FDA's sanitary transportation rule, part of FSMA, makes sure food moved by truck or rail doesn't become unsafe on the way: dirty trailers, broken refrigeration, raw meat dripping on produce. It applies to shippers, loaders, carriers and receivers, whether the food crosses a state line or not, with two big limits for small producers. First, a business averaging under $500,000 a year in revenue over the previous three years, adjusted for inflation, is a non-covered business. Second, the rule doesn't reach food completely enclosed in containers, such as sealed cases of shelf-stable jars, unless the food needs temperature control for safety. So the rule is mostly about refrigerated and frozen food, and food shipped open or in bulk. A covered shipper tells each carrier, in writing, how its trailers must be kept clean and, for cold food, the operating temperature, including pre-cooling, and keeps those records for 12 months after the arrangement ends. Parcel delivery services aren't carriers under the rule. In the example below, a Pittsburgh pierogi maker sets up a refrigerated carrier for a grocery chain.
The short version
- The rule covers shippers, loaders, carriers and receivers moving food by truck or rail in the US.
- Under $500,000 a year in average revenue, adjusted for inflation: a non-covered business.
- Food completely enclosed in containers is outside it, unless it needs temperature control.
- Shippers specify vehicle sanitation and, for cold food, an operating temperature, in writing.
- One written notice is enough until something changes.
- Keep the specifications and procedures 12 months after they stop being used.
- TaroStack keeps each shipment's lots and delivery note, so a temperature question leads to the right cases. More below.
Who does what
| Party | What the rule asks |
|---|---|
| Shipper | Written vehicle and equipment specifications to each carrier; an operating temperature for cold food; written procedures |
| Loader | Check the vehicle is sanitary before loading unenclosed food, and pre-cooled before loading cold food |
| Carrier | Meet the shipper's specifications, pre-cool, and show temperatures were kept when asked |
| Receiver | For cold food, check it wasn't badly warmed in transit: its temperature, the trailer's, and a look and smell |
What a delivery should be checked for at the door is in incoming inspection checklist, and the rest of FSMA for small makers in FSMA requirements for small food businesses.
The rules
| Rule | Where |
|---|---|
| Who | Shippers, receivers, loaders and carriers in transportation operations, interstate or not, except non-covered businesses (21 CFR 1.900) |
| Non-covered business | Under $500,000 average annual revenue over the previous 3 years, adjusted for inflation from 2011 (21 CFR 1.904) |
| Enclosed food | Transportation operations don't include food completely enclosed by a container, except food that needs temperature control for safety and a few others (1.904) |
| Parcel services | A carrier doesn't include a parcel delivery service (1.904) |
| Shippers | Written sanitary specifications and, for cold food, an operating temperature to each carrier; written procedures; one notice until something changes (21 CFR 1.908(b)) |
| Records | Carrier specifications kept 12 months after the agreement ends; procedures 12 months after they stop being used (21 CFR 1.912) |
This is general information, not legal advice.
An example: a refrigerated carrier for a grocery chain
Polish Hill Pierogi Co., a made-up frozen pierogi maker in Pittsburgh, Pennsylvania, ships frozen cases to a grocery chain's warehouse by a refrigerated carrier, and jars of horseradish sauce by parcel and less-than-truckload freight. Its revenue averaged $1,206,667 over the last three years, so it's covered:
| Product | Needs temperature control? | Enclosed in cases? | In scope? | Operating temperature |
|---|---|---|---|---|
| Frozen potato and cheese pierogi | Yes | Yes | Yes | 0 °F or below, trailer pre-cooled to 0 °F |
| Frozen sauerkraut pierogi | Yes | Yes | Yes | 0 °F or below, pre-cooled |
| Shelf-stable horseradish sauce | No | Yes | No |
The company sent the reefer carrier one written notice in March: a clean, dry, odor-free trailer, no damaged floors, no raw meat in the same load, and the operating temperature with pre-cooling. The carrier's agreement says it shows the temperature record on request. The horseradish goes outside the rule, sealed in cases and shelf-stable. Both the notice and the agreement go in a folder kept until a year after the carrier changes. How frozen goods are packed for the trip is in how to package frozen food for sale.
Get the checklist
Download the sanitary transportation checklist. Three sheets: covered or not, with three years of revenue against the $500,000 line; specifications to carriers, each product with whether it's in the rule's scope, its operating temperature, pre-cooling, vehicle specifications and the date the notice went out; and the records, with who keeps each and for how long. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The checklist covers the paperwork with the carrier. When a warehouse rejects a load as warm, the question is which lots were on that trailer and where else those lots went, which the carrier folder doesn't say.
How TaroStack does it
TaroStack keeps each shipment's lots and delivery note, so a temperature question leads to the right cases.
Orders with lots. Each order to the warehouse picks cases by lot, and the delivery note prints each line's lot and best-before date.
Lots by date. Each lot keeps its production and best-before dates, so a warm load's cases can be checked against when they were made.
Recalls. If a load is rejected, one report shows every customer who got those lots.
| The job | Folder | In TaroStack |
|---|---|---|
| Which lots were on a trailer | A bill of lading | Lots on the delivery note |
| Cases left in the freezer | Counted by hand | Stock by item and lot |
| Where else those lots went | Searching invoices | One recall report |
Orders, lots 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.