Biosafety

I. Policy Statement:  Purpose and Scope

This policy establishes the framework of control practices for the safe handling of biological materials and the appropriate assessment of potential risks in UNC Charlotte research and academic programs. Biological materials include biohazardous agents, recombinant or synthetic nucleic acid molecules, and human tissue or materials that may cause disease or injury to other living organisms or cause significant impact to the environment or community.  Control practices are based on the applicable regulatory requirements or current safety guidelines, including:

• National Institutes of Health (NIH): NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
• Centers for Disease Control and Prevention (CDC): Biosafety in Microbiological and Biomedical Laboratories (BMBL)
• United States Select Agent and Toxin Regulations
• OSHA Bloodborne Pathogen Standard
• United States Department of Agriculture (USDA): Animal and Plant Health Inspection Service (APHIS) Policies (including import and export of biologicals)
• North Carolina Department of Natural Resources regulations regarding medical waste handling.

The purpose of the Biosafety Policy is to ensure protection of all faculty, staff, and students who generate, store, process, and dispose of potentially hazardous biological materials at UNC Charlotte, as well as others who may become exposed to biological hazards within the University environment.

The scope of this policy governs the review and conduct of all research and instructional activities involving potentially hazardous biological materials conducted: a) in facilities or on property owned, leased or operated by UNC Charlotte regardless of funding source; b) through the complete or partial sponsorship of UNC Charlotte; c) by faculty, researchers, staff, students, and employees.

A. Background

Any work with hazardous biological materials can pose health risks to persons handling or near the materials or to the environment where such materials are being handled or stored, should the materials escape the containment procedures established for the laboratory. This policy, therefore, sets forth the University’s responsibilities to ensure the safe handling of these materials, the appropriate assessment of potential risks, and the reduction of potential personnel exposure or accidental environmental release.

Furthermore, as a recipient of National Institutes of Health (NIH) research funding, UNC Charlotte must ensure that all research involving recombinant or synthetic nucleic acid molecules, including research involving genetically modified plants and animals and human gene transfer research, conducted at or sponsored by the University, irrespective of the source of funding, is in compliance with NIH Guidelines. 

B.   Policy

UNC Charlotte is committed to planning and implementing control practices for the safe handling of biological materials in its facilities and to protecting the surrounding community and environment. This policy is implemented through the UNC Charlotte Biosafety Manual and the UNC Charlotte Institutional Biosafety Committee (IBC). The Biosafety Manual sets forth practices and procedures to ensure that the University operates its facilities in compliance with all applicable biosafety regulations and good laboratory practices.

The IBC will establish training requirements for all faculty, staff and students involved in the use of biological materials and research.  The IBC will also establish procedures for the registration and review of biological materials and the use of recombinant or synthetic nucleic acid molecules.  Researchers who plan to use or distribute biological materials such as biohazardous agents, human-sourced materials or recombinant or synthetic nucleic acid molecules are responsible for knowledge of and compliance with this policy, the Biosafety Manual and IBC procedures.

Academic and research areas that use hazardous biological agents or recombinant or synthetic nucleic acid molecules must comply with all aspects of the UNC Charlotte Biosafety Program, this Policy, and the Biosafety Manual.

Risk Group 4 (RG4) agents are agents likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.  Risk Group 4 (RG4) agents are prohibited at UNC Charlotte.

II.   Procedures

A. Institutional Biosafety Committee

The UNC Charlotte Institutional Biosafety Committee (IBC) is appointed by the Vice Chancellor for Research. Committee members serve in staggered terms not to exceed three (3) years per term, with no limit on the number of terms one can serve.

The Committee consists of at least five (5) members selected so that they collectively have (1) experience and expertise in biological materials and recombinant or synthetic nucleic acid molecule technology, (2) the capability to assess safe practices for the use of such agents, and (3) the ability to identify any potential risk to public health or the environment. Consideration for Committee appointments is also given to faculty in departments where work or research is being done with biohazardous agents and recombinant or synthetic nucleic acid technology.

The UNC Charlotte IBC must include a minimum of two (2) members who are not otherwise affiliated with the University and who represent the interest of the surrounding community with respect to health and protection of the environment.

The Committee may also include the following in voting or non-voting ex officio capacities:  University Biosafety Officer (BSO), University Attending Veterinarian, Environmental Health and Safety Office representative, Director of Laboratory Animal Resources and an occupational healthcare professional, as well as personnel designated from the Office of Research Compliance.

