Activities Involving Potentially Hazardous Biological Agents

Responsible Officer
Michael Oakes
Vice President for Research (Interim)
Myron Frans
Senior Vice President for Finance and Operations
Owner
Frances Lawrenz
Associate Vice President for Research
Katharine Bonneson
Assistant Vice President for University Health and Safety
Primary Contact
Gregory Park
Director, OBAO
Betty Kupskay
Director, BOHD
Last Revised
Effective Date

Policy Statement

This policy establishes responsibilities for the identification, classification, and control of potentially hazardous biological agents associated with the University’s teaching and research activities, and all use of such biological agents in space owned by the University.  All use of potentially hazardous biological agents must be conducted in a safe manner to protect the academic community as well as the greater community at large.

All University faculty, staff, students, and non-University individuals when the activities occur on University property must comply with federal and state regulations, guidelines and University policies and procedures when conducting research and teaching activities with potentially hazardous biological agents.  This includes obtaining prior review and approval by the Institutional Biosafety Committee (IBC), as specified.  All use of recombinant or synthetic nucleic acid molecules (r/sNA) in research and teaching activities must be conducted in compliance with the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (the NIH Guidelines), regardless of funding source.  Additionally, use of potentially hazardous biological agents must be conducted in accordance with the guidelines in the NIH-CDC publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL).

Non-University entities renting, leasing or otherwise using University facilities that are storing potentially hazardous biological agents must notify Biosafety and Occupational Health Department (BOHD) and are subject to inspection of their facilities and oversight by BOHD.

Individuals using biological material of unknown makeup that is reasonably expected to present a biohazardous risk must:

  • contact the Office of Biotechnology Activities Oversight (OBAO) to determine if IBC review and approval is required for teaching and research activities.; and
  • also contact the BOHD to ensure compliance with handling and/or storage practices.

Section I.  Potentially Hazardous Biological Agents

The IBC is responsible for reviewing all new or unique agents that may pose a biohazard risk to determine if such agents should be considered Potentially Hazardous Biological Agents under this policy.  The IBC may solicit advice from BOHD, expert faculty groups, University administrative leadership and others with relevant expertise in making this determination.  If an agent poses a risk but is determined to not meet the definition of a Potentially Hazardous Biological Agent under this policy, other University units may still require oversight.

Potentially hazardous biological agents include infectious agents, biologically-derived toxins, and recombinant or synthetic nucleic acid molecules (r/sNA) as defined below:

  • Infectious Agents refers to those biological agents that are known to cause disease in healthy adult humans and/or have been classified by the NIH Guidelines (Appendix B) into Risk Groups 2, 3, or 4. Those agents not listed in Risk Groups 2, 3, and 4, are not automatically or implicitly classified in Risk Group 1, and a risk assessment must be conducted by the IBC based on the known and potential properties of the agents and their relationship to agents that are listed. Infectious agents also include those as described by the IBC that may impact animals, plants or the environment but are not generally considered infectious to humans (i.e., USDA High Consequence Livestock Pathogens, some regulated agents of the USDA/APHIS Plant Pest and Disease Programs, or other animal or plant pathogens).
  • Biologically-derived toxins refers to unfractionated mixtures and purified preparations of biological toxins having high acute toxicity (i.e., a mammalian LD50 of less than or equivalent to 100 micrograms/kg body weight) or significant potential for serious subacute or chronic toxicity (e.g., carcinogenicity).  
  • Recombinant or synthetic nucleic acid molecules refers to, in the context of the NIH Guidelines, any of: (i) molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell (i.e., recombinant nucleic acids); (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids); (iii) molecules that result from the replication of those described in (i) or (ii) above.

Select Agents

Select agents are biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products.  The Federal Select Agent Program oversees the possession, use and transfer of biological select agents and toxins.  BOHD administers the Select Agent program on behalf of the University. All use of Select Agents must be approved by the IBC and must follow additional procedures described in Administrative Procedure: Storing and Handling Select Agents.

