Issue 422, November 18, 2003
General: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires that FDA receive Prior Notice of food imported into the United States, beginning on December 12, 2003. The Bioterrorism Act (BTA) 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 is required on all entry summary types and I.T. (In Transit) and T&E (Transport and Export) bonds.

Goods subject to Prior Notice may not be processed under section 321 (small value) provisions.

Goods subject to Prior Notice may not be released under the BRASS (Line Release) process.

Articles Subject to FDA Prior Notice: Prior notice applies to food for humans and other animals that is imported or offered for import 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:

	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

Prior Notice requirements apply regardless of:

	Quantity Imported - Applies to samples, full orders etc.
	Purpose of Importation - Applies to goods imported for testing, consumption etc.

Entry Type Requirements:

	Section 321 (small value) not allowed
	Applies to all entry types excluding: T & E (Transportation and Export) In Bond movements and Warehouse Withdrawals.

Articles Not Subject to FDA Prior Notice: Foods that are excluded from the Prior Notice requirement are:

1)	Food carried by or accompanying an individual arriving in the United States for that individual's personal use (i.e., for consumption by themselves, family, or friends, and not for sale or other distribution)
2)	Food that is exported without leaving the port of arrival until export
3)	Meat food products, poultry products and egg products that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act;
4)	Food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the United States.

Time Requirements: In order to meet the FDA PN requirement the Importer/Submitter must provide complete and accurate information to submit the Prior Notice to the service provider no less than 2 hours prior to the minimal time required by FDA (below).

There are two steps that must be considered when adhering to the FDA time requirements for Prior Notification

1)	Submission of the Prior Notice to FDA. The submission must be made in an effort to adhere to the FDA time limits - BUT - the clock does not begin until FDA confirms they have received the Prior Notice.
1)	FDA's communication confirming they have received the Prior Notice. This action starts the clock. This time must be no more than 5 days prior and before the arrival time specified by mode of transportation.

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

It is important to note that the time frame to determine the minimum Prior Notice requirement begins when FDA confirms the prior notification has been received.

Submitting Prior Notice (PN) to FDA: Prior notice must be submitted electronically either through ABI/ACS or the FDA PN system interface at www.access.fda.gov. Transaction types and articles that have been refused admission must be submitted by the FDA PN web site. Technical assistance is available at: United States, call 1-800-216-7331 or 301-575-0156, All other countries and locations, call 301-575-0156, Fax to 301-210-0247, Emailed to furls@fda.gov

Prior Notice Data Requirements: As the Importer of Record you are responsible to ensure all information in the attached listing is provided timely and accurately to the individual/vendor responsible for submitting the Prior Notice and DHL Danzas. Failure to supply complete and accurate information with import documents in a timely basis may result in Prior Notice not being submitted timely and additional service fees.

A separate FDA PN must be completed for each article of food when any of the following information varies/changes. Example separate Prior Notices must be completed on tuna where the only information that differs is the size of can.

	Identification of the submitter, including contact name, telephone and fax numbers, email address, and firm name, full address and FDA facility registration number. DHL Danzas is not the submitter.
	Identification of the transmitter (if different from the submitter), including name, telephone and fax numbers, email address, and firm name and address. If a FDA registration number is provided city and country may be provided instead of full address. If DHL Danzas is transmitting the Prior Notice we are indicated as the transmitter.
	Entry type and CBP identifier including entry summary number or I.T./T&E bond number. This is only available from DHL Danzas.
	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) and the HTSUS code.
	The identification of the manufacturer, including contact name, telephone and fax numbers, email address, and the firm name, full address and FDA facility registration number.
	The identification of the grower, (if known), including contact name, telephone and fax numbers, email address, and firm name, full address and FDA facility registration number.
	The FDA Country of Production.
	The identification of the shipper, including the name, full address and FDA facility registration number.
	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 including the name, full address and FDA facility registration number.
	The identification of the carrier and mode of transportation.
	Planned shipment information including: - Air: Airway bill number(s), Flight number, Container Number, 6 digit HTSUS code. - Ocean: Bill of lading number(s), Vessel name and voyage number, Container number, HTSUS code. - Truck/Bus: Trip number, Container number, HTSUS code. - Rail: Trip number, Car number, Container number, HTSUS code. - Private Vehicle: License plate number and state or province, HTSUS code.
	Location: Only required when food has been refused including the location and address where the article of refused food will be or is being held, the date the article has arrived or will arrive at that location, and identification of a contact at that location.

