Under 21 CFR 1.226(b), farms are not required to register. “Farm” is defined in
21 CFR 1.227 as:
(1) Primary production farm. A primary production farm is an operation under one
management in one general (but not necessarily contiguous) physical location devoted to the
growing of crops, the harvesting of crops, the raising of animals (including seafood), or any
combination of these activities. The term “farm” includes operations that, in addition to these
activities:
(i) Pack or hold raw agricultural commodities;
(ii) 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 management, or is processed
food identified in paragraph (1)(iii)(B)(1) of this definition; and
(iii) Manufacture/process food, provided that:
(A) All food used in such activities is consumed on that farm or another farm under the
same management; or
(B) Any manufacturing/processing of food that is not consumed on that farm or another
farm under the same management consists only of:
(1) Drying/dehydrating raw agricultural commodities to create a distinct commodity
(such as drying/dehydrating grapes to produce raisins), and packaging and labeling such
commodities, without additional manufacturing/processing (an example of additional
manufacturing/processing is slicing);
(2) Treatment to manipulate the ripening of raw agricultural commodities (such as by
treating produce with ethylene gas), and packaging and labeling treated raw agricultural
commodities, without additional manufacturing/processing; and
(3) Packaging and labeling raw agricultural commodities, when these activities do not
involve additional manufacturing/processing (an example of additional
manufacturing/processing is irradiation); or
(4) Secondary activities farm. A secondary activities farm is an operation, not located on
a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or
holding of raw agricultural commodities, provided that the primary production farm(s) that
grows, harvests, and/or raises the majority of the raw agricultural commodities harvested,
packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in
the secondary activities farm. A secondary activities farm may also conduct those additional
activities allowed on a primary production farm as described in paragraph (1)(ii) and (iii) of this
definition.
Therefore, if your farm operation conducts activities that fall within the definition of “farm” in 21
CFR 1.227, the farm is exempt from registration. However, if your farm is a “farm mixed-type
facility,” you must register. The term “mixed-type facility” means an establishment that engages
in both activities that are exempt from registration and activities that require the establishment to
be registered. For a discussion of “farm mixed-type facility,” please see Question B.1.4 in this
document.
Note that in January 2018, FDA issued a guidance document in which we stated that we intend to
initiate a rulemaking that could change the definition of a “farm.” We also stated that we do not
anticipate that the rulemaking would result in an entity that currently is a “farm” becoming a
“facility.” See “Policy Regarding Certain Entities Subject to the Current Good Manufacturing
Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification
Programs”.
