SearchWhat the source says
A farm or food operation may need FDA registration when it is a food facility that manufactures, processes, packs, or holds food for consumption in the United States, unless an applicable exclusion or exemption applies.
Sources checked August 18, 2026 · 21 CFR Part 1, Subpart H and the farm definitions; State and local rules are not included.
Conditions, thresholds, exceptions, and duties
Coverage triggerThe question of activities that require registration turns on whether the establishment is a facility that manufactures, processes, packs, or holds food, together with the farm and activity exclusions. The establishment must be checked against what it exceeds and the farm mixed-type facility boundary. 21 CFR 1.225–1.227
Farm boundaryThe farm definition includes primary-production and secondary-activities farms, but activities outside that definition can change the registration analysis. 21 CFR 1.227
Information to confirmThe operation, location, food, processing step, ownership, and applicable exclusion must be checked together before deciding whether registration is required. 21 CFR 1.225–1.226
What this source does not answer
- The source does not decide whether a particular operation is a farm, facility, or mixed-type facility.
- Food, processing, ownership, and exemption facts require a separate check.
- State, Tribal, and local food requirements are outside this federal guide.
What to check next
- What occurs at each location?
- Which activities are harvesting, packing, holding, manufacturing, or processing?
- Does the operation satisfy the farm definition?
- Does a retail-food-establishment exclusion apply?
- Are off-farm activities part of a mixed-type facility?