Attachment A.
Recombinant Nucleic Acids, Synthetic Nucleic Acids and Viral Vectors
PI:
BUA#:
General Project Title:
Definitions:
Recombinant or Synthetic Nucleic Acid Molecules:
(i) molecules that
a) are constructed by joining nucleic acid molecules, and
b) can replicate in a living cell (i.e. recombinant nucleic acids);
(ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise
modified but can base pair with naturally occurring nucleic acid molecules (i.e. synthetic nucleic acids); or
(iii) molecules that result from the replication of those described in (i) or (ii) above.
Viral Vector:
Virus modified to introduce genetic material into a cell
Oncogene:
A gene, generally defective, that can cause a cell to divide in an unregulated manner
YES
N/A
Does your research involve recombinant or synthetic nucleic acid molecules, recombinant
or synthetic nucleic acid-containing organisms or cell cultures?
If “Not Applicable”, skip Attachment A and proceed to the next applicable attachment. If
“YES” go to the next question.
1.
YES NO
2.
i.
Are all the recombinant or synthetic nucleic acid molecules and recombinant procedures
used in your research EXEMPT from the NIH Guidelines as described in III-F Experiments
and Appendix C. of the NIH Guidelines for Research Involving Recombinant or Synthetic
Nucleic Acid Molecules? (Refer to Section vii) If “YES” to all EXEMPT recombinant
activities, complete and submit Attachment A and General BUA Application (Sections I-III
and VIII only) for IBC review and registration. If “NO” complete all of General BUA
Application, Attachment A and all other applicable attachments.
Recombinant or Synthetic Nucleic Acids and Vector Summary (Check all that apply)
This project involves:
Foreign nucleic acids inserted into a vector or organism for the purpose of cloning. The nucleic acid to be cloned
will:
be from a Risk Group (RG) 3 agent;
represents more than two-thirds of the genome of a RG1 or 2 agent;
encode a known oncogene;
encode molecules known to be toxic to vertebrates at concentrations less than 1 mg/ml;
encode molecules that impart pharmaceutical resistance;
contain synthetic nucleic acid
Construction and/or use of synthetic DNA/RNA (e.g., probes, DNA or RNA oligonucleotides, base-pair analogs).
Creation of c-DNA/genomic libraries
DNA/RNA sequencing
Recombinants or synthetics are expected to alter virulence or infectivity, change resistance or susceptibility to drug
therapy, or change host range.
Recombinants or synthetics are deliberately created for the biosynthesis of toxin molecules with an LD50 of less than
100nanogram per kilogram body weight.
The host into which I am introducing foreign DNA is a cell or organism other than E. coli K12 or its derivatives,
Saccharomyces cerevisiae, S. uvarum, Bacillus subtilis or B. licheniformis.
Use of recombinant or synthetic nucleic acids in animals (somatic cells or germ-line transgenics) including insects,
nematodes, and mammals.
Creation of a transgenic organism via introduction of recombinant or synthetic nucleic acid molecules or
breeding.
Use of recombinant or synthetic DNA/RNA in plants (somatic cells or germ-line transgenics)
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Attachment A of
General BUA Application
We will be handling or culturing more than or equal to 10 liters at any one time. Complete Attachment H.
Deliberately transferring recombinant DNA, or DNA or RNA derived from recombinant DNA into one or more human
research participants. Complete Attachment I.
Assaying for the production of wild type/helper/replication competent viral particles. Please describe methods and
stage in the experiment at which these assays will be performed.
Potential for infectious agents to be produced/released from recombinant cells, animals, or plants.
Environmental release or field testing of genetically engineered organisms.
Not Applicable
Provide additional information, including the function of all genes inserted or deleted, the method of transfer or
transfection, at what point and how recombinant product or cells will be inactivated or lysed: Briefly summarize the
overall goal, specific objectives and experimental design involving work with these materials ( e.g. using gene therapies for
human macular degeneration)
ii.
Gene Delivery Techniques
If not applicable, check here
.
This project includes research with recombinant or synthetic nucleic acids with the following enhanced gene delivery
techniques:
Liposome complex
Electroporation
Calcium Phosphate precipitation
Nanomaterial (<100 nm in length)
Ballistic (e.g., gene gun)
Viral Delivery
Hydrostatic Pressure
Sonication
Other (specify):
List all gene delivery methods in the table below as they apply to gene transfer experiments and the use of
recombinant cells and microorganisms (engineered in your laboratory or obtained from another source). If additional
spaces are needed, complete and submit as attachment.
