Produce Safety Guidance FDA

This guidance is being distributed for comment purposes only.

The purpose of this guidance is to help to determine if an activity falls under the definition of “farm”. The regulatory framework to determine if a business falls under the definition of “farm” depends mostly on certain denotations (i.e. “farm,” “mixed-type facility”, including a “farm mixed-type facility”, “harvesting,” “packing,” “packaging,” “holding” and “manufacturing/processing”) which are identified within the regulation for Registration of Food Facilities (21 CFR part 1, subpart H)[see note].

For your convenience, we have copied these definitions into sections II.B and II.C of this guidance as identified in 21 CFR 1.227.

Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities