Following the submission of an application (Reference EFSA-GMO-NL-2005-24) under Regulation (EC) No 1829/2003 from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a Scientific Opinion on the safety of the herbicide tolerant genetically modified (GM) soybean (also known as soya bean) 40-3-2 (Unique Identifier MON-Ø4Ø32-6) for cultivation. Although the scope of this application covers only cultivation of soybean 40-3-2, this Scientific Opinion also updates the previous EFSA GMO Panel safety evaluation on the continued marketing of: (1) food containing, consisting of, or produced from soybean 40-3-2; (2) feed containing, consisting of, or produced from soybean 40-3-2; and of (3) other products containing or consisting of soybean 40-3-2.
In delivering its Scientific Opinion, the EFSA GMO Panel considered: the application EFSA-GMO-NL-2005-24; additional information supplied by the applicant; scientific comments submitted by Member States; the environmental risk assessment report of the German Competent Authority (DE CA); and relevant scientific publications.
Soybean 40-3-2 expresses the enzyme CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS), which is derived from the CP4 strain of Agrobacterium tumefaciens (updated scientific name: Rhizobium radiobacter), and renders soybean 40-3-2 tolerant to the herbicidal active substance glyphosate.
The EFSA GMO Panel evaluated soybean 40-3-2 with reference to its intended uses and the appropriate principles described in its guidelines for the following: the risk assessment of GM plants and derived food and feed; the environmental risk assessment of GM plants; the selection of comparators for the risk assessment of GM plants; and the post-market environmental monitoring of GM plants. The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and expression of the target protein. An evaluation of the comparative analyses of composition and agronomic and phenotypic characteristics was undertaken, and the safety of the new protein and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional quality. An evaluation of environmental impacts and the post-market environmental monitoring plan was undertaken.
The molecular characterisation data established that soybean 40-3-2 contains one functional insert expressing CP4 EPSPS and a non-functional insert consisting of a 72 bp fragment of the CP4 epsps coding sequence. No other parts of the plasmid used for transformation are present in the transformed plant. Bioinformatic analyses of the open reading frames spanning the junction site within the functional insert or between the inserts and genomic DNA did not indicate specific hazards. The stability of the inserted DNA and the herbicide tolerance trait were confirmed over several generations. Analyses of the levels of CP4 EPSPS in leaves and seed collected from field trials performed in Europe were considered sufficient.
The EFSA GMO Panel compared the composition and agronomic and phenotypic characteristics of soybean 40-3-2 and its conventional counterpart, assessed all statistical differences identified, and came to the conclusion that soybean 40-3-2 is compositionally equivalent to commercial non-GM soybean varieties, except for the newly expressed protein. The risk assessment included an analysis of data from analytical studies, bioinformatic analyses, and in vitro and in vivo studies. The EFSA GMO Panel concludes that the soybean 40-3-2 is as safe as its conventional counterpart and commercial non-GM soybean varieties and that the overall allergenicity of the whole plant is not changed.
As the scope of the current application covers cultivation, the environmental risk assessment considered the environmental impact of full-scale commercialisation of soybean 40-3-2.
The DE CA provided EFSA with its report on the environmental risk assessment of soybean 40-3-2 (dated 9 September 2008) on 3 October 2008 in line with Articles 6.3(c) and 18.3(c) of Regulation (EC) No 1829/2003. The report on the environmental risk assessment of the DE CA is provided in Annex H of the EFSA Overall Opinion, and has been considered throughout this EFSA GMO Panel Scientific Opinion.
The EFSA GMO Panel considers that soybean 40-3-2 has no altered agronomic and phenotypic characteristics, except for the herbicide tolerance. 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.
It is highly unlikely that the recombinant DNA will transfer and establish in the genome of bacteria in the environment or human and animal digestive tracts. In the rare but theoretically possible case of transfer of the CP4 epsps gene from soybean 40-3-2 to soil bacteria, no novel property would be introduced into the soil bacterial community and thus no positive selective advantage that would not have been conferred by natural gene transfer between bacteria would be provided.
Based on the evidence provided by the applicant and relevant scientific literature on soybean 40-3-2, 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-specificinformation appropriate to assess whether soybean 40-3-2 poses a risk to non-target organisms. However, the EFSA GMO Panel that scientific uncertainty pertaining to the occurrence of adverse effects on pollinators due to potential unintended changes in soybean 40-3-2 remains, as no event-specific data on plant-pollinator interactions were provided by the applicant. The EFSA GMO Panel considered that this scientific uncertainty should be resolved by experiments in relevant receiving environments in Europe that are designed to compare the effects of soybean 40-3-2 and its conventional counterpart (and optionally reference, commercial non-GM soybean varieties, if appropriate) on adult honeybees, as long as the five conditions explicitly stated in this Scientific Opinion are met.
