POLICY STATEMENT #111
BIOSAFETY

I. Background

Research laboratories working with microorganisms and/or recombinant DNA technologies are special, often unique, work environments. The materials being used may pose special risks to persons working in or near the laboratory or to the environment should the material escape the containment procedures established for the laboratory. The University has therefore established this policy in order to ensure the safe handling of biohazardous agents, ensure the appropriate assessment of potential risks, and reduce the opportunity of personnel exposure or accidental environmental release.

II. Policy

UNC Charlotte is committed to the protection of the general environment and the planning and implementation of control practices for the prevention of laboratory-acquired infections in all research programs involving biohazardous agents. The University’s biosafety policy shall be implemented through a Biosafety Manual and two biosafety committees. The Manual provides specific procedures and recommended practices for the handling of biohazardous agents and recombinant DNA molecules. To ensure that the University operates its facilities in compliance with all applicable biosafety regulations and good laboratory practices, a Biosafety Committee will establish procedures for the registration of biohazardous agents and review the use of such agents, and an Institutional Biosafety Committee will review the use of recombinant DNA molecules. Researchers who plan to use biohazardous agents or recombinant DNA molecules are responsible for knowledge of the University’s procedures.

The Vice Chancellor for Research and Federal Relations has responsibility for overseeing the implementation of this policy and for submitting reports to NIH in compliance with federal regulations regarding recombinant DNA.

III. Biosafety Committee

The Biosafety Committee is appointed by the Vice Chancellor for Research and Federal Relations and periodically reviews the Biosafety Manual and recommends revisions to the Vice Chancellor for Research and Federal Relations. The Committee establishes guidelines and procedures for the registration of Biosafety Level (BSL)-2 or higher agents and reviews and approves the use of BSL-3 agents. (BSL-4 agents are not approved for use at UNC Charlotte.) The Committee must approve in advance the procurement and use of agents designated Select Agents [Attachment A]. The Committee consists of not fewer than five members so selected that they collectively have experience and expertise in biohazardous agents and recombinant DNA technology and the capability to assess safe practices for the use of such agents and to identify any potential risk to public health or the environment. The Committee shall include two faculty members from the Department of Biology, one faculty member from the Department of Chemistry, and the Director of the Environmental/Occupational Safety and Health Office, ex officio. The chair of the Committee will be appointed by the Vice Chancellor for Research and Federal Relations for a term not to exceed two years.

IV. Institutional Biosafety Committee

The Institutional Biosafety Committee is responsible for the review, approval, and oversight of recombinant DNA research conducted at or sponsored by the University in accordance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). The Committee shall consist of the members of the Biosafety Committee and two additional members appointed by the Vice Chancellor for Research and Federal Relations 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 Chair of the Biosafety Committee also serves as Chair of the Institutional Biosafety Committee. When the Committee reviews experiments involving plants, animals, or human subjects, the Vice Chancellor for Research and Federal Relations will appoint additional members as necessary to ensure that the membership is constituted in accordance with the NIH Guidelines.

V. Investigator Responsibility

Investigators who have in their possession agents designated BSL-2 or -3 must register such agents with the Biosafety Committee. The Biosafety Committee must approve in advance the use of BSL-3 agents and the procurement and use of agents designated Select Agents [Attachment A]. The Biosafety Committee will not monitor BSL-1 agents, and UNC Charlotte does not permit research with BSL-4 agents. In registering, investigators will document 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 laboratories in which BSL-2 or -3 agents are handled are familiar with the Biosafety Manual and are appropriately trained.

Investigators using recombinant DNA (rDNA) molecules must notify the Office of Research Services, reporting the classification of the rDNA 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.

Investigators shall not possess nor permit the University 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.

VI. Office of Research Services

The Office of Research Services provides administrative support to the Biosafety Committee and the Institutional Biosafety Committee, maintains the University Biosafety Manual, manages all registration and reporting processes, maintains appropriate records, and serves as liaison with the University Brocker Health Center, the University Environmental/Occupational Safety and Health Office, and NIH in the ongoing implementation of the University’s biosafety program. The Office of Research Services and the Biosafety Committee will establish and publish procedures for the implementation of this policy. These procedures will be consistent continuously with regulations published by federal, state, and local agencies.