Providing support, in the form of risk assessment, review, consultation and training, for research at UC Berkeley that involves the use of recombinant DNA, biohazardous materials and biological toxins.
How Do I:
Know if I need a Biological Use Authorization (BUA)?
Your Principal Investigator will need to submit a Biological Use Authorization (BUA) if you are working with biological agents including:
- Recombinant DNA
- Synthetic nucleic acids
- WHO Risk Group 2 or higher pathogens
- Biological toxins
- Material of human or non-human primate origin, including cell lines
To determine if the agent you plan to work with is considered Risk Group 2 or higher, please reference the ABSA website.
Get or renew a Biological Use Authorization (BUA)?
If you are in need of a Biological Use Authorization (BUA), please initiate the BUA process by contacting [email protected]. Only a Principal Investigator may request a BUA. Once the BUA has been established, please log in to RSS BUA to complete your application.
Please note the application deadlines.
The biosafety staff will review all protocols and request additional information and clarification prior to sending the application on for further committee review. The committee will review the protocol at the monthly CLEB meeting.
BUAs need to be renewed every three years. The biosafety team will reach out to you three months prior to the expiration date with instructions on how to renew your BUA.
If you have questions regarding the application, please email [email protected] for clarification.
Change my Biological Use Authorization (BUA)?
If you currently have a BUA, you can make changes to the following:
Experiments or location
If your BUA has been reviewed and approved in RSS BUA: Update your BUA in RSS BUA for review by the biosafety team or at the monthly CLEB meeting. Please note submission deadlines
If your BUA was last approved as a document (March 2024 or earlier): Complete a BUA amendment form and send it to [email protected] for review by the biosafety team or at the monthly CLEB meeting. Please note submission deadlines
Personnel
To add a member to your BUA:
- Navigate to Labs @ Berkeley
- Confirm that ALL users, including those to be added, are up-to-date on ALL required training. Until training is complete, a user is not approved to work on the research described in the BUA and should not handle biological materials. To see what training is required, see How Do I Know what training I need?
- Click Add new members and search for the member using Last Name, First Name
- Click the + icon to the left of their name, then press OK in the prompt
- Find their name on the roster, then press the Pencil and Paper icon under Role(s)
- Select the role that they will have from the dropdown menu
- Select the appropriate boxes based on the substances they will be working with
- Press Done
- Repeat steps 1-8 for each person you wish to add
To remove a member from your BUA, click the Trash Can icon to the left of their name, then press OK in the prompt.
Know what training I need?
All Researchers conducting work covered by a BUA must complete:
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An online training, EHS 201 Biosafety in Laboratories
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Note: an online refresher course EHS 204 Biosafety in Laboratories Refresher must be taken every subsequent 3 years
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A laboratory-specific training with a slide show presentation created and conducted by the Principal Investigator or their Designated Laboratory Safety Coordinator
- A training attestation form for the research group
If you work with human cell lines, human primary tissue, blood, or other potentially infectious material complete:
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Note: this must be taken annually
If you work with aerosol transmissible disease agents:
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EHS 211 Aerosol Transmissible Disease(s) (ATD) Online Training
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Note: this must be taken annually
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List of Aerosol Transmissible Pathogens
If you are also a Principal Investigator complete:
For additional information about the UC Learning Center, visit the EH&S Training page
Dispose of Biohazardous Waste?
Examples of biohazardous/medical waste include human and animal parts, human and primate cell lines, biosafety level II or level III agents/contaminated wastes, and waste produced during vaccine research.
Visit our Dispose of Waste page for more information.
Ship Biological or Medical Materials/Equipment?
Biological substances or medical materials shipping is regulated by domestic and international agencies. In order to comply with all applicable regulations, all biological material shipments from campus must be reviewed, authorized, and managed by EH&S.
For more information, visit the Shipping Research page.