Section II.  Responsibility for Potentially Hazardous Biological Agents

The following individuals and offices work in collaboration as part of the biosafety program to protect the University from risks associated with the use of potentially hazardous biological agents:  Principal Investigators (PIs), the Institutional Biosafety Committee (IBC) (including OBAO), University Health & Safety (UHS) (including BOHD), and University administration.  Each contributes uniquely and in collaboration to the safety of the University community. 

Principal Investigators (PIs)

Individuals (University faculty, staff, students, and visitors) using or storing potentially hazardous biological agents must perform those activities in ways that eliminate or reduce risk. Persons working with potentially hazardous biological agents must be appropriately trained for use of the agents. All individuals must comply with all applicable University, state, and local regulations and guidelines pertaining to personnel health and safety or potential environmental release.

The PI is responsible for establishing, following, and enforcing rules, procedures, and methods for the proper control of potentially hazardous biological agents. The PI is also responsible for:

  • ensuring that staff and students are adequately trained in safety practices and have met all educational requirements;
  • requiring training in the implementation of the NIH Guidelines for activities involving r/sNAs;
  • preparing a safety plan for any research or teaching under their direction, which must include a description of the emergency and/or accident response procedures to be followed in the event of a spill, personnel contamination, or loss of containment;
  • correcting work errors, identifying defective work conditions which could result in personal injury and/or loss of containment, and emphasizing the importance of accident prevention among staff and students; and
  • informing their staff and students of the potential risks posed by agents used in their research or teaching laboratories.

Institutional Biosafety Committee

The IBC is advisory to the Institutional Official for Research on all matters relating to the safe use of potentially hazardous biological agents.  It is the IBC’s responsibility to establish, monitor, and enforce policies and procedures in compliance with applicable guidelines or best practices for potentially hazardous biological agents.  The IBC reviews proposed research and teaching activities for compliance with the NIH Guidelines and the BMBL and approves the proposed research or teaching activities found to conform with the NIH Guidelines and the BMBL. The review includes:

  1. independent assessment of the containment levels required for the proposed research;
  2. assessment of the facilities, procedures, practices, and training and expertise of personnel involved in the research or teaching activities with potentially hazardous biological agents;
  3. assessment focused on biosafety issues for r/sNA research involving human research participants (e.g., safety of staff administering r/sNA materials, potential for environmental release via shedding, etc.); and
  4. review of retrofits and new construction to ensure conditions and containment measures comport with those described in the NIH Guidelines.

The IBC is responsible for the review and approval for the use of potentially hazardous biological agents by University faculty, staff, and students, or by non-University employees when the activities occur at University property.

The IBC has the authority to fully investigate potential violations or compliance problems with research or teaching activities within its oversight, and the authority to stop or restrict activities involving the use of potentially hazardous biological agents.

Office of Biotechnology Activities Oversight

The Office of Biotechnology Activities Oversight (OBAO) reports through OVPR and provides administrative support to the University community for the IBC and the Institutional Review Entity (IRE). The OBAO: (i) assists the University community and the IBC in the interpretation of federal, state, and University guidelines, policies, and regulations; (ii) fulfills the NIH Guidelines reporting responsibilities for the IBC and the Institutional Official (IO); (iii) provides biosafety guidance, technical guidance, and assistance for IBC applications; (iv) works with other University research compliance units (e.g., the Institutional Animal Care and Use Committee (IACUC), the Institutional Review Board (IRB), the Institutional Review Entity (IRE)) to ensure that the IBC and the IO fulfill their responsibilities to the NIH Guidelines; and (v) carries out directed activities from the IBC and assists the IBC in fulfilling its responsibility to Board of Regents Policy: Activities Involving Recombinant and Synthetic Nucleic Acid Molecules or Other Potentially Hazardous Biological Agents.

