Following 11 September 2001, the US introduced a number of measures to improve the security of its citizens. The Bioterrorism Act 2002 (BTA) is aimed at meeting a bio-terrorist threat to the food supply.

While fully supporting the aim of protecting the food supply chain, the EC is concerned about the effectiveness, and potential for trade distortion, of the measures proposed.

The US authorities have asked for comments on the detailed measures proposed. DG SANCO sent preliminary comments to the framework Act to US Food and Drug Administration (116KB) on 30 August 2002.

EC comments on implementing measures " Registration of food facilities" (157KB) , " Prior notice of imported food" (161KB) , were sent to US Food and Drug Administration (FDA) on 4 April 2003. These comments were also submitted to the WTO, Committee on Sanitary and Phytosanitary Measures (SPS Committee), and the Committee on Technical Barriers to Trade (TBT Committee).

EC comments on implementing measures " Establishment and maintenance of records" (152KB) and " Administrative detention of food for human or animal consumption" (128KB) were sent to US Food and Drug Administration (FDA) on 8 July 2003. These comments were also submitted to the WTO, Committee on Sanitary and Phytosanitary Measures (SPS Committee).

On 10 October 2003 the first two interim final rules concerning "Registration of food facilities" and "Prior notice of imported food" were published in the US Code of Federal Register (CFR). FDA has established a further 75 days comment period for some of the adopted provisions (deadline 24 December 2003). The remaining two final rules on "Establishment and maintenance of records" and "Administrative detention of food for human or animal consumption" are expected to be adopted and published in the CFR before the end of the year.

The whole system created by the BTA will enter into force on 12 December 2003.

Copies of the rules can be found on the US Food and Drug Administration (FDA) website