The U.S. Food and Drug Administration (FDA) issued its proposed rule on sanitary transportation under the Food Safety Modernization Act (FSMA) that would require certain shippers, receivers, and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. The proposed “Sanitary Transportation of Human and Animal Food” rule, the seventh and final major rule central to the food safety framework under FSMA was published in the Federal Register on February 5, and will remain open for public comment through May 31, 2014.

Over the past few decades, there have been reports of foodborne illness outbreaks due to food products becoming contaminated during transportation as a result of insanitary transportation practices. In 2009, an FDA research group identified several areas where food may be at risk for physical, chemical, or biological contamination during transport and storage, including:

  • Improper refrigeration or temperature control;
  • Improper packing of transportation units or storage facilities;
  • Improper loading and unloading practices, conditions, or equipment;
  • Poor pest control in transportation units or storage facilities;
  • Lack of training and/or knowledge of food safety issues;
  • Poor transportation unit design and construction;
  • Inadequate maintenance for transportation units or storage facilities, resulting in roof leaks, gaps in doors, and dripping condensation or ice accumulations;
  • Poor employee hygiene;
  • Inadequate policies for the safe and/or secure transport or storage of foods;
  • Improper handling and tracking of rejected products; and
  • Improper holding practices for food products awaiting shipment or inspection.

Despite reports of unsanitary transportation practices, FDA deputy commissioner for foods and veterinary medicine Michael Taylor explained that the likelihood of contracting an illness caused by these practices is slim. He recently wrote on the FDA’s blog, “Truthfully, it’s uncommon for a foodborne illness to be caused by contamination during transportation. But we have received reports of unsanitary practices, and we want to minimize this potential source of illness.”

Congress initially responded to these food safety concerns by passing the Sanitary Food Transportation Act of 1990, which directed the Department of Transportation (DOT) to establish regulations to prevent food or food additives transported in certain types of bulk vehicles from being contaminated by nonfood products that were simultaneously or previously transported in those vehicles. However, following the passage of the 1990 SFTA, it became clear that potential sources of food contamination during transport were not just limited to nonfood products.

In 2005, Congress withdrew the 1990 SFTA and passed the 2005 SFTA, a broader food transportation safety law that amended the Federal Food, Drug, and Cosmetic Act (FDCA) and directed FDA to issue regulations requiring shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use prescribed sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. FDA’s authority for this proposed rule also derives from Section 111(a) of FSMA, which directed the agency to issue sanitary transportation regulations.

The proposed rule focuses on six major areas including: (1) vehicles and transportation equipment; (2) transportation operations; (3) information exchange; (4) training of carrier personnel; (5) maintenance of written procedures and records; and (6) procedures by which the FDA will waive any of these requirements. According to a January 31, 2014 FDA press release:

The proposed rule would apply to shippers, carriers, and receivers who transport food that will be consumed or distributed in the U.S. and is intended to ensure that persons engaged in the transportation of food that is at the greatest risk for contamination during transportation follow appropriate sanitary transportation practices. For example, the proposed rule would require that shippers inspect a vehicle for cleanliness prior to loading food that is not completely enclosed by its container, e.g., fresh produce in vented boxes onto the vehicle. The proposed rule also would apply to international shippers who transport food for U.S. consumption or distribution in an international freight container by air or by oceangoing vessel and arrange for the transfer of the intact container onto a motor vehicle or rail vehicle in the United States.

There is an exception in the rule for small businesses. The proposed rule would not cover shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. In addition, the requirements in the proposed rule would not apply to the transportation of fully packaged shelf-stable foods, live food animals, and raw agricultural commodities when transported by farms.

FDA plans to hold three public meetings regarding the rule. The first two, on Feb. 27 in Chicago and March 13 in Anaheim, CA, also will address the proposed rule on intentional adulteration. The third will take place March 20 in College Park, MD and will focus solely on the transportation rule.