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 roadFour (4) hours before arrival by air or by

land via rail; orEight (8) hours before arrival by water.

Registration through UTi –www.go2uti.com

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.