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Assessing and Monitoring the Impacts of Genetically modified plants on Agro-ecosystems

Periodic Report Summary 1 - AMIGA (Assessing and Monitoring the Impacts of Genetically modified plants on Agro-ecosystems)

Project Context and Objectives:
Genetically Modified (GM) crops outside Europe occupy relevant surfaces mainly with commodity crops (maize, cotton, soybean and oilseed rape). In the EU the situation is quite different, and in 2012 only GM maize was cultivated on 129,071 ha in 5 countries. Three GM events, maize MON810, maize T25 and potato EH92-527-1 (Amflora, now withdrawn from the market), have been approved for cultivation, while several GM products have been approved for import and processing purposes.
The possible environmental impacts of GM crops are still a controversial issue in Europe. The risk assessment framework has recently been reinforced by the European Food Safety Authority (EFSA) whose guidance document (GD) requires harmonized and efficient methodologies. The GD issued in 2010 has increased the requirements for applicants that seek GM crop admission in Europe in several areas, such as:
- Impacts on Non Target Organisms (NTOs e.g. natural enemies and pollinators);
- Impacts on soil biodiversity and biology;
- long-term effects on the environment, biodiversity and biogeochemical cycles;
- Impact of farming practices, with the need to take into account the diversity of management systems that may be associated to GM crops.
The research project AMIGA (Assessing and monitoring Impacts of Genetically modified plants on Agro-ecosystems) aims at meeting this challenge, by:
• Providing baseline data on biodiversity in selected agro-ecosystems and adjacent habitats through field surveys in non-GM cultivations in five different geographical European regions and build a database of species assemblages and ecological functional groups in maize and potato;
• Helping to translate regional protection goals into measurable assessment endpoints by establishing a link between functional groups of arthropod species active in the two selected agro-ecosystems;
• Defining lists of suitable bioindicators (species assemblages and/or ecosystem functions) fine-tuned for specific European regions to provide guidance on the selection of relevant test species;
• Improving knowledge on potential long-term environmental effects of GM plants by assembling background information on change in land use, cropping practices and the economic returns of arable farming;
• Providing examples for testing the efficacy of the EFSA Guidelines for the ERA of GM plants and produce standardized protocols for ERA in laboratory and field experiments;
• Exploring possible strategies for data-driven post market monitoring of GM plants and implement cost-efficient monitoring schemes;
• Estimating the compatibility and sustainability of GM crops within the principles of Integrated Pest Management;
• Evaluating the potential risks of GM crops for pollinators and pollination services
• Providing a systematic analysis of economic aspects of cultivation of GM plants
• Setting a training and communication plan that addresses current public concerns about GM plants in Europe.
More generally, AMIGA project aims to improve the risk assessment process in Europe with the following goals: i) reduce uncertainty in decision-making for the cultivation of GM plants in Europe by developing and verifying robust ERA methods based on testable hypotheses that seek to aid the decision making process; ii) increase confidence in the practicability of EFSA GD for ERA; and iii) contribute to the development of more effective post-market environmental monitoring designs and risk mitigation procedures.
Twenty-two partners, representing 14 EU countries and Argentina are involved in AMIGA activities, which are centred on 11 work packages.