University Health & Safety (UHS)

Biosafety & Occupational Health Department (BOHD)

BOHD reports through UHS and is responsible for inspecting laboratories to evaluate environmental conditions related to biosafety best practices, establishing waste disposal and decontamination standards, developing emergency plans, providing advice on laboratory security, providing biosafety and bloodborne pathogen training, providing technical advice to principal investigators, and consulting with the IBC through participation of the Biosafety Officer.

BOHD has the authority to prohibit non-compliant handling practices or storage of potentially hazardous biological agents found during an inspection or in the course of their work and must report any significant non-compliance to University leadership and/or the IBC. BOHD may stop the work activities of any person who has not undergone the required training.  All handling, storage, decontamination, and disposal of potentially hazardous biological agents must follow practices and procedures described in the current edition of the BMBL or as approved by the IBC. BOHD administers the program that oversees the handling and storing of Select Agents as they relate to responsibilities for the Federal Select Agent Program. 

BOHD’s responsibility also includes the application of the US Government OSHA Bloodborne Pathogens standard for activities not subject to IBC oversight, activities requiring USDA/APHIS permits not covered by the IBC, and consultations for all retrofits and new construction of laboratories where biological material is handled.

Occupational Health Advisor

The occupational health advisor assists the University’s biological safety program by providing services to reduce health risks or treat injuries/illnesses for all UMN faculty and staff (including student workers), and others performing activities involving potentially hazardous biological agents.  These services include health surveillance, medical evaluations and consultations, vaccinations, respiratory protection fit testing, and post-exposure injury/illness accident responses.

The IBC may send protocol applications to the occupational health advisor prior to IBC approval; the advisor may identify risks that must be resolved before the IBC approves the protocol.   The occupational health advisor may also offer recommendations to mitigate occupational health risks.

University Administration

The University administration is required to develop policy in the best interests of the University community and to ensure that the support necessary to carry out the functions involved in this policy is provided. The institutional administration is the ultimate deciding authority in any dispute between entities included in this policy. 

The IO (institutional official) responsible for the oversight of teaching and research activities involving potentially hazardous biological agents is the University’s Vice President for Research, The OBAO reports to the VPR.

For ensuring compliance with the Federal Select Agent Program, the IO is the Senior Vice President for Finance and Operations as assisted by the Responsible Official (RO).  The RO is responsible for the administration of the University’s Select Agent program and is the University’s Biosafety Officer.

Section III.  Dual Use Research of Concern (DURC)

Individuals who conduct life sciences research that can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security must conduct such research in compliance with the US Government Policy for DURC Oversight.  All such research is subject to review by the Institutional Review Entity (IRE) as well as review and approval by the IBC.  See Administrative Procedure: Dual Use Research of Concern.

Section IV. Biosafety Level 3 (BSL3)

Potentially hazardous biological agent research activities that are approved with the designations of BSL3, BL3-N, BL3-P, or ACL3 by the IBC require biosafety, biosecurity, and biocontainment and handling precautions and practices in BSL3 facilities.  

The BSL3 Program:

  • provides programmatic support and oversight for all University BSL3 containment facilities;
  • assists in developing operating procedures for each facility and for individual projects, provides training to all personnel involved in BSL3 operations; and
  • provides facility-specific training to researchers and monitors compliance within the BSL3 facilities.

The BSL3 Advisory Committee (BAC) serves as a resource for the BSL3 Program, research faculty, students, staff and institutional committees to develop solutions for the safe and efficient operation of high containment facilities and the BSL-3 research programs they support. The BAC is composed of research scientists, compliance and safety experts, and facility operations personnel. The BAC reviews all new and continuing renewal applications for research activities requiring BSL3 containment to provide advice on safety considerations prior to submission of applications to the IBC for formal review.   

