Post Market Environmental Monitoring of Genetically Modified Herbicide Tolerant Crops (Working group report from the 4th International Workshop on PMEM of Genetically Modified Plants, Quedlinburg, Germany 2010)

Der kommerzielle Anbau gentechnisch veränderter Pflanzen (GVP) muss gemäß der Gesetzgebung der Euro­päischen Union überwacht werden. Hier fassen wir die Diskussionen einer Arbeitsgruppe zusammen, die sich während des 4. Internationalen Workshops zum Anbaubegleitenden Monitoring von GVP vom 3. bis 4. Mai 2010 in Quedlinburg getroffen hat. Die Arbeitsgruppe hatte zum Ziel, die Notwendigkeit, das Ausmaß und den Aufbau eines Monitoring von gentechnisch veränderten herbizidtoleranten Pflanzen zu diskutieren. Der folgende Arbeitsgruppen-Bericht fasst die spezi­fischen Fragen, die sich bei einem solchen Monitoring stellen, zusammen und es wird versucht, die Frage zu beantworten, was überwacht werden sollte und wer eine solche Überwachung durchführen sollte. Zusätzlich werden die größten Herausforderungen bei der Überwachung von herbizidtoleranten GVP präsentiert, und es wird diskutiert, wie diesen begegnet werden könnte.    According to European Union (EU) legislation, genetically modified (GM) crops released for commercial cultivation have to be monitored. Here we summarise the discussion of a working group that convened during the 4th International Workshop on Post Market Environmental Monitoring (PMEM) of Genetically Modified Plants in Quedlinburg from 3–4 May 2010 to discuss the necessity, extent and design of PMEM plans of genetically modified herbicide tolerant (GMHT) crops. The following workshop report summarises the questions specific to the monitoring of GMHT crops and seeks to answer what should be monitored and who should perform such a monitoring. In addi­tion, the main challenges when monitoring GMHT crops are presented and it is discussed how these challenges could be addressed.   &nbsp

Management of herbicide-tolerant oilseed rape in Europe: a case study on minimizing vertical gene flow

The potential commercialization of genetically modified herbicide-tolerant (GMHT) oilseed rape in Europe raises various concerns about their potential environmental and agronomic impacts, especially those associated with the escape of transgenes. Pollen of oilseed rape can be dispersed in space, resulting in the fertilization of sympatric compatible wild relatives (e.g. Brassica rapa) and oilseed rape cultivars grown nearby (GM and/or non-GM Brassica napus). The spatial and temporal dispersal of seeds of oilseed rape may lead to feral oilseed rape populations outside the cropped areas and oilseed rape volunteers in subsequent crops in the rotation. The incorporation of a HT trait(s) may increase the fitness of the recipient plants, making them more abundant and persistent, and may result in weeds that are difficult to control by the herbicide(s) to which they are tolerant. Vertical gene flow from transgenic oilseed rape to non-GM counterparts may also have an impact on farming and supply chain management, depending on labelling thresholds for the adventitious presence of GM material in non-GM products. Given the extent of pollen and seed dispersal in oilseed rape, it is obvious that the safe and sound integration of GMHT oilseed rape in Europe may require significant on-farm and off-farm management efforts. Crucial practical measures that can reduce vertical gene flow include (1) isolating seed production of Brassica napus, (2) the use of certified seed, (3) isolating fields of GM oilseed rape, (4) harvesting at the correct crop development stage with properly adjusted combine settings, (5) ensuring maximum germination of shed seeds after harvest, (6) controlling volunteers in subsequent crops, and (7) keeping on-farm records. The implementation of the recommended practices may, however, be difficult, entailing various challenges

Surrogate species selection for assessing potential adverse environmental impacts of genetically engineered insect-resistant plants on non-target organisms

Most regulatory authorities require that developers of genetically engineered insect-resistant (GEIR) crops evaluate the potential for these crops to have adverse impacts on valued non-target organisms (NTOs), i.e., organisms not intended to be controlled by the trait. In many cases, impacts to NTOs are assessed using surrogate species, and it is critical that the data derived from surrogates accurately predict any adverse impacts likely to be observed from the use of the crop in the agricultural context. The key is to select surrogate species that best represent the valued NTOs in the location where the crop is going to be introduced, but this selection process poses numerous challenges for the developers of GE crops who will perform the tests, as well as for the ecologists and regulators who will interpret the test results. These issues were the subject of a conference “Surrogate Species Selection for Assessing Potential Adverse Environmental Impacts of Genetically Engineered Plants on Non-Target Organisms” convened by the Center for Environmental Risk Assessment, ILSI Research Foundation. This report summarizes the proceedings of the conference, including the presentations, discussions and the points of consensus agreed to by the participants

