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9 CFR 416.2(d): Ventilation

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The scope of 9 CFR 416.2(d)is limited to ventilation as a means of control for odors, vapors, and condensation.

Ventilation adequate to control odors, vapors, and condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions must be provided.

  • Ventilation is “adequate to control” if it is adequate to positively influence the presence of odors, vapors, or condensation.  Ventilation adequate to control is not ventilation adequate to prevent or eliminate odors, vapors, or condensation.  
  • Ventilation is “to the extent necessary” if it prevents adulteration, not if it prevents odors, vapors, or condensation.

Odors, vapors, and condensation an unavoidable consequence of operating an official establishment.  Per askFSIS FAQ titled ‘Condensation,’ “it is not feasible to … completely eliminate condensation, odors, and vapors.”  9 CFR 416.2(d) does not prohibit odors, vapors, and condensation.  9 CFR 416.2(d) requires control “to the extent necessary to prevent adulteration.”

Allegations of noncompliance based on the presence ofodors, vapors, or condensationalone are unsupportable. Allegations of noncompliance that link the presence ofodors, vapors, or condensationto conditions whereby product may be contaminated with filth or rendered injurious to health are supportable.  For example:

  • Foul odors emanate from the adjacent inedible rendering facility, permeate the slaughter room, and mask the smell of normal and diseased tissue.  Conditions whereby product may become contaminated with filth or rendered injurious to health exist.  The establishment turns on exhaust fans, which reduce the odor intensity to a point where differentiation between normal and diseased tissue is possible.  Ventilation adequate to control odors to the extent necessary to prevent adulteration of product and the creation of insanitary conditions is provided.  9 CFR 416.2(d) compliance exists.
  • Condensation forms on the ceiling of refrigerated semi-trailers during loading operations.  The refrigeration unit is operating at maximum capacity.  Employees ignore the condensation, which drips onto packaged product placed in the semi-trailer.  Conditions whereby product may become contaminated with filth or rendered injurious to health exist.  9 CFR 416.2(d) noncompliance exists.
  • Seasonally hot and humid weather results in dripping condensation on the north two rails in the carcass cooler.  No amount of ventilation is adequate to control the dripping condensation.  The establishment temporarily takes the north three rails out of service and identifies them accordingly.  Ventilation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions is provided.  9 CFR 416.2(d) compliance exists.
  • A refrigeration engineer determines that adding additional refrigeration capacity and ventilation in the ready-to-eat product storage cooler will not control the condensation dripping from refrigeration units.  The establishment installs permanent drip pans to catch dripping condensation and deliver it to the floor drain.  Ventilation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions is provided.  9 CFR 416.2(d) compliance exists.
  • Intermittent condensation is a chronic problem above the portal between the freezer and raw not ground operation.  The establishment implements a procedure to monitor the location and physically remove any condensation present to prevent adulteration of product and the creation of insanitary conditions.  Employees fail to implement the procedure.  Conditions whereby product may become contaminated with filth or rendered injurious to health exist.  9 CFR 416.2(d) noncompliance exists.

Condensation is the transition from the gas state directly to the liquid state.  Sublimation is the transition from the solid state directly to the gas state.  De-sublimation, or deposition, is the transition from the gas state directly to the solid state. The door seal on the freezer door is dysfunctional.  Warm, moist air enters the freezer and deposits on packaged product as frost buildup, which melts and soaks into the packaging material when packaged product is removed from the freezer.  Conditions whereby product may become contaminated with filth or rendered injurious to health exist; however, the problem is not ventilation.  The problem is a failure to keep the establishment buildings, including the structures in good repair to allow for storage of product in a manner that does not result in product adulteration or the creation of insanitary conditions.  9 CFR 416.2(b)(1) noncompliance, not 9 CFR 416.2(d) noncompliance exists.

About the author

Michael Fisher

Husband of one. Father of three. Grandfather of six. Soldier. Traveler. Advisor. Friend.

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