Gene Delivery Method
Gene Inserts
& Key
Regulatory
Elements+
In Vitro
In Vivo
Source
(Specify cell type and
activities)
(specify species and
activities)
(i.e. created in lab, purchased from
vendor, MTA)
*If gene insert is a high risk recombinant DNA inserts, (e.g. toxins with LD50<100 g/kg body weight, antibiotic resistance cassettes or regions of
genomes from RG 2, RG3, or RG4 or restricted organisms) complete Attachment D or E if applicable.
+
General categories of cellular genes and functions: (S) structural proteins: actin, myosin, etc.; (E) enzymatic proteins: serum proteases,
transferases, oxidases, phosphatases, etc.; (M) metabolic enzymes: amino acids metabolism, nucleotide synthesis, etc.; (G) cell growth,
housekeeping; (CC) cell cycle, cell division; (DR) DNA replication, chromosome segregation, mitosis, meiosis; (MP) membrane proteins, ion
channels, G-coupled protein receptors, transporters, etc.; (T) tracking genes such as GFP, luciferase, photoreactive genes; (TX) active subunit
genes for toxins such as ricin, botulinum toxin, Shiga toxin, and Shiga-like toxins; (R) regulatory genes, transcription, cell activators such as
cytokines, lymphokines, tumor suppressors; (Ov and Oc) oncogenes identified via transforming potential of viral and cellular analogs, or mutations in
tumor suppressor genes, resulting in a protein that inhibits/moderates the normal cellular wild-type protein
iii.
Vector Description(s) (Please specify vectors, helper viruses, etc.) If not applicable, check here
Vector
Type
(plasmid, viral,
phage, etc)
Vector Name
Risk Group
More Than
2/3 of viral
genome?
(e.g. vector lineage)
(Genus, species; if plasmid or
viral)
Yes
Yes
Yes
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No
No
No
.
Risk Attenuation
(If yes, indicate how attenuated)
Yes
Yes
Yes
No
No
No
Attachment A of
General BUA Application
*Viral vectors containing Adenovirus or Lentivirus require detailed description of risk attenuation and Guidelines for Research with Adenovirus and
Guidelines for Research with Lentivirus will need to be reviewed and integrated into a lab specific Biosafety SOP.
Negative replication competent virus testing has been performed on the above viral vectors.
iv.
Non-commercially Purchased Vector Risk Attenuation If not applicable, check here
.
If vector is not commercially purchased, describe risk attenuation: (Examples: replicative defective)
v.
Vector Packaging
Name of packaging cell
line(s) or Helper
plasmids used in cotransfection to produce
viral particles
If not applicable, check here
Sources of
cells
(i.e. species)
.
Tropism
(i.e. what
species of cell
virus infects)
Source of
envelope
glycoprotein
(if retro- or lentivirus)
Agents previously
passed through
animals or cell
lines?
Yes
Yes
Yes
vi.
Target
animal/plant/c
ell for
constructs
No
No
No
Experiments Covered by the NIH Guidelines
The NIH Guidelines can be found at http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm.
Check all boxes that apply
III-A Experiments that Require Institutional Biosafety Committee Approval at a Convened Meeting, RAC
Review, and NIH Director Approval Before Initiation
The BUA Application can be submitted to the IBC at any time, independent of RAC review.
RAC review process steps for the PI are 1) submission of relevant information on the proposed
experiment to OBA, 2) publication of the proposal in the Federal Register for 15 days of comment, 3)
review by the RAC at a public meeting, and 4) approval by the NIH Director who stipulates the
containment conditions and any special requirements for the experiments. For FAQs on RAC Review,
click here.
After the NIH Director approval, the IBC will review the BUA Application, all documents submitted to
RAC, and any stipulations from the NIH Director for SDSU IBC approval at a convened meeting.
NIH
Guidelines
III-A-1
Description
Experiments considered as Major Actions, NIH Guidelines Appendix D. Major Actions are defines
as:
1. it involves the use of recombinant or synthetic nucleic acids to introduce drug resistance
into a microorganism, and
2. the drug in question is used to treat disease caused by the organism in humans,
veterinary medicine, or agriculture.
The experiment would not be considered a Major Action if there is sufficient documentation that
resistance to a therapeutically useful concentration of that drug exists in the agent outside of a
laboratory setting. Such evidence should be in the form of articles published in the scientific
literature.
III-A-1-a
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 ability to control disease agents in
humans, veterinary medicine, or agriculture.
