After the events of September 11, 2001, the U.S. Congress passed and President Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act”) to strengthen the safety and security of the United States food supply. Under Title III, the Bioterrorism Act, protecting the Safety and Security of Food and Drug Supply, the FDA is empowered to implement new food and drug policies. The Bioterrorism Act gives the FDA more tools to aid in the detection and response to actual or potential terrorist attacks to the U.S. food supply and other food related emergencies.
The Bioterrorism Act provides the FDA with the ability to order the detention of food articles where credible evidence indicates the food articles present a threat of serious adverse health consequences or death to humans or animals, debar for repeated or serious food import violations, require that prior notice of food shipments be provided to the FDA, and to mark food refused entry into the United States. In addition, the FDA, pursuant to the Bioterrorism Act, requires a facility engaged in the manufacture, processing, packing, or holding of food for consumption in the United States by humans or animals to be registered with the agency and create and maintain records used to determine the immediate sources and recipients of its food products. The registration of food facilities and record keeping requirements allow the FDA to detect, track, and respond to credible food threats.
The Bioterrorism Act also provides additional requirements regarding components used in the Import for Export program. See our Import for Export Program page for more information on this program.
There are many intricacies and exceptions to the Bioterrorism Act. Fuerst Ittleman has experience assisting clients with all the requirements of the Bioterrorism Act. We can help you determine if your facility is exempt from the requirements, and if not, help you comply with all the requirements applicable to your business model.
If your business has any concerns regarding the impact of the Bioterrorism Act upon its international trade or commerce, please contact us at contact@fuerstlaw.com.
