Filling out the BUA Form

This guide will help you fill out your BUA Application to begin the process of obtaining your BUA (Biological Use Authorization). To see more about the process of obtaining your BUA, please see this article. 

Section I. Type of Experiments

Include here all the various items that are mentioned, if applicable, in subsections A - J. Below, an example of the first subsection. Please indicate with an X which items apply to your research.

Section II. Personnel

Who is in your company and will be involved in this work? Your company is responsible for all appropriate safety training for your employees. Bakar Labs provides a 2-hour safety training (which includes general biosafety training), the details of which can be found here. Tenants must supply bloodborne pathogens (BBP) training - there are modules that can be purchased online or through waste-management companies (e.g., Stericycle, Clean Harbors, Clean Earth, etc.) that often have extensive trainings available online. 

Important: Please notify Bakar Labs staff of the BBP (Bloodborne Pathogen) training dates for all employees who require it.

Section III. Location of Research Experiment

Indicate what rooms you will be working in and details surrounding the research. Note, you may need to write “TBD” for a room number if you have not yet confirmed your bench space. The other areas are shared spaces as indicated. We have indicated in this sample below the various cold storage options in shared spaces as well as the various shared user facilities at Bakar Labs.

Section IV. Biosafety Cabinet Information

If performing BSL-2 work, report on the Biosafety cabinets you will be using. If you will be using the shared Tissue Culture facilities at Bakar Labs, the information on the Biosafety cabinets can be found below. (This data can be copied and pasted from here directly into your BUA)

Section V-I. Safety Evaluation

Indicate the ways you will mitigate applicable hazards including the use of sharps and aerosols. Bakar Labs uses 70% ethanol and hydrogen peroxide spray for disinfection.

Section V-II. Other Risks

Use only the reference information below that applies to you. Note, critical information in the highlighted area.

Section VI. Scope of Work Narrative

This is where you explain your work at Bakar Labs. They will be particularly focused on your waste handling. Ask for help if needed. Dr. Olga Draper will be able to comment on this section.

Here is an example “Narrative” based on an academic lab that successfully passed through the BUA process:

Scope of Work Narrative including a mandatory description of spill clean-up procedures:

Narrative:

We aim to develop novel approaches to manufacture and implant therapeutic cell types derived from human pluripotent stem cells (hPSCs). All in vitro cell culture will be confined to approved BSL-2 facilities in Bakar Labs, and performed by personnel with specific training for handling of hPSCs within a functional biosafety cabinet for containment of aerosols. Specifically, we will perform the following experiments with hPSCS in the shared TC Rooms 116 & 502:

• Routine subculture and expansion

• Differentiation assays

  • Media optimization

  • Co-culture in/with engineered polymer systems

  • Scale-up to small bioreactor systems

• Characterization and functional assessment of hPSC-derived cell types

  • Action potential measurements

  • Myelination assays

  • Maturation assays

  • Magnetic Activated Cell Sorting (MACS)

  • Analytical procedures performed on fixed samples

    • Immunocytochemistry

    • Quantitative PCR

    • Flow cytometry in Room 505

    • Cell Sorting in Room 505 (housed inside Class II Biosafety Cabinet)

  • Cryopreservation of hPSCs and hPSC-derived cell types
    
    

Volumes of human cells used are very small, in the order of a milliliters of cells suspended within culture media using standard cell culture dishes, plates and flasks. Success of novel approaches will be assessed quantitatively using previously published quantities (cell production rate, cell survival, etc.) as benchmarks.

Sterilization and decontamination procedures for BSL-2 equipment in contact with human cells, marked by a biohazard sticker, will include wiping down solid surfaces with stabilized hydrogen peroxide solution followed by 70% ethanol. Personal protective equipment (PPE) consisting of nitrile/latex gloves, barrier or disposable lab coat, and safety glasses to be worn at all times within designated BSL2 laboratory space. Risks to personnel from aerosols generated from mixing, pipetting, centrifugation will be mitigated by conducting mixing and pipetting procedures in a biosafety cabinet and using lidded secondary containment when samples are temporarily removed from the biosafety cabinet for centrifugation or flow cytometry & cell sorting. 

BSL2 liquid waste will be inactivated by mixing with an equal volume of 10% bleach for at least 20 minutes before disposal down the laboratory sink with plenty of running water. Solid medical waste disposal will be collected as generated in California-compliant autoclavable red bags lining a leak-proof lidded container. Bags will be sealed with a leak-proof knot and transported in biohazard-labeled lidded secondary containment to waste collection room 202B and placed in the company-specific waste collection bin and picked up within 30 days by the company's contracted medical waste provider. Any sharps waste will, including needles and glass, will be collected in a separate biohazard-labeled sharps container, sealed and collected by the contracted medical waste provider when approaching 3/4 full or the 'maximum fill' line on the container.

BSL1 liquid waste, including recombinant nucleic acids, will be inactivated by mixing with an equal volume of 10% bleach for at least 20 minutes before disposal down the laboratory sink with plenty of running water.  Solid BSL1 waste will be collected as generated in white/opaque autoclavable bags lining a leak-proof lidded container. Bags will be transported to an autoclave for sterilization prior to disposal in regular landfill trash. Autoclave tape will be used to verify proper sterilization.

Any spills containing viable biological material or recombinant nucleic acids will be sterilized using the supplied biological spill kit - covering the spill with paper towels, applying from outside to inside an equal volume of freshly-made 10% bleach. After 20 minutes the paper towels will be gathered and disposed of in trash. Bakar Labs and the Biosafety Office will be notified within 4 working hours of the spill.

Section VII. Sign and Date

The individual who signs should also be present at the inspection. However, be sure that EVERYONE participating during the site inspection is familiar with the submitted BUA.

Attachment II, Section A. Recombinant DNA

Provide detailed information in this section. This information is required and kept confidential. All CLEB committee members and BSO officers are under confidentiality agreements. And the Bakar Lab Operations Staff is also in attendance on your behalf. Withholding sensitive information due to its proprietary nature will hinder your ability to receive BUA approval.

Note, this content covers:

II-A.1 Genes.

II-A.2 Viral vectors.

II-A.3 Vector descriptions.

II-A.4 Packaging cell lines for virus production.

Attachment II, Section B. Biohazardous Agents and Toxins

Describe all applicable materials in your work.

1. Bacteria.

2. Viruses.

3. Fungi.

4. Parasites.

5. Toxins.

6. Human-derived biologicals.

7. Other potentially infectious material.

Attachment II, Section G. Plants

This only applies to companies using plant materials.

Worksheets 1, 2, & 3:

These are guided ways to determine how your materials should be reported. There are

three worksheets including recombinant DNA, plant materials, and transmissible disease

pathogens.