July 8, 2025 Institutional Biosafety Committee Meeting Minutes

Present

Beth Ahner (animal containment expert), Amy Brunner (plant containment expert), Clayton Caswell (Chair, bacteriology), Aaron Gross (entomology), Karen Hall (animal containment expert), Sandy Hancock (lab facilities), Timothy Jarome (Vice Chair, neurobiology), Katherine LaVallee (animal containment expert), Michael Miles (biosafety officer), Dennis Nolan (health and safety), Sally Paulson (virology), Igor Sharakhov (gene drive modified organism expert), Xiaofeng Wang (plant containment expert), James Weger (virology)

Excused Absences

Jen Averill (public safety), Andrea Bertke (virology), Paige Bordwine (local non-affiliated member), Alan Ealy (animal science), Erin Gloag (bacteriology), Kristin Knight (high containment), Calvin Lau (animal containment expert), Andrew Marinik (emergency management), Mike Mulhare (public safety), Pamela Ray (public health), Laurie Spotswood (local non-affiliated member)

Guests

Regina Allen (IBC non-voting contact, IBC Program), Ling Chen (IBC Program), Anna Kroner (biosafety officer; alternate member), John Maurer (Professor, School of Animal Sciences), Sarah Owen (health and safety), Allison Price (health and safety), Charlotte Waggoner (university biosafety officer; non-voting alternate), Barbara Wise (FLSI research operations)

Quorum

Five members are required to conduct business. 13 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 IBC Program director provided an update on the status of the minutes of the IBC meeting held on June 10, 2025. Legal counsel is still reviewing the minutes. When their review is complete, the minutes will be provided to the IBC for review for approval and posting on the website.
   
   
3. Four renewal submissions and six amendment submissions were discussed.
   
   
   1. Protocol 22-035, renewal submission. Dr. Maurer attended the meeting and provided an overview of the lab’s current projects. The principal investigator left the meeting during the IBC’s discussion and vote. There is no rsNA involved with the protocol, and therefore the work is not applicable to the NIH Guidelines. The protocol involves work with RG2 organisms and natural antibiotic resistance acquisition. 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 renewal of protocol 22-035 with final review by the primary reviewer and biosafety officer [13 of 13 members present voted to Require Modifications to the protocol].
      
      
   2. Protocol 20-027, amendment submission. Dr. Kehn-Hall; did not attend the meeting. The amendment is to perform in vitro cell culture experiments to study proteomics and antiviral testing using recombinant Cedar Virus strains that express florescent reporters and Cedar Virus chimeras that have the F and G genes of either Nipah or Hendra Virus.
      
      The Cedar Virus strains will all be obtained from an external collaborator. The lab at Virginia Tech will receive the viruses, not the plasmids, and they will not further modify the viruses. The chimeras were generated by the collaborator using synthetic sequences, so there is no risk of contaminating nucleic acids from the wild type viruses. The principal investigator will need to confirm that the strains received contain only the expected mutations. The principal investigator has proposed that the Cedar Virus and recombinant strains and chimeras meet the definition of risk group 2 and has requested to perform the work at BSL-2.
      
      The IBC reviewed and discussed the genes involved with the chimeras and the genes involved in the pathogenicity of the viruses. The IBC determined that BSL-2 and BL2 containment practices are acceptable for the work proposed. Cedar Virus is not listed in Appendix B of the NIH Guidelines, so final approval by the NIH Office of Science Policy for the use of BL2 containment will be required.
      
      The applicable NIH Guideline is III-D-3. The facilities were reviewed and they are appropriate for the work performed. The researchers’ experience, rsNA & Toxin form, biosafety manual, and SOPs were reviewed and they are appropriate. A new lab inspection is not required at this time. No major concerns were raised. Minor edits and NIH OSP’s approval 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 20-027 with final review by the IBCP [13 of 13 members present voted to Require Modifications to the amendment].
      Katie LaVallee joined the meeting. There are 14 voting members present.
      
