Penalties for food exporters who don't comply with US Bioterrorism Act

Thursday, 23 December, 2004

Austrade has warned that food exporters need to be aware the US Bioterrorism Act is currently in an enforcement phase and they must comply with new regulations or could face severe penalties.

Austrade's Corporate Manager, Dee Wilkes-Bowes said the enforcement phase, which runs from 13 May until 12 August 2004, is the third stage of the US Food and Drug Administration's (FDA) eight month implementation plan that began last December.

"In the earlier phases, FDA inspectors who found violations usually informed the shipper of the new requirements, but did not necessarily assess any fines or penalties," Ms Wilkes-Bowes said.

"During the enforcement phase however, FDA inspectors encountering violations will have the authority to impose stricter penalties in some cases, including outright refusal of the food shipment.

"In other cases though, FDA will still respond to violation by attempting to educate the shipper as to the exact requirements of the new law," she said.

Ms Wilkes-Bowes said the US Bioterrorism Act will be strictly enforced from 12 August 2004 and the majority of violations will then result in refusal of export shipments and/or possible monetary penalties.

The Act will apply to all Australian exporters of food and animal feed products to the USA with the exception of those Australian exporters who supply meat, poultry and egg products, which are under the exclusive responsibility of the US Food Safety and Inspection Service (FSIS).

The Act requires that any Australian facility that manufactures, processes, packs or holds food for export to the US be registered with the US FDA. Each shipment of food exported to the US also requires a prior notification to import being submitted to US FDA. Prior notices must be submitted electronically and prior notice confirmation must be received from FDA before a food shipment enters a US port.

These regulations have been introduced to protect US consumers from the threat of a terrorist attack on the US food supply and are not intended to impede the movement of goods or hold up trade.

Enquiries should be directed to the Department of Agriculture, Fisheries and Forestry (DAFF) on 02 6272 5507 or through Austrade on 13 28 78.

Further information is available on the websites of the US Food and Drug Administration at,, the Australian Government Department of Agriculture, Fisheries and Forestry and Austrade

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