All foreign facilities manufacturing processed packed food for human or animal consumption in the United States are compulsorily required to be registered. This was specified in a notification by the United States Food & Drug Administration (USFDA). Registrations are to be done with the USFDA between 12th October, 2003 and 12th December 2003. USFDA has indicated that no registration shall be sent to them before 12th October 2003.

The registration done free of cost is necessitated by the provisions of the Bio terrorism Act. This will permit FDA to respond quickly to threatened or actual terrorist attack on the US Food supply. The registration will help FDA to determine the location and cause of a potential threat and permit the agency to quickly notify facilities that might be affected.

Owners, operators or agency in charge of domestic or foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the US are required to register with FDA. Domestic facilities in US are required to be registered whether or not food from that facility enters interstate commerce. Foreign facilities that are engaged in the above activities are required to register unless food from that facility undergoes further processing or packaging by another foreign facility before the food is exported to the US. If the subsequent foreign facility performs only a minimal activity such as putting on a label both facilities would be required to register.

Retail food operations, restaurants, non profit operations that prepare food, fishing vessels not engaged in processing and facilities regulated exclusively throughout the entire facility by the US Department of Agriculture are exempted from registration.

The foreign facilities who fail to register and at the same time attempt to import food into the US, the Bioterrorism ACT requires that the food be held at the port of entry unless FDA direct that it be moved to a secure location. When the Food is to be moved, the parties involved must arrange for moving it and promptly notify FDA of its location. The cost associated with the moving and storage will have to be borne by the parties concerned. FDA recommends registration through electronic mode via internet. However registration by paper by surface mail is also accepted.

The proposed regulations are published in the Federal Register to provide interested parties with an opportunity to submit comments. The FDA will consider all timely comments that it receives. Regularly updated information on this regulatory proposal can be accessed from website www.fda.gov/oc/bioterrorism/bioact.html Comments can also be sent by mail to www.fda.gov/dockets/ecomments