Biological Safety

UTK Environmental Health & Safety Program LS-BIO-001

Effective Date: 01/01/2022
Revision Date: 12/12/2023

Purpose

This document describes the biological safety program established to protect faculty, staff, students, visitors, the public, and the environment from exposures (or potential exposures) to biological hazards. Additionally, the roles and responsibilities of affected stakeholders pursuant to compliance with U.S. Federal, State and local laws, regulations and consensus standards are described.

Scope and Applicability

This program applies to research, teaching, diagnostic testing, and other activities conducted at, sponsored by, or on behalf of the University of Tennessee, Knoxville (UTK). As per documented agreements, the program also extends to other UTK-area campuses (hereafter UTK-A) and institutes, including the Institute of Agriculture (UTIA), College of Veterinary Medicine (CVM), and Graduate School of Medicine (GSM). The program scope includes:

Recombinant DNA molecules or synthetic nucleic acids as defined in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (hereafter NIH Guidelines), including transgenic plants and animals.
Biological agents (bacteria, viruses, fungi, protozoa, parasites, and prions) and/or vectors that carry biological agents (arthropods, snails, etc.), which:
- cause or are reasonably expected to cause disease in immunocompetent humans; or
- cause or are reasonably expected to cause significant disease in local livestock (including poultry), agricultural crops, or indigenous wildlife; or
- require containment and safeguards at biosafety level (BSL)-2 or higher.
Acute biological toxins having an LD₅₀<100 ng/kg in mammals and/or those defined as Select Toxins by the Department of Health & Human Services (DHHS).
Human or nonhuman primate blood, blood products, tissues, secretions, excretions, or cell lines, unless documented to be free of bloodborne pathogens or otherwise deemed low risk per documented risk assessment.
Venomous animals posing a risk to humans through bite or sting and housed and/or manipulated in laboratories or other indoor facilities (e.g. greenhouses).
Poisonous plants posing a risk to humans via dermatological contact, inhalation, or other route of exposure and housed and/or manipulated in laboratories or other indoor facilities (e.g. greenhouses).
Novel nanoparticles conjugated to biologically active or cell-modifying molecules.
Diagnostic specimens or environmental samples likely to contain any of the above and posing a significant risk to humans or local livestock (including poultry), agricultural crops, or indigenous wildlife as per documented risk assessment, including materials requiring a federal or state permit (e.g. foreign soils, noxious weeds, etc.).

The following are excluded from the program scope:

Allergens, zoonoses, and other inherent biological risks associated with the routine care and use of research or teaching animals, which are deferred to the Institutional Animal Care & Use Committee (IACUC) occupational health program. (Note: research, teaching, and diagnostic testing involving zoonotic agents are subject to the biosafety program).
Use/exposure to human blood, tissues, and body fluids external to research, teaching, or diagnostic testing settings (e.g., medical/first-aid, law enforcement, facilities maintenance, athletics, custodial services, etc.), which is deferred to the general industry/occupational safety programs and procedures of the respective campus or institute.
CVM, GSM, and UTK Student Health Center patient clinics and procedural areas, which are deferred to the respective hospital/clinic management.

Abbreviations and Definitions

Abbreviations

APHIS: Animal & Plant Health Inspection Service

BMBL: Biosafety in Microbiological & Biomedical Laboratories (6^th Edition)

BSL: Biological Safety (or Biosafety) Level

BSO: Biological Safety Officer

CDC: Centers for Disease Control and Prevention

CFR: Code of Federal Regulations

CVM: College of Veterinary Medicine

DHHS: United States Department of Health & Human Services

DNA: Deoxyribonucleic Acid

DO: Designated Official

DOT: Department of Transportation

EHS: Environmental Health & Safety

EPA: Environmental Protection Agency

FDA: Food and Drug

GSM: Graduate School of Medicine

IACUC: Institutional Animal Care and Use Committee

ICAO/IATA: International Civil Aviation Organization/International Air Transportation Association

IBC: Institutional Biosafety Committee

LD50: Median Lethal Dose

NIH: National Institutes of Health

OSHA: Occupational Safety and Health Administration

PPE: Personal Protective Equipment

PI: Principal Investigator

RO: Responsible Official

rsNA: Recombinant or Synthetic Nucleic Acids

TCA: Tennessee Code Annotated

TDEC: Tennessee Department of Environment & Conservation

USDA: United States Department of Agriculture

UTIA: University of Tennessee Institute of Agriculture

UTK: University of Tennessee, Knoxville

UTK-A: University of Tennessee, Knoxville-Area

Definitions

Biological Hazard (Biohazard) – any agent (bacterium, virus, fungus, unicellular or multicellular parasite, or prion) or molecule/cellular product (protein, lipid, nucleic acid, etc.) capable of causing disease or other negative health effects. Biological hazards may be acquired through punctures/cuts, open or broken skin (cuts, scrapes, rashes, eczema, acne, etc.), mucous membranes, ingestion, or inhalation. Acquisition of disease and disease outcomes is influenced by route of exposure, dose, and individual differences, including age, health (particularly immune status), vaccination history, and genetics.

