U.S. Food and Drug Administration

The Bioterrorism Act of 2002

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The Act

The 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.

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The Bioterrorism Act is divided into five titles:

  • Introduction
  • Title I -- National Preparedness for Bioterrorism and Other Public Health Emergencies
  • Title II -- Enhancing Controls on Dangerous Biological Agents and Toxins
  • Title III -- Protecting Safety and Security of Food and Drug Supply
  • Title IV -- Drinking Water Security and Safety
  • Title V -- Additional Provisions

FDA is responsible for carrying out certain provisions of the Bioterrorism Act, particularly Title III, Subtitle A (Protection of Food Supply) and Subtitle B (Protection of Drug Supply).

Plans for Implementing the Act

Title I (National Preparedness)
Section 123 (Animal Trials):
         Federal Register Notice
         View Comments

Title III (Safety of Food and Drug Supply):
   Subtitle A (Food Supply Protection)
      Section 301 (Security Strategy)
      Section 302 (Food Adulteration)
       Report to Congress: Testing for
       Food Adulteration (February 2005)
      Section 303 (Detention)
         Final Rule (June 4, 2004)
         Press Release (May 27, 2004)
         Fact Sheet
         More Information
       Section 305 (Registration)
         Final Rule (PDF)
         Press Release (Sept. 28, 2005)
         Interim Final Rule (PDF)
         Press Release (Oct 16, 2003)
         Fact Sheet (Spanish version)
         Questions and Answers
         Test of Registration Data Accuracy
         Compliance Information
         Small Entity Compliance Guide
         Compliance Policy Guide
         More Information
      Section 306 (Records Maintenance)
         Final Rule
         Correction to the Final Rule (PDF)
         Press Release (Dec. 6, 2004)
         Qs & As Regarding Establishment          and Maintenance of Records
         Fact Sheet
         Guidance on Records Access
         More Information
      Section 307 (Prior Notice)
         Interim Final Rule (PDF)
         Fact Sheet (Spanish version)
         Questions and Answers
         Prior Notice System Interface
         Compliance Summary Information
         Small Entity Compliance Guide
         Revised Compliance Policy Guide
         Revised Joint FDA/Customs Plan
         Prior Notice Contingency
         Harmonized Tariff Schedule Codes
         More Information
      Section 308 (Marking)
         Withdrawal of Prior Proposal

FDA Actions on Bioterrorism Legislation

Plan Summaries for Developing Bioterrorism Food Regulations (sections 303-307)

   Subtitle B (Drug Supply Protection)
      Section 321 (Foreign Registration)
      Section 322 (Import for Export)
         Letter to Stakeholders
         Federal Register Notice
         Procedures Manual
         Withdrawal of Prior Proposal

Title V:
   Prescription Drug User Fee Act (Although not directly related to the Bioterrorism provisions of the Act, this program reauthorizes the fee program under which FDA reviews and approves drugs.)

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Public Participation

FDA will provide ongoing opportunities for constituents to keep informed and involved in the agency's activities related to developing regulations and guidances associated with the Bioterrorism Act.

Before issuing proposed regulations on food-related issues, the agency provided an opportunity for stakeholders to identify concerns and suggest ways to address them. For example, following a July 17, 2002 stakeholder letter to the FDA foods community, the agency held a series of meetings with consumers, industry, state and local governments, transporters, and other key constituents to brief them on the Bioterrorism Act's food provisions.