Biosafety
Institutional Biosafety Committee Incident
Any research by SDSU faculty, staff or students in the following areas must be reviewed by the Institutional Biosafety Committee:
- Recombinant or synthetic nucleic acid molecules.
- Genetically modified organisms.
- Pathogens/infectious agents (human, animal or plant).
- Select/biological agents and toxins (Centers for Disease Control and Prevention and U.S. Department of Agriculture).
- Any other activity that falls under the National Institutes of Health guidelines.
The Institutional Biosafety Committee assesses the risk of such research and confirms compliance with federal regulations to ensure that dangerous organisms are not created by genetic engineering and that all research involving biohazards is conducted in a manner that minimizes risk to personnel, the community and the environment.
Any investigator planning such research should first determine which of the below National Institutes of Health categories the study falls under. If not exempt, the investigator must complete the online application via InfoReady submission.
Applications must be submitted to InfoReady at least 10 working days before the last Tuesday of the month to be considered at the next Institutional Biosafety Committee monthly meeting.
Amendments to approved biosafety registrations should also be submitted via InfoReady.
Experiments that require Institutional Biosafety Committee approval before initiation. (Biosafety Level 2 or higher containment is required.)
- Use Risk Group 2, 3, 4 or restricted agents as host-vector systems.
- RG2: Associated with human disease that is rarely serious and for which preventive or therapeutic interventions are often available.
- RG3: Associated with serious or lethal human disease for which interventions may be available.
- RG4: Likely to cause serious or lethal human disease for which interventions are not usually available.
- Clone DNA from Risk Group 2, 3, 4 or restricted agents into nonpathogenic prokaryotic or lower eukaryotic host-vector systems.
- Use infectious or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems.
- Alter a whole animal’s genome by stable introduction of rDNA into the germ line or test viable rDNA-modified microorganisms on whole animals.
- Genetically engineer whole plants by rDNA, use or propagate such plants or use with microorganisms or insects containing rDNA.
- Involve more than 10 liters of culture.
- Use influenza viruses generated by recombinant or synthetic methods.
Experiments that require Institutional Biosafety Committee registration simultaneous with initiation. (May be conducted at Biosafety Level 1 containment.)
- Form rDNA molecules containing no more than two-thirds of the genome of any eukaryotic virus.
- Use of RNA-modified whole plants that doesn't fall under Sections III-A, III-B, III-D or III-F of the National Institutes of Health guidelines.
- Involve transgenic rodents in BL1 containment.
Exempt experiments.
Recombinant or synthetic nucleic acid molecules that:
- Can neither replicate nor generate nucleic acids that can replicate in any living cell.
- Are not designed to integrate into DNA.
- Do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 ng/kg body weight.
- Are not in organisms, cells or viruses and have not been modified or manipulated to render them capable of penetrating cellular membranes.
- Do not present a significant risk to health or the environment.
Consist entirely of:
- The exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature.
- Nucleic acids from a prokaryotic host, including its indigenous plasmids or viruses when propagated only in that host or when transferred to another host by well-established physiological means.
- Nucleic acids from a eukaryotic host including its chloroplasts, mitochondria or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).
- DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent.
Also exempt are genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA.
September 2025
IBC Meeting Minutes: Sept. 30, 2025, via Zoom at 11 a.m.
Attendance
Attendees: Daniel Scholl, Kara McCormick, Kenneth Larson, Laura Ruesch- recused Benoit St. Pierre, Sen Subramanian
Guests: Kinchel Doerner, Jen Kuck, Melody Hall
Absent: Sonja Van Holland, Ruanbao Zhou,
The meeting was called to order by the IBC Chair at 11:04 a.m.
Daniel Scholl introduced new committee members and new D.RED staff, Kinchel Doerner
Full Committee Review
1) Title of application: #3843 “Comparative growth rate study”
Principal Investigator: Schmitz-Esser, Stephen
Committee Discussion: Biosafety level 2 meets NIH guidelines; Motion to approve the project made by Larson, seconded by St. Pierre;
Committee Motion: Approved by unanimous vote 6-0.
