TWN Info Service on Biosafety
6 January 2022
Third World Network
www.twn.my
Dear Friends and Colleagues
Plants from New Genomic Techniques Carry Similar or Higher Risk Than Older GM Varieties
The European Commission has proposed a review of its current legal framework for some types of plants derived from new genomic techniques (NGTs). The German Federal Agency for Nature Conservation (BfN) has released a position paper (Item 1) concluding that these plants have a similar or even greater risk potential than plants obtained from older genetic engineering techniques.
The BfN states that, in contrast to conventional breeding, genome editing makes the whole genome accessible for changes. This indicates that directed mutagenesis increases the depth of intervention, and is thus not comparable to conventional breeding, including random mutagenesis. Risks may arise from both the intended and unintended effects of the genetic modification. Even if there is some similarity to the characteristics produced by breeding, this cannot be regarded as equivalent to safety. The BfN maintains that, from a scientific point of view, no criteria exist which would allow certain categories of traits to be regarded as less risky. (Item 2)
The BfN emphasizes that a high level of safety can only be ensured with a case-by-case analysis as required in current genetic engineering legislation, especially since there is no or only very limited experience with the deliberate release of these plants and their products. Furthermore, technology assessment can serve as a science-based tool to operationalise a binding sustainability analysis and proof of benefit to society or the environment.
With best wishes,
Third World Network
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Item 1
NEW DEVELOPMENTS AND REGULATORY ISSUES IN PLANT GENETIC ENGINEERING
Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN)
Oct 2021
https://www.bfn.de/sites/default/files/2021-10/Viewpoint-plant-genetic-engeneering_1.pdf
Summary and Key Messages
Genetic engineering is developing at a rapid pace due to technological advances such as genome editing tools like CRISPR/Cas, digitalisation and automation. The European Commission has now proposed a review of the current legal framework for some types of plants derived from new genomic techniques (NGTs) and has published an Inception Impact Assessment.1
The European Commission has suggested two main pillars for a future policy on genetic engineering: First, the European Commission has highlighted the need to ensure a high level of protection of human and animal health and the environment. Second, the integration of a sustainability analysis has been proposed that is in line with the goals of European Green Deal and its Farm to Fork Strategy, the EU Sustainable Development Strategy and the United Nations Sustainable Development Goals (SDGs). From the perspective of nature conservation, both pillars are desirable and viable for the future: a high safety level based on the precautionary principle as well as additional proof of sustainability.
Maintaining a high safety level of protection of human and animal health and the environment
The precautionary principle ensures a high level of protection of human and animal health and the environment. As a provision of primary law (Art. 191 para. 2 TFEU), it is a guiding principle which is binding for all measures taken by the European Union (EU). In cases where scientific uncertainty exists and gives rise to a potential danger to the environment, it must always be initially assumed that there is uncertainty and a potential danger. Both directed mutagenesis and cisgenesis are rapidly developing fields where few if any experience exists with the deliberate release of these plants and the use of their products.
Directed mutagenesis and cisgenesis can be harnessed for a variety of traits with a wide range of intended and unintended impacts. It is important to keep in mind that naturalness and similarity to breeding does not imply safety. In addition, small changes can also have considerable impacts: at the level of metabolism, the exhibited characteristic of the genetically modified organism (GMO) and on the receiving environment. Also, in contrast to breeding, genome editing makes the whole genome accessible for changes. In return, this also means that directed mutagenesis increases the depth of intervention and is thus not comparable to conventional breeding including random mutagenesis.
Risks may arise from both the intended and unintended characteristics. For example, drought resistance could change the plants’ invasiveness and, as a consequence, pose a risk to vulnerable plant communities, e.g. in arid and ecologically valuable locations. For the risk evaluation, it is irrelevant whether the introduced characteristics of a plant are novel. Drought resistance is an example of a trait that may not be novel, but can entail environmental risks.
