Each campus or institute utilizing biologically hazardous materials anywhere will establish a written program for the safe use, transportation and disposal of these materials. Biologically hazardous materials include: microbiological agents that are infectious to humans, animals or plants, recombinant DNA molecules, toxins of biological origin, human-derived materials covered by the OSHA Bloodborne Pathogens Standard, potentially infectious animal tissues and fluids, and waste items contaminated with such materials.
The biological safety program of the University of Tennessee system shall comply with all existing state, federal and local codes, ordinances, laws and university policies relating to the transportation, use, generation, storage and disposal of whatever may be determined by those regulations to be biological hazards. The program shall be communicated and available to all departments and persons who may be in contact with these materials and/or subject to the requirements governing these materials.
The extent of the program at each campus or institute will be determined by the specific biohazards in use by that campus. At a minimum, the chancellor or vice president at each campus or institute that utilizes biologically hazardous materials will designate a biosafety compliance representative to ensure safety and compliance for the use of these materials.
The chancellor or vice president may establish an institutional biosafety committee and/or biological safety officer at each campus or institute, as appropriate for the types of activites identified, as required by the National Institute of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules.
If the campus or institute has select agents or toxins that require registration with Department of Health and Human Services (DHHS) or the United States Department of Agriculture (USDA), the chancellor or vice president must designate a responsible official as required by the Public Health Security and Bioterrorism Preparedness Response Act of 2002. This responsible official must have authority to ensure safety and compliance for the materials.
It is the responsibility of the applicable biosafety administrator (i.e., biosafety compliance representative, the biosafety officer, and/or the responsible official) to ensure compliance with applicable regulations and codes. It shall be the responsibility of all departments and colleges to comply with the program requirements at their respective campus or institute. The program will include an annual evaluation of the compliance and currency of the program.
In the event of any cited violation by federal, state, or local regulatory agencies, immediate notification and proposed remedy of the same shall be made to the applicable designated biosafety administrator for that campus or institute.
Biological safety program reviews will be part of the annual safety and health report.