San Diego, California, USA
December 1, 2023
- EU notifies World Trade Organization (WTO) Members of its proposal for regulation of plants obtained from New Genomic Techniques (NGTs).
- The notification asks for comments from WTO members by 30 December 2023 and is accompanied with a timetable for Parliamentary Votes.
- Proposed regulation identifies a ‘conventional-like’ category of NGT products that would be regulated as conventional varieties, bringing EU policy closer to that of trading partners in North and South America, Australia, India and Japan.
Cibus, Inc. (NASDAQ: CBUS), a leading agricultural technology company that develops and licenses plant traits to seed companies, acknowledges the European Union notification to World Trade Organization (WTO) members on the European Commission proposal for regulation of plants obtained from New Genomic Techniques (NGTs) on 31st October. The notification is intended to ensure any potential trade barriers are avoided and invites comments from WTO members by the year end.
The proposal is a result of a European Commission study, requested by EU Member States, which concluded that EU GMO legislation was not fit for purpose in relation to applications of NGTs in plants. NGTs include a variety of gene editing techniques leading to genetic changes classed as targeted mutagenesis and cisgenesis.
The proposal, which is part of a package of EU proposals to ensure resilient and sustainable use of the EU's natural resources, describes a category of NGTs producing modifications that could be obtained in nature or by conventional breeding. These are determined to be ‘conventional-like’ and, once verified, would be regulated in the same way as conventional varieties.
The proposal was adopted by the EU College of Commissioners at their meeting on July 5, 2023, and is currently under review in committees of the European Parliament and by Ministers of Member States in the Council of the European Union.
Recent disclosures forecast that Members of the European Parliament are going to vote on the proposal during January 2024. In addition, the recent EU notification proposes an adoption date in July 2024 with additional implementing acts required to be passed within 24 months in order for the new legislation to become fully operational.
“The ambitious schedule for adoption set out in the notification highlights significant progress within EU institutions that will be welcomed by trading partners, many of whom have introduced similar regulatory policy over the past eight years,” said Tony Moran, Senior Vice President at Cibus, Inc.
About Cibus
Cibus is a leader in gene edited productivity traits that address critical productivity and sustainability challenges for farmers such as diseases and pests which the United Nations estimates cost the global economy approximately $300 billion annually. Cibus is not a seed company. It is a technology company that uses gene editing to develop and license traits to seed companies in exchange for royalties on seed sales. Cibus’ focus is productivity traits for the major global crops such as canola, rice, soybean, and wheat. Cibus is the technology leader in high throughput gene editing technology that enables Cibus to develop and commercialize plant traits at a fraction of the time and cost of conventional breeding. Using its Trait Machine process, Cibus has developed a pipeline of five productivity traits including important traits for pod shatter reduction, Sclerotinia resistance and weed management. Three crops: canola, rice, and soybean; with Cibus’ five traits: pod shatter reduction, herbicide tolerance (HT)1, HT2, HT3, and Sclerotinia resistance make up the core of Cibus’ three-crop, five-trait model, which is the central focus of its business. Its initial traits for pod shatter reduction and weed management are developed an in collaboration with leading seed companies. Its other pipeline traits including Sclerotinia resistance are in advanced greenhouse and field trial stages.
About the Cibus RTDS®-based High Throughput Breeding System
A key element of Cibus’ technology breakthrough is its high throughput breeding process (referred to as the Trait Machine™ System). The Trait Machine process is a crop specific application of Cibus’ patented Rapid Trait Development System™ (RTDS). The proprietary technologies in RTDS integrate crop specific cell biology platforms with a series of gene editing technologies to enable a system of end-to-end crop specific precision breeding. It is the core technology platform for Cibus’ Trait Machine: the first standardized end-to-end semi-automated crop specific gene editing system that directly edits a seed company’s elite germplasm. Each Trait Machine process requires a crop specific cell biology platform that enables Cibus to edit a single cell from a customers’ elite germplasm and grow that edited cell into a plant with the Cibus edits. Cibus has Trait Machine platforms developed for canola and rice and has already begun transferring back to customers their elite germplasm with Cibus edits.
The traits from Cibus’ RTDS-based high throughput breeding system are indistinguishable from traits developed using conventional breeding or from nature. Under the European Commission’s current proposal, if adopted, we expect that products from Cibus’ RTDS gene editing platform such as its pod shatter trait and Sclerotinia resistance traits for canola and winter oilseed rape will be considered ‘conventional-like'.
Cibus believes that RTDS and the Trait Machine process represent the technological breakthrough in plant breeding that is the ultimate promise of plant gene editing: high throughput gene editing systems operating as an extension of seed company breeding programs.
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