NOTE: The following information is relevant for DHL Danzas Air & Ocean customers only.

General: The U.S. Food and Drug Administration (FDA) released regulations in response to the Bioterrorism Act (BTA) outlining specific requirements on the importation of food products and the registration of foreign and domestic food facilities. The following information is a summary of the requirements. Compliance with these requirements is critical to ensure timely importation of food products into the U.S.

Key Regulations:

1. Facility registration required by December 12, 2003.
2. Prior notice of food imports effective with the import date of December 12, 2003.
3. Record Keeping Requirements.

The changes outlined in this document are extensive and all Importers - Owners - Consignees - Shippers - Manufacturers - Growers - Freight Holding Facilities must prepare for implementation effective December 12, 2003. An Importer checklist has been provided as part of this document to assist you in determining if you are prepared for the implementation of the FDA BTA.

As the importer of Food and Food Products subject the FDA Bioterrorism Act (BTA) you are responsible to ensure you and your vendors (shippers, suppliers, manufacturers, growers, carriers, freight holding facilities, consignees and customs broker) are prepared to comply with the new law. In order to assist you in ensuring you meet all requirements a checklist is provided within this document.

FACILITY REGISTRATION

Requirement: Domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register with the Food and Drug Administration by December 12, 2003. In the event of a potential or actual bioterrorism incident or an outbreak of food-borne illness, facility registration information will help FDA to determine the location and source of the event and permit the agency to notify quickly facilities that may be affected.

Foreign Facilities Require a U.S. Address and Contact: A foreign facility must also provide the name, address, and phone number of its U.S. agent. The foreign facility must also provide the emergency contact phone number for its U.S. agent unless the facility designates another person to serve as the emergency contact.

DHL Danzas acting as a U.S. Agent: DHL Danzas offers the service of acting as the U.S. Agent for Foreign Facilities without a U.S. location through the DHL Danzas, Technical Services Department, Southfield MI. The primary contact for this service is Paul Vroman, Technical Advisor and can be reached by email at Paul.Vroman@dhl.com or phone at (810) 987-0557.

How to Register: Registration is completed via the FDA Web site and can be done by you or with the assistance of DHL Danzas.

• DHL Danzas Registration Services: Our services may be utilized to register your facilities through the DHL Danzas, Technical Services Department, Southfield MI. The primary contact for this service is Paul Vroman, Technical Advisor and can be reached by email at Paul.Vroman@dhl.com.

• Self-Registration: The owner, operator or agent in charge may complete the registration. If the person submitting the registration is not the owner, operator, or agent in charge a statement must be included indicating that the person is authorized to submit the registration. Registrants must use Form 3537 to register or update a registration. Facilities may register online via the Internet at www.fda.gov/furls.

Information Required: Each registration must include the name, address, and phone number for the facility and its parent company (if applicable); the name, address, and phone number of the owner, operator, or agent in charge; all trade names the facility uses; applicable food product categories as identified in FDA's regulation, 21 CFR 170.3; a statement certifying that the information submitted is true and accurate and that the person submitting the registration, if not the owner, operator, or agent in charge, is authorized to submit the registration.

Registration Changes: Registration must be updated within 60 days when any of the following occur 1) Registration information changes, facility goes out of business, facility acquires a new owner.

Which Facilities Must Register: This new regulation pertains only to facilities that manufacture/process, pack, or hold food, as defined in the regulation, for consumption in the U.S. 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

Food contact substances and pesticides are not "food" for purposes of the interim final rule. Thus, a facility that manufactures/processes, packs, or holds a food contact substance or a pesticide is not required to register with FDA.

Multiple foreign facilities involved with the manufacturing processing, packing and holding of food sent to the US are required to register as follows: If a foreign facility that manufactures/ processes, packs, or holds food sends it to another foreign facility for further manufacturing/processing or packaging before the food is exported to the U.S., only the second foreign facility is required to register. However, if the second foreign facility performs only a de minimis activity, such as putting on a label, both facilities would be required to register. Also, any foreign facility that packs or holds food after the last foreign manufacturer/processor of the food must register.

Which Facilities Do Not Need to Register: The facility types listed below are not required to register with the FDA. However, Prior Notice of an Import may still be required.

• Multiple foreign facilities involved with the manufacturing processing, packing and holding of food sent to the US are required to register as follows: If a foreign facility that manufactures/ processes, packs, or holds food sends it to another foreign facility for further manufacturing/processing or packaging before the food is exported to the U.S., only the second foreign facility is required to register. However, if the second foreign facility performs only a de minimis activity, such as putting on a label, both facilities would be required to register. Also, any foreign facility that packs or holds food after the last foreign manufacturer/processor of the food must register.

• Private residences of individuals, even though food may be manufactured/processed, packed, or held there.

• Non-bottled water drinking water collection and distribution establishments and structures, such as municipal water systems.

• Transport vehicles that hold food only in the usual course of their business as carriers.

• Farms, i.e., facilities in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves, and cooling of produce are considered part of harvesting. The term "farm" also includes facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership, and facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

• Restaurants, i.e., facilities that prepare and sell food directly to consumers for immediate consumption, including pet shelters, kennels, and veterinary facilities that provide food directly to animals. Facilities that provide food to interstate conveyances, such as commercial aircraft, or central kitchens that do not prepare and serve food directly to consumers are not restaurants for purposes of the rule.

