We completed all required safety and compliance steps with our institution's Environmental Health & Safety (EH&S) to ensure we used Pseudomonas aeruginosa Exotoxin A (ExoA) safely. Our ExoA gene fragments were engineered and handled in non-toxic, non-functional forms, and our work received approval from the National Institutes of Health (NIH) and our Institutional Biosafety Committee (IBC). The IBC reviews and approves research involving recombinant or synthetic nucleic acids and other biohazards, and it operates under the NIH Guidelines.
Regulatory References
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, including toxin-gene provisions in Appendix F.
- NIH Office of Science Policy FAQs on toxin experiments and NIH registration requirements.
- CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL), the national biosafety best-practice reference.
- UW EH&S policies and tools for IBC review, BUA applications, Bloodborne Pathogens, and Lab R.A.T. risk assessments.
Document Index
| Title | Description | Access |
|---|---|---|
| Biological Use Authorization (BUA) | IBC-approved description of our project’s organisms, nucleic acids, engineered ExoA fragments, containment level, facilities, PPE, training, and waste streams. Required for biohazard work and reviewed at least every three years. | BUA Documents |
| Institutional Biosafety Committee (IBC) Approval Letter(s) | Formal IBC approval notices corresponding to our BUA and any amendments. Confirms scope, containment, and required practices. | IBC Approval Letters |
| Bloodborne Pathogen (BBP) Exposure Control Plan — Site-Specific | Supplement to UW’s Core BBP Plan detailing covered personnel, tasks, PPE, decontamination, sharps, and exposure response procedures for our lab. Template and core plan per UW EH&S. | Site-specific BBP Plan |
| Laboratory Risk Assessment Tool (Lab R.A.T.) | Step-by-step hazard identification and risk controls for each protocol step. Includes chemical, biological, and procedural risks for ExoA fragments and associated assays. | Completed Lab R.A.T. |
| Standard Operating Procedures (SOPs) | SOPs for handling Exotoxin-A. | ExoA SOPs |
Contacts
Lab Safety Lead: Samaira Bakshi – samaira@uw.edu
PI/Faculty Sponsor: Dr. Jennifer Kong – jennkong@uw.edu