Who does the FSMA Sanitary Transportation rule apply to?

Shippers, loaders, carriers by motor or rail vehicle, and receivers who transport human or animal food in the United States, unless an exemption applies. It does not apply to transport by ship or by air, and it exempts businesses with under $500,000 in average annual revenue, farms, and food that is fully enclosed in a container and does not need temperature control for safety.

How long must sanitary transportation records be kept?

It depends on the type of record and when the covered activity occurred, but the required retention period never exceeds twelve months. The records are written procedures, agreements between shippers and carriers, and carrier training records.

Early access How it works

Sanitary Transportation of Human and Animal Food

The Sanitary Transportation of Human and Animal Food rule, 21 CFR part 1 subpart O, sets requirements for shippers, loaders, carriers by road and rail, and receivers so that food is not made unsafe in transit by an unrefrigerated trailer, an uncleaned tank or a previous load.

What it is: FSMA final rule
Where it lives: 21 CFR part 1, subpart O
Final rule: April 2016
Docket: FDA-2013-N-0013
Published by: U.S. Food and Drug Administration

Who it covers

Shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human or animal food in the United States. Transport by ship or by air is not covered, because the underlying statute, the Sanitary Food Transportation Act of 2005, does not reach it.

What it requires

Vehicles and transportation equipment must be designed and maintained so that they do not make the food unsafe: suitable and adequately cleanable for their use, and able to hold the temperatures the food needs. Transportation operations must keep food safe in practice: adequate temperature control, ready-to-eat food kept from touching raw food, protection from non-food items in the same or a previous load, and protection from allergen cross-contact.

Where the shipper and carrier agree that the carrier is responsible for sanitary conditions, the carrier must train its transportation personnel in sanitary practices and document the training. Written procedures, agreements and training records must be kept; the retention period depends on the record and does not exceed twelve months.

The FDA has waived the rule for three groups whose transport is already controlled elsewhere: Grade A milk operations under the National Conference on Interstate Milk Shipments program, retail and food service establishments delivering to consumers or between their own locations, and molluscan shellfish carried under the National Shellfish Sanitation Program.

In the FDA’s words

“The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.”

U.S. Food and Drug Administration, FSMA Final Rule on Sanitary Transportation of Human and Animal Food, updated 2018-09-12. Read 2026-09-16.

Road and rail only. An importer's sea freight is outside this rule and inside FSVP.

“The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.”

U.S. Food and Drug Administration, FSMA Final Rule on Sanitary Transportation of Human and Animal Food, updated 2018-09-12. Read 2026-09-16.

Twelve months is short next to the two years most other FSMA records carry.

Compliance dates

Who	Date
Small businesses: fewer than 500 persons, or motor carriers under $27.5 million in annual receipts	Two years after publication of the final rule
Other businesses	One year after publication of the final rule

The final rule was published in April 2016, so both dates have passed.

The dates are the FDA’s, as stated on FSMA Final Rule on Sanitary Transportation of Human and Animal Food, updated 2018-09-12, read 2026-09-16. Compliance dates have been extended before; check that page before planning against any of them.

Exemptions

Shippers, receivers and carriers with under $500,000 in average annual revenue; transport by a farm; food transshipped through the United States or imported for future export; compressed food gases and food contact substances; human food by-products moving to animal use without further processing; food completely enclosed by a container, unless it needs temperature control for safety; and live food animals other than molluscan shellfish.

Where it is in 21 CFR

The rule is codified at 21 CFR part 1, subpart O, General Enforcement Regulations. Title 21 is a work of the United States government and in the public domain, so the regulation is reproduced in full on this site. These are the sections a reader of this page most often needs.

What goes wrong in practice

A rule describes the controls; the FDA’s recall records are what happened where a control was missing. These are the hazards and the kinds of food whose records this rule is most often written against.

Questions

Who does the FSMA Sanitary Transportation rule apply to?: Shippers, loaders, carriers by motor or rail vehicle, and receivers who transport human or animal food in the United States, unless an exemption applies. It does not apply to transport by ship or by air, and it exempts businesses with under $500,000 in average annual revenue, farms, and food that is fully enclosed in a container and does not need temperature control for safety.
How long must sanitary transportation records be kept?: It depends on the type of record and when the covered activity occurred, but the required retention period never exceeds twelve months. The records are written procedures, agreements between shippers and carriers, and carrier training records.

The other FSMA rules

FSMA is enforced as 10 rules, and a single business frequently sits under several. The Act itself, and how the rules fit together.

An inspection under this rule asks for the records behind each requirement, and finding them is the work. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.