FAQ

The European Commission defines genomic techniques as techniques that can alter the genetic material of an organism. In the Commission study regarding the status of New Genomic Techniques under Union law, the term new genomic techniques (NGTs) are used to refer to technologies that have been developed over the past two decades after adoption of Directive 2001/18/EC. 

New genomic techniques allow for precise changes at specific locations in the genome. They are different from established genomic techniques because they have novel features, for example, higher precision and speed in introducing the desired genetic modifications and the insertion of genetic material only from a crossable species. They rely only on the breeders’ gene pool, i.e. the total genetic information that is available for conventional breeding including from distantly related plant species that can be crossed by advanced breeding techniques. They include a variety of different techniques, such as: 

1. Targeted mutagenesis: Targeted mutagenesis is a technique used to make specific changes to the DNA of an organism. This method allows scientists to edit the genes at precise locations. Think of it as using a very small pair of scissors to cut and then repair a tiny piece of a long DNA strand exactly where scientists want to make a change.  
2. Cisgenesis (including intragenesis): Insertion of genetic material into a recipient organism from a donor that is sexually compatible with the recipient organism (e.g., changes are made between naturally compatible plants). The exogenous genetic material can be introduced without (cisgenesis) or with modifications/rearrangements (intragenesis). This technique uses genes from the same species or closely related species, ensuring that the genetic modification is something that could potentially happen in nature. 

Targeted mutagenesis and cisgenesis do not introduce genetic material from non- crossable species -transgenesis- whereas this is the case with established genomic techniques. In addition, in some cases, products containing or consisting of plants with genetic modifications introduced by NGTs cannot be differentiated from products containing or consisting of plants bred with conventional breeding methods by analytical methods, whereas this is always possible for established genomic techniques. These methods are used to enhance desirable traits like disease resistance or yield in plants. For example, you have two different potato varieties: one is very tasty but susceptible to a potato disease, the other one is less tasty and resistant to the disease. You could take a gene for disease resistance from one potato variety and insert it into the well tasting potato variety. As end product you would have a good tasting and resistant potato variety.  

https://food.ec.europa.eu/document/download/c03805a6-4dcc-42ce-959c-e4d609010fa3_en?filename=gmo_biotech_ngt_proposal_2023-411_en.pdf 

Responsible Research and Innovation (RRI) is a concept that encourages scientists and researchers to consider the potential impacts of their work on society and the environment right from the start. It’s about making sure that research and innovation contribute positively to society, and that everyone involved behaves ethically and responsibly. 

Here’s how RRI relates to research projects funded by Horizon Europe: 

• Inclusiveness: Projects are encouraged to include a wide range of voices in their development, including those of the public, researchers from different fields, policy makers, and other stakeholders. This ensures that different perspectives are considered. 
• Sustainability: Research should help create a more sustainable world, meaning it should support environmental protection, help reduce waste and pollution, and use resources wisely. 
• Openness and Transparency: Sharing research findings openly makes it easier for others to learn from, use, and scrutinize research. This openness also helps build trust between the public and the scientific community. 
• Ethics: All research must be conducted ethically, respecting human rights and the welfare of both humans and animals involved. 
• Anticipation and Reflexivity: Researchers are encouraged to think ahead about the possible consequences of their work, both good and bad, and reflect on these potential impacts regularly. 

https://research-and-innovation.ec.europa.eu/strategy/strategy-2020-2024/our-digital-future/open-science_en 

https://rri-tools.eu/documents/21503/103925/PositionPaper_WhyandhowtoincludeRRIinHorizonEurope_21-02-20+.pdf/f9071413-398c-4535-8297-8b4c263ae851 

Systems mapping is a method used to understand and visualize complex systems by creating a diagram or map that shows the different elements within a system and how they are connected. It’s like drawing a map of a city to see how everything from roads, schools, businesses, and parks are related to each other. In systems mapping, the “city” is any complex system you want to study, like an ecosystem, a business, or even social behaviors. 

