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

Apply for a new Biohazard Use Authorization (BUA) and manage existing authorizations with UC's Biosafety Information Online (BIO) application.

Requirement for researchers

Principal investigators must obtain an approved BUA from the UC San Diego Institutional Biosafety Committee (IBC) before beginning research, clinical, or teaching activities with biohazardous materials.

An approved BUA will:

PIs are responsible for keeping their BUA current at all times.

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Review and approval process

IBC review

Comprehensive review by the IBC is made of all the biohazardous work proposed in any given laboratory.

All proposals presented from the laboratory of a faculty member who has responsibility for assigned space shall be treated as if they belong to that faculty member.

The combination of all work proposed by a laboratory group—regardless of the source of funding (or even lack of funding)—is subject to a comprehensive "umbrella" review. Therefore, for the purposes of the BUA review, a principal investigator* shall be the ultimate, single point of accountability and responsibility for a given laboratory.

* Principal investigator is defined as the faculty member in whose assigned space a research activity is conducted.

Related reseach authorizations

Other research authorizations for work with regulated materials or human or animal subjects at UCSD may be required.

Apply for a BUA

The BIO application

UC systemwide developed the Biosafety Information Online (BIO) application to provide a standardized and secure Web-based program for managing research, clinical, and teaching activities involving biohazardous materials.

Use the BIO application to apply for a new BUA (see "How to Apply for a BUA" below for instructions), and to amend or renew an active authorization.

Approval must be sought and obtained from EH&S and the IBC prior to the initiation of work involving any of the following (this list is not inclusive):

  • New infectious agents
  • New viruses, new vector systems
  • Enhanced replication or 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

Submission dates

BUA applications are reviewed at the IBC's monthly meeting. Apply well in advance of your intended project to allow time to obtain approval.

How to apply for a BUA


Step 1: First-time applicants

Two things must happen before you can access the BIO application to apply for a BUA:

  1. You must be entered in the Environment, Health & Safety (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.
  2. You must have a UCSD Business Systems (sometimes referred to as Single Sign-On) user name and password to access the BIO application.

Step 2: Apply for a BUA

  1. Go to My Research Safety* Web portal.
  2. Click the Authorizations tab and select Biosafety Information Online to open the BIO application.
  3. Follow instructions on the welcome screen to apply for a new BUA.

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

  • Type 1: Research BUA – for standard research

Renewal

BUAs must be renewed every 1, 3, or 5 years, depending on the risk. EH&S initiates the renewal process by sending the PI a renewal notice.

* The My Research Safety Web portal is operated and maintained by EH&S.

Amend a BUA

When to amend your BUA

The PI must notify EH&S and obtain IBC approval via the BUA amendment process before changing any variable which may carry increased biohazard risk. Notification and subsequent IBC approval is also required of the PI before any given COMBINATION of such variables may be changed.

As a working principle, PIs must decide if a new agent or protocol poses any new or increased hazards from those indicated in the currently approved proposal. If there are new or increased hazards (or if there is any doubt or question), approval must be sought prior to implementing the change.

Amendments require IBC approval before the new work can commence.

Use the BIO (Biosafety Information Online) application to amend your BUA.

How to amend your BUA:

  1. Go to My Research Safety.
  2. Click the Authorizations tab and select Biosafety Information Online to open the BIO application.
  3. Select your BUA from the My BUAs tab and press the Renew or Amend function button at the bottom of the screen to proceed.

    Note: Clinical trial BUAs (gene therapy) have special requirements. Contact EH&S Biosafety, (858) 534-6059 or 534-0353, for consultation and formatting instructions.

Update personnel or training anytime

Changes to personnel and their training dates can be done at any time in the BUA by the PI or PI Contact with editing ability. Do not create an amendment for this task!

Request a BUA verification letter

Funding agencies often require proof of approved BUA status. You must have a current BUA (approval granted within the last 11 months) to obtain a BUA verification letter.

How 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.

Deactivate a BUA

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

How to deactivate a BUA:

  • Request BUA deactivation by notifying EH&S Biosafety in writing, referencing the BUA number:

Clinical trial BUAs

Deactivations of clinical trial BUAs (gene therapy) have special requirements. Contact EH&S Biosafety, (858) 534-6059 or 534-0353, for consultation.

Related links:

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