Sanitary Transportation Rule

The Sanitary Transportation of Human and Animal Food Rule is a regulation under the Food Safety Modernization Act that establishes requirements for shippers, loaders, carriers, and receivers engaged in the transportation of food to prevent practices that create food safety risks. The rule, codified at 21 CFR Part 1, Subpart O, became fully effective in April 2017 for large businesses and applies to all modes of transportation including truck, rail, ship, and air.

The rule focuses on four core areas. First, it requires that vehicles and transportation equipment be designed, maintained, and operated to prevent contamination of food during transport. Second, it mandates transportation operations that prevent temperature abuse, cross-contamination from previous loads, and contamination from non-food items. Third, it requires that personnel involved in food transportation receive adequate training in sanitary transportation practices. Fourth, it requires that records be maintained documenting compliance.

Shipper and Carrier Responsibilities

Under the rule, shippers must specify temperature and other transportation conditions in written agreements with carriers. They must also take steps to ensure that carriers and loaders have appropriate equipment and procedures. Carriers must pre-cool vehicles to the shipper's specifications, maintain temperature control during transit, and keep vehicles in appropriate sanitary condition. Loaders must ensure that vehicles meet the shipper's specifications before loading.

Non-compliance can result in FDA enforcement actions including warning letters, import alerts, and judicial actions such as injunctions and seizures. While the FDA has taken an education-first approach to enforcement, the frequency and severity of enforcement actions have increased as the industry has had time to implement the requirements. Companies involved in food transportation should ensure they have documented procedures, training programs, and record-keeping systems that demonstrate compliance with the rule.