Risk Assessment for rDNA/Genetically Modified Microorganisms (GMMOs) Form
This form is to be completed if the biological and/or biohazardous material is genetically modified or contains rDNA.
Background
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).
As per guidelines from Public Health Agency of Canada (PHAC), Canadian Food Inspection Agency (CFIA), and the National
Institutes of Health (NIH), there are standard risk group assessments based on the modification, however, for the most part, a
comprehensive examination on the effect of modification is required. The risk factor can be more subjective.
Use Table 1 to determine the recombinant level for each recombinant biological material. Based on the recombinant information
provided for each recombinant risk group level identified, complete Table 2 for each recombinant/ genetically modified biological
material.
Table 1: Recombinant Level scale
Recombinant Level
0
1
2
Safety Resources
Description
Not applicable, biological agent not a recombinant.
The recombinant is a risk group 1 organism; the modifications
have not changed the risk.
The recombinant is a risk group 2 organism; the modifications
have not changed the risk; or DNA from risk group 2 or 3
organisms is transferred into risk group 1 organism, but not the
whole genome; or the recombinant is a risk 3 or 4 organism;
however, the modification has resulted in proven attenuation.
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Recombinant Level
3
4
Description
The recombinant is a risk group 3 organisms; the modifications
have not changed the risk; or the recombinant is based on a risk
group 2 organism; however, the modifications have increased the
risk.
The recombinant is a risk group 4 organisms; the modifications
have not changed the risk; or DNA from the risk group 4
organism is transferred into a risk group 1 organism in absence
of demonstration of lack of virulence or pathogenicity.
Table 2: Recombinant/ Genetically Modified Biological Material Information
Recombinant level (1-4)
(from Table 1):
Provide a brief description of the recombinant:
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?
rDNA 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?
Does the inserted material increase virulence or decrease the
effectiveness of the anti-infective agents?
Does the inserted gene encode a known toxin or relatively
uncharacterized toxin?
Safety Resources
☐ Human
☐ Plant
☐ Yes
☐ Yes
☐ Animal
☐ Cell lines
☐ No
☐ No
☐ Increase ☐ Decrease
☐ Yes
☐ No
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Does the modification have the potential to alter the host range or
cell tropism of the virus or bacteria?
Does the modification have the potential to increase the
replication capacity of the virus or bacteria?
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?
☐ Yes
☐ No
☐ Yes
☐ No
☐ Yes
☐ No
☐ Yes
☐ No
☐ Yes
☐ Low
☐ High
☐ No
☐Intermediate
What is the probability of generating replication-competent virus
or bacteria?
Does the modification have an effect of increasing or decreasing
☐ Increase ☐ Decrease
the efficacy of available treatment or prophylaxis?
Will the genetic material be released to the environment?
☐ Yes
☐ No
For each gene, describe the potential for adverse health effects on humans/animals/plans 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/plans arising from exposure to the gene/gene
product as found in the host organism:
Describe the replication competency of the recombinant (if replication is deficient, explain the propagation system):
If available, attach a copy of the genetic map of your vectors.
☐ Attached ☐ N/A
Complete the rDNA Summary Table (Refer to Table 3 on next page) ☐ Complete
References:
Safety Resources
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TABLE 3: RECOMBINANT DNA SUMMARY TABLE
(Complete the following table for all recombinants)
Risk
Group
Level for
Source
Organism
Gene or
DNA
Fragment
Function of Gene or
DNA Fragment and
Identify of its
Product(s)
Cambylobacter
jejuni
2
Chaperonin60 (cpn60),
partial
Aequorea vistoria
1
Green
fluorescent
protein (GFP)
Organism That
is Source of
Gene
Vector Used1
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
Molecular chaperone
involved in protein folding
pGEM T Easy
1
E. coli JM109
1
Fluorescent marker
(green fluorescent
protein)
dE1/E3 (human
adenoviral viral
vector, type 5)
2
Human cell line (HEK293)
2
Examples:
1
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.)
Safety Resources
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