Bakar Labs mini-guide to writing a successful BUA

All biological research at Bakar Labs is subject to review by the University’s biosafety committee. This mini-guide explains the application process for receiving a Biological Use Authorization (BUA) and provides tips to help you fill out the application. No biological work can begin until your BUA is approved and a site inspection is conducted. The BUA application is detailed, feedback for revision is intensive, and committee discussion is rigorous. The BUA application undergoes a multistep review before it is brought before the committee.

Please read this guide carefully and plan ahead for the month-long review process. 

You can also find a pdf with all the BUA information at this link.

Step 1. Complete the BUA form. 

A step-by-step guide to this form can be found here. The pointers and reference information apply to common situations such as the shared use of equipment. Note: if you have a private lab with additional equipment (biosafety cabinet, fridge, etc.) it will also need to be listed on the BUA form.

Step 1a. If planning to work with Stem Cells, obtain Stem Cell Research Oversight Commitee (SCRO) approval.

If you are not working with stem cells, ignore this step.

Step 2. Complete preliminary review with the biosafety committee liaison. Only if needed! 

If you want additional assistance, plan to attend Dr. Laura Flores' Drop-In BUA Help sessions, held on the last Tuesday of every month. These sessions also appear on the Events @ Bakar Labs calendar. She will answer questions you may have, and provide an informal review. We recommend you incorporate her feedback before formally submitting the application. 

In parallel you should be working with EHS to complete your MOU. Thom Opal (opal@berkeley.edu) manages all EHS MOUs 

Step 3. Formally submit the application in word format. 

Email it to bso@berkeley.edu and cc bakarlabsbua@berkeley.edu with the following subject: "Companyname_Lastname_BUAApplication_year_month" (This should also be the name of your file.)

You must submit your BUA by the first Monday of the month in order to get it reviewed at the next month's CLEB review meeting, on the first Monday of the following month.

Step 4. Respond to Reviewer's Feedback.

During this month-long interactive period, you will likely receive a number of reviewer questions. We recommend you follow the suggestions and clarify any parts as requested. It is imperative that you respond in a timely manner. This gives you the best chance of a timely and successful review.

Step 5. Formal committee review of your BUA.

The Committee for Laboratory and Environmental Biosafety (CLEB) will review your application. Members include UCB faculty, members of the local community and biosafety office staff. Most applications will receive provisional approval, provided the prompts from the reviewers have been adequately answered during the prior weeks. Following the meeting you will receive an email from biosafety staff, usually within a few working days.

-- You can pause at this point to make sure you are ready (with our help) for inspection --

This is the time to purchase items for your lab and get it set up for use. However, remember no biological materials may be purchased until the BUA process is complete.

Step 6. Schedule a pre-inspection.

Once you receive provisional approval, review the Site Inspection Mini-Guide (feel free to download and print out), and contact Lab Ops at Bakar Labs (bakarlabsbua@berkeley) about a pre-inspection walk through. During this step, you will be briefed on how to prepare your lab area(s) and your staff for the formal site inspection.

Step 7. Scheduling your site inspection.

Email bakarlabsbua@berkeley.edu to coordinate a time that works for you and the inspector. PLEASE DO NOT REACH OUT TO THE BSO OFFICE YOURSELF. Site inspections are generally completed within 5 working days of the date requested and should take no more than 1 hour. A member of the Bakar Labs staff will be present at your site inspection on your behalf.

Additional Planning Tips: 

You may move into Bakar Labs and set up your lab while your BUA is in process. Though setup work may be started, no biological samples may be brought onsite until a site inspection is completed, nor are you allowed to do any work with biological materials. Move-in date is not dependent on your BUA approval timeline.  

Additional safety review will be required when work with stem cells or nano materials is involved. Please consult with the Bakar Labs staff for more information.