On February 3, 2003, FDA and the Department of Treasury jointly issued a proposed rule requiring certain food facilities to register with FDA.  The events of September 11, 2001, had highlighted the need to enhance the security of the infrastructure of the United States, including the food supply.  Congress responded by enacting the Bioterrorism Act, which was signed into law on June 12, 2002.  The Bioterrorism Act includes a provision in title III (Protecting Safety and Security of Food and Drug Supply), Subtitle A-Protection of Food and Drug Supply, section 305, which requires the Secretary of Health and Human Services to develop a regulation to require domestic and foreign facilities that manufacture, process, pack or hold food for consumption in the United States to register with FDA .

A few of the major components of section305 of the Bioterrorism Act are as follows:

The owner, operator, or agent in charge of a facility is responsible for the submission of a registration to FDA:

Each facility must be separately registered and the registration must include the name and address of facility, and all trade names under which the registrant conducts business form that facility.  The registration for foreign facilities also must include the name of the U.S. agent for the facility:

FDA also may require each registration to include the general food category of the food manufactured, processed, packed, or held at the facility, if FDA determines through guidance that this submission is necessary.  FDA issued guidance on July 17, 2003, available at http://www.fda.gov/oc/bioterrorism/bioact.html, that concluded that information about food product categories is necessary for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency;

Foreign facilities that manufacture/process, pack or hold food that is exported for consumption in the United States are required to register unless the food undergoes further processing or packaging at another facility outside the United States.

Updates to registration information or cancellation of registration must be submitted with 60 calendar days of any change to any of the required information submitted;

Failure of a domestic or foreign facility to register, update or cancel its registration in accordance with this regulation is a prohibited act under section 301(dd) of the FDandC Act.

R. Donnelly and Associates, Inc.  has thoroughly reviewed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and can assist your facility in registering with the FDA.  RDA also meets the requirement to serve as U.S. Agent.  RDA will handle facility registration as well as keeping your establishment up to date on any changes that affect your facility.  Our trained staff will serve as your link between you and the FDA.