The U.S. Food and Drug Administration (FDA), as part of the Food Safety Modernization Act (FSMA), created seven major rules that will help to prevent food contamination during transportation. One rule affecting carriers, the Sanitary Transportation of Human and Animal Food (STHAF) rule, took effect June 6, 2016. It requires those involved in transporting human and animal food by motor or rail vehicle to follow recognized best practices for sanitary transportation, such as properly refrigerating food, adequately cleaning vehicles between loads, and properly protecting food during transportation.

The STHAF rule allows the transportation industry to continue to use best practices, i.e., “commercial or professional procedures that are accepted or prescribed as being correct or most effective.” These best practices cover cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment to ensure that food is transported under conditions and controls necessary to prevent adulteration.

• The STHAF rule affects the transport of food in the United States by motor or rail vehicle.
• Certain types of shippers, receivers, and carriers are exempt from the STHAF rule.

The Sanitary Transportation of Human and Animal Food (STHAF) rule applies to food transported within the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. Shippers, loaders, carriers, and receivers engaged in transportation operations of food imported by motor or rail vehicle and consumed or distributed in the United States are also subject to the rule.

Shippers are ultimately responsible under the STHAF rule, but in contracts, shippers can delegate much of the responsibility for training, reporting, temperature control, etc. to the carrier and driver.

There are several exemptions. The most inclusive one: Food in a closed container that doesn’t require temperature control for safety (not quality) is exempt under this rule.

That said, if an entity or driver is not covered under one of the following exemptions, that entity, driver, and the shipper are required to comply with the STHAF rule.

The following are exempt from the rule:

• Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue;
• Transportation activities performed by a farm;
• Transportation of food that is transshipped through the United States to another country;
• Transportation of food that is imported for future export and that is neither consumed nor distributed in the United States;
• Transportation of compressed food gases (e.g., carbon dioxide, nitrogen, or oxygen authorized for use in food and beverage products) and food contact substances;
• Transportation of human food byproducts transported for use as animal food without further processing;
• Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety; and
• Transportation of live food animals, except molluscan shellfish.

If the driver is involved in the delivery of certain products that qualify under the STHAF rule, that driver and anyone else taking part in transportation of the qualified products must receive training and report any condition that could make the product unsafe. (Food quality such as appearance or texture is not covered under this rule unless the product is unsafe for consumption).The U.S. Food and Drug Administration (FDA) will grant waivers for any of the requirements, provided that the waiver will not lead to transportation of food in an unsafe manner and the waiver is not contrary to the public interest. The regulations detail the process of applying for a waiver.

• Requirements for vehicles, transportation equipment, operations, training, and records are all addressed in the STHAF rule.
• Though the shipper is ultimately responsible for transportation operations, those responsibilities might be assigned to the carrier.

The Sanitary Transportation of Human and Animal Food (STHAF) rule is found in 21 CFR Part 1, and covers vehicles and transportation equipment, transportation operations, training, and records.

Vehicles and transportation equipment

Vehicles and equipment (totes, bins, tanks, pallets, pumps, hoses, etc.) used to transport food must be designed and maintained to be suitable for transportation of food products and cleanable. The trailer and equipment must be kept sanitary at all times to prevent food being transported from becoming unsafe, contaminated, or adulterated.

If the food being transported requires temperature control, the equipment used must be designed, equipped, and maintained to provide adequate temperature control during transport.

Finally, the vehicle and other equipment must be maintained and stored to prevent the harboring of pests (bugs and rodents) or becoming otherwise contaminated. For example, any exposed insulation or other interior damage must be repaired immediately. Wooden floors and walls should be avoided due to sanitization and cleaning issues, as well as splinters.

Transportation operations

If food being transported fits into one of the categories requiring compliance, such as food not completely enclosed in a container or food requiring temperature control, the shippers for which a carrier or driver routinely hauls food must be contacted to see what procedures are required. Current practices will need to be reviewed to see how they compare with what the regulations and shippers require.

Also, be prepared to develop one’s own procedures and driver training related to inspecting and cleaning the inside of vehicles that transport food, avoiding contamination and cross-contamination of food shipments, precooling vehicles, and monitoring and recording temperature-controlled shipments.

