Scientific Opinion on application (EFSA‐GMO‐NL‐2008‐52) for the placing on the market of herbicide tolerant genetically modified soybean A5547‐127 for food and feed uses, import and processing under Regulation (EC) No 1829–2003 from Bayer CropScience

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doi:10.2903/j.efsa.2011.2147

Cited by 10 publications

(19 citation statements)

References 18 publications

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“…Based on the known biological function (Table 3) of the newly expressed proteins, no interactions at biological level are foreseen. The genetic stability of the inserted DNA over multiple generations in single soybean events FG72 and A5547-127 was demonstrated previously (EFSA GMO Panel, 2011c, 2015. Integrity of these events in soybean FG72 9 A5547-127 was demonstrated by Southern analyses.…”

Section: Genetic Elements and Their Biological Functionsmentioning

confidence: 85%

“…50% was observed. Such reduction was not observed for the single events FG72 and A5547-127 previously assessed by the GMO Panel (EFSA GMO Panel, 2011c, 2015. The GMO Panel requested further information, but from the submitted data, 18 it was not possible to fully characterise the observed differences.…”

mentioning

confidence: 94%

“…Since the publication of the scientific opinions on the single soybean events by the GMO Panel (EFSA GMO Panel, 2011c, 2015, no safety issue pertaining to the two single events has been reported by the applicant.…”

Section: Updated Information On Single Eventsmentioning

confidence: 99%

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Scientific opinion on application EFSA‐GMO‐NL‐2013‐120 for authorisation of genetically modified soybean FG72 × A5547‐127 for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Bayer CropScience LP and M.S. Technologies LLC

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO) assesses the twoevent stack soybean FG72 x A5547-127 for food and feed uses, import and processing. The EFSA GMO Panel previously assessed the two single events combined to produce the two-event stack soybean FG72 x A5547-127 and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on soybean FG72 x A5547-127 did not give rise to safety concerns and no reason to expect interactions between the single events impacting on the food and feed safety of the two-event stack soybean was identified. Although the EFSA GMO Panel cannot conclude on forage composition, soybean forage is not expected to be imported in a significant amount for use as feed. Considering the routes of exposure and limited exposure levels, the EFSA GMO Panel concludes that soybean FG72 x A5547-127 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean FG72 x A5547-127. The EFSA GMO Panel concludes that soybean FG72 x A5547-127 is as safe as the non-genetically modified (GM) comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment. AbstractIn this opinion, the EFSA Panel on Genetically Modified Organisms (GMO) assesses the two-event stack soybean FG72 9 A5547-127 for food and feed uses, import and processing. The EFSA GMO Panel previously assessed the two single events combined to produce the two-event stack soybean FG72 9 A5547-127 and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on soybean FG72 9 A5547-127 did not give rise to safety concerns and no reason to expect interactions between the single events impacting on the food and feed safety of the two-event stack soybean was identified. Although the EFSA GMO Panel cannot conclude on forage composition, soybean forage is not expected to be imported in a significant amount for use as feed. Considering the routes of exposure and limited exposure levels, the EFSA GMO Panel concludes that soybean FG72 9 A5547-127 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean FG72 9 A5547-127. The EFSA GMO Panel concludes that soybean FG72 9 A5547-127 is as safe as the non-genetically modified (GM) comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

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Section: Genetic Elements and Their Biological Functionsmentioning

confidence: 85%

mentioning

confidence: 94%

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Scientific opinion on application EFSA‐GMO‐NL‐2013‐120 for authorisation of genetically modified soybean FG72 × A5547‐127 for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Bayer CropScience LP and M.S. Technologies LLC

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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“…The PAT protein has been previously assessed by the GMO Panel (e.g. EFSA 2007; EFSA GMO Panel, 2011cPanel, , 2013a, and no safety concerns for humans and animals were identified. Updated bioinformatics analyses did not reveal similarities of the PAT protein to known toxins.…”

Section: Toxicological Assessment Of Newly Expressed Proteinsmentioning

confidence: 99%

“…The GMO Panel has previously evaluated the safety of the PAT protein in the context of several other applications and no concerns about allergenicity were identified (e.g. EFSA 2007;EFSA GMO Panel, 2011c, 2013a.…”

