Oct. 14, 2025 Institutional Biosafety Committee Meeting Minutes

Present

Andrea Bertke (virology), Paige Bordwine (local non-affiliated member), Amy Brunner (plant containment expert), Clayton Caswell (Chair, bacteriology), Alan Ealy (animal science), Rajshekhar Gaji (parasitology), Aaron Gross (entomology), Karen Hall (animal containment expert), Timothy Jarome (Vice Chair, neurobiology), Mike Klemba (parasitology), Michael Miles (biosafety officer), Dennis Nolan (health and safety), Clayton Oliver (emergency management), Sally Paulson (virology), Pamela Ray (public health), Igor Sharakhov (gene drive modified organism expert), Laurie Spotswood (local non-affiliated member), Xiaofeng Wang (plant containment expert), Charlotte Waggoner (university biosafety officer), James Weger (virology)

Excused Absences

Jen Averill (public safety), Erin Gloag (bacteriology), Kristin Knight (high containment), Calvin Lau (animal containment expert), Katherine LaVallee (animal containment expert), Andrew Marinik (emergency management)

Guests

Regina Allen (IBC non-voting contact, IBC Program), Brooke Bollinger (veterinarian), Ling Chen (IBC Program), Anna Kroner (biosafety officer; alternate member), Christine McCoy (health and safety), Sarah Owen (health and safety), Allison Price (health and safety), Michael Miles (Associate biosafety officer; alternate member), Barbara Wise (FLSI research operations), Kong Wong (biomolecular engineering), Qi Ye (Fralin Biomedical Research Institute)

Quorum

Five members are required to conduct business. 19 voting members were present at the start of the meeting.

Conflicts of Interest

Attendees were reminded that they are required to disclose conflicts of interest with applications being reviewed prior to the start of each discussion. Attendees with a conflict will be asked to leave the meeting during the members’ final discussion and vote.

AGENDA

1. With the establishment of a quorum, the Chair called the meeting to order at 2 p.m. This was an open meeting. 
   
   
2. The minutes of the IBC meeting held on Sept. 9, 2025 were reviewed. No edits were requested [18 of 19 members present voted to approve the Minutes of the Sept. 9, 2025 IBC meeting, to be posted in accordance with the IBCP SOP that includes review by University Legal Counsel.]
   Clayton Oliver joined the meeting; there are 20 members present.
   
   
3. Four new submissions, six renewal submissions, and three amendment submissions were discussed.
   
   
   1. Protocol 25-042, new submission. Dr. Wong attended the meeting and provided an overview of the project. The principal investigator left the meeting during the IBC’s discussion and vote.
      
      The protocol involves the modification of plants, including Thlaspi arvense, Medicago truncatula, and Brachypodium distachyon. They will use EMS-mediated mutagenesis and Agrobacterium-mediated CRISPR gene editing to generate point mutations, small indels, frameshifts, and gene deletions. The modifications will be used to study increases and decreases of genes involved in the metabolism and transport of lipids, sugars, strigolactones, nitrates, ammonia, the phytohormone signaling pathway, and legume-rhizobia symbiosis.
      
      Plants will be grown in greenhouses and growth chambers. BL1-P containment practices will be used. Containment practices, such as bags, will be used to mitigate seed and pollen dispersal. Seeds will be collected in a separate space designated for such procedures. The cloning vectors used are standard cloning vectors. The antibiotic resistances used for cloning in RG1 bacteria are not used to treat infections, and there are no concerns with the antibiotic resistances used in the plants, kanamycin and hygromycin. The agents used are RG1. The appropriate containment levels used are BSL-1, BL1-P, and BL1. The applicable NIH Guidelines are III-E-2 and III-F-8-C-II. The facilities were reviewed and they are appropriate for the work performed.
      
      The principal investigator has the expertise to perform the work. The BSL-1 self-inspection, rsNA & Toxin form, biosafety manual, and SOPs were reviewed and they are appropriate for the work performed. No major concerns were raised, and minor edits will be required to better clarify greenhouse practices for final approval.
      
