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Institutional Biosafety Committee (IBC)

The Institutional Biosafety Committee (IBC) functions as the UCR review body responsible for approval and oversight of activities involving the use, storage and handling of biohazardous materials (defined below), in accordance with the NIH's Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), the CDC's Biosafety in Microbiological and Biomedical Laboratories (BMBL), and other regulatory or guidance documents. The IBC may choose to implement additional guidelines or policies based on risk assessments as outlined in the IBC Charter.
 

What materials are under IBC purview?

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Teaching and research laboratories that uses or stores biohazardous materials must submit a Biological Use Authorization application. The term “biohazardous materials” includes:

  • Recombinant/synthetic nucleic acid molecules and genetically-modified organisms, as covered by the NIH Guidelines
  • Potentially infectious organisms (typically Risk Group 2 or greater organisms) such as viruses, bacteria, fungi, or prions that can cause disease in humans or cause significant environmental or agricultural impact
  • Select agents and select toxins, as covered by the CDC's Division of Select Agents and Toxins (DSAT) regulations
  • Human and nonhuman primate materials (including established cell lines), as covered by the Cal/OSHA Bloodborne Pathogen Standard
  • At its discretion or upon IACUC request, the IBC may also review protocols involving animals or animal specimens known to be reservoirs/vectors of zoonotic diseases
  • Dual Use Research of Concern (DURC) and/or Gain-of-Function (GOF)
  • Materials not within the IBC purview by regulation, that UCR may add to IBC oversight: 
    • Plant infectious agents or other infectious agents with potential environmental impact
    • Exotic arthropods or microorganisms
    • Biological materials requiring an APHIS, CDFA, EPA or other governmental permit
       
risk groups and biosafety levels

 

*Risk Group does not necessarily equate to the corresponding biosafety level.  The IBC will determine the appropriate biosafety level based on risk assessment

 

Do I have to submit a BUA application?

A Biological Use Authorization (BUA) is required for every laboratory that uses or stores biohazardous materials. The term “biohazardous materials” includes:

  • Recombinant/synthetic nucleic acid molecules and genetically-modified organisms, as covered by the NIH Guidelines
  • Potentially infectious organisms (typically Risk Group 2 or greater organisms) such as viruses, bacteria, fungi, or prions that can cause disease in humans or cause significant environmental or agricultural impact
  • Select agents and select toxins, as covered by the CDC's Division of Select Agents and Toxins (DSAT) regulations
  • Human and nonhuman primate materials (including established cell lines), as covered by the Cal/OSHA Bloodborne Pathogen Standard
  • At its discretion or upon IACUC request, the IBC may also review protocols involving animals or animal specimens known to be reservoirs/vectors of zoonotic diseases
  • Dual Use Research of Concern (DURC)
  • Materials not within the IBC purview by regulation, that UCR may add to IBC oversight:
    • Plant infectious agents or other infectious agents with potential environmental impact, exotic arthropods, exotic microorganisms, BSL-1 microorganisms, biological material requiring an APHIS, CDFA, EPA or other governmental permit.