III-B. Experiments That Require NIH/OBA and Institutional Biosafety Committee Approval at a Convened
Meeting Before Initiation
The BUA Application can be submitted to the IBC at any time, independent of NIH/OBA review.
NIH/OBA review process steps for the PI are 1) submission of relevant information on the proposed
experiment to OBA:
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Attachment A of
General BUA Application


details of the proposed experiment (BUA application);
Indicate whether the current proposal is similar to an experiment already approved by OBA
NIH Guidelines Section , and clearly indicate which approved experiment is being referenced;
and
 The proposed level of containment under which the experiment will be conducted.
2) OBA will then make the final determination and grant an approval as appropriate.
After the NIH/OBA approval, the IBC will review the BUA Application, all documents submitted to
NIH/OBA, and any stipulations from NIH/OBA for SDSU IBC approval at a convened meeting.
NIH
Guidelines
III-B-1
Description
Experiments involving the cloning of toxin molecules with LD50 of less than 100 nanograms per
kilogram body weight – such as botulinum toxins, tetanus toxins, diphtheria toxins, and Shigella
dysenteriae neurotoxins. For FAQs on NIH/OBA review of toxins, click here. Complete and
submit Attachment E for work with Select Toxins. Click here for the list of Select Toxins.
III-B-2
Experiments that are equivalent to what has been approved (under Section III-A-1-a Appendix D)
as Major Actions under the NIH Guidelines
III-C. Experiments that Require Institutional Biosafety Committee and Institutional Review Board Approvals at a
Convened Meeting and RAC Review Before Research Participant Enrollment
The BUA Application can be submitted to the IBC at any time, independent of RAC review.
RAC review process steps for the PI are 1) submission of relevant information on the proposed
experiment to OBA including responses to Appendices M-II through M-V of the NIH Guidelines, 2)
publication of the proposal in the Federal Register for 15 days of comment, 3) review by the RAC at a
public meeting, and 4) a letter with the outcome of the review with advice and recommendations for
the experiment. For FAQs on RAC Review for human gene transfer research, click here.
After receipt of the RAC letter, the IBC will review the BUA Application, all documents submitted to
RAC, and any recommendations or advice from RAC for SDSU IBC approval at a convened meeting.
NIH
Guidelines
III-C-1
Description
Experiments involving deliberate transfer of recombinant or synthetic nucleic acid molecules, or
DNA/RNA derived from recombinant or synthetic nucleic acid molecules, into one or more human
research participants
III-D. Experiments that Require Institutional Biosafety Committee Approval at a Convened Meeting Before
Initiation
Submit BUA to the IBC for review and approval at a convened meeting.
NIH
Description
Guidelines
III-D-1
RG 2, RG 3, RG 4, or Restricted Agents as Host-Vector Systems
III-D-1-a
Introduction of recombinant or synthetic nucleic acid molecules into Risk Group 2 agents at BSL
2.
III-D-1-b
Introduction of recombinant or synthetic nucleic acid molecules into Risk Group 3 agents at BSL
3.
III-D-1-c
Introduction of recombinant or synthetic nucleic acid molecules into Risk Group 4 agents at BSL
4.
III-D-1-d
Introduction of recombinant or synthetic nucleic acid molecules into restricted agents. This will
also require a permit from USDA/APHIS and OBA/NIH review for containment. Contact the BSO
for assistance applying to USDA/APHIS and OBA/NIH for restricted agents.
III-D-2
DNA from RG 2, RG 3, RG4, or Restricted Agents is cloned into Nonpathogenic
Prokaryotic or Lower Eukaryotic Host-Vector Systems
III-D-2-a
DNA from RG 2 or RG 3 agents is transferred into nonpathogenic prokaryotes or lower
eukaryotes at BSL 2.
DNA from RG 4 agents transferred into nonpathogenic prokaryotes or lower eukaryotes only if
demonstrated that only a totally and irreversibly defective fraction of the agent’s genome is
present in a given recombinant at BSL 2.
III-D-2-b
DNA from restricted agents is transferred into nonpathogenic prokaryotic or lower eukaryotic.
This will also require a permit from USDA/APHIS and OBA/NIH review for containment.
Complete and submit Attachment E for use of Select Agents. Click here for list of Select Agents.