      On a motion and a second, a majority of the IBC members voted to Require Modifications to protocol 25-042 with final review by the IBCP and biosafety officer after the edits are completed [20 of 20 members present voted to Require Modifications to the protocol].
      
      Dennis Nolan and Paige Bordwine joined the meeting. There are 17 voting members present.
      
      
   2. Protocol 25-044, new submission. Dr. Ye attended the meeting and provided an overview of the project. The principal investigator left the meeting during the IBC’s discussion and vote.
      
      The protocol involves the in vitro study of genes involved in tumor development and suppression and fluorescent tags, in human cancer cell lines and primary mouse neural stem and astrocyte cells, using cDNAs for over-expression, sh/siRNAs for knockdown expression, and CRISPR/Cas9 for gene knockout. The sequences will be delivered using plasmid transfection or lentiviral transduction. In vivo studies will involve the injection of plasmid or AAV viral vectors expressing cDNAs and CRISPR/Cas9 constructs, to over-express and delete genes involved in tumor suppression and development, into wild type mice to study tumor development.
      
      Chicken fibroblast cells will be transduced with an avian RCAS viral vector that will overexpress an oncogene, Pdgfb, to induce low-grade gliomas. The vector uses the avian leukosis virus subgroup A envelope. The RCAS-vector-expressing cells, and human and mouse glioma cell lines, will be stereotaxically injected into wild type and glioma and fluorescent mouse models that are obtained from commercial vendors. BSL-2 and ABSL-2 containment is used for the work with the RCAS-vector.
      
      The cloning vectors used are standard cloning vectors. The antibiotic resistances used are not antibiotics used to treat infections with the cloning RG1 bacteria organisms. The agents used are RG1, RG2, and human and animal cells and tissues. The appropriate containment levels used are BSL-1, BSL-2, BL1, BL2, ABSL-1, and ABSL-2. The applicable NIH Guidelines are III-D-1, III-D-3, III-D-4, III-E-1, III-F-8-C-I, III-F-8-C-II, III-F-8-C-VII, and III-F-8-C-VIII. The facilities were reviewed and they are appropriate for the work performed. The labs are shared with other research groups working with similar agents and procedures.
      
      The principal investigator has the expertise to perform the work. The lab has been previously inspected by EHS, and EHS has scheduled a walkthrough of the lab with the new principal investigator. The rsNA & Toxin form, PSDS forms, and SOPs were reviewed and they are appropriate for the work performed. The lab sketches, biosafety manual, and one SOP have minor edits that are needed, but they are otherwise appropriate. No major concerns were raised, and minor edits will be required for final approval.
      
      On a motion and a second, a majority of the IBC members voted to Require Modifications to protocol 25-044 with final review by the IBCP and biosafety officer after the edits are completed [20 of 20 members present voted to Require Modifications to the protocol].
      
      
   3. Protocol 25-045, new submission. The co-investigator, Dr. Weger, attended the meeting and provided an overview of the project. The co-investigator, who is an IBC member, left the meeting during the IBC’s discussion and vote. There are 19 voting members present.
      
      There is no rsNA involved with the protocol, and therefore the work is not applicable to the NIH Guidelines. The protocol involves the use of a wild type RG2 strain of Zika Virus, as a treatment for canine soft-tissue sarcomas. The members discussed the experiments, risk assessment, SOPs, training, and PPE. Additional information is required.
      
      On a motion and a second, a majority of the IBC members voted to Table protocol 25-045 pending submission of requested information, to be re-reviewed at an upcoming meeting [19 of 19 members present voted to Table the protocol].
      
      James Weger returned to the meeting. There are 20 voting members present.
      
      
   4. Protocol 21-067, amendment submission. Dr. Ealy attended the meeting and provided an overview of the project. The principal investigator, who is an IBC member, left the meeting during the IBC’s discussion and vote. There are 19 voting members present.
      
