The Sanitary Transportation of Human and Animal Food rule was the last regulation finalized as part of the implementation of the Food Safety Modernization Act (FSMA). It requires shippers, loaders, carriers, and receivers involved in the transportation of human or animal food to use practices to ensure food safety. The rule took effect for large companies last year, with compliance for smaller entities just in force last month and is the first-ever regulation around the transportation of food.

The story of these regulations actually predates FSMA by two decades. The original legislation, the Sanitary Food Transportation Act, was enacted back in 1990 and focused on the use of nonfood products in tanker trucks and rail cars that would later carry food products. The law gave jurisdiction over the transportation of food to the Department of Transportation, but given that agency’s lack of food expertise, was never acted upon. In 2005, Congress transferred responsibility for the law to the U.S. Food and Drug Administration (FDA), although again the agency took no action. The lack of major outbreaks traceable to transportation and the agency’s limited understanding of the transportation industry meant that implementation was not a priority. Congress then included the requirement as part of FSMA to ensure the agency did take action.

FDA worked closely with the transportation sector throughout the rulemaking process. The original proposal would have created significant problems by using food quality terms to create regulatory triggers. While many carrier agreements specify temperatures for food transportation, those terms generally focus on food quality. The original proposal would have made failure to meet these quality conditions a regulatory event, potentially even rendering the food adulterated despite the lack of a real food safety concern. The final rule made significant changes that recognized the relative lower risk of transportation and takes a flexible approach to allow current best practices in the supply chain to meet the regulatory requirements.

By breaking down the requirements into the four different areas—shippers, loaders, carriers, and receivers—the rule places the appropriate responsibilities on the different parties that play a role in food safety in transportation. The mechanisms of the rule are to be implemented by agreements between parties occupying these various positions.  Companies can also occupy more than one position, such as our foodservice distributor members who handle all areas of responsibility. The rule allows them to use integrated procedures to ensure compliance with the responsibilities for each function.

There has been a great deal of misinformation circulating around the specifics of the regulation. In particular, there has often been a lack of understanding regarding the flexible nature of the rules. Rather than design a restrictive regulatory regime, the agency created a rule that allows supply chain participants to implement their own solutions appropriate to the food they are handling and the equipment they are using. As an example, food requiring temperature control for safety must be transported in vehicles or equipment designed for this purpose, but the rule allows this to be accomplished through a variety of mechanisms, ranging from refrigerated trailers to the use of ice or insulated coolers. The same is true regarding the cleaning of equipment, only requiring that it be maintained in an appropriate sanitary condition. Trailers that will only carry food on pallets do not have the same needs as a tanker truck carrying ice cream mix.

Ultimately, the rule recognizes that meeting the requirements of transporting food safely can be done in a wide variety of ways and allows the parties involved to determine the manner that best meets their particular needs. As an example, many distributors transport cleaning supplies on their trucks, which the rule permits as long as the proper steps are taken to prevent contamination. It also allows parties to determine for themselves the best way to ensure temperature controls; companies can determine which procedures work best for their operations. Finally, it does not mandate the use of specific technologies. As an example, the rule allows companies to determine their own method to ensure temperature maintenance rather than requiring the use of temperature-monitoring devices.

Thus far, FDA has taken a patient approach with enforcement, and little activity has been seen. Using an open process during the rulemaking, the agency learned a great deal about the complexity of the food supply chain and was able to write a rule that meets the needs of a very broad industry. Our association and others in the industry continue working with the agency to help them develop their understanding of transportation and ensure the safety of the nation’s food supply.

Jonathan Eisen is the senior vice president, government relations, for the International Foodservice Distributors Association.