FSMA reefer records: temperature, pre-cooling and sanitation
The FDA's rule on the Sanitary Transportation of Human and Animal Food, one of the FSMA rules, is short and specific about temperature. The shipper puts an operating temperature in writing. The loader checks the reefer was pre-cooled. A carrier that has agreed in writing to be responsible pre-cools to the shipper's spec and, if asked, shows the temperature held. The receiver checks for temperature abuse on arrival. The records the rule requires (procedures, agreements, training) are each kept for 12 months after they stop applying. The regulation itself is 21 CFR Part 1, Subpart O; every section cited below is in it.
Who does the rule cover?
Shippers, loaders, carriers and receivers moving food in the United States by motor or rail vehicle (§ 1.900). Two definitions in § 1.904 matter for trucking companies:
- A shipper is a person "e.g., the manufacturer or a freight broker," who arranges the transportation. A broker can carry the shipper's duties.
- A carrier is whoever physically moves the food by motor or rail vehicle in the U.S. Parcel delivery services are excluded.
FDA's summary adds that shippers in Canada or Mexico who send food into the U.S. directly by truck or rail are covered too. Businesses with less than $500,000 in average annual revenues (in US dollars, inflation-adjusted, three-year rolling average) are "non-covered businesses." Transportation operations exclude food completely enclosed by a container, unless the food needs temperature control for safety, so a sealed pallet of canned goods is out and a pallet of yogurt is in. FDA has also published three waivers, for Grade "A" milk operations, food establishments delivering directly to consumers, and Interstate Shellfish Sanitation Program participants.
What does each party have to do about temperature?
Most of the temperature rules are in § 1.908. The carrier's duties apply "when the carrier and shipper have a written agreement that the carrier is responsible, in whole or in part, for sanitary conditions," as set out in that agreement.
How the carrier shows the temperature held is left to the carrier and shipper: "any appropriate means agreeable to the carrier and shipper, such as the carrier presenting measurements of the ambient temperature upon loading and unloading or time/temperature data taken during the shipment."
What counts as the operating temperature?
§ 1.904 defines it as a temperature that keeps the food safe "under foreseeable circumstances of temperature variation during transport," and names seasonal conditions, refrigeration unit defrosting and multiple loading and unloading stops as examples. A defrost cycle that nudges the air temperature up is expected; the operating temperature is supposed to allow for it.
What written procedures does a carrier need?
Under § 1.908(e)(6), a carrier writes and follows procedures that:
- Specify how it cleans, sanitizes if necessary, and inspects the trailers and equipment it provides for food.
- Describe how it will meet the temperature control duties: giving the operating temperature and showing it was maintained.
- Describe how it handles bulk vehicles (previous cargo and the most recent cleaning, when the shipper asks).
The first of these, the cleaning and inspection procedures, must stay onsite for as long as they're in use.
What training does a carrier need?
When the carrier has agreed in a written contract to be responsible for sanitary conditions, § 1.910 requires training for its people in transportation operations, on hiring and as needed afterwards. It must cover awareness of potential food safety problems, basic sanitary transportation practices, and the carrier's own responsibilities under the rule. The training record shows the date, the type of training and who was trained. FDA offers a free one-hour online module for carriers with a certificate of completion at the end.
Which records, and for how long?
Every retention period in § 1.912 is 12 months, but each counts from a different point:
Notice what isn't on the list: the trip's temperature readings. The rule sets no retention period for them. What it does require is that a carrier responsible for temperature control can show, when asked, that the temperature held. A shipper's or receiver's question, or a claim, can come weeks after delivery, so the practical answer is to keep each load's readings with the load, not only in the telematics portal.
How fast must records be produced?
"Promptly upon oral or written request" to a duly authorized individual (§ 1.912(f)). The 24 hours often quoted comes from § 1.912(i): records may be stored offsite only if they "can be retrieved and provided onsite within 24 hours of request for official review," and electronic records "are considered to be onsite if they are accessible from an onsite location." Originals, true copies (photocopies, scans) and electronic records are all accepted, and records kept only for this rule are exempt from Part 11's electronic-record requirements.