      There is no rsNA involved with the protocol, and therefore the work is not applicable to the NIH Guidelines. The amendment involves the study of a dietary supplement to reduce symptoms in cattle fed endemic RG1 fungal-infected feed. The members discussed the experiments, risk assessment, SOPs, training, and PPE. No major concerns were raised, and minor edits will be required for final approval.
      
      On a motion and a second, a majority of the IBC members voted to Require Modifications to the amendment od protocol 21-067 with final review by the IBCP [19 of 19 members present voted to Require Modifications to the amendment].
      
      Alan Ealy returned to the meeting, and Xiaofeng Wang left the meeting. There are 19 voting members present.
      
      
   5. Protocol 20-040, amendment submission, Dr. Senger. The amendment is to add Project 3 to the protocol to perform a phenotypic analysis of RG1 Bacillus subtilis 168 wild type and gene knockout strains that are treated with environmental toxins, such as heavy metals and insecticides. Aptamers that consist of published sequences that have been found to bind various environmental toxins will also be applied to the bacteria.
      
      The aptamers will be synthetic sequences consisting of ~15 amino acids, and will be obtained from commercial vendors. They will not be cloned or inserted into the chromosome of the bacteria. The aptamers will be applied to the media of the bacteria, and will cause the outer membrane to change when in the presence of different environmental toxins. The knockout B. subtilis 168 strains will be obtained from a culture collection, and the deleted genes are involved in sporulation and fatty acid biosynthesis pathways.
      
      The lab will not generate any B. subtilis modifications themselves. The knockout strains will have antibiotic resistance to chloramphenicol, erythromycin, kanamycin, or tetracycline, and the use of the antibiotic resistance would not inhibit treatment of exposure to the strains. The agents used are RG1. The appropriate containment levels used are BSL-1 and BL1. The applicable NIH Guidelines are III-E and III-F-1. The facilities were reviewed and they are appropriate for the work performed.
      
      The principal investigator has the expertise to perform the work. A lab inspection is not required for this amendment. The rsNA & Toxin form, biosafety manual, and SOPs were reviewed and they are appropriate for the work performed. No major concerns were raised, and minor edits will be required for final approval.
      
      On a motion and a second, a majority of the IBC members voted to Require Modifications to the amendment of protocol 20-040 with final review by the IBCP after the edits are completed [19 of 19 members present voted to Require Modifications to the protocol].
      
      
   6. Protocol 22-039, renewal submission, Dr. Sherif. The protocol includes two projects. Project 2 is new for the renewal.
      
      Project 1 involves the use of naked and minicell-encapsulated dsRNA as a biofungicide on wild type plants infected with an endemic fungus, Botrytis. The dsRNA is expressed on a plasmid in RG1 E. coli, and is isolated by the lab for use on plants. The minicell-encapsulated dsRNA is obtained from a collaborator. Prior to use on plants, the lab will separate the minicells from the RG1 E. coli, and the naked dsRNA will be extracted and purified for use on the plants. The dsRNA will be sprayed onto plants in greenhouses and in field trails.
      
      Project 2 involves the use of CRISPR/Cas9 to knockout genes linked to cold stress responses in tobacco, apples, and plums. Agrobacterium-mediated transformation and antibiotic selection is used to produce the transgenic plants. The plants will be grown in greenhouses to analyze cold tolerance, abscisic acid levels, reactive oxygen species accumulation, and gene expression profiling to determine the effects of gene knockouts on stress signaling pathways. The agents used are RG1. The appropriate containment levels used are BSL-1, BL1-P, and BL1. The applicable NIH Guidelines are III-E, III-E-2, and III-F-8-C-II. The facilities were reviewed and they are appropriate for the work performed.
      
      The principal investigator has the expertise to perform the work. The BSL-1 self-inspection and rsNA & Toxin form were reviewed and they are appropriate for the work performed. Minor edits will be needed to the biosafety manual and SOPs, but they are otherwise appropriate. No major concerns were raised, and minor edits will be required for final approval.
      
