|IKE 04-07 (Revision 1):
Experimentation with On-line Poultry Reprocessing In Accordance with 9 CFR 381.3(b)
Purpose: This IKE is designed to help
inspection program personnel understand verification
activities and control actions when performing inspection of
on-line reprocessing (OLR) systems in poultry slaughter
Scenario: You are an off-line inspector
assigned to a poultry slaughter establishment with an
experimental OLR system that is not a CCP in the establishment's
HACCP plan. Today's daily task list includes 04C04 and you decide
to verify that the experimental on-line reprocessing system meets
the regulatory requirements.
Discussion: You are aware that OLR systems
do not comply with the requirements of 9 CFR 381.91(b)(1).
You are also aware that, in specific cases, 9 CFR 381.3(b),
authorizes the Administrator to waive regulatory
requirements to permit experimentation, so that new
procedures, equipment, and processing techniques can be
tested to facilitate definite improvements. You are aware
that FSIS permits OLR experimentation in accordance with 9
CFR 381.3(b) only after the official establishment submits
an experimental protocol and obtains a "No Objection" letter
A "No Objection" letter sets out the conditions under which
the official establishment can use the technology. The "No Objection"
letter might set out one or more of the following
Depending on the experimental protocol, the "No Objection"
letter may identify additional conditions.
- Submission of experimental data at specified frequencies
- Written notification of additional equipment installations
- Written notification of equipment modifications
- Notification of related regulatory compliance requirements
- Requirements to conduct employee information and
Determination: First, you request access to
the official establishment's experimental protocol and FSIS
"No Objection" letter for the experimental OLR system. You
review the documents to familiarize yourself with the
experimental protocol and identify the specific conditions
set out in the "No Objection" letter. Next, you proceed to
the slaughter department and verify the establishment's
operation of the experimental OLR system against the
experimental protocol and conditions set out in the "No Objection"
letter. You observe that the official
establishment implements the experimental protocol, but
fails to meet one of the specific conditions set out in the
"No Objection" letter.
You inform the official establishment of your findings. You
take an appropriate regulatory control action in accordance
with 9 CFR 500.1(a) and attach a US Reject Tag to the OLR
system equipment. You document your findings/actions on a
Noncompliance Record. You enter 9 CFR 381.91(b)(1) in Block
6 and 04C04 in Block 8. You mark the checkboxes for
"PRODUCT" and "Protocol" in Block 9C. In the narrative, you
describe the specific conditions set out in the "No Objection"
letter with which that the establishment failed
to comply. Once the official establishment complies with the
conditions set out in the "No Objection" letter, and after
you verify compliance against the conditions set out in the
"No Objection" letter, you remove the US Reject Tag.
Last Modified: Aug 31, 2007