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III-D-3
III-D-3-a
III-D-3-b
III-D-3-c
III-D-3-d
III-D-3-e
III-D-4
III-D-4-a
III-D-4-b
III-D-4-c
III-D-4-c-(1)
III-D-4-c-(2)
III-D-5
III-D-5-a
III-D-5-b
III-D-5-c
III-D-5-d
III-D-5-e
III-D-6
III-D-7
III-D-7-a
III-D-7-b
III-D-7-c
III-D-7-d
Contact the BSO for assistance applying to USDA/APHIS and OBA/NIH for restricted agents.
Infectious DNA or RNA Viruses or Defective DNA or RNA Viruses in the Presence of
Helper Virus in Tissue Culture Systems
Infectious or defective RG 2 viruses in the presence of helper virus at BSL 2.
Infectious or defective RG 3 viruses in the presence of helper virus at BSL 3.
Infectious or defective RG 4 viruses in the presence of helper virus at BSL 4.
Infectious or defective restricted poxviruses in the presence of helper virus. This will also require
a permit from USDA/APHIS and OBA/NIH review for containment.
Infectious or defective viruses in the presence of helper virus which are not included in III-D-3-a
to III-D-3-d.
Whole Animals Click here for a list of animal experiments covered under the NIH Guidelines.
Click here for an FAQ on genetically modified or transgenic animals.
Recombinant or synthetic nucleic acid molecule, or DNA or RNA molecules derived therefrom,
from any source except for greater than two-thirds or eukaryotic viral genome transferred to any
non-human vertebrate or any invertebrate organism and propagated at BSL1 and ABSL1.
Animals that contain sequences from viral vectors, which do not lead to transmissible infection
either directly or indirectly as a result of complementation or recombination in animals at BSL 1
and ABSL 1.
Recombinant or synthetic nucleic acid molecule, or DNA or RNA derived therefrom, involving
whole animals, including transgenic animals not covered under III-D-4-a.
Exceptions to III-D-4
Generation of transgenic rodents that require BSL 1 containment is classified as III-E-3.
Purchase or transfer of transgenic rodents is classified as III-F, Appendix C-VI.
Whole Plants
Exotic infectious agents with recognized potential for serious detrimental impact on managed or
natural ecosystems when recombinant or synthetic nucleic acid molecule techniques are
associated with whole plants a PBSL 3 or PBSL 2 + biological containment.
Plants containing cloned genomes of readily transmissible exotic infectious agents with
recognized potential for serious detrimental effects on managed or natural ecosystems in which
there exists the possibility of reconstituting the complete and functional genome of the infectious
agent by genomic complementation in planta at PBSL 3 or PBSL 2 + biological containment.
Small number of readily transmissible exotic infectious agents, such as soybean rust fungus and
maize streak or other viruses in the presence of their specific arthropod vectors that have the
potential of being serious pathogens of major U.S. crops at PBSL 4 containment.
Sequences encoding potent vertebrate toxins introduced into plants or associated or organisms
at PBSL 3.
Microbial pathogens of insects or small animals associated with plants if the recombinant or
synthetic nucleic acid molecule-modified organism has a recognized potential for serious
detrimental impact on managed or natural ecosystems at PBSL 3 or PBSL 2 biological
containment.
More than 10 Liters of Culture in a single vessel.
Influenza Viruses Click here for FAQ on RG 3 Influenza virus.
Human H2N2 (1957-1968) - Influenza virus containing the H2 hemagglutanin (HA) segment at
BSL 3 enhanced.
H2 HA gene in cold-adapted, live attenuated vaccine strains (e.g., A/Ann Arbor/6/60 H2N2) with
segments with mutations conferring temperature sensitivity and attenuation not altered in the
recombinant or synthetic virus at BSL 2.
RG 2 influenza virus containing genes from human H2N2 other than the HA gene at BSL 2.
Highly Pathogenic Avian Influenza H5N1 Strains with the Goose/Guangdong/96-like H5 lineage
(HPAI H5N1) – Influenza virus containing a majority of genes and/or segments from a HPAI
H5N1 influenza virus at BSL 3 enhanced.
Influenza virus containing a minority of genes and/or segments from a HPAI H5N1 influenza
virus.
1918 H1N1 – Influenza virus containing any gene or segment from the 1918 H1N1 at BSL 3
enhanced.
Antiviral Susceptibility and Containment – Influenza virus containing genes from one of the 1918
H1N1, HPAI H5N1, and human H2N2 (1957-1968) viruses is resistant to both classes of current
antiviral agents, adamantanes and neuraminidase inhibitors.
