More countries are getting comfortable with science showing that gene-edited plants are the same as those developed by conventional breeding.
Update: Since this article was written, the Financial Times reports the European Union has reached a political agreement to relax regulation of gene-edited crops, treating simple gene edits more like conventionally bred varieties and less like traditional GMOs — a major policy shift that aligns the bloc more closely with other global markets.
It wasn’t that long ago that countries began discussing how best to regulate a suite of new agricultural technologies collectively known as new breeding techniques. These technologies use gene editing tools to improve crop genetics and introduce new plant varieties to crop seed markets faster than ever before—in 1-3 years instead of the five or more years previously required.
Regulators, recognizing the importance of innovation in plant breeding, started to implement regulatory policy that enabled researchers and developers to produce plants identical to those which could be produced by the plants’ own genome-repair mechanisms and without introducing DNA from other, “foreign” species, an older method which has been safely used for decades but which requires higher investment and remains tightly regulated. While precision breeding offered a faster, easier path to new varieties, existing government regulations did not provide for such new methods, leaving seed producers without a clear path to market.
A More Favorable Landscape
Today, the global regulatory landscape is shifting, permitting use of these new technologies, and they are now in the toolbox of seed companies and breeding programs around the world.
For a look at the pace of innovation in the U.S., a good reference is the Department of Agriculture’s (USDA) “Am I Regulated?” Letters of Inquiry Table, a list of plants the USDA has evaluated and determined do not fall under their biotechnology regulations (and are therefore regulated the same as conventional plant varieties). The USDA has completed 237 such evaluations. The determinations cover everything from apples to zoysia grass, row crops, specialty crops, fruits, vegetables, and ornamentals. The submissions have been from companies of all sizes, from large multinationals too small to mid-size companies and academia. The list illustrates the breadth of applications and the potential of new breeding techniques and how they will inevitably change the future of our agri-food system.
While deregulatory progress has been quick in the U.S, Canada, and across Latin America, the United Kingdom (UK) and European Union (EU) have lagged. This is now changing. In May of this year, the UK passed secondary legislation adopting the Genetic Technology (Precision Breeding) Act and the UK’s Department for Environment, Food, and Rural Affairs (DEFRA) and the Food Standards Agency (FSA) have released industry guidance establishing a regulatory framework for gene editing technology in the UK. At the same time, progress towards adoption of the EU’s draft legislation for New Genomic Techniques (NGTs) – the EU’s preferred terminology for plants developed from gene editing – is poised to be adopted perhaps as soon as the end of 2025, based on the trajectory of procedural legislative steps. And while Asia remains a regulatory patchwork, major markets including Japan, Thailand, and China have implemented regulations that allow for the evaluation of gene-edited plants.
This positive trajectory was on full display in October at the Euroseeds Congress in Edinburgh where a panel session focused on how the UK’s imminent regulatory modernization will change the future of agriculture in Europe. It wasn’t that long ago that those of us in the industry were having discussions with governments about what precision breeding is and how its applications have the potential to significantly impact the future of sustainable agriculture. Now, we are talking about how quickly we can move to bring new varieties to the market.
This regulatory shift means first adopters are poised to have an advantage. In the world of plant breeding, speed and precision are the key success factors. As an example, one of the biggest challenges facing agriculture is disease resistance, where breeding traits can take many years. Now, with gene-editing, Sclerotinia-resistant canola/rapeseed is under development to enhance productivity while reducing the need for fungicide application. It has been trialed in the U.S. with positive results. Disease resistance is particularly challenging given the complexity and fast evolution of plant diseases and the need to introduce multiple modes of action to provide durable protection. While these changes would have taken many years to introduce through traditional breeding programs, rapid genetic editing permits multiple modes of action in a single plant in about a year.
While the technology is there, and we have traits that are primed for use in commercial breeding programs, we have been waiting for the regulatory environment to catch up to the pace of development. Now, we see that coming to reality.
Cibus is an agricultural genetics company which develops advanced plant traits and licenses them to major seed producers, with emphasis on higher yields and lower costs. Its headquarters and labs are in San Diego and its shares trade on Nasdaq as CBUS.
Dr. Peter Beetham, with over 30 years in the bio-agriculture industry, is the co-founder and Interim CEO of Cibus. Beetham was Research Director of ValiGen (formerly Kimeragen) and served eight years at the Victorian Department of Agriculture in Australia, where he led of team that provided pathogen-testing of root crops for many countries in Southeast Asia and the South Pacific to help increase crop yields and improve farmer economics.
Katie Davis brings over 20 years of experience in the agrifood industry to the post of Senior Director, Regulatory & Quality at Cibus. Davis served in management and regulatory policy positions at BASF, Sygenta and at Apeel Sciences, where she worked to build market access for the company’s novel fruit and vegetable coatings across North America, Europe and Latin America.