Select Agents are potentially hazardous biological materials and as such are subject to Administrative Procedure: Activities Involving Potentially Hazardous Biological Agents including review and approval by the Insitutional Biosafety Committee (IBC). In addition, the following procedures apply to the use of Select Agents (SA) in research or teaching:
1.1 Responsible Official (RO) Notifications
Persons proposing to use, or store, Select Agents must contact the RO. IBC approval must be obtained before final approval by the RO will be granted.
This includes the use and storage of genetic elements, recombinant or synthetic nucleic acid molecules, recombinant organisms, vaccine strains, and attenuated strains. Diagnostic or clinical laboratories must report the identification of a Select Agent as a result of diagnosis, verification or proficiency testing to the RO immediately.
The RO must be notified immediately if there is an occupational exposure to a Select Agent or if any amount of a Select Agent is lost, stolen or released into the environment. The RO will notify the appropriate federal agencies as required by Federal Regulations.
1.2 Shipping, Receiving and Disposal Notifications
The RO must be notified prior to shipping Select Agents outside the University or receipt of Select Agents from outside the University. UHS will forward requests to the Centers for Disease Control (CDC) for approval.
Transfer of Select Agents within the University is only allowed between laboratories that are approved and registered for Select Agent use by UHS and CDC or the United States Department of Agriculture (USDA). A "Record of Transfer to Registered Lab within the University of Minnesota" or "Destruction of a Select Agent" form must be filed with UHS prior to either of these actions.
2. Administration of the Select Agent Program
The RO will register the University with the Department of Health and Human Services (HHS) and/or USDA Secretary, as required by law. The Institutional Official (IO) will designate the RO and the RO will designate Alternate ROs who will ensure compliance with Select Agent regulations and who will act on behalf of the University. UHS will centrally administer the Select Agent requirements for all researchers. Researchers who use or store Select Agents must provide all required information to the RO.
The name of the Principal Investigator (PI) and all those individuals with legitimate need for access to the Select Agent(s) and all requested information will be collected by the RO and submitted to the Department of Justice (DOJ) for a security risk assessment. No individual without approval from both the federal government and the University will be allowed access to Select Agents. Written safety, security and emergency response plans are required.
3. Storing and Securing Select Agents
Select Agents must be locked in secured storage areas and access to these agents must be limited to only those who have a legitimate need and are authorized according to 42CFR Part 73. The RO, BSO and Central Security will conduct a security analysis of the laboratory and storage areas and take appropriate measures to ensure compliance. Individuals with access to or using select agents must follow all safety, security and emergency response procedures developed in conjunction with this security analysis.
Labeling of stock supplies or stored samples of Select Agents must be done in a way that is permanent and readable.
4. Record Keeping
Laboratories using or storing Select Agents are subject to inspection by University or federal authorities at any time. UHS Biosafety personnel conduct annual audits of laboratories approved for Select Agent activities. A current inventory of Select Agents must be maintained and available to inspectors upon request.
All individuals with access to or using Select Agents must have information and training on safety and security procedures before working with the agent. Training must be documented.