B. Exceptions

Exceptions to this policy may be granted by the Vice Chancellor for Research on a case-by-case basis based on unusual circumstances. Such exceptions must be requested in advance in writing from the Vice Chancellor for Research and provided to the responsible department head in writing prior to the implementation of the approved procedures.

C. Compliance

Failure to abide with this policy shall be considered a violation of University Policy in accordance with University Policy 801, Violation of University Policy.

III. Roles and Responsibilities

A.  Institutional Biosafety Committee

1. The IBC establishes guidelines and procedures for the registration of recombinant or synthetic nucleic acid molecule research and all biohazard work regardless of Risk Group or recommended biosafety containment level.
2. The IBC reviews, approves, and oversees:
   1. Recombinant or synthetic nucleic acid molecule research conducted at or sponsored by the University in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
   2. The use of Risk Group 2 (RG2) agents.
3. The IBC shall review, approve (prior to use), and oversee:
   1. The use of Risk Group 3 (RG3) agents.
   2. The procurement and use of Select Agents as defined by the Centers for Disease Control and Prevention and listed in the National Select Agent Registry.
4. The IBC shall review and approve experiments involving the use of hazardous biological agents in plants, animals, or human subjects.  NOTE:  The Vice Chancellor for Research may appoint additional members to the IBC as necessary to ensure that the membership is constituted in accordance with the NIH Guidelines.
5. The IBC may authorize the BSO to coordinate the review and investigation of noncompliance or biosafety accidents as needed.

B. Biosafety Officer (BSO)

1. The University Biosafety Officer (BSO) assists the IBC and the University research community in meeting the compliance requirements of this policy and NIH Guidelines.
2. The BSO advises the IBC, faculty, and staff regarding biohazards and risk control practices.
3. The BSO is tasked with duties such as reviewing proposed work using biological materials, performing laboratory assessments as required by the NIH Guidelines, conducting research and teaching laboratory inspections, assisting researchers and the IBC with the development of policies and emergency procedures, serving as a voting member of the IBC, coordinating biosafety training, overseeing shipping training and transport practices for biological materials, and other duties as required.
4. The BSO shall track and inform the IBC about all review activities, protocol submissions, approvals, amendments, renewals, and the use and location(s) of Risk Group 1 (RG1) biohazardous materials, as well as any work with human-sourced materials.
5. The BSO periodically reviews the Biosafety Manual and recommends revisions to the IBC.
6. The BSO has independent authority to curtail or stop any UNC Charlotte campus activity or operation related to the use of biohazardous materials that constitutes an imminent danger to health and safety of the University community.

C. Investigators

1. Investigators must register all biological materials with the Office of Research Compliance for initial IBC review and appropriate assessment of potential risks.
2. In registering, investigators will certify that protocols and facilities do not jeopardize the health and well-being of themselves, their employees, students, or the general public, and that all personnel working in BSL-2 and BSL-3 laboratories are familiar with, trained on and will follow the Biosafety Manual and its Appendices and Laboratory Standard Operating Procedures.
3. Investigators planning to use recombinant or synthetic nucleic acid molecules must notify the Office of Research Compliance and report the classification of the research as specified by NIH Guidelines. If the reported classification requires review under NIH Guidelines, the Institutional Biosafety Committee will conduct such review and issue approval as warranted.
4. Investigators shall neither possess nor permit the University and its employees, volunteers, researchers and students to possess on their behalf any biological agents, toxins, or delivery systems not reasonably justified by prophylactic, protective, bona fide research, or other peaceful purposes.

D. Office of Research Compliance

1. The Office of Research Compliance (ORC) provides administrative support to the IBC, maintains the University Biosafety Manual, manages all registration and reporting processes, maintains appropriate records, and serves as liaison with the occupational health medical surveillance provider, the University Environmental Health and Safety Office, and NIH in the ongoing implementation of the University’s biosafety program.
2. The ORC and the IBC will establish and publish procedures for the implementation of this policy. These procedures will be reviewed/updated annually and will comply with the most current regulations published by federal, state, and local agencies. 
3. The ORC tracks completions of IBC-required training as well as completion of OSHA Bloodborne Pathogen training in conjunction with Environmental Health and Safety.

IV. Policy Implementation

The Vice Chancellor for Research is responsible for overseeing the implementation of this policy and delegation of responsibilities for submitting reports to NIH in compliance with federal regulations regarding recombinant and synthetic nucleic acid molecules and other programmatic aspects.