Degradation of transgenic Cry1Ab DNA and protein in Bt‐176 maize during the ensiling process

Lutz, Bodo; Wiedemann, S.; Albrecht, Christiane

doi:10.1111/j.1439-0396.2005.00571.x

Cited by 58 publications

(57 citation statements)

References 20 publications

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“…Moreover, these Cry proteins are degraded by enzymatic activity in the gastrointestinal tract of animals fed on cotton MON 15985 or derived products (see Section 5.1.4.2), meaning that only low amounts of Cry proteins would remain intact to pass into faeces. This was demonstrated for Cry1Ab (Einspanier et al, 2004;Lutz et al, 2005Lutz et al, , 2006Wiedemann et al, 2006;Guertler et al, 2008). There would subsequently be further degradation of these Cry proteins in the faecal material due to intrinsic microbial proteolytic activity.…”

Section: Interactions Of the Gm Plant With Non-target Organisms 78mentioning

confidence: 98%

Scientific Opinion on applications (EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985) for the placing on the market of insect-resistant genetically modified cotton MON 15985 for food and feed uses, import and processing, and for the renewal of authorisation o

Arpaia¹,

Birch²,

Chesson³

et al. 2014

EFSA Journal

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Cotton MON 15985 was developed by biolistic transformation of cotton MON 531 to express Cry2Ab2 and GUS in addition to the Cry1Ac and NPTII proteins. Cry proteins in MON 15985 confer resistance to major lepidopteran cotton pests, whereas the GUS and NPTII proteins were used as markers during product development. Molecular characterisation of MON 15985 did not give rise to safety issues. The EFSA GMO Panel could not conclude on the potential occurrence of unintended effects for agronomic and phenotypic characteristics owing to data limitations. Compositional data gave no indication of unintended effects for which further assessment was needed. The Panel concludes that cotton MON 15985, as described in these applications, is as safe and nutritious as its conventional counterpart and other non-genetically modified varieties, and considers it unlikely that the overall allergenicity of the whole plant is changed. Environmental risk assessment was restricted to the exposure through faecal material from animals fed with cotton products of MON 15985 and its accidental spillage. Following a weight of evidence approach and considering the poor ability of cotton to survive outside cultivated land, despite the agronomic and phenotypic data limitations, the Panel concludes that there is very low likelihood of any adverse environmental impacts. The aadA and oriV sequences in MON 15985 may facilitate the stabilisation of nptII through double homologous recombination. However, considering the limited presence of intact DNA from MON 15985 in feed and the limited occurrence of horizontal transfer of DNA from plant material to bacteria, the Panel concludes that it is highly unlikely that nptII from MON 15985 will be transferred to bacteria. Since both EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985 cover cotton MON 15985, the EFSA GMO Panel provides a single scientific opinion, valid for both applications.The EFSA GMO Panel evaluated cotton MON 15985 with reference to the scope and appropriate principles described in its guidance documents for the risk assessment of genetically modified (GM) plants and derived food and feed (EFSA, 2006a; EFSA GMO Panel, 2011a), environmental risk assessment (ERA) (EFSA GMO Panel, 2010a) and for renewal of authorisations of existing GMO products lawfully placed on the market (EFSA, 2006b). The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and analysis of the expression of the corresponding proteins. An evaluation of the comparative analyses of compositional, agronomic and phenotypic characteristics was undertaken, and the safety of the newly expressed proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An evaluation of environmental impacts and the post-market environmental monitoring (PMEM) plan was also undertaken.The scope of applications EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985 covers the MON 15985 event in cotton species Gossypium hirsutum L. and G. barba...

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Section: Interactions Of the Gm Plant With Non-target Organisms 78mentioning

confidence: 98%

Scientific Opinion on applications (EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985) for the placing on the market of insect-resistant genetically modified cotton MON 15985 for food and feed uses, import and processing, and for the renewal of authorisation o

Arpaia¹,

Birch²,

Chesson³

et al. 2014

EFSA Journal

View full text Add to dashboard Cite

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“…Cry proteins are degraded by enzymatic activity in the gastrointestinal tract, meaning that only low amounts of intact Cry proteins would remain in the faeces. This was demonstrated for Cry1Ab (Einspanier et al, 2004;Lutz et al, 2005;Lutz et al, 2006;Wiedemann et al, 2006;Guertler et al, 2008;Paul et al, 2010). Further degradation of the protein in manure and faeces will take place because of microbiological proteolytic activity.…”