      
   3. Protocol 25-021, renewal submission for 22-021. Dr. Eastwood; did not attend the meeting. There is no rsNA involved with the protocol, and therefore the work is not applicable to the NIH Guidelines. None of the members had a conflict of interest with the protocol.
      
      The protocol involves work with wild type ticks, wild type mosquitoes, and RG2 and RG3 organisms to perform surveillance studies and to study pathogen ecology, vector competence, and transmission potential. The members discussed the experiments, risk assessment, SOPs, training, and PPE. For the renewal, completed projects were removed. 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 25-021 with final review by the primary reviewer and biosafety officer [14 of 14 members present voted to Require Modifications to the protocol].
      
      
   4. Protocol 20-063, amendment submission. Dr. Smyth; did not attend the meeting. The lab studies intercellular communication of adenovirus and has worked with wild type murine adenovirus Type 3. The amendment is to include the use of a recombinant murine adenovirus Type 3 that expresses GFP. 
      
      The recombinant strain will be obtained from an external collaborator. It will be used for in vitro cell culture studies using human and murine cells and for in vivo experiments with wild type mice. The agents used for the amendment are RG2 and human and murine cells. The appropriate containment levels used are BSL-2, BL2, and ABSL-2.
      
      The applicable NIH Guidelines for the amendment are III-D-3 and III-D-4. The facilities were reviewed and they are appropriate for the work performed. The researchers’ experience, SOPs, rsNA & Toxin form, and biosafety manual were reviewed and they are appropriate. A new lab inspection is not required at this time. No major concerns were raised, and no edits are required.
      
      On a motion and a second, a majority of the IBC members voted to Approve the amendment of protocol 20-063 [14 of 14 members present voted to Approve the amendment].
      Beth Ahner left the meeting. There are 13 voting members present.
      
      
   5. Protocol 21-067, amendment submission. Dr. Ealy; did not attend the meeting. The amendment is to add a new project to use CRISPR Cas9 systems to knockout target interferon genes in bovine one-cell embryos, using electroporation.
      
      The embryos will not be implanted. They will be used for in vitro functional assays and co-culturing assays with bovine cells to study how loss of the genes influences gene, protein, and metabolite profiles. Additionally, an antiviral assay will be developed to monitor interferon protein production in bovine kidney cells that are treated with a wild type Indiana strain of vesicular stomatitis virus. The agents used for the amendment are RG2 and bovine cells. The appropriate containment levels used are BSL-1, BSL-2, BL1, and BL2.
      
      The applicable NIH Guidelines for the amendment are III-D-3 and III-E. The facilities were reviewed and they are appropriate for the work performed. The researchers’ experience, SOPs, rsNA & Toxin form, and biosafety manual were reviewed and they are appropriate. A new lab inspection is not required at this time. No major concerns were raised, and no edits are required.
      
      On a motion and a second, a majority of the IBC members voted to Approve the amendment of protocol 21-067 [13 of 13 members present voted to Approve the amendment].
      
      Igor Sharakhov left the meeting. There are 12 voting members present.
      
      
   6. Protocol 22-031, renewal submission. Dr. Morozov; did not attend the meeting. The protocol uses non-replicative and purified AAV vector systems that express reporters, opsins, and chemogenetic proteins in wild type and transgenic mice to characterize neuronal microcircuits and to identify therapeutic targets for mental disorders. The recombinant AAV and the transgenic mice are obtained from vendors. The agents used are RG1. 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 BSL-1 self-inspection checklist, rsNA & Toxin form, and SOPs were reviewed and they are appropriate for the work performed. The biosafety manual has a minor edit that is needed, 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 22-031 with final review by the IBCP and biosafety officer after the edits are completed [12 of 12 members present voted to Require Modifications to the protocol].
      
      Beth Ahner returned to the meeting and Dennis Nolan left. There are 12 voting members present.
      
