rDNA #______

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 beginsinclude:

  • 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) 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 C-VIII).

Special Note on Knock-Out Animals:

Knock-out (gene silencing, gene ablation, etc.) rodents are exempt from the NIHGuidelines 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 themolecule used to create the knock-out is permanently inserted into the genome, theexperimentwill 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.

1. Principal Investigator(s):

Department:

E-Mail:

Phone:

2.Project Title:

Sponsor (if applicable):

Dates of Project: From to

3. Location(s) of Experiments – Building/Room #:

4. Please provide a brief description of your research (in lay terms) -Maximum of

250 words.

  1. 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

  • 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 BiomedicalLaboratories, 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 inNIH Guidelines for Research Involving Recombinant DNA Moleculesand 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.

______

Signature of Principal Investigator Date

Project Title:

Location(s) of Experiments – Building/Room #:

Review by ORPC______

Date

Review by ESH______

Date

______

Approved, recombinant DNA Safety Officer Date

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

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

UseofExemptRecombinantDNA-3a.doc - 06/26/2013