Tufts University & Tufts Medical Center
Institutional Biosafety Committee (IBC)
Tel: 617-636-4109, Fax: 617-636-8354
E-mail: ibc-office@tufts.edu
Website: http://www.tufts.edu/central/research/IBC/
FOR IBC OFFICE USE ONLY
APPROVAL DATE
EXPIRATION DATE
To submit for review, please e-mail this form to the IBC Office (ibc-office@tufts.edu)
AMENDMENT FORM
Please note that amendments may also affect other aspects of that registration, and those areas should also be reflected
in this document. Some amendments may require submission to the full Institutional Biosafety Committee. Others may
be approved administratively by a Biosafety Officer. The Biosafety Officers reserves the right to call to full Committee
review of the amendment or to require a new registration instead, if necessary. When submitting an amendment, the
Principal Investigator is required to review all of the details of the original registration to assure the IBC that all
unamended details remain identical to the original registration. Complete this form and send it electronically to ibcoffice@tufts.edu to submit for review.
Amendment to Registration #
Registration Title
Mark the checkboxes as confirmation:
I am familiar with and agree to abide by the NIH Guidelines for Recombinant and Synthetic Nucleic Acid
Molecules, CDC/NIH Biosafety Guidelines, OSHA Standards, institutional policies, and other federal, state
and local regulations relating to this project.
I attest that the information contained in the attached registration is accurate and complete.
I accept responsibility for ensuring that all personnel involved in this project will be trained regarding the
procedures approved, the potential biohazards, relevant biosafety practices, and emergency procedures.
I confirm that the relevant Exposure Response Plan(s) will be followed.
I will submit written reports to the Institutional Biosafety Committee concerning:
1. Any accident that results in a known or potential exposure to recombinant or synthetic nucleic acid
materials, infectious agents or biological toxins; or any incident resulting in the known or suspected
release into the environment of recombinant or synthetic nucleic acid materials, infectious agents or
biological toxins into the environment.
2. Any problems with physical or biological containment safety procedures or equipment, or facility
failures.
3. Any new information bearing on the safety of this work such as technical data relating to hazard and
safety procedures.
Electronic Signature of the
Principal Investigator:
Date:
By typing your name you are submitting an electronic signature that confirms your understanding and adherence to the
above statements and IBC policies. This is considered legal documentation and confirmation of your agreement to
execute all activities as approved.
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INSTRUCTIONS FOR COMPLETING THIS FORM
- Please type responses within the space/box provided. You can mark the checkboxes by double-clicking on the box.
- Submit the completed draft electronically to the IBC Office e-mail (ibc-office@tufts.edu)
- A Biosafety Officer will pre-review the form and determine if the research requires IBC Full Committee Approval or IBC
Administrative Approval. Please be aware that it is in your best interest to submit the draft to the IBC office well in
advance of the submission deadline for the IBC meeting.
I. PROPOSED MODIFICATION(S)
More than one of the Sections below may be affected by the proposed modification. Please complete each section as
necessary.
Addition/change in use of rDNA or synthetic DNA
Addition/change in use of infectious agents, human material, and biological toxins (exempt amount)
Addition/change in procedure used
Addition or relocation where agent(s) is/are used (any new space must be inspected prior to use)
II. RECOMBINANT OR SYNTHETIC DNA
A. Type of Modification
Addition of recombinant or synthetic DNA (new vectors, etc.)
Change in use of recombinant or synthetic DNA
B. Justification and Technical Details
1. Purpose of addition/change:
2. Name(s), biosafety level(s), and NIH Guidelines categorization(s) of DNA to be added
Name
Animal Biosafety Level
Biosafety Level
BSL-1
BSL-1
BSL-2
BSL-2
(containment/housing)
BSL-3
BSL-3
ABSL-1
ABSL-1
ABSL-2
ABSL-2
ABSL-3
ABSL-3
Check all that apply below:
Section III-F: Experiments that are exempt from NIH Guidelines, but covered by local regulations.
Section III-E: Experiments that require IBC notice simultaneous with initiation.
Section III-D: Experiments that require IBC approval PRIOR TO initiation of experiments.
