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Shippers, carriers, receivers, foreign exporters and others in the food supply chain should act now to evaluate how broad new regulatory requirements for sanitary transportation recently proposed by the Food and Drug Administration could affect their operations. Interested parties also have until May 31 to submit comments on the proposed rule, including recommendations for further changes. Members of Sandler, Travis & Rosenberg’s FDA regulatory and life sciences practice are available to assist with either of these efforts.
The FDA’s 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 U.S.

The sanitary transport rule has been referred to in at least one major trade publication as “the sleeping giant” of FDA’s panoply of proposed regulatory changes to implement the Food Safety Modernization Act. The reason for this characterization has to do primarily with the broad impact the rule would have across the entire supply chain. With some exceptions, the rule would apply to shippers, receivers and carriers who transport food in the U.S. by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. It would also apply to persons outside the U.S., such as exporters, who ship food to the U.S. 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 U.S. onto a motor vehicle or rail vehicle for transportation in U.S. commerce, provided that the food will be consumed or distributed in the U.S.

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

Domestic and international food shippers, carriers and receivers are therefore advised to review their operations, policies and procedures to ensure that they are ready to move quickly when a final food transport rule is in place. There is also still time to let the FDA know if specific provisions of the proposed rule would pose a burden to your business. For more information on preparing for, or submitting comments on, the FDA rules, please contact Arnie Friede at (305) 894-1033 or Shelly Garg at (305) 894-1043.