Besides the negative impacts of the introduced characteristics, modified plants can exhibit unintended characteristics that originate either from adverse genetic effects or from unintended changes in the plant’s metabolism triggered by the intended trait. Some traits like herbicide and insect resistance in plants have also not proven to be sustainable in the past. Here we conclude that plants produced by both directed mutagenesis and cisgenesis have a similar if not greater risk potential compared to the plants produced by genetic engineering to date.
Grouping certain NGTs depending on their risk profile has been discussed. In general, traits cannot be categorised and deemed less risky. From a scientific point of view, no criteria exist which would allow these NGTs to be grouped in a general manner. The size of the genetic modification – for example – cannot be regarded as a reliable denominator of risks and safety of the specific modifications in an individual plant. Only a case-by-case analysis as performed under the current legislation can ensure a high safety level.
The genetic engineering law already takes different risk profiles into account on this case-by-case basis. Here we argue that the EU’s current legislative framework is fit for purpose especially in terms of the risk assessment. Directive 2001/18/EC was amended in 2018 in order to adapt to technical progress, taking into account experience gained in the environmental risk assessment of genetically modified (GM) plants.2 Also, Directive 2001/18/EC allows for flexibility because the scope of the environmental risk assessment is determined on a case-by-case basis. The required information may thus, under present legislation, already vary depending on the type of the GMOs concerned, their intended use and the potential receiving environment.
In addition, the genetic engineering law is the best regulatory framework to address the specific hazards arising from the release and placing on the market of GMOs. Other legislative frameworks, e.g. European seed legislation, are not suitable. The European genetic engineering law needs to remain unfragmented. The European legislator has established a coherent, independent and complete regulation for GMOs with the complementary Directives 2001/18/EC and 2009/41/EC. This systematic approach is necessary in view of the fact that other legislative acts, such as European seed legislation, food and feed legislation, as well as plant protection and plant variety protection legislation, already serve other purposes. Integrating GMOs into these regulatory systems would therefore not be appropriate either from a scientific or legal perspective.
Despite claims of challenges in identifying NGTs, so far there has been no known case where applicants failed to provide a method to detect or identify a plant derived by NGTs for which they are seeking approval. Directive 2001/18/EC is sufficiently general to allow applicants to develop detection and identification methods, taking into account further technical developments in the field. There is no need to change the respective legislative requirements, which consistently implement the polluter-pays principle (Art. 191 para 2 TFEU). An international GMO registry, however, would greatly improve detection and identification of unapproved GMOs in the EU.
Limited relevance of current NGT-based plants for EU-level strategies and SDGs
The development of NGT plants is often equated with the achievement of sustainable agriculture, assuming that new plant varieties can substantially contribute to policy goals. However, the assumption that the envisaged goals could be achieved in short timeframes, e.g. the 2030 period of the European Green Deal, is not substantiated by scientific analyses.
Currently, only a few NGT-based plants are close to entering the market. In addition, the extent to which new plant varieties developed by NGTs could realistically contribute to food security, to biodiversity conservation or the adaptation of agriculture to climate change remains unclear and uncertain at present. The political goals mentioned before are complex and multi-layered. NGT-based plant varieties designed for this purpose need to respond to several environmental stimuli at the same time. Traits such as abiotic stress tolerances are highly complex and therefore usually still at a very early stage of development.
The cornerstones of resilient and sustainable agriculture can therefore currently best be achieved by changing agricultural practices. For example, soil quality and integrated pest management play a major role. Cultivation systems can, for example, increase the soil’s water-retention capacity and its ability to store water and nutrients over the long term.
Integration of proof of sustainability in future policies
A binding sustainability analysis is based on established policies. Established international policies at the level of the CBD (as well as most recently in the EU: European Green Deal, Farm to Fork Strategy, EU Sustainable Development Strategy) provide a convincing basis for including a sustainability analysis in the assessment of new technologies. A technology assessment can serve as a science-based tool to operationalise a binding sustainability analysis and proof of benefit. The German Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN) is currently working on operationalising a technology assessment. This integrated scientific assessment goes beyond current statutory risk assessment by taking into account societal needs as reflected in the SDGs and requiring proof of its benefit for society or the environment.
