Issue 421, October 24, 2003
The U.S. Bioterrorism Act requires that the Food and Drug Administration (FDA) receive prior notice of food imported into the United States, beginning on December 12, 2003. DHL Danzas Air & Ocean is providing this information to keep our customers updated regarding the requirements of the Act. In order to keep it relatively brief, we shall only be discussing commercial shipments, not personal or mail shipments.

When foods arrive in the United States, the Bioterrorism Act requires that this information be provided to FDA in advance of an imported food's arrival to the United States. FDA will use this information in advance of the arrival to review, evaluate, and assess the information, and determine whether to inspect the imported food.

Prior notice must be received and confirmed electronically by FDA no more than 5 days before arrival and, as specified by the mode of transportation below, no fewer than:
2 hours before arrival by land by road
4 hours before arrival by air or by land by rail
8 hours before arrival by water

Any individual with knowledge of the required information may submit the prior notice, including, but not limited to, Customs Brokers, importers, and U.S. agents.

Prior notice applies to food for humans and other animals that is imported into the United States. "Food" is defined as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles.

Examples of "food" include, but are not limited to:
Dietary supplements and dietary ingredients
Infant formula
Beverages (including alcoholic beverages and bottled water)
Fruits and vegetables
Fish and seafood
Dairy products and shell eggs
Raw agricultural commodities for use as food or components of food
Canned and frozen foods
Bakery goods, snack food, and candy (including chewing gum)
Live food animals
Animal feeds and pet food
Foods that are excluded from the prior notice requirement are
Food carried by or otherwise accompanying an individual for personal use
Food to be exported without leaving the port of arrival until export
Meat food products, poultry and egg products that are under the exclusive jurisdiction of the US Department of Agriculture (USDA)
The prior notice must be submitted to FDA electronically and MUST contain the following information supplied by the shipper: It is the shipper' responsibility to provide this information to the party that will transmit the information to FDA (generally the Customs broker).
Identification of the submitter, including name, telephone and fax numbers, email address, and firm name and address
Identification of the transmitter (Custom Broker), including name, telephone and fax numbers, email address, and firm name and address
The identification of the article of food, including complete FDA product code, the common or usual name or market name, the estimated quantity described from the smallest package size to the largest container, and the lot or code numbers or other identifier (if applicable)
The identification of the manufacturer
The identification of the grower, if known
The FDA Country of Production
The identification of the shipper
The country from which the article of food is shipped
The anticipated arrival information (location, date, and time)
The identification of the importer, owner, and ultimate consignee, except for food to only be transshipped through the United States
The identification of the carrier and mode of transportation
Entry type and number
Planned shipment information

Food that has been refused for inadequate prior notice requires additional information in prior notice. The prior notice for food that has been refused for inadequate prior notice also must include the port of arrival, the location where the refused food is being held, the date it arrived or will arrive at that location, and the identification of the contact person at that location.

Food that is offered for import with inadequate prior notice is subject to refusal and holding at the port. FDA has policies on injunctions, prosecution, and debarment related to failure to provide timely and accurate prior notice, as well as the Agency' policies regarding refusals. FDA does intend to include a transition period in this guidance, during which it will emphasize education to achieve compliance.

It is a good idea for the carrier to have confirmation of notification before crossing the border. To make it easier for the carrier at the port, the carrier should have a copy of the confirmation, which includes a prior notice confirmation number in his/her possession.

Keep in mind that, while FDA requires two hours by road and four hours by air or rail there will be a lag between DHL Danzas Air & Ocean getting the information and transmitting the information to Customs. It is expected that a minimum of one hour should be allowed for the re-transmittal of arrival information and the transmission of the confirmation from FDA. This is an estimate based on the current information we have and could be longer once the program actually begins. DHL Danzas Air & Ocean is taking steps to minimize the delay, but it would be wise to expect it, especially for the first few weeks. We do not know for sure how quickly FDA will respond to the transmissions.

More details will be forthcoming after FDA sets the exact procedures. Until then we suggest that you begin making plans to notify FDA well in advance of the shipment' arrival at the U.S. border. Our contributing writer, Karl Krueger is the Technical Advisor for DHL Danzas Air & Ocean Air & Ocean in Port Huron, Michigan. If you have any questions or require further information, please contact Mr. Krueger at karl.krueger@dhl.com or 810 987-0567.

Our contributing writer, Karl Krueger is the Technical Advisor for DHL Danzas Air & Ocean in Port Huron, Michigan. If you have any questions or require further information, please contact Mr. Krueger at karl.krueger@dhl.com or 810 987-0567.

Please note that due to the complex nature of the subject matter, DHL Danzas Air & Ocean cannot be responsible for actions taken by the reader in reliance on the information contained herein without prior consultation with DHL Danzas Air & Ocean.