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| IKE Scenario 01-07: Citing Relevant Regulations When Documenting
SRM Noncompliance
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Purpose: This IKE is issued in support of FSIS Notice 01-07. It is designed
to help inspection program personnel to understand that they need to include all relevant regulatory
citations when documenting noncompliance, including the failure to properly remove, segregate, or
dispose of specified risk materials (SRMs).
You are an off-line inspector assigned to an establishment that slaughters cattle of
various ages. You are familiar with FSIS Notices 9-04 and 5-04. From reading 9 CFR 310.22 you
are aware that cattle slaughter and processing establishments are required to develop, implement,
and maintain written procedures that are incorporated into their HACCP plan, or in their Sanitation
SOP or other prerequisite program for the removal, segregation, and disposition of SRMs.
Also, FSIS Notice 9-04 instructs inspection personnel to verify the establishment's implementation
of these procedures when performing HACCP or Sanitation SOP verification procedures, as appropriate.
The plant has a CCP for removing spinal cord from beef carcasses from cattle 30 months of age and older.
Today, unlike other days, you observed that a carcass marked as 30 months of age or older has a fragment
of spinal cord remaining after passing the CCP monitoring location. The QA technician was performing the
CCP monitoring procedure, but did not catch the fragment of spinal cord.
Is there a regulatory noncompliance? What actions should you take?
The carcass did not meet the critical limit specified for the CCP (i.e. spinal cord removed).
This is a HACCP monitoring noncompliance because the plant's monitoring procedure did not ensure
that every carcass met the critical limit. After the carcass passed the QA technician's monitoring
location, you notify the slaughter foreman, and point out the affected carcass. He notifies the QA technician,
who initiates corrective actions.
You proceed to the USDA office to document the noncompliance. You enter a result of "C" for
the scheduled 03J02 procedure, to indicate monitoring noncompliance. You select 9 CFR 417.2(c)(4)
from the list of available regulatory citations. Because you are aware that you must cite all
applicable non-complying regulatory citations you also select 9 CFR 310.22(d)(1) because the plant
has failed to implement it's procedures for removal of SRMs. Then you fully describe your findings
in the description block of the NR, including the nature of the SRM (spinal cord from bovine 30 months
of age and older) and your observation of how the plant failed to meet the critical limit of the CCP.
You present the NR to plant management.
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For IKE related questions, send e-mail to Ike@fsis.usda.gov. For technical or regulatory questions, send e-mail to TechCenter@fsis.usda.gov.
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Last Modified: February 2, 2007 |
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