With regard to the assessment of sustainability and the benefit, it should be noted that these are additional instruments aimed at strengthening the goals of the European Green Deal and its Farm to Fork Strategy, the EU Sustainable Development Strategy and the United Nations SDGs. Only the safe use of new technologies will enable the resulting opportunities to be fully harnessed and ensure their long-term use. It is essential that the precautionary principle be applied to ensure that the measures taken to implement the policies do not lead to results that contradict their underlying aims. The protection of the environment must therefore always be considered separately when defining and implementing EU policies and measures. At the end of this paper, we propose the most important issues and criteria to consider in order to achieve these goals for the impact assessment – once all policy options have been described and defined in more detail.
Endnotes
- European Commission Legislative Proposal, “Legislation for plants produced by certain new genomic techniques” Ref. Ares(2021)5835503 – 24/09/2021. https://ec.europa.eu/info/law/better-regulation/haveyour-say/initiatives/13119-Legislation-for-plants-produced-by-certain-new-genomic-techniques_en
- COMMISSION DIRECTIVE (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms
Item 2
GERMAN FEDERAL AGENCY FOR NATURE CONSERVATION – POSITION PAPER ON NEW GENOMIC TECHNIQUES AND THEIR REGULATION
Testbiotech
23 Oct 2021
https://www.testbiotech.org/en/news/german-federal-agency-nature-conservation-position-paper-new-genomic-techniques
High risk potential requires case-by-case analysis
The German Federal Agency for Nature Conservation (BfN) has outlined its position in a paper published in October on the intention of the EU Commission to evaluate new legislative proposals for the regulation of certain new genomic techniques (NGTs) in plants. The paper concludes that these plants have a similar or even greater risk potential than plants obtained from older genetic engineering techniques. According to the BfN, a high level of safety can only be ensured with a case-by-case analysis as required in current genetic engineering legislation, especially since there is no or only very limited experience with the deliberate release of these plants and their products.
The BfN states that, in contrast to conventional breeding, genome editing makes the whole genome accessible for changes. This indicates that directed mutagenesis increases the depth of intervention, and is thus not comparable to conventional breeding, including random mutagenesis. Risks may arise from both the intended and unintended effects of the genetic modification. Even if there is some similarity to the characteristics produced by breeding, this cannot be regarded as equivalent to safety. The BfN notes: “We conclude that plants produced by both directed mutagenesis and cisgenesis have a similar if not greater risk potential compared to the plants produced by genetic engineering to date.“
One suggestion, first introduced into the debate in April by the EU Commission, was to divide New Genetic Engineering techniques into groups and then exempt individual groups from legislation. Meanwhile, the BfN paper maintains that, from a scientific point of view, no criteria exist which would allow certain categories of traits to be regarded as less risky: “The size of the genetic modification – for example – cannot be regarded as a reliable denominator of risks and safety of the specific modifications in an individual plant. Only a case-by-case analysis as performed under the current legislation can ensure a high safety level.” A paper published in July by a number of experts from various European environmental authorities comes to a similar conclusion.
Even though current genetic engineering legislation is often portrayed as outdated by particular interest groups from industry and research, it is, according the BfN, still the most sensible option since it considers different risk profiles on a case-by-case basis. In addition, directive 2001/18/EG was amended in 2018 in order to accommodate technical progress.
NGT plants are often presented as a way to achieve the sustainability goals of the EU’s “Green Deal“. However, this paper concludes that scientific analyses demonstrate the unreliability of the assumption that these plants will even become available within such short periods of time.
Contact:
Christoph Then, info@testbiotech.de, Tel 0151 54638040