New trade rules impact all importers, manufacturers and suppliers of food and beverages to the U.S.

Two new regulations announced by the FDA this month mark the implementation of key provisions of the Public Health Security and Bio-terrorism Preparedness and Response Act of 2002. Commonly known as the Food Bio-Terrorism Act, the law gives FDA expanded authority to protect the nation's food supply against actual or threatened terrorist acts and other food-related emergencies.

• The first regulation will require food importers to provide FDA with advance notice of food shipments for humans and animals imported or offered for import on or after December 12, 2003. As with other freight transportation security rules, the goal is to push the line of defense away from U.S. borders by enabling FDA to be aware in advance of when specific food shipments will reach U.S. ports-of-entry and what those shipments contain. Fortified with the advance information, FDA, working with U.S. Customs and Border Protection (CBP), will be better able to effectively target inspections and ensure the safety of imported food products.

• The second regulation requires domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the agency by December 12, 2003. As a result, FDA will have for the first time a complete roster of foreign and domestic food facilities, enabling it to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food. Key awareness points for international shippers and third party logistics providers (filers), to ensure compliance with the Food-Bio-terrorism Act.

• Registration of Facilities

  • Prior notification of locations required. (Domestic and foreign facilities)
  • Registration with FDA required prior to importing
  • Registration number must be obtained via the Internet or FDA form no.
  • Foreign Facilities must designate a U.S. representative

• Facilities

  • Owner is responsible for filing registration
  • Each facility must be registered
  • Any changes to facilities ownership must be submitted to FDA (within 60 days of change)

• Prior Notification of imported foods

  • Importer has the opportunity to file via FDA web site or the ABI entry system
  • Time frames for filing FDA required information (by transportation mode):
    • 2 hours prior to arrival by truck
    • 4 hours prior to arrival by air or rail
    • 8 hours prior to arrival by water

• FDA will confirm the timely submittal of information via the same message format as that submitted by the filer.

• If cargo information is not submitted within the modal timeframes outlined above, it must be exported, or else classified as General Order (GO) merchandise. When entered as GO merchandise, the shipment must also be transferred immediately to a Customs (CBP) facility.

• If cargo is still designated as a U.S. import, prior notification must be filed with the FDA and CBP. Under this scenario, expect a more vigorous inspection. The cargo owner, importer, and submitter (agent, other) are responsible to perform this task. Accordingly, prior notice will be considered late and the importing party may be subject to penalties.

BDP is working closing with the FDA to review and understand the systems and procedural adjustments associated with these new regulations. We will be fully systems-compliant prior to the December 12 effective date.

For more information, contact BDP Regulatory Compliance.

Thank you,

Michael Ford
Vice President
mford@bdpnet.com