      On a motion and a second, a majority of the IBC members voted to Require Modifications to the renewal of protocol 22-039 with final review by the IBCP and biosafety officer after the edits are completed [19 of 19 members present voted to Require Modifications to the protocol].
      
      
   7. Protocol 22-030, renewal submission, Dr. Olsen. The protocol includes four projects that use commercially obtained rAAV vectors and transgenic rodents.
      
      Project 1 involves the use of AAV vectors that express wild type mouse Kir4.1. The rAAV are stereotaxically injected into Kir4.1-deleted mouse and rat models to rescue Kir4.1, to study the function of the gene in Rett Syndrome.
      
      Project 2 uses AAV vectors that express TrkB.T1 and fluorescent reporters to evaluate astrocyte morphology in wild type mice, mice with a global TrkB.T1 knockout, and mice with an astrocyte-specific knockout of TrkB.T1. An rAAV will also be used to express HCKCR1, which is activated by light, to inhibit activation of astrocytes.
      
      Project 3 uses AAV vectors and wild type and mouse CD38 knockout models to understand the role of glial inflammation in brain regions impacted by Parkinson disease. Wild type mice will be stereotaxically injected with rAAV expressing short hairpin RNAs to knockdown expression of CD38. rAAV will also be used to express AQP4 in wild type and CD38 knockout mice, and to knockdown AQP4 expression. Tetrodotoxin will be used to inhibit NA⁺ channels in brain slice electrophysiology. The use of tetrodotoxin has been added for the renewal. The lab will not have amounts of tetrodotoxin that would be regulated as a select toxin.
      
      Project 4 examines the astrocyte transcriptome, proteome, and morphology using wild type and Alzheimer disease pre-clinical mouse models as they age. rAAV expressing AQP4 will be injected into mice to overexpress AQP4 in astrocytes.  rAAV expressing an shRNA construct will be used to knockdown AQP4 in mice. The agents used are RG1 and rodent cells and tissues. The appropriate containment levels used are BSL-1, BL1, and ABSL-1. The applicable NIH Guidelines are III-D-4, III-E-1, III-F-8-C-VII, and III-F-8-C-VIII. The facilities were reviewed and they are appropriate for the work performed.
      
      The principal investigator has the expertise to perform the work. The BSL-1 self-inspection, rsNA & Toxin form, biosafety manual, and SOPs were reviewed and they are appropriate for the work performed. No major concerns were raised, and completion of some training will be required for final approval.
      
      On a motion and a second, a majority of the IBC members voted to Require Modifications to the renewal of protocol 22-030 with final review by the IBCP and biosafety officer after the trainings are completed [19 of 19 members present voted to Require Modifications to the protocol].
      
      Aaron Gross left the meeting. There are 18 voting members present.
      
      
   8. Protocol 22-048, renewal submission, Dr. Weston. The protocol includes two projects. No changes were made to the agents and procedures of the protocol for the renewal.
      
      Project 1 uses AAV vectors to express fluorescent reporters, Cre recombinase, and GCaMPs in wild type and transgenic mice and cultured primary neurons. The AAV and transgenic mouse models are obtained from commercial vendors.
      
      Project 2 uses rAAV to manipulate mTOR signaling in rats. The rAAV are injected into the hypothalamus of rats to express shRNAs targeting components of mTORC1 signaling, fluorescent reporters, and an myc-epitope-tagged BDNF fusion protein. The agents used are RG1 and rodent cells and tissues. The appropriate containment levels used are BSL-1, BL1, and ABSL-1. The applicable NIH Guidelines are III-D-4, III-E-1, III-F-8-C-VII, and III-F-8-C-VIII. The facilities were reviewed and they are appropriate for the work performed.
      
      The principal investigator has the expertise to perform the work. The BSL-1 self-inspection, rsNA & Toxin form, and SOPs were reviewed and they are appropriate for the work performed. The biosafety manual requires a minor edit, but is otherwise appropriate. No major concerns were raised, and minor edits will be required for final approval.
      