      
   7. Protocol 21-072, amendment submission. Dr. Gourdie; did not attend the meeting. The amendment is to change the principal investigator to Dr. Gourdie. The previous principal investigator has left Virginia Tech. The lab is finishing projects and will be closed out this Fall.
      
      The lab studies genes involved in cardiac insulin signaling and circadian cycle regulation. Human cell lines are transfected with replication deficient adenovirus vectors, that are generated in the lab, that express shRNAs to increase or decrease expression the genes of interest. Transgenic mouse models to study cardiac insulin signaling and circadian cycle regulation genes are used purchased from vendors. Recombinant replication-deficient AAV vectors, that are purchased from vendors and purified, are administered to the mouse models to re-express or knockdown the targeted genes to study the function of the genes.
      
      The principal investigator has experience working with the agents being used and performing the procedures described. His expertise is adequate to act as the new principal investigator. The agents used for the amendment are RG1, RG2 and human cells. The appropriate containment levels used are BSL-1, BSL-2, BL1, BL2, and ABSL-1.
      
      The applicable NIH Guidelines for the amendment are III-D-1, III-D-2, III-D-3, III-D-4, and 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 SOPs, rsNA & Toxin form, and biosafety manual were reviewed and they are appropriate. A new lab inspection is not required at this time. No major concerns were raised, and no edits are required.
      
      On a motion and a second, a majority of the IBC members voted to Approve the amendment of protocol 21-072 [12 of 12 members present voted to Approve the amendment].
      
      
   8. Protocol 25-007, amendment submission. Dr. Ghosh; did not attend the meeting. The amendment is to include experiments to characterize the sugar-binding specificity of lectin-based probes that were developed under the original protocol. They will develop a platform to recombinantly express and purify hemagglutinin glycoprotein ectodomains in Human Embryonic Kidney cells and Chicken Embryonic Fibroblast cell lines, to mimic viral glycosylation through the host glycosylation machinery.
      
      The ectodomains will be synthetic sequences based on Influenza A. The cells will be fixed for imaging and flow cytometry to test the binding of the probes. The lab will not work with live viruses. They will obtain the hemagglutinin glycoprotein ectodomains from vendors, and will clone them into eukaryotic expression vectors. The use of human cells will require the lab to be approved for BSL-2 work. The agents used are RG1 and human and chicken cells. The appropriate containment levels used are BSL-1, BSL-2, BL1, and BL2.
      
      The applicable NIH Guidelines for the amendment are III-D-2, III-D-7, III-E, III-F-8-C-I, III-F-8-C-II. The facilities were inspected and they are appropriate for the work proposed. The researchers’ experience, SOPs, rsNA & Toxin form, and biosafety manual were reviewed and they are appropriate. No major concerns were raised, and no edits are required.
      
      On a motion and a second, a majority of the IBC members voted to Approve the amendment of protocol 25-007 [12 of 12 members present voted to Approve the amendment].
      
      
   9. Protocol 22-025, renewal submission. Dr. Cohen did not attend the meeting. There is no rsNA involved with the protocol, and therefore the work is not applicable to the NIH Guidelines. The lab analyzes drinking water, wastewater, and human samples for microbiological and chemical contaminants and physiochemical parameters. 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 renewal of protocol 22-025 with final review by the IBCP and biosafety officer [12 of 12 members present voted to Require Modifications to the protocol].
      
      
   10. Protocol 23-033, an amendment submission, was discussed at this time. Dr. Leisner, did not attend the meeting. There is no rsNA involved with the protocol, and therefore the work is not applicable to the NIH Guidelines. The amendment adds a project to study temperature impacts on pepper plant pathogens. The plant pathogens are not pathogenic to humans and are endemic to Blacksburg, Virginia. 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 of protocol 23-033 with final review by the IBCP [12 of 12 members present voted to Require Modifications to the amendment].
        
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, Aug. 12, 2025, from 2 - 5 p.m.
   
   
7. With no further business, and with no objections from the members, the Chair adjourned the meeting at 3:26 p.m.

Minutes recorded by R. Allen.