Principal investigators (PI) must obtain a Biohazard Use Authorization to use biohazard materials for research or teaching activities.

A Biohazard Use Authorization (BUA) describes all the work with biohazard materials to be conducted by a PI, establishes the biosafety containment conditions set by the Institutional Biosafety Committee (IBC) for the work, and authorizes the PI to conduct the work.

The term "biohazard materials" includes:

• Infectious organisms that can cause disease in humans or cause significant environmental or agricultural impact
• Human or primate tissues, fluids, cells, or cell cultures
• Animal tissues, fluids, cells, or cell cultures that have been exposed to infectious organisms
• Recombinant DNA in vitro, in vivo, and in clinical trials
• Transgenic plants or animals
• Human gene transfer clinical trial
• Releases of recombinant DNA to the environment
• Animals known to be reservoirs of zoonotic diseases
• Select Agents

To be eligible for a BUA, a PI must be a laboratory space owner as determined by the university.

Apply for a BUA:  Read How to Open, Amend, and Deactivate a Biohazard Use Authorization (BUA) for instructions on completing the initial BUA application, including requirements for applications involving human gene transfer clinical trials (gene therapy).

BUA renewal:  One year after initial approval, the BUA is subject to review, updating, and renewal. Environment, Health & Safety (EH&S) initiates the renewal process by sending the PI a renewal notice.

Amend your BUA prior to changing any research variable, or combination of variables, that may increase biohazard risk. IBC approval is required before beginning work involving any of the following examples (this list is not inclusive):

• New infectious agents
• New vector systems
• Enhanced infectivity
• Expression of toxins or oncogenes
• Work with human or primate cell lines
• Partial genomes increased to more than two-thirds of whole genome
• Changes in constructs or systems that result in significantly higher titres
• Changing work with non-human systems into work in human systems
• New or altered procedures that pose increased risk of aerosol or other type of exposure to biohazards
• Any recombinant DNA in vitro, in vivo, and in clinical trials

Deactivate a BUA when the PI retires, leaves UCSD, or no longer uses biohazard materials.

BUA verification letter: Various funding agencies require verification of Biohazard Use Authorization. If you already have a BUA, read How to Get a Biohazard Use Authorization (BUA) Verification Letter for instructions.

If you are a UCSD employee and have questions, contact EH&S Biosafety, (858) 534-5366.