Risk Assessment and Risk Management Plan Application for licence for dealings involving intentional release of a genetically modified organism into the environment dir 034/2003 Title: Field Trial of Genetically Modified Cotton


Conclusions of the Risk Assessment



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Conclusions of the Risk Assessment


The Regulator considers that the limited and controlled release of the GM insecticidal cotton will not pose risks to public health and safety, or to the Australian environment, that cannot be managed. The assessment of each potential hazard identified above is summarised under a separate heading below.

Toxicity or allergenicity to humans


The GM cotton is unlikely to prove more toxic or allergenic to humans than non-GM cotton. Toxicity to VIP3A protein is specific to lepidopteran caterpillars. There have been no reports of toxic or allergenic effects from previous releases and there is no sequence homology with known allergens or toxins for the expressed proteins. Humans are commonly exposed to VIP3A and Hph, as these proteins are widespread in the environment. GM cotton pollen is not wind dispersed and unlikely to be allergenic. Lint from the release would be sold commercially for use in fabric, upholstery and other non-food products, as lint contains no DNA or protein and is not used in food. However, none of the material from the release will be used in human food or therapeutics. Therefore, the potential for human exposure to the GM cotton is very low.

Food Standards Australia New Zealand (FSANZ) is responsible for human food safety assessment, and FSANZ approval would be needed before products from these GM cottons could be used in human food. The applicant has advised that it has applied to FSANZ for pre-market safety assessment of material from the GM cotton for use in human food.


Toxicity to non-target organisms


The GM cotton is unlikely to prove more toxic to non-target organisms than non-GM cotton. Toxicity to VIP3A protein is specific to lepidopteran caterpillars. Organisms are commonly exposed to VIP3A and Hph, as these proteins are widespread in the environment. There have been no reports of toxic effects from previous releases and there is no sequence homology with known toxins for the new proteins. The proposed release is small, limited and controlled and none of the material from the release will be used in animal feed. Therefore, the potential for non-target organism exposure to the GM cotton is very low.

Weediness


The risk of the GM cotton establishing as a weed is low and not likely to be greater than that of non-GM cotton. Cotton does not possess characteristics commonly associated with weediness, and is not known to be a problematic weed in any environment. Major constraints on weediness of GM and non-GM cotton are water availability, nutrient availability, plant competition, herbivory by non-lepidopteran species, frost and fire. Cotton has low dispersal by natural means. Volunteers do not spread or persist in the environment and can be easily controlled by cultivation or herbicides. The genetic modifications are unlikely to change these characteristics.

The licence includes conditions to minimise this risk.


Gene transfer


Some gene transfer from the GM cottons to other cultivated cottons would be likely under uncontrolled conditions, even though the overall frequency of out-crossing would be very low. It is highly unlikely, that the inserted genes would alter the likelihood or frequency of such gene transfer. Even if this occurred, it would not pose any risks additional to those posed by the GM cotton itself.

The potential for gene transfer to native cotton species is negligible due to geographic isolation from known populations and genetic incompatibility which prevents the production of fertile hybrids. The potential for gene transfer to feral (naturalised) cotton is low because of geographic isolation of such populations from the trial site.

The likelihood of transfer of the introduced genes to other plants and organisms is negligible due to genetic incompatibility, but even if such transfer occurred it would be unlikely to pose any risk to human health and safety or the environment.

The licence includes conditions to minimise this risk.


Insecticide resistance


This risk would be managed by the APVMA through conditions of the permit for the use of the insecticidal gene as an insecticide in the GM cotton lines.



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