CSU Select Agent Program

Select Agents and Toxins are those biological agents and toxins that have the potential to pose a severe threat to public health and safety, animal health or to animal products. Select Agents and Toxins are regulated by the Department of Health and Human Services (DHHS), through the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture/Animal Plant Health Inspection Service (USDA/APHIS) as mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Federal regulations (42 CFR Parts 72 & 73, 7 CFR Part 331, 9 CFR Part 121) govern the use, transfer, and storage of Select Agents and Toxins at Colorado State University (CSU). The current list of Select Agents and Toxins can be found on the Federal Select Agent Program website.

Research that makes use of Select Agents or Toxins at CSU must be approved by the IBC and conducted under the oversight of the Responsible Official (RO). Any principal investigator (PI) who intends to use, transfer, or store Select Agents and Toxins at CSU must first contact the Responsible Official in the Biosafety Office (BSO) in order to register personnel and facilities with the CDC Select Agent Program before research may proceed. A security risk assessment (SRA) of personnel (including a personnel suitability assessment for those requiring access to Tier 1 select agents) and facilities will be conducted by the RO. After the registration and SRA have been approved by CDC, an inspection may be required by the USDA/APHIS/CDC.

Biological and chemical technology subject to Select Agent restrictions may also be subject to Export Controls.