The RAGES project (Risk Assessment of genetically engineered organisms in the EU and Switzerland) investigated from 2016 to 2019 in detail the approval processes for genetically engineered plants. The project is completely independent of the interests of the biotechnology industry. Results from the RAGES project show that risk assessors in the EU and Switzerland have failed, and are still failing, to deal with the risks to public health and the environment. The approval process does not take into account all relevant risks but, instead, confines its focus to those risks that can most easily be assessed.
Insufficient risk assessment of herbicide-tolerant genetically engineered soybeans intended for import into the EU
Risk assessment of genetically engineered plants that can persist and propagate in the environment
Summary report of the results from the RAGES project 2016-2019
RAGES subreport: Serious shortcomings in the European risk assessment of herbicide tolerant GE plants for human health
RAGES subreport: Insecticidal Bt crops. EFSA's risk assessment approach for GM Bt plants fails by design
RAGES subreport: Health risk assessment of genetically engineered nutrionally-altered GM crops
RAGES subreport: Assessment of health risks associated with the consumption of products derived from genetically engineered plants with a combination of traits
RAGES subreport: Environmental risk assessment of genetically engineered crops that can persist and spontaneously propagate in the environment
RAGES subreport: New genetic engineering technologies
Tabled overview on cross cutting gaps and deficiencies in current risk assessment as currently performed in the EU and Switzerland (Annex II to the summary report of the results from the RAGES project)
European Network of Scientists for Social and Environmental Responsibility (ENSSER)
Critical Scientists Switzerland (CSS)
Content of the project
The European research consortium will focus on the risks of genetically engineered organisms, especially transgenic plants. Partners within the project are the European Network of Scientists for Social and Environmental Responsibility (ENSSER), its Swiss branch CSS (Critical Scientists Switzerland), GeneWatch UK and Testbiotech. It involves more than a dozen experts from five European countries.
The project is completely independent of the interests of the biotech industry. It aims to improve the scientific understanding of risks and potential hazards caused by the introduction of genetically engineered plants into agroecosystems and food production.
The project was set up after it became evident that current practise as applied in risk assessment of genetically engineered plants in Europe is not sufficient to safeguard the protection of health and the environment.
The consortium will not carry out experimental risk research itself, but will base its analysis on a wide range of scientific publications and databases. The RAGES aims to provide recommendations for the future risk assessment and regulation of genetically engineered crops.
The consortium held its first meeting in Zurich, Switzerland in November 2016 and presented its results at a public workshop in 2019 at the University of Neuchâtel. The final results of the project were also presented in Berlin and in Brussels.
Dr Christoph Then, Testbiotech Tel + 49 151 54638040, info[a]testbiotech.org
Dr Helen Wallace, GeneWatch UK, helen.wallace[a]genewatch.org
Dr Angelika Hilbeck, ENSSER, angelika.hilbeck[a]env.ethz.ch
Dr Luigi d' Andrea, CSS, l.dandrea[a]stopogm.ch
Working groups will be tackling a range of topics in the first half of 2017. The outcomes will be published after further discussions and reviews. We selected the following topics:
- An overall, fit for purpose concept for EFSA risk assessment of genetically engineered (GE) plants
- Herbicide-resistant / -tolerant GE plants
- GE plants expressing insecticides
- Stacked GE plants and combinatorial effects
- GE plants with changed nutritional quality
- GE with enhanced fitness
- New methods of genetic engineering
An overall, fit for purpose concept for European Food Safety Authority (EFSA) risk assessment
According to a preliminary analysis of the experts, the current EFSA concept, known as the 'comparative approach', is not sufficient to identify and investigate the relevant differences between genetically engineered plants and their conventional counterparts. At present, the work that EFSA does is oversimplified and fails to place sufficient emphasis on uncertainties and limits of current knowledge. Low quality data submitted by industry and the lack of independent research are further general issues that negatively affect the processes and outcomes of risk assessment.
The working group is chaired by Angelika Hilbeck from ENSSER. Angelika Hilbeck has been actively involved in the risk assessment of genetically engineered plants for many years. She works at the ETH in Zurich and has published a large number of peer reviewed scientific papers. Read a publication by Angelika Hilbeck: http://journal.frontiersin.org/article/10.3389/fenvs.2015.00071/full
GE herbicide-resistant / -tolerant plants
Dozens of herbicide resistant plants have already been authorised for import into the EU (http://www.testbiotech.org/en/gendatenbank_bilder). These plants raise issues of specific environmental risks, not only during cultivation but also regarding imports. Food and feed derived from these plants contain specific patterns of residues from the herbicides they were made resistant to. However, the health impact of these residues has not been assessed in detail for import authorisation.
The working group is chaired by Nicolas Defarge from ENSSER. For several years, Nicolas Defarge has been investigating the toxicity of herbicide mixtures containing glyphosate that can be applied to genetically engineered plants. Read a publication by Nicolas Defarge: http://www.sciencedirect.com/science/article/pii/S027869151530034X
GE plants expressing insecticides
Plants expressing insecticidal toxins are the second largest group of genetically engineered plants, after herbicide-resistant plants. At the beginning of 2017, around 30 such events had been registered in the EU for import, mostly maize and cotton (www.testbiotech.org/en/gendatenbank_bilder). Genetically engineered maize expressing Bt-toxin is also allowed for cultivation in the EU. It is grown in Spain on around 100.000 hectares. In near future, companies will be able to offer genetically engineered plants expressing small molecules (miRNA). Insects feeding on the plants will ingest the small molecules (miRNA) - this can interfere with their gene activity and ultimately kill them. There are many open questions in this area, especially in regard to environmental risk assessment.
The working group is chaired by Angelika Hilbeck from ENSSER (see above).
Stacked plants and combinatorial effects
In an increasing number of gene-tech plants, herbicide resistance is being combined with insecticidal toxins. A well-known example is the Bt maize known as 'SmartStax', which produces six different insecticidal Bt toxins and is resistant to two herbicides. In these plants, the toxicity of residues from spraying might, for example, act synergistically with the insecticidal toxins. EU regulation requests that accumulated effects are assessed during risk assessment. This is, however, something that the EFSA so far has failed to do.
The working group is chaired by Christoph Then from Testbiotech. For several years, Christoph Then has worked on regulatory science and standards applied in the risk assessment of genetically engineered plants. Read a publication by Christoph Then: http://enveurope.springeropen.com/articles/10.1186/s12302-016-0099-0
GE plants with changed nutritional quality
There are already several genetically engineered plants that have been changed in their composition on the market. Most of these plants have had their oil composition changed, with the aim of enhancing their nutritional food/ or feed value. However, hardly any empirical investigations have been conducted in regard to their actual impact on health. EFSA never developed specific guidance for the risk assessment of these plants or the food and feed derived thereof.
The working group is chaired by Helen Wallace from GeneWatch UK. For several years, Helen Wallace has been actively involved in work on regulatory science and standards applied in the risk assessment of genetically engineered organisms, such as plants and insects. Read a publication by Helen Wallace: http://www.world-agriculture.net/issue/8/World-Agriculture-Vol4-No1-Summer-2013
GE plants with enhanced fitness
While conventional breeding has already successfully created many varieties with enhanced tolerance to environmental stressors, such as drought or humidity, " genetic engineering so far only brought one maize event onto the market that is claimed to show some tolerance to reduced water supply. At the same time, several publications have found that enhanced fitness in genetically engineered plants can emerge unintentionally, giving them an unexpected ability for persistence or invasiveness. So far, EFSA has not investigated any of these risks in detail.
The working group is chaired by Christoph Then from Testbiotech (see above).
New methods of genetic engineering
New methods of genetic engineering, such as CRISPR Cas, are intended to enable more targeted but also more radical changes in the genome. Unintended side effects have been observed on several levels of the organisms. The marketing of plants and animals derived from these methods is imminent.
The working group is chaired by Janet Cotter from Logos Environmental. Janet Cotter works as a consultant providing scientific research to environmental organisations. Specialist research areas include GMOs, gene-editing techniques, pesticides in food and the environment and ecological agriculture. Previously, Janet Cotter was a senior scientist at Greenpeace International for 15 years (2000-2015). Read a publication by Janet Cotter: http://link.springer.com/article/10.1186/s40550-014-0005-8