      On a motion and a second, a majority of the IBC members voted to Require Modifications to the renewal of protocol 22-048 with final review by the IBCP after the edits are completed [18 of 18 members present voted to Require Modifications to the protocol].
      Aaron Gross returned to the meeting. There are 19 voting members present.
      
      
   9. Protocol 25-040, new submission, Dr. Amo. The protocol includes two projects.
      
      Project 1 uses RG1 E. coli to construct replication deficient AAV to clone the tetanus light chain sequence and diphtheria toxin subunit A sequence into the viral vector system. The rAAVs will be packaged and validated using human cell lines. The toxin expression will be under the control of a transactivation element such as tTA, or a recombinase such as Cre/Lox, Dre/Rox, FLIP/FRT, VCre/VLoxP, or SCre/SLoxP, to ablate or inhibit neural transmission in a defined population of neurons. This will help mitigate systemwide exposure of the toxin if an accidental inoculation occurred. The toxins will also be tagged with fluorescent promoters and optogenetic sequences. Human cell lines will also be used to generate and culture replication deficient EnvA pseudotyped G-deleted Rabies Virus and replication deficient G-deleted rabies virus vectors. The rabies viruses will not be used to express the toxin sequences. Non-toxin expressing rAAV and rabies virus vectors will be used to express and modulate calcium, dopamine, and chloride channels with optogenetic and fluorescent tags, using the transactivation element and recombinase controls used with rAAV. AAV will be used as a helper virus to package the rabies viruses.
      
      Project 2 involves the use of materials generated and cultured in Project 1 for in vivo studies to elucidate the neurocircuit mechanisms of learning and decision-making. Wild type and transgenic mice will be stereotaxically injected with rAAV expressing toxins to ablate or inhibit neural transmission in the genetically defined subpopulation of neurons. The rAAV and rabies viruses will be stereotaxically injected into mice to label, monitor neural activity in, and manipulate gene expression of neurons in the mouse models. Transgenic mice are obtained from commercial vendors, and have genes involved in dopamine, calcium, and chloride conditionally knocked out, and express fluorescence. The agents used are RG1, RG2, human cell lines, and rodent cells and tissues. The appropriate containment levels used are BSL-1, BSL-2, BL1, BL2, ABSL-1, and ABSL-2. The applicable NIH Guidelines are III-B-1, III-D-2, III-D-3, III-D-4, III-E-1, III-F-8-C-II, III-F-8-C-VII, and III-F-8-C-VIII. The facilities were reviewed and they are appropriate for the work performed.
      
      The lab inspection will be performed by EHS. The principal investigator has the expertise to perform the work. The BSL-1 self-inspection, PSDS forms, and toxin SDS forms were reviewed and they are appropriate for the work performed. The biosafety manual, rsNA & Toxin form, and SOPs require minor edits, but are otherwise appropriate. No major concerns were raised, and minor edits will be required for final contingent approval by the IBC. When the IBC review is completed, the IBCP will submit the information to the NIH OSP for III-B-1 review and approval. If NIH approval is obtained, the IBCP will approve the IBC protocol.
      
      On a motion and a second, a majority of the IBC members voted to Require Modifications to protocol 25-040 with final review by the IBCP and the biosafety officer after the edits are completed [19 of 19 members present voted to Require Modifications to the protocol].
      
      Erin Gloag left the meeting. There are 18 voting members present.
      
      
   10. Protocol 20-034, amendment submission, Dr. Kehn-Hall. The protocol is approved for recombinant work with RG3 select agents, Venezuelan equine encephalitis virus, eastern equine encephalitis virus, and Rift Valley fever virus. The amendment is to include a new inactivation protocol for virus-infected mouse plasma samples, to remove the samples from the BSL-3 space. The new inactivation method is to use methylene blue plus UV inactivation. The agents used are RG3. The containment levels used are BSL-3, BL3, and ABSL-3. The applicable NIH Guidelines are III-D-1, III-D-2, III-D-3, III-D-4, III-F-8-C-VII, and III-F-8-C-VIII. The facilities were reviewed and they are appropriate for the work performed.
       
