BIOLOGICAL use authorization
Acquiring biological material for research at JSNN requires a Biological Use Authorization (BUA) form that will be submitted to the appropriate UNCG or NCA&T Institutional Biosafety Committee (IBC) for review and approval. The following biological materials require approval prior to the procurement of the materials necessary to initiate the project:
- Recombinant/synthetic nucleic acid molecules in organisms including their use in animals (including arthropods) and plants.
- Human and other primate-derived substances (blood, blood products, cell lines, or tissues).
- Organisms or viruses infectious to humans, animals or plants (e.g., parasites, viruses, bacteria, fungi, prions, rickettsia) or biological materials that may contain these microorganisms.
- Select agent or toxins (human, animal, or plant) – refer to the list here at: http://www.selectagents.gov/SelectAgentsandToxinsList.html.
- Biologically active agents (e.g., venoms and toxins produced by living organisms) that may cause disease in other living organisms or cause significant impact if released into the environment.
Biological safety training
All biological material users are required to complete the annual biological safety training. Biological safety processes must be added to the lab safety plan.
Bloodborne Pathogen Safety
The OSHA Bloodborne Pathogen Program applies to all employees and students who may have exposure to human blood, blood products, tissues, or cells. Examples include (but are not limited to):
- Staff with job duties that require them to protect others by immediately cleaning up small blood spills or confine large spills for proper clean-up
- Laboratory workers handling human blood, tissue, or established human cell lines or waste from such procedures
- Designated emergency teams that perform spill clean-up response
To be compliant with OSHA Bloodborne Pathogens standards, PIs must complete the following:
- The Model Exposure Control Plan is completed by the supervisor/principal investigator. Plans must be updated annually and be available to workers at all times.
- Hepatitis B vaccinations must be offered to the worker within 10 days of assignment to duties covered under the Exposure Control Plan or be officially declined. Review the guidance provided by the Centers for Disease Control
- Training requirements for bloodborne pathogens must be completed by each employee/student according to instructions provided in their specific Bloodborne Pathogens Exposure Control Plan, within 10 days of assignment to duties covered under the Exposure Control Plan, and annually thereafter.
- Reviewing Safer Sharps Devices is a requirement of the Exposure Control Plan. Use the resources from the CDC ‘Stop Sticks’ program to help you review your sharps devices: https://www.cdc.gov/nora/councils/hcsa/stopsticks/default.html. This CDC resource provides guidance to elicit feedback on safer sharps devices used in your work area: https://www.cdc.gov/sharpssafety/a13.html
- A copy of the OSHA Bloodborne pathogen standard must be made available to all employees upon request. Laboratories should review the June 21,1994 OSHA interpretation letter which provides additional insight on the applicability of the OSHA BBP standard to established human cell lines. Employees must complete the training within 10 days of assignment.
Biological waste disposal
Biological waste must be autoclaved before disposal. Autoclave safety training is required for all autoclave users. See the JSNN biological waste disposal flow chart for more information on proper disposal of different types of biological wastes. Mixture of the hazardous chemicals and biological material shall not be autoclaved. Use chemical disinfection with proper contact time and dispose of based on your IBC approval.
Requirements for using an autoclave
- Autoclave use log is posted
- Autoclave user manual is available
- SOPs for maintenance and malfunction are posted
- Vendor has trained end users
- Autoclave use is listed as a process on lab safety plan
- All autoclaves greater than 5 cubic feet meet boiler certification requirements which includes being posted according to the NC DOL Boiler Safety Bureau (see laws regarding boiler certification requirements)
- Proper Use of a Steam Autoclave is posted at the autoclave
- Users have received hands-on training from their supervisor or lab designee on each autoclave device unit they use.
- The Safe Use of Autoclaves training has been developed to supplement hands-on training for users. It covers the basics of how to safely operate an autoclave.
Shipping biological materials
Shipping hazardous materials, including biologicals, will require DOT/IATA training. Please contact ROEHS for more information.
Biological materials spill
Contact ROEHS at 336-285-2878 (normal working hours) or 919-357-1134 (after hours) for assistance with biological spills clean up. Do not attempt cleaning up spilled material without ROEHS approval. Make sure that your IBS spill clean up procedure is available and followed.