Risk Assessment for rDNA/Genetically Modified Organisms

This form is to be completed if the biological and/or biohazardous material is genetically modified or contains rDNA, is a genetically modified organism or microorganism, or a transgenic animal or plant.

Definitions:

Ø  A recombinant is defined as any biological material produced by combining (through recombination) genetic material from more than one origin (e.g. chromosome, cell, or organism).

Ø  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.

Ø  Genetically modified microorganism (GMMOs) refers more specifically to GMOs that are microorganisms.

Ø  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:

1.  Complete Section 1 to determine the risks involved with the rDNA and/or the GMMO.

2.  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:
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): / ☐ Human ☐ Animal ☐ Other: ______
☐ Plant ☐ Cell lines
Will the research involve the expression of cloned DNA? / ☐ Yes ☐ No
Will research involve the purification of cloned DNA product? / ☐ Yes ☐ No
Will the recombinant used for genome editing by CRISPR/cas9? / ☐ Yes ☐ No
If genome editing will be done, will it be performed on germ line cells? / ☐ Yes ☐ No ☐ n/a
Does the inserted genetic material increase, decrease or cause no change in pathogenicity of the biological material (once inserted)? / ☐ Increase ☐ Decrease ☐ No change
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? / ☐ Yes ☐ No
Does the inserted gene encode a known toxin or relatively uncharacterized toxin? / ☐ Yes ☐ No
Does the modification have the potential to alter the host range, or cell tropism of the recipient virus or bacterium? / ☐ Yes ☐ No
Does the modification have the potential to increase the replication capacity of the virus or bacterium? / ☐ Yes ☐ No
Does the inserted gene encode a known oncogene? / ☐ Yes ☐ No ☐ n/a
Does the inserted gene have the potential for altering the host cell cycle? / ☐ Yes ☐ No ☐ n/a
Does the viral or bacterial DNA integrate into the host genome? / ☐ Yes ☐ No ☐ n/a
What is the probability of generating replication-competent virus, or bacteria? / ☐ Low ☐Intermediate ☐ n/a
☐ High
Does the modification have an effect of increasing or decreasing the efficacy of available treatment or prophylaxis? / ☐ Increase ☐ Decrease ☐ n/a
Will the genetic material be released to the environment? / ☐ Yes ☐ No
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:

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 / Gene or DNA Fragment 1 / Function of Gene or DNA Fragment and Identify of its Product(s) 1 / State the Type of Vector Used 2 (refer to instructions below) / 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
Examples:
Cambylobacter jejuni / 2 / Chaperonin-60 (cpn60), partial / Molecular chaperone involved in protein folding / pGEM T Easy (E coli based) / 1 / E. coli JM109 / 1
Aequorea vistoria / 1 / Green fluorescent protein (GFP) / Fluorescent marker (green fluorescent protein) / dE1/E3 (human adenoviral viral vector, type 5) / 2 / Human cell line (HEK293) / 2

1 For transgenic animals, state the name of the gene and state its function, which was either deleted or inserted within the animal

2 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; poxvirus vectors; herpesvirus vectors; alphavirus vectors; baculovirus (insect cells) vectors; etc.).

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 (once inserted)? / ☐ Increase ☐ Decrease ☐ No change
Will any genetic sequences, when inserted to a cell, animal, and/or plant, produce substances that are biohazardous to individuals handling the cells, animals, and/or plants? / ☐ Yes ☐ No ☐ n/a
Does the inserted gene encode a known toxin or relatively uncharacterized toxin? / ☐ Yes ☐ No ☐ n/a
Does the inserted gene encode a known oncogene? / ☐ Yes ☐ No ☐ n/a
Does the inserted gene have the potential for altering the host cell cycle? / ☐ Yes ☐ No ☐ n/a
Will the transgenic animal/plant be released to the environment? / ☐ Yes ☐ No
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:

Table 2: TRANSGENIC ANIMAL Summary Table

(Complete the following table for all transgenic animals or plants)

Species of the transgenic animal/plant / State the Source Organism of the Inserted/Deleted Gene in the Animal/plant / Risk Group Level for Source Organism / Name of Gene or DNA Fragment / Function of Gene or DNA Fragment and Identify of its Product(s) / Nature of Modification / 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? / Risk Group Level of Transgenic Animal/Plant
Example:
Mouse / Aequorea vistoria / 1 / Green fluorescent protein / Fluoresces / GFP inserted into mouse genome with promoter of P45scc / Yes, and yes / No / 1
Rat / Tn5 transposon / 1 / Neo / Confers resistance to neomycin / Inserted into knock-out phospholipase C gene / Yes, and yes / No / 1

1 State how the genetic modification was done (e.g. adenoviral vectors)

Safety Resources 3 | Page

September 2017