Section III-C: Experiments that require IBC and Institutional Review Board (IRB) approvals and Recombinant DNA
Advisory Committee (RAC) review before research participant enrollment.
Section III-B: Experiments that require NIH/OBA and IBC Approval BEFORE initiation of experiments.
Section III-A: Experiments that require IBC Approval, Recombinant DNA Advisory Committee (RAC) review, and NIH
Director Approval PRIOR TO initiation of experiments.
3. Nature and species of sequence(s) added
Name of Sequence
Source
(species name)
Nature of Insert or
Expressed Protein
Function
Promoter
4. New vectors and host cells
Name of Vector
Source of Vector
Gene Transfer
Method
Name of Host for
Propagation or of
Packaging Cell Lines
Target Recipient of
rDNA
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5. Provide additional information for sequences that code for toxins, oncogenes, increased virulence, or other
potentially hazardous RNA/protein.
6. What is the percent of viral genome in the sequence(s)’s construct?
7. Provide restriction maps of vectors unless they are commercially available. If commercially available, please indicate
vendor.
8. What is the percent of viral genome in the vector(s)’s construct?
9. If using a lentiviral vector system, state its generation.
10. Is the vector attenuated or replication deficient?
NO
YES
11. Please describe in detail the testing that will be done to confirm attenuation or replication incompetence. Include
the location of records. See “Policy on Retroviral Replication Competency Testing” for more information.
NOTE: Insertion of oncogenes also requires testing (describe below).
12. Please confirm that results of testing will be available for review.
13. Is a helper virus required for replication?
NO
YES
NO
YES
14. Describe the assay used to measure titer of replication competent virus (background) generated or helper virus.
15. What is the percent of synthetic DNA in the construct and anticipated function?
III. ADDITION OF INFECTIOUS AGENTS, HUMAN SOURCE MATERIALS, OR BIOLOGICAL TOXINS
A. Type of Modification
Addition of infectious agent(s)
Addition of human or non-human primate (NHP) material(s)
Addition of biological toxin(s)
B. Justification and Technical Details
1. Purpose of agent addition:
2. Name, source, and biosafety level(s) of each agent to be added
Name
Source
Animal Biosafety Level
Biosafety Level
BSL-1
BSL-1
BSL-2
BSL-2
(containment/housing)
BSL-3
BSL-3
ABSL-1
ABSL-1
ABSL-2
ABSL-2
ABSL-3
ABSL-3
3. If the agent is toxic, provide LD50:
4. If the agent is a human pathogen, what is the infectious dose?
5. The risk of exposure will be mitigated by the following:
*Check all that apply and indicate with what agent each is used and the location of use (e.g. lab room #, DLAM facility, etc.)
Personal Protective Equipment (PPE)
Agent(s) & Location of Use (N/A if not applicable)
Gloves
Lab Coat
Disposable Lab Gown
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Disposable Booties
Tyvek Suit
N-95 Respirator
Surgical Mask
PAPR (Powered Air Purifying Respirator)
Safety Glasses
Other:
Engineering Controls
Biosafety Cabinet
Other:
Date of Certification
C. Decontamination
If the amendment contains more than one agent, provide clarification for each of the answers below.
1. Please check
to confirm the information is the same as described in the original registration. If different answers
are applicable for this amendment, please describe below.
2. What chemical and/or thermal process will be used for decontamination?
3. Describe the processes involved in the decontamination and/or disposal of the following:
a. Liquid waste:
b. Contaminated solid waste:
c. Cultures, plates, stocks, etc.:
d. Animal bedding:
If handled by DLAM/LAMS/CBU, please check the box:
Per standard ABSL-appropriate DLAM/LAMS/CBU procedures
e. Animal cages:
If handled by DLAM/LAMS/CBU, please check the box:
Per standard ABSL-appropriate DLAM/LAMS/CBU procedures
f. Animal carcasses:
If handled by DLAM/LAMS/CBU, please check the box:
Per standard ABSL-appropriate DLAM/LAMS/CBU procedures
D. Exposure Response Plan(s)
1. Please check
to confirm that the necessary Exposure Response Plan(s) is/are the same as described in the original
registration. If different plans apply to this amendment, please complete the questions below.
2. Please list the titles of ALL Exposure Response Plan(s) associated with this AMENDMENT ONLY. Many plans are
available for download on the IBC website.
Title of each Exposure Response Plan to be utilized
3. If a specific plan has not been developed for the agent you are proposing to work with or if you require changes to
the existing Exposure Response Plan, the Biosafety Officer will work directly with you at the time of pre-review to
develop a specific Plan, if necessary. To aid in this process, please provide the following information:
a. Are there signs and symptoms of exposure?
b. Identify prophylactic medicines or vaccinations for this agent, if available.
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c. Is there an increased risk to immunocompromised individuals exposed to this agent?
IV. ADDITION/CHANGE IN PROCEDURE
A. Procedure to Be Added/Changed
B. Justification and Technical Details
V. PROCEDURES WITH LIVE ANIMALS
Only complete this section if the biohazardous materials will be administered to live animals.
A. Administration of Agent
1. Name of species to be exposed to agent:
2. Are the animals immunosuppressed?
No
Yes
3. Agent(s) and dose(s) administered:
4. Route(s) of administration:
5. Location(s) of administration (building and lab room #):
6. Will administration(s) be done inside a biosafety cabinet?
Yes
No
7. Will the biological agent or hazardous metabolite be excreted by urine, feces or wound drainage? Provide
duration, if applicable.
B. Housing/Handling Inside and Outside of Centralized Facilities
1. Will animals be removed from the centralized facilities?
Yes
No
a. If yes, will animals be returned to DLAM/LAMS/CBU post administration of the agent(s)?
b. Please indicate location in centralized animal facility where the animals are returned:
No
Yes
c. Please indicate the Animal Biosafety Level necessary in the centralized facilities for the animals upon return:
ABSL-1
ABSL-2
2. Will a DLAM/LAMS/CBU biohazard cage card be used to identify the agent used?
a. If no, will an alternative method be used to identify the biohazardous agent?
b. Describe alternate method, if applicable:
Yes
No
No
Yes
3. Will handling and disposal of bedding, cages, and animal carcasses be done by DLAM/LAMS/CBU staff in
accordance with standard ABSL-appropriate DLAM/LAMS/CBU procedures?
Yes
No
a. If no, will handling and disposal of bedding, cage, and animal carcasses be done by laboratory staff?
No
Yes
b. Describe staff’s method, if applicable:
VI. LOCATION(S)
List ONLY NEW Laboratories/Facilities where research is to be conducted and the corresponding biosafety level. Include
cold/warm rooms, equipment rooms, and location(s) of biosafety cabinets (BSC). All new spaces must be inspected by a
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Biosafety Officer prior to use. This does not apply to locations within the centralized animal facilities.
Room Purpose
Room Number for Labs
(Main Lab, Storage, Tissue Culture,
Procedure, etc.)
Biosafety Level
BSL-1
BSL-1
BSL-1
BSL-2
BSL-2
BSL-2
BSL-3
BSL-3
BSL-3
OTHER RELEVANT LINKS
OVPR IBC Website:
http://www.tufts.edu/central/research/IBC/index.htm
Tufts University EHS Website:
http://publicsafety.tufts.edu/ehs/
Pathogen Safety Data Sheets:
Biosafety in Microbiological and
Biomedical Laboratories (BMBL):
NIH Recombinant DNA Guidelines:
http://www.phac-aspc.gc.ca/msds-ftss/index.html#menu
http://www.cdc.gov/biosafety/publications/bmbl5/
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
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APPENDIX A - NIH Recombinant or synthetic nucleic acid molecules Categories
BIOHAZARDOUS MATERIALS REGISTRATION FORM
The NIH rDNA Guidelines identify six categories of experiments involving recombinant DNA:
(i)
those that require Institutional Biosafety Committee (IBC) approval, RAC review, and NIH Director
approval before initiation,
(ii)
those that require NIH/OBA and Institutional Biosafety Committee approval before initiation,
(iii)
those that require Institutional Biosafety Committee and Institutional Review Board approvals and
RAC review before research participant enrollment,
(iv)
those that require Institutional Biosafety Committee approval before initiation,
(v)
those that require Institutional Biosafety Committee notification simultaneous with initiation, and
(vi)
those that are exempt from the NIH Guidelines.
