General Requirements
The purchase, possession, and handling of certain biological materials identified as “select agents” by the Center for Disease Control (CDC) of the U.S. Department of Agriculture (USDA) requires laboratory registration prior to obtaining and using these materials. The registration process includes development of and maintenance of specific laboratory programs and written plans before approval is granted to obtain and use the select agent.

Regulations
42 CFR Part 73, Possession, Use and Transfer of Select Agents and Toxins
7 CFR Part 331
9 CFR Part 121

Keys to Compliance for Supervisors
Note:; This applies only to supervisors of research laboratories using these agents

• Supervisors must prepare a Biosafety Pan, and Emergency Response Plan, and a Security Plan, addressing the select agent to be used, and the manner in which it will be used.
• Supervisors must work closely with IU’s “Responsible Official, i.e., the University Biosafety Officer for all activities involving a select agent.
• All laboratory personnel must be trained in proper use and proper security measures for the select agent
• If a select agent is stolen, lost, or released, the Biosafety Officer must be immediately notified, so that appropriate actions and reporting can be done.

Frequently Asked Questions

Q. How do I find out if the biological agent or toxin I plan to use is considered a “Select Agent”?
A. The list can be found here (PDF)

 

back • home • next