IKE Scenario 01-05 - Establishment Notification Prior to Sampling Ready-to-Eat Product: Process Example 1-Brine Reused for Multiple Days
You are a GS- 9 CSI assigned to a large processing facility which manufactures hot dogs which you verify under the 03G HACCP procedure code. The establishment uses Alternative 2 (post lethality treatment) to meet the regulatory requirements of 9 CFR 430. The product is cooked in a semi-permeable casing and chilled in a brine solution. The establishment reuses the brine for five consecutive days prior to disposal. The brine reuse is addressed in the company's hazard analysis and meets the requirements of 9 CFR 416.2(g)(2).
On Wednesday June 1, you receive an OPHS Directed Sample Request (FSIS Form 10, 210-3, Requested Sample Programs), for Project Number RTERISK1.
You are aware that the purpose of Agency's sampling activity is to verify that the process, as designed and under normal operations, is producing a safe product. Because of that fact, you would not expect the company to alter their operations (e.g. dispose of the brine chilling solution at the end of each production day) once you notify plant management that you will be collecting a sample, although the company can choose to do so after the sample has been collected.
Based on your knowledge of the establishment's production operations, including the fact that the company reuses their brine for five consecutive days, you determine that you will collect the sample during the next full week of operation, which begins on Monday June 6. Because the company reuses the brine solution and does not dispose of it between batches, there will potentially be five production days of product which could be affected if there is a positive test result. You determine that you will need to notify plant management of your intention to collect the sample by the beginning of operations next Monday. This is ensure that you provide plant management as much advance notice as possible in order to allow the establishment to hold any product that they determine may be affected in the event of a positive sample result.
You arrive at the establishment on Monday morning prior to the beginning of operations where you meet with the plant manager regarding the sample collection. You follow the instructions in FSIS Directive 10, 210.1, Project Number RTERISK1 concerning Establishment Management Notification and advise plant management that at some randomly selected time during the week's operations, you will be collecting a sample of the hot dogs. You also advise the plant manager that you are providing them this information early enough in the process to ensure that they will have the opportunity to hold all affected product, should they elect to do so.
You return to the government office and use the random number generator on your FSIS computer to select a day and time to collect your sample. You determine that the collection day/time will be Wednesday, June 8, at 10:00 a.m. On Wednesday at 9:45 a.m. you proceed to the plant manager's office where you notify him that you are on your way to the packaging area to collect your sample. While in the manager's office, you provide further notification of the sample collection to the plant manager by supplying him with the sampling notification form (LW-A-0032, To: Establishment management) which is included in each sample shipment box. The plant manager elects to accompany you in order to collect a companion sample. You follow the instructions in FSIS Directive 10, 210.1 and 10, 240.4 and collect the sample of packaged product at 10:00 a.m. , after the product has received the post lethality treatment. The plant manager decides to discard the current brine solution after the sample is collected to limit the amount of any potentially affected product.
You hold the sample under refrigeration until the company has completed pre-shipment review. At that time, you contact Fed-Ex for pick-up and prepare the sample for shipment and seal it according to the instructions in FSIS Directive 7355.1 (Rev.2, Amend. 1), Use of Sample Seals for Laboratory Samples and Other Applications. The sample is picked up by Fed-Ex before the close of business that day.
You complete your duties for the day by documenting an unscheduled 05B02 procedure on the PBIS procedure schedule.