EH&S: Biosafety Manual - Biological Use Authorization

A. REQUIREMENTS FOR REVIEW AND APPROVAL OF PROJECTS USING INFECTIOUS AGENTS AND/OR RECOMBINANT DNA

Classification and containment requirements for use of recombinant DNA (R-DNA) molecules can be found in the NIH publication NIH Guidelines for Research Involving Recombinant DNA Molecules are required for all projects involving R-DNA.

Biosafety Level 1 (BSL 1), Animal Biosafety Level 1 (ABSL 1) and NIH-Exempt Projects

The organisms in this level are defined as organisms that are not known to cause disease in healthy human adults. All projects involving infectious agents classified as BSL 1 must be reviewed and approved by the Biosafety Officer (BSO) and must follow the general guidelines specified for that level.

Projects involving R-DNA molecules that are classified NIH-exempt and BSL 1 require review and approval by the BSO.
Biosafety Level 2 (BSL 2) or 3 (BSL 3) and Animal Biosafety Level 2 (ABSL 2) or 3 (ABSL 3)

All projects involving infectious agents and/or R-DNA classified as BSL 2 or 3 must be reviewed and approved by the Institutional Biosafety Committee (IBC) and must follow the general guidelines specified for that level.

A BUA application may receive approval following IBC review and discussion. The committee may impose additional requirements when the BUA application is reviewed and approved. If the committee identifies concerns or revisions, the committee may grant a conditional approval. Once the revisions and/or concerns have been addressed and reviewed by the committee, a full approval will be granted. An approval is valid for three years from the date of review before it requires renewal. Any changes to an approved BUA application must be reviewed and approved by the IBC prior to implementation. The Principal Investigator (PI) will submit an amendment form to initiate this review. However, major changes such as adding new infectious agents or modifying procedures may require a new BUA application.

Approval from other compliance committees e.g., Institutional Animal Care and Use Committee (IACUC), Institutional Review Board (IRB), Radiation Safety Committee (RSC) relevant to the project must also be obtained before work commences.
Currently, no facilities at SDSU meet the minimum criteria for Biosafety Level 4 (BSL 4) or Animal Biosafety Level 4 (ABSL 4); therefore, this type of work is prohibited.

Investigators who create transgenic animals must complete a transgenic animal registration document (Appendix D of the BUA Application Form) and submit it to the Graduate and Research Affairs, Division of Research Administration, at <ibc@mail.sdsu.edu> for IBC approval prior to initiation of experimentation. In addition, IACUC requires that these protocols be approved by its committee prior to initiation of work.

Requirements for the safe and secure transportation, storage and possession of listed select agents and toxins can be found in the Code of Federal Regulations (42 CFR Part 73). BUA application forms

are required for select agents and toxins. Any PI whose research involves any of the select agents or toxins listed in Appendix E of the BUA application must register with CDC through EHS in addition to completing the BUA application. Contact EHS at 619-594-6778 or <mdizon@mail.sdsu.edu> for registration information.

D. REQUIREMENTS FOR SUBMISSION OF A NEW BIOLOGICAL USE AUTHORIZATION APPLICATION

PIs must decide if a new agent or procedure poses any new or increased hazards from those indicated in the currently approved protocol. If there are new or increased hazards (or if there is any doubt or question), a new BUA application

must be completed and an approval must be sought prior to implementing the change. Approval must be obtained from the IBC prior to the initiation of work involving any of the following:

Note: documents in Portable Document Format (PDF) require Adobe Acrobat Reader 5.0 or higher to view; download Adobe Acrobat Reader. Documents in Word format (DOC) require Microsoft Viewer, download word.


