Food Safety under the Bioterrorism Act of 2002The events of Sept. 11, 2001, reinforced the need to enhance the security of the United States. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which President Bush signed into law June 12, 2002.
To carry out the provisions of the Bioterrorism Act, FDA published, on October 10, 2003, an interim final regulation, Registration Of Food Facilities, which requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with the FDA. Under this interim final regulation, all affected facilities must register by December 12, 2003. In the event of a potential or actual bioterrorism incident or an outbreak of food-borne illness, facility registration information will help FDA to determine the location and source of the event and permit the agency to notify quickly facilities that may be affected.
In addition to the registration rule, FDA also published interim final rules on October 10, 2003 that require companies to provide advance notice to FDA of any shipment of human or animal food imported or offered for import beginning Dec. 12, 2003. Most of the prior notice information required by the interim final rule is data usually provided by importers or brokers to the Bureau of Customs and Border Protection (CBP) when foods arrive in the United States. Now, the Bioterrorism Act requires that this information also be provided to FDA in advance of an imported food's arrival to the United States.
“Improving the FDA’s food safety inspection, detection and monitoring capabilities is and has been a top priority of the Department even before the events of 9/11. Since then we have taken strong steps to enhance the FDA’s ability to make our food supply safer,” said Secretary of Health and Human Services Tommy G. Thompson. “This FDA effort is the latest in a series of measures we are taking to build stronger safeguards for the American people.”
Texts in German• Übersicht über die neue Verordnung der FDA zu Bioterrorismus
• Maßnahmen der Federal Drug Administration im Rahmen der neuen Gesetzgebung zu Bioterrorismus
• Amerikanische Zulassungsbehörde FDA legt Verordnung zur Registrierung von Unternehmen in der Lebensmittelindustrie vor
Links to help companies comply with the new BTA rules• The Bioterrorism Act of 2002 (U.S. Food and Drug Administration)
Registration - Section 305
• Register your company online with FDA
• Fact sheet on the Interim Final Rules – Registration of Food Facilities
• Interim Final Rule on Registration of Food Facilities (68 FR 58893) (Oct 2003)
• Questions and Answers on Food Facility Registration (Oct 2003)
• Final Guidance for Industry regarding Registration of Food Facilities (Dec 2003)
Prior Notice – Section 307
• Fact sheet on the Interim Final Rules – Prior Notice of Imported Food Shipments
• Interim Final Rule on Prior Notice (68 FR 58975) (Oct 2003)
• Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators (Nov 2003)
Other Guidance for Companies
• Guidance for Companies on the New Bioterrorism Regulations 10/16/03 (2 MB, pdf)
• FDA and CBP Announce Transitional Compliance Policy on Food Imports under the Bioterrorism Act (Dec 2003)
• Imported Meat, Poultry and Egg Products Remain under USDA Jurisdiction (Dec 2003) (pdf)
• Frequently Asked Questions & Answers Regarding CBP Procedures under the Bioterrorism Act (BTA)
• FDA, Customs Bolster Safeguards on Imported Food
• Notice About Firms That Offer Food Registration Services
Contact FDA for Assistance
Background Documents• Protecting the Food Supply: FDA Actions on New Bioterrorism Legislation
• Chronology of FDA Actions on New Bioterrorism Legislation
• Bioterrorism (U.S. Food and Drug Administration)
• Food Safety and Terrorism (U.S. Food and Drug Administration)
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