Worked example: one reefer load, one excursion
Load 48263 is one of the examples used across this site, the one on our reefer page. Prairie Foods ships fresh dairy from Mississauga ON to Heartland Foods Distribution in Joliet IL, in Ashgrove Freight's trailer TRL 7104, on Monday, September 28. Prairie Foods' written spec: operating temperature 34°F (1.1°C), allowed range 32°F to 38°F, pre-cool to 36°F or below. For the example, Ashgrove Freight has agreed in writing to be responsible for temperature control, so the carrier duties above are its duties. Times are Eastern.
Across the 50 readings from loading to unloading, taken every 15 minutes, 96% are in range. In transit the air averages 34.6°F, with a low of 33.8°F. The two out-of-range readings make 30 minutes out of range, all of it during the inspection.
What the rule asks of each party here:
- The carrier tells Prairie Foods at the time (the update went out at 09:34), and when Prairie Foods or Heartland Foods asks, gives the operating temperature and shows the temperature held. Time/temperature data taken during the shipment is exactly what § 1.908(e)(2) names.
- The receiver assesses the load on arrival: the product's temperature (35.1°F), the trailer's temperature and setting, and a sensory check.
- Whether 30 minutes of air at up to 40.8°F is "an indication of a possible material failure of temperature control" is a judgment for a qualified individual under § 1.908(a)(6). Until someone makes it, the food isn't sold or distributed. The record's job is to put the facts in front of that person: how long, how far, when it recovered, and the product probe. Air temperature changes faster than the temperature inside a pallet of dairy, which is why the probe matters as much as the peak.
The record also answers the trailer questions an auditor or a shipper might ask: what TRL 7104 carried last, at what set point, and when it was washed out before this load.
Where Roadmark fits
Roadmark reads the reefer unit's telematics on every load: the temperature, the set point and the unit's out-of-range alerts. It keeps the continuous temperature record attached to the load and its POD, for claims and customer proof, and keeps the FSMA records around it: the shipper's set points, pre-cooling, washouts and each trailer's history. When a reading leaves the range, the Tracking agent drafts the update to the customer for a person to send, as it did at 09:31 on 48263. Reefer fuel is tracked separately from the tractor's, and multi-temp loads are planned zone by zone.
Your written procedures, your training and the qualified individual's decision after an excursion remain yours, as the rule assigns them. The reefer page shows 48263's full record, drawn from the same readings as this example.
Questions and answers
How long must carriers keep FSMA sanitary transportation records?
Twelve months, counted from different points: written procedures for 12 months beyond when they are in use, training records for 12 months beyond when the trained person stops doing those duties, and written agreements assigning tasks for 12 months beyond their termination (21 CFR 1.912).
Does the FSMA rule require a temperature log for every reefer load?
Not in those words. A carrier responsible for temperature control must, if the shipper or receiver asks, demonstrate that it kept the shipper's operating temperature, by any means the carrier and shipper agree on, such as temperatures at loading and unloading or time/temperature data taken during the shipment (21 CFR 1.908(e)(2)).
How quickly must records be given to the FDA?
Promptly, on an oral or written request from a duly authorized individual. Records kept offsite are allowed only if they can be retrieved and provided onsite within 24 hours; electronic records reachable from an onsite location count as onsite. The carrier's written cleaning and inspection procedures must stay onsite while in use (21 CFR 1.912(f) and (i)).
Who has to pre-cool the trailer?
A carrier responsible for temperature control under a written agreement pre-cools each mechanically refrigerated compartment as the shipper specifies before offering the trailer. The loader then verifies, before loading, that each compartment was properly pre-cooled if necessary (21 CFR 1.908(c)(2) and (e)(3)).
Are small carriers exempt from the Sanitary Transportation rule?
A shipper, loader, receiver or carrier with less than $500,000 in average annual revenues, adjusted for inflation and averaged over the previous three years, is a non-covered business (21 CFR 1.904). Farms, food transshipped through the U.S. and food completely enclosed by a container that doesn't need temperature control are also outside the rule.