For assistance, contact the RO or ARO staff at 303-724-0345 or by email:
Responsible Official Ethan.Carter@ucdenver.edu
ARO/Asst. Biosafety Officer Zachary.Wilson@ucdenver.edu
ARO/Asst. Biosafety Officer Denise.Donnelly@ucdenver.edu
ARO/ECIHHM Manager Christina.Aguilera@ucdenver.edu
ARO/Hazardous Materials Specialist Jerman.Lopez@ucdenver.edu
Under the Select Agent Regulations*, any entity or organization that works with Select Agents must appoint a Responsible Official (RO) who is responsible for the management of Select Agents at the institution and register with the appropriate federal agency.
42 CFR Part 73
9 CFR Part 121
7 CFR Part 331
Univeristy of Colorado Denver is currently registered with the CDC-Division of Select Agents and Toxins (CDC-DSAT). The current Responsible Official for UCDenver is the Director, Department of Environmental Health and Safety.
For initial approval of Select Agent work seek IBC/RO approval BEFORE:
Acquiring any agent or toxin (see Select Agent Toxins tab below)
Initiating experiments with any new select agent or strain
For ongoing Select Agent work seek IBC/RO approval BEFORE:
Changing the scope of work (e.g., antibiotic resistance)
Adding new personnel
Changing the location of existing experiments
Internally or externally transferring any Select Agent materials to another investigator on or off the University property
All individuals with access to Select Agents are required to obtain a security clearance (Security Risk Assessment or SRA) from the Department of Justice. The RO initiates and facilitates the SRA approval process for UCDenver.
Every person who enters a laboratory containing Select Agents must either have a security risk assessment (SRA) clearance or must be escorted by an SRA approved person. This includes visitors and employees performing routine or emergency maintenance and repairs.
Principal Investigators are required to have a Biosafety Plan (Manual) addressing all BSL-3 (or ABSL-3) requirements in the CDC-NIH Guidelines Biosafety in Microbiological and Biomedical Laboratories, which is reviewed and approved by the RO and the IBC.
A Select Agents Security Plan and and Emergency and Incident Response Plan have been created, reviewed, and approved for the University, to include physical security, inventory, and provisions for activity reporting.
Thre are additional biosafety, security, emergency and incident response annual training requirements for all personnel prior to approval for the Select Agents program, conducted by the RO and ARO staff.
Any missing, lost, stolen or release (including spills in containment) of Select Agents will be reported immediately to the Responsible Official or the University Police Department. Missing materials must always be reported to the RO, even if subsequently recovered.
Toxins on the Select Agent list include some commonly used research materials. University policy is that all toxins on this list are required to be registered with the IBC. There are threshold limits that are allowed under the regulations without full registration with the CDC-DSAT.
Any possession, use, or transfer above the limits REQUIRES full Select Agents Program registration with the appropriate authorities.
Any waste or unused Select Agent Toxins must be inactivated prior to being picked up as chemical wasted.