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Exempt Recombinant DNA Verification Form
The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH
Guidelines) specify institutional review and approval procedures as well as practices for
constructing and handling DNA molecules and organisms and viruses containing
recombinant DNA molecules. Principal investigators have the responsibility to assess
risks, understand and comply with institutional requirements and federal, state and local
regulations and train personnel that will minimize or eliminate risks associated with
research involving biohazardous materials.
UMBC also has the responsibility for reviewing and approving the risk assessment and
the biosafety containment level for such experiments. Research projects requiring
institutional biosafety committee review and approval before work begins include:
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generates more than 10 liters of culture
is the viral construct from DNA a risk group 3, 4 or a Select Agent
generates toxic products or oncogenes lethal for vertebrates
contains viral DNA from more than 2/3 of any eukaryotic viral genome
involves the transfer of recombinant DNA into human subjects
involves the generation of transgenic animals
involves the generation of transgenic plants
Contact the Office for Research Protections and Compliance to identify the steps for
review.
In most cases, recombinant DNA research at UMBC fall under Section III-F of the NIH
Guidelines where IBC registration is not required but review and assessment by the
recombinant DNA Safety Officer, the Office for Research Protections and Compliance
and Environmental Safety and Health the before an investigator is approved to commence
a research project. All such experiments maybe conducted at Biosafety Level 1
containment
Please check all that apply and continue with the application below:
Section III-F-1. Those that are not in organisms or viruses.
Section III-F-2. 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.
Section III-F-3. 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.
Section III-F-4. Those that consist entirely of DNA from an eukaryotic host
including its chloroplasts, mitochondria, or plasmids (but excluding viruses)
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when propagated only in that host (or a closely related strain of the same
species).
Section III-F-5. 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. Appendix A of the
guidelines shows a current list of natural exchangers that are exempt from the
NIH Guidelines- see below
Section III-F-6. Those that do not present a significant risk to health or the
environment, as determined by the NIH Director, with the advice of the RAC,
and following appropriate notice and opportunity for public comment. Appendix
C of the guidelines shows a current list of classes of experiments which are
exempt from the NIH Guidelines – see below
Section III-F-6. The purchase or transfer of transgenic rodents for experiments
that require Biosafety Level 1 containment (The Purchase or Transfer of
Transgenic Rodents - Appendix C-VII)
Section III-F-6. 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 Biosafety Level
1 containment 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. (Generation of BL1 Transgenic Rodents via Breeding - Appendix CVIII).
Special Note on Knock-Out Animals:
Knock-out (gene silencing, gene ablation, etc.) rodents are exempt from the
NIH Guidelines as long as the method to generate the knock-out animal does not leave
any “new” genetic material behind in the genome after the procedure. If DNA from
the molecule used to create the knock-out is permanently inserted into the genome,
the experiment will require registration, review, and approval by an IBC.
If this project involves the use of animals or human tissue/human subjects, you must
submit an application for review by the IACUC or IRB.
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1.
Principal Investigator(s):
Department:
E-Mail:
Phone:
2.
Project Title:
Sponsor (if applicable):
Dates of Project: From
to
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Location(s) of Experiments – Building/Room #:
4.
Please provide a brief description of your research (in lay terms) - Maximum of
250 words.
5.
Provide a description of the recombinant DNA you plan to use (e.g. the nature of
the inserted DNA, the sequence/expressed gene, host(s), vector(s), etc.)
Investigator Assurance
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I agree to use Biosafety Level 1 (BSL 1) containment practices with all exempt
recombinant DNA work. UMBC currently has BSL-1 facilities. Reference: Biosafety
in Microbiological and Biomedical Laboratories, 5th Edition
I will initiate no recombinant DNA research subject to the NIH Guidelines until that
research has been reviewed and approved/exempted by the UMBC recombinant DNA
safety officer.
I understand if I plan to conduct research with DNA molecules that do not meet any of
the NIH exemptions; I will inform the recombinant DNA safety officer before initiating
the research.
I have read the research definitions in NIH Guidelines for Research Involving
Recombinant DNA Molecules and verify that all uses listed herein are classified as
exempt.
I will train staff in best microbiological practices and techniques required to ensure safety
for this project, in the procedures for dealing with accidents, and in waste management
procedures.
I acknowledge my responsibility to secure and control the biological agents used in this
project.
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Signature of Principal Investigator
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________________
Date
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Project Title:
Location(s) of Experiments – Building/Room #:
Review by ORPC
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Date
Review by ESH
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Date
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Approved, recombinant DNA Safety Officer
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Date
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APPENDIX A. EXEMPTIONS UNDER SECTION III-F-5—SUBLISTS OF NATURAL
EXCHANGERS
Appendix A-I. Sublist A
Genus Escherichia
Genus Shigella
Genus Salmonella -including Arizona
Genus Enterobacter
Genus Citrobacter -including Levinea
Genus Klebsiella -including oxytoca
Genus Erwinia
Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonas fluorescens, Pseudomonas
mendocina
Serratia marcescens
Yersinia enterocolitica
Appendix A-II. Sublist B
Bacillus subtilis
Bacillus licheniformis
Bacillus pumilus
Bacillus globigii
Bacillus niger
Bacillus nato
Bacillus amyloliquefaciens
Bacillus aterrimus
Appendix A-III. Sublist C
Streptomyces aureofaciens
Streptomyces rimosus
Streptomyces coelicolor
Appendix A-IV. Sublist D
Streptomyces griseus
Streptomyces cyaneus
Streptomyces venezuelae
Appendix A-V. Sublist E
One way transfer of Streptococcus mutans or Streptococcus lactis DNA into Streptococcus
sanguis
Appendix A-VI. Sublist F
Streptococcus sanguis
Streptococcus pneumoniae
Streptococcus faecalis
Streptococcus pyogenes
Streptococcus mutans
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APPENDIX C. EXEMPTIONS UNDER SECTION III-F-6
Appendix C-I. Recombinant DNA in Tissue Culture
Recombinant DNA molecules containing less than one-half of any eukaryotic viral genome (all
viruses from a single family being considered identical that are propagated and maintained in
cells in tissue culture.
Appendix C-II. Escherichia coli K-12 Host-Vector Systems
Experiments which use Escherichia coli K-12 host-vector systems, 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 or Ff bacteriophages or non-conjugative plasmids shall be
used as vectors.
Appendix C-III. Saccharomyces Host-Vector Systems
Experiments involving Saccharomyces cerevisiae and Saccharomyces uvarum host-vector
systems.
Appendix C-IV. Bacillus subtilis or Bacillus licheniformis Host-Vector Systems
Asporogenic Bacillus subtilis or asporogenic Bacillus licheniformis strain which do not revert to
a spore-former with a frequency greater than 10-7 may be used for cloning DNA.
Appendix C-V. Extrachromosomal Elements of Gram Positive Organisms
Recombinant DNA molecules derived entirely from extrachromosomal elements of the org
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