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General BUA Application
III-E Experiments the Require Institutional Biosafety Committee Approval at a Convened Meeting Before
Initiation
Submit BUA to the IBC for review and approval at a convened meeting.
NIH
Description
Guidelines
III-E-1
Formation of Recombinant or Synthetic Nucleic Acid Molecules Containing No More than
2/3 of the Genome of any Eukaryotic Virus in cells in tissue culture.
Cells must lack helper virus. DNA may contain fragments of the genome of viruses from more
than one Family but each fragment shall be less than 2/3 of a genome. If containing more than
2/3 of the genome, refer to III-D.
III-E-2
Whole Plants
III-E-2-a
Recombinant or synthetic recombinant or synthetic nucleic acid molecule-containing plants and
plant-associated microorganisms at PBSL 1.
Recombinant or synthetic nucleic acid molecule-modified plants that are not noxious weeds or
that cannot interbreed with noxious weeds in the immediate geographical area at PBSL 1.
Whole plants and recombinant or synthetic nucleic acid molecule-modified non-exotic
microorganisms that have no recognized potential for rapid an widespread dissemination or for
serious detrimental impact on managed or natural ecosystems at PBSL 1.
III-E-2-b
PBSL 2 or PBSL 1
III-E-2-b-(1) Plants modified by recombinant or synthetic nucleic acid molecules that are noxious weeds or
can interbreed with noxious weeds in the immediate geographical area.
III-E-2-b-(2) Plants in which the introduced DNA represents the complete genome of a non-exotic infectious
agent.
III-E-2-b-(3) Plants associated with recombinant or synthetic nucleic acid molecule-modified non-exotic
microorganisms that have a recognized potential for serious detrimental impact on managed or
natural ecosystems.
III-E-2-b-(4) Plants associated with recombinant or synthetic nucleic acid molecule-modified exotic
microorganisms that have no recognized potential for serious detrimental impact on managed or
natural ecosystems.
III-E-2-b-(5) Plants associated with recombinant or synthetic nucleic acid molecule-modified arthropods or
small animals associated with plants, or with arthropods or small animals with recombinant or
synthetic nucleic acid molecule-modified microorganisms associated with them if the
recombinant or synthetic nucleic acid molecule-modified microorganism have no recognized
potential for serious detrimental impact on managed or natural ecosystems.
III-E-3
Transgenic Rodents
Generation of rodents in which the animals’ genome has been altered by stable introduction of
recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefrom, into the
germ-line at ABSL 1.
III-E-3-a
Exemption for III-E-3 – Breeding of certain ABSL 1 transgenic rodents covered under III-F
Appendix C-VII.
III-F Administrative Review Experiments. Require Institutional Biosafety Committee Approval Before Initiation.
This section is exempt from the NIH Guidelines; however, it is not exempt from review and oversight from the
SDSU IBC.
If all recombinant activities are covered under the NIH Guidelines III-F and/or Appendix C, complete and submit
Attachment A and General BUA Application (Sections I-III and VIII only) for IBC Administrative Review.
For FAQs on experiments exempt from the NIH Guidelines, click here.
NIH
Description
Guidelines
III-F-1
Synthetic nucleic acids that (1) can neither replicate nor generate nucleic acids that can replicate
in any living cell, and (2) are not designed to integrate into DNA, and (3) do not produce a toxin
that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight.
III-F-2
Recombinant or synthetic nucleic acid molecules not in organisms, cells or viruses and that have
not been modified or manipulated to render them capable of penetrating cellular membranes.
III-F-3
Recombinant or synthetic nucleic acid molecules that consist solely of the exact Recombinant or
synthetic nucleic acid molecule from a single source that exists contemporaneously in nature.
III-F-4
Recombinant or synthetic nucleic acid molecules that consist entirely of nucleic acids from a
prokaryotic host, including its indigenous plasmids or viruses when propagated only in that host
or closely related strain of the same species, or when transferred to another host by wellEHS, SDSU
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Attachment A of
General BUA Application
established physiological means.
Recombinant or synthetic nucleic acid molecules 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.
III-F-6
Recombinant or synthetic nucleic acid molecules that consist entirely of DNA segments from
different species that exchange DNA by known physiological processes, though one or more
segments may be a synthetic equivalent.
III-F-7
Genomic DNA molecules that have acquired a transposable element provided the transposable
element does not contain any recombinant and/or synthetic DNA.
III-F-8
Recombinant or synthetic nucleic acid molecule that do not pose a significant risk to health or the
environment as listed in Appendix C.
