FDA today released a proposed rule that would prescribe sanitary transportation practices for shippers, receivers, motor and rail carriers, and other companies that are engaged in the transportation of food in the United States. The proposed rule is designed to implement the amendments to the Federal Food, Drug and Cosmetic Act (FDCA) that were made by the Sanitary Food Transportation Act of 2005 (SFTA), which directed FDA to issue such regulations “to ensure that food is not transported under conditions that may render the food adulterated.” In addition, the proposed rule is designed to account for the subsequent amendments to the FDCA that were adopted in 2011 under the FDA Food Safety Modernization Act (FSMA). In its release of the rule, FDA noted that “the proposal marks the seventh and final major rule in the . . . FSMA central framework aimed at systematically building preventive measures across the food system.”

Under the SFTA, FDA’s implementing regulations are required to prescribe sanitary transportation practices with respect to “sanitation,” “packaging, isolation, and other protective measures,” “limitations on the use of vehicles,” and related recordkeeping requirements. Under the FDA proposed rule, transportation companies would be required to ensure that vehicles and transportation equipment are suitable and adequately cleanable in order to prevent the adulteration of food.

The regulations impose distinct obligations on shippers, receivers and carriers. For instance, shippers would be required to specify to the carrier the necessary sanitary requirements pertaining to the carrier’s vehicle and transportation equipment and would be required to visually inspect the vehicle or transportation equipment provided by the carrier before loading food not completely enclosed by a container. Amongst other obligations, carriers would be required to demonstrate to the shipper and, if requested, the receiver, that the carrier has maintained temperature conditions consistent with those specified by the shipper. The proposed rule would also impose certain record retention requirements on shippers and carriers.

The rule would not apply to shippers, receivers or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. The rule would apply broadly to all food, as defined in section 201(f) of the FDCA, including conventional food and beverage products, dietary supplements, pet food, animal feed, and raw materials and ingredients. However, the rule would not apply to the transportation of fully packaged shelf-stable foods, live food animals, and raw agricultural commodities when transported by farms.

Comments are due on the proposed rule by May 31, 2014. FDA intends to hold three public meetings on the proposed rule – two in tandem with public meetings scheduled on the proposed rule on the Intentional Adulteration of Food and one standalone meeting.