2) Title of application: #3855 “Listeria monocytogenes adaptation to animals and food production environments”
Principal Investigator: Schmitz-Esser, Stephen
Committee Discussion: Question 3 is supposed to be lay language for the project but instead describes the justification; committee felt the lay description should be provided with an elaboration on how the project will be done and explain what equipment will be used; wasn’t clear what they are doing or what the containment will be; verify the biosafety containment level–2 was proposed; the committee decided to wait for more information before making a decision; Motion to request an updated lay description and an explanation of the approach to the project before approval made by Larson, seconded by StPierre;
Committee Motion: Passed by unanimous vote 6-0 to request additional information before further review.
3) Title of application: #3860 “The saboteur's tools in action: cytoplasmic incompatibility genes of the bacterial arthropodsymbiont Cardinium hertigii”
Principal Investigator: Schmitz-Esser, Stephen
Committee Discussion: need to confirm biosafety level (application is for biosafety level 1); committee discussed that the lay language could be improved and the project description needs to be revised; Motion to approve the application with a request to modify the response on Question 3 and to list the actual activities to be conducted was made by Subramanian; seconded by Larson;
Committee Motion: Approved by unanimous vote 6-0, request additional information. Kinchel Doerner explained federal regulations that are developing for “Gain-of- function”. May involve pathogens or those pathogens that could lead to a pandemic. Most routine lab processes are considered “gain of function.” NIH information shows pathogens but references pathogens for a pandemic and human pathogens.
The language is vague and definitions are broad. Could we set up pre-approved gain-of-function research and not require that each experiment be reviewed? We would need a system for documenting that. Could add a question to the form, “If you select recombinant DNA, do you expect this to be gain-of-function?” Discussion about whether this topic included US or just other countries and Doerner responded that some projects were halted this summer due to using human pathogens.
Conclusion
The meeting adjourned at 11:36 a.m. (Motion made by Subramanian, Seconded by Larson)
October 2025
IBC Meeting Minutes: Oct. 29, 2025, via Zoom 11 a.m.
Call to Order
Attendees: Daniel Scholl, Kara McCormick, Kenneth Larson, Laura Ruesch, Sen Subramanian, Sonja Van Holland Guests: Kinchel Doerner, Melody Hall Absent: Benoit St Pierre, Xiuqing Wang, Ruanbao Zhou
The meeting was called to order by the IBC Chair at 11:03 a.m.
Motion to approve the minutes from the Sept. 30, 2025 meeting made by Larson, seconded by Van Holland, motion carries.
Full Committee Review
1) Title of application: #3869 “Collaborative Research: FEC: Establishing Infrastructure for AI Driven Discovery of Small Molecules to Combat Antibiotic Resistance, Biofilms, and Aflatoxin Contamination”
Principal Investigator: Nicholas Butzin Committee Discussion: Chair approved that the experiment may commence simultaneously with biosafety committee review. Chair approved under NIH Guide, Section III-E. Committee thought the lay-language was adequate and that the vector maps should be uploaded to the application. Committee Action: Subramanian moved to “affirm classification under NIH guidelines Section III-E, and the investigator is asked to upload vector maps to supplement the application”; seconded by Larson; motion carried unanimously.
2) Title of application: #3883 “NARMS Antibiotic Resistance Surveillance in Retail Meat Samples from South Dakota and North Dakota”
Principal Investigator: Laura Ruesch Committee Discussion: Exempt from rDNA registration requirements. Chair would like committee review for approval of BSL 2 containment. Committee Motion: McCormick moved to “affirm conduct of project at BSL 2 containment”; seconded by Larson; motion carried unanimously. Ruesch recused.
3) Title of application: #3888 “Listeria monocytogenes adaptation to animals and food production environments” – 2nd application (3855)
Principal Investigator: Stephan Schmitz-Esser Committee Discussion: L. monocytogenes is a Risk Group 2 agent; committee agreed with that level and thought the application was improved. Committee Motion: Larson moved to “affirm biosafety level 2 containment and to affirm revisions that had made to the initial project description”; seconded by Van Holland; motion carried unanimously. Ruesch recused.
