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9 CFR 416.2(b)(4): Edible/Inedible Separation

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The scope of 9 CFR 416.2(b)(4)is limited to the physical space where edible and inedible product are processed, handled, and stored.  

Rooms or compartments in which edible product is processed, handled, or stored must be separate and distinct from rooms or compartments in which inedible product is processed, handled, or stored, to the extent necessary to prevent product adulteration and the creation of insanitary conditions.

  • Physical space is separate when edible and inedible product do not share the same physical space at the same time.  
  • Physical space is distinct when the space occupied by edible and inedible product is clearly identified as edible and inedible. 

9 CFR 416.2(b)(4)requires rooms or compartments where edible and inedible product are processed, handled, and stored to be “separate and distinct,” not ‘separate or distinct.’ Many FSIS inspection program personnel (IPP) interpret ‘separate’ as requiring physically separate rooms or compartments, each enclosed by walls, floor, and ceiling, which is false. Many IPP also interpret ‘distinct’ to require visual identification of the room or compartment, which is also false.  The meaning of the terms ‘room’ and ‘compartment’ is not limited to a division of a building enclosed by walls, floor, and ceiling.  A room or compartment can also be a space that can be occupied or where something can be done.  Edible and inedible product can be processed, handled, and stored in the same division of a building enclosed by walls, floor, and ceiling and still be “separate and distinct.”

Allegations of noncompliance based on the presence of edible and inedible product processed, handled, or stored in the same division of a building enclosed by walls, floor, and ceiling alone are unsupportable.  Allegations of noncompliance that link the presence of the presence of edible and inedible product processed, handled, or stored in the same division of a building enclosed by walls, floor, and ceiling with an absence of separation and distinctness are supportable.  For example:

  • A cardboard bulk storage bin labeled ‘edible meat trim’ placed in the same product storage cooler, and on the opposite wall from a cardboard bulk storage bin marked ‘inedible’ is “separate and distinct.”  Edible and inedible product do not share the same physical space at the same time, and the space taken up by the storage bins is clearly identified as edible and inedible.  9 CFR 416.2(b)(4) compliance exists.
  • A cardboard bulk storage bin labeled ‘edible meat trim’ placed in the same product storage cooler adjacent to a cardboard bulk storage bin marked ‘inedible’ is distinct, but not separate.  The edible and inedible product share the same physical space at the same time.  9 CFR 416.2(b)(4) noncompliance exists.

An unmarked cardboard bulk storage bin containing edible meat trim placed in the same product storage cooler, and on the opposite wall from an unmarked cardboard bulk storage bin containing ‘inedible scraps’ is separate but not distinct.  The space taken up by the storage bins is not clearly identified as edible and inedible.  9 CFR 416.2(b)(4) noncompliance exists.

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Michael Fisher

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

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