       The principal investigator has the expertise to perform the work, and to test the new inactivation method for use. An SOP outlining the procedure and QC/QA tests was submitted. A validation report was also provided. The lab will perform safety testing before removing samples from the BSL-3 lab after inactivation. The safety testing will include cytopathic effect documentation along with measuring infectious virus using plaque assays. Nucleic acids are also regulated as select agents, and the lab will perform safety testing to confirm that any nucleic acids in the samples are also non-infectious. The associate biosafety officer will submit the new inactivation SOP and documentation to FSAP. The SOP requires minor edits to clarify some information, but is otherwise appropriate. No major concerns were raised, and minor edits will be required for final approval.
       
       On a motion and a second, a majority of the IBC members voted to Require Modifications to the amendment of protocol 20-034 with final review by the IBCP and biosafety officer after the edits are completed [18 of 18 members present voted to Require Modifications to the amendment].
       
       Erin Gloag returned to the meeting. There are 19 voting members present.
       
       
   11. Protocol 22-032, renewal submission, Dr. Osorio. The protocol includes two projects. No changes were made to the experiments and agents for the renewal.
       
       Project 1 uses murine and bovine cell lines and microfluidic systems to study inflammation using lipopolysaccharide. The project does not involve rsNA, but the RAW264.7 cell line requires BSL-2 containment.
       
       Project 2 inserts reporter systems into murine and bovine cells. Commercially available fluorescent protein systems will be inserted into the cells. There are four systems that will be used. The first system will include a histone modified to include a FRET system tagged to the histone tail to track histone methylation. The second system has a modified region within mTOR that can be phosphorylated and detected with a FRET system. The third system is a FRET-based protein sensor with two metal binding domains for Zn. The fourth system uses fluorescence to characterize the activity of Vitamin A-related transcription factors. The agents used are rodent and bovine cell lines. The appropriate containment levels used are BSL-1, BSL-2, BL1, and BL2. The applicable NIH Guidelines are III-E, III-F-1, III-F-2, III-F-8-C-I, and III-F-8-C-II. The facilities were reviewed and they are appropriate for the work performed.
       
       The principal investigator has the expertise to perform the work. EHS will inspect the BSL-2 lab. The biosafety manual, rsNA & Toxin form, and SOPs were reviewed and they are appropriate for the work performed. No major concerns were raised, and minor edits will be required for final approval.
       
       On a motion and a second, a majority of the IBC members voted to Require Modifications to the renewal of protocol 22-032 with final review by the IBCP and biosafety officer after the edits are completed [19 of 19 members present voted to Require Modifications to the protocol].
       
       Raj Gaji left the meeting. There are 18 voting members present.
       
       
   12. Protocol 22-040, renewal submission, Dr. Mulvaney. No changes were made to the experiments and agents for the renewal. The protocol has a single project. RG1 E. coli are used to clone and isolate methyltransferases, such as PRMT5 and genes involved in transcription regulation, such as DBC1. The genes will also be expressed on lentiviral vectors, purchased from commercial vendors. shRNA molecules will also be purchased to downregulate the genes in experiments.
       
       The experiments will consist of modifying human cancer cell lines and insect cell lines to modulate expression of the genes of study. shRNA and lentiviral vector systems will be used to knockout genes, repress genes, and to activate genes. CRISPR systems will also be used for some experiments. Gene deletion would use CRISPR/Cas9), gene repression would use CRISPRi, and gene activation would use CRISPRa. The modified tumor cells will be injected into mice to study tumors and to test new treatments. Some mice will receive unmodified cells, and the tumors will be injected with shRNA to knockdown genes involved in tumorigenesis. The agents used are RG1, RG2, and human and insect cell lines. The appropriate containment levels used are BSL-1, BSL-2, BL1, BL2, and ABSL-2. The applicable NIH Guidelines are III-D-1, III-D-3, III-D-4, III-E, III-F-8-C-II, III-F-8-C-VII, and III-F-8-C-VIII. The facilities were reviewed and they are appropriate for the work performed.
       
