Could terrorists put poison into food intended for grocery stores in the U.S.? Could they put an organism that causes disease into food being shipped to restaurants? Can the U.S. food supply be made safe from international contamination by lethal substances?
These potential problems are one reason the U.S. Congress enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, better known as the Bioterrorism Act [see last month’s cover story, “Frozen at the border”].
Is the threat real? In 2002 three people in Israel were arrested for planning a mass poisoning of food. In January of this year the British arrested several persons for plotting to add ricin (a poison derived from castor beans) to the food supply at a military installation. The unfortunate fact is that food supplies are already on the radar scope of terrorist organizations.
To cope with this situation, and as mandated by the Bioterrorism Act, the U.S. Food and Drug Administration (FDA) (www.fda.gov) on October 10, 2003, issued extensive new regulations mandating registration and notification for food items — both for humans and animals, including imported food. The regulations have an effective date of December 12, 2003.
The rules will impact the entire supply chain for food items.
Under the regulations those who import food into the U.S. will have to provide the FDA with an advanced notice of the shipment. Prior notice of imported food must be received and confirmed by the FDA at least two hours before the items arrive in the U.S. by motor carrier, four hours before arrival by air or rail and eight hours if arriving by water carrier. Notices may not be transmitted more than five days before arrival in the U.S.
The FDA expects that there will be an average of 25,000 such notices each day. That’s over 9 million notices a year.
To make it easier on shippers the FDA has indicated that these notices may be submitted electronically using the existing automated broker interface system of the U.S. Bureau of Customs and Border Protection. In addition, the FDA also operates its own prior notice system to receive the required notices.
Under the regulations it is the responsibility of the importer to provide the notice. The type of information required in the notice includes the name, address and contact information for the importer, the origin of the shipment, its destinations, port of entry, quantity, commodity code description, etc.
These import notice requirements are in addition to the already existing 24-hour prior-to-loading rule of Customs. This is the rule that requires notice at least 24 hours before a container intended for the U.S. is loaded on a ship at a foreign port. Imported food moving by container into the U.S. via an ocean carrier would have to comply with both the Customs 24-hour prior-notification-before-loading rule and the FDA prior notification rule.
On October 10, 2003, the FDA also issued regulations requiring all domestic and foreign food facilities that manufacture, process, pack or hold food — for either human or animal consumption in the U.S. — to register with it. This registration is to be completed by December 12, 2003. The FDA anticipates that about 420,000 facilities will register. These regulations require each facility to be registered, so if a company has five food processing plants and three food warehouses, eight registrations will be required.
As originally proposed, it appeared as if carriers such as cargo airlines, motor carriers and ocean carriers would be required to register. However, under the final regulations, carriers who merely transport food items do not have to register.
The facility registration requirements include, among other things, providing the FDA with all trade names under which the registrant conducts business and the identity of the U.S. agent of a foreign facility. The registration may be submitted electronically (Internet or fax) or by mail.
It is estimated that about 20% of all imports into the U.S. are food, so these regulations impact a considerable amount of commerce.
What will FDA do with all this information? Mark McClellan, the FDA’s commissioner, and Robert Bonner, Customs’ commissioner, both say that the information will be processed through a computer system that is to consider over 100 risk factors. This will alert the agencies to shipments that may need to be inspected closely. Among the factors is the country of origin of the food, the type of food and the history of the importer and food producer.
Because of the increased responsibility the Bioterrorism Act places on the FDA, Congress has provided that agency with an extra $150 million to hire more than 650 additional inspectors.
Everyone in the supply chain for food products is now faced with new registration and reporting requirements. The FDA will give companies four months to adjust and then enforcement begins. LT
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 in-depth legal analysis of particular problems. Readers are urged to seek counsel concerning individual situations.