Biological Safety

BUA Submittal

Email the unsigned BUA form in MS Word format to the biosafety officer at

Please wait to send signature pages electronically or by campus mail until the BUA has been finalized and you have received the letter of approval.

Campus mail code: 5132
Campus phone: 805.893.8894

Biological Use Authorizations

Principal investigators must first obtain a Biological Use Authorization (BUA) from the Institutional Biosafety Committee (IBC) in order to conduct research with the following materials and/or strategies:

Click here for the NIH OBA list of experiments that are exempt from IBC oversight.


BUA Approval Process

The IBC meets on the second Wednesday of the month during the academic year, and during the summer as necessary. Agenda items are sent out one week before the IBC meets.
Submit BUA forms to the biosafety officer by the begining of each month for consideration at the next meeting.

Principal investigators are responsible for completing the BUA form and assessing the risks associated with the biological materials and experimental procedures. The biosafety officer reviews applications to ensure that the materials and procedures are described with enough detail for the IBC to prescribe or confirm containment measures. 

The biosafety officer follows up with the principal investigator (PI) by email with a summary of questions and recommendations from the IBC. Upon finalization of the BUA, the biosafety officer emails the PI with the final version of the BUA and a letter of approval.

Letters of approval contain the BUA title, tracking number, expiration date, biosafety level(s) of containment, applicable section(s) of the NIH Guidelines, training requirements, and any occupational health recommendations or requirements. Letters of approval are forwarded to the IACUC Coordinator for BUAs associated with an IACUC protocol.

BUAs are effective for 3 years from the date of the letter of approval.


Registering Work with Human Cell Lines

Human cell lines that are derived from apparently healthy donors and screened for a panel of the most common bloodborne pathogens are considered well characterized. Well characterized human cell lines are accompanied by a Certificate of Analysis from the vendor indicating that the cells have been screened and found to be negative for, at a minimum, hepatitis B virus, hepatitis C virus, and the human immunodeficiency virus. The Certificate of Analysis documents reduced concerns for the presence of bloodborne pathogens by ruling out the main pathogens that have been encountered in hospital settings. The panel of bloodborne pathogens is specific to the vendor and varies slightly.

Principal investigators register their work with well characterized human cell lines with the IBC via the biosafety officer using the standard BUA form. Use of such cell lines does not require IBC review or approval before work begins.

The California Department of Public Health does not designate well characterized human cell lines as medical waste.
• See California Health and Safety Code Sections 117600 – 118360, specifically, 117700 (a) and (b), for biological materials excluded as medical waste.

The Occupational Safety and Health Administration exempts well characterized cell lines from the Bloodborne Pathogens Standard.
• OSHA Standard Interpretation issued 1994:

For established tumor cell lines, human or NHP origin does not intrinsically make them medical waste unless there is information about contamination with pathogens or integration of non-defective pathogenic viral sequences.

Example cell line registration


Changes to Approved BUA Applications

Changes to the project, e.g., additional research personnel, biological materials, or facilities must be registered with the IBC. Changes or additions that increase the risk of the project are reviewed and approved by the IBC at the regular monthly meeting. Use MS Word Track Changes within the originally approved BUA to note amendments, and update the training roster and biosafety cabinet certification dates. 


Additional Oversight

Please note that you may also need approval from Institutional Committees that oversee the ethics of research with human subjects, animals subjects, and/or stem cells. These Committees are administered by Research Integrity within the Office of Research.