Bioterrorism & “Select Agents and Toxins”
The 1996 Select Agents Rule, which was part of broader anti-terrorism legislation, required organizations transferring (shipping or receiving) any of approximately three dozen highly virulent microorganisms or potent toxins to register with the CDC. Shipments had to be tracked from the supplier until the material was either destroyed or used up, with tracking information sent to the CDC. Some exemptions from the registration requirement applied to research laboratories for vaccine strains of some microorganisms and most toxins.
The US Patriots Act, enacted in October 2001, outlawed the possession of Select Agents for any purposes not justified by legitimate scientific research and added access restrictions based on criminal or medical history, country of origin, and immigration status. At that time, previously advisory laboratory security measures were made mandatory for laboratories using Select Agents.
The most recent legislation, the Public Health Security and Bioterrorism Response Act of 2002 includes the following provisions affecting research laboratories and clinical sites:
- The possession of any Select Agent must be reported to the CDC without regard to exempt/non-exempt status under the 1996 Select Agents Rule.
- Agents defined by the USDA as High Consequence Livestock Pathogens and Toxins require registration through that organization.
- The Attorney General, the CDC and the USDA have developed personnel screening procedures to prevent access to Select Agents by restricted individuals. All individuals seeking access to select agents or toxins require clearance through an FBI-administered process.
- Increased criminal and civil penalties for those possessing or transferring such agents without registration and approval.
- Quantity limits for toxins may exempt some laboratories from registration reuqirements. Exemptions remain for certain vaccine strains and organisms altered so as to reduce their pathogenicity.
EH&S is responsible for compliance with select agent and toxin regulations at Columbia Unniversity.