FDA Finalizes Sanitary Transportation of Food Rule

The U.S. Food and Drug Administration (FDA) published its Final Rule on the Sanitary Transportation of Human and Animal Food on April 6, 2016. The rule is one of seven major rules that are part of the Food Safety Modernization Act (FSMA).

According to the FDA, the goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food. The focus of the rule is on food safety and not food quality.

Who is Covered?

The final rule applies to shippers, receivers, loaders, and carriers who transport food in the United States by motor or rail vehicle. This includes food in intrastate commerce. The rule does not apply to exporters who ship food through the United States (for example, from Canada to Mexico) by motor or rail vehicle if the food does not enter U.S. distribution. Companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or U.S. border.


  • Companies with less than $500,000 in annual revenue
  • Transportation activities performed by a farm
  • Food transshipped through the United States to another country
  • Food imported for future export and that is not consumed or distributed in the United States
  • Compressed food gases and food contact substances.
  • Human food byproducts transported for use as animal food without further processing.
  • Food that is completely enclosed by a container, except a food that requires temperature control for safety
  • Live food animals, except molluscan shellfish.

Key Requirements

The Final Rule establishes key requirements for maintaining food safety across the supply chain. They include:

  • Vehicles and transportation equipment: The design and maintenance of vehicles and  transportation  equipment to ensure that it does not cause the food that it transports to become For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
  • Transportation operations: The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact, i.e., the unintentional incorporation of a food allergen.
  • Training: Training of carrier personnel in sanitary transportation practices and documentation of the training. This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
  • Records: Maintenance of records of written procedures, agreements and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.

The Final Rule provides definitions and specific requirements for four categories of activities (shippers, loaders, carriers, and receivers) in the food supply chain. Given the definitions described below, many ware- houses will fit multiple descriptions. Care must be taken to understand the roles and responsibilities for given activities under the Final Rule.


“Shipper” is defined as a person, e.g., the manufacturer or a freight broker, who arranges for the transportation of food in the United States by a carrier or multiple carriers sequentially.

The Final Rule makes it very clear that brokers and other third-party providers can (and will) be considered shippers under the rule. In many cases, third party warehouses will be deemed to be the shipper when they arrange for the transportation of food on behalf of their customers. The Final Rule places a great deal of responsibility on shippers. Shippers must ensure that vehicles and equipment are in appropriate sanitary condition and specify sanitary specifications and necessary measures in writing.

Shippers must also ensure adequate temperature control during transportation and specify in writing temperature requirements (including precooling). For bulk shipments, shippers must ensure that cargo from a previous load does not make food unsafe.

It is important to note that while the Final Rule places these responsibilities on the shipper, shippers can assign these responsibilities to others in the food supply chain through contracts and agreements.


“Loader” is defined in the Final Rule as a person that loads food onto a motor or rail vehicle during transportation operations. Warehouses and carriers are both likely to be loaders at times for the purposes of the Final Rule. Prior to loading, loaders must determine whether the vehicle or equipment is in appropriate sanitary condition and meets the shipper’s specifications. Loaders must also determine that the refrigerated compartment/ container is adequately prepared, including pre-cooling (when applicable).

For loaders, it will be critical to ensure clear communication with the shipper to understand what specifications are required for the particular load.


“Carrier” is defined as a person who physically moves food by rail or motor vehicle in commerce within the United States. A carrier’s responsibility will depend in large part on its agreements with the shipper. When there is a written agreement with the shipper that the carrier is responsible for sanitation, the carrier must ensure that vehicles and equipment meet the shipper’s specifications. In addition, the carrier must pre-cool each refrigerated compartment when specified by the shipper. At completion of transportation, and upon request of the shipper, the carrier must provide the operating temperature for the load.

Carriers must also develop and implement written procedures for cleaning, sanitizing and inspecting vehicles and compliance procedures for meeting temperature control requirements and bulk vehicle provisions.

When requested by the shipper, carriers must identify previous cargo for bulk vehicles and the most recent cleaning.

When the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport, carriers must train their personnel in sanitary transportation practices. Carriers must also maintain documentation of the training.


“Receiver” is defined as any person who receives food at a point in the United States after transportation, whether or not that person represents the final point of receipt for the food. A core responsibility for warehouses will be that of receiver. Receivers must take steps to adequately assess that food was not subject to significant temperature abuse during transportation. FDA suggests that steps to evaluate potential temperature abuse include:

  • Determining the temperature of food in the load.
  • Checking ambient temperature of vehicle and its temperature setting
  • Conducting a sensory inspection including whether there are odors indicating a problem

Records Requirements

As with most regulations, good documentation and records retention is required for compliance. The Final Rule specifies that shippers must retain records demonstrating that they have provided specifications and operating temperatures. These records must be retained a minimum of 12 months. Carriers must document written procedures to address cleaning, sanitation, and temperature control. Carriers must also keep records of personnel training, in situations where the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.

In addition to the documents specified, the rule also acknowledges that current industry practices include the development of written agreements. The approach taken by the FDA to place the specifications of sanitation and temperature on shippers is likely to drive even more written agreements, with shippers seeking to shift some of these responsibilities to others along the supply chain. Records for these types of agreements must be retained for a minimum of 12 months.

Effective and Compliance Dates

The Final Rule became effective on June 6, 2016. Large businesses will have one year from that date to come into compliance with the Final Rule. Small businesses have until June 6, 2018 to comply.

In preparation for compliance, GCCA members are encouraged to actively communicate with their customers and partners. Good communication and consistent understanding of expectations and responsibilities across the supply chain will be critical. In addition, the International Refrigerated Transportation Association (IRTA), a GCCA Core Partner, is currently developing a best practices guide to assist industry with compliance. Completion of the guide is expected in the summer of 2016. Sessions related to the guide are planned for the 2016 Assembly of Committees.

Lowell Randel is Vice President, Government and Legal Affairs at GCCA. This article as originally published in the July-August 2016 issue of COLD FACTS magazine.