The shipper is ultimately responsible but can assign responsibility to the carrier to ensure that:

• Shipper requirements for cleaning and sanitation are met.
• The vehicle and equipment meet the shipper’s specifications and requirements.
• Precooling the vehicle or equipment occurs before loading, if required (the shipper should verify that the temperature is correct before loading).
• Effective measures are taken to avoid contamination or cross-contamination.
• Food is isolated or segregated to avoid contamination by raw food products or non-food products that are part of the same shipment.
• Temperature control and monitoring requirements provided by the shipper are met throughout the trip and proof is provided, if requested. The proof (mechanical temperature tracking, a temperature log completed by the driver, etc.) must meet the shipper’s requirements. Avoid loading two different foods with separate cooling requirements for an extended period.
• Information is provided to the shipper about the previous product carried in the vehicle, if the vehicle is a “bulk vehicle” (a vehicle that carries bulk shipments that are in direct contact with the inside of the vehicle) and the shipper requests the information.
• Proof is provided as to the most recent cleaning of a bulk vehicle, if requested.

Loaders and drivers should never reuse dunnage that is likely to contaminate food and should practice good hygiene habits. These include washing hands, wearing beard nets, and wearing sanitary clothing as required by the customer.

Loaders must inspect the vehicle and transportation equipment to ensure sanitary conditions and that the trailer has been adequately precooled.

Receivers must do the following upon receipt of temperature-sensitive foods:

• Determine if there was any temperature abuse in-transit,
• Check the food and vehicle’s temperature, and
• Smell for odors.

Carriers must also have written procedures covering:

• Cleaning, sanitizing, and inspecting vehicles and equipment;
• The process to monitor and record temperature of a shipment; and
• The process to maintain and provide records related to the last shipment and most recent cleaning of bulk vehicles.

Notification of possible unsafe food

If the shipper, loader, carrier, driver, or receiver becomes aware of a failure in the measures to protect the food (such as a temperature deviation or cross-contamination), and the failure caused the food to be rendered unsafe, that party is responsible for notifying the other parties involved. The shipment can no longer be sold or distributed as food. The only exception is if a qualified individual can determine that the temperature deviation or other problem did not actually render the food unsafe.

Training

The shipper is responsible for training drivers transporting food, unless the shipper’s written agreement with the carrier requires that the carrier provide the training, which must include:

• An awareness of potential food safety problems that may occur during transportation,
• Training on basic sanitary food transportation practices,
• Instruction on requirements of food safety regulations, and
• Training required upon hire and then as needed thereafter. The carrier will be responsible for maintaining records of the training, and records must include the driver’s name, the date, and the topic.

Records

Shippers and carriers are required to create and maintain specific records related to food shipment. Carriers must maintain records of:

• Any written agreements related to procedures or responsibilities assigned to them by shippers. These must be kept the entire time they are in effect, and then for an additional 12 months.
• Procedures that a carrier is required to have under the regulations, or required by a shipper to have and/or follow under terms of an agreement. These must be kept the entire time they are in effect, and then for an additional 12 months.
• Individual driver training records, which are to be kept the entire time the driver is involved in food transportation, and then for an additional 12 months.

The records can be paper or electronic. They must be made available within 24 hours if requested by an authorized individual. However, procedures related to cleaning and inspecting vehicles and equipment must be available at all times onsite where the vehicles are loaded.

It is advisable to review driver training and processes for compliance with the regulation. Also, contact major shippers to understand their requirements for inspection, cleaning, contamination avoidance, precooling vehicles, and recording temperature of shipments.

• Safety precautions mandated by shippers or carriers must be kept in mind by drivers hauling perishable food.
• A checklist of suggested practices at pick-up, enroute, at delivery, and for staged equipment can help prevent a rejected load.
• A broken cargo seal can cause an entire shipment to be rejected due to food safety concerns.

Commercial drivers who transport perishable food should be reminded of their company- and/or shipper-mandated safety precautions. A little vigilance may prevent a rejected load at the receiver. Consider the following suggested practices.

At pick-up:

• Know the correct shipping temperature for the product;
• Find out if the refrigeration unit should be in stop/start or continuous mode;
• Perform a pretrip inspection of the refrigeration unit, including these components:
  • Belts
  • Fluid levels (oil, coolant, and fuel)
  • Signs of leakage
  • Electrical connections
  • Chute or duct condition
  • Compartment door seals
• Test the refrigeration unit by making sure it starts and stays running, and the thermometer works;
• Before loading, precool the trailer to the temperature required by the shipper;
• Minimize loading time unless backed up to a cold storage dock; and
• For proper air flow, use spacers on the sidewalls and at the ends of the trailer, use pallets on the floor, and close trailer doors immediately after pulling away from the dock.

Enroute at each stop:

• Inspect the trailer’s exterior for damage or signs of tampering;
• Check for signs of leakage (fluids) or other problems with the refrigeration unit;
• Monitor the temperature function of the refrigeration unit, or at least once every three hours;
• Check the refrigeration unit’s fuel level;
• Keep in-transit time to a minimum to reduce opportunity for spoilage; and
• Record trailer temperatures at specific intervals either manually or through the temperature log on the refrigeration unit.

