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Select Agents are potentially hazardous biological materials and as such are subject to the administrative procedure: Storing and Using Potentially Hazardous Biological Agents including review and approval by the IBC. In addition, the following procedures apply to the use of Select Agents in research or teaching:

1. Notify the Responsible Official (RO)
Persons proposing to use, store, or transfer (within or outside the University of Minnesota) Select Agents must contact the RO. This includes the use, storage or transfer of genetic elements, recombinant nucleic acids, recombinant organisms, vaccine strains, attenuated strains and exempt quantities of toxins. The RO will determine if agents or toxins meet the qualifications for exclusion or exemption from the Select Agent Regulations.

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.

Persons must notify the RO at least 10 days prior to destroying a Select Agent or toxin.

2. Registering the University of Minnesota

The RO will register the University with the HHS and/or USDA Secretary, as required by law. The director of DEHS will designate the RO and an Alternate ROs who will ensure compliance with Select Agent regulations and who will act on behalf of the University. DEHS 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 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 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, IBC, BSO or ORA 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. Keeping records

Laboratories using or storing Select Agents are subject to inspection by University or federal authorities at any time. DEHS Biosafety personnel conduct quarterly audits of laboratories approved for select agent activities. Laboratories using exempt quantities of select agents are audited on an annual basis. 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.