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Scientific Opinion on applications (EFSA-GMO-RX-40-3-2[8-1a/20-1a], EFSA-GMO-RX-40-3-2[8-1b/20-1b]) for renewal of authorisation for the continued marketing of (1) food containing, consisting of, or produced from genetically modified soybean 40-3-2; (2) feed containing, consisting of, or produced from soybean 40-3-2; (3) other products containing or consisting of soybean 40-3-2 with the exception of cultivation, all under Regulation (EC) No 1829/2003 from Monsanto

EFSA Journal 2010;8(12):1908 [38 pp.]. doi:10.2903/j.efsa.2010.1908
  EFSA Panel on Genetically Modified Organisms (GMO) Panel Members Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal Acknowledgment The Panel wishes to thank the members of the Working Group on Molecular Characterisation, Food and Feed and Environment for the preparatory work on this scientific opinion, Boet Glandorf, Niels Hendriksen as external experts and EFSA’s staff members Zoltán Divéki (MC), Karine Lheureux (ENV) and Claudia Paoletti (FF) for the support provided to this EFSA scientific opinion. Contact gmo@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2007-142 , EFSA-Q-2007-141 Adopted: 10 November 2010 Published: 01 December 2010 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

This scientific opinion is an evaluation of a risk assessment for the renewal of authorisations for continued marketing of the genetically modified herbicide tolerant soybean 40-3-2 (Unique Identifier MON-Ø4Ø32-6) for (1) food containing, consisting of, or produced from genetically modified (GM) soybean 40-3-2; (2) feed containing, consisting of, or produced from soybean 40-3-2; and (3) of other products containing or consisting of soybean 40-3-2 with the exception of cultivation. Soybean 40-3-2 has been developed for tolerance to glyphosate herbicides by the introduction, via particle gun acceleration technology, of a gene coding for 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4 (CP4 EPSPS). Molecular analyses indicated that soybean 40-3-2 contains one functional insert expressing CP4 EPSPS and a non-functional insert consisting of a fragment of the CP4 EPSPS coding sequence. Updated bioinformatic analyses of the flanking sequences and the open reading frames spanning the insert-plant DNA junctions and the levels of the newly expressed protein in soybean 40-3-2 did not raise any safety concern. The stability of the inserted DNA was confirmed over several generations. Available compositional and agronomic data show that soybean 40-3-2 is compositionally and agronomically equivalent to its conventional counterpart and to other commercial soybean varieties, except for expressing the CP4 EPSPS protein. It is estimated that the European consumers have been exposed to soybean 40-3-2 mainly via soybean oil Processed meal of soybean 40-3-2 has been given to farm animals in the EU at an estimated maximum dietary inclusion levels around 21% for broiler chickens, 18% for pigs, and 12% for dairy cattle. No adverse effects have been linked to these exposures. The safety assessment of the CP4 EPSPS protein expressed in soybean 40-3-2 and the whole soybean plant identified no concerns regarding potential toxicity and allergenicity of soybean 40-3-2. Considering the intended uses of soybean 40-3-2, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of GM soybean 40-3-2 was required. In case of accidental release of viable grains produced by soybean 40-3-2 into the environment during transportation and processing, there are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glyphosate herbicides. The EFSA GMO Panel considers unlikely that the recombinant DNA in soybean 40-3-2 transfers to bacteria and other micro-organisms and that the risk caused by a rare but theoretically possible transfer of the recombinant epsps gene from soybean 40-3-2 to environmental microorganisms is regarded to be negligible due to the lack of a selective advantage in the context of its intended use that would be conferred. Taking into account the scope of the application, the rare occurrence of feral soybean plants and the low levels of exposure through other routes, indicate that the risk to non-target organisms is extremely low. The scope of the monitoring plan provided by the applicant and the reporting intervals are in line with the intended uses of soybean 40-3-2 since cultivation is excluded.
In conclusion, on the basis of the information considered in the original application, updated studies in the present applications, and other peer-reviewed scientific data on soybean 40-3-2, the EFSA GMO Panel confirms that soybean 40-3-2 is as safe and nutritious as the conventional counterpart and other commercial soybean varieties.
 

© European Food Safety Authority, 2010

Summary

This document provides a scientific opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on two applications (References EFSA-GMO-RX-40-3-2[8-1a/20-1a] and EFSA-GMO-RX-40-3-2[8-1b/20-1b]) submitted by Monsanto under Regulation (EC) No 1829/2003 for renewal of the authorisation for continued marketing of (1) food containing, consisting of, or produced from genetically modified (GM) soybean 40-3-2 (Unique Identifier MON-Ø4Ø32-6); (2) feed containing, consisting of, or produced from soybean 40-3-2; and (3) other products containing or consisting of soybean 40-3-2 with the exception of cultivation.

The scopes of the two renewal applications cover the continued marketing of:

  • existing food containing, consisting of, or produced from soybean 40-3-2 (including food additives) (Reference EFSA-GMO-RX-40-3-2[8-1a/20-1a]) that have been placed on the market in accordance with Part C to the Directive 90/220/EC before the entry into force of Regulation (EC) No 258/97 and under Directive 89/107/EEC (Commission Decision 96/281/EC);
  • existing feed containing, consisting of, or produced from soybean 40-3-2 (Reference EFSA-GMO-RX-40-3-2[8-1b/20-1b]) that have been placed on the market in accordance with Part C to the Directive 90/220/EEC (Commission Decision 96/281/EC) and as feed materials and feed additives subject to Directive 70/524/EEC;
  • other products containing or consisting of soybean 40-3-2 with the exception of cultivation (Commission Decision 96/281/EC).

