Legal Briefs: How to defend against the FDA's full-court press

April 1, 2005
For logistics professionals, "March madness" isn't a reference to the NCAA basketball tournament it's how I'd characterize the latest rules of the U.S.

For logistics professionals, "March madness" isn't a reference to the NCAA basketball tournament — it's how I'd characterize the latest rules of the U.S. Food & Drug Administration (FDA) related to transporting and storing food.

Last month, the FDA issued the fourth revision of its Compliance Policy Guide pertaining to the prior notice requirements for food imported into the U.S. The original guidance was published in December 2003, so revisions are coming out about every three-and-half months. This means those who are involved with the logistics of food distribution have to remain ever on the ready for changes.

The latest revision doesn't present a lot of new things, but logistics managers need to know that there are special procedures related to food distribution that do not apply to other commodities. Those experienced in the logistics aspects of non-food items will find that there are many additional rules with respect to the movement of food and a whole new agency (FDA) to contend with.

The extensive requirements of the FDA are a result of Congressional action after 9/11. In 2002 Congress passed what is known as the Bioterrorism Act, a comprehensive piece of legislation. Among its objectives is to provide for a more secure food supply in the U.S.

The Bioterrorism Act placed certain responsibilities on the FDA and the U.S. Bureau of Customs and Border Protection (CBP) for the U.S. food supply.

The FDA, in conjunction with the CBP, has issued regulations and compliance guides pertaining to the distribution of food. These requirements generally relate to recordkeeping so that if an incident occurs, the FDA will be able to determine where the food came from, who transported it, where it was stored and how it was distributed.

The most extensive of these requirements pertains to imported food. A key aspect of the FDA's imported food requirements is prior notification. For most food items, notification must be made to the FDA at certain time periods before the item arrives in the U.S. The time limits for prior notification depends upon the mode of arrival. The times are:

  • by motor carrier, at least 2 hours before arrival;
  • by rail, at least 4 hours before arrival;
  • by air, at least 4 hours before arrival;
  • by ship, at least 8 hours before arrival (this requirementis in addition to the CBP's 24-hour notice requirement before a container is loaded on-board a ship at a foreign port).

The Bioterrorism Act also requires that all domestic and foreign facilities that manufacture, process, pack, or hold food for consumption (by humans or animals) in the U.S. register with the FDA. There are a few exceptions. The notification transmissions to the FDA pertaining to food products prior to import must include registration numbers assigned to the foreign manufacturer's and shipper's facilities.

What happens if there has been no prior notification (or incorrect notification), or no registration number (or the wrong number) or other information is missing or wrong? If this happens there is a good chance the food will be denied admission at the port. The Bioterrorism Act provides that it may not be delivered to the owner, importer or consignee. For food articles, detention creates real problems as the food may spoil or attract insects and vermin. It also means that storage costs increase. All of this occurs while efforts are made to straighten out the problem.

The FDA has indicated that it receives over 20,000 such notices each day. Even with a notice, the FDA may detain food items if they believe they may present a health problem.

The FDA rules for food distribution from domestic sources are less extensive than for imports. The FDA's regulations require those who manufacture, process, pack, transport, distribute, or store food maintain various records. These records do not have to be routinely turned over to the FDA, but must be produced if the agency requests them and can be part of an FDA inspection process. The required information may be maintained electronically.

What the FDA terms "food transporters" may meet their recordkeeping requirements by adhering to the record retention requirements of the Federal Motor Carrier Safety Administration and the Surface Transportation Board (such things are bills of lading and expense bills) and the requirements of the Warsaw Convention for movements by air.

The Bioterrorism Act has spawned a new round of record and notification requirements. If you are new to food shipments, beware — the rules are often modified.

James Calderwood is a partner with the law firm of Zuckert, Scoutt & Rasenberger L.L.P., in Washington, D.C., where he concentrates on transportation matters. He can be reached at [email protected]. This column is designed to provide information of general interest. It cannot substitute for indepth-legal analysis of particular problems. Readers are urged to seek counsel concerning individual situations.

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