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The Bioterrorism Act

The events of September 11, 2001 highlighted the need to enhance the overall security of the U.S. food supply. As part of the nation's response, Congress passed and the President signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (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.

Under a special agreement, CBP personnel at many ports of entry around the country have been formally commissioned and specially trained to conduct cargo and other examinations under the BTA. CBP personnel will have authority to hold suspect shipments for further examination and sampling.

New (Interim) Final Rules Require Registration of Facilities, Prior Notice Filing for Food Shipments

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:

  • Registration of Facilities: With few exceptions, FDA has determined that 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. Having a complete roster of foreign and domestic food facilities will enable the FDA to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food.

    FDA is proposing to exempt several types of facilities from the registration requirement including farms, retail facilities, restaurants, and nonprofit food facilities in which food is prepared for or served directly to the consumer.

    • Prior Notice: 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.

      The intent is to provide advance information to target potentially high-risk shipments that could threaten public health and the security of the food chain by an act of bioterrorism.

      Prior notice of imported foods must be received and confirmed electronically by FDA no more than ten days before arrival in the United States and no fewer than:

      Two hours before arrival by land via road

      • Four hours before arrival by air or by land via rail; or
      • Eight hours before arrival by water.

      Some commodities are excluded from filing prior notice, including:

      Personal use food accompanying a traveler (although agricultural rules and required declarations still apply)

      • Food immediately exported without leaving the port of arrival
      • Meat, poultry, and egg products (subject to the exclusive jurisdiction of the U.S. Department of Agriculture)
      • Homemade goods shipped as gifts
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