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G-TwYST is operated by 8 project partners:

 

The senior scientists involved in G-Twyst have been asked to declare their interests and activities in the field of GMOs and food safety research on a voluntary basis.

 

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The Stiftung Tierärztliche Hochschule Hannover, University of Veterinary Medicine Hannover (TiHo), is a university foundation with approx. 1300 staff members, 30% of them being scientists, and consists of six clinics, 18 institutes and 5 specialized research centers. The main research interests of the TiHo are infection medicine, neuroscience, animal health and food quality as well as clinical research. Institute for Food Toxicology and Analytical Chemistry (IFT): The main research areas of IFT are the elucidation of the mechanisms of toxicity of chemicals present in foods of animal and plant origin, the development of analytical-chemical methods to study the biological activities of food constituents and contaminants as well as the development of alternative methods to animal testing. At the present time the IFT is concretely working on the role of compounds that are formed during the heating of foods in colorectal cancer development (heterocyclic aromatic amines and endogenously formed nitroso compounds), the development of methods to assess the toxicity of pesticide mixtures present on and in foods and the development of methods to test the reproductive toxicity and carcinogenicity in vitro. Moreover, IFT has a modern animal housing facility, in which chronic toxicity and carcinogenicity studies in rats are performed.

 

TiHo is coordinator of the project and leader of work package 5: evaluation of the scientific value of and broader societal issues associated with animal feeding trials and risk assessment of genetically modified organisms. TiHo  also contributes to WP3, WP4, WP6 and WP7.

 

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The Julius Kühn-Institut, Federal Research Centre for Cultivated Plants (JKI) is both a Federal Authority in its own right and a Federal Research Centre under the jurisdiction of the Federal Ministry of Food and Agriculture (BMEL). The 16 institutes within JKI are involved in several fields of plant research (basic to applied). JKI has branches at 11 locations in Germany with approx. 1200 staff members including about 250 scientists.
The Institute for Biosafety in Plant Biotechnology (SB) focuses on the assessment of, and research on new biotechnological methods applied to plants, including genetic engineering and introduction of novel crops. It is involved in the authorization of the deliberate release and placing on the market of GM organisms. The own research supports the scientific advice provided to the BMEL. SB is also partner in the EU-funded projects GRACE (coordinator) and Pre Sto GMO Era-Net establishing the links with G-TwYST.

The Data Processing Unit (DV) manages the IT services of the JKI with the following tasks: planning, development and maintenance of central IT systems, network and communication infrastructure, IT services for research and management. It participates in IT-related research projects in the domains of plant protection, plant genetic resources, and bioinformatics.

JKI supports the coordinator and is responsible for establishment of the flow of information about feeding trials in all work packages and linking G-TwYST, GRACE, GMO 90plus and PreSto GMO ERA-Net. JKI coordinates logistics for plant, feed material, and external services and hosts the web application CADIMA for the integration and dissemination of study results.

 

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The Centre for Research in Agricultural Genomics (CRAG) is a public consortium that comprises research groups from Spanish Research Council (CSIC), the Institute for Food and Agricultural Research and Technology (IRTA), and the Universities Autonomous of Barcelona (UAB) and Barcelona (UB).CRAG is specialized in the study of characteristics of interest in plants and farm animal species, combining basic and applied research in model and crop species and applying molecular and genetic approaches for breeding and food production. The institute has a very strong tradition in molecular biology studies on plants, especially maize, rice, and potato. It has a service of GMO analysis (ENGL member), in which frame we developed GMO detection and quantification methods and worked on coexistence or detection of unauthorised GMOs. Towards GMO safety assessment, we studied the stability of transgene DNA loci and mRNA transcripts and as well as unintended effects of the transgene in plants using transcriptomics (both, with Affymetrix microarrays and 454Roche sequencer) and proteomics approaches, using GM maize and rice.

 

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The University of Girona (UDG), third party in this project, has educational and research tasks, in particular in the food and agricultural areas. Areas of research of interest for this project: GMO safety assessment area, specifically using omics approaches; coexistence of GM and conventional crops in agricultural fields; design and biotechnological production of antimicrobial peptides with plant protection applications.

 

The Fundació Mas Badia (FMB), collaborator in this project, is an agricultural experimental station intended to guide and enhance agriculture in the region through research and communication with farmers. Its board has a broad representation of institutions from the agricultural sector. FMB has a centre with 30 ha agricultural area and works on extensive cultivation, crop protection, fruit growing, irrigation and agro-meteorology.
In close geographical proximity, CRAG, UDG and FMB have a large experience in collaborating together to develop research projects in the field of GMO.

CRAG and UDG (third party) are involved in the coordination of the supply of GM and conventional maize grain to prepare rat diets (work package 2); CRAG will carry out, together with UDG, the omics characterisation of the plant material used to prepare feed.

 

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The Slovak Medical University (SZU) has long-standing experience in the area of environmental health research with multidisciplinary know-how and combination of experimental and clinical research. The most important research part of the SZU - Centre of Excellence is involved in the original research in environmental health, food safety and health and occupational health. SZU coordinated the EU-funded FP5 projects PCB RISK and HEAR NAS and is/was involved in the FP6 projects ENVIRISK, HENVINET, INTARESE, HEIMTSA and FP7 Grace, NanoTEST, NanoImpactNet and QualityNano. Activities are conducted in compliance with GLP regulations.


SZU leads work package 3 and performs the combined chronic toxicity / carcinogenicity study with GM maize NK603, a 90-day feeding trial with GM maize NK603, as well as a carcinogenicity study with GM maize MON810.

 

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Roger Alison Ltd. (RA Ltd), Lampeter, United Kingdom offers reliable, rapid and cost-effective services for non-clinical/veterinary pathology since 1989. Areas of special expertise include routine histopathological evaluation of short term and carcinogenicity studies, GLP compliant histopathology peer review, and ovarian neoplasia.
RA Ltd is GLP certified by the regulatory authorities. The owner Roger Alison holds his own full license for PathDataTM, the leading Pathology Data Capture Software used by 80% of the world’s major pharmaceutical companies.

Roger Alison performs GLP compliant histopathological examination of rat tissues in work package 3 and will communicate of histopathological findings in work pakage 7.

 

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Wageningen University & Research (WUR), The Netherlands, specialises in strategic and applied research, based on the combination of knowledge and experience in genetics and reproduction, genomics, proteomics, metabolomics, bioinformatics, crop protection, crop ecology and agro-systems. Wageningen Plant Research (WPR) works for the entire agro-production chain with scientific products, from the DNA level to production system concepts.
The business unit Biometris of WPR is involved in research on statistical genetics, systems biology, statistical models for food safety and health, pattern recognition, and mathematical and statistical education. Biometris provides statistical consultancy and research for projects on GMO risk assessment since 2005.

WUR leads work package 4: Biostatistics to perform prospective power analyses to ensure that the animal studies will be fit for purpose. WUR performs statistical analyses of the results from the animal studies, reports on the results of the statistical analyses and provides recommendations on the statistical methodology for long-term feeding trials.

 

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Alpen-Adria-Universität Klagenfurt - Vienna - Graz (AAUK, Austria) at the Graz branch of the Institute of Science, Technology and Society Studies at Alpen-Adria-Universitaet Klagenfurt | Vienna | Graz has a long-standing experience and expertise in participatory

sts_logo_gruen_rgb.jpgresearch into GMO risk assessment and broader governance issues. The Institute employs 30 scientists and conducts inter- and

 transdisciplinary research frequently applying insights and concepts developed in Science and Technology Studies (STS) and provides policy advice on a broad range of science, technology and society issues.


AAUK leads work package 7: Stakeholder Engagement, Communication and Dissemination. AAUK is als co-leader of work package 5: analysis of normative dimensions linked to the scientific controversy.

 

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LIS Consult is an independent consultancy on social and ethical issues in innovations in the Life Sciences. LIS contributes to a constructive dialogue on responsible innovation in Life Sciences between relevant stakeholders by advice based on analysis of technological developments, societal impacts and policy options for innovation strategies and stakeholder engagement. LIS has conducted several studies on technological and regulatory developments, the socio-economic impacts and public attitudes and public perceptions of biotechnology and genomics. LIS has been involved in several initiatives aiming at debate and constructive dialogue about GMO issues between scientists, public authorities, industry representatives, NGOs and the public. Clients are research institutions, public authorities, companies and civil society organizations.

 

LIS is co-leader of work package 7: Stakeholder Engagement, Communication and dissemination. Lis is also involved in work package 5: analysis of the normative dimensions and how they relate to the scientific aspects.
 

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Latest news

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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.