In the context of social transformative science, systems mapping is used to better understand social issues and the various factors that influence them. Here’s how it works in this field: 

1. Identifying Key Elements: First, you identify all the important elements that make up the social aspects you’re studying. For example, if you’re looking at NGTs, elements might include targets for gene editing, tools used (like CRISPR-Cas9), the organisms being modified, regulatory frameworks, ethical considerations, and potential value chains (such as agriculture, processing industry, medicine, or environmental conservation). 
2. Mapping Relationships: Next, you draw connections between these elements to show how they interact. This might include, for example how the availability of CRISPR technology (tool) influences the ability to edit genes in agricultural crops (application), and how this is regulated by government policies (regulatory frameworks). 
3. Analyzing the System: With the map created, you can analyze how altering one element affects others. This helps researchers and policymakers in understanding the complexity and interdependence of factors within the system. 
4. Designing Interventions: By understanding these relationships, it’s easier to plan actions or policies that target the root causes of the issue rather than just the symptoms.  

Systems mapping in social transformative science is especially useful because it helps break down complex social problems into more manageable parts and reveals the best points for intervention. It’s a tool for planning, decision-making, and explaining social phenomena in a clear, visual way. 

Since the invention of agriculture, humans have been improving grains, fruits, vegetables ever since we started growing them. Plants have been crossed and selected to get the right characteristics to get better crops.   Breeders use many methods in their breeding programs to increase genetic variability, increase breeding efficiency and evaluate their breeding materials, from crossing and selecting plants in the field and glasshouses to using innovative tools in the laboratory. Today’s innovations in plant breeding utilize sophisticated methods and disciplines, such as cell biology, genome and proteome research, gene mapping and marker-assisted breeding, which have enabled the development of other innovative methods such as gene editing to generate variation (FAQ International Seed Federation).  

NGTs allow scientists to modify organisms in specific ways in the laboratory that are faster and more precise than traditional breeding methods. The breeders identify and select the right characteristics from the plant’s own DNA or from a related plant. Breeders can then use NGTs to develop new characteristics or improve existing plants with greater precision and speed than with conventional breeding techniques.  

The precision of NGTs means there is less chance of unwanted changes to the plants’ genetic material, which can happen in traditional breeding due to the random nature of genetic mixing. This precision helps in speeding up the development of new plant varieties and can lead to innovations that were not feasible with older breeding techniques. The goal of these techniques is often to improve crop resistance to diseases and pests, enhance nutritional content, or adapt to climate change. 

Overall, NGTs are one of several tools in the breeder’s toolbox, helping to address challenges like food security and sustainability by supporting the development of crops that are better adapted to current and future agricultural needs. 

The difference between new genomic techniques (NGTs) and classic genetically modified organisms (GMOs) lies mainly in the precision and nature of the genetic changes they introduce: 

Precision of Changes: 

• Classic GMOs: Traditional genetic modification involves transferring genes from one organism to another, which can be from different species. This process introduces new genes into a plant or animal to give it new traits, such as resistance to pests or tolerance to herbicides. The insertion is relatively less precise, and the foreign DNA can integrate in various places in the genome, potentially disrupting other genes. 
• NGTs: These newer techniques, like CRISPR, allow scientists to make very specific changes to an organism’s existing genes. This can mean turning off a specific gene, making small tweaks to a gene’s sequence, or adding a new gene more precisely. There is no need to use genes from other species necessarily, as the edits can often be made within the species’ own genetic material. 

Regulatory and Public Perception: 

• Classic GMOs: Due to the insertion of foreign DNA, especially from different species, GMOs have faced significant regulatory scrutiny and public concern. People are often worried about the ecological and health impacts of introducing genes from one species into another. 
• NGTs: As these techniques often result in changes that could occur naturally or through traditional breeding methods, the end-product is similar to conventionally bred organisms in contrast to GMOs. 

Applications and Development Time: 

• Classic GMOs: To place a GMO variety on the market, applicants must apply for GMO authorizations by submitting a dossier with experimental data and a risk assessment. This thorough assessment is costly and time-consuming, which increases the development time of classical GMOs. 
• NGTs: NGTs can potentially produce results faster because they modify genes already in the organism, which can speed up development cycles and reduce costs.  Based on the categorization of the EC proposal, NGT plants that could also occur naturally or by conventional breeding (‘category 1 NGT plants’) would be subject to a verification procedure, based on criteria set in the proposal. NGT plants that meet these criteria would be treated like conventional plants and exempted from the requirements of the GMO legislation, which both would reduce cost and time to place NGT varieties on the market. In summary, NGTs offer a more precise, potentially less controversial way of editing organisms compared to traditional GMOs, which involve transferring genes between organisms, often across species boundaries. 

