Produce packing that does not occur on a farm would not be subject to the proposed
rule because the proposed rule would only apply to covered farms as defined in the rule
(see proposed § 112.4).
Packing produce for consumption on the farm would not be covered by the rule because
the rule would not apply to produce for on-farm consumption (see proposed §
112.2(a)(2)).
When a covered farm packs produce grown on that farm (or another farm under the
same ownership) for distribution into commerce, that activity would be covered by the
rule because the activity is within the definition of “farm” in the rule (see proposed
§112.3(c) definition of farm: “’Farm’ includes (i) facilities that pack or hold food, provided
that all food used in such activities is grown, raised, or consumed on that farm or
another farm under the same ownership”).
When a covered farm packs produce that was not grown on that farm (or another farm
under the same ownership) for distribution into commerce, that activity would not be
subject to the proposed rule because it would not be within the definition of “farm” in the
rule (see proposed §112.3(c) definition of farm: “’Farm’ includes (i) facilities that pack or
hold food, provided that all food used in such activities is grown, raised, or consumed on
that farm or another farm under the same ownership”).
The definition of “farm” and related definitions in the proposed rule are based in part on
FDA’s tentative conclusions that:
• the basic purpose of farms is to produce raw agricultural commodities
(RACs) and RACs are the essential products of farms;
• activities that involve RACs and that farms traditionally do for the purposes
of growing their own RACs, removing them from the growing areas, and
preparing them for use as a food RAC, and for packing, holding and
transporting them, should all be within the definition of “farm”; and
• activities farms may perform on others’ RACs should appropriately be
classified as manufacturing/processing, packing, or holding in the same
manner as these activities are classified off-farm when the RACs are to be
distributed into commerce.
