In 2002, U.S. Congress passed legislation regarding public health security and bioterrorism to take steps to protect the public from attacks on the U.S. food supply. In October of 2003, the United States Food and Drug Administration (FDA) issued a regulation which requires domestic and foreign “facilities” to register with the FDA if they manufacture, process, pack or hold food for human or animal consumption in the U.S. The primary objective of the registration is to allow the FDA to notify facilities promptly in the event of an incident relating to the food supply.

Under the registration rules, a foreign “facility” must designate a U.S. agent having a physical place of business in the U.S.

Under FDA regulations the concept of “food” is quite broad, ranging from dietary supplements and infant formula to all sorts of foods and beverages, whether raw, alive, packaged or frozen. Similarly, animal feeds and pet food fall within the definition.

We have received many inquiries from Canadian carriers engaged in the transportation of food, as to whether the carrier falls within the definition of “facility.” Registration was required by Dec. 12, 2003. Based on information we received from the FDA, and from a plain reading of the regulation, it appears that Canadian and U.S. carriers are not required to register. However, some carriers have decided to do so, to eliminate any ambiguity, and as a matter of caution.

The regulation states the owner, operator or agent in charge of a domestic or foreign facility that manufactures/processes, packs or holds food for human or animal consumption in the U.S., or an individual authorized by one of them, must register the facility with the FDA. The word creating some ambiguity is “holds,” because a motor carrier could easily be viewed as holding food while in the process of making a delivery. In the literal sense, the carrier is certainly “holding” food in a trailer during transport. The FDA regulations specifically attempt to clear up that technicality by excluding “transport vehicles that hold food only in the usual course of their business as carriers.”

But that doesn’t resolve all questions that arise. What is the “usual course of business” as a carrier? Not all carriers operate the same way. Sometimes trailers are parked at terminals while awaiting a different power unit or trailer. Is there a certain point in time when the transportation of the goods is deemed to end and the storage of the goods is deemed to begin? What about produce, fruit or other perishable goods that are intentionally loaded in an unripe state so that that they will ripen in transit. Is that acting as a “processor” of the food?

These questions may seem over-technical and silly, but we have seen too many examples of a “zero-tolerance” mentality when it comes to Homeland Security in the post 9/11 world. In the past two-and-a-half years there have been hundreds of individuals deported, or awaiting deportation, from the U.S. due to Immigration Law infractions that would have been viewed as trivial in the past. Prosecutors have scrutinized the language of laws and regulations to construct new legal theories in order to build cases against individuals who violate the Immigration Laws and/or are suspected of being a threat to security. The ambiguities in these FDA regulations open up broad opportunities for the same, and the FDA owes the transportation industry some clarification. An additional question may arise in connection with carriers who also conduct warehousing operations. Although “transport vehicles” are excluded under the regulation, warehousing operations would appear to fall squarely within the intent of the registration requirement. This would be true even if the warehouse operations are in Canada, if food from that “facility” is offered for import into the U.S.

Violations of the registration requirement could lead to a hold or delay on imported goods into the U.S.

From the short time since the rule has been in effect, we are unaware of any problems involving Canadian carriers.

– Daniel Joyce can be reached at Hirsch and Joyce, Attorneys at Law, at 716-564-2727.