Dual Use Research of Concern – 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.

Recombinant and Synthetic Nucleic Acid Molecules (rsNA) – as per the NIH Guidelines:

Molecules that are constructed by joining nucleic acid molecules that are not found contemporaneously in nature that can replicate in a living cell (recombinant DNA); or
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 (synthetic nucleic acids); or
Molecules that result from the replication of those described above.

Select Agents & Toxins – the infectious agents and biological toxins which have been declared by the Department of Health and Human Services (DHHS) or by the United States Department of Agriculture (USDA) to have the potential to pose a severe threat to public health and safety and/or agriculture.

Roles and Responsibilities

Institutional Biosafety Committee (IBC)

The IBC is an appointed committee of UTK-A faculty, technical staff, and non-affiliated community representatives that:

Serves to protect faculty, staff, students, research subjects, the public, and the environment from biological hazards used in university research, teaching, and diagnostic testing.
Establishes, recommends, and/or approves plans, procedures and guidelines on the proper use of biological hazards, including rsNA as stipulated by the NIH Guidelines.
Reviews and approves the use of biological hazards, including rsNA, and respective safety practices and containment facilities.
Provides safety/compliance concurrence to other relevant committees; e.g., the IACUC.
Review and establish corrective measures for any reported biosafety concerns, violations, and/or lab-related accidents or illnesses.
Recommends disciplinary actions in the event of egregious noncompliance with applicable standards and guidelines and/or the unsafe use, storage, or security of biological hazards.
See https://biosafety.utk.edu/biosafety-program/ibc/ for IBC bylaws, roles and responsibilities, and other supporting.

IBC Administrator

The IBC administrator is the UTK chancellor-designated official responsible for staffing, equipping, and supporting the IBC, particularly in its duties prescribed by the NIH Guidelines. The IBC Administrator shall:

Maintain an active IBC, including appointing the IBC Chair, Vice-Chair, and voting committee members in accordance with the NIH Guidelines and other university requirements.
Liaising our IBC with the NIH Office of Science Policy, specifically officially registering the committee, providing routine updates on committee activity, and reporting incidents/concerns as stipulated in the NIH Guidelines.
Ensure that the IBC is properly staffed and trained as described in the NIH Guidelines.
Provide IBC management resources, including a meeting framework and a protocol management system.
Act as the official IBC signatory for the UTK-area campuses, including but not limited to:
- Annual registration of the IBC with the NIH Office of Science Policy
- Documents or reports related to IBC proceedings, particularly those that may be required by federal regulatory bodies and/or funding agencies
- Notices of safety violations or regulatory non-compliance filed to federal, state, or local agencies
- Notices of safety violations or regulatory non-compliance filed to funding agencies as per codified agency requirements including, but not limited to, the NIH Office of Science Policy
- Documentation related to the receipt, storage, manipulation, transfer, or destruction of select agents as defined by the Federal Select Agent Program (i.e. APHIS/CDC Forms 1-5)
- Biosafety and biocontainment agreement/assurance documents required by various biological repositories or suppliers.
In partnership with research administration, verify that all IBC-approved projects include the necessary resources for the construction and operation of safe research and for the implementation of the biosafety program.
Report any significant problems, or violations to U.S. Federal, State or local agencies as applicable.
Represent the IBC as needed.

Biological Safety Officer

The BSO oversees biosafety operations and is the primary intermediary between Environmental Health & Safety (EHS), the IBC, and other stakeholders. The BSO (and designated staff) shall:

Support implementation of IBC programs, procedures, and guidelines.
At the discretion of the IBC and/or EHS, establish/implement a framework for oversight of biological hazards and associated procedures in teaching and diagnostic testing laboratories.
Perform risk assessments and provide technical advice to the IBC, DO, and/or RO as required or requested.
Perform inspections of facilities where biological hazards are being used or stored to ensure safety and containment measures as outlined in the NIH Guidelines and other applicable regulations and consensus standards (see References).
Investigate and report any significant biosafety concerns, violations, and/or lab-related accidents or illnesses to the IBC, the RO, or other campus administrators as applicable.
Communicate programmatic expectations, provide training and technical advice, conduct facility inspections, and providing hands-on assistance as necessary.
Develop emergency plans for handling accidental spills and personnel contamination and investigate laboratory accidents involving biological hazards.
Collaborate with campus stakeholders in the development and implementation of an exposure control plan for those research and teaching programs handling human derived materials as stipulated by the OSHA Bloodborne Pathogens Standard.
Administratively review registrations submitted by PIs and laboratory supervisors and make recommendations to the IBC Chair.
Review IACUC and other compliance committee protocols as necessary; consult with animal facility management, veterinarians, and PIs regarding appropriate containment procedures for biological hazards.
Prepare periodic reports for institutional management regarding IBC activities and biosafety program status.
Serve as an ex officio member of the IBC. If the University conducts rsNA research requiring BSL3 or BSL4 containment or engages in large-scale research or production involving viable organisms containing rsNA, act as a voting member of the IBC per requirements of the NIH Guidelines.

