Revisions to Select Agents Regulations: 
What It Means for the MSU Research Community

The Revised Regulations: Registration of Select Agent & Toxin Possession is MANDATORY

Under previous select agent regulations, an individual was permitted to use select agent materials without registering with the federal authorities. Registration was only required if an individual planned to send or receive materials on the select agent list. Under the revised regulations which take effect on February 7, 2003, all individuals who possess select agents must register with the CDC and/or APHIS through the designated institutional responsible official (RO). At MSU, the ORCBS Director and Biosafety Officer serve in this capacity. The registration process is rigorous and includes many provisions such as:

• Description of research space including HVAC details, safety equipment and security features
• Research summary outlining use of agent
• Agent-specific safety and biocontainment procedures
• Safety and technical training of lab personnel
• Security & emergency response plans
• Security risk assessment, including U.S. Attorney General background check of personnel with access to agent

Once the registration document is prepared and submitted to the appropriate federal authorities, the turnaround time for approval is expected to be at least 2 months. For new registrations, the agent cannot be transferred to MSU facilities until approval is granted by the CDC and/or APHIS.

Index of Select Agents Regulations
Index of Current Topics