Risk assessment of new sequencing data on GM maize event MIR604

In 2009 and 2010, the EFSA GMO Panel concluded the assessment of genetically modified (GM) maizes MIR604, MIR604 × GA21, MIR604 × Bt11 and MIR604 × GA21 × Bt11. These maizes were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. On 23 July 2015, the European Commission (EC) received from Syngenta new nucleic acid sequencing data on maize event MIR604 and updated bioinformatic analyses using the new sequencing data. EC tasked EFSA to analyse these data and to indicate whether the previous conclusions of the EFSA GMO Panel on the above-listed GM maizes remain valid. The EFSA GMO Panel used the appropriate principles described in its guidelines for the risk assessment of GM plants to analyse the received data. The new sequencing data indicated a single base pair difference compared to the sequencing data originally provided, located in a non-coding region of the insert. which had already been present in the original plant material used for the risk assessment. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment remain valid. The new sequencing data and the bioinformatic analyses performed on the new sequence did not give rise to safety issues. Therefore, the GMO Panel concludes that the original risk assessment of event MIR604 as a single and as a part of stacked events remains valid

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

Scientific opinionRequestor: Competent Authority of BelgiumQuestion number: EFSA-Q-2013-00765In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three-event stack maize MON 87427 9 MON 89034 9 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 9 MON 89034 9 NK603 into the environment, the three-event stack maize would not raise environmental safety concerns. The GMO Panel concludes that the threeevent 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 9 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 9 NK603 and maize MON 87427 9 MON 89034 9 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

Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants

As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel, 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. The European Commission has mandated EFSA to develop a technical note to the applicants on, and checking of, the quality of the methodology, analysis and reporting covering complete sequencing of the insert and flanking regions, insertion site analysis of the GM event, and generational stability and integrity. This Technical Note puts together requirements and recommendations for when DNA sequencing is part of the molecular characterisation of GM plants, in particular for the characterisation of the inserted genetic material at each insertion site and flanking regions, the determination of the copy number of all detectable inserts, and the analysis of the genetic stability of the inserts, when addressed by Sanger sequencing or NGS. This document reflects the current knowledge in scientific‐technical methods for generating and verifying, in a standardised manner, DNA sequencing data in the context of RA of GM plants. From 1 October 2018, this Technical Note will replace the JRC guideline of 2016 (updated April 2017) related to the verification and quality assessment of the sequencing of the insert(s) and flanking regions. It does not take into consideration the verification and validation of the detection method which remains under the remit of the JRC

Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

Soybean MON87751 was developed through Agrobacterium tumefaciens-mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. None of the compositional, agronomic and phenotypic differences identified between soybean MON87751 and the conventional counterpart required further assessment. The GMO Paneldid not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.105 and Cry2Ab2 proteins as expressed in soybean MON87751, and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean MON87751. The nutritional impact of soybean MON87751-derived food and feed is expected to be the same as those derived from the conventional counterpart and non-GM commercial reference varieties. The GMO Panelconcludes that soybean MON87751, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non-GM soybean reference varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of accidental release of viable soybean MON87751 seeds into the environment, soybean MON87751 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON87751. In conclusion, soybean MON87751, as described in this application, is as safe as its conventional counterpart and the tested non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment

Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003

This document provides guidance for the risk assessment under Regulation (EC) No1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of AnnexII of Regulation (EU) No503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority

Guidance on allergenicity assessment of genetically modified plants

This document provides supplementary guidance on specific topics for the allergenicity risk assessment of genetically modified plants. In particular, it supplements general recommendations outlined in previous EFSA GMO Panel guidelines and Implementing Regulation (EU) No 503/2013. The topics addressed are non-IgE-mediated adverse immune reactions to foods, in vitro protein digestibility tests and endogenous allergenicity. New scientific and regulatory developments regarding these three topics are described in this document. Considerations on the practical implementation of those developments in the risk assessment of genetically modified plants are discussed and recommended, where appropriate. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority