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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-BE-107952-1   |   PDF   |   Print   |  
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last updated: 28 Apr 2015
General Information
Scientific field evaluation of maize with modified growth characteristics
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20 Jan 2015
Risk assessment details
  • Maize with altered growth and tolerance to herbicides
    | VIB - Universiteit Gent(VIB-UGent) | Changes in physiology and/or production (Growth rate, Reproduction, Yield), Resistance to herbicides (Glufosinate), Tolerance to abiotic stress (Cold / Heat, Drought)
Methodology and points to consider
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No increased persistence in the field or invasiveness into natural habitats compared to non-GM maize is expected, as the intended changed characteristic (bigger leaves) is not known to confer a selective advantage to survivability. Other (unintended) changed characteristics observed are extra lateral side-branches in the tassel, later florescence and a shorter anthesis silking interval. These characteristics will however not impact selective advantage as the tassels will be removed. 
Vertical gene transfer through seed and pollen can virtually be ruled out due to the measures taken during the release and the biology of maize:
- pollen dispersal will be prevented by removal of the tassels,
- the cobs will be manually collected, preventing the natural dispersal of seeds,
- the low winter tolerance of spilled seed, and
- the low probability of appearance of volunteers.
The possibility of horizontal gene transfer between plants and micro-organisms is considered as a rare event under natural conditions. The possibility of horizontal gene transfer between the GM maize plants and bacteria has been given particular attention due to the presence of the recombination sites attB4, attB1 and attB2. However, the occurrence of an active integrase-excisionase complex in an environment where attP4, attP1 and attP2 are present is estimated low. In case gene transfer from the GM maize to micro-organisms would take place, negative effects on environment and humans are not expected, as the resistance gene (i.e. bar) occurs naturally in microbes and the KLUH gene will not confer a selective advantage to bacteria.
Further, it is not expected that the GM maize would have significant effects on organisms (invertebrates, vertebrates and soil micro-organisms) and humans, as no gene that affects organisms has been integrated. Given the restricted scale of the field trial, any potential effect to organisms and biogeochemical processes - if these would occur - will be of a local and temporal nature. As the GM maize will not produce pollen, a possible altered allergenicity of the transgenic pollen (allergy from maize pollen is rare and may occur in case of occupational exposure to high amounts of pollen grains) does not form a concern for human health.
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The management measures proposed are considered as sufficient to prevent potential adverse effects to the environment, animal and human health during and after the field trial. The removal of any appearing tassel in the transformed line will prevent gene flow by pollen spread. Careful manual harvesting of the cobs and storing them in closed bags will prevent seed dispersal. The seeds, after analysis, and the tassels will be destroyed. To prevent the spread of transgenes into the environment after termination of the field trial, monitoring for GM maize volunteers will be done.
The Biosafety Advisory Council concludes that it is very unlikely that this proposed small scale field trials with GM maize will harm human health, animals or the environment.
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The field trial will be conducted during three consecutive growing seasons (from April/May 2015 until October 2017). The surface of the area for cultivation will not exceed 1000 m2. No glufosinate will be applied to control weeds. Harvesting will occur each year in October.
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Additional information
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Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1