Registration and Review of Exempt Protocols - Recombinant and Synthetic Nucleic Acids (r/sNA)

IBC Standard Operating Procedure

It is anticipated that most research and instructional activities utilizing r/sNA conducted at the Institution will be exempt from IBC review according to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

Registration Procedure

  1. All exempt activities must be registered with the IBC and shall be reviewed and deemed as exempt by the IBC Chair or designee.
  2. Research discipline expert IBC members may be consulted as needed.
  3. The reviewer may request additional information or clarification.  If questions remain as to whether a project qualifies for exemption, it will be referred for review by the IBC.
  4. Modifications to the registered activities shall be submitted by the Principal Investigator (PI) prior to instituting the changes.  If a project is modified to the extent that it is no longer exempt, application for IBC Review must be submitted and approved prior to instituting the changes.
  5. Every two years, a form will be sent to the PI requesting an update on the project. 

Exempt Activities

SECTION III-F

Section III-F-1.  Those synthetic nucleic acids that

(i)    can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and

(ii)   are not designed to integrate into DNA, and

(iii)  do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight. 

 

Section III-F-2.  Those that are not in organisms, cells, or viruses and that have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes.

Section III-F-3.  Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature.

Section III-F-4.  Those that consist entirely of nucleic acids 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.

Section III-F-5.  Those that consist entirely of nucleic acids from a 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).

Section III-F-6.  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.  See Appendices A-I through A-VI, for a list of natural exchangers that are exempt.

Section III-F-7.  Those genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA.

Section III-F-8.  Those that do not present a significant risk to health or the environment (Appendix C)

APPENDIX C

For the exempt laboratory experiments outlined below Biosafety Level (BL) 1 physical containment conditions are recommended.  For large-scale fermentation experiments, the appropriate physical containment conditions need be no greater than those for the host organism unmodified by recombinant or synthetic nucleic acid molecule techniques; the Institutional Biosafety Committee can specify higher containment if deemed necessary.  

Appendix C-II.  Escherichia coli K-12 Host-Vector Systems - Experiments which use Escherichia coli K-12 host-vector systems are exempt provided that: 

(i)    the Escherichia coli host does not contain conjugation proficient plasmids or generalized transducing phages or

(ii)   lambda or lambdoid or Ff bacteriophages or non-conjugative plasmids shall be used as vectors.

However, experiments involving the insertion into Escherichia coli K-12 of DNA from prokaryotes that exchange genetic information with Escherichia coli may be performed with any Escherichia coli K-12 vector (e.g., conjugative plasmid).  When a non-conjugative vector is used, the Escherichia coli K-12 host may contain conjugation-proficient plasmids either autonomous or integrated, or generalized transducing phages. 

Appendix C-III.  Saccharomyces Host-Vector Systems - Experiments involving Saccharomyces cerevisiae and Saccharomyces uvarum host-vector systems.

Appendix C-IV.  Kluyveromyces Host-Vector Systems - Experiments involving Kluyveromyces lactis host-vector systems are exempt provided laboratory-adapted strains are used (i.e. strains that have been adapted to growth under optimal or defined laboratory conditions).

Appendix C-V.  Bacillus subtilis or Bacillus licheniformis Host-Vector Systems -  Any asporogenic Bacillus subtilis or asporogenic Bacillus licheniformis strain which does not revert to a spore-former with a frequency greater than 10-7 may be used for cloning DNA.

Bacillus amyloliquefaciens

Bacillus thuringiensis

Streptococcus cremoris

Bacillus amylosacchariticus

Clostridium acetobutylicum

Streptococcus dorans

Bacillus anthracis

Lactobacillus casei

Streptococcus equisimilis

Bacillus aterrimus

Listeria grayi

Streptococcus faecalis

Bacillus brevis

Listeria monocytogenes

Streptococcus ferus

Bacillus cereus

Listeria murrayi

Streptococcus lactis

Bacillus globigii

Pediococcus acidilactici

Streptococcus ferns

Bacillus licheniformis 

Pediococcus damnosus

Streptococcus mitior

Bacillus megaterium

Pediococcus pentosaceus

Streptococcus mutans

Bacillus natto

Staphylococcus aureus

Streptococcus pneumoniae

Bacillus niger

Staphylococcus carnosus

Streptococcus pyogenes

Bacillus pumilus

Staphylococcus epidermidis

Streptococcus salivarius

Bacillus sphaericus

Streptococcus agalactiae 

Streptococcus sanguis

Bacillus stearothermophilus

Streptococcus anginosus

Streptococcus sobrinus

Bacillus subtilis

Streptococcus avium

Streptococcus thermophilus

Appendix C-VII.  The Purchase or Transfer of Transgenic Rodents - The purchase or transfer of transgenic rodents for experiments that require BL1 containment are exempt from the NIH Guidelines.

Appendix C-VIII.  Generation of BL1 Transgenic Rodents via Breeding - The breeding of two different transgenic rodents or the breeding of a transgenic rodent and a non-transgenic rodent with the intent of creating a new strain of transgenic rodent that can be housed at BL1 containment will be exempt from the NIH Guidelines if:

(i)    both parental rodents can be housed under BL1 containment; and

(ii)   neither parental transgenic rodent contains the following genetic modifications:  (i) incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or (ii) incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR); and

(iii) the transgenic rodent that results from this breeding is not expected to contain more than one-half of an exogenous viral genome from a single family of viruses.

NOTE: The following categories are not exempt from the NIH Guidelines: 

(i)    experiments described in Section III-B which require NIH OSP and Institutional Biosafety Committee approval before initiation,

(ii)   experiments involving DNA from Risk Groups 3, 4, or restricted organisms or cells known to be infected with these agents,

(iii)  large-scale experiments (e.g., more than 10 liters of culture),

(iv) experiments involving the deliberate cloning of genes coding for the biosynthesis of molecules toxic for vertebrates, and

(v) whole plants regenerated from plant cells and tissue cultures are covered by the exemption provided they remain axenic cultures even though they differentiate into embryonic tissue and regenerate into plantlets.

IBC Approved:  October 18, 2017