Intellectual Property & Technology
ETSU Policies for the Use of Recombinant DNA
The Recombinant DNA
Subcommittee of the ETSU Biosafety Committee has responsibility for
reviewing all experimentation that involves the use of
recombinant DNA and recommending the appropriate course of
action to the Biosafety Committee for a decision. The Biosafety
Committee functions on behalf of ETSU in matters of compliance with
applicable federal and state regulations regarding the use of
Institutes of Health (NIH) has grouped Recombinant DNA experiments
into the following six categories:
Section 1. Exempt Experiments The following recombinant DNA molecules are exempt.
(PI must complete part of the registration
document linked at the top of this page and submit it to the
that are not in organisms or viruses.
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.
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)
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.
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 Committee Notice Simultaneous with Initiation of the
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.
involving formation of recombinant DNA molecules containing no more
than two-thirds of the genome of any eukaryotic virus.
involving whole plants (involving use of non-pathogenic plant
microorganisms, or recombinant plants with non-hazardous
involving transgenic rodents.
Section 3. Experiments that Require ETSU Biosafety Committee Approval Before
using the following risk groups as defined in NIH Guidelines for
Research Involving Recombinant DNA Molecules (January 2001;
http://www4.od.nih.gov/oba): Risk Group 2, Risk Group 3, Risk
Group 4, or Restricted Agents as Host-Vector Systems.
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.
involving the use of infectious DNA or RNA Viruses or Defective DNA
or RNA viruses in the presence of helper virus in tissue culture
involving whole animals.
involving whole plants (involving use of pathogenic plant
microorganisms/insects, or recombinant plants with potentially
involving more than 10 liters of culture.
Section 4. Experiments that
Require Institutional Biosafety Committee Approval, Approval of the
Recombinant DNA Advisory Committee (RAC) of the NIH, and NIH
Director Approval Before Initiation
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
Require NIH/Office of Biotechnology Activities (OBA) and
Institutional Biosafety Committee Approval Before Initiation
that involve the cloning of toxin molecules with LD50 of less than
100 nanograms per kilogram of body weight are included in this
Section 6. Experiments that
Require ETSU Biosafety Committee and Institutional Review Board
Approvals and RAC Review Before Research Participant Enrollment
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
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