The US Food and Drug Administration’s Sanitary Transportation of Human and Animal Food rule is one of the Food Safety Modernization Act (FSMA) rules, and it reaches further than many Canadian shippers expect. It applies to shippers, loaders, carriers and receivers moving food by truck or rail in the United States. That includes Canadian shippers sending food into the US to be eaten or sold there. A food load from Ontario to a US distribution centre is covered from the moment it is loaded.

In short

  • The rule assigns duties to the shipper, loader, carrier and receiver, and lets them be reassigned only in a written agreement.
  • For temperature-controlled food, the shipper specifies an operating temperature in writing, including pre-cooling where needed, and the carrier pre-cools to it.
  • On request, the carrier must show it held that temperature. If temperature control may have failed, the food can’t be sold until a qualified person decides it is safe.

Who is covered, and who isn’t

The rule covers food moved in the US by motor or rail vehicle, whether or not it crosses state lines. The main exemptions:

  • Businesses with less than $500,000 in average annual revenue.
  • Food transshipped through the US to another country, such as a load from Canada to Mexico that never enters US distribution.
  • Food completely enclosed in a container, unless it needs temperature control for safety.
  • Transportation done by a farm, live food animals (other than molluscan shellfish), and compressed food gases.

Everything else, including chilled meat, dairy, produce and prepared food, is in scope.

Who owes what

The rule splits responsibility four ways:

  • The shipper sets the requirements. It specifies to the carrier, in writing, the sanitary condition the trailer must be in, including any cleaning procedures. For food that needs temperature control, it also specifies an operating temperature, including a pre-cooling phase if the food needs one. One notice is enough until the food or conditions change.
  • The loader checks the trailer before loading: that it is in sanitary condition and, for temperature-controlled food, that the refrigerated compartment is properly prepared and pre-cooled.
  • The carrier, where the shipper and carrier have agreed in writing that it is responsible for sanitary conditions, must:
    • supply equipment that meets the shipper’s specification;
    • pre-cool each refrigerated compartment as specified before offering the trailer;
    • give the receiver the specified operating temperature on request;
    • show, if the shipper or receiver asks, that it held that temperature, using measurements at loading and unloading or time-and-temperature data from the trip;
    • keep written procedures for cleaning, sanitizing and inspecting its trailers.
  • The receiver assesses the food on arrival for signs of temperature abuse, for example by checking product and air temperatures.

One provision matters more than the rest. If any of these parties becomes aware of a possible material failure of temperature control, the food must not be sold or distributed until a qualified individual determines it was not made unsafe. A reefer alarm that nobody reports doesn’t make that duty go away. It only means the decision gets made too late.

Training and records

Where the carrier has agreed to be responsible for sanitary conditions, its transportation staff must be trained in sanitary transportation practices, and the training documented. Written procedures, agreements and training records must be kept, for periods that depend on the record but never exceed 12 months. FDA publishes a free training module that meets the requirement.

What to put in writing

The rule rewards shippers who write things down. A good transportation specification for a temperature-controlled food load covers:

  • Setpoint and mode, in both °C and °F, with continuous operation for products that need constant airflow.
  • The pre-cool target and how it is confirmed before loading.
  • The sanitary standard for the trailer: a washout between loads, what counts as clean, and any restrictions on what the trailer last carried.
  • Temperature evidence: what the carrier provides with the freight or on request, such as a printout, a data download or readings at loading and unloading.
  • Alarm response: who the carrier calls if the unit drifts or fails, how quickly, and what happens to the load.

Our reefer guide covers how cold-chain loads actually fail, and our produce checklist covers the pulp temperatures and chilling ranges that belong in the specification.

The Canadian side

Food moving in Canada falls under the Safe Food for Canadians Regulations, which set comparable expectations for conveyances: trailers designed and maintained to prevent contamination, kept clean, and able to hold the temperatures the food needs. A carrier running the same trailers on both sides of the border should hold one standard high enough to meet both.

Questions to ask any reefer carrier

  1. Will you agree in writing to be responsible for sanitary conditions, and train your drivers to match?
  2. Do you pre-cool to my specification, and record that you did?
  3. What is your washout standard, and what proof comes with the trailer?
  4. Can you produce the temperature record for my load on request, and how quickly?
  5. Who is alerted when a unit drifts off setpoint, and what do they do in the first hour?
  6. Do you run produce and other respiring loads in continuous mode?

A carrier that answers these quickly and in writing has done this before. A carrier that needs a week to find out isn’t one to trust with your food.

How Alpha Trans handles it

Washouts between loads are standard on our reefers. Every unit logs temperature continuously, alerts our 24/7 dispatch desk the moment a load drifts off setpoint, and delivers a full temperature printout with the freight. We pre-cool to the shipper’s specification and record it, and our cold chain is run to meet CFIA and FDA requirements, so it holds up to any receiver’s audit. See how we run refrigerated trucking for food and beverage shippers.

This article is general information, not legal advice. Check your own obligations with your food-safety team or counsel.

Talk to dispatch about your temperature-controlled lanes.

Filed under Cold chain

Cover photo: Anna Shvets via Pexels