|IKE Scenario 03-05
Establishment Notification Prior to Sampling Ready-to-Eat
(RTE) Product: Process Example 3-Brine Held for
You are a GS-9, CSI/IIC assigned to a small further processing facility that only manufactures fully
cooked and sliced roast beef and turkey breast products. The products are produced daily, using
Alternative 2 (post lethality treatment), which you verify under the 03G HACCP procedure code. Both the
roast beef and turkey breast products are placed into a semi-permeable bag for the lethality and
stabilization step. The company has determined that each smokehouse cook / run is a lot. Slicing
operations are conducted in separate departments with each department using one slicing line.Each
slicing line is designated to slice one lot of product. In addition, the company has elected to implement
a cleaning and sanitizing procedure, between each lot, as described in their pre-operational Sanitation
SOP. For the stabilization process, the company utilizes a brine solution, which is used continuously for
30 days. The establishment addresses the brine re-use in a prerequisite program where the brine is
pasteurized at the start of each production day to a temperature that is lethal to Listeria monocytogenes
(Lm) and Salmonella. In addition, the establishment verifies and documents the pH and salinity of the
brine, at a prescribed frequency each production day, to maintain a solution that will not support the
growth of Lm or Salmonella. The establishment QC office keeps documentation which validates the brine pH
and salinity levels in combination with the pasteurization process will maintain the brine in a
pathogen-free state. The brine re-use process in this prerequisite program meets the regulatory
requirements of 9 CFR 416.2 (g) (2).
Through your PBIS 03 verification activities, you have determined that:
1) The implementation of the prerequisite program, as written, will support the company's decision
that the brine chilling solution is not a potential source for Listeria or Salmonella
2) Slicing operations are conducted in separate departments, and
3) Each slicing line is cleaned and sanitized between lots, thus, only the product sliced on that specific
line will be affected product should an RTE sample return a positive result.
On Thursday June 30, you receive an OPHS Directed Sample Request (FSIS Form 10,210-3, Requested Sample Programs)
for Project Number RTERISK1.
As a critical thinker, you must determine (a) when to notify plant management of your intention to
collect the sample, (b) when you would need to collect the sample, and (c)determine a random sample
collection date, time and line.
You understand that the purpose of the Agency's sampling activity is to verify that the production
process, as designed and under normal operations, is producing a safe food product. Because of that fact,
you would not expect the company to alter its operations (e.g. discard the chiller brine solution) once
you notify plant management of your intent to collect a Ready-to-Eat (RTE) product sample, although the
establishment can choose to do so after the sample has been collected.
You are aware that you must notify plant management in advance of sample collection so that the
establishment has the opportunity to place all
product(s) which may be affected, on hold in the event a
positive result is returned.
Based on your knowledge of production operations and by using the random number generator on your FAIM
computer you determine a date, time and line number for collection of intact samples of July 19 at 1100
hours on slicing line 2. Based on Directive 10,240.4 and past history of product selection, you determine
to collect a sliced turkey breast sample.
Prior to the start of operations on July 19, you verbally notify the establishment QC manager of your
intent to collect intact samples of the sliced turkey breast product to be submitted for microbial
testing, sometime during the day's operations. Because the brine chilling solution is not a potential
source of Salmonella or Lm and because the beef and turkey products are sliced in separate areas and each
line is lot specific, you have provided management sufficient time to hold any product they determine may
be affected by a positive sample result. Prior to leaving the manager's office, you also provide a copy
of the written notification of the intended sample collection (Form LW-A-0032.00, To: Establishment
Manager, which is included in the return sample shipping container).
At 1050 hours, you proceed to the QC manager's office and advise her you are going to collect the required
intact products samples from slicing line two and that you will be holding the samples under
refrigeration, in the secured USDA section of the cooler, until the establishment has signed pre-shipment
review for that lot. Plant management chooses to accompany you to the turkey slicing line where you
follow the instructions in FSIS Directive 10,210.1 to collect the intact samples. The QC manager chooses
to collect a companion sample and also informs you that the entire lot of product that was sliced on line
two will be placed on company hold pending the company's results.
After you have verified that pre-shipment review has been conducted on the specific lot, you remove the
intact product samples from the secured area and prepare the samples for shipment according to the
instructions in FSIS Directive 7355.1 (Rev. 1, Amend.1) and contact Fed-Ex for a pick-up.
You complete your duties for the day by documenting an unscheduled 05B02 procedure into the schedule as performed.