Environmental Health and Safety

1. What is a Biological Use Authorization (BUA)?

A BUA is a document prepared by the principal investigator to describe research involving biohazardous materials or recombinant DNA. A biohazardous material, as defined in the SDSU Biohazard Control Program Manual, is a material hazardous to humans, animals or plants as a result of its biological or infectious properties. A BUA is reviewed by the SDSU Institutional Biosafety Committee (IBC) and evaluated as per federal and state regulations, NIH and CDC Guidelines, and institutional requirements.

If the IBC approves the BUA, the principal investigator is given authorization to conduct research. Research that involve the use of human or animal subjects (including tissues) must also receive formal approval from the relevant Committee (Institutional Review Board or Institutional Animal Care and Use Committee) in advance of conducting research. Contact Graduate and Research Affairs, Division of Research Administration with questions related to the review process.

2. Who must apply for a BUA?

A Principal Investigator who currently has or plan to possess, store, work with or transport infectious agents, select agents and toxins, human or non-human primate materials, or recombinant DNA/ RNA must submit a BUA form for review and receive approval in advance of initiating the research.

The form can be found at the Environmental Health & Safety web site, Biosafety Training. For more information contact Millie Tran, SDSU Institutional Biosafety Officer, <mdizon@mail.sdsu.edu> or call 619-594-2865.

3. What are the Responsibilities and Qualifications of a Principal Investigator?

The Principal Investigator (PI) is responsible for full compliance with the federal and state regulations, NIH and CDC Guidelines, and institutional requirements for research involving biohazardous materials. The PI is also responsible for ensuring that the reporting requirements are fulfilled and will be held accountable for any reporting lapses. A full-time faculty or professional staff member with an advanced degree must agree to accept responsibility for the project and serve as the PI. Student researchers, residents, and postdoctoral fellows cannot be identified as principal investigators.

4. Where do I find the BUA form?

Access the BUA form (see Forms), instructions and other pertinent information by visiting the SDSU Biosafety Management Program Web site at Biosafety.

5. How Should I Complete the BUA?

All sections must be completed. If a section is not applicable, indicate N/A. Failure to answer each question thoroughly may delay the review process. Please submit all necessary supporting information. Appendices to the BUA serve as checklists to assist in completing the BUA; however, it is not necessary to submit the appendices, with the exception of Biosafety, if applicable.

6. What if I Need Assistance?

EH&S Biosafety provides information that may assist you in completing your application. Should you have questions completing the application, contact the Institutional Biosafety Officer (BSO), Millie Tran <mdizon@mail.sdsu.edu> or 619-594-2865.

7. How do I Submit the BUA Application?

Submit a signed hard copy of the completed application to the Institutional Biosafety Committee (IBC), AD-222, MC1643 and an electronic copy to <ibc@mail.sdsu.edu>. In addition, please forward a signed hard copy of the application to Division of Research Administration & Technology Services.

8. What is the outcome of a BUA Review?

The investigator may receive approval following IBC review and discussion. An approval is valid for three years from the date of review. If the IBC identifies revisions needed or concerns a conditional approval may be granted by the committee. Once the revisions and / or concerns have been addressed and reviewed by the Committee, a full approval will be granted.

9. What is a three-year renewal?

The BUA is approved for a period of three years. Three months prior to the end of your three-year cycle, you will need to submit a new BUA for review and approval in order to continue the project. The renewal form will be submitted electronically to <ibc@mail.sdsu.edu> with one hard copy sent to Division of Research Administration & Technology Services.

10. How do I modification an Existing BUA?

Any changes to an approved BUA must be reviewed and approved by the IBC. An amendment form is used by the Principal Investigator to initiate this review. However, major changes such as adding new infectious agents or modifying procedures may require a new application. For example, changing from a BSL 1 to a BSL 2 or 3 will require the submission of a new application and approval from the IBC, while the addition of labs or other spaces will involve a site review of the spaces to be added.

For assistance in determining if a new application is needed, contact the Institutional Biosafety Officer at <mdizon@mail.sdsu.edu> or 619-594-2865. New protocols and amendments are submitted to the IBC via Graduate and Research Affairs, Division of Research Administration. Send one electronic copy to <ibc@mail.sdsu.edu> and one hard copy to Division of Research Administration & Technology Services.

11. How do I terminate the BUA?

When the research project is complete or no longer active, please provide written notification to the to the IBC via Division of Research Administration & Technology Services.

12. How do I ensure my research is in compliance?

To be in compliance with Protocol 42CFR73, means that the Principle Investigator of any research project, whose study utilizes said agents or toxins listed in Appendix E of the BUA, must register his or her work with the Department of Environmental Health and Safety in addition to having a current BUA on file.