Recombinant DNA or Synthetic Nucleic Acid


The Recombinant or Synthetic Nucleic Acid Subcommittee of the ETSU Biosafety and Chemical Safety Committee has responsibility for reviewing all experimentation that involves the use of recombinant or synthetic nucleic acid and recommending the appropriate course of action to the Biosafety and Chemical Safety Committee for a decision. The Biosafety and Chemical Safety Committee functions on behalf of ETSU in matters of compliance with applicable federal and state regulations regarding the use of recombinant and synthetic nucleic acid.

The National Institutes of Health (NIH) has grouped Recombinant and Synthetic Nucleic Acid experiments into the following six categories: 


Section 1. Exempt Experiments

The following recombinant DNA molecules are exempt. (PI must complete part of the registration form linked from this page and submit it to the Biosafety and Chemical Safety Committee). Section III F:
http://oba.od.nih.gov/rdna/nih_guidelines_new.htm#_Toc331174008

  • Those that are not in organisms or viruses.
  • Those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.  Note that cloned DNA segments from eukaryotic viruses fall under category 5. 
  • Those that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means. 
  • Those that consist entirely of DNA from an eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species)
  • Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent.  A list of such exchangers will be prepared and periodically revised by the NIH Director with the advice of the RAC. 
  • Those that do not present a significant risk to health or environment, as determined by the NIH Director, with advice of the RAC.   

Section 2. Experiments that Require ETSU Biosafety and Chemical Safety Committee Notice Simultaneous with Initiation of the Experiment. Section III E:
http://oba.od.nih.gov/rdna/nih_guidelines_new.htm#_Toc331174004  

  • Experiments not included in categories 1-4 or 6, are considered category 5.  All such experiments may be conducted at BL 1 containment.  For example, experiments in which all components derived from non-pathogenic prokaryotes and non-pathogenic lower eukaryotes may be conducted at BL 1 containment. 
  • Experiments involving formation of recombinant DNA molecules containing no more than two-thirds of the genome of any eukaryotic virus. 
  • Experiments involving whole plants (involving use of non-pathogenic plant microorganisms, or recombinant plants with non-hazardous properties). 
  • Experiments involving transgenic rodents.  

Section 3. Experiments that Require ETSU Biosafety and Chemical Safety Committee Approval Before Initiation. Section III D:
http://oba.od.nih.gov/rdna/nih_guidelines_new.htm#_Toc331173996   

  • Experiments using the following risk groups as defined in NIH Guidelines for Research Involving Recombinant DNA Molecules ( http://oba.od.nih.gov/oba/):  Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as Host-Vector Systems. 
  • Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems. 
  • Experiments involving the use of infectious DNA or RNA Viruses or Defective DNA or RNA viruses in the presence of helper virus in tissue culture systems.
  • Experiments involving whole animals.
  • Experiments involving whole plants (involving use of pathogenic plant microorganisms/insects, or recombinant plants with potentially hazardous properties). 
  • Experiments involving more than 10 liters of culture.  

Section 4. Experiments that Require Institutional Biosafety and Chemical Safety Committee Approval, Approval of the Recombinant DNA Advisory Committee (RAC) of the NIH, and NIH Director Approval Before Initiation. Section III A:
http://oba.od.nih.gov/rdna/nih_guidelines_new.htm#_Toc331173989

  • Experiments that involve the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture, will be reviewed at this level.  

Section 5. Experiments that Required NIH/Office of Biotechnology Activities (OBA) and Institutional Biosafety Committee Approval Before Initiation. Section III B:
http://oba.od.nih.gov/rdna/nih_guidelines_new.htm#_Toc331173991

  • Experiments that involve the cloning of toxin molecules with LD50 of less than 100 nanograms per kilogram of body weight are included in this category. 

Section 6. Experiments that Require ETSU Biosafety and Chemical Safety Committee and Institutional Review Board Approvals and RAC Review Before Research Participant Enrollment. Section III C:
http://oba.od.nih.gov/rdna/nih_guidelines_new.htm#_Toc331173994

  • Experiments involving the deliberate transfer of recombinant DNA or DNA or RNA derived from recombinant DNA into one or more human research participants are included in this category. Note that RAC approval must be granted before the Biosafety Committee can approve any such protocol.


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