THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
EU’s Risk Assessment of Herbicide-Tolerant GE Soybeans Falls Short
Herbicide tolerance, in particular to glyphosate, is a dominant trait in genetically engineered (GE) plants. A large number of weeds (47 individual species) globally have developed resistance due to the massive use of glyphosate in countries where herbicide-tolerant (HT) GE crops are grown. This has led to an accelerating amount of herbicides being used, leading to substantial problems in the environment as well as new challenges for the risk assessment of health effects since products derived from these plants can introduce new herbicide residues into the food chain.
The GMO and pesticide regulation provisions of the EU both request for the conditions of agricultural production to be taken into account and for the evaluation of combinatorial effects. Implementing regulations explicitly request field trials with and without the application of the complementary herbicide. However, a recent peer reviewed paper has found that the dossiers currently submitted for market approval of HT GE soybean imported for food and feed, are seriously flawed. Herbicide applications in studies for risk assessment do not correspond with real-life farming practice. Material prepared for feeding studies is different from the material entering the food chain. Crucial data are missing, such as for the safety testing of the residues from spraying, cumulative and combinatorial effects related to the application of the complementary herbicides, and herbicide–plant interactions and long-term effects.
The authors therefore conclude that current dossiers do not meet regulatory standards in the EU and that the EU risk assessment of food and feed derived from HT GE plants needs substantial improvement. They consider it highly likely that concerns about the health risks of HT GE plant material used for food and feed have been underestimated.
The researchers recommend the following for the risk assessment of HT GE plants: (i) All residues of active substances must be assessed; (ii) All applied additives/adjuvants and their residues must be assessed; (iii) Combinatorial effects of the applied herbicides must be investigated, i.e. both herbicide–herbicide interactions, but also herbicide–plant interactions; (iv) Potential changes in plant composition due to various herbicide applications must be investigated; and (v) Long-term effects of consumption of HT GE soybeans must be investigated, also including potential effects on the endocrine system, reproduction and the intestinal microbiome.
We reproduce the Abstract and Conclusion of the paper below.
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/
To subscribe to other TWN information services: www.twnnews.net
———————————————————————————————————
INSUFFICIENT RISK ASSESSMENT OF HERBICIDE-TOLERANT GENETICALLY ENGINEERED SOYBEANS INTENDED FOR IMPORT INTO THE EU
Miyazaki, J., Bauer-Panskus, A., Bøhn, T., Reichenbecher, W., & Then, C.
Environmental Sciences Europe, 31(1), 92
https://doi.org/10.1186/s12302-019-0274-1
10 Dec 2019
https://link.springer.com/article/10.1186/s12302-019-0274-1
Abstract
The introduction of herbicide-tolerant (HT) genetically engineered (GE) soybeans has raised new challenges for the European risk assessment of imported food and feed. Food and feed products derived from these plants may show specific patterns of chemical residues and altered nutritional composition. Furthermore, there has been a substantial increase in the usage of herbicides in soybean production due to the emergence of resistant weeds. This concerns particular glyphosate-based herbicides and also other herbicides. In this review, we give an overview of available data regarding glyphosate application on HT GE soybeans in North and South America. We have further compared this data with herbicide applications in experimental field trials conducted by the industry. We conclude that field trials carried out for risk assessment purposes do not generally represent the real agronomic conditions in commercial HT GE plant cultivation. In most cases, neither the applied dose nor the number of applications match real conditions. This finding is especially relevant for risk assessment since a review of relevant publications shows that the amount and timing of spraying glyphosate as a complementary herbicide onto HT GE plants can impact their composition; this is relevant to EFSA comparative risk assessment of GMOs. Further, closely related issues were identified that overlap with EU GMO and pesticide regulation, but are not currently considered. These issues concern indirect, cumulative and combinatorial effects as well as the assessment of mixed toxicity. Consequently, current risk assessment practice for HT GE plants cannot be considered to fulfil EU regulatory standards which require the safety of food and feed to be demonstrated. It is much more likely that concerns about the health risks of HT GE plant material used for food and feed have been underestimated. We therefore conclude that the EU risk assessment of food and feed derived from HT GE plants needs substantial improvement.
Conclusion
A large number of weeds (47 individual species globally have adapted to the massive use of glyphosate in agriculture and have become resistant. These HT weeds are an increasing problem in countries where HT GE crops are grown. Their widespread adoption has led to an accelerating amount of herbicides being used and has consequently led to an “arms race” in genetic engineering technology and usage of complementary herbicides. The increasing amount of herbicides sprayed onto these plants not only causes substantial problems in the environment, but also creates new challenges for the risk assessment of health effects since products derived from these plants can introduce new herbicide residues into the food chain.
The GMO and pesticide regulation provisions of the EU display a substantial overlap in terms of the requirements for the assessment of health risks: both regulatory areas require a high level of protection for health and the environment. Both request that the conditions of agricultural production are taken into account. Additionally, both request the evaluation of combinatorial effects. Finally, Implementing Regulation (EU) No 503/2013 explicitly combines the two areas of risk assessment by requesting field trials with and without the application of the complementary herbicide.
As shown, the dossiers currently submitted for market approval are seriously flawed: (i) herbicide applications in studies for risk assessment do not correspond with real-life farming practice; (ii) material prepared for feeding studies is different from the material entering the food chain; (iii) crucial data are missing for the safety testing of the residues from spraying and (iv) cumulative and combinatorial effects related to the application of the complementary herbicides as well as (v) herbicide–plant (constituent) interactions and long-term effects. Therefore, current dossiers cannot be considered to meet regulatory standards in the EU which require that safety for health and the environment is demonstrated.
Although our analyses focus on HT GE soybean, it can be anticipated that most of the outcomes also apply in principle to other HT GE crops, which are already or in the foreseeable future on the market, such as the MON 87429 corn which is resistant to four active ingredients.
We recommend the following requirements for the risk assessment of HT GE plants:
- All residues of active substances must be assessed, including taking various practical conditions into consideration (e.g. dosage and frequency of herbicide application, PHIs).
- All applied additives/adjuvants and their residues must be assessed.
- Combinatorial effects of the applied herbicides must be investigated, i.e. both herbicide–herbicide interactions, but also herbicide–plant (constituent) interactions.
- Potential changes in plant composition due to various herbicide applications must be investigated.
Long-term effects of consumption of HT GE soybeans must be investigated, also including potential effects on the endocrine system, reproduction and the intestinal microbiome.