Farms, as well as restaurants and retail food establishments, are not required to register with FDA under the
Bioterrorism Act. Therefore, aside from the FSMA-mandated produce safety rule that applies to fruits and
vegetables, the law does not apply to farms that are exempt from the registration requirement.
Importantly, under FSMA, FDA has proposed to define “farm” in the following manner. Farm means an
establishment under one ownership in one general physical location devoted to the growing and harvesting of
crops, the raising of animals (including seafood), or both. The term “farm” includes establishments that, in addition
to these activities:
1. Pack or hold raw agricultural commodities;
2. Pack or hold processed food, provided that all processed food used in such activities is either consumed
on that farm or another farm under the same ownership, or is processed food identified in paragraph
(3)(ii)(A) of this definition; and
3. Manufacture/process food, provided that:
i. All food used in such activities is consumed on that farm or another farm under the same
ownership; orii. Any manufacturing/processing of food that is not consumed on that farm or another farm under
the same ownership consists only of:
A. Drying/dehydrating raw agricultural commodities to create a distinct commodity, and
packaging and labeling such commodities, without additional manufacturing/processing;
and
B. Packaging and labeling raw agricultural commodities, when these activities do not involve
additional manufacturing/processing.