Guide to Amending your Biological Use Authorization (BUA)

Note: this guide covers how to amend you BUA for location and method changes. If you still need to complete your original BUA, please see this article.

This mini guide explains the process for amending a Biological Use Authorization. You must amend the BUA whenever there are changes in lab location, your PI and/or CEO changes, or whenever there are changes in your experimental protocol. An amendment that is for modification of the experimental items (e.g., cell lines added, new plasmid, etc.) to the BUA may or may not result in the need for another inspection, to be determined by the biosafety officer once they review the amendment.

*Note: for personnel ONLY changes there is no need to submit an amendment as of Dec 2022. Simply update Bakar Labs staff of the new personnel by email bakarlabsbua@berkeley.edu. Provide BBP (blood-borne pathogens) training dates and certificates of completion.

BUA Amendments are separated into three types:

Location: The Location change amendment is for administrative changes and uses a simple notification form. This does not typically require inspection. However, it may require an inspection to make sure the new space and set-up can support the same level of containment and that the previous workspace-specific safeguards are met (or no longer needed). The latter situation is usually the result of moving experiments/processes from the Bakar Labs shared TC rooms into a private lab.

Experimental: The Experimental change amendment follows the BUA application process, requiring CLEB and/or Biosafety Office review with submission deadlines sometimes followed by inspections.
New Biological Agents: Inform bso@berkeley.edu and bakarlabsbua@berkeley.edu of the new agents you intend to use. BSO will determine if the BUA is broad-enough to cover the new agents, or if a full amendment is needed. If an amendment is required, BSO will determine if the amendment can be expedited via internal review.

Step 1. Select the form that you need to complete. 

Below is a table showing which form you need in what situation and the timeline for approval. If you are unsure which form to use, you can consult with Bakar Labs Staff (bakarlabsbua@berkeley.edu) to determine the right form to use.

Step 2. Use the step-by-step guide to complete each form.

The pointers and reference information apply to common situations.

Step 3. Complete preliminary review with the biosafety committee liaison or Bakar Labs Staff. 

For Experimental change amendment plan to attend one of Dr. Laura Flores' Drop-In BUA Help sessions, held on the last Tuesday of every month (also found 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. 

For Location change amendment very little to no review will be required, but you are welcome to consult with Bakar Labs Staff (bakarlabsbua@berkeley.edu) if necessary.

Step 4. Formally submit the amendment.

Email it to bso@berkeley.edu and cc bakarlabsbua@berkeley.edu with the following subject:

"Companyname_Lastname_xxxamendment_year_month" (This should also be your file name)

For the Location change amendment, you are done, just wait for a confirmation from biosafety acknowledging the amendment. Turnaround time is generally less than 5 working days.

For the Experimental Change Amendment, you must submit it before a deadline for CLEB review, but note that there is about a month between deadlines and CLEB review meetings. During that time you will go through revisions with biosafety office staff. The deadline for submission is the FIRST Monday of each month. This ensures your experimental change amendment will be reviewed one month later at the CLEB meeting, on the first Tuesday of the following month.

Step 5. (Only for Experimental Change Amendment) Respond to reviewers’ comments.

During this month-long interactive period, you will likely receive several 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 6. (Only for Experimental Change Amendment) Receive notification of your BUA amendment review.

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.

Step 7. (Only for Experimental Change Amendment) Schedule your site inspection *if it is requested by the BSO*.

Bakar Labs staff will coordinate a time that works with you and your inspector. 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.

Additional Planning Tips:

You may continue your original work while the BUA amendment is in process. Though setup work may be started, no new biological samples may be brought onsite until a site inspection is completed. Move-in date is not related to BUA amendment approval.

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.