The short answer
FDA’s Sanitary Transportation of Human and Animal Food rule (21 CFR part 1, subpart O) covers food moved in the U.S. by truck (motor vehicle) or rail. It applies to four roles — shippers, loaders, carriers and receivers — and asks them to keep vehicles clean, control temperature where safety needs it, prevent contamination and allergen cross-contact, train carrier staff and keep records.
Ship and air transport are not covered. But a foreign exporter can be covered when it ships by truck or rail from Canada or Mexico, or when it ships by sea or air and arranges for the intact container to go onto a U.S. truck or train.
Who is covered?
| Situation | Covered? |
|---|---|
| Canadian or Mexican supplier trucking food into the U.S. | Yes |
| Overseas exporter ships a container by sea and arranges the U.S. truck to the importer’s warehouse | Yes — for the U.S. leg |
| Overseas exporter ships by sea; the U.S. importer arranges inland trucking | The importer and its carrier are covered; the exporter generally is not |
| Ocean or air transport itself | No — outside the law’s scope |
| Food passing through the U.S. to another country | No — transshipment is exempt |
Exemptions
- Shippers, receivers or carriers with less than $500,000 in average annual revenue
- Farm transportation activities
- Food transshipped through the U.S., and imported food held for future export that is not consumed or distributed in the U.S.
- Food completely enclosed in a container — except food that needs temperature control for safety
- Compressed food gases and food contact substances
- Live food animals (except molluscan shellfish)
What the rule requires
- 1Vehicles and equipmentDesigned and maintained so they can be cleaned for their intended use and can hold the temperatures needed for safety.
- 2OperationsTemperature control, separating ready-to-eat food from raw food, and preventing contamination and allergen cross-contact during loading, transport and unloading.
- 3Written agreementsShipper and carrier agree in writing who is responsible for which sanitary requirement, including temperature setting and pre-cooling.
- 4TrainingCarrier personnel are trained in sanitary transportation when the carrier is responsible for sanitary conditions, and the training is documented.
- 5RecordsWritten procedures, agreements and training records — kept for periods up to 12 months.
Example: frozen berries from Canada, frozen shrimp from Ecuador
A Canadian frozen berry packer trucks product to a U.S. distributor. As shipper, it gives the carrier written temperature requirements (−18 °C), checks the trailer is pre-cooled and clean before loading, and keeps the agreement and loading records. An Ecuadorian shrimp exporter ships by sea; its U.S. importer books the inland reefer truck, so the importer handles the shipper–carrier agreement for that leg.
FSVP program development from $400 per supplier. FDA food facility registration with U.S. Agent from $300. Prior Notice $15 per shipment.
Frequently asked questions
Does the sanitary transportation rule apply to ocean shipping?
No. It covers transport by motor vehicle and rail in the U.S. Ocean and air transport are outside its scope.
Does it apply to foreign exporters?
Yes, if they ship to the U.S. by truck or rail (for example from Canada or Mexico), or ship by sea or air and arrange for the intact container to move onto a U.S. truck or train, and the food will be consumed or distributed in the U.S.
Are packaged shelf-stable foods covered?
Food completely enclosed in a container is exempt, unless it needs temperature control for safety.
Is there a small business exemption?
Shippers, receivers and carriers with less than $500,000 in average annual revenue are exempt.
Sources
- FDA — FSMA Final Rule on Sanitary Transportation of Human and Animal Food
- FDA — Sanitary Transportation small entity compliance guide
Requirements checked on November 12, 2026. This article is general information, not legal advice.