Appendix 2
Risk Assessment Criteria
DEGREE OF SCRUTINY REQUIRED
Hazard Component
Less
More
A. Parents (Wild Type Organism)
A1. Domesticated
Semi-domesticated, wild or feral populations known
No reproduction without human aid
Self-propagating, wild
A2. Origin
Indigenous
Exotic
A3. Pest/Pathogen
Relatives pest/pathogen
Relatives not pest/pathogen
Pest/pathogen itself
A4. Survival Under Adverse Conditions
Short term
Long term (e.g. spores, cycsts, seeds, dormancy)
A5. Distribution, Habitat
Narrow range
Broad or unknown range
A6. Gene Exchange in Natural Population
None
Frequent
A7. Host Range
Unchanged
Changed
B.Genetic Constituents
B1. Source of Insertion
Closely related species
Same species
Unrelated species
B2. Characterization
Fully
Poor, or unknown
B3. Vector
Non-self transmissible
None
Self-transmissible
B4. Vector DNA/RNA in Altered Genome
Present but non-functional
Absent
Functional
B5. Gene Stability
Stable
Unstable
C. Phenotype of GMOs
C1. Fitness
Reduced Irreversibly
Increased
C2. Infectivity, Virulence Pathogenicity,or Toxicity
Reduced Irreversibly
Increased
C3. Host Range
Unchanged
Shifted or broadened
C4. Substrate Resource
Altered
Unchanged
Expanded
D5. Range of Environments For Testing or Use: Potential Geographical Range
Very restricted
Broad, Widespread
D6. Simulation of Test Conditions
Can simulate Realistically
Very difficult to simulate realistically
D7. Effectiveness of Monitoring and Mitigation Plans
Proven Effective
Untested or Unlikely to be effective
D8. Effect on Non-Target Organism
Known
Unknown
E. Food Safety
E1. Substantial Equivalence
Yes
No
E2. Toxicity and Allergenicity
No
Yes
E3. Concentration of GMO/its Products in Food Chain
No
Yes
E4. Quantity of GMO/its Products to be Consumed
Low
High
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