Program: Biosafety

Back to main biosafety page

Program Lead: Bob Hashimoto
Phone: (510) 643-6562
E-mail: bobhash@berkeley.edu

Alternate: Krystyna Kozakiewicz
Phone: (510) 643-1397
E-mail: krystyna.kozakiewicz@berkeley.edu

Biological Use Authorization (BUA)

1. Definition:
A Biological Use Authorization (BUA) is a master document identifying the research involving recombinant DNA or infectious or pathogenic biological agents (human, animal, or plant) carried out by a Principal Investigator (PI) at UC Berkeley.

2. BUA is required for:

• Research involving recombinant DNA/RNA as specified in the NIH Guidelines for Research Involving Recombinant DNA Molecules, regardless of the Biosafety Level (BSL) containment requirement for any component or product.
• Research involving infectious (human, animal, or plant, Risk Group 1-3), pathogenic, or toxin-producing agents that require BSL 2 or 3 containment as specified in the NIH publication “Biosafety in Microbiological and Biomedical Laboratories” (BMBL). This includes all manipulations of any of these agents in a research context as well as culture, isolation, detection, possession, storage, transportation, and shipment of the agents.
• Post-doctoral fellows and visiting scholars who plan to work with biohazardous agents must submit proposals as amendments to the supervising investigator’s BUA.

3. Specific projects requiring the BUA approval:

• Any gene transfer into a host other than E. coli K-12 (or its derivatives), Saccharomyces cerevisiae, S. uvarum, Bacillus subtilis or B. licheniformis
• Transfer of genes that encode toxins or toxin production factors, certain other hazardous genetic factors, or more than two-thirds of the single-strand genome of any infectious agent into any host
• Gene transfer involving viral or bacterial vectors or self-assembling or synthetic agents such as “nanoparticles” into any host
• Research involving RNA interference vectors or other RNA interference systems
• Large scale (usually ›10 liter) production of vectors or host agents, including “exempt” agents such as E. coli K-12
• Production of transgenic plants or animals, including commissioned production of incipient transgenic lines
• Human gene therapy trials (Human gene therapy trials also require UC Berkeley Institutional Review Board and NIH Recombinant DNA Advisory Committee approval)
• The use of human blood, human clinical specimens, and human cell lines
• Research involving genetically modified stem cells

4. BUA Submission
The BUA application has to be fully completed and signed by the PI in order to be reviewed at the Committee on Laboratory and Environmental Biosafety (CLEB) convened meeting. Electronic submissions are required and electronic signatures are approved. In order to be reviewed at a CLEB convened meeting, the BUA applications are due at EH&S 10 calendar days prior to the CLEB convened meeting.

5. BUA approval:

• CLEB’s review of the experimental procedures, determination of the appropriate biosafety level and final approval are based on the “Scope of Work” narrative attached to the BUA application and information provided in the completed BUA application.
• All provisos noted by the committee must be adjudicated before final approval is granted.

6. BUA duration
Unless noted on the approval, Biological Use Authorization is valid for three (3) years. All amendments to the existing Biological Use Authorization expire on the date of expiration of the amended BUA.

7. Termination of a BUA
When the research project is complete or is no longer active, please notify UC Berkeley Biosafety Officer by email at bobhash@berkeley.edu. Your BUA will be officially terminated upon notification at the next CLEB meeting and in most circumstances you will be required to transfer or destroy and dispose any remaining biohazardous materials from that project in your possession.

Forms (Word documents to download)
CLEB BUA Application Form
CLEB BUA Amendment

Training
All personnel listed on a BUA must complete the EH&S training course “Introduction to Biosafety” before they start experimental work and a refresher course every two years thereafter. Personnel can enroll on the Learning Center available at https://blu.berkeley.edu.

Back to main biosafety page