Assessing the ecological risks from the persistence and spread of feral populations of insect-resistant transgenic maize

One source of potential harm from the cultivation of transgenic crops is their dispersal, persistence and spread in non-agricultural land. Ecological damage may result from such spread if the abundance of valued species is reduced. The ability of a plant to spread in non-agricultural habitats is called its invasiveness potential. The risks posed by the invasiveness potential of transgenic crops are assessed by comparing in agronomic field trials the phenotypes of the crops with the phenotypes of genetically similar non-transgenic crops known to have low invasiveness potential. If the transgenic and non-transgenic crops are similar in traits believed to control invasiveness potential, it may be concluded that the transgenic crop has low invasiveness potential and poses negligible ecological risk via persistence and spread in non-agricultural habitats. If the phenotype of the transgenic crop is outside the range of the non-transgenic comparators for the traits controlling invasiveness potential, or if the comparative approach is regarded as inadequate for reasons of risk perception or risk communication, experiments that simulate the dispersal of the crop into non-agricultural habitats may be necessary. We describe such an experiment for several commercial insect-resistant transgenic maize events in conditions similar to those found in maize-growing regions of Mexico. As expected from comparative risk assessments, the transgenic maize was found to behave similarly to non-transgenic maize and to be non-invasive. The value of this experiment in assessing and communicating the negligible ecological risk posed by the low invasiveness potential of insect-resistant transgenic maize in Mexico is discussed

Assessment of genetically modified maize Bt11\ua0x\ua0MIR162\ua0x\ua01507\ua0x\ua0GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No\ua01829/2003 (application EFSA-GMO-DE-2010-86)

In this opinion, the GMO Panel\ua0assessed the four-event stack maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 and three of its subcombinations, independently of their origin. The GMO Panel\ua0previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events in the four-event stack maize did not give rise to food/feed safety issues.\ua0Based on the nutritional assessment of the compositional characteristics of maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21, foods and feeds derived from the genetically modified (GM) maize are expected to have the same nutritional impact as those derived from non-GM maize varieties. In the case of\ua0accidental release of viable grains of maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 into the environment, this\ua0would not raise environmental safety concerns. The GMO Panel\ua0concludes that maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 is nutritionally equivalent to and as safe as its non-GM comparator in the context of the scope of this application. For the three subcombinations included in the scope, for which no experimental data were provided, the GMO Panel\ua0assessed the likelihood of interactions among the single events and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and the four-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 and its subcombinations. A minority opinion expressed by a GMO Panel\ua0member is appended to this opinion

Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐134)

Maize MON 87427 ×MON 87460 × MON 89034 × MIR162 × NK603 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 87427, MON 87460, MON 89034, MIR162 and NK603. The GMO Panel previously assessed the five single maize events and eleven of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 11 subcombinations that could lead to modification of the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the five‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the five‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 14 maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the five‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment

Assessment of genetically modified maize MON89034x1507xNK603xDAS-40278-9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No1829-2003 (application EFSA-GMO-NL-2013-112)

Maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations that could lead to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicates that the combination of the single maize events and of the newly expressed proteins in the four‐event stack maize does not give rise to food/feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations for which no experimental data were provided, and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. No post‐market monitoring for food/feed is necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment

Flux de gens entre blat de moro transgènic i convencional

[cat] Davant l'augment de la sensibilitat i les reticències cap als conreus transgènics per part de la societat europea, han sorgit una sèrie de legislacions i recomanacions creades per la Unió Europea per tal de garantir la informació i la lliure el·lecció d'aquest tipus de productes per part dels consumidors. Entre aquestes recomanacions cal destacar-ne una que aconsella a cada estat membre la creació d'una normativa de coexistència entre cultius transgènics, convencionals i ecològics basada en dades científiques. Aquesta coexistència ve limitada per una normativa que obliga l'etiquetatge de productes que continguin un percentatge superior al 0.9% d'organismes genèticament modificats (OGM). Els factors que determinen la presència adventícia de blat de moro transgènic en camps convencionals són molts i diversos: impureses a la llavor de sembra utilitzada, pol·linització creuada, barreges durant el procés de collita i emmagatzematge del gra o males herbes compatibles, entre altres. D'entre tots aquests factors, el més dificil de controlar és el flux de pol·len entre camps, el qual comporta un flux gènic. L'objectiu principal d'aquesta tesi és quantificar la importància relativa dels principals factors que influeixen en el flux de gens enre camps transgènics i convencionals. Per a portar a terme aquest objectiu, es recullen cinc publicacions on es tracten aquests factors principals. En concret, als dos primers articles compendiats s'exposen la distància entre camps transgènics i convencionals i la coincidència en la floració d'aquests com a factors determinants del 80% del flux gènic. També es fa una aproximació a la millor tècnica per a l'anàlisi per PCR quantitativa, i a la metodologia de presa de mostres a seguir. Les barreres físiques també són un factor estudiat en aquests articles. Els altres tres articles recollits se centren en ressaltar aspectes concrets que influeixen en el flux gènic. Així en el tercer es fa un estudi profund sobre la relació entre la data de sembra i la de floració d'un conreu de blat de moro i planteja la possibilitat d'establir separacions temporals en les dates de sembra entre cultius transgènics i convencionals per tal d'obtenir decalatges en la floració d'aquests cultius i així mantenir el flux gènic per sota del 0.9% d'OGM en camps convencionals. El següent article estudia la importància dels renadius, que són aquelles plantes que germinen en un camp fruit del gra dispersat al sòl durant l'any anterior. En els casos de parcel·les conreades amb blat de moro trasngènic un any i amb convencional el següent, els possibles renadius podríen ser transgènics i aportar certa quantitat d'OGM a la collita final del camp. Els resultats obtinguts mostren que els renadius solen ser plantes poc vigoroses i que rarament arriben a produir pol·len. Només haurien de ser considerats en camps on superin el 10% del nombre total de plantes, no com a factor únic per arribar al llindar d'etiquetatge, sinó com a un factor més a afegir a tots els altres que intervenen en el flux de gens. Per últim, s'exposa un article on s'estudia la importància de la mida del camp, tant del donador transgènic com del receptor convencional, en el flux de gens cap aquest últim. Amb un assaig experimental que combina quatre varietats transgèniques diferents i a través de la identificació varietal per microsatèl·lits, es pretén demostrar que per tal de duplicar el flux gènic cal multiplicar per quatre el camp transgènic o reduïr 16 vegades la mida del convencional. Amb aquest recull de publicacions es pretén donar eines fiables per a la determinació de la importàncai relatuiva dels principals factors que intervenen en el flux gènic.[eng] « GENE FLOW BETWEEN TRANSGENIC AND CONVENTIONAL MAIZE » TEXT: In Europe, there is a special sensibility towards genetically modified crops. As a result of this ill will, some recommendations and laws have been created by the European Union in order to guarantee consumers information and freedom of choice of these products. Among all these recommendations, it is worth to stress the advice to all Member States to create some scientific data-based rules for coexistence between transgenic, conventional and organic crops. This coexistence is limited by a normative who forces products containing more than 0.9% of Genetically Modified Organisms (GMO) to be labeled. Many factors influence the adventitious presence of transgenic maize in conventional fields (seed impurities, cross pollination, harvesting and post farming mixtures, compatible weeds.). The most difficult one to be controlled is pollen flow between fields, which involves gene flow. The objective of this thesis is to quantify the relative importance of the main factors influencing in gene flow between GM and conventional fields, such as distance among fields, flowering coincidence, volunteers, relative sizes of donor and receptor fields, physical barriers or differences on compatibility between varieties

Scientific opinion on applications EFSA-GMO-RX-T25 and EFSA-GMO-NL-2007-46 for the renewal of authorisation of maize T25, and for the placing on the market of herbicide-tolerant genetically modified maize T25, both for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience AG

This scientific opinion reports on a risk assessment for the authorisation for (continued) marketing of genetically modified maize T25 for food and feed uses, import and processing. Maize T25 contains a single insertion locus containing a pat cassette conferring tolerance to glufosinate-based herbicides. Bioinformatic analyses, protein expression data and genetic stability studies did not raise safety issues. The compositional, agronomic and phenotypic characteristics of maize T25 grain and its conventional counterpart showed no differences that are of relevance for food/feed safety. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced PAT protein. The compositional data indicating the nutritional equivalence of maize T25 were supported by the results of the feeding studies. There was no evidence that the genetic modification might significantly change the overall allergenicity of maize T25. Considering all available information related to the agronomic and phenotypic characterisation of maize T25, the EFSA GMO Panel did not observe any enhanced fitness characteristics of maize T25 that will change its capacity to spread, establish or persist compared with non-genetically modified (GM) maize, except in the presence of glufosinate-based herbicides. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from maize T25 to bacteria have not been identified. The monitoring plan and reporting intervals were in line with the intended uses. The Panel concluded that maize T25, as described in the applications, is as safe as its conventional counterpart with respect to potential effects on human and animal health or the environment in the context of its intended uses for food and feed, import and processin