Italian Wine News


BIO TERRORISM ACT: Seminars to be Held in Italy

From the Custom's Attachè Office, American Embassy - Rome, Italy - October 8, 2003

On June 12, 2002, President Bush signed into law the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002," also known as the Bioterrorism Act (BTA).

In an effort to reduce the number of inquiries from the foreign food industry world wide and potential problems that may impact CBP operations upon inception of the new regulation, the FDA and CBP have opted for a series of town hall meetings to inform the foreign exporting community about the new rules.

In Italy the Embassy intends to seek the cooperation of Italian business associations, such as the Italian Trade Commission and Confindustria, in attending the BTA seminars and subsequently assisting corporate members in the registration process and by answering questions on prior notice.

The first Italy town hall meeting will be held at the Westin Excelsior Hotel, via Veneto 125, Rome, starting at 9:00 a.m., on Monday, October 20, 2003.

The second Italy meeting is set for Tuesday, October 21, at 9:00 a.m., and will be held at the Milan Chamber of Commerce conference room, entrance from via Meravigli, 9/B.

Attendees to the seminar will have to register with the Customs and Border Protection office of the Department of Homeland Security of the American Embassy in Rome, Italy. Attendees are requested to notify the Customs and Border Protection office of the Embassy to provide their names and the names of the company or companies they represent by October 16, 2003.

Registration may be accomplished by forwarding the information by e-mail,, or by fax, +39-06-46742351.


Title III of the Act is designed to protect the United States against bio-terrorist threats to its food supply including food from foreign sources. This law has four major provisions:

Registration · Prior Notice · Administrative Detention · Record keeping

Registration and Prior Notice will impact on foreign manufacturers as well as on the U.S. importing community. Customs and Border Protection is tasked with the enforcement of the provisions of this law at the U.S. border. Examples of commodities listed in the proposed rules that the FDA considers to be food include: fruits; vegetables; fish; dairy products; eggs; raw agricultural commodities for use as food or components of food; animal feed, including pet food; food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food; dietary supplements and dietary ingredients; infant formula; beverages, including alcoholic beverages and bottled water; live food animals (such as hogs and elk); bakery goods; snack foods; candy; and canned foods. This list is not all-inclusive and will become finalized when the final rule is published. The FDA has sole authority to determine the scope of the covered commodities.

Key provisions include:

  • Registration of Facilities: The Food and Drug Administration (FDA) would require that domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States register with the FDA by December 12, 2003.
  • Prior Notice on Importation of Food: The FDA would require that U.S. purchasers or U.S. importers or their agents submit to the FDA prior notice on the importation of food starting no later than December 12, 2003.
  • Submission of Prior Notice: Originally, FDA proposed exclusive use of a separate FDA web portal to accept Prior Notice information. However, in response to significant input from the trade community, FDA and the Bureau of Customs and Border Protection (CBP) announced on May 27 that they will streamline the implementation of the prior notice requirements.
  • Implementation Date: The FDA anticipates publishing the Final Rules by October 12, 2003 and the Act will be implemented on December 12, 2003.

More documents on the subject available for free download:

  1. Comments sent by the European Commission on implementing rule of US Bioterrorism Act.
  2. Rettifica del decreto ministeriale del 29 aprile 2002 "Autorizzazione all'organismo di controllo SGS ICS s.r.l. - Servizi di Certificazione Internazionale" – Gazzetta Ufficiale della repubblica Italiana del 18 giugno 2002.(Italian only)

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