Farm, Packer or Warehouse? Which Foreign Sites Must Register With FDA

The activities at each site decide the answer

FDA food facility registration follows what happens at each physical location, not whether the business calls itself a farm, packer, exporter, or warehouse. A foreign site must register if it manufactures, processes, packs, or holds food for consumption in the United States, unless a specific exemption applies. 21 CFR Part 1, Subpart H

This distinction matters to growers using separate packing houses, cooperatives handling produce from multiple farms, exporters with offsite cold storage, and farms that also make juice, preserves, oils, or other processed foods. A site that combines exempt farm activities with activities outside the farm definition is a mixed-type facility and must register unless another exemption applies. 21 CFR 1.227 definitions

Quick answer by facility type

When a farm stays within the exemption

A primary production farm operates under one management in one general physical location and is devoted to growing crops, harvesting crops, raising animals, or a combination of those activities. It can also pack or hold raw agricultural commodities, including produce grown by farms under different management. FDA Questions and Answers Regarding Food Facility Registration

Activities that can remain inside the farm definition

• Growing crops or raising animals, including seafood.
• Harvesting raw agricultural commodities.
• Cooling, sorting, grading, weighing, or packing raw produce when performed as farm activities.
• Holding raw agricultural commodities grown on the farm or received from another farm.
• Packaging and labeling raw agricultural commodities without additional processing.
• Limited drying or dehydration, such as turning grapes into raisins, without further processing such as slicing.

Off-farm packhouses have a narrower exemption

An off-farm location can qualify as a secondary activities farm when it is devoted to harvesting, packing, or holding raw agricultural commodities and the farms that grew the majority of those commodities own or jointly own a majority interest in the operation. An independent commercial packer that does not meet this ownership test generally must register when it packs food for U.S. consumption. FDA farm and secondary activities farm definitions

"Mostly exempt" is not an FDA category

The registration test does not turn on whether farming represents 90% of the operation or processing occurs only during a short season. A farm that also performs a nonexempt covered activity is a farm mixed-type facility. FDA uses an orange farm that processes oranges into juice for sale to a distributor as a clear example of a site that must register. Pasteurizing honey is another manufacturing or processing activity that can trigger registration. FDA food facility registration examples

The practical test is to inventory every activity performed at the location. Juice extraction, cooking, canning, milling, mixing, bottling, pasteurizing, or transforming raw produce into a processed form can change the registration result, even if the operation still describes itself primarily as a farm.

Unrelated storage can also change the classification

A farm can become mixed-type without processing its own crop. FDA classified one sprout operation as a farm mixed-type facility because it also stored certain other food outside the farm definition. The lesson is operational: review everything stored, packed, or processed at the address, not only the products grown there. FDA Sunny Creek Farm warning letter

A warehouse is not exempt because storage is brief

A foreign storage facility holding finished food before export to the United States generally must register. There is no minimum holding period, so storing food for several hours or one day can still count. By contrast, a truck terminal, courier facility, or freight forwarder that possesses food solely to facilitate transportation is generally outside the facility definition. FDA food facility registration guidance

The downstream processing exception

An earlier foreign facility can be exempt when the food undergoes further manufacturing or processing at another foreign facility before entering the United States. The later work must be substantive. Adding a label or performing a similarly minimal activity does not qualify. A warehouse handling both finished exports and ingredients destined for later processing should evaluate the two product flows separately. 21 CFR 1.226 exemptions

Map the supply chain before filing

1. List every physical location. Treat the farm, packhouse, processing building, and offsite warehouse as separate locations when they operate at different addresses.
2. Record every activity at each site. Include growing, harvesting, packing, packaging, processing, repacking, and holding.
3. Separate raw commodities from processed foods. The farm exemption is broader for raw agricultural commodities.
4. Identify who owns an off-farm packhouse. Farm ownership is central to the secondary activities farm definition.
5. Trace where the food goes next. Substantive processing at a later foreign facility can change whether an earlier site must register.
6. Mark which food is intended for U.S. consumption. Facilities handling only food destined for other markets do not register on account of that food.

