Yes, the FDA’s Proposed Rule, required to be published by March 31, 2016, will apply to food shipments being transported into the U.S., directly, by motor or rail vehicle, or transferred onto a motor or rail vehicle for transportation in U.S. commerce, if the food will be consumed or distributed within the U.S.

What are the steps for determining whether the Proposed Rule applies to an international shipment?

First, it is important to determine what modes of transportation will be used to transport the food shipment. The Proposed Rule’s requirements will only apply to food transported within the U.S. by motor or rail vehicle. For instance, if a shipper engages a motor or rail carrier, to transport an international food shipment, through a broker, or otherwise, directly into the U.S., e.g. from Mexico to the U.S., by truck, and then transported further within the U.S., by truck or rail, the new regulations would apply. Further, an entity outside of the U.S., exporting an international food shipment, by container ship or via an air carrier, would have to comply with the Proposed Rule, as a shipper, if that exporter were to arrange for the intact container’s transloading onto a motor or rail carrier for transportation within the U.S. This is because the exporter would be initiating a shipment of food, by motor or rail carrier, to enter U.S. commerce, notwithstanding having done so from abroad.

However, if the shipper or broker and carrier conduct the international transportation operation by a direct shipment to the U.S., by way of another mode, besides motor or rail carrier, such as food shipped from China, by ocean vessel, and then, subsequently, transported within the U.S. by air carriage, the Proposed Rule would not apply.

Second, shippers and brokers should determine the purpose and final destination of the food shipment because, under one exception, food shipments entering into and being transported within the U.S. that will not be consumed or distributed into the U.S. market will be excepted from coverage under the Proposed Rule. For instance, food transshipped from a foreign country, e.g., Mexico, through the U.S., and into another foreign country, e.g., Canada, would not be governed by the Proposed Rule. Similarly, food shipments that are transported from abroad to a facility within the U.S. for processing, and, subsequently, exported to another foreign country, without being consumed or distributed within the U.S., would also be free from coverage by the Proposed Rule.

What are the consequences for noncompliance with international food shipments?

As with any shipper, should the importer or exporter fail to comply with the Proposed Rule’s requirements, and the FDA determine that the food shipped to the U.S. was, consequently, adulterated, then the food shipment could be rejected, and refused admission, upon being offered for entry, into the U.S.

What is the takeaway for brokers?

Brokers should keep in mind, when arranging the transportation of international food shipments, to be consumed or distributed within the U.S., that, as the initiator of a shipment, or as required by the shipper, they will likely have to comply with the Proposed Rule where the move includes inland transportation, within the U.S., by motor or rail carrier. Following the aforementioned two-step approach should streamline the process of determining whether the new FDA’s regulations would govern a particular international food shipment.