IBC # 00-000
Recombinant DNA in Animals
SECTION 1: GENERAL INFORMATION
Protocol Title:
Principal Investigator:
SECTION 2: RECIPIENTS OF RECOMBINANT DNA
This program involves:
Y
N
The use of recombinant DNA-containing pathogens in unmodified animals or invertebrate
organisms.
The introduction of recombinant DNA directly into animals or invertebrate organisms
(i.e., creating transgenic animals).
The purchase of recombinant DNA-containing animals or invertebrate organisms
(i.e., purchase of transgenic animals).
The use of recombinant DNA-containing pathogens in recombinant DNA-containing animals or
invertebrate organisms.
The organism can be found:
Organism
(animal) name
(Genus,
species)
Common
name and
strain
Normal (WT)
Containment
Level for this
Organism
Within
the
state
of VA
(yes
or no)
Within
the
U.S.
(yes or
no)
Country
of Origin
(if not
the U.S.)
Is the
organism
already
modified (i.e.
purchased
transgenic)?
(Yes or No)
Will
naturally
occurring
(WT)
pathogens
be
introduced
to this
organism?
Will
recombinant
pathogens be
introduced to
this
organism?
(Yes or No)
(Yes or No)
*Note: An existing spreadsheet including the specific information requested above may be inserted or submitted
with your application -as APPENDIX F- in place of the above table.
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SECTION 3: MODIFIED DNA DIRECTLY INTRODUCED INTO ANIMALS/INVERTEBRATE ORGANISMS
*Note: The following questions apply to recombinant DNA introduced directly into an animal or invertebrate
organism. If you are introducing modified organism(s) to the animals/invertebrate organisms, 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)
Non-coding
miRNA
Catalytic RNA
Double-stranded RNA/siRNA
Epitope tag
Antisense RNA
Complex sample (genomic library, etc)
Other
Method of recombinant DNA transfer into the target organism (Check all that apply)
Germline
Somatic
Virus
Biolistics
Transplantation (nuclei)
Transposon
Recombination
Transplantation (organs/tissues/cells)
Nanoparticles
Injection
Other
Briefly describe how recombinant DNA molecules will be introduced into the target organism:
Note: An existing spreadsheet including the specific information requested below may be inserted or
submitted with your registration -as APPENDIX G- 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 of gene or
catalytic RNA (e.g., name
of native organism or
“synthetic”)
Known or suspected function(s)
Organism DNA is being inserted
into (if more than 1 organism is
listed in Section 2)
For non-coding segments, miRNA/dsRNA/siRNA/asRNA or complex samples, provide the source organism:
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Type
Source Organism
Organism DNA is being inserted into
(if more than 1 organism is listed in
Section 2)
If "Other", please explain the type and source of recombinant DNA:
Type
Source Organism
Organism DNA is being inserted into
(if more than 1 organism is listed in
Section 2)
SECTION 4: ADDITONAL INFORMATION
Y
N
Does this program involve the generation of transgenic rodents?
Does this program involve the purchase or transfer of transgenic rodents?
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:
Y
N
Is the organism(s) to be modified a known invertebrate pest of plants or animals?
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If yes, briefly describe the nature and importance of this pest species (include information as to whether
any of the pest species to be modified as:
Is the organism(s) to be modified an invertebrate vector of plant disease agents?
If yes, briefly describe the nature and importance of this vector species:
Is the organism(s) to be modified an invertebrate vector of animal (including human) disease
agents?
If yes, briefly describe the nature and importance of this vector species:
SECTION 5: MODIFIED VIRAL DNA
Y
N
Is this the deliberate transfer of recombinant DNA derived from a eukaryotic viral genome into an
animal and/or invertebrate organism?
If yes, please list all sources of viral-derived recombinant DNA in the table below:
Viral
genome
(Source of
recombinant
DNA)
Is the viralderived
recombinant
DNA to be
transferred
replication
competent
itself?
% of viralderived
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?
Organism DNA is
being inserted into
(if more than 1
organism 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: MODIFIED PATHOGENS INTRODUCED INTO ANIMALS/INVERTEBRATE ORGANISMS
In the table below, please list the pathogens that will be introduced to animals
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Name of pathogen
Animal it will be introduced (if more
than 1 animal is listed in Section 2)
SECTION 7: EFFECT OF MODIFICATION(S) ON THE ANIMAL/INVERTEBRATE ORGANISM(S)
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 system?
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, 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
Drug/Antibiotic Resistance
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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
Is there an intentional release of the target animal organism(s) (either recombinant DNA-modified, or
those introduced to 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 human or animal health, as well as the environment:
*Note: The process and act of releasing genetically-modified non-human vertebrates or invertebrates into the
environment may be 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.
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