#BIOSPAIN2023Interview | "Genome editing has the potential to address real challenges for farmers and the planet"

Genomic editing is a new approach to genetic improvement based on knowledge that harnesses the natural solutions of plants, contributing to reducing the current need for external inputs and enabling more environmentally friendly food production.

New Genomic Techniques (NGTs) have the potential to contribute to a more sustainable food system as part of the objectives of the European Green Deal and the Farm to Fork Strategy.

Genetic editing techniques can be a great ally in developing an adequate quantity of more nutritious food for a growing population. Through these techniques, we can develop crops that are more resistant to diseases and pests, improve food production, enhance nutritional properties, or reduce allergens.

In early July, the European Commission made its regulatory proposal on these new genetic editing techniques public. This regulation aims primarily to allow the development and commercialization of plants and plant products obtained from NGTs, specifically through directed mutagenesis or cisgenesis (including intragenesis), as well as food and feed products produced through such plants.

The subject we are discussing will be one of the central topics of the upcoming BIOSPAIN edition, an internationally renowned event in the biotechnology sector, which will take place in Barcelona from September 26 to 28. This interview with Richard Borreani, Public Affairs, Science & Sustainability Iberia at Bayer, the Gold Sponsor of BIOSPAIN 2023, delves into this scenario.

AseBio. New genomic editing techniques are emerging as key tools to meet the objectives of the European Green Deal. What are the main advantages they offer?

Richard Borreani. Genome editing has the potential to address real challenges for farmers and the planet, such as reducing the need for plant protection products and the use of energy, land, and water. In agriculture, this process typically aims to improve a beneficial trait within an organism or eliminate an undesirable trait. The latest advances in plant breeding techniques are used to enhance seeds, achieving greater efficiency and specificity than ever before.

Genome editing combines deep knowledge of genes and gene networks with a systematic breeding approach. The technique allows scientists to create genetic variation precisely by editing or "fine-tuning" the plant's own genetic material to develop desired traits (or phenotypes). Editing enables specific changes in the genome of crops that are comparable to changes that could occur through natural selection or conventional breeding, although both are limited in accuracy and the time required for natural variation to occur spontaneously.

By accelerating the discovery, development, and delivery of improved crops, genome editing has enormous potential to address the increasingly complex challenges faced by farmers, consumers, and the planet by providing the following advantages:

• Increasing yield
• Improving resistance to extreme weather conditions, including drought
• Enhancing resistance to diseases and pests, thus reducing the use of plant protection products
• Reducing food waste, for example, by extending shelf life
• Providing additional health and nutrition benefits
• Responding to changing consumer demands, such as greater variety, better taste, and appearance

AseBio. NGTs offer solutions to pressing challenges such as climate change or population growth, among others. What is the current landscape of their use in Europe?

Richard Borreani. Climate change is putting significant pressure on the food production system, exacerbated by supply chain disruptions due to the COVID-19 pandemic and sociopolitical instability, including the war in Ukraine, all of which further threaten the production and global supply of safe, healthy, and affordable food. While short-term solutions are urgently needed, fundamental changes will be required in the medium and long term to ensure that the food system can withstand current and future pressures while reducing the impact of agriculture on the planet. At Bayer, we believe that ensuring food security and mitigating climate change will not be possible without innovation in agriculture, including the use of new techniques like genome editing, such as CRISPR.

AseBio. Recently, the European Commission made its regulatory proposal for NGTs public. Does it address the current landscape?

Richard Borreani. The Commission's proposal is an important first step toward a science-based and proportionate regulatory framework for NGT plants. Other regions have widely adopted the approach that some NGT plants are equivalent to conventionally bred plants and should not be treated as GMOs.

To enable the development and adoption of NGTs in the EU, three factors need to be addressed in the final legislation:

• 1. Science-based criteria: proportionate and science-based criteria for determining which NGT plants fall into category 1 (conventional-type plants) and can, therefore, be exempt from GMO requirements.

The most suitable criterion for establishing equivalence with conventional plants is the absence of foreign genetic material in the final product. The Commission's proposal for a limit of 20 modifications to determine equivalence with conventional plants is very conservative and more restrictive than that of most third countries.

These limitations do not represent what can happen in a plant's genome through conventional breeding or in nature. It would restrict, for example, the development of important traits such as abiotic stress resistance (e.g., drought tolerance), which is complex and affected by many genes. Additionally, crops like wheat, which have more complex genomes, would have limited potential to benefit from NGT innovation if such a conservative limit is applied.

• 2. Simplified verification process: The verification process for determining a product's category must be agile, predictable, and simplified. This will allow all stakeholders to bring various products to market that are necessary for sustainable agriculture.

Simplification and maintaining the integrity of the process could be achieved by ensuring that the verification process is carried out by national authorities, which should be responsible for addressing any questions or concerns raised by Member States or the Commission.

• 3. Proportionate authorization requirements: To realize all the benefits of science and innovation and be commercially viable for farmers, category 2 NGT products for which a detection method cannot be developed should also be exempt from GMO traceability, labeling, and coexistence requirements.

In such a situation, existing challenges in the applicability of traceability, labeling, and coexistence requirements for certain NGT products will remain unresolved, and this would occur when NGT products cannot be distinguished from conventional plants.

AseBio. Science is evolving rapidly, as seen with the CRISPR genome editing tool, which we did not have a decade ago. However, regulations in Europe do not keep pace with this evolution. What are the disadvantages for Europe compared to other markets like the United States or China that are embracing this technology?

Richard Borreani. The lack of an enabling framework puts developers, farmers, academics, and research institutions in the EU at a competitive disadvantage compared to their counterparts in other regions. It also jeopardizes the EU's sustainability goals.
Therefore, the regulation of plants obtained through NGTs should not be discriminatory and should apply the same regulatory oversight to similar plants, based on the regulation of conventional plants, which takes into account the characteristics of the plant rather than the technique used to obtain it.
We must align with the regulation of other countries to reduce uncertainty and regulatory burdens for food and feed chain operators, always ensuring consumer safety.

AseBio. What role is biotechnology playing in shaping the future of agriculture?

Richard Borreani. To answer this question, I will quote the ANTAMA Foundation when it says that this is an important moment for Europe. To produce more with fewer resources in a scenario of climate change, a new agricultural revolution is needed to sustainably intensify agriculture and adapt crops to new climate scenarios. In this sense, the activity of the plant breeding sector, which develops new seed and plant varieties, is essential, but the pace of innovation in plant improvement until 2050 must accelerate significantly, necessitating access to all the tools that science provides.

AseBio. What does Bayer expect from BIOSPAIN 2023?

Richard Borreani. Bayer expects a constructive and open BIOSPAIN with a 360-degree view.
It is important that all stakeholders are aligned, and science should be the determining factor for policymakers.