Activities Involving Potentially Hazardous Biological Agents

1. Approval and Notification Requirements

  1. Activities using potentially hazardous biological agents must have a qualified Principal Investigator (PI) that fulfills the responsibilities as defined in the Administrative Policy: Activities Involving Potentially Hazardous Biological Agents.
  2. The PI must obtain Institutional Biosafety Committee (IBC) approval for their research or teaching activities prior to initiation. The IBC application is available at the IBC website (ibc.umn.edu).
  3. Non-University entities renting, leasing or otherwise using University facilities that are handling or storing potentially hazardous biological agents must notify University Health and Safety’s (UHS) Biosafety and Occupational Health Department (BOHD) by contacting the Biological Safety Officer (BSO) or designate at 612-626-6002. BOHD has the authority to inspect, oversee, and prohibit the handling and storage of all potentially hazardous biological agents if non-compliant practices are found.

2. Review of Activities involving Potentially Hazardous Biological Agents

  1. The IBC reviews and approves (if appropriate) the use of all potentially hazardous biological agents in research and teaching activities.

Use of potentially hazardous biological agents in human subjects

  1. The PI must submit the application for use of potentially hazardous biological agents in humans to the University of Minnesota Institutional Review Board (IRB) for review and approval in addition to the IBC.
  2. Final approval by the IRB is not granted until IBC approval is obtained.

Use of potentially hazardous biological agents in animals

  1. The PI must submit the application for use of potentially hazardous biological agents with animals, or the generation and/or use of animals that contain potentially hazardous biological agents to the University of Minnesota Institutional Animal Care and Use Committee (IACUC) for review and approval as required by IACUC Policies and Procedures (see https://research.umn.edu/units/iacuc/policies-guidelines/overview) and review and approval by the IBC before initiating activities.
  2. The PI must obtain approval from the IBC for use of potentially hazardous biological agents with animals not subject to IACUC before initiating those activities.

Continuing Review and Amendments

  1. IBC approvals for each protocol are valid for three years and are subject to an annual continuing review and approval.
  2. All proposed changes to approved IBC protocols must be reviewed and approved by the IBC or IBC administration.
  3. All proposed changes to research or teaching activities (amendments) must be approved before initiation.
  4. Changes to projects that are subject to Dual Use Research of Concern regulations must be reviewed and approved by the Institutional Review Entity (IRE) before initiation.

3. Determining the Biological Safety Level (BSL)

A Biological Safety Level 1-4 is determined by a risk assessment which considers infectivity, severity of disease, transmissibility, and the nature of the work being conducted. The objective of determining a BSL is to confine biohazardous agents or organisms containing biohazardous agents and to reduce the potential for exposure of the laboratory worker, students, persons outside of the laboratory, and the environment to potentially hazardous biological agents or to organisms containing potentially hazardous biological agents. Each biosafety level consists of combinations of facility design features and safety equipment (primary and secondary barriers), facility practices and procedures, and personal protective equipment.

  1. The investigator will propose the BSLs to be used in the laboratory for the activities involving potentially hazardous biological agents.
  2. The IBC has the final authority to determine and approve BSLs based on the NIH Guidelines and in accordance with practices and procedures described in the NIH-CDC publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL). Selection of the appropriate combinations to safely conduct the work is based on a comprehensive facility-specific biosafety risk assessment that documents the properties of the biological agents and toxins to be used, potential host characteristics, potential routes of infection, and the laboratory work practices and procedures.
  3. The IBC can require additional procedures or equipment necessary for activities with these agents. The IBC will also use other related BSL designations described in the NIH Guidelines or as adopted by professional organizations to assist in the identification of laboratory practices, containment equipment, and facility design/safeguards for specific activities (e.g., NIH Guidelines: Biosafety Level 1 is BL1, BL1-Animals is BL1-N, BL1-Large Scale is BL1-LS, BL1-Plants is BL1-P; Arthropod Containment Level 1 is ACL-1).
  4. Any use of potentially hazardous biological agents that requires approval by the IACUC will receive an Animal Biological Safety Level (ABSL) designation (defined in the BMBL) by the IBC in consultation with Research Animal Resources (RAR) and/or the BSL3 Program. RAR or the BSL3 Program administration will provide animal facilities with practices and equipment that are in compliance with the BMBL.

