FDA clarifies sanitary transportation rule waiver
The U.S. Food and Drug Administration (FDA) has issued guidance to clarify that a waiver to the Sanitary Transportation of Human and Animal Food final rule covers retail food establishments that sell food for humans, including those that sell both human and animal food, but does not apply to establishments that only sell food for animals.
The U.S. Food and Drug Administration (FDA) has issued guidance to clarify that a waiver to the Sanitary Transportation of Human and Animal Food final rule covers retail food establishments that sell food for humans, including those that sell both human and animal food, but does not apply to establishments that only sell food for animals.
The Sanitary Transportation rule established a process by which the FDA may waive any of the rule’s requirements for certain classes of persons, vehicles, or types of food if doing so will not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.
In April 2017, the FDA announced three waivers for businesses whose transportation operations are subject to existing regulatory controls at the federal, state, or local levels, including one that waives certain requirements for restaurants, retail food establishments, and nonprofit food establishments. Since publishing the waivers, the FDA has received questions asking if the term “retail food establishment” also applies to businesses that sell animal food, because the definition of retail food establishment in our regulations can include establishments that sell food for human or animal consumption.
When the waivers were published, the FDA intended that the term “food establishment” collectively represent specific types of establishments, including restaurants, retail food establishments, and non-profit food establishments, that hold valid permits as initially described in the proposed Sanitary Transportation rule. The purpose of the guidance document is to clarify that the waiver is intended to apply to establishments that are covered by human food regulations based on the FDA Food Code and administered by state and local authorities.
The Final Rule on Sanitary Transportation of Human and Animal Food is part of the FDA’s effort to keep food safe throughout the supply chain, including during transportation and distribution. The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting certain types of human and animal food. The first compliance date was April 6, 2017. The compliance date for small businesses covered by the rule is April 6, 2018.