This article originally appeared in the March/April issue of PARCEL.

On April 6, 2016, the Food and Drug Administration published new regulations relating to the sanitary transportation of food. These are sometimes referred to as the FSMA (fez-ma) regulations as they were prompted by the Food Safety Modernization Act. While it is my sense that most parcel shippers deal with manufactured goods, there are certainly others involved in the production and distribution of food products. For those, here is the “tip of the iceberg” of what you need to know… and do now.

One: The first effective date is April 7, 2017 — in other words, right about NOW. For small businesses employing fewer than 500 persons and having less than $25.5 million in revenue, the effective date is April 7, 2018.

Two: Although there are no new criminal or civil penalties included in the new regulations themselves, long existing statutes established under the Food, Drug, and Cosmetic Act make it a criminal act to sell adulterated food. There can be other serious, adverse consequences for failure to comply. In particular, a failure to establish and follow procedures required by the regulations can lead to the products shipped to be “deemed to be adulterated.” The possibility of a shipment being adulterated is treated, for legal purposes, the same as if the shipment was in fact adulterated.

Within the supply chain, failure to follow the procedures can lead to disruptions such as imported goods being denied entry into the United States. Another example would be a consignee refusing to accept a shipment of food products simply because there were no FSMA compliant procedures in place.

Three: A parcel shipper’s first task is to determine if it is subject to the regulations. Generally speaking, it applies to shippers, brokers and other intermediaries, receivers, loaders, and carriers engaged in food transportation operations with certain exceptions. One notable exception is a business engaged in food transportation operations that has less than $500,000 in average annual revenue.

Although the regulations cast a wide net over any and all categories of food, including pet food, food additives, and dietary supplements, there are numerous exceptions within the regulations. For instance, food completely enclosed by a container… unless refrigeration is needed for safety (as opposed to needed for quality).

Four: If a parcel shipper is subject to the new FSMA regulations, then procedures must be adopted and implemented to comply with the regulations. A core requirement of the regulations is to develop measures to ensure food safety during transportation such as adequate temperature controls and preventing contamination. Along with this is the requirement for the training of personnel.

A further requirement is for the shipper to specify in writing to the shipper’s carriers and brokers, loaders, warehouses, and receivers all necessary requirements developed by the shipper for the sanitary transportation of its shipments. It should be noted that this would not have to be done for each and every shipment, but rather could be done through a contractual requirement covering all shipments that would be transported by a particular carrier. Finally, there is a requirement to maintain records that the procedures have indeed been developed and communicated to the carriers.

All for now!

Brent Wm. Primus, J.D., is the CEO of Primus Law Office, P.A. and the Senior Editor of transportlawtexts, inc. Previous columns, including those of William J. Augello, may be found on the Parcel website at Your questions are welcome at