- Federal Regulation for Select Agents
- Federal Select Agent List & Toxin Exemptions
- Procedures for Labs Working with Federally Regulated Select Agents
- Procedures for Labs Working with Federally Exempt Quantities of Select Agents
- Disposal of Select Agents & Other Biologically-Derived Toxins
- Record Keeping for Labs Using Federally Regulated Quantities of Select Agents
Select Agent Legislation
The Anti-terrorism and Effective Death Penalty Act was passed in 1996 and built upon the Biological Weapons Anti-terrorism Act (1989) and other earlier anti-terrorism legislation. This legislation directed the Department of Health and Human Services to develop and maintain a list of biological agents that could pose a threat to the public health and to regulate the transfer of such agents while maintaining the availability of these agents for research, education, and other legitimate purposes. In response to this legislation, the Center for Disease Control (CDC) developed a list of 31 infectious agents and 12 biological toxins with additional provisions for recombinant organisms and drug resistant organisms and exemptions for research quantities and vaccine strains of organisms.
On March 18, 2005 the Department of Health and Human Services published 42 CFR Parts 72 and 73 Possession, Use, and Transfer of Select Agents and Toxins; Final Rule which goes into effect April 18, 2005. The final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to protect public health and safety.
All facilities possessing select agents or wishing to ship or receive select agents must be registered with the federal government. All University of Minnesota researchers working with or storing select agents must be included on the University's Certificate of Registration with the CDC and must follow all applicable federal regulations and University policies. Prior approval and training is required to use, store, ship, or receive a select agent. Please follow the instructions provided in this section and contact the biosafety officer in Environmental Health & Safety (612- 626-6002) for additional questions and information.