According to the Guidelines, the PI is responsible for identifying which category the proposed rDNA work falls under. The
6 categories are listed and defined below. Mark the box next to the category that you chose.
Section III-F Experiments that are exempt from NIH Guidelines but covered by local regulations. Exempt experiments
must be registered with the Tufts University IBC or the TCSVM IBC as appropriate.
III-F-1
Those synthetic nucleic acids that: (1) 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 (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. If a synthetic nucleic acid is deliberately
transferred into one or more human research participants and meets the criteria of Section III-C, it is not
exempt under this 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.
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.
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 a closely related
strain of the same species), or when transferred to another host by well established physiological
means.
III-F-5
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 closely related strain of the same species).
III-F-6
Thosethat 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
Appendix A-I through A-VI for a list of natural exchangers that are exempt from the “NIH Guidelines”.
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.
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III-F-8
Recombinant or synthetic nucleic acid molecules in experiments that do not present a significant risk to
health or the environment as determined by the NIH Director, RAC and following appropriate notice and
opportunity for public comment. See Appendix C of the NIH Guidelines.
Check the following classes of experiments that are exempt under Section III-F-8 Appendix C
C-1
Recombinant or synthetic nucleic acid molecules in Tissue Culture?
Recombinant or synthetic nucleic acid molecules containing less than one-half of any eukaryotic viral
genome (all viruses from a single family being considered identical – see Appendix C-VII-E, Footnotes and
References of Appendix C), that are propagated and maintained in cells in tissue culture are exempt from
these NIH Guidelines with the exceptions listed in Appendix C-1-A.
C-2
Escherichia coli K-12 Host-Vector Systems?
Experiments which use Escherichia coli K-12 host-vector system, with the exception of those experiments
listed in Appendix C-II-A are exempt from the NIH Guidelines provided that: (i) the Escherichia coli host
does not contain conjugation proficient plasmids or generalized transducing phages; or (ii) lambda or
lambdoid of Ff bacteriophages or non-conjugative plasmids (see Appendix C-VIII-B, Footnotes and
References of Appendix C) shall be used as vectors. However, experiments involving the insertion into
Escherichia coli K-12 of DNA from prokaryotes that exchange genetic information (see Appendix C-VIII-C,
Footnotes and References of Appendix C) 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. For these exempt laboratory experiments, Biosafety Level 1 (BSL1) physical
containment conditions are recommended. For large scale fermentation experiments, the appropriate
physical containment conditions need not be greater than those for the host organism unmodified by
techniques using recombinant or synthetic nucleic acid molecules; the Institutional Biosafety Committee
can specify higher containment if deemed necessary.
C-III
Saccharomyces Host-Vector Systems?
Experiments involving Saccharomyces cerevisiae and Saccharomyces uvarum host-vector systems, with
the exception listed in Appendix C-III-A, are Exempt from the NIH Guidelines. For these exempt
experiments, BL1 physical containment is recommended. For large scale fermentation experiments, the
appropriate physical containment conditions need be no greater than those for the unmodified host
organism; the Institutional Biosafety Committee can specify higher containment if deemed necessary.
C-IV
Kluyveromyces Host-Vector Systems
Experiments involving Kluyveromyces lactis host-vector systems, with the exception of experiments listed
in Appendix C-IV-A, are exempt from the NIH Guidelines provided laboratory-adapted strains are used (i.e.
strains that have been adapted to growth under optimal or defined laboratory conditions). For these
exempt experiments, BL1 physical containment is recommended. For large-scale fermentation
experiments, the appropriate physical containment conditions need be no greater than those for the
unmodified host organism; the Institutional Biosafety Committee may specify higher containment if
deemed necessary.
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 with the exception of those
experiments listed in Appendix C-V-A, Exceptions. For these exempt laboratory experiments, BL1 physical
containment conditions are recommended. For large scale fermentation experiments, the appropriate
physical containment conditions need be no greater than those for the unmodified host organism; the
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Institutional Biosafety Committee can specify higher containment if deemed necessary.
C-VI
Appendix C-VI. Extrachromosomal Elements of Gram Positive Organisms
Recombinant or synthetic nucleic acid molecules derived entirely from extrachromosomal elements of the
organisms listed below (including shuttle vectors constructed from vectors described in Appendix C),
propagated and maintained in organisms listed below (see Guidelines for list) are exempt from these NIH
Guidelines.
C-VII
The Purchase or Transfer of Transgenic Rodents?
The purchase or transfer of transgenic rodents for experiments that require BL1 containment (see
Appendix G-III-M, Footnotes and References of Appendix G) 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 nontransgenic 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:
(1) Both parental rodents can be housed under BL1 containment; and
(2) 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
(3) 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.
Section III-E Experiments that require IBC notice simultaneous with initiation.
III-E
Experiments not included in Sections III-A, III-B, III-C, III-D, III-F and their subsections are considered in
this section. All such experiments may be conducted at BL 1.
III-E-1
Experiments involving the formation of recombinant or synthetic nucleic acid molecules containing no
more than 2/3 of the genome of any eukaryotic virus (all viruses from a single Family being considered
identical) may be propagated and maintained in cells in tissue culture using BL 1 containment. It must
be shown that the cells lack helper virus for the specific Families of defective viruses used. The 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.
III-E-2
Experiments involving whole plants modified with recombinant or synthetic nucleic acid molecules,
and/or experiments involving organisms modified with recombinant or synthetic nucleic acid molecules
- associated with plants, except those that fall under Section III-A, III-B, III-C, III-D, or III-F. See Section IIIE-2 for recommendation of containment levels.
III-E-3
Experiments involving the generation of rodents in which the animal’s genome has been altered by
stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived
therefrom, into the germ-line (transgenic rodents). Only experiments that require BL1 containment are
covered under this section; experiments that require BL2, BL3, or BL4 containment are covered under
Section III-D-4.
Section III-D Experiments that require IBC approval before initiation of experiments.
III-D-1
Experiments using Risk Group 2, Risk Group 3, Risk Group 4, or restricted agents as host-vector systems.
(See Section II-A Risk Assessment.)
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III-D-1-a
Introduction of recombinant or synthetic nucleic acid molecules into Risk Group 2 (RG-2) agents is
usually conducted at BSL2 containment. Experiments with such agents will usually be conducted with
whole animals at BSL2 or BL2-N containment. ( III-D-1-b
Introduction of recombinant or
synthetic nucleic acid molecules into Risk Group 3 (RG-3) agents is usually conducted at BSL3
containment. Experiments with such agents will usually be conducted with whole animals at BSL3 or
ABSL-3 containment. ( III-D-1-c
Introduction of recombinant or synthetic nucleic acid molecules
into Risk Group 4 (RG-4) agents is usually conducted at BSL4 containment. Experiments with such agents
will usually be conducted with whole animals at BSL4 or ABSL-4 containment.
III-D-2 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
formation of recombinant or synthetic nucleic acid molecules for certain genes coding for molecules
toxic for vertebrates require NIH/OBA approval.
III-D-2-a
Experiments in which DNA from RG- 2 or RG- 3 agents is transferred into nonpathogenic prokaryotes or
lower eukaryotes may be conducted at BSL2 containment. Experiments in which DNA from RG-4 agents
is transferred into nonpathogenic prokaryotes or lower eukaryotes may be performed under BSL2
containment after demonstration that only a totally and irreversibly defective fraction of the agent’s
genome is present in a given recombinant. The IBC may approve the specific lowering of containment
for particular experiments to BSL1. Many experiments in this category are exempt from the “NIH
Guidelines”.
III-D-2-b
Experiments in which DNA from restricted agents is transferred into
nonpathogenic prokaryotes or lower eukaryotes shall be performed under containment conditions
determined by NIH/OBA following a case-by-case review.
III-D-3
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.
III-D-3-a
Experiments involving the use of infectious or defective RG-2 viruses in the presence of helper virus may
be conducted at BSL2 containment. (See Appendix B for information on Risk Groups.)
III-D-3-b
Experiments involving the use of infectious or defective RG-3 viruses in the presence of helper virus may
be conducted at BSL3 containment. (See Appendix B for information on Risk Groups.)
