Biological Safety

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.

Labs

If you are in need of a Biological Use Authorization (BUA), please initiate the BUA process by contacting bso@berkeley.edu. 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 bso@berkeley.edu for clarification.

Industry-affiliated Research Groups

Complete a BUA Application Form (Word) and send it to bso@berkeley.edu for review by the biosafety team or at the monthly CLEB meeting. Please note submission deadlines

Labs

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 bso@berkeley.edu for review by the biosafety team or at the monthly CLEB meeting. Please note submission deadlines

Personnel

To make personnel changes to your BUA:

1. Log into the Risks and Safety Solution Website

2. Navigate to your BUA

3. Click on the Personnel section to add or delete personnel. Important: DO NOT start a renewal, amendment or submit your draft for review at any point during this process.

4. To add personnel: 

1. Click on the blue circle with white plus sign

2. Search for them by name or email and choose them

3. Click on the Delegate role if you want to enable them to make changes to the BUA. Click Save.

4. Review and, if needed, update project role and the materials the person will work with. Click Save.

5. To remove personnel, click the red trash can

Track the training status of personnel on Labs @ Berkeley (L@B). Until training is complete, a user is not approved to work on the research described in the BUA and should not handle biological materials. For more information about BUA training requirements, visit the “Know what training I need?” section of the EH&S biosafety webpage.

Note: There may be an overnight delay for personnel or training status updates to be reflected on L@B.

Industry-affiliated Research Groups

Experiments, location or personnel

Complete a BUA amendment form and send it to bso@berkeley.edu for review by the biosafety team or at the monthly CLEB meeting. Please note submission deadlines.

All Researchers conducting work covered by a BUA must complete:

• An online training, EHS 201 Biosafety in Laboratories

• Note: an online refresher course EHS 204 Biosafety in Laboratories Refresher must be taken every subsequent 3 years

• A laboratory-specific training with a slide show presentation created and conducted by the Principal Investigator or their Designated Laboratory Safety Coordinator

• Download the Training for Research Group Members Template (Standard)

• Download the Training for Research Group Members Template (Recombinant DNA)

• A training attestation form for the research group
  • Download the Biosafety Comprehensive Training Documentation Form

If you work with human cell lines, human primary tissue, blood, or other potentially infectious material complete:

• EHS 202 Bloodborne Pathogens (BBP) Online Training

• Note: this must be taken annually

• Hepatitis B Declination Form

If you work with lentiviral or retroviral viruses or vectors complete:

• Access to University Health Services (UHS):
  • Lentivirus post-exposure control plan
  • Retroviral post-exposure control plan (to be posted)

• Access to Non-UHS medical services: 
  • Lentivirus post-exposure control plan
  • Retroviral post-exposure control plan (to be posted)

If you work with aerosol transmissible disease agents:

• EHS 211 Aerosol Transmissible Disease(s) (ATD) Online Training

• Note: this must be taken annually

• List of Aerosol Transmissible Pathogens

If you are also a Principal Investigator complete:

• EHS 203: PI Responsibilities

For additional information about the UC Learning Center, visit the EH&S Training page

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.

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.