EFSA finds GM-soybean safe for cultivation

26-06-2012 | |

Following the submission of an application from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) considered the herbicide tolerant genetically modified (GM) soybean 40-3-2 safe for cultivation.

Soybean 40-3-2 expresses an enzyme, which is derived from bacterium Agrobacterium tumefaciens (updated scientific name: Rhizobium radiobacter), and renders soybean 40-3-2 tolerant to the herbicidal active substance glyphosate.
The likelihood of unintended environmental effects due to the establishment, survival and spread of soybean 40-3-2 is considered to be extremely low, and will be no different from that of conventional soybean varieties.
Based on the evidence provided by Monsanto and relevant scientific literature, the EFSA GMO Panel concludes that there are no indications of the occurrence of adverse effects on predators, herbivores and decomposers due to potential unintended changes in soybean 40-3-2, and therefore considers trait-specific information appropriate to assess whether soybean 40-3-2 poses a risk to non-target organisms.
Since Monsanto did not provide event-specific data on plant-pollinator interactions the EFSA GMO Panel considered that this scientific uncertainty should be resolved by experiments on adult honeybees, as long as the conditions in the Scientific Opinion are met.
The EFSA GMO Panel does not expect potential adverse effects on biogeochemical processes and the abiotic environment of soybean 40-3-2.
The EFSA GMO Panel is of the opinion that potential adverse environmental effects of the cultivation of soybean 40-3-2 are associated with the use of the complementary glyphosate-based herbicide regimes.
These potential adverse environmental effects could, under certain conditions, comprise:
(1) a reduction in farmland biodiversity;
(2) changes in weed community diversity due to weed shifts;
(3) the selection of glyphosate resistant weeds; and
(4) changes in soil microbial communities.
The potential harmful effects could occur at the level of arable weeds, farmland biodiversity, and food webs and the ecological functions they provide.
The magnitude of these potential adverse environmental effects will depend on a series of factors, including the specific herbicide and cultivation management applied at the farm level, the crop rotation and the characteristics of the receiving environments.
The EFSA GMO Panel
  • considers that the information available for soybean 40-3-2 addresses the scientific comments raised by Member States and that soybean 40-3-2 is as safe as its conventional counterpart and commercial non-GM soybean varieties with respect to potential adverse effects on human and animal health.
  • concludes that soybean 40-3-2 is unlikely to raise additional environmental safety concerns compared with conventional soybean, but that management of its cultivation could result in environmental harm under certain conditions.
  • recommends managing the use of glyphosate on soybean 40-3-2 in ways that result in similar or reduced environmental impacts compared with conventional soybean cultivation.
  • recommends the deployment of case-specific monitoring to address:
    • changes in weed community diversity; and
    • evolution of resistance to glyphosate in weeds due to changes in herbicide and cultivation regimes.


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