       The principal investigator has the expertise to perform the work. EHS will inspect the BSL-2 lab. The BSL-1 self-inspection, rsNA & Toxin form, PSDS files, and SOPs were reviewed and they are appropriate for the work performed. The biosafety manual requires a minor edit, but is otherwise appropriate. No major concerns were raised, and minor edits will be required for final approval.
       
       On a motion and a second, a majority of the IBC members voted to Require Modifications to the renewal of protocol 22-040 with final review by the IBCP and biosafety officer after the edits are completed [18 of 18 members present voted to Require Modifications to the protocol].
       
       Raj Gaji returned to the meeting. There are 19 voting members present.
       
       
   13. Protocol 22-041, renewal submission, Dr. Chen. For the renewal, Project 5 was added. The protocol includes five projects.
       
       Project 1 involves the modification of different serovars of Salmonella enterica to study invasion and intracellular survival. Genes of study will also be cloned for complementation studies. Genes involved in sugar processing and virulence factors will be deleted and replaced by reporter sequences, using homologous recombination. Genes that naturally exist in some serovars, such as genes involved in synthesis of metabolism associated genes, will be inserted into other serovars using homologous recombination. The cloning vectors used are standard cloning vectors. The antibiotics used are not used to treat infections with the organisms and resistance encoded by the plasmids does not provide cross-resistance to other types of antibiotics.
       
       Project 2 will use wild type S. enterica and the mutants generated in Project 1 to infect human cell lines to assess the cellular outcome of infection with different subtypes of S. enterica. The infected cells will be fixed and used for characterization using flow cytometry and immunofluorescence staining.
       
       Project 3 studies the typhoid toxin and its relation to pathogenesis. The typhoid toxin gene will be cloned in RG1 E. coli to make modifications. The lab will modify the sequence to express alternative subunits of the toxin. The altered toxin will replace the wild type toxin in Salmonella isolates that already carry the typhoid toxin. They are studying how differences in the binding subunit affect binding and cellular outcomes of infection in human cell lines. The modifications are configurations of the toxin that are found naturally. They will not overexpress or purify the toxin. This project is not applicable to NIH Guideline III-B-1. The IBCP has registered the experiment with the NIH OSP as required in Appendix F-1 of the NIH Guidelines.
       
       Project 4 involves the characterization and screening of wild type Salmonella enterica using PCR, transcriptomic, proteomic, microscopic, and flow cytometry analysis. There is no rsNA involved with this project.
       
       Project 5 is new for the renewal. Wild type Salmonella enterica will be used to generate a novel filtration unit to concentrate low numbers of the bacteria from large volumes, to be used in PCR detection systems. There is no rsNA involved with this project. The agents used are RG1, RG2 and human cell lines. The appropriate containment levels used are BSL-2 and BL2. The applicable NIH Guidelines are III-D-1, III-D-2, III-E, and III-F-8-C-II. The facilities were reviewed and they are appropriate for the work performed. The principal investigator has the expertise to perform the work. EHS will inspect the BSL-2 lab. The rsNA & Toxin form, PSDS files, and SOPs were reviewed and they are appropriate for the work performed. The project description requires minor edits to clarify some information, but is otherwise appropriate. No major concerns were raised, and minor edits will be required for final approval.
       
       On a motion and a second, a majority of the IBC members voted to Require Modifications to the renewal of protocol 22-041 with final review by the IBCP and biosafety officer after the edits are completed [19 of 19 members present voted to Require Modifications to the protocol].
        
4. Other Business
   
   No other business was discussed.
   
   
5. Public Comments
   
   There were no public comments.
   
   
6. The next regularly scheduled IBC meeting will be held on Tuesday, Nov. 11, 2025, from 2 - 5 p.m.
   
   
7. With no further business, and with no objections from the members, the Chair adjourned the meeting at 4:10 p.m.

Minutes recorded by R. Allen.