On Aug. 20, 2015, the Food Safety and Inspection Service (FSIS) issued Directive 10,010.1, Rev. 4 (http://bit.ly/regleg1015). This directive instructs inspection program personnel (IPP) on how to conduct shiga toxin-producing Escherichia coli (STEC) sampling activities at establishments producing raw beef products, including veal and not-ready-to-eat beef. This directive is limited to sampling activities and is discussed below. FSIS also issued a separate directive for other agency STEC verification activities, 10,010.2, which will be discussed in next month’s column.

One purpose in issuing the revised directive is to improve the selection of establishments and products for sampling. Since sampling is scheduled through the Public Health Information System (PHIS), the directive instructs the IPP review the plant profile so that it is complete and correct. FSIS noted that incomplete profile information has resulted in scheduling incorrect sampling tasks. The IPP are to review and complete the sections on the raw beef products manufactured at the establishment (including whether raw materials were purchased or generated on site) and the volume of each, so appropriate sampling projects can be assigned at the proper frequency. Upon updating the plant profile, the IPP are to share the information with establishment management to ensure accuracy.

On collecting of samples, the IPP are to provide the establishment with adequate notice of sampling so the establishment can comply with the requirement to hold product implicated by a pending agency sample.

As to product implicated by a sample, the IPP are to advise the establishment that it is responsible for determining what product is represented by the sample. The directive provides guidance on determining the implicated product.

• Clean-up to clean-up by itself is insufficient to support a lot definition.
• Product implicated could be expanded if there is potential cross-contamination through improper sanitary dressing, insanitary contact surfaces or improper employee hygiene.
• Product from same source, as well as carry over or rework, may implicate other lots using the same source materials unless the establishment has a basis to justify lot separation, such as:
  • Microbial testing or
  • Processing interventions that limit or control STEC contamination.

If the IPP have questions on the establishment’s definition of the lot, they are to contact an EIAO. As to the actual collection of the sample, the directive:

• Provides a step-by-step guide with illustrations on how to collect the samples,
• Instructs IPP to collect only one type of trim or other components when sampling,
• Requires the sample be collected in an aseptic manner,
• Specifies raw ground product be sampled in the final package whenever practical, and
• Notes that the IPP are to collect supplier information at time of sampling.

If there is a positive finding, the IPP at the establishment with the positive STEC (and, when applicable, the IPP at the supplying slaughter and processing establishments) will perform directed HACCP and sanitation verification tasks and, at the supplying slaughter establishment, a directed beef sanitary dressing task.

PHIS will automatically schedule follow-up sampling:

At the establishment with the positive, the IPP are to collect 16 samples (or 8 if the establishment produces less than 1,000 pounds per day of the product) of the type of product testing positive for STEC and continue sampling until there are 16 (or 8 where appropriate) consecutive negative results. If the establishment makes both trim and ground, the IPP are to sample trim.

At the supplying slaughter establishment, the IPP are to sample depending on the circumstances:

• If the slaughter supplier was the only supplier or was previously entered into STEPS within the past 4 months, 16 samples (or 8 for very small plants). A positive during follow-up will trigger additional samples until there are 16 (or 8) consecutive negative results.
• If the slaughter supplier was not the only supplier and was not entered into STEPS within the past 4 months, a single sample will be taken.
• In the case of a positive AMS raw ground sample, the IPP are to collect samples until 8 consecutive negative samples are received.

In addition, the district office is to schedule a “for cause” Public Health Risk Evaluation (PHRE) at the establishment with the positive result and, if warranted, take appropriate enforcement actions, e.g., NOIE or schedule a “for cause” Food Safety Assessment (FSA). In terms of action at the supplying establishment, the district office will take action based on the findings of the IPP and the EIAO.

The directive is intended to improve the efficiency and effectiveness of STEC sampling. In this regard, establishments should ensure the accuracy of their PHIS plant profile so that samples are scheduled as appropriate; that all product implicated by the sample is held; and that their systems are operating as intended so if there is a positive STEC result, it represents a random event, not a systemic problem. NP