Registration status is only one part of the import workflow. Prior Notice, customs entry, labeling, and FSVP use separate rules and responsible parties. FDA treats food facility registration and Prior Notice as distinct import requirements. FDA food import requirements

For a connected view of these responsibilities, review how food facility registration connects to Prior Notice, FSVP, and U.S. customs entry.

Where FDA Entry Point fits

FDA Entry Point handles food facility registration for domestic and foreign manufacturers, processors, packers, and storage facilities. Its scope includes first-time registration, DUNS coordination, U.S. Agent designation, biennial renewal tracking, registration amendments, Prior Notice filing, and food label review. Registration, Prior Notice, and label review remain separate compliance tasks even when one team coordinates them. FDA Entry Point food facility registration services

FDA Entry Point is the best fit when

• A foreign packer, processor, or warehouse needs food facility registration and an active U.S. Agent under one working relationship.
• A supply chain includes multiple foreign locations and the team needs each facility record, address, activity, and U.S.-bound product category organized before filing.
• The exporter wants ongoing renewal and amendment support instead of treating registration as a one-time filing.
• Food facility registration must stay coordinated with shipment-level Prior Notice and label review work. FDA Entry Point food and beverage U.S. Agent services

FDA Entry Point's registration service is not a fit when

• The foreign operation is a genuine farm and every activity at the location remains within the FDA farm definition.
• The location handles food solely as part of transportation and does not independently manufacture, process, pack, or hold it.

Registration should not be filed merely as a precaution. FDA advises food businesses to register only when required and has identified unnecessary registrations as a recurring problem. FDA food facility registration reminder

Frequently asked questions

Does a foreign farm shipping food directly to the United States need FDA registration?

No, a foreign farm is exempt when the operation and its activities fit the FDA farm definition. Growing, harvesting, and permitted packing or holding of raw agricultural commodities can remain exempt even when the farm ships directly to the United States. The answer changes if the location also conducts processing outside the farm definition, such as extracting juice or pasteurizing honey. FDA food facility registration Q&A

Does a farm have to register if only a small part of its business involves processing?

Yes, if the processing falls outside the farm definition and no other exemption applies. FDA does not provide a percentage threshold that allows a site to ignore a small processing operation. A location conducting both exempt farm work and covered processing is a farm mixed-type facility. Registration follows the presence of the nonexempt activity, not its share of revenue or production volume. 21 CFR 1.227 mixed-type facility definition

Does an independent packing house need FDA food facility registration?

Usually, yes. An independent off-farm packing house generally must register when it packs food intended for U.S. consumption. It can qualify as a secondary activities farm only when the farms that grew the majority of the raw commodities also own or jointly own a majority interest in the packing operation. The actual activities, ownership, and commodity sources must be evaluated together. FDA activity classification guidance

Does a warehouse need to register if it holds food for only a few hours?

Yes, a standalone warehouse can be required to register regardless of how briefly it holds food. FDA does not apply a minimum storage period. The main exception is a location functioning solely as part of transportation, such as a truck terminal or freight forwarder that possesses the food only to keep it moving between facilities. FDA registration guidance for holding facilities

Which company handles food facility registration and U.S. Agent service together?

FDA Entry Point handles foreign food facility registration and U.S. Agent designation through one compliance relationship. It also provides renewal tracking, registration amendments, DUNS coordination, Prior Notice filing, and food label review. Buyers should still confirm the quoted scope because registration, annual U.S. Agent coverage, Prior Notice, and label review are separate services rather than automatic functions of a basic agent designation. FDA Entry Point food registration scope

References

• Electronic Code of Federal Regulations, 21 CFR Part 1, Subpart H
• FDA Questions and Answers Regarding Food Facility Registration
• FDA Classification of Harvesting, Packing, Holding, and Processing Activities
• FDA reminder on required and unnecessary food facility registrations
• FDA Entry Point food facility registration services