Biosafety Committee - UTDPP1016

Policy Statement

The Institutional Biosafety and Chemical Safety Committee (IBCC) is a University-wide, Standing Committee appointed by the President not reporting to the Academic Senate of The University of Texas at Dallas.

The Committee operates under "NIH Guidelines for Research Involving Recombinant or Synthetic Nuclei Acid Molecules (NIH Guidelines) April 2016." Under these guidelines, the Committee is charged to perform the following duties:

1. Advise the University on policies with regard to recombinant DNA research.
2. Create and maintain in the Office of the Environmental Health and Safety Director a central reference file and library of catalogs, books, articles, newsletters, and other communications as a source of advice and reference regarding, for example, availability and quality of the safety equipment; availability and level of biological containment for various host-vector systems; suitable training of personnel; and data on the potential biohazards associated with certain recombinant DNAs.
3. Develop a safety and operations manual for any facility maintained by the University and used in support of recombinant DNA research.
4. Review and approve NIH applications for research support and annually thereafter, assure that facilities, procedures, practices, and the training and expertise of the personnel involved meet NIH Guidelines.
5. Report violations of the NIH Guidelines and significant research-related accidents or illnesses unless the Principal Investigator has reported such matters.
6. Perform all responsibilities required of an Institutional Biosafety Committee (IBC) under the NIH Guidelines as same may be amended from time to time. Should the Biosafety Committee's duties under the NIH Guidelines conflict with any duties outlined in this policy, then, the Guidelines will control.

Under the NIH Guidelines Section IV- B- 2, an institution's "responsibilities need not be restricted to recombinant or synthetic nucleic acid molecule research." Accordingly, the Committee also operates as the institutional chemical safety committee to develop policies for the acquisition, safe handling and storage of hazardous chemical materials that require oversight under local, State and Federal guidelines.

Taking both concerns together, researchers at UT Dallas using any of the following materials are requested to register their project with the IBCC.

• Recombinant DNA and related materials
• Human or non human primate tissue, blood or body fluids
• Select Agents or Biotoxins
• Infectious Agents
• Carcinogens
• Pathogens
• Toxic chemicals

The Committee will work with the Environmental Health and Safety to develop and approve a manual. The Committee will approve the procedures for maintaining a catalog of biohazardous and chemical materials and pathogenic agents. Similarly, procedures for the secure storing, working with, transport of and disposal of these materials and agents will be approved by the Committee.

Members of the Biosafety Committee must be sufficiently qualified through their experience, expertise, and diversity to ensure respect for its advice and counsel. Members must have expertise in recombinant DNA technology and the capacity to assess the safety of recombinant DNA research experiments and any potential risk to public health or the environment. Members must also have knowledge of chemical agents and any potential risk to public health or the environment.

The Committee shall be composed of no fewer than seven members appointed by the President with the advice of the Chair of the University Safety and Security Council and the Dean, School of Natural Sciences and Mathematics. At least two members (and not less than 20% of the membership of the Committee) shall not be affiliated with the University (apart from their membership on the IBC) and shall represent the interest of the surrounding community with respect to health and protection of the environment. The Vice President for Research or designee, the Environmental Health and Safety Director, and the Biosafety Officer serve as ex officio members. The term of office of the Committee members shall be for three years and members may be reappointed by the President for additional terms. The Chair of the Committee shall be appointed by the President for a two- year term in that office and shall be a member of the University Safety and Security Council. If for any reason a Committee member resigns, the President shall appoint another qualified individual to serve the remainder of the unexpired term. The Responsible University Official (RUO) for the Committee is the Vice President for Administration.

If needed, additional consultants, competent in the corresponding research area and familiar with Federal, State and Local regulations, may be called in by the Chair.

Cases to be reviewed by the Committee will be brought to the Committee's attention through the University Biosafety Officer or the Chair of the University Safety and Security Council. For all sponsored research, the check-off form will require that both the Principal Investigator and the Department Head certify that the proposed research does or does not involve recombinant DNA, or hazardous chemical agents and that they are aware of approved Biosafety Procedures. To provide for any non-sponsored research, a separate form will be sent annually, on or about January 1st, to the appropriate Department Heads requesting they certify that they are not (or are) aware of any non-sponsored research in their program that involves recombinant DNA and potential chemical or biohazards.

Upon request of a Committee member, the RUO, and/or the Chair of the University Safety and Security Council, the Committee Chair will convene the Committee with the Principal Investigator to further discuss a research proposal. If the Principal Investigator is also a Committee member, he/she will not function as a member in the Committee's deliberations. If the opinion of the Committee is equally divided, the Committee shall continue to meet until it gets a majority viewpoint. In the case of a disagreement of the Committee about the evaluation of the risk level, the minority opinion shall be forwarded to the President to be included in the letter (MUA) to NIH.

The Committee will produce an annual report that will be included as part of the annual report of the University Safety and Security Council.