As part of the Food Safety Modernization Act (FMSA), signed into law January 2011, the Food and Drug Administration (FDA) has published a final rule on section 111—Sanitary Transportation of Human and Animal Food.

According to the FDA, “the goal of the rule is to ensure that transportation practices do not create safety risks”. The FDA hopes to address three areas:

  1. Ensuring food is properly refrigerated
  2. Vehicles and equipment are properly cleaned and sanitized
  3. Ensuring food is properly protected during transportation.

The rule is part of the implementation of the FSMA and the Sanitary Food Transportation Act of 2005.  The rule is meant to be based upon current best industry practices. Significant changes were made from the proposed rule offering more flexibility to carriers and shippers to set industry specific guidelines, minimizing burdensome requirements. While primary responsibility for determining appropriate transportation operations now rests with the shipper, the shipper may rely on contractual agreements to assign some of these responsibilities to other parties (such as the carrier). Thus, be sure to review your shipping contracts.

The rule went into effect in June 6, 2016. Small businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and having less than $27.5 million in annual receipts will have to comply within two years after the final rule goes into effect. All other businesses subject to the rule will have one year to comply.


The FSMA was enacted into law after several food borne related outbreaks, including salmonella and E. coli, were reported across the U.S. Many of these outbreaks have been traced back to the handling, processing and manufacturing of the food. Due to this recent history, the majority of the FSMA was directed at those sections of the food supply chain, and the sanitary transport of food section simply closes loopholes within that supply chain.

Cost / Benefit

The new rule estimates it will cover 83,609 firms, including carriers engaged in transporting food and food facilities that ship food. Total first year cost is estimated to be $162.7 million, and total annual cost is estimated at $93.5 million. Unfortunately, the FDA “lacks the sufficient data to quantify the potential benefits of the proposed rule.” They further explain that there is not sufficient data to quantify the likelihood of food becoming adulterated during its transport.

Established Requirements

The rule defines transportation as “any movement of food in commerce by motor vehicle or rail vehicle within the United States”. The rule will establish requirements for sanitary transportation for shippers, loaders, carriers, and receivers engaged in food transport operations. Specifically the rule established requirements for:

  • Vehicles and transportation equipment—The design and maintenance of vehicles and transportation equipment to ensure that they do not cause the food that they transport to become contaminated.
  • Transportation operations—The measures taken during transportation to ensure food is not contaminated, such as adequate temperature controls and separation of food from non-food items in the same load. Packaging may constitute separation.
  • Information exchange—Procedures for exchange of information about prior cargos, cleaning of transportation equipment and temperature control between the shipper, carrier, and receiver, as appropriate to the situation. For example, a carrier transporting bulk liquid non-dairy foods would want to ensure that vehicles that have previously hauled milk will not introduce allergens into non-dairy foods through cross contact.
  • Training—Training of carrier personnel in sanitary transportation practices and documentation of the training.
  • Records—Maintenance of written procedures and records by carriers, loaders, and shippers related to transportation equipment cleaning, prior cargos, and temperature control, when contractually required.
  • Waivers—Procedures by which the FDA will waive any of these requirements if it determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and that it is the public’s interest.


  • Transportation of food that is completely enclosed by a container, except food that requires temperature control for safety;
  • Shippers, loaders, receivers, or carriers with less than $500,000 in total annual revenue;
  • Transportation activities performed by a farm;
  • Food transshipped through the United States to another country; food imported for future export that is not consumed or distributed in the United States (frozen food is not subject to these regulations);
  • Transportation of compressed food gasses; and
  • Transportation of live food animals.

—Quoted from whitepaper provided by Agricultural and Food Transporters Conference (AFTC)

All Joe Morten & Son, Inc customers are encouraged to read the full rule and consult with their legal counsel with any questions or concerns. The full rule can be found by clicking here.