Effective immediately, pursuant to Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Bioterrorism Act”), owners, operators and agents in charge of domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States must register with the Food and Drug Administration (“FDA”) and foreign facilities must designate a United States registration agent. Failure to register and/or appoint an agent may result in civil or criminal sanctions.

The Bioterrorism Act substantially broadens the FDA’s responsibilities over America’s food supply. Domestic and international food and food-related facility registration is intended to provide the FDA with critical information on the origin and distribution of food products. In the event of a potential or actual bioterrorism threat or an outbreak of food-borne illness, food facility registration information will help the FDA to determine the location and cause, and expedite notice to threatened and affected facilities.

Facilities exempted from registration include: farms, retail food establishments, restaurants and non-profit establishments that prepare food.

On October 10, 2003, the FDA published an interim final regulation which requires the immediate registration of covered domestic and foreign facilities. All facilities should have registered by December 12, 2003unless the facility is exempted. Following the December 12, 2003 effective date, the FDA initiated education and outreach programs to inform facilities of the registration requirements. The FDA recently issued a Compliance Policy Guide that outlines how the FDA generally intends to exercise its enforcement discretion. Right now, the FDA and the U.S. Bureau of Customs and Border Protection expect facilities to make a good faith effort at compliance. After the awareness initiative, however, the agencies are permitted to impose civil and criminal sanctions on unregistered facilities, and, ultimately, to refuse shipments from unregistered foreign facilities. This phase-in period will end in August, 2004.

The list of registered facilities is not subject to disclosure under the Freedom of Information Act and there is no fee for registration or for updates of any registration. Facilities may register online at https://www.access.fda.gov/.

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If you would like more information on this topic, contact Susan Usatine, a partner in the firm’s Litigation Department at susatine@coleschotz.com.