The studies, supplied or reviewed by the applicant, showed no adverse effects on different types of non-target organisms due to the expression of the CP4 EPSPS protein in glyphosate tolerant crops.
The EFSA GMO Panel does not expect potential adverse effects on biogeochemical processes and the abiotic environment due to the expression of CP4 EPSPS protein in 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 conclusions of the EFSA GMO Panel on the environmental safety of soybean 40-3-2 are consistent with those of the DE CA. The DE CA concluded that “no adverse effects on human and animal health and the environment are to be expected from the cultivation of soybean 40-3-2”,but that “glyphosate-containing herbicides can be applied after germination of the soybean plants and thus could have effects on the accompanying weed flora. Based on experience from using conventional plant protection products it is to be expected that sooner or later tolerance to the active ingredient of glyphosate-containing herbicides will develop in the weed flora” (see section 6.5 of the environmental risk assessment report of the DE CA). In its evaluation, the DE CA noted that “there is potentially also an indirect interaction between the use of glyphosate-containing herbicides and nitrogen-fixing symbiotic partners of the soybean (e.g. Bradyrhizobium japonicum, Moorman et al., 1992, King et al., 2001), which could lead to a reduction in harvest yield (King et al., 2001). To compensate, potential increased application of nitrogen fertilizer might be necessary with the cultivation of HT soybeans” (see section 6.5 of the environmental risk assessment report of the DE CA). With regard to potential adverse effects on non-target organisms due to potential unintended changes in soybean 40-3-2, the DE CA recommended “conducting an additional study to confirm the absence of unintended adverse effects on non-target organisms” (see section 6.3 of the environmental risk assessment report of the DE CA).
The EFSA GMO Panel anticipated that the repeated use of glyphosate at recommended application rates on soybean 40-3-2 grown either in rotation with other glyphosate tolerant crops, or continuously may lead to a greater risk of reducing weed community diversity than the current practices applied in soybean cropping systems. This may therefore result in reductions in weed community diversity and/or weed density to a level that might adversely affect food chains and webs, but not necessarily biological control functions, at the field and landscape level. Such reductions in weed community diversity and consequential reductions in farmland biodiversity may be considered problematic by risk managers depending upon protection goals pertaining to their region, especially in receiving environments that sustain little farmland biodiversity or in environmentally sensitive areas. Under such situations, the EFSA GMO Panel recommends that risk mitigation measures are put in place to manage potential herbicide effects, in order to ensure that glyphosate is used on soybean 40-3-2 in ways that result in similar or reduced adverse effects on farmland biodiversity compared with conventional soybean cultivation. Possible risk mitigation measures include reduced tillage, crop rotation, less intense in-crop weed management, protecting adjacent habitats from herbicide drift, and (re)introduction and better management of field margins and other ‘out of crop’ measures.
Soybean 40-3-2 grown in rotation with other glyphosate tolerant crops or continuously, in conjunction with the repeated and/or exclusive application of glyphosate-based herbicides, will cause changes in the weed flora, and will favour the evolution and spread of glyphosate resistant weeds due to the selection pressure exerted by glyphosate. The EFSA GMO Panel recommends that risk mitigation measures are put in place to reduce the selection pressure and hence to delay the evolution of resistance. This can be achieved by crop rotation (i.e., rotating glyphosat tolerant crops with non-glyphosate tolerant crops, alternating autumn- and spring-sown crops), using variable rates and timing of herbicide application, applying a variety of herbicidal active substances with different modes of action, and using non-herbicide weed control tools such as pre- and post-emergence cultivation and cover crops. To be most effective, these methods should be used in combination. A clear advantage of increasing cropping system diversity is that it would increase or conserve farmland biodiversity as well as reducing the risk of weed shifts and the evolution of glyphosate resistant weed biotypes.
The EFSA GMO Panel considers that current management practices are sufficient to cope with potential adverse effects on symbiotic nitrogen fixation arising from the use of glyphosate on soybean 40-3-2, but advises that risk managers inform farmers of the possibility of the occurrence of such effects.
The conclusions of the EFSA GMO Panel on the environmental safety of soybean 40-3-2 are consistent with those of the DE CA. In its evaluation, the DE CA recommended that “herbicide and cultivation management of soybean 40-3-2 should be adapted to minimize potential negative effects” (section 6.5 of the environmental risk assessment report of the DE CA).
The EFSA GMO Panel gives its opinion and makes recommendations on the scientific quality of the post-market environmental monitoring plan proposed by the applicant. In order to assess the efficacy of risk mitigation measures put in place to reduce levels of risk and in order to reduce the remaining scientific uncertainty identified in the environmental risk assessment, the EFSA GMO Panel recommends case-specific monitoring to address: (1) changes in weed community diversity; and (2) evolution of resistance to glyphosate in weeds due to changes in herbicide and cultivation regimes. In addition, the EFSA GMO Panel considers that it would be proportionate to the risk for the post-market studies on the occurrence of adverse effects on pollinators due to potential unintended changes in soybean 40-3-2, proposed by the applicant, to be conducted as case-specific monitoring. No case-specific monitoring is required to assess changes in soil microbial communities, but the EFSA GMO Panel recommends that the applicant establishes stewardship systems encouraging farmers to report problems that may be due to reduced symbiotic nitrogen fixation. General surveillance (including appropriately designed farmer questionnaires) offers an effective approach to detect and report early warning signs indicating that such effects occur. The EFSA GMO Panel considers that risk managers should adapt monitoring methodologies to their local receiving environments, management systems and the interplay between the legislation for GMOs and plant protection products.
The EFSA GMO Panel agrees with the general surveillance plan for the cultivation of soybean 40-3-2 proposed by the applicant: (1) to establish farmer questionnaires as a reporting format of any on-farm observations of effects associated with the cultivation of soybean 40-3-2; (2) to use existing monitoring networks that observe changes in biota and production practices from farm up to regional level to obtain data on environmental impacts in the landscape where soybean 40-3-2 is cultivated; (3) to review all new scientific, technical and other information pertaining to soybean 40-3-2; and (4) to develop stewardship programmes for the introduction, marketing, management and stewardship of soybean 40-3-2. However, the EFSA GMO Panel requests that its proposals and those made by the DE CA to strengthen general surveillance are implemented. The EFSA GMO Panel agrees with the reporting intervals and modalities proposed by the applicant. The general surveillance plan for the import and processing of soybean 40-3-2 has been previously evaluated by the EFSA GMO Panel.
The DE CA considered that “based on the safety assessment of soybean 40-3-2, no specific cause-effect relationship for adverse environmental impacts has been identified that would necessitate a case specific monitoring by the applicant”. However, with regard to the occurrence of adverse effects on non-target organisms due to potential unintended changes in soybean 40-3-2, the DE CA recommended that “the applicant shall carry out a field study to confirm the absence of unintended adverse effects on non-target organisms in the EU with placing soybean 40-3-2 on the market. The design of such a study should be of a quality to allow appropriate scientific assessment as proposed in the application”.
Further, the DE CA was of the opinion that “the monitoring plan needs some clarifications (reporting monitoring annually, and delivery of more comprehensive overviews after six and nine years); and improvement of the questionnaires”. The DE CA recommended that “monitoring of the herbicide use is conducted as part of the stewardship for the herbicides by the companies involved, and under the auspices of the pesticide regulatory systems operating in Member States, in order to record compliance with the approved uses of the herbicides on GMHT, levels of weed control, and development of resistant weeds. The German Competent Authority assumes that possible indirect effects of complementary herbicide application will be taken into account by the applicant in the context of a Stewardship Program harmonized with the pesticide assessment authorities. This should ensure that unexpected effects (in general surveillance) can be detected” (see section 8 of the environmental risk assessment report of the DE CA).
In conclusion, 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, as described in this application, is as safe as its conventional counterpart and commercial non-GM soybean varieties with respect to potential adverse effects on human and animal health, in the context of its intended uses. The EFSA GMO Panel also 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. The EFSA GMO Panel therefore 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. The EFSA GMO Panel recommends the deployment of case-specific monitoring to address: (1) changes in weed community diversity; and (2) evolution of resistance to glyphosate in weeds due to changes in herbicide and cultivation regimes. In addition, the EFSA GMO Panel considers that it would be proportionate to the risk for the post-market studies on the occurrence of adverse effects on pollinators due to potential unintended changes in soybean 40-3-2, proposed by the applicant, to be conducted as case-specific monitoring, as long as the five conditions explicitly stated in this Scientific Opinion are met.If subjected to appropriate management measures, the cultivation of soybean 40-3-2 is unlikely to have environmental effects any more adverse than those associated with conventional soybean cultivation.