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1. RESPONSIBILITIES

 

1.1 University-wide laboratory safety responsibilities


University leadership is responsible for:

  • Promoting a culture of safety designed to protect thewell-being of faculty, staff, students and the university as a whole.
  • Designating campus safety officers with responsibility for implementation, management, and enforcement of environmental health and safety programs.

The UTK Associate Vice-Chancellor for Research & Research Integrity is the Designated Official for the UT Biosafety Program.

The DO is responsible for the following:

  • Coordinating with applicable University administrators to ensure that research, teaching, diagnostic testing or other activities involving biological hazards are conducted safety and in compliance with applicable regulations standards and guidelines
  • Establishing and implementing policies that provide for the safe conduct of research, teaching and diagnostic testing involving biological hazards
  • Maintaining an active IBC; appointing the IBC Chair, Vice-Chair and committee members in accordance with the NIH Guidelines and other University requirements as applicable
  • Granting the IBC and BSO authority to oversee the safe and responsible use of biological hazards at the UTK-area campuses
  • Verifying 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
  • Providing adequate resources for the dissemination of information on biosafety policies and procedures, including training programs and workshops
  • Coordinating or providing resources for medical surveillance measures or occupational health programs to protect the health and safety of faculty, staff, students, and visitors
  • Imposing or upholding disciplinary actions or sanctions on principal investigators or laboratory supervisors who fail to comply with established regulations, standards, guidelines, or University policies
  • Reporting any significant problems, or violations to U.S. Federal, State or local agencies as applicable. If appropriate, agency reporting may be delegated to the IBC or BSO
  • Representing the IBC as needed

The RO is the University delegate with the legal authority and responsibility to oversee the possession,   use, and transfer of select agents, or those infectious agents and toxins that are considered by the Department of health & Human Services (DHHS) or the United States Department of Agriculture (USDA) as having the potential to pose substantial harm or a severe threat to human, animal or plant health.

The RO is appointed by the DO, approved by the applicable federal agencies, and charged with the legal authority and responsibility to oversee the possession, use and transfer of select agents. The RO is responsible for the following:

  • Possessing a detailed knowledge of the Select Agent Regulations to the extent that he/she can ensure the University is compliant with all of the programmatic requirements.
  • Conducting annual inspections for each laboratory and all other registered areas where select agents are stored or used in order 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.
  • Conducting annual emergency preparedness, spill response, and/or security drills as required.
  • Having 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 the incident response plans.
  • Be granted sufficient authority to speak and act on behalf of the University

NOTE:  UTK-area campuses are not currently authorized to possess select agents or select toxins (over defined de minimis limits); therefore, an RO has not been assigned.

The IBC establishes, recommends, and approves policies ensuring the prudent management of biological hazards, including recombinant & synthetic nucleic acid molecules. Policy objectives are to protect faculty, staff, students, research subjects, the general public, and the environment from biological hazards used in university research, teaching, diagnostic testing, or other specified activities. The IBC is responsible for the following:

  • Establishing, communicating, and monitoring policy, practices, and procedures covering biological hazards which are in accordance with applicable regulatory standards and guidelines.
  • Reviewing biological hazard registrations to ensure compliance with regulations, guidelines, and adopted policies. Review will include an independent assessment of the risk(s), required safety practices, biological/physical containment and associated facilities, and training and expertise of affiliated personnel. The IBC will communicate registration review outcomes and necessary actions to the principal investigator or laboratory supervisor in a timely manner.
  • Regularly assessing safety practices and containment facilities to ensure they are appropriate for the proposed biological hazards and affiliated procedures. The IBC will use the biosafety levels published by the CDC, NIH, and USDA as the usual standards of containment to be set for work with a given biological agent. To the extent allowed by Federal law and regulation, the IBC may, at its discretion, increase or reduce the BSL depending on the circumstances presented by a specific project.
  • Investigating and recommending corrective actions for accidents, exposures, illnesses, environmental releases or other adverse events involving biological hazards. The NIH Office of Science Policy (OSP), CDC, USDA, or other regulatory or funding agencies will be notified if required.
  • Investigating and setting corrective actions for violations of policies, practices, or procedures. The IBC, at its discretion, may deny, suspend, or terminate approval for use of biological hazards if such use poses a risk to personnel or public health and safety, or for issues of noncompliance. If necessary, recommendations for additional disciplinary actions may be made to UTK administration. The NIH OSP, CDC, USDA, or other regulatory or funding agencies will be notified if required.
  • In conjunction with the BSO and/or Select Agents RO:
  • Reviewing and approving design specifications and certification criteria for high-containment laboratories (i.e., BSL-3).
  • Reviewing and approving policies and procedures related to select agents (or others categorized as Risk Group 3), including security/access, inventory management, laboratory protocols and emergency response plans.
  • Reviewing and assessing compliance with permit or license-related requirements for biological materials subject to USDA APHIS, FDA, and/or EPA regulations.
  • Consulting with the BSO on biological hazards used in teaching or diagnostic testing laboratories as necessary.
  • Establishing a framework for the identification, management and reporting of dual use research of concern as defined in the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern as applicable. In the event that dual use research of concern is identified, an IBC-selected panel will serve as the Institutional Review Entity (IRE) as described in the policy.
  • Performing other functions as delegated by UTK administration.