At delivery:

• Check and document overall condition of the product including damage, quality, and temperature;
• Record temperature readings on shipping papers including pulp or core temperature (i.e., inside of product), and trailer temperature; and
• Move product from loading docks into storage immediately.

Staged equipment (if managed by motor carrier):

• Clean the trailer interior regularly;
• Keep the box or trailer free of debris and dirt;
• Remove residues from previous cargo;
• Wash and sanitize load-securing devices and loading equipment, e.g., hand trucks and forklifts; and
• Make sure cleaning and sanitizing solutions do not create a contaminant.

Handling a broken trailer seal

When a driver delivers a load in good condition except for the seal not being intact, this often leads to the entire shipment being rejected. The Sanitary Transportation of Human and Animal Food (STHAF) rule will likely be cited as the reason, and food safety will be called into question.

The STHAF rule states that “[a] broken cargo seal or any evidence of food cargo tampering would not necessarily create a per se presumption of adulteration” and noted that broken seals are a food security concern. If a customer uses the STHAF rule as the basis for rejecting a load due to a broken seal, this is not correct. The driver should refer to the contract with the customer for disposition of the product in case of a broken seal.

• Trailers transporting temperature-controlled or temperature-sensitive product must receive a thorough inspection process.
• Inspections should be performed at each level of a shipment, including pretrip, on-the-road, and post-trip stages.

In addition to checking the items on a standard van trailer, the following steps should be taken for refrigerated trailers.

Pretrip inspection

Before each trip:

• Ensure that trailer specifications meet shipper requirements (an example is “no wood floors”);
• Inspect the trailer to verify that it has been cleaned and sanitized to the shipper’s standards;
• Do not load the trailer unless all defects from the Driver Vehicle Inspection Report (DVIR), including those related to the refrigeration system, are repaired; and
• During the walk-around inspection, open the refrigeration unit on the front of the trailer and:
  • Look over the belts, hoses, and connections to verify that no potential issues could lead to failure; and
  • Make sure the fluids are at appropriate levels to avoid an automatic shutdown of the refrigeration system engine due to low oil or water.
• After checking that the landing gear is in good working order, check the fuel tank and:
  • Inspect the tank for damage,
  • Ensure there is adequate fuel in the tank,
  • Confirm the cap is in place and tight,
  • Make sure the gasket or seal is in good condition,
  • Verify the mounting straps are secure, and
  • Check the fuel tank for leaks.
• As the walk-around continues, check for cracks, dents, holes, or other damage that could affect the ability to maintain the set point (exact thermostat temperature set);
• Open the trailer doors, inspect the interior of the trailer, and:
  • Confirm that the trailer has the proper amount of insulation and can meet the required set point of the load;
  • Inspect the trailer for debris or spills and check for odors (wash and/or sanitize the trailer if cross-contamination is possible);
  • Make sure floor channels and drains are clear and not clogged with debris;
  • If the trailer is equipped with an air chute (or canopy), check that it is in good condition and that air flow will not be affected;
  • Check for holes or cracks in interior walls to see if any insulation is exposed; and
  • Check that rear/side doors and vent doors close properly and that each door has intact gaskets that seal tightly.
• After the walk-around is complete, verify the refrigeration compartment is closed, start the unit, and:
  • Adjust the thermostat and make sure the cooling or heating cycle is activated when the current set point is changed;
  • If pre-cooling is required for the next shipment, adjust the set point per the shipper’s instructions; and
  • Make sure that both “run” modes —, continuous (used for narrow temperature range or continuous air flow) and start/stop (used when products are not as temperature-sensitive) — operate correctly. Use the mode per the shipper’s instructions, if available, or consult dispatch for the correct mode.

On-the-road inspections

Some carriers and shippers will require the driver to stop at specific intervals. When stopped:

• If required, record the temperature in a temperature log and be aware of changes in temperature, and actions to be taken if required;
• Do a walk-around inspection of the vehicle;
• Check the fuel level in the refrigeration system tank and confirm that it will run until well after the next fuel stop; and
• Check the security seal/tag on the trailer door to ensure the integrity of the load has not been breached.

Post-trip inspections

In addition to the post-trip checks, after each trip:

• Check all refrigerated trailer-specific items inspected in the pretrip, except those affected by heat (such as refrigeration system engine oil);
• Do not shut off the refrigeration system engine unless directed by the shipper or carrier, and be clear on when to shut down the refrigeration system;
• If the company wants the refrigeration system shut down to check the oil and other fluids, immediately restart the unit after checks are complete; and
• If there are any defects that can affect the safe or efficient operation of the refrigeration unit, include those items on the DVIR along with any defects found during the checks on Driver Handout #2. Do not load the trailer until these defects are repaired.