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FDA: The Bioterrorism Act of 2002



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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.
Complete Text: HTML; PDF

The Bioterrorism Act is
divided into five titles:


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
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.)

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.

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Recent Activities
Report to Congress:
Testing for Food
Adulteration (February
FDA Bioterrorism
Bioterrorism Act
Other Bioterrorism
Act Information
White House
Customs & Border Protection

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