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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