Responsible Official

The Responsible Official is the University delegate with the legal authority and responsibility to oversee the possession, use and transfer of Select Agents. The RO is appointed by the DO, approved by applicable federal agencies, and charged with the legal authority and responsibility to oversee the possession, use and transfer of Select Agents. The RO shall:

Possess a detailed knowledge of the Select Agent regulations to the extent that he/she can ensure the University is compliant with all the programmatic requirements.
Conduct annual inspections for each laboratory and all other registered areas where Select Agents are stored or used to determine compliance with the requirements of the Select Agent regulations. The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected by specified date.
Conduct annual emergency preparedness, spill response, and/or security drills as required.
Immediately resolve any reported concerns, violations, accidents, incidents, or security/access breaches involving Select Agents. Provide timely notifications and reports to the respective federal agency as required by the Select Agent regulations.
Have a physical presence at the University to maintain compliance with the Select Agent regulations and be able to respond in a timely manner to onsite incidents involving Select Agents in accordance with incident response plans.
Be granted sufficient authority to speak and act on behalf of the University.

Principal Investigator

The PI is defined as the faculty member or other University employee in whose assigned space(s) research is conducted. The PI is accountable for all activities occurring in his/her space(s) and responsible for full compliance with regulatory standards as well as programs, procedures, and guidelines set forth by the University. The PI is primarily responsible for the prudent management of biological hazards and the safety and health of laboratory staff, students, and visitors. Although the PI may choose to delegate these aspects to other laboratory personnel or faculty, this does not absolve the PI of his/her ultimate responsibility. The PI shall:

Comply with all requirements relative to handling, storage, disposal, inventory, security/access, and transportation of biological hazards.
Develop, implement, and maintain written laboratory-specific biosafety procedures appropriate for the biological hazards used in the laboratory. The PI shall ensure that all laboratory staff, students, and visitors understand and comply with these laboratory-specific biosafety procedures.
Delay initiation of research involving biological hazards until the research has been registered with and approved by the IBC or BSO as required.
Maintain an inventory of all biohazards used or stored in the laboratory. Logs should include the approximate quantity of the materials and storage location.
Restrict access to the laboratory and stored biological hazards to authorized personnel only.
Ensure that all laboratory personnel, maintenance personnel and visitors who may be exposed to any biological hazards are informed in advance of the potential risk and of the practices required to minimize that risk.
Supervise the performance of the laboratory staff to ensure that required safety practices are employed.
Provide feedback and coaching of laboratory members to ensure the work errors and conditions that may result in accidental releases or exposures are discussed and corrected.
Provide and maintain all PPE designed by risk assessment, including routine cleaning and/or replacement of dirty or contaminated PPE as appropriate. Additionally, the PI shall ensure that all affected laboratory faculty, staff, students, and visitors wear PPE as prescribed.
Ensure that all safety and containment equipment is maintained in good condition and functionally verified as necessary. Maintenance work in, on or around contaminated equipment is to be conducted only after that equipment is thoroughly decontaminated by the laboratory staff or PI.
Properly segregate and decontaminate biohazardous wastes before final disposal. All laboratory faculty, staff, and students are to be familiar with the appropriate methods of waste disposal.
Complete training as required by the IBC or any other oversight agency, ensure that all staff, students, and visitors participating in biohazard related activities have completed appropriate training, and maintain documentation of training. The PI or designee must provide protocol-, agent-, and laboratory-specific training.
Inform affected personnel of signs/symptoms that may result from accidental exposures. Ensure that they are informed of and receive medical surveillance or occupational health reviews as necessary.
Coordinate with the BSO and develop emergency plans for accidental spills and exposures.
Comply with shipping and permit regulations for biological hazards. The PI should contact the BSO to ensure that all applicable transportation safety regulations have been met prior to shipping microbiological cultures, tissues (human or animal) or body fluids. Contact EHS for information regarding Category A and Category B shipping of dangerous goods.
Immediately notify the BSO of any of the following:
- Laboratory spills, accidents, containment failure or violations of biosafety practice that result in the release of biological hazards and/or the exposure of laboratory personnel or the public.
- A laboratory-acquired infection is known or suspected.
- A Select Agent or other high-consequence pathogen (i.e., Risk Group 3 or 4) has been isolated and confirmed from environmental and/or diagnostic specimens.
- A Select Agent or other high-consequence pathogen (i.e., Risk Group 3 or 4) is discovered in laboratory freezers, refrigerators, or other storage devices.
Cooperate with follow-up investigations of any reported biosafety concerns, violations, and/or lab-related accidents or illnesses.
Create and foster an environment in the laboratory that encourages open discussion of biosafety issues, problems, and violations of procedure. The PI will not discipline or take any adverse action against any person for reporting problems or violations to the IBC, BSO, DO, Risk Management, or State or Federal agencies.

