The U.S. FDA recently published a new final rule on the Sanitary Transportation of Human and Animal Food, which is designed to meet the agency’s objective of protecting the U.S. food system by limiting the risk of food contamination during transport. The rule governs “any movement of food in commerce by motor vehicle or rail vehicle” and includes “all activities associated with food transportation that may affect the sanitary condition of food including cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment.”

The rule went into effect on June 6, 2016 and requires businesses, other than small businesses, to comply with the rule’s requirements by April 6, 2017; small businesses (those with fewer than 500 employees and less than $27.5 million in receipts) must comply by April 6, 2018. Companies involved in any stage of food transportation within the U.S. are well advised to study the rule. Highlights are provided here. 

Companies Subject to the Rule & Their Responsibilities
Subject to the exemptions noted below, the rule applies to the following entities:

• Shippers, defined to include any person who arranges for transportation of food, including brokers and intra-company shipments, are primarily responsible for ensuring that food is safe during transport. Shippers can assign their responsibility to other companies subject to the rule via written agreement that specifies the particular criteria that must be met to ensure safe food transport.
• Carrier (except parcel delivery services) responsibility under the rule is defined by the agreement with the shipper. Once a carrier assumes responsibility for ensuring sanitary conditions for a food shipment, it must have in place appropriate operating and training procedures and retain related records. 
• Loaders, those who physically loadfood onto rail or motor vehicles for transport in commerce, are responsible for determining, prior to loading food for transport, that the vehicle is in appropriate sanitary condition consistent with the shipper’s requirements and that it meets any temperature requirements.
• Receivers of food after transportation, whether or not they represent the final point of receipt for the food, must assess whether the food was subjected to significant temperature abuse that rendered the food unsafe. Receivers do not include consumers or people who hold food on behalf of consumers and who are not also a party to the transaction and not in the business of distributing food.  

Companies involved in the transportation of food for export are also subject to the rule (until the shipment meets a port or U.S. border), as are shippers that ship food directly into the U.S. by motor, rail, ship or air and arrange for the transfer of the intact container onto a rail or motor vehicle for transport within the U.S.

The Sanitary Transport Rule does not apply to 1) shippers, receivers and carriers that have less than $500,000 in average annual revenue, 2) farm-related transportation activities, 3) transportation of food that is transshipped through the U.S. to another country, and 4) food imported for future export that is neither consumed nor distributed in the U.S.

The rule states that if any person subject to the rule becomes aware of a condition that may render food unsafe, that person must take action to ensure that the food is not sold or distributed until a qualified individual has made a determination that the food is safe.

Food Covered by the Rule
The Sanitary Transport Rule applies to the full scope of foods regulated by the Federal Food, Drug, and Cosmetics Act (the FD&C Act), including pet food, food additives and dietary supplements. Exemptions include: 1) food that is completely enclosed by a container, unless refrigeration is needed for safety, 2) packaged alcoholic beverage products, 3) frozen food, 4) compressed food gases, 5) food contact substances (i.e., packaging), 6) human food byproducts transported for use as animal food without further processing, and 7) live food animals, except molluscan shellfish.

The rule also does not apply to Grade A milk under the National Conference on Interstate Milk Shipments program and permitted food establishments, such as restaurants, supermarkets, and home grocery delivery operations.

Key Requirements
The rule establishes the following requirements:

• Vehicles and transportation equipment must be adequately designed and maintained to ensure they do not cause food to become unsafe. Trucks, containers and other equipment must be: adequately cleaned to protect against allergen cross-contact and contamination between loads; able to properly manage temperature for shipments requiring temperature control; and stored in a manner to prevent contamination by pests or other materials.
• Transportation operations must ensure food safety, such as by providing adequate temperature controls and load segregation, preventing contamination of ready-to-eat food, protecting against contamination by non-food items in the same or previous load, and protecting food from cross-contact (i.e., unintentional incorporation of a food allergen).
• Training of carrier personnel is required to ensure compliance with sanitary transportation practices.
• Record keeping requirements are imposed on shippers and carriers. Shippers must retain records demonstrating they provided appropriate specifications to carriers and loaders and maintain written agreements with those entities; carriers must retain records of the specifications received from shippers and records of their personnel training. Shippers and carriers must maintain these records for 12 months. 

Responding to Contamination
Any company involved in the transportation of food that suspects or detects possible contamination must take appropriate steps to ensure that the food is not sold or otherwise distributed until a qualified individual makes a determination that the suspected failure did not render the food unsafe.

Entities covered by the rule need to have written corrective action plans that include FDA-mandated actions, such as reporting to the reportable food registry, as well as corrective action to ensure the food is not used or sold where necessary through market withdrawal or recall.

Penalties for Failure to Comply
Any food that is not transported in compliance with the Sanitary Transport Rule may be deemed adulterated under the FD&C Act and carries the risk of not only civil enforcement, but also significant criminal penalties. Persons that commit a prohibited act may be subject to misdemeanor and felony liability regardless of negligence and regardless of whether the person knew of the violation. Companies that violate the rule also run the risk of exposure to litigation by private plaintiffs.

Any company involved in transporting food in the U.S., even if for export outside the country, is well advised to consult with its legal advisor to determine whether it is subject to the Sanitary Transport Rule and, if appropriate, begin implementing policies and procedures that ensure compliance with the rule.

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Ronie M. Schmelz and Matthew Kaplan are attorneys at Tucker Ellis LLP. They can be contacted at [email protected] and [email protected].