The rapid advancement of CRISPR-based genome editing technologies offers unprecedented opportunities to develop crop varieties with improved yield and nutritional quality, and with traits that are increasingly critical in the context of climate change, such as resilience to drought, heat, salinity and flooding, and efficient utilisation of dwindling natural resources. However, regulatory approaches governing genome-edited products vary widely across countries. While several nations treat genome-edited crops without foreign DNA similar to the conventionally bred varieties, others continue to regulate them under stringent GMO (genetically modified organism or GM crops) regulatory frameworks. This divergence creates regulatory uncertainty and can impede international collaboration, technology deployment, and trade in global markets, ultimately affecting the smooth and timely movement of food across countries. Such barriers may hinder efforts to ensure easy access to food worldwide. Timely access to food has become particularly critical in the current context of geopolitical tensions and conflicts in some regions of the world, which continue to disrupt global food supply chains.
There is, therefore, an urgent need for greater harmonisation of regulatory frameworks for genome-edited products at the global level. As scientific principles are universal and genome-editing regulatory frameworks are based on sound scientific evidence, global harmonisation of regulatory processes is both logical and feasible.
Several countries around the world have adopted such science-based regulations to facilitate the responsible development, testing, and commercialisation of genome-edited crops. However, as mentioned above, there is a need to have the harmonised regulations across the globe, to enable smoother cross-border exchange of improved crop varieties and associated technologies, benefiting consumers and farmers; in other words, the people and the planet.
The scientific reasoning behind the regulation of CRISPR-based genome editing technologies is backed by the idea that many of the genetic changes produced through these tools are similar to those that could occur naturally in plants or arise through conventional breeding methods, such as cross-breeding or mutation breeding. Because these types of changes can also happen in nature or through traditional breeding, scientists generally consider them to pose no greater risk than crops developed by conventional methods. For this reason, many countries have adopted regulatory approaches that focus on whether foreign DNA has been introduced into the plant. If genome editing results only in small alterations in the plant’s own genes and does not involve inserting genetic material from other organisms, as is the case in SDN1 and SDN2 categories of genome editing, several regulatory systems treat such edited crops similarly to the conventionally bred varieties rather than subjecting them to strict regulations that are applied to GMOs.
About 25 countries, so far, treat genome-edited products developed through SDN1 or SDN2 techniqueswithout foreign DNA as equivalent to conventionally bred crop varieties, and exempt them from the stringent regulatory oversight, thus allowing their faster development and commercialisation. These countries also permit cultivation, import and export of genome-edited plants for any use. While the exemption of certain genome-edited crops from biosafety regulations by these countries is a welcome step, studies indicate considerable diversity in regulatory approaches across several other nations. This highlights the need for developing a common regulatory framework, particularly for genome-edited crops that do not contain foreign DNA.
In Latin American countries, including Argentina, Brazil, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Honduras, Paraguay, Ecuador, and Uruguay, if the final product does not contain a new combination of genetic material, it is generally treated as equivalent to conventionally bred varieties.
African countries, including Burkina Faso, Ghana, Kenya, Malawi, and Nigeria, and countries such as Australia, Japan, the Philippines, Singapore, India and Bangladesh, exempt certain genome-edited products developed through SDN1 or SDN2 techniques and lacking foreign DNA from the stringent regulatory assessment. Recently, Thailand has adopted a similar position by exempting SDN1-derived products from strict regulations.
Canada adopts a product-based regulatory system, focusing on the novel traits rather than the breeding method used to develop a genome-edited product, and those edited plants that do not contain any foreign DNA are exempt from regulation. Similarly, in the USA, the CRISPR-edited plants are regulated based on the end product, and not the technique used for developing them, and products with minor deletions or single base pair substitutions are exempted from regulation. The United Kingdom has differentiated the precision-bred plants from GMO regulations and has permitted field trials of genome-edited plants.
China has recently adopted new guidelines to regulate genome-edited crops that do not involve foreign gene insertion; however, the crops that possess foreign genes remain regulated under the standards GMOs regulations.
Some countries, such as Indonesia, Vietnam, Ethiopia and South Korea, are in the process of developing, revising or updating their regulatory frameworks. The European Union, as of now, treats genome-edited organisms as GMOs, although proposals are under active consideration to establish specific regulatory provisions.
Conclusion: In an era of rapidly changing climate and growing global population, enabling timely access to climate-resilient and nutritionally enhanced food crops is essential for strengthening global food, nutritional and environmental security. International cooperation and global harmonisation of regulatory principles will play a key role in accelerating the process of realising the full potential of genome editing in crops for sustainable agriculture and resilient food systems.
Leave a Reply