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| IKE Scenario 01-08:
FSIS Verification of 9 CFR 416.2(d) Regarding Frozen
Condensate in Product Freezers (Part II) |
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IKE scenarios are a tool that FSIS inspection program personnel can use to better understand Agency policy. In addition, the IKE scenario result may be just one approach to address a specific situation and is not intended to be a definitive answer, indicating there may be multiple approaches.
Purpose: This IKE is the second in a
series to highlight the questions that inspection program
personnel should ask when verifying compliance with 9 CFR
416.2(d), Ventilation. The instructions in
FSIS Directive 5000.1,
Verifying an Establishment’s Food Safety System, provide the
basis for this scenario.
Situation: You are a recently promoted
Consumer Safety Inspector (CSI) assigned to a processing
facility that produces a variety of fully cooked meat and
poultry products. The establishment has elected to utilize
separate freezers to store raw meat and poultry ingredients
and finished products.
Today's PBIS schedule states that you are to perform
Sanitation Performance Standard (SPS) procedure 06D01. You
have randomly selected the regulatory requirements of 9 CFR
416.2(d), Ventilation, to verify throughout the facility.
Because this is your first time in the facility, and because
you know that it is important to learn the operation, you
ask the plant manager if he would like to join you as you
conduct your tour of the operation. He agrees and you
proceed to walk through multiple areas of the facility. You
explain to the plant manager that as part of your tour, you
will be observing whether the ventilation is adequate to
control odors, vapors, and condensation to the extent
necessary to prevent the adulteration of product and the
creation of insanitary conditions. You evaluate the
establishment’s control of odors, vapors and condensation in
each of the product processing areas throughout the
facility. You determine that the measures that the
establishment has in place today in the processing areas are
adequate to meet the regulatory requirement of 9 CFR
416.2(d). However, because you are aware that the control of
ventilation is also necessary to prevent the creation of
insanitary conditions that may affect products held in
product storage areas, you also elect to observe the
finished product storage freezer.
Upon entering the finished product freezer, you observe an
accumulation of ice on the overhead doorframe of the freezer
entrance. Further investigation reveals that there is an
accumulation of ice on an overhead freezer unit and support
structures as well as on closed boxes of product stored
below the freezer unit. At this point, you determine that
you will need to gather additional information by asking
question such as, but not limited to:
- What conditions do you see in the freezer that could lead to the formation
of ice over the door and on the overhead freezer unit?
- Is product affected (i.e. contaminated or adulterated) by the ice?
- Is there evidence that the establishment has initiated actions to address
the observed conditions?
You observe the conditions over the entrance door and see
that there is a damaged seal along the top of the door that
is allowing warm air to continually enter the freezer. You
then further investigate the boxes stored below the freezer
unit and note that they, although covered with ice, are
intact. You request that the plant manager open several
boxes so you can observe the conditions of the package
product inside. In doing so, you see that the ice has not
contacted the fully packaged product inside the boxes. The
plant manager then ensures that the boxes are free from ice
and adequately resealed. You then survey the overhead
freezer unit and observe a build-up of ice on the drip pan
as well as on the support structures of the freezer unit.
Based on what you have seen, you determine that the fully
packaged product is not adulterated. However, you must now
determine whether the presence of the ice has created an
insanitary condition, and whether or not the ice is an
indication of inadequate ventilation or an indication of
inadequate facilities maintenance. You continue to ask
questions, such as the following, in order to determine
whether an insanitary condition, and therefore a
non-compliance, exists:
- Is this amount of ice expected to be present above the freezer door and on
the freezer unit?
- Is this amount of ice expected to be contacting boxed product?
- Is there evidence that the establishment has not been pro-active in
maintaining the facility (i.e. is there evidence that the ice has been there for
a long time)?
Discussion: As you think about the
conditions you have observed, you are aware that opening and
closing the door throughout the production day can allow
warm air from outside the freezer to contact the cold
doorframe. In addition, you understand that improperly
maintained door seals can allow additional warm air to enter
the freezer when the door is closed, further allowing the
creation of ice on the overhead doorframe. You suspect that
the drip pan drain line is plugged and that during the
defrost cycle, water flows out of the drip pan onto the
support structure and the boxes below and then refreezes
when the freezer unit re-starts. You consider whether the
apparent lack of repair of the drip pan has lead to the
build-up ice on the freezer unit’s support structure and on
the boxes of stored product.
You discuss your observations with the plant manager and,
although you have drawn some conclusions about what you have
observed, you understand that management will have to
determine the cause of these observed conditions. He informs
you that the only full time maintenance person quit two
months ago, and that it has been hard to get basic repairs
done. He is aware that the drip pan is plugged, but he just
hasn’t been able to get it repaired. He thought the ice on
the boxes was not an issue because the boxes were closed. He
indicates that he was not aware that the door seals were
damaged.
Resolution: Based on your observations
throughout each of the product processing areas, you
conclude that the establishment has controlled odors,
vapors, and condensation in accordance with the regulatory
requirement of 9 CFR 416.2(d) in those areas. However, based
on your observations of the product storage freezer, you
determine that the accumulation of ice on the door frame,
drip pan, product boxes, and freezer unit support structures
has created an insanitary condition. Even though you
observed the non-compliance while performing the 06D01
procedures and while verifying the ventilation requirements
of 9 CFR 416.2(d), the non-compliance is directly associated
with the establishment’s lack of maintenance of the facility
and should be documented accordingly. You carefully describe
the insanitary conditions and document the non-compliance on
a Non-compliance Record (NR) as 06D01/Facility/Structural
citing 9 CFR 416.2(b) as the appropriate regulation.
Access the IKE Scenario home page and review previously posted IKEs from: https://webarchive.library.unt.edu/eot2008/20080921172242/http://www.fsis.usda.gov/FSIS_Employees
/IKE_Scenarios/index.asp
This information should also be shared with plant management.
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Last Modified: January 15,
2008 |
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