Biological Use Authorization

Purpose of the SJSU Institutional Biosafety Committee (IBC) reviews

The purpose of IBC reviews is to ensure that all activities involving biological agents and the facilities used to conduct such work are in compliance with all external regulations, and applicable University policies. The committee will function to ensure that investigators handle biological agents in a safe and responsible manner, and meet criteria as described by the NIH Guidelines for recombinant DNA research (specifically those defined in section IV-B-2); the CDC/NIH publication Biosafety in the Microbiological and Biomedical Laboratories; applicable regulations defined by the state of California; the Cal/OSHA Bloodborne Pathogens Standard; HHS and USDA final rules for the possession, use, and transfer of select agents and toxins; and other applicable requirements. Foremost, the IBC’s objective shall be to ensure that such activities meet the standards of good biological safety practice emphasizing protection of personnel, the public and the environment.

Who needs to submit a Biological Use Authorization (BUA) to the SJSU IBC

All SJSU faculty, staff and lecturers need to submit a BUA to the IBC for the use of all biological agents or activities described below that are used in research or teaching:

A. Activities involving recombinant/synthetic nucleic acid molecules or recombinant/synthetic nucleic acid-containing organisms/viruses/cell cultures;

B. Biological agents above biosafety level 1 (BSL-1), including field activities that collect environmental samples (e.g., soil, water), or that collect/use animals that harbor zoonotic agents.

C. Unfixed materials derived from human and nonhuman primates;

D. Activities that collect plants/animals, work with plants/animals/samples with potential zoonotic agents, or cultivate exotic/noxious plants; 

E. Biological Toxins with an LD50 of less than 100 micrograms per kilogram of body weight in vertebrates;

F. Select agents or toxins subject to 42 CFR Part 73, 9 CFR Part 121, or 7 CFR Part 331;

G. Proposed research subject to the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.

Concurrent Submission of BUAs

BUAs may be submitted concurrently with other requirements, such as Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) submissions.  BUAs do not substitute for IRB or IACUC approvals.

BUA Forms

The below forms are designed for use in Microsoft Word. First complete the Main BUA form to determine which additional attachments are needed for your work. The completed Word files and a pdf of the Signature page (signed in DocuSign) should be submitted as attachments in an email to biosafety@sjsu.edu

Main BUA [docx]

Attachment A [docx] - Project involves recombinant/synthetic nucleic acid molecules, recombinant/synthetic nucleic acid-containing organisms, viruses or cell cultures.

Attachment B [docx] - Project involves potential human, animal, or plant pathogens or infectious agents. 

Attachment C [docx] - Project involves unfixed human or non-human primate organs, tissues, or cell cultures (OTCC) with proven or potential hazard to humans, other animals or plants. (All work with human blood, human blood products, human body fluids, or other potentially infectious human materials such as brain, CNS tissues, lymphoid tissues, gut, bone marrow, and human cell cultures fall into this category. Note: human source material that has been previously fixed are excluded and do not need a BUA.)

Attachment D [docx] - Project involves the collection and analysis of environmental samples (e.g., soil, water). 

Attachment E [docx] - Project involves biological toxins. Toxins are toxic substances produced by bacteria, fungi, protozoa, insects, animals, or plants that have the capability of causing harmful effects when inhaled, ingested, injected or absorbed. Note: Toxins not administered to cells or animals do not warrant a BUA. Select Toxins, regardless of use, require a BUA. 

Attachment F [docx] - Project involves collection of animals and plants; use of animal- or plant-derived samples that harbor zoonotic agents (e.g., wild trap animals, farm animals, and non-human primates); or cultivation of exotic or noxious plants

Attachment G [docx] - Project involves laboratory animals and/or plants in conjunction with materials described above in Attachment A, B, C, or E. 

Attachment H [docx] - Project involves storage only of biohazardous agents.

Sample Documents

The below sample documents are intended to be helpful resources as you prepare your BUA.

Sample BUA forms:

Main BUA Sample [pdf]

Attachment A Sample [pdf]

Attachment B Sample [pdf]

Attachment C Sample [pdf]

Attachment D Sample [pdf]

Attachment E Sample [pdf]

Attachment F Sample [pdf]

Attachment G Sample [pdf]

Attachment H Sample [pdf]

Standard Operating Procedure (SOP) templates:

Biosafety level-1 SOP [doc]

Biosafety level-2 SOP [docx]

Recombinant DNA SOP [docx]

Renewals and Amendments

Upon approval of the BUA, Principal Investigators will complete a BUA renewal yearly for active biosafety level 2 (BSL-2) research or every 3 years for all other research requiring a BUA (including storage only of BSL-2 materials). To amend an approved BUA, apply changes directly to the approved BUA using Track Changes. Submit the revised BUA to biosafety@sjsu.edu. Note, while you do not need to submit an amendment to the BUA each time your lab/course personnel changes, you must maintain a current list of laboratory/course personnel and training documentation that can be produced upon request of the IBC or a lab auditor. In addition, an amendment must be submitted each semester for the instructor in charge of a course if they were not on the approved BUA.