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 48mentioning

confidence: 99%

Scientific Opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2011‐91) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐68416‐4 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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Soybean DAS-68416-4 was developed by Agrobacterium tumefaciens-mediated transformation to express the aryloxyalkanoate dioxygenase-12 (AAD-12) protein, conferring tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides, and the phosphinothricin acetyltransferase (PAT) protein, conferring tolerance to glufosinate ammonium-based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring further assessment for food/feed safety. The agronomic and phenotypic characteristics tested revealed no relevant differences between soybean DAS-68416-4 and its conventional counterpart, except for 'days to 50% flowering'. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 36%) in lectin activity in soybean DAS-68416-4. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition for soybean DAS-68416-4 as compared to its conventional counterpart and the non-GM reference varieties. There were no concerns regarding the potential toxicity and allergenicity of the two newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS-68416-4. Soybean DAS-68416-4 is as nutritious as its conventional counterpart and the non-GM reference varieties. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS-68416-4 plants, unless these are exposed to the intended herbicides. The likelihood of environmental effects resulting from the accidental release of viable seeds from soybean DAS-68416-4 into the environment is therefore very low. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS-68416-4. The GMO Panel concludes that the information available addresses the scientific comments of the Member States and that soybean DAS-68416-4, as described in this application, is as safe as its conventional counterpart and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. The GMO Panel evaluated soybean DAS-68416-4 with reference to the scope and appropriate principles described in its guidelines for the risk assessment of GM plants. The evaluation addressed the following components of the risk assessment: the molecular characterisation of the inserted DNA and analysis of the expression of the corresponding proteins; the comparative analyses of compositional, agronomic and phenotypic characteristics; the safety of the newly...

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Inter‐species protein trafficking endows dodder (Cuscuta pentagona) with a host‐specific herbicide‐tolerant trait

Jiang

et al. 2013

New Phytologist

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SummaryBesides photosynthates, dodder (Cuscuta spp.) acquires phloem-mobile proteins from host; however, whether this could mediate inter-species phenotype transfer was not demonstrated. Specifically, we test whether phosphinothricin acetyl transferase (PAT) that confers host plant glufosinate herbicide tolerance traffics and functions inter-specifically.Dodder tendrils excised from hosts can grow in vitro for weeks or resume in vivo by parasitizing new hosts. The level of PAT in in vivo and in vitro dodder tendrils was quantified by enzyme-linked immunosorbent assay. The glufosinate sensitivity was examined by dipping the distal end of in vivo and in vitro tendrils, growing on or excised from LibertyLink â (LL; PATtransgenic and glufosinate tolerant) and conventional (CN; glufosinate sensitive) soybean hosts, into glufosinate solutions for 5 s. After in vitro tendrils excised from LL hosts reparasitized new CN and LL hosts, the PAT level and the glufosinate sensitivity were also examined. When growing on LL host, dodder tolerated glufosinate and contained PAT at a level of 0.3% of that encountered in LL soybean leaf. After PAT was largely degraded in dodders, they became glufosinate sensitive. PAT mRNA was not detected by reverse transcription PCR in dodders.In conclusion, the results indicated that PAT inter-species trafficking confers dodder glufosinate tolerance.

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Scientific Opinion on application (EFSA‐GMO‐NL‐2008‐52) for the placing on the market of herbicide tolerant genetically modified soybean A5547‐127 for food and feed uses, import and processing under Regulation (EC) No 1829–2003 from Bayer CropScience

Cited by 10 publications

References 18 publications

Scientific opinion on application EFSA‐GMO‐NL‐2013‐120 for authorisation of genetically modified soybean FG72 × A5547‐127 for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Bayer CropScience LP and M.S. Technologies LLC

Scientific opinion on application EFSA‐GMO‐NL‐2013‐120 for authorisation of genetically modified soybean FG72 × A5547‐127 for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Bayer CropScience LP and M.S. Technologies LLC

Scientific Opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2011‐91) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐68416‐4 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Inter‐species protein trafficking endows dodder (Cuscuta pentagona) with a host‐specific herbicide‐tolerant trait

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