Domestic or foreign facilities that manufacture, process, pack or hold food for consumption by humans or animals in the US will have to register with the Food and Drug Administration (FDA) no later than December 12, as mandated by the Bioterrorism Act, a release from the US Embassy in Georgetown stated.

Following the events of September 11, 2001, the US Congress passed the Bioterrorism Act to strengthen security against bioterrorism. According to the release, the Act provides the FDA with new tools that will enable it to act quickly in responding to threatened or actual terrorist attacks on the US food supply or other food-related emergencies by providing the agency with better information than before about the production and distribution of food consumed in, or entering, the US.

The FDA published the new regulations as proposals for comment and is currently evaluating the feedback. But registrations will not be accepted until the final regulation is published. At that time, the owner, operator or agent in charge of a domestic or foreign facility will be able to register via the Internet, but registrations by mail will also be accepted although that will be a much slower process. And there is no fee associated with registration.

From December 12, the FDA must receive advance notice of each article of food imported or offered for import into the US, regardless of whether the food will be consumed in the US. And if prior notice is not submitted or is inadequate, the Act provides that the food would be held at the port of entry until adequate notice is provided. In addition, it is a prohibited act to fail to register if required to do so, and the owner, operator, or agent-in-charge of the facility could be subject to criminal or civil penalties.

The FDA, the release said, plans to publish the final registration and prior notice regulations by mid-October 2003, to allow the food industry time to understand the new requirements and be in compliance by December 12.

For more information, the release said, persons may log on to the FDA’s web page on the Bioterrorism Act at: http://www/fda.gov\oc\bioterrorism\bioact.html.