Project Results:
To prepare a list of relevant protection goals, a survey was conducted interviewing experts from competent authorities for GMOs of EU Member States (MS). Protected species and areas receive the highest attention by MS and are an inherent part of the ERA in some of them. Experts also underline the importance of protected species at the regional level with regard to GMOs, while in some cases this issue is exclusively dealt with at national level.
Background information were collected from 5 different EU regions on change in land use, cropping practices and economic returns of arable farming for representative crops over the last 30 years. From these data AMIGA will derive a comprehensive set of indicators and use them to assess the effects of the given GM crops against impacts due to other factors.
Field experiments with GM maize (event MON810) and potato (DuRPh) and their near isogenic counterparts were setup in 5 countries already in the first year of the project. Seven countries are involved in field experiment in 2013. A triple stack maize event (Bt11 x MIR604 x GA21) is also used in this field season.
Rhizosphere samples were collected from field trials to characterize the responsiveness of different functional guilds to GM crops. Analyses of physico-chemical soil parameters, bacterial abundance, diversity and abundance of their functional genes involved in the nitrogen cycle were carried out in preparation of the ultra-deep sequencing. For fungal diversity, the 454 sequencing platform has been established. The same samples were analyzed for nematode abundance, their taxonomic diversity is currently assessed. Focal species have been selected for ongoing nematode and earthworm bioassays
Selection of above-ground arthropod NTOs for lab, greenhouse and field bioassays was finalized for maize and potato. Tests on performance and preference for herbivores and their natural enemies have started, measurement endpoints that are suitable predictor for immediate and delayed effects are used.
An in vitro rearing method was developed to expose honey bee larvae to GM toxins under controlled laboratory conditions. No significant adverse effect of single or multiple Cry-proteins on survival and weight of honey bee larvae were found using different GM maize pollen doses. A protocol for testing effects of GM toxins on solitary wild bee larvae (Osmia cornuta) was developed. Behavioural observations are being conducted in a flight room with adults of Bombus terrestris.
An inventory of existing butterfly monitoring schemes was completed and butterfly samplings started in 2013. A field monitoring on commercial GMHT crops was initiated in Argentina on GM Sorghum, to characterize existing resistant populations. The task also explored room for improvement as well as those monitoring-related issues which need further attention.
Spatially-explicit models are being implemented for estimating effects on non-target Lepidoptera and for evaluating the consequences of cropping systems and herbicide management regimes on weed abundance and diversity.
The design and implementation of field trials incorporating Integrated Pest Management (IPM) approaches was completed and these field trials are on-going in 5 countries using the same experimental design and varying the actual IPM practices according to the locally accepted production rules.
An inventory of field studies relevant for ERA of NTOs was made. Example datasets were obtained from various partners and preliminary statistical analyses were performed. A large amount of zero counts, and over-dispersion were found to be common features of data sets. Some first explorations of possibly useful statistical models were made.
A review was completed on the possible economic effects of adoption of GM crops by European farmers mostly based on data obtained elsewhere, their possible relevance on European agriculture was considered. The construction and initial use of an economic model has been the following step.

Potential Impact:
AMIGA will contribute to facilitate the implementation of the new principles included in the “Guidance on the environmental risk assessment of genetically modified plants” of the European Food Safety Authority, and to harmonize approaches, methods and tools among applicants. The project will deliver validated and cost effective methodologies on key aspects of environmental risk assessment such as: impacts on non-target organisms, soil biology, post-market environmental monitoring, long term effects. In addition, the biogeographical variation across Europe is specifically addressed by the large geographical representation in the project team which will conduct research on baseline biodiversity and assessment endpoints in five European regions (Boreal, Atlantic, Central, Mediterranean and Balkans). This will enable to consider the regional variability in terms of climatic, agricultural and socio-economic conditions.
The methodologies developed during the project and the results obtained will provide scientific support to risk assessors, risk managers and regulators both at European and national level with benefits to the quality of safety assessment of future possible introductions of GM crops in Europe.
It is expected that the scientific results obtained in AMIGA will produce advances, among other, in:
- Selection of focal species of NTOs in European environments;
- Defining similarities and differences in biodiversity in agro-ecosystems in different regions;
- Producing protocols for biosafety experiments tailored at detecting acute and chronic effects, impacts at organismal and population levels;
- Modeling spatial effects of GM plants on non-target Lepidoptera;
- Modeling long term environmental effects by analyzing the main drivers of change experienced in agriculture;
- Focusing “hot-spots” areas for post-market monitoring programs;
- Determining the extent of European farmers’ economic advantage of cultivating GM or non GM crops
- Evaluating the compatibility of GM crops with the principles of Integrated Pest Management, which represent the only option of pest management in the EU after 2014;
- Producing software to support the analysis for difference and equivalence tests
AMIGA project operates in a hotly debated area for the EU where, unlikely other geographic areas, the dispute on GM organisms is still polarized between “for and against” and the positions are also very different between Member States. The biggest effort being made by the members of the Consortium is to shed light on contentious issues (e.g. receiving environments, non-target organisms) with a scientifically sound approach and to help risk assessment and risk management activities in Europe for the years to come.
AMIGA Consortium has established from the very beginning an open dialogue with all different stakeholders using several communication channels. A permanent Stakeholder Consultation Platform has been established, through which the EFSA, Member States, EuropaBio, farmers' associations, FAO, NGOs are informed and consulted on the status of the activities. Moreover, the communication program provides a constant information flow to journalists and the wider public via press releases, press conferences, newsletter and an updated project web site. The communication of scientific results to the larger public will likely improve the objectivity of the debate and will promote a transparent and unbiased science-based decision process.

List of Websites: