91猎奇

Biological Use Authorization

Purpose of the 91猎奇 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 for recombinant DNA research (specifically those defined in section IV-B-2); the CDC/NIH publication ; applicable regulations defined by the state of California; the Cal/OSHA ; HHS and USDA final rules for the possession, use, and transfer of ; and other applicable requirements. Foremost, the IBC鈥檚 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 91猎奇 IBC

All 91猎奇 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, including human embryonic stem cells;

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. 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 .

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

First complete the Main BUA form to determine which additional attachments are needed for your work. Then, email biosafety@sjsu.edu to create a BUA submission folder in the IBC google drive. You may also submit the BUA forms as Word documents. 

- Project involves recombinant/synthetic nucleic acid molecules, recombinant/synthetic nucleic acid-containing organisms, viruses or cell cultures.

- Project involves potential human, animal, or plant pathogens or infectious agents. 

- 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.)

- Project involves the collection and analysis of environmental samples (e.g., soil, water). 

- 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. 

- 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

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

- Project involves storage only of biohazardous agents.

- Emergency relocation plan for live invertebrates, tissues, or cells

- authorization by managers of shared spaces for the PI to use the space and hazard communication plans to inform other shared space users

Sample Documents

Reach out to biosafety@sjsu.edu to request sample documents or to set up a consultation to help you develop your BUA. The following resources may be helpful as you prepare your BUA. 

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 renew or amend an approved BUA, reach out to biosafety@sjsu.edu to create a submission file in the IBC google drive. Then, you will be able to apply changes directly to the approved BUA using the "Suggesting" mode in Google Docs. Once your BUA amendment package is completed inform biosafety@sjsu.edu to initiate committee review. 

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.