FDA Prior Notice Confirmation: FDA will issue a confirmation of Prior Notice to the transmitter upon successful receipt of the Prior Notice information. If FDA Prior Notice was completed through the FDA PN Web site, by fax or email the Prior Notice confirmation must be included with the arrival documents.

Confirmation means the information has been received and is facially complete. Subsequent system and manual review by FDA staff may result in inspection of the imported food upon arrival.

When the Prior Notice is submitted via the FDA web site the Prior Notice confirmation must be printed and provided with the import documentation. Printing the Prior Notice is not required when submitted via ABI/ACS.

When Prior Notice is submitted by DHL Danzas via ABI the Importer of Record and submitter (if different) will receive email confirmation of FDA PN Confirmation Number. Please contact your DHL Danzas representative to ensure you are established to receive automatic email notification.

Correcting FDA Prior Notice, Failing FDA Confirmation: If the transmission fails the validation, it will be rejected and the transmitter must to make corrections.

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.

The FDA PN System Interface has Help features and interactive feedback to assist the submitter and minimize spelling mistakes and omissions. In addition, the online Help Desk will be available to assist users, beginning December 12, 2003. The Help Desk will be staffed on business days from 7 AM until 11 PM U.S. Eastern Time.

Shipment/Data Changes after Prior Notice Confirmation: If any of the following required information changes after confirmation, then a new Prior Notice must be submitted:

	Identification of the submitter, including name, telephone and fax numbers, email address, and firm name and address
	Identification of the transmitter (if different from the submitter), including name, telephone and fax numbers, email address, and firm name and address
	Entry type and CBP identifier
	The identification of the article of food, except the estimated quantity
	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 or, for food imported by international mail, the anticipated date of mailing
	The U.S. recipient (name and address) if the food is imported by international mail
	The identification of the importer, owner, and consignee
	The identification of the carrier and mode of transportation
	Planned shipment information unless the food will not be imported

Failure to Submit Prior Notice: Food that is imported or offered for import with inadequate Prior Notice is subject to refusal and holding at the port or in secure storage. FDA will provide its staff with enforcement guidance containing the Agency's policies on injunctions, prosecution, and debarment related to failure to provide timely and accurate Prior Notice, as well as the Agency's policies regarding refusals under § 801(m)(1) and holds under § 801(l). FDA intends to include a transition period in this guidance, during which it will emphasize education to achieve compliance. While FDA will nonetheless be authorized to take various types of enforcement action for violations of the Prior Notice requirements, this planned transition period will allow FDA to focus its resources on the most appropriate circumstances. FDA also intends to provide guidance to its staff on enforcing the Prior Notice requirements after a transition period. FDA's guidance documents will be available to the public, and FDA will publish a notice of availability in the Federal Register.

Prior Notice Confirmation Requirements Upon Arrival: It is prudent that the FDA Prior Notice Confirmation Number be provided with the import documents upon arrival. For a Prior Notice that is submitted through the ABI/ACS interface, the Prior Notice confirmation number together with a "PN received" message will be made available to the filer through the ACS/ABI interface. If Prior Notice is submitted through the FDA PN System Interface, then the transmitter will receive a confirmation online as soon as the submission is confirmed. To make it easier for the carrier or individual at the port, the carrier should have a copy of the confirmation, which includes a Prior Notice confirmation number in his/her possession. For international mail packages, the Prior Notice Confirmation Number must accompany the package. For food carried by or otherwise accompanying an individual arriving in the United States, the Prior Notice Confirmation Number must accompany the food.

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.