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Rule 4

Sanitary Transportation of
Human and Animal Food Rule

Covered facilities that operate under Sanitary Transportation of Human and Animal Food should be aware of the following changes outlined in the Ruling:

Compliance has already taken effect for some firms for the FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food which is now final. Based on safeguards envisioned by the 2005 Sanitary Food Transportation Act (SFTA), the aim of this rule is to prevent poor practices that can often occur during food transportation.

Who is covered?

Carriers, loaders, receivers, and shippers that transport food in or into the U.S. by water or train are covered under this rule.

Key Requirements:

Vehicles and transportation equipment: To ensure the design and maintenance of vehicles and transportation equipment does not cause the food that it transports to become unsafe.

Transportation operations: To implement measures to ensure food safety during transportation of food (such as temperature controls, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact).

Training: Training of carrier personnel in sanitary transportation practices and documentation of the training (when the carrier is responsible for sanitary conditions during transport).

Records: Maintenance of records of written procedures, agreements and training (required of carriers).

Exemption From This Rule:

Following entities are exempted from the rule:

  • Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue
  • Transportation activities performed by a farm
  • Transportation of food that is transshipped through the United States to another country
  • Transportation of food that is imported for future export and that is neither consumed or distributed in the United States
  • Transportation of compressed food gases (e.g. carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances
  • Transportation of human food byproducts transported for use as animal food without further processing
  • Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety
  • Transportation of live food animals, except molluscan shellfish


This FSMA rule can be waived if it determines that the conditions of the food to be transported would not result in the contamination of human or animal food and consequent effect on human or animal health. The FDA intents to waive two entities:

1. Vessels that hold valid permits under the National Conference on Interstate Milk Shipments (NCIMS).

2. Entities which relinquish food to customers after being transported to the establishment that are already covered under the Retail Food Program.

Compliance Dates:

  • Small Businesses – businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts would have to comply two years after the publication of the final rule.
  • Other Businesses – a business that is not small and is not otherwise excluded from coverage would have to comply one year after the publication of the final rule.