FSMA contains language that states FDA may, by regulation, exempt or modify the requirements for
compliance under the hazard analysis and preventive controls section with respect to facilities that are solely
engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that
are not exposed to the environment.
Within its supplemental CGMP and preventive controls rules for human food and animal feed/pet food, FDA has
proposed that facilities solely engaged in storing raw agricultural commodities – such as grains and oilseeds –
would be exempt from the regulations’ requirements. In doing so, FDA clarified that being “solely engaged in
storage” encompasses activities that grain elevators perform to safely and effectively store grains and oilseeds.
For example, FDA’s current position is that, among others, the activities of drying, screening, blending and
fumigation of grains and oilseeds inherently are associated with being “solely engaged in storage.”