After the date of entry into force of the Regulation (EC) No 1829/2003, the products mentioned above were notified to the European Commission according to Articles 8 or 20 of this Regulation and subsequently included in the Community Register of GM food and feed.

Soybean 40-3-2 has been developed for tolerance to glyphosate herbicides by the introduction, via particle gun acceleration technology, of a gene coding for 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium tumefaciens (renamed Rhizobium radiobacter) strain CP4 (CP4 EPSPS). In delivering its scientific opinion, the EFSA GMO Panel considered the renewal applications (EFSA-GMO-RX-40-3-2[8-1a/20-1a], EFSA-GMO-RX-40-3-2[8-1b/20-1b]); a consolidated application on the cultivation of soybean 40-3-2 (application EFSA-GMO-NL-2005-24); additional information submitted by the applicant on request of the EFSA GMO Panel; the scientific comments submitted by Member States; and relevant scientific publications. In accordance with the Guidance Document for renewal of authorisations of existing GMO products, the EFSA GMO Panel has taken into account the new information, experience and data on soybean 40-3-2, which have become available during the authorisation period.

The EFSA GMO Panel assessed soybean 40-3-2 with reference to the intended uses and appropriate principles described in the Guidance Documents of the EFSA GMO Panel for the Risk Assessment of Genetically Modified Organisms and Derived Food and Feed and the Guidance Document of the Scientific Panel on Genetically Modified Organisms for renewal of authorisations of existing GMO products lawfully placed on the market. The scientific assessment included molecular characterisation of the inserted DNA and expression of the target proteins. A comparative analysis of agronomic traits and composition was undertaken and the safety of the new protein and the whole food/feed were evaluated with respect to potential toxicity, allergenicity and nutritional quality. An assessment of environmental impacts and the post-market environmental monitoring plans were undertaken.

The molecular characterisation data establish that the genetically modified 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. Updated bioinformatic analyses of the flanking sequences and the open reading frames spanning the insert-plant DNA junctions and the levels of the newly expressed protein in soybean 40-3-2 did not raise any safety concern. The stability of the inserted DNA was confirmed over several generations and a Mendelian inheritance pattern was demonstrated.

The EFSA GMO Panel compared the composition and agronomic 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 and agronomically equivalent to its conventional counterpart and other commercial soybean varieties, except for the expressing the glyphosate tolerance trait. The risk assessment of the newly expressed protein and the whole crop included an analysis of data from analytical studies, bioinformatics, and in vitro and in vivo studies. The EFSA GMO Panel concluded that the soybean 40-3-2 is as safe as its conventional counterpart and that the overall allergenicity of the whole plant is not changed.

According to the information provided by the applicant, food and feed products produced from soybean 40-3-2 have been consumed without reports of adverse effects since they were approved in the EU in 1996. Scientific publications which have become available since the previous evaluation of soybean 40-3-2 by the Advisory Committee of the Competent Authority of the United Kingdom (UK-ACNFP, 1995) did not raise safety issues. In addition, bioinformatics studies comparing the amino acid sequences of the newly expressed CP4 EPSPS protein in soybean 40-3-2 with amino acid sequences in updated databases of toxic or allergenic proteins confirmed the results of the older studies which identified no relevant similarities to known toxic or allergenic proteins.

The applications EFSA-GMO-RX-40-3-2 concern food containing, consisting of, or produced from genetically modified (GM) soybean 40-3-2 (Unique Identifier MON-Ø4Ø32-6); feed containing, consisting of, or produced from soybean 40-3-2; and other products containing or consisting of soybean 40-3-2 with the exception of cultivation. Therefore, there is no requirement for scientific assessment of possible environmental effects associated with the cultivation of soybean 40-3-2. There are no indications of an increased likelihood of establishment and spread of feral soybean plants in case of accidental release into the environment of viable grains produced by soybean 40-3-2 during transportation and processing, except in the presence of glyphosate herbicides. Taking into account the scope of the applications, the rare occurrence of feral soybean plants and the low levels of exposure through other routes, the risk to non-target organisms is extremely low. The EFSA GMO Panel considers unlikely that the recombinant DNA in soybean 40-3-2 transfers to bacteria and other microorganisms and that the risk caused by a rare but theoretically possible transfer of the recombinant epsps gene from soybean 40-3-2 to environmental microorganisms is regarded to be negligible due to the lack of a selective advantage in the context of its intended use that would be conferred. The EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the general surveillance plan. The EFSA GMO Panel recommends that appropriate management systems should be in place to restrict seeds of soybean 40-3-2 entering cultivation as the latter requires specific approval under Directive 2001/18/EC or Regulation (EC) No 1829/2003.

In conclusion, the EFSA GMO Panel considers that the information available for soybean 40-3-2 addresses the scientific comments raised by the Member States and that the soybean 40-3-2, as described in these applications, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. The EFSA GMO Panel concludes that soybean event 40-3-2 is unlikely to have any adverse effect on human and animal health and the environment, in the context of its intended uses.

Keywords

GMO, soybean, 40-3-2, glyphosate tolerance, risk assessment, food and feed safety, environment, import and processing, Regulation (EC) No 1829/2003, renewal