• Retail food establishments, such as groceries, delis, and roadside stands, that sell food directly to consumers as their primary function, meaning that annual sales directly to consumers are of greater dollar value than annual sales to other buyers. An establishment that manufactures/processes, packs, or holds food and whose primary function is to sell food directly to consumers, including food that the establishment manufactures/processes, from that establishment is a retail food establishment and is not required to register.

• Nonprofit food establishments, which are charitable entities that meet the terms of § 501(c)(3) of the Internal Revenue Code and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S. Central food banks, soup kitchens, and nonprofit food delivery services are examples of nonprofit food establishments.

• Fishing vessels that harvest and transport fish. Such vessels may engage in practices such as heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel and remain exempt.

• Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture, that is, facilities handling only meat, poultry or egg products.

Failing to Register Facilities: Failure of a domestic or foreign facility to register, update required elements, or cancel its registration in accordance with this regulation is a prohibited act under the Federal Food, Drug, and Cosmetic Act. The Federal government can bring a civil action to ask a Federal court to enjoin persons who commit a prohibited act, or it can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act. If a foreign facility is required to register but fails to do so, food from that foreign facility that is offered for import into the U.S. is subject to being held within the port of entry for the article unless otherwise directed by FDA or the Bureau of Customs and Border Protection (CBP). FDA plans to issue enforcement guidance regarding the agency's policies regarding refusals of imported food under section 801(m)(1) or holds of imported food under section 801(l). This guidance document will be available to the public, and FDA will publish a notice of its availability in the Federal Register.

PRIOR NOTICE REQUIREMENTS

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.

2. 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.

RECORD KEEPING REQUIREMENTS

FDA BTA requires the Secretary, through FDA, to issue final regulations by December 12, 2003, to establish requirements for the creation and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food, (i.e., one up, one down). Such records are to allow FDA to address credible threats of serious adverse health consequences or death to humans or animals. Entities subject to these provisions are those that manufacture, process, pack, transport, distribute, receive, hold or import food. Farms and restaurants are exempt from these requirements.

Checklist For Food and Food Product Importers

As the importer of Food and Food Products subject the FDA Bioterrorism Act (BTA) you are responsible to ensure you and your suppliers, vendors, manufacturers, growers, importer, owners, consignees, carriers and broker are prepared to comply with the new law. The following document is intended as a checklist to review your readiness for December 12, 2003.

1. Communicate to all levels within your company the changes with the FDA BTA that become effective on December 12, 2003. Ensuring the process, procedures and penalties for non-compliance are understood and documented.

2. Register all company facilities with FDA that handle your food and food products. Registration must be completed prior to December 12, 2003. If you require assistance please contact DHL Danzas, Technical Services, Paul Vroman, DHL Danzas (810) 987-0557 email paul.vroman@dhl.com

3. Ensure that all foreign and domestic vendors (shippers, suppliers, manufacturers, growers, importers, owners, freight holding facilities, consignees) within your supply chain have registered with FDA prior to December 12, 2003. Document the following items with/for each vendor:

• Contact name, phone number, fax number and email address for each vendor. The contact must be available 24 hours/7 days a week in case of emergency FDA BTA notification. If the vendor is foreign the contact must be in the U.S. and may be provided through agent services.

• Document your process, procedure and timelines required to meet the FDA BTA requirements from the time of placing an order through confirmation of FDA may proceed. Ensure document outlines the process to confirm steps have been completed, the escalation plan if steps fail and the penalties and consequences for failing to comply.

4. Ensure all foreign facilities have designated a U.S. Agent. DHL Danzas provides this service. If required please contact DHL Danzas, Technical Services, Paul Vroman, DHL Danzas (810) 987-0557 email paul.vroman@dhl.com.

5. Ensure all forwarders and carriers have:

• Registered all facilities (US and Foreign) that will physically handle goods subject to FDA BTA.

• Established process and procedures for handing transactions that will travel in bond through the U.S. on either an I.T. (In Transit) or T&E (Transport & Export) bond.

6. Ensure that all vendors (shippers, suppliers, manufacturers, growers, importers, owners, freight holding facilities, consignees, freight forwarders, carriers) within your supply chain are prepared for all aspects of the FDA BTA Prior Notice (PN) requirements and their role in obtaining timely release of goods when imported.

7. Determine who will be responsible for handling the FDA BTA Prior Notice (PN) and how the communication will be handled including:

• The customs house broker located in the US communication via ABI/ACS.

• Yourself/vendors/origin shipping locations via the FDA PN system interface at www.access.fda.gov with a hard copy of the PN confirmation supplied with import documents prior to arrival.

Note: In order to meet the FDA Prior Notice requirements you must provide complete and accurate information to your service provider a minimum of 2 hours prior to the minimum FDA time requirement. All required information must be included with your import documents as outlined in this document.

8. Document your process and establish service level agreements (SLA) internally and with vendors as necessary covering the following items:

• Import document contains all information required to submit and accurate and timely prior notification to FDA. Including FDA prior notification confirmation when PN is submitted via the FDA system interactive system (web site).

• Contingency plans are in place when any or all of the FDA PN communication methods are inoperable (Broker through ABI/ACS and/or Vendors/Shipping points through the FDA PN system interface).

• Process to notify carriers and truckers of Prior Notice confirmation and minimum time requirement prior to arrival in the U.S.

• Establish process for shipments arriving without the FDA PN.

• Audit process to ensure processes are adhered to.

9. Establish internal record keeping procedures and review with FDA record keeping requirements. Ensure vendors have also established record keeping procedures.

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