United States: Carriers & Brokers: Info You Need NOW On FDA's Food Transport Rule

On April 6, 2016, the Food and Drug Administration (FDA) published the final rule entitled "Sanitary Transportation of Human and Animal Food" (the SFT Rule) pursuant to the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the Food Safety Modernization Act (FSMA). FDA enforcement of the SFT Rule does not begin until April 6, 2017 (April 6, 2018 for small businesses), but it is critical for carriers and freight brokers involved in food transportation operations to get an early understanding of the SFT Rule's scope and requirements to ensure timely compliance. Here is what carriers and brokers should know now about the SFT Rule.

What Is the SFT Rule?

The SFT Rule establishes requirements for sanitary transportation practices applying to shippers, carriers, loaders, and receivers engaged in the transportation of food to ensure the safety of the food they transport. The focus of the SFT Rules is on the prevention of food contamination, rather than responding to outbreaks, thus making each party in the transportation chain responsible for ensuring that food is transported safely.

Does the SFT Rule Apply to You?

With some exceptions, the SFT Rule applies to shippers, loaders, receivers, and carriers involved in transportation operations for the transportation of human and animal food by rail or motor vehicle in commerce within the United States, whether or not the food is being offered for or enters interstate commerce. The SFT Rule defines "shippers" as persons who arrange for the transportation of food in the United States by a carrier(s), including brokers. "Carriers" are defined as persons who physically move food by rail or motor vehicle in commerce within the United States, regardless of ownership of the vehicles, excluding parcel delivery carriers. A carrier may also be a "loader" or "receiver."

The SFT Rule contains several exclusions for certain types of food and businesses, particularly where the food and/or business is already subject to extensive federal regulation. The SFT Rule also excludes businesses that have less than $500,000 in average annual revenues, as adjusted for inflation, and calculated on a rolling, three-year basis. Further, the SFT Rule does not apply to issues other than the establishment of sanitary transportation practices, such as cargo security and food quality or appearance. Cargo security will be addressed in the FDA's upcoming Intentional Contamination rule.

What Requirements Are Imposed by the SFT Rule?

The SFT Rule sets out equipment, operational, training, and records requirements for those who serve as shippers/brokers, carriers, receivers, and loaders engaged in transportation operations. Because the same person may act and be responsible in more than one of the above four capacities on a given shipment, it is now necessary to ensure that the parties' roles are specified in writing and that all participants in the transportation chain have written procedures in place to ensure compliance. The responsibilities should be assigned among the parties in a written contract maintained in accordance with recordkeeping requirements set forth in the SFT Rule. It is important for those involved in the transportation of food to specify in their contracts precisely who is responsible for ensuring compliance, particularly for those requirements that do not designate the responsible party. If the SFT Rule does designate the party responsible for a particular function, that function generally can be re-assigned to another party in a written contract.

Some requirements apply only to shippers/brokers or carriers. Importantly, absent a contractual agreement assigning some of these responsibilities to other parties, shippers/brokers have primary responsibility for determining appropriate vehicles and transportation equipment for transportation operations (V&TE), and, if necessary, adequate temperature controls. While default responsibility falls to the shipper/broker unless otherwise agreed by contract, all parties should make sure their procedures and contracts clearly delineate who has responsibility. All parties should also ensure that their procedures address documentation and records necessary to support their compliance and a mechanism for ensuring others in the supply chain are compliant.

Where the carrier and shipper/broker have a written agreement that the carrier is responsible, in whole or in part, for sanitary conditions during the transportation operations, the SFT Rule imposes requirements that must be included in the contract and triggers training requirements for carriers.

Proper records of all written procedures, agreements and required training by carriers must be maintained as required by the SFT Rule. 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 records must be kept as originals, including true copies or electronic copies, and must be available "promptly" or within 24 hours if kept offsite. However, records of procedures that are currently in effect at a particular facility must be kept on-site.

Is the Death of Carmack Greatly Exaggerated?

The proposed rule prompted several questions about the impact it would have on cargo loss and damage claims under the Carmack Amendment. Specifically, there was a concern that a failure to adhere to shipper/broker-specified conditions for transportation would be directly linked to adulteration of, or damage to, food products during storage, thereby triggering the carrier's liability under the Carmack Amendment without possibility of salvage or other loss mitigation by the carrier or shipper. However, the final SFT Rule clarifies that only a failure to comply with SFT Rule requirements that causes the food to be "actually unsafe" will render the food adulterated and is a prohibited act under the Federal Food, Drug, and Cosmetic Act (FDCA). An "inconsequential failure" by a carrier to meet the shipper/broker's temperature control specifications, or a broken seal or other evidence of tampering, will not create a "per se presumption of adulteration." But if a covered person "becomes aware" or there is evidence of possibly "material" deviation from the specifications, a "qualified individual" must determine that the food is not unsafe. Failure to take such action may render the food adulterated. While the evident ambiguities in the FDA's current position would benefit from further regulatory guidance, the final rule at least offers the possibility of negotiated settlements after fact-finding – rather than absolute carrier liability for every SFT Rule infraction.


The SFT Rule will significantly impact the procedures of and contractual relations between shippers/brokers and carriers involved in food transportation operations. Shippers/brokers and carriers should review their current procedures and contracts as soon as possible to allow adequate time to determine whether and how their business rules should be changed to ensure compliance with the SFT Rule.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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