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The events of September 11, 2001 reinforced the need to enhance the security of the U.S. food supply. The U.S. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which was signed into law on June 12, 2002 by President Bush.
The Act is divided into five Titles; National Preparedness, Biological Agents and Toxins, Safety and Security of the Food and Drug Supply, Drinking Water Security and Safety, and Additional Provisions.
Title III of the Act concerns protecting the safety and security of the food and drug supply.
Section 305 of Title III requires that domestic and foreign food facilities that export to the U.S. register with the Food and Drug Administration (FDA) by December 12, 2003.
The registration process is intended to gather basic information. Facilities must register, however, or their food will be held at the U.S. port of entry until the facility is registered. The FDA registration is a new process that only applies to FDA-regulated products (e.g. all foods except meat, poultry and egg products) and is not related to any pre-approval process, such as USDA/Animal Plant Health Inspection Service/Plant Protection and Quarantine Pre-Approval Program. There is no fee associated with this registration.
Other provisions of Title III include recordkeeping requirements, prior notice of imported food shipments, and administrative detention.
FDA will propose implementing regulations for these and other provisions. Notice of any proposed regulation with the potential to have a significant effect on food imports will be made to the World Trade Organization to ensure transparency. FDA is committed to receiving and considering the input from stakeholders as the proposed and final regulations are developed.
The U.S. government will be conducting outreach activities to explain important provisions of Title III of the Act.
For further information, including complete text of the Act, FDA contact information and plans for implementation of all the Act's provisions, please visit the following internet address: http://www.fda.gov/oc/bioterrorism/bioact.html