GeneBEcon has chosen potato and microalgae as case studies for the use of new genomic techniques for several reasons: 

Importance and Utility: 

• Potatoes: They are a staple food crop around the world, widely consumed and a key part of global agriculture. By using new genomic techniques on potatoes, scientists can aim to improve traits like disease resistance and starch composition. This can have a significant impact on food security, agricultural efficiency and industrial processing in view of reduction of pesticide use and chemical inputs. 
• Microalgae: These are incredibly versatile organisms used in various industries, including food, cosmetics, and biofuel production. Microalgae can be engineered to be more efficient at photosynthesis, produce valuable compounds, or grow under harsh conditions. Residual biomass could be a valuable source for chicken feed, which makes them relevant in view of circular bioeconomy. Microalgae are an excellent model for demonstrating the capabilities of genomic technologies in both environmental and industrial applications. 

Genetic Diversity and Editability: 

• Potatoes: They have a complex genetic structure that can be challenging to work with using traditional breeding methods. New genomic techniques allow for precise edits that are not possible with conventional methods, potentially speeding up the breeding process and introducing desirable traits more effectively. 
• Microalgae: They often have simpler genomes that are easier to manipulate. This simplicity allows researchers to make genetic changes more efficiently, making microalgae a good candidate for showcasing the effectiveness and speed of genomic editing. 

Broader Implications: 

• Studying these two organisms can provide insights that apply to other crops and microorganisms. Innovations in potato and microalgae could lead to technological advancements that benefit a wide range of species and industries, demonstrating the broad potential of new genomic techniques. 

By focusing on these organisms, GeneBEcon can address significant agricultural and industrial challenges, showcase the transformative potential of genomic technologies, and potentially accelerate adoption and regulatory approval of these techniques across various sectors. 

In the European Union, organisms bred with New Genomic Techniques (NGTs) are currently regulated   as genetically modified organisms (GMOs) under Directive 2001/18/EC, which requires thorough risk assessments and labeling. 

The EU’s framework aims to protect human and animal health, as well as the environment, by mandating a rigorous safety assessment before GMOs can be marketed. Additionally, it establishes harmonized procedures for the risk assessment and authorization of GMOs and requires that GMOs and products derived from them be clearly labeled, enabling both consumers and professionals to make informed decisions. There is also a strong emphasis on the traceability of GMOs once they are on the market​ (Food Safety)​​. 

Key directives and regulations include: 

• Directive 2001/18/EC: Governs the deliberate release of GMOs into the environment. 
• Regulation (EC) No 1829/2003: Covers genetically modified food and feed. 
• Directive (EU) 2015/412: Allows Member States to restrict or prohibit the cultivation of GMOs in their territory. 
• Regulation (EC) No 1830/2003: Concerns the traceability and labeling of GMOs and products produced from them​ (Food Safety)​. 

In April 2021, the European Commission released a study suggesting that current EU legislation on genetically modified organisms (GMOs), adopted in 2001, is not fit for purpose for new genomic techniques (NGTs). NGTs did not yet exist in 2001, when the EU legislation on genetically modified organisms (GMOs) was adopted. The EC stated that current rules lag behind scientific and technological progress and are not designed to facilitate the development and placing on the market of innovative NGT products. The EU needs an adapted framework for safe NGT plants tailored to their specificities to provide benefits to farmers, consumers and the environment (EC Factsheet on new genomic techniques). This led to considerations for new regulations that would better reflect the scientific and technological advances since the original legislation was enacted. 

The proposed new regulation aims to ensure safety while fostering innovation. It suggests a more proportionate regulatory approach based on the risks associated with the specific modifications and traits introduced into the organisms, rather than the method used to produce them. This means that some products developed using NGTs could be subjected to less stringent regulations if they could have been produced through traditional breeding methods or result in similar changes. 