Reason for Policy

The University has the responsibility to protect researchers, the University community and its assets, and the environment, by assuring the safe use and storage of potentially hazardous biological agents at the University. The University also has the responsibility to assure compliance with all federal, state, and internal requirements to prevent the theft, diversion, or misuse of biohazardous agents. This administrative policy implements Board of Regents Policy: Activities Involving Potentially Hazardous Biological Agents.

Contacts

Policy Contacts
Subject Contact Phone Fax/Email
Primary Contact OBAO Gregory Park 612-625-9153 [email protected]
Primary Contact BOHD Betty Kupskay 612-626-5590 [email protected]

Definitions

Biocontainment
Related to biosafety; pertains to the physical containment of potentially hazardous biological agents, usually by isolation in environmentally and biologically secure cabinets or rooms, to prevent accidental infection of workers or release into the surrounding community.
Biologically-derived toxin
Biologically-derived toxins are toxins of biological origin, and they reside between traditional definitions of biological and chemical agents. Biologically-derived toxins encompass a vast range of peptides, small molecules, and macromolecular proteins that cause disease by interfering with biological processes. Those biologically-derived toxins subject to IBC oversight are specified as unfractionated mixtures and purified preparations of biological toxins having high acute toxicity (i.e., a mammalian LD50 of less than or equivalent to 100 micrograms/kg body weight) or significant potential for serious subacute or chronic toxicity (e.g., carcinogenicity). 
Biosafety
Discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials. The practice of safe handling of biohazardous agents and their toxins in the biological laboratory is accomplished through risk assessment and the application of biocontainment principles. 
Biosafety and Occupational Health Department (BOHD)
The Biosafety and Occupational Health Department (BOHD) is responsible for risk mitigation activities related to biosafety, biocontainment, and biosecurity. This includes the administration of the Federal Select Agent program. BOHD provides the University community with technical guidance, training, and resources to promote a culture of safety in biological research, teaching, and diagnostic activities.
Biosecurity
The risk- and threat-based control measures established to prevent the unauthorized access, misuse, loss, theft, diversion and intentional release of valuable biological materials, pathogens, toxins, information, expertise, equipment, technology and intellectual property that have the potential to cause harm to humans, animals, plants, the environment, public safety or national security.
Decontamination
The process or treatment that renders a biohazardous agent safe to handle by way of sterilization or disinfection.
Dual Use Research of Concern (DURC)
Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security.
Human Gene Transfer
Human gene transfer (HGT) is the deliberate transfer into human research participants of: (1) recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules; or (2) synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any of the following criteria: (a) contain more than 100 nucleotides; (b) possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); (c) have the potential to replicate in a cell; (d) can be translated or transcribed.
Infectious Agent
Agents that are known to cause disease in healthy humans and/or have been classified by the NIH Guidelines (see Appendix B in those Guidelines) into Risk Groups 2, 3, or 4. Risk Group classification does not account for instances in which an individual may have increased susceptibility to agents. Those agents not listed in Risk Groups 2, 3, and 4, are not automatically or implicitly classified in Risk Group 1, and a risk assessment must be conducted based on the known and potential properties of the agents and their relationship to agents that are listed. Potentially hazardous infectious agents also include those that may impact animals, plants or the environment but are not generally considered infectious to humans (i.e., USDA High Consequence Livestock Pathogens, some regulated agents of the USDA/APHIS Plant Pest and Disease Programs, or other animal or plant pathogens).
Institutional Animal Care and Use Committee (IACUC)
The committee established by the University President or delegate in accordance with federal regulations to review University activities involving the use of vertebrate animals. The IACUC can be reached at [email protected].
Institutional Biosafety Committee (IBC)
