Download Risk Assessment for rDNA-GMMO-transgenics

Risk Assessment for rDNA/Genetically Modified Organisms Form
This form is to be completed if the biological and/or biohazardous material is genetically modified or contains rDNA, genetically
modified organisms, includes genetically modified microorganisms (GMMOs), and transgenic animals and plants.
Definition:
A recombinant is defined as any biological agent produced by the combining of genetic material from more than one origin (e.g.
chromosome, cell, organism) the genetic makeup of which results from recombination).
Genetically modified organisms (GMOs) are organisms (i.e. plants, animals or microorganisms) in which the genetic material (DNA)
has been altered in a way that does not occur naturally by mating and/or natural recombination.
Genetically modified microorganism (GMMOs) refers more specifically to GMOs that are microorganisms.
Transgenic animals and plants are animals or plants in which there has been a deliberate modification of the genome, in contrast to
spontaneous mutation. Foreign DNA is introduced into the animal or plant, using recombinant DNA technology, and then must be
transmitted through the germ line so that every cell, including germ cells, of the animal or plant contain the same modified genetic
material.
Instructions:
Complete Section 1 to determine the risks involved with the rDNA and/or the GMMO.
Complete Section 2 to determine the risks involved with the transgenic animal or plants.
Section 1: Recombinant DNA/ Genetically Modified Microorganisms Information
Provide a brief description of the recombinant/GMMO:
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If the modification has resulted in a form of attenuation, how extensively has this strain been utilized without incident and/or has the
attenuation been proven in animal models? (if applicable)
rDNA/GMMO/transgenic animal research to be conducted with
(select applicable type):
Will the research involve the expression of cloned DNA?
Will research involve the purification of cloned DNA product?
Will the recombinant used for genome editing by CRISPR/cas9?
If genome editing will be done, will it be performed on germ line
cells?
Does the inserted genetic material increase, decrease or cause
no change in pathogenicity of the biological material (once
inserted)?
Will the rDNA, when inserted to a cell, animal, and/or plant,
produce substances that are biohazardous to individuals
handling the cells, animals, and/or plants?
Does the inserted gene encode a known toxin or relatively
uncharacterized toxin?
Does the modification have the potential to alter the host range,
or cell tropism of the recipient virus or bacterium?
Does the modification have the potential to increase the
replication capacity of the virus or bacterium?
Does the inserted gene encode a known oncogene?
Does the inserted gene have the potential for altering the host
cell cycle?
Does the viral or bacterial DNA integrate into the host genome?
What is the probability of generating replication-competent virus,
or bacteria?
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April 2016
☐ Human
☐ Plant
☐ Yes
☐ Yes
☐ Yes
☐ Animal
☐ Cell lines
☐ No
☐ No
☐ No
☐ Yes
☐ No ☐ n/a
☐ Other: ________________
☐ Increase ☐ Decrease ☐ No change
☐ Yes
☐ No
☐ Yes
☐ No
☐ Yes
☐ No
☐ Yes
☐ No
☐ Yes
☐ No ☐ n/a
☐ Yes
☐ No ☐ n/a
☐ Yes
☐ Low
☐ High
☐ No ☐ n/a
☐Intermediate
☐ n/a
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Does the modification have an effect of increasing or decreasing
☐ Increase ☐ Decrease ☐ n/a
the efficacy of available treatment or prophylaxis?
☐ Yes
☐ No
Will the genetic material be released to the environment?
For each gene, describe the potential for adverse health effects on humans/animals/plants arising from exposure to the gene/gene
product as found in the source organism:
For each gene, describe the potential for adverse health effects on humans/animals/plants arising from exposure to the gene/gene
product as found in the recipient organism:
Describe the replication competency of the recombinant (if replication is deficient, explain the propagation system) (if applicable):
If available, attach a copy of the genetic map of your rDNA constructs/vectors.
