collection procedures for these projects or product eligibility. IPP should continue to follow the sample collection procedures located in FSIS Directive 10,010.1, Sampling Verification Activities for Shiga Toxin- Producing Escherichia coli (STEC) in Raw Beef Products.
  2. BACKGROUND
    1. On November 18, 2022, FSIS announced in the Federal Register (87 FR 69242) that it will begin analyzing all raw beef samples for non-O157 STEC. Currently, FSIS tests domestic beef manufacturing trimmings samples (MT60) and imported beef manufacturing trimmings samples (MT51) for E. coli O157:H7 and six non-O157 STEC. Beginning February 1, 2023, FSIS will implement routine verification testing for the six adulterant non-O157 STEC (O26, O45, O103, O111, O121, and O145) in all raw beef sampling projects subject to FSIS STEC testing. These products include raw ground beef (MT43), bench trim (MT65), other raw ground beef components (MT64), imported ground beef samples (MT08), and all associated follow-up sampling in response to positives. All raw beef samples are also co-analyzed for Salmonella.
    2. FSIS has fully aligned the testing criteria for E. coli O157 with that for non-O157 STEC as announced in the Federal Register (87 FR 69242) on November 18, 2022. Under the updated criteria, a sample is confirmed positive if it has an stx gene, an eae gene, and is identified by the laboratory as O157, O26, O45, O103, O111, O121, or O145. This update does not affect current FSIS laboratory protocols leading to the reporting of potential and presumptive STEC positive results.
  3. EXPANSION OF ROUTINE VERIFICATION TESTING
    Table 1. Comparison of previous analyses and expanded analyses by project code.
    Project Code Product Type Previous Analyses Expanded Analyses
    MT60_C Beef manufacturing trimmings O157 STEC,
    6 non-O157 STEC,
    and Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT64 Raw ground beef components other than trim O157 STEC and
    Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT65_C Bench trim derived from cattle not slaughtered onsite O157 STEC and
    Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT43 Raw ground beef products O157 STEC and
    Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT05 Retail ground beef products O157 STEC and
    Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT08 Imported ground beef products O157 STEC and
    Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT51 Imported beef manufacturing trimmings O157:H7 STEC,
    6 non-O157 STEC,
    and Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT51 Imported other raw ground beef components O157 STEC and
    Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT44,
    MT52_C,
    MT53_C,
    MT44T_C    		 Follow-up sampling in response to a positive result on domestic products O157 STEC and
    Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT08 Follow-up sampling in response to a positive result on imported
    ground beef products    		 O157 STEC and
    Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT51 Follow-up sampling in response to a positive result on imported beef manufacturing trimmings O157 STEC,
    6 non-O157 STEC,
    and Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
    MT51 Follow-up sampling in response
    to a positive result on imported other raw ground beef components    		 O157 STEC and
    Salmonella    		 O157 STEC,
    6 non-O157 STEC,
    and Salmonella
  4. AWARENESS MEETING WITH PLANT MANAGEMENT
    1. Upon issuance of this notice, IPP at beef establishments that produce product(s) listed above or at import establishments that receive raw beef product(s) listed above are to review the information in this notice with establishment management during the next weekly meeting. IPP are to advise establishment management that the additional analyses will begin on or after February 1, 2023. IPP are to explain that, consistent with current requirements, establishments are required to hold the sampled production lot pending the receipt of STEC sample results, and positive product is considered adulterated unless it is further treated to destroy the pathogen.
    2. IPP are to document the awareness meeting in a memorandum of interview (MOI) as described in FSIS Directive 5010.1 section IV.
  5. SAMPLE RESULTS REPORTING
    1. FSIS is merging the individual E. coli O157 and non-O157 STEC reported results into a single "Shiga Toxin-Producing E. coli" reported result in the Laboratory Information Management System (LIMS)-Direct and the Public Health Information System. The "Escherichia coli serogroup" result will be reported, and that result will contain the serogroup(s) identified during testing (e.g., O26, O157) (See attachment). The change to results reporting will occur automatically. There is no action required by IPP or the establishment.
    2. LIMS-Biological Information and E-mail System (BITES) notifications will be updated to include this new information. The BITES notifications will include the identified E. coli serogroups in both the subject line and body of the message. See Attachment for comparison examples of previous and new result reports.
  6. QUESTIONS
    Refer questions regarding this notice to your supervisor or as needed to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select Sampling as the Inquiry Type.

    NOTE: Refer to FSIS Directive 5620.1, Rev. 1, Using askFSIS, for additional information on submitting questions.