The committee established by the University President or delegate in accordance with the NIH Guidelines and the Regents Policy to review University research or teaching activities involving recombinant or synthetic nucleic acid molecules and potentially hazardous biological agents. The IBC administration can be reached at [email protected]
Institutional Official
The official appointed by the University President or delegate who ensures compliance with ethical standards, laws, regulatory requirements, institutional policies, and mandatory reporting requirements.
Institutional Review Board (IRB)
The committee established by the president or delegate in accordance with federal regulations to review University research involving human subjects. The IRB can be reached at [email protected]
Institutional Review Entity (IRE)
The University committee responsible for the evaluation of research activities subject to the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (Sept 2014) or subsequent amendments, and empowered to enact the requirements in section 7.2.B.i-iii, v, and viiii. (https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf).
NIH Guidelines
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
Non-University Entity
A group or individual not a part of the University, as well as University employees using University real estate for personal use and student organizations not covered by the University's liability insurance.
Occupational Health Representative
An occupational health representative acting on behalf of the University to provide occupational health services to the University with respect to the use of potentially hazardous biological agents.
Office of Biotechnology Activities Oversight (OBAO)
The OBAO aims to promote science, safety, and ethics in biological research at the University of Minnesota. The OBAO provides administrative support to the University community for the IBC and the IRE. The OBAO assists in the interpretation of Federal, State, and University guidelines/policies/regulations, and fulfills the NIH Guidelines incident reporting responsibilities for the IBC and University. Staff of the OBAO contribute biosafety knowledge, assist in risk assessment and provide biosafety guidance, technical guidance, and assist in IBC application content for the IBC review.
Potentially Hazardous Biological Agent
Infectious agents, biologically-derived toxins, and recombinant or synthetic nucleic acid molecules (r/sNA). See specific definitions.
Principal Investigator (PI)
A University employee who serves as the lead investigator for their life sciences research or who is in charge of a teaching laboratory and who is responsible for all aspects of their research projects at the University, including the actions of their staff. For an IBC application, the Principal Investigator must meet the eligibility requirements set forth in the Board of Regents policy Submitting and Accepting Sponsored Projects. The Principal Investigator is responsible for full compliance with the NIH Guidelines in the conduct of r/sNA research. The DURC policy requires the PI to notify the IRE as soon as they propose any work that may fall under the DURC policy (see Dual Use Research of Concern – A Companion Guide).
Recombinant or Synthetic Nucleic Acid (r/sNA)
Any of: (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell (i.e. recombinant nucleic acids); (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids); (iii) molecules that result from the replication of those described in (i) or (ii) above, as defined by the National Institutes of Health.
Research
Systematic investigation, including development, testing and evaluation designed to develop or contribute to generalizable knowledge.
Responsible Official (RO)
The individual designated by the registered entity (i.e., University) with the authority and responsibility to act on behalf of the entity to ensure compliance with the Federal Select Agent Program. The University’s Biosafety Officer serves as the RO.
Select Agent
Biological agents and toxins that have the potential to pose a severe threat to human and animal health, or to animal or plant products. Refer to the Department of Health and Human Services (HHS) and United States Department of Agriculture (USDA) identified Select Agents and Toxins List (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73) as amended or revised.
Storage
Retention of potentially hazardous biological agents by University employees or on University property, including materials kept in open laboratory space, incubators, refrigerators, or freezers.
Teaching
Activities that include classroom demonstrations, laboratory exercises and research projects that are required for completion of a course at the undergraduate, graduate, or professional level.

