IKE Scenario 03-03 Update to FSIS Directive 10,010.1. Microbiological Testing Program for E. coli O157:H7 in Raw Ground Beef.

The next two IKE scenarios are designed to illustrate the update to FSIS Directive 10,010.1 provided in FSIS Notice 11-03 published on 4/18/2003. The Notice provides updated instructions to inspection personnel on some of issues covered by FSIS Directive 10,010.1, Microbiological Testing Program for Escherichia coli O157:H7 in Raw Ground Beef. FSIS issued the Notice because the prevalence of E. coli O157:H7 has been shown to be seasonal and begins to rise in April and May. As a result, the Agency needs to increase verification efforts at this time. Where inconsistencies exist, FSIS Notice 11-03 supercedes FSIS Directive 10,010.1.

You are an IIC at a very small plant that processes ground beef. The plant produces bulk ground beef in one pound packages and fabricated beef cuts for hotels, restaurants and Institutions (HRI). The plant receives all of its bone-in (half and quarter carcasses) beef and all of its boneless beef and beef trim used in the grinding process from one supplier. The plant also uses the trim generated from their HRI fabrication process in their ground beef process.

The plant has determined that E. coli O157:H7 is not a hazard reasonably likely to occur in their operation. As part of a pre-requisite program, the establishment has specified that product testing be conducted by the supplier (i.e. purchase specifications). As a result, the supplier has implemented one or more CCP(s) to prevent, eliminate or reduce to acceptable levels the E. coli O157:H7 food safety hazard. The ground beef plant specifically requires that its supplier test all lots of raw commodity beef that it receives. This beef must test negative before it is allowed to be used in either process at the ground beef plant. The ground beef plant routinely holds all potentially affected product when FSIS collects a verification sample, pending laboratory results.

You have just received a sample collection request form (FSIS Form 10210.1-3) with instructions to collect a ground beef sample for E. coli O157:H7. In order to prepare for the collection of sample, you thoroughly review the sample request form (see attached sample form), FSIS Directive 10,010.1 and FSIS Directive 10,210.1 attachment 2, Amendment 3. Then, you carefully review the updates addressed in FSIS Notice 11-03.

In accordance with FSIS Notice 11-03, you understand that a raw ground beef sample is to be taken whenever you receive a sample request form for sampling project MT03. After consulting with the Technical Service Center (TSC) you know this means that you should disregard the instructions stated in Directive 10,010.1 section VI. B. This section precludes sampling for E. coli O157:H7 under certain circumstances (i.e., plants that conduct routine daily testing; when suppliers certify that each lot has been tested and found negative for E. coli O157:H7; or when establishments use validated pathogen reduction interventions on beef carcasses to routinely verify the effectiveness of the interventions through testing for E. coli O157:H7 and they prevent the use of boneless beef or carcasses from outside sources). The TSC also told you that FSIS Directive 10,010.1 will be revised to reflect this change in the near future.

At a randomly selected time, you aseptically collect a sample from the current day's production. In this case, you collect the sample in its final packaged form to ensure that the sample is representative of the plant's process. As always, you have provided plant management with sufficient notification of the sample collection so that they may hold the affected lot of product, if they wish. You timed the notification based on your knowledge of the plantís production process. You also recommended that the establishment hold the sampled lot; pending laboratory results (see FSIS Notice 47-02).

After further consultation with the TSC you know that although you have collected the sample, you are not to ship the sample until the plant has conducted their pre-shipment review for that sampled lot of product. The TSC also explained that despite the instructions in Directive 10,210.1, samples held more than one night should be frozen. Again, you remember that the Directive will be revised to reflect this change in the near future.

In preparation for shipping the sample, you complete the information requested on FSIS Form 10,210-3 (sample request form), including the new information requested in Block 28 concerning volume of product produced at the establishment. The TSC has explained to you this information is being collected to assist the Agency with future development of risk-based verification activities. In order to properly fill in this information, the TSC explained that in contrast to the statement in Notice 11-03, which indicates that inspection personnel are to obtain this information from the plant's pre-shipment clearance records, that you may estimate the volume amount based on your knowledge of plant activities and history.

Finally, after you verify that the pre-shipment review has been conducted, you ship the sample to the lab on the next available Federal Express service.



For IKE related questions, send mail to ike@fsis.usda.gov. For all other general questions, send to Tech Center address listed below.