The long awaited regulations for implementation of the Food Safety Modernization Act of 2011 were published on April 6, 2016.

The regulations require shippers, and others involved with the transportation of food, to use sanitary transportation practices when shipping food that is placed into a container partially open to the surrounding environment. The regulations define “shipper” as a person who arranges transportation of food in the U.S. by a carrier.

In addition the regulations cover international shippers that export food to the U.S. by air and ocean transportation, if the food is shipped in an intact container, that will be transshipped on a motor or rail carrier, will be transported in interstate commerce, and will be eaten or distributed in the U.S.

The regulations cover food subject to the federal Food, Drug and Cosmetic Act. However, there are exemptions: shippers, with less than $500,000 in average annual revenue; farm transportation; food transshipped through the U.S. to a foreign country; imported goods which will not be consumed or distributed in the U.S.; compressed gases and food contact material; human food by-products for use as animal food; food that is completely enclosed by a container, unless it requires temperature control handling; and live food animals, except shellfish.

Although not expressly excluded, the FDA has advised that frozen food is not subject to the regulations.

What must shippers do to comply with the regulations? There are both general requirements and ones specific to shippers.

Among many specific responsibilities, a shipper is responsible for ensuring that food transportation is in compliance with all the requirements of the act and regulations. That means that a shipper must ensure a shipment of food is handled under controls and conditions suitable to prevent the food from becoming unsafe during transport.

What is “suitable” will depend on the nature of the commodity and is something that the shipper is in the best position to know as a manufacturer, distributor, or dealer in the food. So, even if the shipper’s responsibility is assigned to a third party by agreement, at the very least the shipper will continue to be responsible to make sure that all information and documents needed to ensure safe handling of the food is complete and accurate so as to inform the third party about what must be done to prevent contamination or adulteration of the food in transit.

This broad responsibility can be assigned by written agreement between the shipper and a third party involved in arranging for or actually carrying the food, such as a property broker, freight forwarder, or actual carrier. However, if the shipper is acting as its own carrier it will remain liable for full compliance, including the requirement that all vehicles and equipment used to transport food are in sanitary condition so as to prevent the food from becoming unsafe.

There are also training and recordkeeping and retention requirements that must be fulfilled, whether or not the shipper is acting as the actual carrier.

These specifics, and more, are set forth in the new regulations, 21 C.F.R. Part 1, §1.900-1.934. Shippers, carriers, and others subject to the act are well advised to become familiar with them.

Richard Furman is a member of the law firm of Carroll, McNulty & Kull LLC, in New York. He has over forty years experience providing legal advice and representation in connection with cargo transportation and import and export trade regulation. Mr. Furman has also worked for an all-cargo airline and in freight forwarding and customs brokerage.