Section: Interactions Of the Gm Plant With Non-target Organisms 34mentioning

confidence: 99%

Scientific Opinion on application EFSA‐GMO‐BE‐2013‐117 for authorisation of genetically modified maize MON 87427 × MON 89034 × NK603 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three‐event stack maize MON 87427 × MON 89034 × NK603 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the three single events combined to produce this three‐event stack maize 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. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the three‐event stack maize did not give rise to issues regarding food and feed safety or nutrition. In the case of accidental release of viable grains of maize MON 87427 × MON 89034 × NK603 into the environment, the three‐event stack maize would not raise environmental safety concerns. The GMO Panel concludes that the three‐event stack maize is as safe and as nutritious as the non‐GM comparator and the tested non‐GM reference varieties in the context of its scope. The GMO Panel considered that its previous conclusions on the two‐event stack maize MON 89034 × NK603 remain valid. For the two maize subcombinations for which no experimental data were provided the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their combination would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed maize MON 89034 × NK603 and maize MON 87427 × MON 89034 × NK603. Since the post‐market environmental monitoring plan for the three‐event stack maize does not include any provisions for the two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.

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“…This was demonstrated for Cry1Ab (Einspanier et al, 2004;Lutz et al, 2005Lutz et al, , 2006Wiedemann et al, 2006;Guertler et al, 2008). There would subsequently be further degradation of these Cry proteins in the manure and faeces because of intrinsic microbial proteolytic activity.…”

Section: (B) Plant-to-plant Gene Transfermentioning

confidence: 99%

Scientific Opinion on application EFSA‐GMO‐NL‐2011‐97 for the placing on the market of insect‐resistant and herbicide‐tolerant genetically modified cotton T304‐40 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience AG

Arpaia¹,

Birch²,

Chesson³

et al. 2013

EFS2

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Cotton T304-40 contains a single insert consisting of the cry1Ab and the bar expression cassettes, providing insect resistance and herbicide tolerance, respectively. Bioinformatic analyses and genetic stability studies did not raise safety issues. Levels of the Cry1Ab and PAT proteins in cotton T304-40 have been sufficiently analysed. No biologically relevant differences were identified in the compositional analysis when the seed of T304-40 was compared with its conventional counterpart and non-GM cotton varieties. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced Cry1Ab and PAT proteins. Based on the information available, there is no evidence that the genetic modification might significantly change the overall allergenicity of cotton T304-40. Nutritional equivalence of cotton T304-40 to its conventional counterparts was indicated by compositional data. The EFSA GMO Panel concludes that cotton T304-40 is as safe and nutritious as its conventional counterpart and that it is unlikely that the overall allergenicity of the whole plant is changed. There are no indications of an increased likelihood of establishment and spread of feral cotton plants. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from cotton T304-40 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of cotton T304-40. The EFSA GMO Panel considers that the information available for cotton T304-40 addresses the scientific comments raised by the Member States and states that cotton T304-40, as described in the application, 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 as proposed by the applicant. ABSTRACTCotton T304-40 contains a single insert consisting of the cry1Ab and the bar expression cassettes, providing insect resistance and herbicide tolerance, respectively. Bioinformatic analyses and genetic stability studies did not raise safety issues. Levels of the Cry1Ab and PAT proteins in cotton T304-40 have been sufficiently analysed. No biologically relevant differences were identified in the compositional analysis when the seed of T304-40 was compared with its conventional counterpart and non-GM cotton varieties. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced Cry1Ab and PAT proteins. Based on the information available, there is no evidence that the genetic modification might significantly change the overall allergenicity of cotton T304-40. Nutritional equivalence of cotton T304-40 to its conventional counterparts was indicated by compositional data. The EFSA GMO Panel concludes that cotton T304-40 is as safe and nutritious as its conventional counter...

show abstract

Degradation of transgenic Cry1Ab DNA and protein in Bt‐176 maize during the ensiling process

Cited by 58 publications

References 20 publications

Scientific Opinion on applications (EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985) for the placing on the market of insect-resistant genetically modified cotton MON 15985 for food and feed uses, import and processing, and for the renewal of authorisation o

Scientific Opinion on applications (EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985) for the placing on the market of insect-resistant genetically modified cotton MON 15985 for food and feed uses, import and processing, and for the renewal of authorisation o

Scientific Opinion on application EFSA‐GMO‐NL‐2011‐97 for the placing on the market of insect‐resistant and herbicide‐tolerant genetically modified cotton T304‐40 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience AG

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