On June 4, six non-O157 STECs (O26, O45, O103, O111, O121, O145) officially became per se adulterants in various raw beef products. On that date, FSIS began analyzing raw beef manufacturing trimmings for these six.

 

What product will FSIS analyze for non-O157 STECs?

FSIS will begin by limiting the analysis to samples of beef trim for manufacturing as defined in FSIS Directive 10,010.1, Rev. 3, at § VI. B. 1. These products are sampled under the MT60 program (formerly MT50) at a slaughter establishment only.

Samples will be analyzed for non-O157 STEC if the trim is from cattle slaughtered on or after June 4th. If product from an earlier slaughter date is in the sampled lot, the product will only be analyzed for E. coli O157:H7.

If there is a positive FSIS finding for E. coli O157:H7 in a raw product, any follow-up samples of beef trim (MT52 and MT53) based on that positive will also be analyzed for non-O157 STEC.

Through a series of questions, PHIS will ensure the inspection program personnel (IPP) have accurately identified product for non-O157 analysis before printing a sample submission form.

Reporting results

FSIS will report the results of the E. coli O157:H7 and non-O157 STEC analysis together. FSIS does not expect the non-O157 analysis to delay the reporting.

What happens if there is a positive non-O157 STEC finding?

FSIS will respond in the same manner as it currently does for a positive E. coli O157:H7 sample, except no “for cause” FSA will be scheduled during the first 90 days.

As to product implicated by a positive non-O157 STEC, FSIS will accept the lotting used by an establishment for E. coli O157:H7 testing, even if the lot tested negative for E. coli O157 (absent evidence of a high event period). For example, if there is a positive in a five combo lot of trim, then only that lot is implicated by a non-O157 STEC positive, regardless of that lot’s E. coli O157:H7 result.

On corrective actions for an agency or other positive test, the agency will verify the establishment is taking appropriate action depending on whether non-O157 STEC is a hazard reasonably likely to occur in the HACCP plan (§ 417.3(a)) or not (§417.3(b)). If an establishment did not determine non-O157 STEC is a hazard reasonably likely to occur, the agency will not expect that the establishment institute a testing program for non-O157 STECs (if it does not have one), or include non-O157 STEC in the HACCP plan, provided the establishment’s current plan addresses E. coli O157:H7.

Following a non-O157 positive, FSIS will assess the effectiveness of the sanitary dressing procedures; especially “how the establishment is preventing visible contamination on the carcass at all stages of the hide removal process.”

FSIS present expectations for establishment programs

FSIS will not require, nor take any enforcement action, if an establishment (slaughter or processing) does not reassess its HACCP plans or begin non-O157 STEC analysis on June 4th. That said, FSIS expects establishments to use the next 90 days to consider how to address non-O157 STEC in their HACCP systems. This could include gathering data to support/validate their handling of non-O157 STEC; documenting any HACCP reassessment; and, where applicable, assessing the establishment’s purchase specifications (Letters of Guarantee and Certificates of Analysis) to ascertain whether the non-O157 STEC are being controlled with the supplier’s E. coli O157:H7 controls. FSIS intends to survey at the end of the first 90 days to determine what establishments have done in this regard.

The non-O157 STEC adulteration policy applies NOW to all raw ground beef and component

At present, FSIS will only be testing raw beef trim for non-O157 STEC. One should not expect FSIS analysis of raw ground beef and other ground components until fall at the earliest. That said, the adulteration determination applies to all raw non-intact products or components. Consequently, if another federal or state agency, or a third party conducts its own non-O157 of raw ground beef or components, a positive finding would render the product adulterated and any implicated product in commerce would be subject to recall, provide FSIS recognizes the laboratory result pursuant to the criteria in Directive 10,000.1.