4. Completing Appropriate Required Training

  1. The PI is responsible for ensuring that all persons working with or who may come into contact with potentially hazardous biological agents are appropriately trained for use of the agents with which they are working or to which they are potentially exposed.
  2. Faculty, lab personnel, and students are required to complete Biological Safety in the Laboratory
  3. Teaching laboratories are required to provide lab specific safety training for all potentially hazardous biological agents to all students enrolled in the course and account for this in the course The course director and all teaching assistants are required to take the relevant IBC required training.
  4. If a laboratory works with any infectious agent or blood/fluids/cells from humans or non-human primates then the PI and personnel must complete BOHD’s Bloodborne Pathogen Bloodborne pathogen training must be retaken annually for all personnel if the laboratory works with human/zoonotic infectious agents or blood/fluid/cells from humans or non-human primates.
  5. Laboratory work with recombinant or synthetic nucleic acid molecules requires training in the implementation of the NIH Guidelines.
  6. Training can be accessed from the IBC training page or the BOHD training page.  
  7. Custodial, Information Technology (IT), mechanical, structural, and other non-laboratory staff must also be appropriately trained before entering areas where potentially hazardous biological agents are used and when disposing of infectious waste. Training for Facilities Management staff is managed through Workplace Safety. The training for other non-laboratory staff is managed by those responsible for granting access to the facility.

5. Determining Appropriate Biosecurity

  1. All potentially hazardous biological agents must be stored in a secure manner according to the security risk they pose.
  2. Access to potentially hazardous biological agents must be limited.
  3. The IBC and/or BOHD will assist in the determination of biosecurity needs according to an assessment of biosecurity risk and in accordance with regulations and guidelines.
  4. Detailed information about biosecurity is available in Biosafety in Microbiological and Biomedical Laboratories (BMBL).

6. Incident Reporting involving Potentially Hazardous Biological Agents

  1. Principal Investigators must promptly report any research or teaching-related accidents or incidents involving potentially hazardous biological agents to the IBC administration and/or BOHD.
    1. If the incident occurred in association with activities approved by the IBC, the report must be either the IBC Incident Report Form (fillable PDF document) or the Incident Report via eProtocol.
    2. If the incident occurs in a BSL2 or BSL3 laboratory and activities are subject to the NIH Guidelines, the incident must be reported to the IBC administration and BOHD immediately.
  2. Incidents reportable to the IBC administration include (1) events that are unexpected, involve new or increased risks, and are related to the research, (2) personal injury, accident, or spill resulting in an overt or potential exposure, or (3) an environmental release.

7. Conducting Inventories, Inspections, and Monitoring

  1. BOHD has the authority to conduct inventories and inspections of all laboratories that handle or store potentially hazardous biological agents.
  2. The IBC may conduct monitoring of any protocol approved by the IBC, which may include facility visits.
  3. Researchers are required to cooperate with inventories and inspections of their laboratories, which may be announced or unannounced and are conducted at intervals determined by the IBC, BSO or BOHD.
  4. Researchers may be required to maintain a list of the potentially hazardous biological material handled or stored in their laboratories.
  5. Non-University entities using University facilities are also subject to inspection of that facility by BOHD related to their handling, storage, security, and equipment.

8. Storing Potentially Hazardous Biological Agents

  1. The PI must store potentially hazardous biological agents in an appropriate and safe manner as determined by the BSO and/or BOHD.
  2. The PI must ensure access to materials is limited to those with a legitimate need.
  3. All stored potentially hazardous biological agents must be claimed by an individual, who is a University employee (or a non-University entity using University facilities, as described above) and who is responsible for the storage of the material.
  4. Investigators must label all materials so that contents can be properly identified.
  5. Unidentified biological material must be treated as hazardous and disposed of in a proper manner.

9. Transferring Potentially Hazardous Biological Agents

  1. Transfer of material handled at BSL2 or above must be carried out in accordance with applicable regulations and approved UHS procedures. This refers to transfer of agents within the University as well as transfers outside the University.
  2. Requirements for Export Controls may also apply.
  3. All applicable regulations for shipping of hazardous materials must be followed (see Hazardous Materials Shipping Services).
  4. A Material Transfer Agreement (MTA) is used when appropriate.

10. Disposing of Potentially Hazardous Biological Agents

  1. Investigators must ensure that potentially hazardous biological agents are appropriately decontaminated before disposal.
  2. The BSO and IBC will determine appropriate decontamination procedures and disposal requirements for specific potentially hazardous biological agents.
  3. Any costs associated with decontamination and disposal will be borne by the laboratory/department/college in which the material originated.

11. Laboratory Close Out/Relocation

  1. In the event that a researcher leaves the University or moves their laboratory area, the researcher and the Department are responsible for ensuring that appropriate laboratory closeout procedures are followed, including disposal of any unwanted material.
  2. Laboratory closeout information is available from UHS.

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