 

IBC Chair responsibilities include:

  • Setting meeting agendas and establish meeting dates.
  • Conducting meetings.
  • Prescreening submitted registrations as assigned.
  • Approving registrations.
  • Reviewing and approving amendments and updates as necessary.
  • Ensuring member training; this task may be designated to the

BSO or other qualified individual.

 

IBC Vice-Chair responsibilities include:

  • Substituting for the Chair as necessary.
  • Coordinating the periodic review and revision of the IBC Charter.
  • Prescreening submitted registrations as assigned.
  • Approving registrations, amendments, or updates in the absence of the Chair.

 

IBC member (including non-affiliated members) responsibilities include:

  • Completing biosafety regulatory awareness training (IBC training) before participating in voting activities of the committee; completing annual retraining covering IBC-related topics as necessary.
  • Attending monthly meetings; notifying the IBC Chair if attendance is not possible.
  • Prescreening submitted registrations as assigned.
  • Reviewing registrations and providing feedback to the IBC as necessary.

The BSO is the primary intermediary between the IBC and principal investigators (PIs) and/or laboratory supervisors. The BSO and staff (pictured below) are responsible for the following:

  • Managing the administrative tasks of the Biosafety Program and supporting implementation of IBC policies and procedures.
  • At the discretion of the IBC, establishing/implementing a framework for oversight of biological hazards and associated procedures in teaching and diagnostic testing labs.
  • Performing risk assessments, confirming NIH Guidelines review categories, and providing technical advice to the IBC, DO, RO, PIs, or other stakeholders as required or requested.
  • Performing annual inspections of facilities where biological hazards are being used or stored to ensure safety and containment measures as outlined in the NIH Guidelines, the BMBL, the OSHA BBP Standard, and/or other standards as applicable.
  • Reporting any significant problems, violations, or research, teaching, or diagnostic testing-related accidents or illnesses to the IBC, DO, RO, or other campus administrators as applicable.
  • Assisting PIs, laboratory supervisors, staff and students in conforming to applicable regulations, standards, guidelines and IBC policies by communicating expectations, providing training and technical advice, conducting facility inspections, and providing hands-on assistance as necessary (e.g., shipping biological materials).
  • Developing emergency plans for handling accidental spills and personnel contamination and investigating laboratory accidents involving biological hazards.
  • Developing and implementing an exposure control plan for those research and teaching programs handling human derived materials as stipulated by the OSHA BBP Standard.
  • Administratively reviewing proposals and protocols submitted by PIs and laboratory supervisors and making recommendations to the IBC Chair.
  • Screening protocols submitted to the IACUC for identification of occupational hazards; consulting with animal facility management, veterinarians and PIs regarding appropriate containment procedures for biological hazards. Employing a similar mechanism of review, assessment, and implementation for other UT compliance committees (e.g., human subjects research involving biological hazards submitted to the Institutional Review Board).
  • Preparing periodic reports for institutional management regarding IBC activities and Biosafety Program status.
  • Serving as an ex officio member of the IBC. If the university conducts research involving recombinant or synthetic nucleic acid molecules requiring BSL3 or BSL4 containment or engages in large-scale research or production involving viable organisms containing recombinant or synthetic nucleic acid molecules, then the BSO shall become a voting member of the IBC as per requirements of the NIH Guidelines.

The PI is defined as the faculty member or other University employee in whose assigned space research activity is conducted.  The PI is primarily responsible for the prudent management of biological hazards, the safety and health of laboratory staff, students and visitors, and full compliance with applicable regulatory standards, guidelines and policies/procedures. 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 is responsible for the following:

  • Creating and fostering 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.
  • Complying with all regulations, standards, guidelines and University policies involving handling, storage, disposal, inventory, security/access, and transportation of biological hazards.
  • Developing, implementing, and maintaining 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.
  • Delaying initiation of research involving biological hazards (including recombinant and synthetic nucleic acids) until the research protocol has been submitted to, reviewed, and approved by the IBC or BSO as required.
  • Maintaining an inventory of all biohazards used or stored in the laboratory. Logs should include species/strain-specific details, approximate quantity on hand, and where they are stored in the laboratory.
  • Restricting access to the laboratory and stored biological hazards to authorized personnel only.
  • Ensuring 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.
  • Adding staff, students, and visitors working on IBC-approved projects to the respective IBC registration(s). Regularly reviewing listed personnel and providing updates to the IBC or BSO as applicable.
  • Completing training as required by the IBC or any other oversight agency, ensuring that all staff, students, and visitors participating in biohazard-related activities have completed appropriate training, and maintaining documentation of training. The PI or designee must provide protocol-, agent- and laboratory-specific training. The PI should contact the BSO for assistance with all biosafety training needs.
  • Supervising the performance of the laboratory staff to ensure that required safety practices are employed. Work errors and conditions that may result in accidental releases or exposures are to be corrected immediately.
  • Providing and maintaining all personal protective equipment (PPE) designated 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.
  • Ensuring 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 segregating and decontaminating biohazardous wastes before final disposal. All laboratory faculty, staff, and students are to be familiar with the appropriate methods of waste disposal.
  • Coordinating with the BSO to develop emergency plans for accidental spills and exposures.
  • Immediately notifying the BSO of any laboratory spills, accidents, containment failure or violations of biosafety practice which result in the release of biological hazards and/or the exposure of laboratory personnel (or the public). The IBC may be consulted by the BSO as necessary.
  • Informing affected personnel of signs/symptoms that may result from accidental exposures and ensuring that they are informed of and receive medical surveillance or occupational health reviews as necessary.
  • Notifying the BSO immediately if a laboratory-acquired infection is known or suspected, or if a spill of any quantity involving an agent infectious to humans, plants, or animals occurs in a public area.
  • Complying with shipping and permit regulations for biological hazards. The BSO conducts shipping training for affected PIs and personnel as necessary. 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.
  • Immediately notifying the BSO if 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.

Note:  The Principal Investigator is the linLab-Specific Biosafety Manualin for biosafety in the laboratories.  The effectiveness of the information contained in this Biosafety Manual is dependent upon strong laboratory leadership that embraces a culture of safety in the lab. 

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

  • Complying with all regulations, standards, guidelines and University policies involving handling, storage, disposal, inventory, security/access, and transportation of biological hazards.
  • Registering biological hazards with the IBC or BSO (as designated).
  • Completing training, and ensuring that all teaching or diagnostic 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, communicating to teaching or diagnostic testing staff and students/trainees the signs and symptoms which may result from accidental exposures to the biological hazards in use.
  • Stipulating the safety precautions to be followed by teaching or diagnostic testing staff, students, and trainees and ensuring that these are followed. Work errors and conditions that may result in accidental releases or exposures are to be corrected immediately.
  • Determining the proper PPE to be worn for designated procedures. The laboratory supervisor (or designate) shall ensure that PPE is worn as directed and cleaned/replaced as appropriate.
  • Immediately notifying the BSO of any laboratory spills, accidents, containment failures, or violations of biosafety practice which result in the release of biological hazards and/or the exposure of laboratory personnel or students/trainees. The IBC may be consulted by the BSO if necessary.
  • Notifying the BSO immediately if a laboratory-acquired infection is known or suspected, or if a spill of any quantity involving an agent infectious to humans, plants, or animals occurs in a public area.

The Department Head is responsible for the following:

  • Reviewing and approving IBC registrations submitted by the departmental faculty members
  • Verifying that appropriate facilities are available to control biological hazards
  • Verifying that the PI or teaching lab supervisor has competency commensurate with the proposed project and/or assigned laboratory course(s)
  • Ensuring that any reported safety deficiencies or compliance concerns/violations are corrected by the PI or teaching supervisor in a timely fashion
  • Notifying the BSO or new faculty hires, preferably before the new PI arrives on campus, if he/she plans to work with biological hazards
  • Notifying the BSO/IBC if a PI can no longer carry out his/her responsibilities (e.g. leaves the University, retires, etc.). If this is the case, the Department Head must select one of the following actions within 30 days of the PI’s departure:
  1. Assume responsibility for PI’s registration(s) and manage it/them under his/her own program.  This        change in proprietorship must be reported to the BSO/IBC, and the Department                 Head must comply with all IBC provisions; or
  2. Assign the registration(s) to another investigator.  This change in proprietorship must be                 reported to the BSO/IBC, and the designated PI must comply with all IBC provisions; or
  3. Terminate the registration
  • Ensuring that the PI and/or designated staff follow laboratory close-out procedures (see EHS LS-003 Guide), including the appropriate disposal of biological hazards and disinfection of affected surfaces and equipment.

Laboratory personnel (staff, students, volunteers) are responsible for the following:

  • Notify your Principal Investigator of health status changes (i.e., pregnancy, immunocompromised state, etc.) that could impact risk for working with specific agents/specific protocols in the lab.
  • Participating in biosafety orientation and training programs offered by the University.
  • Becoming familiar with lab-specific biological hazards.
  • Abiding by all biosafety precautions that are relevant to the assigned duties.
  • Using prescribed personal protective equipment directed by the supervisor and in accordance with proper biosafety precautions.
  • Exercising good judgment and ask questions regarding lab practices where you question the level of risk.
  • Looking out for the safety of others in the lab and lab facilities.
  • Reporting any observed unsafe conditions and unsafe practices to the University administration.
  • Maintaining a positive attitude toward safety that promotes safe working behavior.
  • Exercising their right to disclose research misconduct.
  • Providing information regarding changes to health status that could impact their health and safety in the research environment.