Protecting the Food Supply The Bioterrorism Act of 2002 (BTA) FDA’s role in the BTA Final Rule Requirements UTi as U.S. Agents Prior Notice Requirements How UTi can handle FDA Registrations

Bioterrorism Act (BTA). On June 12, 2002, President Bush signed into law the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002," also known as the Bioterrorism Act (BTA) The Act includes a number of provisions designed to improve the food safety efforts of the Food and Drug Administration (FDA) in cooperation with U.S. Customs and Border Protection (CBP), including new authority to protect the food supply against terrorist acts and other threats.

FDA’s role in the BTA FDA is responsible for carrying out certain provisions of the Bioterrorism Act, particularly the Protection of the Food Supply On October 10, 2003, the Food and Drug Administration (FDA) published two interim final rules implementing the Registration and Prior Notice requirements of the Bioterrorism Act. Although the requirements of the Bioterrorism Act technically entered into force on December 12, 2003, FDA and CBP agreed to an eight month phase-in period for enforcement of the PN requirement (i.e., from December 12, 2003 through August 12, 2004)

New (Interim) Final Rule Requirements As an important part of these ongoing efforts to protect the nation's food supply against terrorism and other food-related emergencies, FDA recently published two interim final rules that require as of December 12, 2003: 1.Registration of Facilities 2.Prior Notice Filing for Food Shipments

FDA Registration – Few Exceptions With few exceptions – All domestic and foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States must register with the FDA

What is a Foreign Facility? If the facility is located outside the United States, that facility is called a "foreign facility", and it must designate a U.S. Agent. The U.S. Agent is the communications link between FDA and the foreign facility for emergency or routine communications.

UTi as U.S. Agents for Foreign Registrants UTi can register the foreign facility and act as the U.S. Agent The agent’s representations will be treated as those of the facility and the information furnished to the agent will be considered furnished to the facility.

Prior Notice of Imports Prior Notice must be submitted for any shipment of human or animal food imported or offered for import subject to the Act. Anyone with knowledge of the shipment may submit the Prior Notice, however UTi will submit Prior Notice of Imports when acting as Customs Broker. UTi systems have been enhanced with BTA screens interfacing directly with FDA.

When is Prior Notice required? Prior notice of imported foods must be received and confirmed electronically by FDA no more than five (5) days before arrival in the United States and no fewer than: Two (2) hours before arrival by land via road Four (4) hours before arrival by air or by land via rail; or Eight (8) hours before arrival by water.

Registration through UTi –

Sample UTi FDA Registration screen

Consequences of Failure to Register Civil injunction actions Criminal prosecution Debarment Detention of imported food

Phase 2 – Beginning March 12, 2004 In Phase 2, Informed Compliance Notices, Penalties to be Issued During Phase 2, FDA will provide information to CBP regarding those entities that have failed to file PRIOR NOTICE data as required, and CBP will issue informed compliance notices to those entities that the FDA has identified as non-compliant. Phase 2 enforcement also includes the ability for CBP to issue monetary penalties to egregious violators for non- compliance with the PRIOR NOTICE filing requirement. The notice states that during this phase-in period, CBP and FDA are committed to pursuing informed compliance prior to the issuance of any Bioterrorism Act-related penalty action.