The Food and Drug Administration’s (FDA) sanitary transport rule will have a broad impact on the food supply chain as these proposed regulatory changes are made to implement the Food Safety Modernization Act, according to several reports. With some exceptions, the rule would apply to shippers, receivers, and carriers who transport food in the United States, by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.

The rule would also apply to persons outside the United States, such as exporters, who ship food to the United States in an international freight container by oceangoing vessel or in an air freight container and arrange for the transfer of the intact container in the United States onto a motor vehicle or rail vehicle for transportation in U.S. commerce, provided that the food will be consumed or distributed in the United States.

FDA said its proposal is designed to prevent the physical, chemical, or biological contamination of human and animal food during transportation by motor or rail vehicles through practices such as improperly refrigerating food, inadequately cleaning vehicles between loads, and failing to properly protect food during transportation.

Specific requirements that would be established under this rule would apply to the design and maintenance of vehicles and transportation equipment; measures taken during transportation to ensure food is not contaminated; exchanging information about prior cargos and cleaning of transportation equipment; training of carrier personnel; and maintenance of written procedures and records. Failure to comply with the proposed regulations could result in food shipments being refused entry into the United States, FDA said.

FDA’s rule would not apply to the transportation of fully packaged shelf-stable foods completely enclosed by a container; live food animals; raw agricultural commodities when transported by farms; food transshipped through the United States to another country; food imported for future export that is not consumed or distributed in the United States; or entities with less than $500,000 in annual sales or that have been granted a waiver by FDA.

Interested parties have until May 31 to submit comments on the proposed rule, including recommendations for further changes, FDA said.