Responsibilities

Biological Safety Officer (BSO)
A member of the IBC with responsibilities specified in the NIH Guidelines. Briefly, the BSO’s duties include, but are not limited to: (i) periodic inspections to ensure that laboratory standards are rigorously followed, (ii) reporting to the IBC and the institution any significant problems, violations of the NIH Guidelines or Regents Policy, and any significant research or teaching-related accidents or illnesses of which the BSO becomes aware unless the BSO determines that a report has already been filed by the PI, (iii) developing emergency plans for handling accidental spills and personnel contamination and investigating research or teaching laboratory accidents involving r/sNA or involving other potentially hazardous biological agents, (iv) providing advice on laboratory security, (v) providing technical advice to PIs and the IBC on research or teaching lab safety procedures, (vi) performing other duties as requested by the IBC and approved by UHS leadership.
Biosafety and Occupational Health Department (BOHD)
Department in UHS that coordinates and collaborates with the IBC in shared biosafety, biosecurity, and biocontainment compliance activities. Administers the Select Agent Program. Conducts inspections of university facilities. Provides information and training to the University community on the safe storage, biocontainment, biosecurity, and decontamination and disposal of biohazardous agents. Provides expert advice for all retrofits and new construction of areas where biological agents and animals are used or manipulated. Provides recommendations to the IBC during IBC review of research or teaching activities via the BSO.
Institutional Biosafety Committee (IBC)
Reviews research and teaching proposals involving the use of potentially hazardous biological agents and grants approval before work begins. Review practices, procedures, and containment for the handling and use of potentially hazardous biological agents used in research or teaching. Suspends or terminates research or teaching activities, or refers incidents to the IO in the event of noncompliance or an unresolved safety hazard. See above for more specific definitions.
Institutional Review Entity (IRE)
Review of life sciences dual use research of concern as identified by PIs: verification that the research involves one or more of the agents listed in the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (Sept 2014) or subsequent amendments; review of the PIs assessment and final determination of whether the research meets any of the seven experimental effects; when appropriate, make a determination of whether the research meets the definition of DURC. For research determined to be DURC, the IRE: considers the risks and benefits of conducting the research; works with the appropriate Federal funding agency to develop a risk mitigation plan; reviews the risk mitigation plan at least annually and modifies the plan, as warranted.
Office of Biotechnology Activities Oversight (OBAO)
The OBAO assists the IBC in the interpretation of Federal, State, and University guidelines, policies, and regulations, and fulfills the NIH Guidelines incident reporting responsibilities for the IBC and University. Staff of the OBAO contribute biosafety knowledge, assist in risk assessment and provide biosafety guidance, technical guidance, and assist in IBC application content for the IBC review.
Principal Investigators/Researchers
The primary responsibility for establishing, following, and enforcing rules, procedures, and methods for the proper control of potentially hazardous biological agents rests with the PI. Detailed responsibilities are described earlier in this policy.
Senior Vice President for Finance and Operations
Oversees University Health & Safety and serves as IO for the Select Agent program.
University Health and Safety (UHS)
Department overseen by the Senior Vice President for Finance and Operations that is comprised of the Biosafety & Occupational Health Department (BOHD), the Department of Environmental Health & Safety (DEHS), the Department of Radiation Safety (DRS), the Building Codes Department (BCD), the Department of Emergency Management (DEM), and Health Emergency Response Office (HERO). UHS departments work cooperatively with each other and with their clients to provide comprehensive safety services with the ultimate goal of fostering a culture of safety throughout the University of Minnesota System.
Vice President for Research (VPR)
Supervises the Office of Biotechnology Activities Oversight and serves as the Institutional Official (IO) for research. As IO for research, the VPR is responsible for taking steps to ensure compliance with ethical standards, laws, regulatory requirements, institutional policies, and mandatory reporting requirements. The IO also ensures adequate resources are available for proper functioning of the IBC, IACUC, IRE, IRB, and OBAO.

History

Amended:
December 2021 - Comprehensive Review. The policy was clarified to specify the roles for BOHD and the IBC.
Amended:
September 2015 – Comprehensive Review, Minor Revision. Added information on Dual Use Research of Concern. Removed outdated language, updated UMN departments, added contacts, and revised definitions. Responsibilities and Procedures updated.
Amended:
June 2012 - Comprehensive Review, Minor Revision. Removed outdated language, updated UMN departments, added contacts, and revised definitions. All minor updates with no substantive change to policy statement. Title of this policy should be changed to read "Potentially" rather than "Potential" in order to align with other Board of Regents policies and NIH Guidelines. Responsibilities and Procedures updated.
Effective:
January 2004

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