☐ Attached ☐ N/A
Complete the Summary Table (Refer to Table 1 on next page) for rDNA/GMMO biological material - ☐ Complete
References:
Safety Resources
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TABLE 1: RECOMBINANT DNA/GMMO SUMMARY TABLE
(Complete the following table for all recombinants)
Organism That
is Source of
Gene
Risk Group
Level for
Source
Organism
Function of Gene or
DNA Fragment and
Identify of its
Product(s) 1
Gene or
DNA
Fragment 1
2
Chaperonin60 (cpn60),
partial
Molecular chaperone
involved in protein
folding
1
Green
fluorescent
protein (GFP)
Fluorescent marker
(green fluorescent
protein)
State the
Type of
Vector Used
Risk Group
Level of
Vector
List Propagation
Mechanism or
Recipient of Gene or
DNA Fragment ( e.g.
cells line, bacteria)
Risk
Group
Level of
Recipient
pGEM T Easy
(E coli based)
1
E. coli JM109
1
dE1/E3
(human
adenoviral viral
vector, type 5)
2
Human cell line (HEK293)
2
2 (refer to
instructions below)
Examples:
Cambylobacter
jejuni
Aequorea vistoria
1
For transgenic animals, state the name of the gene and state its function, which was either deleted or inserted within the animal
Identify the vector used and state the type of vector used (e.g. basic expression vector from E. coli; shRNA expression vectors; retroviral vectors; lentiviral vectors: include the
generation used; adenoviral vectors; adeno-associated viral vectors; poxviral vectors; herpesviral vectors; alphaviral vectors; baculoviral (insect cells) vectors; etc.).
2
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Section 2: Transgenic Animals and Plants Information
Provide a brief description of the transgenic animal or plant:
What was the method used to generate the transgenic animal or plant?
Does the inserted genetic material increase, decrease or cause
no change in infectious nature/toxicity of the biological material
☐ Increase ☐ Decrease ☐ No change
(once inserted)?
Will any genetic sequences, when inserted to a cell, animal,
and/or plant, produce substances that are biohazardous to
☐ Yes
☐ No ☐ n/a
individuals handling the cells, animals, and/or plants?
Does the inserted gene encode a known toxin or relatively
☐ Yes
☐ No ☐ n/a
uncharacterized toxin?
☐ Yes
☐ No ☐ n/a
Does the inserted gene encode a known oncogene?
Does the inserted gene have the potential for altering the host
☐ Yes
☐ No ☐ n/a
cell cycle?
☐ Yes
☐ No
Will the transgenic animal/plant be released to the environment?
For each gene that was inserted or deleted, describe the potential for adverse health effects on humans/animals/plans arising from
exposure to the gene/gene product as found in the animal/plant:
If available, attach a copy of journal article describing the transgenic animal/plant.
☐ Attached ☐ N/A
Complete the Summary Table (Refer to Table 2 on next page) for TRANSGENIC animals or plants - ☐ Complete
References:
Safety Resources
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TABLE 2: TRANSGENIC ANIMAL SUMMARY TABLE
(Complete the following table for all transgenic animals or plants)
Species of State the Source
the
Organism of the
transgenic Inserted/Deleted
animal/plant
Gene in the
Animal/plant
Risk
Group
Level for
Source
Organism
Example:
1
Mouse
Aequorea vistoria
Rat
Tn5 transposon
1
1
Name of
Gene or
DNA
Fragment
Function of
Gene or
DNA
Fragment
and Identify
of its
Product(s)
Green
fluorescent
protein
Fluoresces
Neo
Confers
resistance to
neomycin
Nature of
Modification
GFP inserted into
mouse genome with
promoter of P45scc
Inserted into knockout phospholipase
C gene
Does the
inserted/deleted
gene affect the
phenotype? Can
the animal/plant
pass on traits to
offspring?
Can the gene
product be
excreted
from the
animal/plant?
Yes, and yes
No
Yes, and yes
No
Risk Group
Level of
Transgenic
Animal/Plant
1
1
State how the genetic modification was done (e.g. adenoviral vectors)
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