FDA's sanitary transportation rule sets duties for moving food by truck or rail in the United States so it doesn't become unsafe on the way. It splits the work by role. The shipper, who arranges the transport, gives the carrier written sanitary specifications and, for food that needs temperature control, a written operating temperature. The loader checks that the trailer is clean and pre-cooled before loading. The carrier meets the specs, shows the temperatures it held if asked, and trains its drivers, when a written agreement makes it responsible. The receiver checks food that needs temperature control for temperature abuse on arrival. Businesses averaging under $500,000 a year in revenue, adjusted for inflation, aren't covered, and neither is food fully enclosed in packaging that doesn't need temperature control. One business doing every role with its own truck can use one set of written procedures. In the example below, a Wisconsin yogurt maker hires a refrigerated carrier.
The short version
- Covers moving food by truck or rail in the United States.
- Not covered: businesses averaging under $500,000 a year in revenue, adjusted for inflation.
- Not covered: food fully enclosed in packaging that doesn't need temperature control.
- Shippers give carriers written sanitary specs and an operating temperature.
- Loaders check the trailer; receivers check temperature-controlled food on arrival.
- Records are kept 12 months past the agreement or procedure.
- TaroStack keeps each delivery's lot and each order's lots. More below.
Who does what
| Role | Who it is | What the rule asks |
|---|---|---|
| Shipper | Arranges the transport: the maker, or a freight broker | Written sanitary specs for the vehicle; a written operating temperature for food needing temperature control; written procedures; records |
| Loader | Loads the vehicle | Check the vehicle is clean and fit, and that refrigerated space is pre-cooled |
| Carrier | Moves food by truck or rail; not a parcel service | When a written agreement makes it responsible: meet the specs, show temperatures if asked, train staff, keep training records |
| Receiver | Receives the food | Check food needing temperature control for temperature abuse on arrival |
| One business with its own truck | All four roles | One set of common written procedures |
Temperatures on arrival go on a receiving log, in food receiving log template, and keeping temperature records in temperature log template.
The rules
| Rule | Where |
|---|---|
| Who's covered | Shippers, receivers, loaders and carriers in transportation operations, interstate or not; not food transshipped or imported for export, or USDA-only facilities (21 CFR 1.900) |
| Not covered | A business under $500,000 average annual revenue over 3 years, adjusted for inflation from 2011; food completely enclosed by a container unless it needs temperature control; food contact substances; transport by a farm; parcel services aren't carriers (1.904) |
| Shippers | Written sanitary specifications to the carrier; a written operating temperature for food needing temperature control, including pre-cooling; written procedures (1.908(b)) |
| Loaders and receivers | Loaders check sanitary condition and pre-cooling; receivers assess temperature-controlled food for temperature abuse, such as the food's temperature, the vehicle's temperature and setting, and a sensory check (1.908(c), (d)) |
| Carriers | Under a written agreement: meet the specs, show temperatures if asked, pre-cool; train personnel on hiring and as needed, with records (1.908(e), 1.910) |
| One business | Under one legal entity, common integrated written procedures can replace the separate duties (1.908(a)(5)) |
| Records | Kept 12 months beyond the agreement or procedure, or beyond when a trained person stops the duties (1.912) |
This is general information, not legal advice.
An example: a carrier to Chicago
Prairie Hollow Creamery, a made-up yogurt maker in Mount Horeb, Wisconsin, with about $2.6 million a year in sales, used to deliver everything in its own two trucks. This year it hired a refrigerated carrier to take pallets to a distributor in Chicago, and it sorted out its roles:
| Movement | Its role | What it did |
|---|---|---|
| Yogurt to the Chicago distributor, by the hired carrier | Shipper and loader | Wrote the carrier its specs: a clean, odor-free trailer, pre-cooled, held at 34 to 38°F; dock staff check the trailer before loading |
| Cream from a dairy, by the dairy's tanker | Receiver | Checks the cream's temperature and the tanker's reading on arrival, on the receiving log |
| Yogurt to Madison stores, in its own trucks | Shipper, loader and carrier | One set of written procedures for cleaning, pre-cooling and temperatures |
| Cups, lids and cases from a packaging supplier | Receiver | Outside the rule: food contact substances aren't covered |
At $2.6 million a year it's well over the $500,000 line, so it's covered. The carrier's contract makes the carrier responsible for sanitary conditions on the road, so the carrier trains its drivers and keeps those records, and sends the trailer's temperature record for a load when asked. The creamery keeps its written specs and procedures for 12 months past the contract. The yogurt itself is in yogurt business plan.
Get the checker
Download the sanitary transportation checker. One sheet: each movement, your role, whether the food needs temperature control and is fully enclosed, and whether you're over the revenue line; whether it's covered and what the rule asks fill in. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The checker sorts each movement. The specs and the operating temperature are on paper; whether last Tuesday's pallet left at 36°F, and which lots were on it, is somewhere else.
How TaroStack does it
TaroStack keeps each order's lots and each delivery's lot, so which lots went on which truck is on record.
Lots on every order. Each order to the distributor records the lots it took, so a load that arrived warm leads straight to its lots.
Receiving by lot. Each delivery of cream is received from its supplier with its lot, and each batch of yogurt records the cream it used.
Recalls. If a load has to be pulled, one report shows every customer who got those lots.
| The job | Notebook | In TaroStack |
|---|---|---|
| Which lots were on a load | Bills of lading | Lots on each order |
| Which cream went into a batch | Not recorded | Batches by lot |
| Who got a recalled lot | Invoices | One recall report |
Orders, lots, batches and recalls are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.