IKE Scenario 04-03 Update to FSIS Directive 10,010.1. Microbiological Testing Program for E. coli O157:H7 in Raw Ground Beef.

This IKE scenario is the second of two that were 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 0157: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.

To continue with the previous scenario (IKE Scenario 04-03), you are an IIC at a very small plant that processes ground beef. The plant produces ground beef in one pound chubs for retail distribution and fabricates 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 though 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 previously randomly collected a one pound sample of ground beef (lot number 2-01) late Tuesday morning after the last FedEx pickup, so the sample was properly identified using the small bar codes from FSIS form 7355-2A/2B. You put one bar code on the bag containing the one pound chub and another bar code on the 10,210-3 sample form. You then secured the sample in the lock box in the plants freezer. On Wednesday morning you evaluate the plants HACCP records and find that the plant has completed the pre-shipment review for the lot of ground beef that you have sampled. You then proceed to pack the sample following the instruction in FSIS Directive 7355.1 (Use of Sample Seals for Laboratory Samples and Other Applications) and contact FedEx that a sample carton is ready for shipment. Prior to sealing the sample box, you double checked the name and address of the receiving laboratory in block 9 of the sample form to make sure it compares to the address on the FedEx Air Bill.

You’re aware that the sample was picked up by FedEx on Wednesday morning so you check LEARN on Thursday and find that the laboratory has received the sample. Following FSIS Directive 10,200.1 (Accessing Laboratory Sample Information via LEARN) you check LEARN again on Friday and find that the sample is listed as potential positive and , as a courtesy, inform plant management. Again, on Monday morning you check LEARN and find the sample listed as a presumptive positive.

As a critical thinker, what are your next actions?

· You notify plant management of the presumptive positive and inform them that if the sample is confirmed positive, that you will be collecting information regarding the supplier of the positive product as per FSIS Notice 47-02 (FSIS Actions Concerning Suppliers that may be Associated with Escherichia coli (E. coli) 0157:H7 Positive Raw Ground Beef Product).

· You verify whether the product was shipped or held by the plant pending sampling results.

· If the product was shipped, you advise plant management to start collecting the following information; Name of establishment, point of contact, phone number, supplier lot number and production date.

Upon returning to work on Wednesday morning you check LEARN and find the ground beef sample has been confirmed positive for E. coli O157:H7.

· You notify plant management of the positive result and request they provide you with the supplier information you requested from them previously.

· Plant management informs you that the lot of product that was sampled (200 pounds – lot # 2-01) is currently on QA Hold and is located in the shipping cooler.

· You return to the USDA office and complete an NR documenting the positive sample result. Shortly there after, you give the NR to plant management at which time they provide you with the requested supplier information.

· You email the supplier information for the positive ground beef sample to the district office contact, who for your district is the inspection coordinator, and you “cc” your circuit supervisor.

Since an NR was written on ISP code 03B01 because of the positive E. coli O157:H7; ISP code 03B02 should be performed as a follow up on that sampled production lot by checking all CCP’s from the beginning of the process of the sampled production lot through the pre-shipment review. Again, you’re aware the sampled production lot (lot #2-01) was placed on hold by the QC and is located in the shipping cooler.

Later that day plant management informs you that corrective action has been taken as per 9 CFR 417.3 and the positive lot of ground beef has been condemned and denatured. (Note: There may be other appropriate corrective actions for the positive lot of ground beef. This is the option the plant chose in this scenario.) Further, the HACCP plan was reassessed. Since PBIS procedure 03B01 is scheduled for today, you choose to verify that the “Corrective Action” regulatory requirement has been met.

· You proceed to the inedible room and find a 55 gallon drum, that is identified as “Inedible”, containing what appears to be about 200 pounds of ground beef that has been properly denatured to preclude its use as human food.

· You proceed to the plant QA office and review the corrective action log and find it has been completed. The record indicates that the HACCP plan has been reassessed as a result of the positive ground beef sample. The record further shows that the establishment has reemphasized the purchase specifications to the supplier as well as the consequences of not meeting these specifications, up to being dropped as a supplier. The establishment then evaluated all of the data from their pre-requisite program and determined that the supplier was in violation of the purchase specifications. After discussions with the supplier and analyzing their proposed actions, it was determined that the supplier was making appropriate changes to their program to prevent further shipment of positive product. The establishment also set up a more rigorous verification process of the supplier’s adherence to these purchase specifications by contracting with an outside auditor. At this point the establishment determined that the hazard was not reasonably likely to occur in their operation and did not make any changes to their HACCP plan. (Note: This is the establishment’s chosen action for this scenario, there are other potential solutions.)

Later that day the front-line supervisor calls you and reminds you that there will be no routine follow-up sampling conducted as a result of the positive sample. FSIS Notice 11-03 III (A)(6) revoked the follow-up sampling provisions that are in FSIS Directive 10,010.1 Section VI (E)(2). The front-line supervisor’s guidance to you is if the effectiveness of the plant’s proposed corrective and preventive actions were in question then further discussion would be necessary to develop a follow-up verification plan. The discussion may result in deciding to request through the district office additional sample request forms for collecting samples from subsequent lots of production. How many samples to request should be determined on a case-by-case basis. The district office will coordinate the generation of additional sample request forms through the TSC. The collection of additional samples will serve as a useful adjunct to the enhanced verification activities conducted in-house by the inspection team. Together, the results of these enhanced verification activities and the results from additional sampling will provide a meaningful measure of the overall effectiveness of the plant’s corrective and preventive actions.



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