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Table 1 Comparison of current and alternative approaches to environmental risk assessment of genetically modified organisms

From: Environmental risk assessment of genetically modified plants - concepts and controversies

 

Current ERA model

Alternative ERA model

Focus

Novel trait = novel protein (pesticide model) as separate singular component

GMO (novel protein is integral component)

Stressor (characteristic causing adverse effect)

Primary

Primary (= GMO)

 

= novel trait

Secondary (any other measure required to realize benefit and intended effect of GMO)

 

= novel protein

 

Test material

Bacteria-produced and purified novel protein

Bacteria-produced and purified novel protein

 

Pollen

Pollen

  

GMO

Tested effects

  

Direct acute effects

Yes

Yes

Direct chronic effects

No, unless significant adverse direct effects at low tier

Yes, for selected species

Indirect effects

No, unless significant adverse direct effects at low tier

Yes, for selected species

Interaction effects with other primary and secondary plant compounds and/or the environment

No, unless significant adverse direct effects at low tier

Yes, for selected species

Test organisms

Standard set of universal testing species, representative for trophic levels of a generic ecosystem (i.e., first producer, first consumer, second consumer, etc.) according to OECD [33] guidelines for pesticide testing

Procedure for case-specific selection of suitable testing species, representative for important ecological functions of the receiving environments

Testing procedures

Prescriptive regarding detailed standardised experimental protocols according to OECD [33] guidelines for pesticide testing

Prescriptive regarding procedure to develop proper risk hypotheses and derive relevant testing protocols for the selected testing species