III-D-3-c
Experiments involving the use of infectious or defective RG-4 viruses in the presence of helper virus may
be conducted at BSL4 containment. (See Appendix B for information on Risk Groups.)
III-D-3-d
Experiments involving the use of infectious or defective restricted poxviruses in the presence of helper
virus shall be determined on a case-by-case basis following NIH/OBA review. A USDA permit is required
for work with plant or animal pathogens.
III-D-3-e
Experiments involving the use of infectious or defective viruses in the presence of helper virus which are
not covered in Sections III-D-3-a through III-D-3-d may be conducted at BSL1.
III-D-4
Experiments involving whole animals.
III-D-4-a
Recombinant or synthetic nucleic acid molecules, or DNA or RNA molecules derived therefrom, from any
source except for greater than two-thirds of eukaryotic viral genome may be transferred to any nonhuman vertebrate or any invertebrate organism and propagated under conditions of physical
containment comparable to BSL1 or ABSL1 and appropriate to the organism under study. 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, may be propagated under
conditions of physical containment comparable to BSL1 or ABSL1 and appropriate to the organism under
study. Experiments involving the introduction of other sequences from eukaryotic viral genomes into
animals are covered under Section III-D-4-b. The investigator must demonstrate that the fraction of the
viral genome being utilized does not lead to productive infection.
III-D-4-b
Experiments involving recombinant or synthetic nucleic acid molecules , or DNA or RNA derived
therefrom, involving whole animals, including transgenic animals, and not covered by Sections III-D-1 or
III-D-4-a, may be conducted at the appropriate containment determined by the IBC.
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III-D-4-c-1
Experiments involving the generation of transgenic rodents that require BSL1 containment are described
under Section III-E-3.
III-D-4-c-2
Purchase or transfer of transgenic rodents is exempt from the “NIH Guidelines” under Section III-F.
III-D-5
Experiments involving whole plants. Experiments to genetically engineer plants by methods using
recombinant or synthetic nucleic acid molecules , to use plants for other experimental purposes, to
propagate such plants, or to use plants together with microorganisms or insects containing recombinant
or synthetic nucleic acid molecules , may be conducted under the containment conditions described in
the “NIH Guidelines”, Section III-D-5a through Section III-D-5e.
III-D-6
Experiments involving more than 10 liters of culture. The appropriate containment will be decided by
the IBC. Where appropriate, Appendix K of the “NIH Guidelines” will be used to determine containment
conditions.
III-D-7
Experiments Involving Influenza Viruses. Experiments with influenza viruses generated by recombinant
methods (e.g., generation by reverse genetics of chimeric viruses with reassorted segments,
introduction of specific mutations) shall be conducted at the biosafety level containment corresponding
to the Risk Group of the virus that was the source of the majority of segments in the recombinant virus
(e.g., experiments with viruses containing a majority of segments from a RG3 virus shall be conducted at
BL3). Experiments with influenza viruses containing genes or segments from 1918-1919 H1N1 (1918
H1N1), human H2N2 (1957-1968) and highly pathogenic avian influenza H5N1 strains within the
Goose/Guangdong/96-like H5 lineage (HPAI H5N1) shall be conducted at BL3 enhanced containment
(see Appendix G-II-C-5, Biosafety Level 3 Enhanced for Research Involving Risk Group 3 Influenza
Viruses) unless further noted in the Guidelines.
Section III-C Experiments that require IBC and Institutional Review Board (IRB) approvals, and RAC review before
research participant enrollment.
III-C-1
Experiments involving the deliberate transfer of (1) recombinant or synthetic nucleic acid molecules, or
(2) DNA or RNA derived from recombinant or synthetic nucleic acid molecules, into one or more human
Research participants
Section III-B Experiments that require NIH/OBA and IBC approval before initiation.
III-B-1
III-B-2
Experiments involving the cloning of toxin molecules with LD50 of less than 100 nanograms per kilogram
body weight.
Experiments that have been Approved (under section III-A-1-a) as Major Actions under the NIH Guidelines (“me
too” experiments)
Section III-A Experiments that require Institutional Biosafety Committee (IBC) approval, Recombinant DNA Advisory
Committee (RAC) review, and NIH Director approval before initiation of experiments.
III-A-1-a
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.
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