Uncle Sam to Food Importers: Register
This past August, Friday the 13th meant more than just bad luck for food importers. Those companies not registered under the Food and Drug Administration’s (FDA) new Bioterrorism Act faced a slew of problems—including delayed deliveries, fines, and heavy scrutiny of all cargo—by failing to meet the Aug. 13 registration deadline.
Set forth in February 2002, six months after the Sept. 11 attacks, the Bioterrorism Act was created by the FDA after Congress mandated regulations be implemented to protect the nation’s food supply from terrorist threats.
The interim final rule, enacted in October 2003, outlined the registration process that all food manufacturing, storage, and packing facilities had to complete by the Aug. 13, 2004, deadline. A provision requiring prior notice of all food imports to the FDA was also included.
Many companies have failed to adhere to these regulations, however, and are currently in jeopardy of receiving anti-compliance penalties. Some confusion still surrounds registration, regulations, and what it all means for the food industry and importers.
Here are some common questions and answers.
1. Who must register? “Any facility, foreign or domestic, that engages in the manufacturing/processing, packing, or holding of food for consumption in the United States” must register with the FDA, according to the official FDA registration forms. For importers, this means any time food is placed into a container it must be registered. As the legislation passed by Congress states, however, the owner, operator, or agent in charge of that facility must complete the registration process or authorize a third party to do it.
Identifying Food Sources
Importers—who themselves might not own or operate such facilities—may not be responsible for the registration process. But they may, in the future, be required to create and maintain the records necessary to identify the food’s immediate previous sources (where it came from) and its subsequent recipients (where it is going). This would allow the United States to follow up on credible threats and trace the food to remove it from all commerce as quickly as possible.
2. Are there exceptions? There are several exceptions to the registration process. The most common groups exempt are:
- Retail food establishments —Facilities that sell food products directly to consumers as their primary function. This includes grocery stores, convenience stores, and vending machine locations.
- Restaurants — Defined by the FDA as facilities that prepare and sell food directly to consumers for immediate consumption. This group includes cafeterias, lunchrooms, delis, hospital and/or nursing home kitchens, and fast-food establishments.
3. How are importers affected? Perhaps the biggest consequence of non-compliance with the FDA registration requirement is shipping delays. According to the FDA’s Prior Notice Clause, if prior notice—including the facility registration information—is not supplied, then all food items will be held at the port of entry until adequate notice is provided. Not only can shipments back up, but, for those shipping perishable food items, for example, entire deliveries could be spoiled as a consequence.
Additionally, those who have not properly registered are subject to fines and penalties. This ensures that the entire chain of distribution, from manufacturers to carriers to point-ofentry workers, is safeguarded from terrorist attacks on our food supply.
Keeping Our Nation Safe
We live in a very different world today than we did before Sept. 11. Sadly, as a result, everything—even something as mundane as food—has to be protected against the threat of terrorism. That’s why, with the help of Congress, the FDA, food manufacturers, and the entire logistics community, we can work to fight the threat of biological warfare and keep our nation safe and secure from harm.