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:
- Title I --
National Preparedness for Bioterrorism and Other Public Health
- 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 --
FDA is responsible for carrying out certain provisions of
the Bioterrorism Act, particularly Title
A (Protection of Food Supply) and Subtitle
B (Protection of Drug Supply).
Plans for Implementing the Act
Title I (National Preparedness)
123 (Animal Trials):
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.)
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.