June 10, 2025 Institutional Biosafety Committee Meeting Minutes

Present

Paige Bordwine (local non-affiliated member), Amy Brunner (plant containment expert), Clayton Caswell (Chair, bacteriology), Alan Ealy (animal science), Erin Gloag (bacteriology), Aaron Gross (entomology), Karen Hall (animal containment expert), Sandy Hancock (lab facilities), Timothy Jarome (Vice Chair, neurobiology), Kristin Knight (high containment), Katherine LaVallee (animal containment expert), Michael Miles (biosafety officer), Dennis Nolan (health and safety), Sally Paulson (virology), Pamela Ray (public health), Igor Sharakhov (gene drive modified organism expert), Laurie Spotswood (local non-affiliated member)

Excused Absences

Beth Ahner (animal containment expert), Jen Averill (public safety), Andrea Bertke (virology), Calvin Lau (animal containment expert), Andrew Marinik (emergency management), Mike Mulhare (public safety), Xiaofeng Wang (plant containment expert), James Weger (virology)

Guests

Regina Allen (IBC non-voting contact, IBC Program), Ling Chen (IBC Program), Anna Kroner (biosafety officer; alternate member), 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. 16 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 May 13, 2025 were reviewed at this time. No edits were requested [15 of 16 members present voted to approve the minutes; 1 of 16 members present abstained].
   
   Paige Bordwine left the meeting. There are 15 voting members present.
   
   
3. One renewal submission and three amendment submissions were discussed.
   
   
   1. Protocol 22-017, renewal submission. Dr. Parker, did not attend the meeting. The protocol includes three projects that use commercially available recombinant cell lines, mice, and non-replicative and purified AAV vector systems that express reporters, opsins, and chemogenetic proteins. The AAV-infected cells are used for in vitro analyses using toxins that are not applicable to select agent regulations. 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, biosafety manual, and SOP were reviewed. Each document has minor edits that are needed, but are all 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 22-017 with final review by the IBC Program and BSO after the edits are completed [15 of 15 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 21-038, amendment submission. Dr. Duggal, did not attend the meeting. The amendment is to generate an Australian Japanese Encephalitis virus strain using recombinant methods to synthesize the virus using synthetic sequences from a vendor, for use in cell culture, mosquito infection, and bird infection experiments using previously approved SOPs.
      
      The natural sequence of the Australian strain will not be modified. There is no evidence that the Australian strain is more virulent or that disease symptoms are different with this strain, and therefore there are no additional risks associated with the generation and use of the Australian JEV strain. The project description needs minor edits to clarify strain details. Two projects were also removed for the amendment. For the amendment, the agent is RG3. The appropriate containment levels used are BSL-3, BL3, ACL-3, and ABSL-3.
      
      The applicable NIH Guidelines are III-D-1, III-D-2, III-D-3, and III-D-4. The facilities were reviewed and they are appropriate for the work performed. The researchers’ experience, vaccination requirements, rsNA & Toxin form, biosafety manual, and SOPs were reviewed and they are appropriate. The animal care staff form needs a minor edit to clarify PPE for facility staff and is otherwise appropriate. A new lab inspection is not required at this time. 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 21-038 with final review by the Primary Reviewer [17 of 17 members present voted to Require Modifications to the amendment].
      
      
   3. Protocol 22-023, amendment submission. Dr. Meng, did not attend the meeting. The lab studies Hepatitis E Virus replication and pathogenesis. The amendment is to add the use of commercially available CRISPR/Cas9/GFP kits to knock out two lipid synthesis genes in commercially available human liver cells to assess the effect of the knocked-out genes on HEV replication.
      
      Transfection of the cells will occur using lipofectamine. After transfection, uninfected knockout cells will be sorted by the FLSI flow cytometry core, which is approved for sorting of live human cells. The agents used for the amendment are RG2 and human cells. The appropriate containment levels used are BSL-2 and BL1.
      
      The applicable NIH Guideline for the amendment is III-E. The facilities were reviewed and they are appropriate for the work performed. The researchers’ experience and SOPs were reviewed and they are appropriate. The rsNA & Toxin form and biosafety manual have minor administrative errors that need to be edited, and are otherwise appropriate. A new lab inspection is not required at this time. 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 22-023 with final review by the IBCP [17 of 17 members present voted to Require Modifications to the amendment].
      
      
   4. Protocol 20-055, an amendment submission, was discussed at this time. Dr. Smyth, did not attend the meeting. The amendment adds Project 2 to the protocol, to study the role of wild type Coxsackie Virus infection in heart dysfunction and pulmonary hypertension in commercially available cell lines, and in commercially available transgenic mouse models that are exempt from the NIH Guidelines. The agents used are RG2 and human cells. The containment levels used are BSL-2, BL2, BSL-1, BL1, ABSL-1, and ABSL-2.
      
      The applicable NIH Guidelines for the amendment are III-D-4 and III-F-8-C-VII. The facilities were reviewed and they are appropriate for the work performed. The researchers’ experience, rsNA & Toxin form, and SOPs were reviewed and they are appropriate. The biosafety manual has a minor administrative error that needs to be edited, and is otherwise appropriate. A new lab inspection is not required at this time. 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 20-055 with final review by the IBC Program and BSO [17 of 17 members present voted to Require Modifications to the amendment].
       
4. Other Business
   The IBC members reviewed edits made to the IBC Meeting Minutes Standard. On a motion and a second, a majority of the IBC members voted to Approve the edits [17 of 17 members present voted to Approve].
   
   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, Jul. 8, 2025, from 2 - 5 p.m.
   
   
7. With no further business, and with no objections from the members, the Chair adjourned the meeting at 2:46 p.m.

Minutes recorded by R. Allen.