IBC # 00-000

Recombinant DNA in Plants

Section 1: General Information

Protocol Title:

Principal Investigator:

SECTION 2: Recipients of recombinant dna

This program involves:

Y N

The introduction of recombinant DNA directly into plants (generation of transgenic plants) and/or the use

of recombinant DNA-containing plants that were purchased and/or received from another institution.

The use of recombinant DNA-containing animals, and/or invertebrate organisms with unmodified plants.

The use of recombinant DNA-containing pathogens in plants.

The use of recombinant DNA-containing animals, microorganisms and/or invertebrate organisms with transgenic plants.

Organism (plant) name
(Genus, species) / Common name / Normal Containment Level for this Organism* / Recombinant DNA containing organism?
(Yes or No) / This organism will be used in conjunction with the following naturally occurring: / This organism will be used in conjunction with the following recombinant DNA- containing:
Plant or animal pathogens / Non-human vertebrate or invertebrate organisms / Plant or animal pathogens / Non-human vertebrate or invertebrate organisms

*Note: An existing spreadsheet including the specific information requested above may be inserted or submitted with your application -as APPENDIX D- in place of the above table.

SECTION 3: Modified plants

*Note: The following questions apply to recombinant DNA introduced directly into plants. If you are introducing modified organism(s) to the plants, please skip to Section 4.

Recombinant DNA categories to be transferred to this organism (Check all that apply):

Protein-coding (marker/reporter) Protein-coding (other) Epitope tag

Non-coding Catalytic RNA miRNA Antisense RNA

Double-stranded RNA/siRNA Complex sample (genomic library, etc) Other

Method of transfer (Check all that apply)

Germline Somatic Agrobacterium Graft Transposon Recombination

Protoplast transfection Biolistics Virus Nanoparticles Other

Briefly describe how recombinant DNA molecules will be/were introduced into the research organism:

Note: An existing spreadsheet including the specific information requested below may be inserted or submitted with your registration -as APPENDIX E- to satisfy the information required in the following 3 tables.

For each protein-coding gene (except marker/reporter genes) or catalytic RNA, provide:

Name / Source / Known or suspected function(s) / Plant DNA is being inserted into (if more than 1 plant is listed in Section 2)

For each non-coding segment, miRNA/dsRNA/siRNA/asRNA or complex sample, provide the source organism:

Type / Source / Plant DNA is being inserted into (if more than 1 plant is listed in Section 2)

If "Other" is checked, please explain the type and source of recombinant DNA:

Type / Source / Plant DNA is being inserted into (if more than 1 plant is listed in Section 2)

Y N

The spatial expression of recombinant DNA molecules will be ubiquitous in the target organism. If no, list specific tissues/organs where expression will occur:

The temporal expression of recombinant DNA molecules will be ubiquitous in the target

organism.

If no, list times during development or life stages when expression will occur:

Is this a modification of a noxious weed?

Is this a modification of a plant that can interbreed with a noxious weed in the immediate area?

Will the plant be modified to contain the genome of a readily transmissible exotic agent with a

recognized potential for serious detrimental impact on managed or natural ecosystems?

SECTION 4: Agents introduced to modified and un-modified plants

Unmodified or recombinant DNA-containing plants will be associated with:

Y N

Recombinant DNA-modified, non-exotic microorganisms with no recognized potential for serious detrimental impact on managed or natural ecosystems (Agrobacterium spp, Rhizobium spp.).

Y N

Recombinant DNA-modified, exotic microorganisms with no recognized potential for serious detrimental impact on managed or natural ecosystems.

If yes, list all microorganisms and describe recombinant DNA modifications:

Y N

Recombinant DNA-modified, non-exotic microorganisms with recognized potential for serious detrimental impact on managed or natural ecosystems.

If yes, list all microorganisms and describe recombinant DNA modifications:

Y N

Recombinant DNA-modified, exotic mciroorganisms with recognized potential for serious detrimental impact on managed or natural ecosystems.

If yes, list all microorganisms and describe recombinant DNA modifications:

SECTION 5: Modified Viral DNA

Y N

Will a competent insect vector be used?

Y N

Is this the deliberate transfer of recombinant DNA derived from a eukaryotic viral genome into a plant?

If yes, please list all sources of viral-derived recombinant DNA in the table below:

Viral genome
(Source of recombinant DNA) / Is the viral-derived recombinant DNA to be transferred replication competent itself? / % of viral-derived recombinant DNA to be transferred into the target pathogen
(*Note: all members of the same family are considered identical) / If <66% of a viral genome will be introduced, will a Helper be used to restore infectivity of the source virus following introduction into the target pathogen? / Is there a reasonable expectation that complementation or recombination could restore infectivity of the source virus once introduced into the target pathogen? / Plant DNA is being inserted into (if more than 1 plant is listed in Section 2)

For each recombinant viral pathogen to be transferred, if less than 100% of the genome is used, provide a brief summary as to the potential for the fraction of the viral genome being utilized to lead to a productive infection:

SECTION 6: Effect of modification on the pLant

For the following questions, consider the effect of the recombinant DNA modification(s) on the target organism(s) either through direct introduction or in the context of a recombinant DNA-containing pathogen.

Y N

Modifications include the introduction of recombinant DNA with the intent of reducing a specific biological activity within the target organism.

Y N

Are any of the targeted biological activities known or suspected components of the target organism's immune or defense systems (e.g., effective function against

microbial pathogens or insect / animal herbivores, etc.)?

Could the loss any of the proposed biological activities lead to the production of undesirable traits in the target organism?

For each Yes, briefly describe all biological activities whose reduction or loss may lead to immunosuppression or increased susceptibility, increased transmission of pathogens, or the development of any undesirable traits:

Y N

Modifications include the introduction of recombinant DNA with the intent of adding a specific biological activity to the target organism.

The specific biological activities to be added to or augmented in the target organism are known or suspected to be:

Y N

Immunomodulatory

Pathogen Receptor or other Critical Host Factor

Herbicide or Drug/Antibiotic Resistance

Could the addition of the biological activity lead to the production of undesirable traits in the target organism?

For each Yes, briefly describe all biological activities to be added / augmented:

Y N

Are you using herbicide-resistance gene(s) for selection of transgenic plants?

If yes, list any / all herbicide resistance which will be conferred.

Y N

Is there an intentional release of the target plants (either recombinant DNA-modified, or containing

recombinant pathogens) into the environment planned for this program?

If yes, briefly describe how these experiments will be conducted; and describe the anticipated effect on plant health as well as the environment.

*Note: The process and act of releasing genetically modified plants into the environment may regulated by USDA-APHIS and/or the FDA. If you have answered, "Yes" to this question, your application will not be considered complete unless this application is accompanied by the appropriate permit application and a copy of the approved permit. See http://www.aphis.usda.gov/biotechnology/index.shtml for more information.

Recombinant DNA in Plants 6 of 6 Rev. 8/1/14