Introduction

The University of Houston (UH) is a major scientific research center, as such, potentially bio-hazardous materials and/or known bio-hazardous agents may present on the campus. In order to ensure the safety of the UH community as well as allow researchers to continue their scientific pursuits, the following protocol has been established. This protocol has been developed by the Environmental Health and Risk Management Department (EHRM) and the Office of Research to satisfy both the needs of the University in maintaining a safe research environment for the UH community as well as the compliance requirements of applicable National Institutes of Health (NIH) and Centers for Disease Control (CDC) regulations. NIH has specific regulations concerning recombinant DNA research and the CDC has specific regulations for laboratories that use specified etiologic agents that are known as “Select Agents”. The goal of this protocol is to assist UH researchers in maintaining compliance with all applicable regulations in the most efficient manner possible.

Etiologic agents are those microorganisms and microbial toxins that cause disease in humans and include bacteria, bacterial toxins, viruses, fungi, rickettsiae, protozoans, and parasites. These disease-causing microorganisms may also be referred to as infectious agents. Arthropods and other organisms that transmit pathogens to animals (including humans) are called vectors. Etiologic agents, vectors, and materials containing etiologic agents (such as unsterilized specimens of human and animal tissues containing blood, body discharges, fluids, excretions, cell cultures or similar) are recognized as bio-hazardous materials.

The UH Institutional Biosafety Committee (IBC) has been charged with the responsibility of reviewing and approving research that involves any etiologic agent or use of recombinant DNA molecules in campus laboratories. Researchers who wish to work with recombinant DNA or any etiologic agent must secure approval from the UH Biosafety Committee prior to the commencement of research activities. This protocol does not include the use of animals. The UH Animal Care Committee is the first step for animal projects and that committee will contact the Biosafety Committee if additional review is required.

Memorandum of Understanding and Agreement

The Memorandum of Understanding and Agreement (MUA) for research involving recombinant DNA or research involving bio-hazardous materials is the standard format used by the University to review and approve research on campus. All researchers working with recombinant DNA, human cell lines/tissues, and/or bio-hazardous materials on campus must have an MUA approved by the Institutional Biosafety Committee and available for audit by UH or regulatory agency personnel.

Upon review by the Biosafety Committee the researcher will be notified of the outcome. The committee has 4 options for review of MUAs. These options are as follows:

• Approved (no further information and/or action required by researcher)
• Conditionally Approved (further information and/or action still needed)
• Tabled (pending further action specified by committee)
• Disapproved (additional information and/or action required as specified).

Select Agent Requirements

In addition to recombinant DNA research that may produce or encode for a factor associated with a disease, the CDC also regulates a list of biological agents that are known as Select Agents. These agents are either viral in nature (i.e. capable of causing epidemics) or toxic in nature (capable of being refined for biological weapons). Appendix C contains a list of these Select Agents.

Researchers involved in the use of Select Agents will be directed by the UH Biosafety Committee to complete a CDC Select Agent application for the respective laboratory. Upon review the CDC may impose additional requirements to individual laboratories that use Select Agents. UH researchers are expected to follow the requirements of the CDC in order for the University to keep its registration certification. Failure to follow CDC requirements jeopardizes not only the individual laboratory but also the university as a whole.

As part of the Select Agent Laboratory Registration program, researchers must track the quantity and type of Select Agent used in their respective laboratories from the introduction of the Select Agent to its disposal or deactivation. In order to meet these requirements, EHRM will act as a receiving and transfer point for all Select Agents used on the campus. Researchers who have completed the MUA process and the Select Agent Laboratory Registration process will be allowed to order Select Agent for use in their laboratory.