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UPDATED: 5/7/05

New (Proposed) FDA Regulations

Effective Dec. 12, 2003

As part of the Public Health Security & Bioterrorism Preparedness and Response Act, the Food & Drug Administration has issued new regulations regarding the way food shipments are cleared.

Under the new rules, importers and brokers will have to electronically file advanced notice of any shipments of food, beverages or animal feed, before 12 noon the day before arrival of the shipment.

The new system will be internet based, and stand alone from the present process of filing FDA information through the Customs ACE system at the time of entry.

The new system will require most of the same data that FDA recieves now, with the addition of more detailed descriptions of the merchandise and packaging. The key with this new program, is that FDA will have additional time to review the data, and inspect cargo as deemed necessary.

There will also be a mandatory registration of all food facilities with FDA. This includes the following:
  • All domestic and foreign facilities that manufacture, process or pack food for human or animal consumption.
There is a 60 day comment period for concerned parties to be heard.

The final rule will be published on 10/12/03. Registration will begin at this time.

Homeland Security

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