Appendix C. Administrative Review. Exemptions Under Section III-F-8 of the NIH Guidelines
This section is exempt from the NIH Guidelines; however, it is not exempt from review and oversight from the
SDSU IBC.
If all recombinant activities are covered under the NIH Guidelines III-F and/or Appendix C, complete and submit
Attachment A and General BUA Application (Sections I-III and VIII only) for IBC Administrative Review.
NIH
Description
Guidelines
C-I
Recombinant or synthetic nucleic acid molecules containing less than ½ of any eukaryotic viral
genome that are propagated and maintained in cells in tissue culture.
C-I-A
Exceptions – Following categories are not exempt
i. III-B
ii. DNA from RG 3, 4 or restricted organisms or cells known to be infected with these agents
iii. Deliberate introduction of genes encoding for biosynthesis of molecules that are toxic for
vertebrates
iv. Whole plants regenerated from plant cells and tissue cultures that do not remain axenic
cultures.
Escherichia coli K-12 host-vector systems provided that
C-II
i. Host does not contain conjugation proficient plasmids or generalized transducing phages
ii. Lambda or lambdoid or Ff bacteriophages or non-conjugative plasmids.
C-II-A
Exceptions – Following categories are not exempt
i. III-B
ii. DNA from RG 3, 4 or restricted organisms or cells known to be infected with these agents
iii. Large-scale experiments more than 10 liters of culture
iv. Cloning of toxin molecule genes encoding for the biosynthesis of molecules toxic for
vertebrates.
Saccharomyces cerevisiae and Saccharomyces uvarum host-vector systems.
C-III
C-III-A
Exceptions – Following categories are not exempt
i. III-B
ii. DNA from RG 3, 4 or restricted organisms or cells known to be infected with these agents
iii. Large-scale experiments more than 10 liters of culture
iv. Cloning of toxin molecule genes encoding for the biosynthesis of molecules toxic for
vertebrates.
Kluyveromyces lactis host-vector systems provided laboratory-adapted strains are used.
C-IV
C-IV-A
Exceptions – Following categories are not exempt
i. III-B
ii. DNA from RG 3, 4 or restricted organisms or cells known to be infected with these agents
iii. Large-scale experiments more than 10 liters of culture
iv. Cloning of toxin molecule genes encoding for the biosynthesis of molecules toxic for
vertebrates.
Bacillus subtilis or asporogenic Bacillus licheniformis strain which does no revert to a sporeC-V
former with a frequency greater than 10-7 used for cloning DNA.
C-V-A
Exceptions – Following categories are not exempt
i. III-B
ii. DNA from RG 3, 4 or restricted organisms or cells known to be infected with these agents
iii. Large-scale experiments more than 10 liters of culture
iv. Cloning of toxin molecule genes encoding for the biosynthesis of molecules toxic for
vertebrates.
III-F-5
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General BUA Application
C-VI
C-VI-A
C-VII
C-VIII
Recombinant or synthetic nucleic acid molecules derived entirely from extrachromosomal
elements including shuttle vectors constructed from vectors, propagated and maintained in
organisms listed below:
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
Exceptions – Following categories are not exempt
i. III-B
ii. DNA from RG 3, 4 or restricted organisms or cells known to be infected with these agents
iii. Large-scale experiments more than 10 liters of culture
iv. Cloning of toxin molecule genes encoding for the biosynthesis of molecules toxic for
vertebrates.
Purchase or transfer of transgenic rodents for experiments that require BSL 1 containment.
Breeding of two different transgenic rodents or the breeding of a transgenic rodent and a nontransgenic rodent with the intent of creating a new strain of transgenic rodent that can be housed
at BSL 1 containment if:
i. Both parental rodents can be housed under BSL 1 containment; and
ii. Neither parental transgenic rodent contains the following genetic modifications
1. Incorporation of more than one-half of the genome of an exogenous eukaryotic virus
from a single family of viruses
2. Incorporation of a transgene that is under the control of a gammaretroviral long term
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 or viruses.
Submission
Submit completed Attachment A with General BUA Application to the IBC at Gateway Center
3519D, MC 1933 and an electronic copy to ibc@mail.sdsu.edu.
Acronyms
ABSL – Animal Biosafety Level
BSL – Biosafety Level
NIH – National Institute of Health
NIH Guidelines – NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
OBA – Office of Biotechnology Activities
PBSL – Plant Biosafety Level
RAC – Recombinant DNA Advisory Committee
RG – Risk Group
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Attachment A of
General BUA Application