Old Business
- Rejected Sept. 30, 2025 requested additional information - #3855-Schmitz-Esser, Stephen – “Listeria monocytogenes adaptation to animals and food production environments” Committee Discussion: The committee approved #3888 under new business. #3888 replaces #3855,
- Approved Sept. 30, 2025 requested additional information - #3860-Schmitz-Esser, Stephen – “The saboteur's tools in action: cytoplasmic incompatibility genes of the bacterial Aarthropodsymbiont Cardinium Hertigii” Committee Discussion: After review of the additional information, biosafety level 1 is sufficient. Larson moved to “approve the application with the modifications to the project description and conduct at biosafety level 1”; seconded by Subramanian; motion carried unanimously. Ruesch recused.
Conclusion
The meeting adjourned at 11:31 am (Motion made by McCormick, seconded by Larson)
January 2026
IBC Meeting Minutes: Jan. 29, 2026, via Zoom 11 a.m.
Call to Order
Attendees: Daniel Scholl, Benoit St Pierre, Laura Ruesch, Kenneth Larson, Xiuqing Wang, Kara McCormick, Sonja Van Holland
Guests: Kinchel Doerner, Lauren Shearer Absent: Sen Subramanian, Ruanbao Zhou
The meeting was called to order by the IBC Chair at 11:01 a.m. Motion to approve the minutes from the October 2025 meeting made by Larson, seconded by McCormick, motion carries.
Full Committee Review
1) Title of application: #3912- “Understanding the pathogenesis mechanisms of Hepatitis E Virus”
Principal Investigator: Debin Tian Committee Discussion: Chair would like committee review for approval of BSL 2 containment. Committee thought the disinfectant process with 70% ethanol and UV for 10 minutes were sufficient. Committee Action: Larson moved to “affirm conduct of project at BSL 2 containment”; seconded by Wang; motion carried unanimously.
Applications Additional Information
- Committee was notified that the Vector Maps requested for #3869 were submitted for review. Committee Discussion: After reviewing the additional information, the Vector Maps were deemed sufficient.
Discussions
- IBC Minutes Publicly Available on a Federally Registered Website
- Research Integrity and Compliance - Doerner Committee Discussion:
- 1.) DURC under SDSU policy 8.11 requires a committee, IRE, which constitutes as needed and is not the IBC. Recommendation on merging IRE and IBC for simplicity and adherence. Ad Hoc voting members will be needed.
- 2.) Select agents and Associated Toxins recommendation to update and change in IBC application to meet Federal requirements. Discussion on elaboration of facilities that would be exempt from IBC policy but also have facility specific federal requirements.
- 3.) Discussion on request for instructors using RG1 and RG2 organisms in teaching settings to submit IBC application. Committee was favorable.
- InfoReady Gold Upgrade allows for logic and application questionnaire could move to InfoReady.
Conclusion
The meeting adjourned at 11:37 a.m. (Motion made by Larson, seconded by St. Pierre)
February 2026
IBC Meeting Minutes: Feb. 20, 2026, via Zoom 1 p.m.
Call to Order
Attendees: Daniel Scholl, Laura Ruesch, Kenneth Larson, Xiuqing Wang, Kara McCormick, Sonja Van Holland
Guests: Kinchel Doerner, Lauren Shearer
Absent: Sen Subramanian, Ruanbao Zhou, Benoit St Pierre,
The meeting was called to order by the IBC Chair at 1:02 p.m. Motion to approve the minutes from the January 2026 meeting made by Larson, seconded by Van Holland, motion carries.
Full Committee Review
1) Title of application: #4066- “Investigate the pathogenesis mechanisms and develop novel vaccines for porcine reproductive and respiratory syndrome virus”
Principal Investigator: Debin Tian
Committee Discussion: Chair requests committee review for approval of BSL 2 containment.
Committee Action: Larson moved to “affirm conduct of project at BSL 2 containment”; seconded by Wang; motion carried unanimously.
2) Title of application: #4079- “Functional analysis of genes involved in climate resilience: translational studies from model to crop plants”
Principal Investigator: Karen Sanguinet
Committee Discussion: Chair requests committee review for approval for the continuation of experiment simultaneous with the review of approval of BSL 1 containment.
Committee Action: McCormick moved to “approve continuation of experiment simultaneous of committee review of approval of BSL 1 containment. Committee review tabled until a fuller committee representation”; seconded by Larson; motion carried unanimously.
Conclusion
The meeting adjourned at 1:17 pm (Motion made by Larson, seconded by Van Holland)
