TWN Info Service on Biosafety
6 March 2024
Third World Network
www.twn.my
Dear Friends and Colleagues
Current Characterization of GM Plants in the EU Inadequate for Effective Environmental Risk Assessment
The evaluation of agronomic and phenotypic plant traits is a standard requirement and part of the comparative assessment of a GM plant and its conventional counterpart, which is a starting point for environmental risk assessment (ERA). However, an analysis of current approaches for the agronomic and phenotypic characterization of GMPs in EU market applications has found that these were not fit to inform risk assessors to draw conclusions on environmental risks.
The authors, from the Austrian Environment Agency and German Federal Agency for Nature Conservation, propose implementing a range of conceptual and methodological aspects in the agronomic and phenotypic characterization of GMPs, which would improve the assessment of environmental risks, specifically in terms of the ability of the GMP to survive and persist in the receiving environment.
The results can then be linked to the problem formulation step in ERA, complemented by a comprehensive, case-by-case and hypothesis-driven testing strategy and validated by post-market environmental monitoring once the GMP is placed on the market or released into the environment. Only then can the comparative safety approach fulfil its original intention to act as the starting point for problem formulation in ERA.
We reproduce below the Abstract and Conclusions of the paper.
With best wishes,
Third World Network
AGRONOMIC AND PHENOTYPIC PLANT TRAITS AS INDICATORS FOR ENVIRONMENTAL RISKS OF GENETICALLY MODIFIED PLANTS
Marion, D., Marianne, M., Andreas, H. et al.
Environ Sci Eur 36, 3 (2024)
https://doi.org/10.1186/s12302-023-00828-y
https://enveurope.springeropen.com/articles/10.1186/s12302-023-00828-y
5 January 2024
ABSTRACT
Background
For market approval of genetically modified plants (GMPs), the evaluation of agronomic and phenotypic plant traits is a standard requirement and part of the comparative assessment of the GMP and its conventional counterpart. This comparative assessment is a starting point for environmental risk assessment (ERA) and should inform all areas of risk. We scrutinize frequently used approaches to characterize GMPs in EU market applications and discuss their usefulness for drawing conclusions on risks related to the plant’s ability to survive, persist or become invasive.
Results
Our analysis shows that the agronomic and phenotypic characterization of GMPs, although based on guidelines, is confined to plant traits and test designs that are relevant for the quality control and agronomic performance of genetically modified (GM) crops. We provide evidence of how methodological approaches frequently applied during the agronomic and phenotypic characterization of the GMP could be improved and complemented to better inform on potential phenotypic changes relevant to assessing environmental risks. These approaches refer to (i) the assessment of the survival of GM seeds and plants (e.g., volunteers); (ii) the consideration of environmental exposure and (iii) improved methodological approaches for the assessment of biotic and abiotic stress responses for GMPs.
Conclusions
The comparative assessment of agronomic and phenotypic plant traits currently does not provide suitable data to draw conclusions on environmental risks relating to the persistence and invasiveness of the GMP. Ecologically more realistic assessments should be part of the phenotypic characterization of GMPs and need guidance and decision criteria to be implemented in ERA. This is of considerable importance, as new genomic techniques are expected to increase the diversity and complexity of GM plants and traits, particularly stress tolerance, which may affect the survival of GMPs in the environment.
[….]
CONCLUSIONS
The persistence and invasiveness of a GMP in its receiving environment can entail risks for biodiversity and ecosystem services; therefore, its assessment is an important cornerstone in ERA. As a starting point for ERA, the agronomic or phenotypic assessment can be used to inform risk assessors about potential differences between the GMP and the non-GM counterpart with respect to the GMP’s ability to survive or persist in or outside agricultural fields. As our analysis shows, the agronomic and phenotypic characterization is currently not fit to inform about these aspects and a weak starting point to identify unintended environmental effects of the GMP. We notice that applicants generate standard data that characterize product quality aspects and agronomic risks, while environmental risks are poorly addressed. We criticize that the scope of the application (import and/or cultivation) and the resulting different exposure routes of the environment to the GMP are not taken into consideration when defining study designs and test parameters. Consequently, the usefulness of the submitted agronomic and phenotypic data is of limited use for risk assessors to draw conclusions on environmental risks.
We propose implementing a range of conceptual and methodological aspects in the agronomic and phenotypic characterization of GMPs, which would improve the assessment of environmental risks, specifically in terms of the ability of the GMP to survive and persist in the receiving environment. These proposals refer to an extended assessment of GM seed and plant survival, both in the laboratory and under field conditions, also taking other than optimal environmental conditions into account. These would not only be of relevance for GM crops but also for any type of GM plant. The consideration of the receiving environment when characterizing GMPs accounts for the possibility of accidental spillage and unintended exposure of the environment, e.g., during import, transport, or processing activities. Specifically, for GMP applications intended for cultivation in agricultural fields (GM crops), the assessments of potential changes in volunteer occurrences in the field provide first insights into the potentially increased survivability of GMP with consequences for environmental and agronomic protection goals. The current practice of assessing a standard set of agronomic plant traits together with a few selected additional assessments, without link to environmental exposure, should not be used to justify the absence of environmental risks with respect to the persistence and invasiveness of the GMP. At the same time, improved methodological approaches and standardized protocols are needed when assessing the response of GMP to biotic and abiotic stress conditions. This is a necessary cornerstone to improve the informative value of such assessments, not only for the evaluation of the agricultural performance of the respective GM crop but also for the indication of environmental risks.
In order to be useful for ERA, an adaptation of the EFSA guidelines for the assessment of agronomic and phenotypic traits of GMPs would be useful. Guidance would improve when referring to methodological and conceptual approaches that are suited to better integrate ecological realism in laboratory assessments (e.g., seed germination), as well as to further phenotypic assessments that will enable risk assessors to conclude on potential effects on different protection goals in field and off-field habitats. Together with further methodological guidance for the selection and assessment of biotic and abiotic stressors, the currently performed unspecific profiling of GM crops would be avoided and better inform the ERA.
Ecological processes such as survival, persistence or invasiveness can only be approximated during risk assessment, as these are complex, context-specific and long-term. Any observed unintended agronomic and/or phenotypic changes in a GMP are useful as indicators. However, this is only possible if appropriate methodological approaches and relevant environments are considered. The results can then be linked to the problem formulation step in ERA, complemented by a comprehensive, case-by-case and hypothesis-driven testing strategy and validated by post-market environmental monitoring once the GMP is placed on the market or released into the environment. Only then can the comparative safety approach fulfil its original intention to act as the starting point for problem formulation in ERA.