1. 1 Recent Bioterrorism Legislation Madelyn Miller August 2003

2. 2 Introduction Recent developments after September 11, 2001 have prompted the Federal Government to mandate the use and possession of certain biological agents and toxins. The Centers for Disease Control and Prevention had an existing law mandating the registration for certain agents and toxins. However, new laws have been released to supplement this standard.

3. 3 Overview Centers for Disease Control and Prevention (CDC) “Select Agent” Requirements Patriot Act of Oct. 2001 “Uniting and strengthening America by providing appropriate tools required to intercept and obstruct terrorism” Tauzin Bill (HR 3448) ”Public Health and security and bioterrorism preparedness and Response Act of 2002.”

4. 4 Center for Disease Control In 1997, the CDC released a standard designed to tract the acquisition and transfer of certain biological agents and toxins that have a potential for military and terrorist use. The new standard was known as Additional Requirements for Facilities Transferring or Receiving Select Infectious Agents – 42 CFR Section 72.6

5. 5 CDC Tracks Transfers Safe guards the transfers Collects information on locations of select agents. Establishes a process for unauthorized attempts to obtain these agents. Tracks the acquisitions of these agents.

6. 6 Institutional Responsibilities: Maintain a database of every laboratory using CDC Select Agents Retain copies of all transfers Maintain a facility plan of each individual labs using Select Agents Biological Safety Officer (NIH requirement)

7. 7 Investigator Responsibility Prior to ordering – Notify Biosafety Officer / EH&S office. Notify CDC Prepare a Standard Operating Procedure Approval by Institutional Biosafety Committee (IBC)

8. 8 Security of Select Agents Secured in Laboratory Rooms The Agent should be kept in limited access areas. Notify CDC if there is any attempt for an outsider to obtain any Select Agent without Authorization.

9. 9 2001 Patriots Act In November 2001, Congress expanded the scope of the CDC authorization expanding scope from transfer and shipment of Select Agents to: Prohibits the production, stockpiling transfer, acquisition, or possession of select agents for use as a weapon Select Agents are to be used for research, education, and other “legitimate” purposes. Establishes criminal and civil penalties

10. 10 Tauzin Bill (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) June 2002, Public Law, amending the Patriot Act Currently utilizing the same listed “select agents” but adds USDA agents – Dangerous to Animal Declaration of possession – due Sept. 10, 2002 RFO (Responsible Facility Officer) shall be designated to complete the application and ensure management oversight

11. 11 Enhanced Security Health & Human Services (HHS) to establish standards and procedures for the transfer, possession and use including preventing access to terrorists and criminals. Insurance Issues HHS forms a National Database.

12. 12 Institutional Responsibility Limiting access to Select Agents to Aliens: Cuba Iran Iraq Libya North Korea Sudan Syria

13. 13 Background Checks Indicted or convicted of any felony Fugitive from justice Unlawful user of any controlled substance Illegally in the United States Mental Defective Dishonorable discharge for U. S. Armed Service

14. 14 Future Regulations Government Agencies have issued six regulatory notices on this subject in the past few months. They intend to base future regulatory action on the inventories they receive.