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G-TwYST is closely related to a number of other (EU funded) research projects.

Directly related research

Like G-TwYST, the projects GRACE and GMO90+ focus on the assessment of food and feed safety of genetically modified plants and apply methods for long term safety testing on genetically modified maize events: MON810 and NK603. The coordinators of these projects agreed on adapting methods, sharing materials and a coordinated publication strategy to increase the transparency of the studies. They've published a letter to the editor in Archives of Toxicology (open access) that we explains how they will cooperate.

GRACE

 

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GRACE: "GMO Risk Assessment and Communication of Evidence" is an EU FP7 research project with two key research objectives: Assessing health, environmental and socio-economic impacts of GM plants (risks and benefits) and testing and comparing various types of animal feeding trials (in particular 90-days feeding trials) and alternative in-vitro methods (including analytical and in-silico approaches) for health risk assessments of GM food and feed.

 

GRACE also:

  • Elaborates methods for systematic reviews of GMO studies which were initially developed for medicine and later used in environmental and social studies. The outcome will be a tested framework for Good Review Practice (GRP) for studies on GMP impacts. 
  • conducts comprehensive and systematic reviews of studies investigating potential health, environmental, and socio-economic impacts (risks and benefits) of GM plants (GMPs) or food and feed derived from GMPs
  • identifies knowledge gaps in regard to impacts and impact assessment of GMPs.
  • improves the availability and presentation of the scientific information by providing an open-access database of reviewed studies and data relevant to GMP impacts.

Like G-TwYST, GRACE gives high priority to consulting professional users (mainly GMO risk assessors and risk managers, policy makers) and a broad range of stakeholders throughout the entire project. Their input is meant to influence the design, content and output of the reviews.
 

1-year feeding study with MON810

In October 2016 ARTE broadcasted "OGM - Mensonges et vérités" (GMOs - Lies and truths) on French and German Television. In this 100 minutes long documentary Frédéric Castaignède sheds light on genetically modified crops, the impact on farmers, biodiversity and human health. We have selected and translated a fragment in which G-TwYST project leader Prof Pablo Steinberg presents the results of the 1-year feeding study with MON810 maize in the GRACE project.

 

The documentary provides a ‘snapshot’ of the GRACE final Conference which took place on November 9-10 2015 in Potsdam, Germany. We refer to videos on the GRACE Youtube channel  for a full account.

 

 

GMO90+

 

GMO90+ (Genetically modified organism, 90 days up to 180 days testing; website in French, click the button at the bottom of each webpage for english version) is a research project aimed at improving the 90-day subchronic toxicity testing in rats. The objective of this study is to investigate whether feeding rats with GM MON810 or NK603 maize may relate to biomarkers of effects. The project is supported by the French Ministry of Ecology, Sustainable Development and Energy (MEDDE).

 

This project is based on a consortium of teams from laboratories at INRA (National Institute in Agronomy), INSERM (National Institute in Human Health), CNRS (National Institute in Scientific Research), ANSES (French Agency for food Environmental and Occupational Health and Safety) and specialized partners in statistics, modeling, proteomics and bioinformatics.

 

Rats are followed for six months (180 days) with monthly blood and urine samples allowing the search for biomarkers by high-throughput (omics) techniques in conjunction with pathophysiological analysis mainly centered on the gut, liver,
kidney and reproductive apparatus. The characterization and validation of biomarkers of interest will be discussed by the GMO90+ consortium in close relationship with the coordinators of the GRACE and G-TwYST programs.

 

Results generated in the frame of GMO90+ should provide useful information to both academic research and regulatory
agencies in order to improve the predictability of the 90-day rodent studies.
Raw data will be loaded in the open-access
database CADIMA and frozen tissues will be stored and available in a first step for the GRACE and G-TwYST researchers and thereafter for the research community in general.

 

The GMO90+ project is developed in a constant dialogue with stakeholders by insuring full transparency on this controversial research object.

 

Indirectly related research

More indirectly related to G-TwYST are PreSto GMO ERA-Net, AMIGA and MARLON

PreSto

 

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PreSto GMO ERA-Net: Preparatory steps towards a GMO research ERA-Net aims to clearly map out the steps needed to create and successfully implement an ERA-Net that will coordinate transnational research on the effects of genetically modified organisms (GMOs) in the areas of human and animal health, the environment, and techno- economics and societies. The focus of the ERA-Net will be on GMOs which are intentionally released into the environment and/or used immediately in feed and food applications.

 

PreSto GMO ERA-Net brings together ministries, agencies and funding bodies from different Members States the scientific community in order to jointly prepare a strategic plan and roadmap for the implementation of the ERA-Net. In addition, the ERA-Net explicitly takes into account the wide range of views of a broad diversity of stakeholders and end-users. This aims to enhance collaboration between actors, to increase the relevance of the ERA-Net research programme and its future results also from a broader societal perspective and to encourage participation of different scientific communities in future joint transnational calls.

MARLON

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MARLON: "Monitoring of Animals for Feed-related Risks in the Long Term" aims to create an inventory of which epidemiological and monitoring initiatives exist, both within and outside the EU, which could provide useful data for the purpose of monitoring for health impacts of animal feeds, in particular those containing GM ingredients, on livestock animals. It also collates, in a systematized manner, information on the factors that have to be considered when developing an epidemio-logical model specifically geared towards this purpose.

AMIGA

 

amiga myriad FIN.jpgAMIGA: "Assessing and Monitoring the Impacts of Genetically modified plants on Agro-ecosystem" is a European project funded by the European Commission under the Framework Programme 7, aiming at producing scientific data related to the possible environmental and economic impacts of cultivation of genetically modified plants (GMPs), relevant to European environments.

 

A project’s cornerstone is the application of the EFSA ERA Guidelines, which is the basis for the update of the regulatory process of GMPs in the EU. The Guideline has provided ecologically sound principles for ERA, triggering the need of practically testing them. Partners of the consortium participated to the preparation of guidelines and 3 of them are senior authors of relevant chapters. The scientific activities will consist of case studies of maize and potato, the two GM crops currently approved for cultivation in the EU, and surveys in non-GM agro-ecosystems.

The final outcome will include a network of EU representative sites for pre-market risk assessment and long-term monitoring studies, a set of standardised testing methods and a geographical information system integrating relevant datasets, protocols and tools to help EU decision-makers.

Launched on the 1st of December 2011, AMIGA project will run for 4 years, until the end of 2015.


The Marlon project started on 1 August, 2012 and will run for 3 years. It has 11 project partners from 8 different countries. - See more at: http://web.spi.pt/marlon/index.html#sthash.tgwzf7ey.dpuf

 

 

 

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1-year feeding study with MON810 on ARTE

In October 2016 ARTE broadcasted "OGM - Mensonges et vérités" (GMOs - Lies and truths) on French and German Television. In this 100 minutes long documentary Frédéric Castaignède sheds light on genetically modified crops, the impact on farmers, biodiversity and human health. We have selected and translated a fragment in which G-TwYST project leader Prof Pablo Steinberg presents the results of the 1-year feeding study with MON810 maize in the GRACE project.

 

The documentary provides a ‘snapshot’ of the GRACE final Conference which took place on November 9-10 2015 in Potsdam, Germany. We refer to videos on the GRACE Youtube channel  for a full account.

 

Paper published describing the statistical approach for equivalence testing in G-TwYST

An open access paper describing the statistical approach for equivalence testing in G-TwYST has now been published in Food and Chemical Toxicology. The method was tested on data from the GRACE project, as described in this paper. We will now progress by applying the method in the statistical analyses of the G-TwYST feeding trials, to be reported first in the statistical reports as project deliverables.

Highlights

  • An equivalence testing method is proposed to assess the safety of regulated products
  • We combine data from a current study with test and control, and historical studies with assumedly safe reference products
  • The method is illustrated with animal feeding studies using genetically modified and reference maize varieties
  • A high statistical power of the equivalence test is the basis for the equivalence criterion
  • Generalized fiducial inference is used to integrate uncertainties from the historical and the current data

 

van der Voet H, Goedhart PW, Schmidt K (2017). Equivalence testing using existing reference data:  an example with genetically modified and conventional crops in animal feeding studies. Food and Chemical Toxicology, 109: 472-485. https://doi.org/10.1016/j.fct.2017.09.044

G-TwYST Interim Report available

15 February 2017

 

The G-TwSYT team completed a publicly available Interim report with information about the progress that has been made in the first 1.5 years of the project. The report can be downloaded here.