THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
Environmental Risk Assessment of Genome-Edited Plants
The European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, genome-edited plants have to undergo an Environmental Risk Assessment (ERA) prior to deliberate release or being placed on the market in the EU.
Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques. Regarding genome-edited plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case-specific manner. Since EFSA did not provide further guidance, a recent review (Item 1) addresses some issues relevant for the case-specific assessment of genome-edited plants.
The review finds that the approach incorporated in the EU regulatory framework is a viable way forward, provided that further guidance for the risk assessment of genome editing applications is developed. This is necessary, as general considerations concerning risk/safety of all genome editing applications or of different classes of applications are insufficient to address all the challenges. Further, the precautionary approach of the existing EU GMO regulations should not be weakened by excluding whole groups of genome editing applications from their scope without having regard to the characteristics of the individual genome-edited plants.
Therefore, a focused approach should be followed to provide a robust risk assessment of individual genome-edited plants. This ERA approach should focus on risks that may plausibly manifest themselves in the phenotype or the interaction with the environment of a particular genome-edited plant.
Towards this end, the review suggests that two sets of considerations are considered: (1) trait related-considerations to assess the effects associated with the newly developed trait(s); and (2) method-related considerations to assess unintended changes associated with the intended trait(s) or with other modifications in the genome-edited plant. The latter is important, as it is not sufficient to simply assess the intended effects (Item 2). Risk assessment should therefore also include detailed assessment of unintended changes in the genome and the metabolome of genome-edited plants.
With best wishes,
Third World Network
131 Jalan Macalister
10400 Penang
Malaysia
Email: twn@twnetwork.org
Websites: http://www.twn.my/and http://www.biosafety-info.net/
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Item 1
BIOSAFETY OF GENOME EDITING APPLICATIONS IN PLANT BREEDING: CONSIDERATIONS FOR A FOCUSED CASE-SPECIFIC RISK ASSESSMENT IN THE EU
Michael F. Eckerstorfer et al.
BioTech 10(3), 10
https://doi.org/10.3390/biotech10030010
https://www.mdpi.com/2673-6284/10/3/10
22 June 2021
Abstract
An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants.
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Item 2
https://www.testbiotech.org/en/news/new-ge-how-assess-environmental-risks
New GE: How to assess the environmental risks?
Scientific publication identifies important cornerstones
9 July 2021 / Experts from environmental authorities in Austria, Germany, Italy, Poland and Switzerland have published a new scientific paper that, for the first time, defines some important initial cornerstones in the environmental risk assessment of plants altered with new genomic techniques (i.e. ‘New GE’ or ‘genome editing’). The authors show that there can be no justification for only risk assessing plants with additionally inserted genes or with extensive genomic changes. Rather, all plants derived from New GE must be subjected to mandatory risk assessment.
In this regard, the authors disagree with the findings set out in a recent EU Commission report, which suggests that only specific categories of New GE plants should be subjected to mandatory risk assessment. The authors of the new publication state: “With a view to the wide range of plant species, GE methods and traits that need to be considered, there is no safety by default for whole groups of GE applications encompassing different individual GE organisms, i.e. without an appropriate ERA prior to the release of GE plants into the environment.”
Furthermore, according to the publication, it is not sufficient to simply assess the intended effects, any unintended changes should also be taken into account. The authors conclude: “We suggest integrating two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g. due to off-target modifications.” In this context, the experts also disagree with the EU Commission, which has suggested that, in many cases, only the intended changes in the plants should be subjected to mandatory risk assessment.
One of the examples, the authors of the paper use to support their findings is wheat genetically engineered with CRISPR/Cas-technology. This particular example is especially interesting because it has already been discussed by the European Food Safety Authority (EFSA), and is also an example that Testbiotech has looked into.
This specific wheat variety contains a group of gluten proteins (alpha-gliadins) which are thought to be a cause for inflammatory diseases in the large intestine. These genes are part of a larger gene family which can be found in several regions of the genome. So far, conventional breeding has been unable to sufficiently reduce this large number of genes. However, CRISPR/Cas technology was used in 2018 to knock out a great many (35) of the relevant genes.
Consequently, the altered wheat exhibits a unique pattern of genetic change. While single mutations in the relevant genes may also occur randomly, this specific combination of genetic alteration can only be achieved with New GE. It can also lead to the emergence of specific risks such as the possible accumulation of unwanted plant components. In addition, it can unintentionally trigger the production of new gluten protein variants that can subsequently trigger inflammatory processes. Interactions of the wheat plants with the environment are a further possible risk that could, for example, lead to the emergence of new plant diseases. Therefore, risk assessment must include detailed assessment of unintended changes in the genome and the metabolome of the New GE plants.