Biological Safety

The primary objective of the OSU CHS Biosafety Program is to ensure a safe working environment for faculty, staff and students. In pursuit of this goal, our office ensures that laboratory facilities and operations conform to the regulatory requirements as set by the OSU CHS Institutional Biosafety Committee (IBC), and federal agencies such as the National Institutes of Health (NIH) and the Occupational Safety and Health Administration (OSHA). To mitigate the inherent risks associated with the laboratory setting, we seek to build a culture of safe work practices at the university.

What is the Institutional Biosafety Committee?

The University requires Institutional Biosafety Committee (IBC) review and approval of activities involving biohazardous material prior to initiating the activity. This includes activities involving recombinant or synthetic nucleic acid molecules that qualify for exemption from the NIH Guidelines. Agents (e.g., faculty, researchers, staff, students, and employees) of OSU CHS may only self-exempt for activities involving synthetic nucleic acid molecules that cannot replicate or generate nucleic acids that can subsequently replicate in any living cell (e.g., oligonucleotides). Examples of synthetic nucleic acid molecules which researchers cannot self-exempt include those designed for use in human gene transfer experiments, those that contain genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD₅₀ of less than 100 ng/kg body weight (e.g., microbial toxins such as the botulinum toxins, tetanus toxin, diphtheria toxin, and Shigella dysenteriae neurotoxin), and those that are designed for generation of transgenic plants or animals. All other activities involving recombinant or synthetic nucleic acids, biological agents, and/or biologically-derived toxins require IBC approval prior to initiation. For these activities, principal investigators must conduct risk assessments and submit an application for IBC review.

The role of the IBC and the Principal Investigator is further detailed in these documents:

OSU CHS Institutional Biosafety policy

OSU CHS Biosafety Manual

What needs IBC approval?

The IBC is responsible for reviewing and approving activities, such as research, instructional, and testing with:

• any recombinant DNA activity (refer to this summary);
• any transgenic animal (cross-over review with IACUC);
• human or animal blood, bodily fluids, or tissues (use of human blood and body fluid for clinical, diagnostic, and treatment purposes is excluded);
• known infectious materials;
• Select Agents, including exempt amounts;
• any infectious agents in Risk Group 2, 3, or 4; and/or
• experiments with transgenic plants.

* All other activities involving biohazardous materials not specifically outlined in the list above can be considered by the IBC on a case by case basis

How do I get started?

If you plan to conduct activities with biohazardous materials, you must:

• Submit an application via Cayuse.
• One component of the IBC approval process is satisfactory completion of an inspection of laboratories/facilities that are classified as biosafety containment level 1, 2 or 3. Facilities designated BSL2 or greater must be re-inspected every three years. The biosafety officer will use this inspection checklist Laboratory Biosafety Level 2 Registration and Inspection Report, or this one Animal Biosafety Level 2 Registration and Inspection Report
• Another component of the IBC approval process is generation of a Lab Specific Biosafety Plan (example). Once drafted send to chsibc@okstate.edu for review.

What biosafety training is required?

Training is required initially for all those working with biohazards as determined by the principal investigator/supervisor. Refresher training is required every three years.

Training Instructions (PDF)

There was an incident. What do I do?

All incidents must be reported immediately to the laboratory PI or manager. The IBC requires all laboratory biosafety incidents occurring in a BSL-2 or BSL-3 space to be reported to the Biosafety Officer (BSO) within 48 hours. Large spills of biohazardous material (i.e., >10 mL in volume) that occur outside of primary containment should be immediately reported to the BSO. An

Employee Injury Report must be taken as directed by the OSU CHS Occupational Health Nurse with the injured person if the person is seen by a health care professional. If the injured person is not seen by a health care professional the Report shall be submitted to the OSU-Tulsa Safety Manager, fax (918) 561-1261, with a copy sent to chslabsafety@okstate.edu

If there is a biohazard spill, please follow these procedures: Biohazard Spill Response Standard Operating Procedure (SOP).

Emergency & Incident Response is also addressed in the OSU CHS Biosafety Manual.

Other relevant policies and guidance

• Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH)
• Guidelines for Biosafety in Teaching Laboratories
• Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories
• CDC Office of Health and Safety-Biosafety
• American Biological Safety Association
• The National Pesticide Information Center (NPIC)
• Canadian MSDS's for Infectious Agents
• Occupational Safety and Health Administration (OSHA) – Biological Agents
• American Type Culture Collection
• Virus Databases Online
• Journal of Gene Medicine
• Knowing How to Practice Safe Science (Howard Hughes Institute)
• OIE - World Organization for Animal Health
• Argonne National Laboratory
• Biosafety in Microbiological Laboratories (BMBL)
• Select Agent Program
• Laboratory Biosafety Manual (World Health Organization)
• NIH Office of Biotechnology Activities
• Dual Use Research of Concern Program
• Risk Group Classification for Infectious Agent
• American Biological Safety Association “Risk Group Database”
• CDC Permit to Import or Transport Etiologic Agents, Hosts, or Vectors of Human Disease

IBC Members

• IBC Member Guidance Documents
  • IBC Member- Cayuse Manual (pdf)
  • IBC Member- How to Submit a Review (pdf)
  • IBC Member- How to Submit a Review (video)

IBC Minutes

On March 28, 2025, the National Institutes of Health (NIH) published the following Implementation Update: Promoting Maximal Transparency Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
In accordance with this update, for all OSU IBC meetings taking place on or after June 1, 2025, the OSU IBC will post approved meeting minutes here. IBC meeting minutes will be posted immediately after approval and after all appropriate and allowable redactions for proprietary or security-sensitive information are made.