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	Environmental Health and Safety SDSU Biosafety Manual San Diego State University BIOHAZARD CONTROL PROGRAM Part II: Biological Use Authorization Application, Review and Approval Process PART II. A. REQUIREMENTS FOR REVIEW AND APPROVAL OF PROJECTS USING INFECTIOUS AGENTS AND/OR RECOMBINANT DNA PART II. B. REQUIREMENTS FOR REVIEW AND APPROVAL OF TRANSGENIC ANIMAL PROJECTS PART II. C. REQUIREMENTS FOR REVIEW AND APPROVAL OF SELECT AGENTS AND TOXINS PROJECTS PART II. D. REQUIREMENTS FOR SUBMISSION OF A NEW BIOLOGICAL USE AUTHORIZATION APPLICATION PART II. Attachment A: Frequently Asked Questions about the BUA PART II. Attachment B: Biological Use Authorization (BUA) Application Form and its Appendices A. REQUIREMENTS FOR REVIEW AND APPROVAL OF PROJECTS USING INFECTIOUS AGENTS AND/OR RECOMBINANT DNA Infectious agents classified according to risk can be found in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (4th Ed., 1999). If the agent is not listed, contact Environmental Health and Safety (EHS). Biological Use Authorization (BUA) applications are required for all projects involving infectious agents. Classification and containment requirements for use of recombinant DNA (R-DNA) molecules can be found in the NIH publication NIH Guidelines for Research Involving Recombinant DNA Molecules are required for all projects involving R-DNA. Biosafety Level 1 (BSL 1), Animal Biosafety Level 1 (ABSL 1) and NIH-Exempt Projects The organisms in this level are defined as organisms that are not known to cause disease in healthy human adults. All projects involving infectious agents classified as BSL 1 must be reviewed and approved by the Biosafety Officer (BSO) and must follow the general guidelines specified for that level. Projects involving R-DNA molecules that are classified NIH-exempt and BSL 1 require review and approval by the BSO. Biosafety Level 2 (BSL 2) or 3 (BSL 3) and Animal Biosafety Level 2 (ABSL 2) or 3 (ABSL 3) All projects involving infectious agents and/or R-DNA classified as BSL 2 or 3 must be reviewed and approved by the Institutional Biosafety Committee (IBC) and must follow the general guidelines specified for that level. A BUA application may receive approval following IBC review and discussion. The committee may impose additional requirements when the BUA application is reviewed and approved. If the committee identifies concerns or revisions, the committee may grant a conditional approval. Once the revisions and/or concerns have been addressed and reviewed by the committee, a full approval will be granted. An approval is valid for three years from the date of review before it requires renewal. Any changes to an approved BUA application must be reviewed and approved by the IBC prior to implementation. The Principal Investigator (PI) will submit an amendment form to initiate this review. However, major changes such as adding new infectious agents or modifying procedures may require a new BUA application. Approval from other compliance committees e.g., Institutional Animal Care and Use Committee (IACUC), Institutional Review Board (IRB), Radiation Safety Committee (RSC) relevant to the project must also be obtained before work commences. Currently, no facilities at SDSU meet the minimum criteria for Biosafety Level 4 (BSL 4) or Animal Biosafety Level 4 (ABSL 4); therefore, this type of work is prohibited. B. REQUIREMENTS FOR REVIEW AND APPROVAL OF TRANSGENIC ANIMAL PROJECTS Investigators who create transgenic animals must complete a transgenic animal registration document (Appendix D of the BUA Application Form) and submit it to the Graduate and Research Affairs, Division of Research Administration, at <ibc@mail.sdsu.edu> for IBC approval prior to initiation of experimentation. In addition, IACUC requires that these protocols be approved by its committee prior to initiation of work. C. REQUIREMENTS FOR REVIEW AND APPROVAL OF SELECT AGENTS AND TOXINS PROJECTS Requirements for the safe and secure transportation, storage and possession of listed select agents and toxins can be found in the Code of Federal Regulations (42 CFR Part 73). BUA application forms are required for select agents and toxins. Any PI whose research involves any of the select agents or toxins listed in Appendix E of the BUA application must register with CDC through EHS in addition to completing the BUA application. Contact EHS at 619-594-6778 or <mdizon@mail.sdsu.edu> for registration information. D. REQUIREMENTS FOR SUBMISSION OF A NEW BIOLOGICAL USE AUTHORIZATION APPLICATION PIs must decide if a new agent or procedure poses any new or increased hazards from those indicated in the currently approved protocol. If there are new or increased hazards (or if there is any doubt or question), a new BUA application must be completed and an approval must be sought prior to implementing the change. Approval must be obtained from the IBC prior to the initiation of work involving any of the following: New infectious agents, new viruses, new vector systems Work with new cell lines Changes in constructs or systems that result in significantly higher titers Enhanced replication or infectivity Expression of toxic products Partial genomes increased to more than two-thirds of whole genome New or altered procedures that pose increased risk (e.g., aerosol or other type of exposure) Work with non-human systems being changed into work in human systems Attachment A: Frequently Asked Questions about the BUA Attachment B: Biological Use Authorization (BUA) Application Form and its Appendices Note: documents in Portable Document Format (PDF) require Adobe Acrobat Reader 5.0 or higher to view; download Adobe Acrobat Reader. Documents in Word format (DOC) require Microsoft Viewer, download word.
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Environmental Health and Safety

SDSU Biosafety Manual

Part II: Biological Use Authorization Application, Review and Approval Process

Part II:
Biological Use Authorization Application, Review and Approval Process