Laboratory Supervisor

The laboratory supervisor is the individual (faculty member or departments designate) with primary responsibility for the use of biological hazards in the University’s teaching or diagnostic testing laboratories. The laboratory supervisor shall:

Comply with all requirements relative to handling, storage, disposal, inventory, security/access, and transportation of biological hazards.
Inform (in writing) the IBC or BSO of biological hazards used in teaching or diagnostic testing (e.g. reference organisms).
Complete training and ensure that all teaching or testing staff have completed training, as required by the IBC or any other oversight agency as applicable. Comparable information or training materials should be provided to students and trainees. Training and/or distribution of training materials should be documented by the laboratory supervisor.
As necessary, communicate the signs and symptoms, which may result from accidental exposure to the biological hazards used in the laboratory to staff and students/trainees.
Stipulate enforce the safety precautions to be followed by staff, students and trainees.
Ensure work errors and conditions that may result in incident, injury or exposure are pointed out and corrected.
Determine the proper PPE to be worn for designated procedures. The laboratory supervisor (or designate) shall ensure that PPE is worn as directed cleaned/replaced as appropriate.
Immediately notify the BSO of any of the following:
- Laboratory spills, accidents, containment failure or violations of biosafety practice that result in the release of biological hazards and/or the exposure of laboratory personnel or the public.
- A laboratory-acquired infection is known or suspected.
- A Select Agent or other high-consequence pathogen (i.e., Risk Group 3 or 4) has been isolated and confirmed from environmental and/or diagnostic specimens.
- A Select Agent or other high-consequence pathogen (i.e., Risk Group 3 or 4) is discovered in laboratory freezers, refrigerators, or other storage devices.
Cooperate with follow-up investigations of any reported biosafety concerns, violations, and/or lab-related accidents or illnesses.

Laboratory Personnel

Laboratory personnel (staff, students, volunteers) shall:

Participate in biosafety orientation and training programs offered by the University.
Become familiar with laboratory-specific biological hazards.
Abide by all biosafety precautions that are relevant to the assigned duties.
Use prescribed personal protective equipment directed by the supervisor and in accordance with proper biosafety precautions.
Report any observed unsafe conditions and unsafe practices to the University administration (e.g. PI/laboratory supervisor, department head, dean or associate dean, BSO, IBC Chair, or DO).

Cooperate with follow-up investigations of any reported biosafety concerns, violations, and/or lab-related accidents or illnesses.
Exercise good judgment and ask questions regarding risk and appropriate methods of risk mitigation.

Look out for the safety of others in the laboratory and supporting facilities.

Department Head

The department head or administrative equivalent (e.g. center or institute director) shall:

Review and approve IBC registrations submitted by departmental faculty members.
Verify that appropriate facilities are available to control biological hazards.
Verify that the PI or teaching laboratory supervisor has competency commensurate with the proposed project and/or assigned laboratory course(s).

Cooperate with follow-up investigations of any reported biosafety concerns, violations, and/or lab-related accidents or illnesses.
Ensure that any reported safety deficiencies or compliance concerns/violations are corrected by the PI or teaching supervisor in a timely fashion.

Notify the BSO of new faculty hires, preferably before the new PI arrives on campus, if he/she plans to work with biological hazards.
Notify the BSO/IBC if a PI can no longer carry out his/her responsibilities (e.g. leaves the University, retires, etc.), for which the department head must select one of the following actions within 30 days of the PI’s departure:
- Assume responsibility for a PI’s biological hazards and manage under his/her own program. Change in proprietorship must be reported to the BSO/IBC, and the department head must comply with all biosafety-related provisions; or
- Assign the biological hazards to another investigator. Change in proprietorship must be reported to the BSO/IBC, and the designated PI must comply with all biosafety-related provisions; or
- Inactivate/destroy/dispose of biological hazards and terminate applicable IBC registration(s).
Ensure that the PI and/or designated staff follow laboratory commissioning/decommissioning procedures (see EHS LS-003 Guide) as applicable.

References

The following apply to the possession, use and transfer of biological hazards. In case of conflicting requirements between regulations, consensus standards, and/or UTK policies, programs, etc., the more protective requirements shall prevail, as applicable.