Biosafety: Apply for and Manage a Biohazard Use Authorization (BUA)

Apply well in advance of your intended project to allow time to obtain BUA approval.

Step 1: First-time applicants

First-time applicants must be entered in EH&S' database to enable certain research safety authorizations and access EH&S online applications.

• Use the PI Information form to be entered into the EH&S database or to report information changes.

If you've already submitted a PI Information form, acknowledged by EH&S, proceed to Step 2.

Step 2: Apply for a BUA

1. Go to My Research Safety.
2. Click the Authorizations tab and select Biohazard Use Authorization to open the BUA Web application.
3. Follow instructions on the BUA welcome screen to apply for a new BUA.

Choose the appropriate type of BUA. Two types of BUA applications are offered:

• Research BUA – for standard research
• Clinical trial BUA – for human gene transfer (gene therapy)
  • Clinical trial applications have special requirements:
    • See the list of requirements (Word) (PDF).
    • Contact EH&S Biosafety, (858) 534-6059 or 534-0353, for detailed formatting and submission instructions.
    • Send the required material to EH&S Biosafety:
      E-mail: ehsbio@ucsd.edu (preferred method)
      Mail Code: 0091
      Fax: (858) 534-1510

Submission deadline: To ensure your BUA application is reviewed at the IBC's monthly meeting, submit your complete application no later than the 20th of the month.

Note: BUAs are subject to review, updating, and renewal 1 year after initial approval. Environment, Health & Safety (EH&S) initiates the renewal process by sending the PI a renewal notice.

Amend your currently approved BUA before changing any research variable, or combination of variables, that may carry an increased 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

To amend your BUA:

1. Go to My Research Safety.
2. Click the Authorizations tab and select Biohazard Use Authorization to open the BUA application.
3. Follow instructions on the BUA welcome screen to amend an active BUA.
   Note: Clinical trial BUAs (gene therapy) have special requirements. Contact EH&S Biosafety, (858) 534-6059 or 534-0353, for consultation and formatting instructions.

Submission deadline: To ensure your BUA application is reviewed at the IBC's monthly meeting, submit your complete application no later than the 20th of the month.

PIs and laboratory personnel often must provide funding agencies with proof of their approved BUA status.

To get a BUA verification letter:

• Print a BUA Verification Letter for Funding Agencies request form (Word) (PDF).
• Complete the form and have both the applicant and responsible PI sign it.
• Send the form to EH&S Biosafety:
  • Mail Code: 0091 (preferred method)
  • Fax: (858) 534-1510
• A verification letter signed by the UCSD Biosafety Officer will be sent to you according to instructions you provide on the request form.

  Important: EH&S needs at least 3 days to process the form.

  Note: You must have a current BUA (approval granted within the last 11 months) to obtain a BUA verification letter.

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

• Request BUA deactivation by notifying EH&S Biosafety in writing, referencing the BUA number:
  • E-mail: EH&S Biosafety
  • Mail Code: 0091
  • Fax: (858) 534-1510
• Deactivations of clinical trial BUAs (gene therapy) have special requirements.
  • Contact EH&S Biosafety, (858) 534-6059 or 534-0353, for consultation.
• See How to Close or Relocate a UCSD Laboratory if the lab is being closed.