Overall, the European Commission’s approach seeks to leverage the benefits of genomic innovations while maintaining high safety standards for health and the environment. 

With the rise of more precise genomic techniques like CRISPR, the European Commission has proposed a new regulatory approach. This proposal, adopted on 5 July 2023, aims to differentiate between NGTs based on their characteristics and the complexity of their genetic modifications.  

This proposal only concerns plants produced by targeted mutagenesis and cisgenesis and their food and feed products. Targeted mutagenesis induces mutations in the genome without insertion of foreign genetic material (e.g., changes are made within the same plant species). Cisgenesis is an insertion of genetic material into a recipient organism from a donor that is sexually compatible with the recipient organism (e.g., changes are made between naturally compatible plants). 

The proposal does not include plants obtained by NGTs that introduce genetic material from a non-crossable species (transgenesis). Such techniques remain subject to the existing GMO legislation. 

The new proposal creates two categories for NGT-derived plants: 

• NGT plants that could also occur naturally or by conventional breeding (‘category 1 NGT plants’) would be subject to a verification procedure, based on criteria set in the proposal. NGT plants that meet these criteria would be treated like conventional plants and exempted from the requirements of the GMO legislation. Information on category 1 NGT plants would be provided through the labelling of seeds, in a public database and through the relevant catalogues on plant varieties. This ensures choice for farmers and value chains who want to specifically chose for NGT seeds or avoid NGT seeds like the organic sector. 
• For all other NGT plants (‘category 2 NGT plants’), the requirements of the current GMO legislation would apply. They would be subject to risk assessment and authorisation before could be put on the market. They would be traced and labelled as GMOs, with the possibility of a voluntary label to indicate the purpose of the genetic modification. The risk assessment, detection method and monitoring requirements would be adapted to different risk profiles and regulatory incentives would be available for NGT plants featuring traits that can contribute to sustainability goals. 

This new approach aims to foster innovation and research, particularly benefiting small and medium-sized enterprises (SMEs), while maintaining a high level of health and environmental protection. The proposed regulations also aim to steer developments towards contributing to sustainability goals across a wide range of plant species, especially in the agri-food system. 

The regulation is still under discussion and must be approved by both the European Parliament and the Member States in the Council following the ordinary legislative procedure before it can become law​ (Food Safety)​​ (eur-lex.europa)​. 

https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_3568 

New Genomic Techniques (NGTs) offer several benefits across different sectors, particularly for farmers, consumers, and citizens: 

Farmers: 

• Increased Crop Efficiency: NGTs can make crops more resistant to pests and diseases, reducing the need for chemical pesticides, which can save costs and labor. Also, these techniques can improve crop tolerance to adverse weather conditions, like drought or frost, potentially increasing yields and reliability of production. 
• Enhanced Quality: Genetic modifications can help improve the nutritional value or taste of crops, making them more appealing and beneficial for consumption. Additionally, they can be used to enhance the appearance or shelf-life of agricultural products, making them more marketable. 

Consumers: 

• Better Quality Foods: NGTs can produce foods with enhanced nutritional profiles, such as increased vitamins or healthier fats. For instance, oil from genetically edited soybeans can have fewer unhealthy fats. 
• Environmentally Friendly Options: By reducing the need for chemical inputs like pesticides and fertilizers, NGTs contribute to a lesser environmental footprint of agricultural practices, aligning with the preferences of environmentally conscious consumers. 

Manufacturers and traders: 

•  Sustainability: reduced use of natural resources and reduced emissions associated with food transport and properties facilitating processing. 

Citizens: 

• Sustainability: By improving crop efficiency and reducing dependency on chemical treatments, NGTs support more sustainable farming practices, which is beneficial for long-term environmental health. 

These benefits of NGTs, however, come with the need for careful regulation and oversight to ensure that their deployment is safe and that the benefits are distributed fairly across different groups in society. The overarching goal is to utilize these advanced techniques to address urgent global challenges such as food security, climate change, and biodiversity loss, while maintaining public trust and ethical standards. 

https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_3568