European Parliament’s Environment Committee Votes to Support New Proposal for the Regulation of New Genomic Techniques
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Insights
The recent vote by the Environment Committee of the European Parliament holds substantial implications for the agricultural biotechnology industry. The proposed legislation for New Genomic Techniques (NGTs) represents a significant shift towards a more innovation-friendly regulatory environment in the European Union. By categorizing certain NGT products as 'Conventional-like', the EU is reducing the regulatory burden on these technologies, potentially accelerating their adoption and market entry.
From a biotechnological perspective, the techniques in question—targeted mutagenesis and cisgenesis—allow for precise genetic modifications that can mimic natural genetic variations or those achieved through traditional breeding methods. This precision can lead to crops with enhanced resistance to diseases, pests and environmental stressors, thereby increasing yield stability and reducing the need for chemical inputs. The alignment of EU policy with that of other major agricultural producers may also facilitate international trade and cooperation in the development and distribution of NGT-derived crop varieties.
The endorsement of NGTs by the Environment Committee underscores a broader policy trend towards embracing technological solutions to environmental challenges. The legislation's focus on sustainability and resilience is aligned with the EU's Green Deal objectives, aiming to transform the bloc into a modern, resource-efficient economy. By easing the path for NGT products, the EU is signaling its commitment to leveraging science to achieve these goals.
However, it is crucial to monitor the environmental impact of NGTs in the long term. While these techniques promise to make agriculture more sustainable, rigorous oversight must ensure that they do not inadvertently harm biodiversity or lead to unforeseen ecological consequences. The legislation's success will hinge on its ability to balance innovation with environmental stewardship, maintaining public trust in the safety and sustainability of the EU's food system.
The potential economic impact of the new NGT regulations cannot be overstated. By streamlining the regulatory process for 'Conventional-like' NGT products, the EU may attract more investment in agricultural biotechnology, particularly benefiting small and mid-sized enterprises and academic institutions. This could catalyze a wave of innovation in the sector, leading to job creation and economic growth.
Moreover, enhanced crop resilience and sustainability can translate into cost savings for farmers and the agricultural sector at large, reducing the volatility of food prices. The alignment with international standards may also reduce trade barriers, fostering economic cooperation with countries that have already adopted similar approaches to NGTs. Nevertheless, the economic benefits will be contingent upon the effective implementation of the regulations and the market's receptiveness to NGT-derived products.
- The Environment Committee of the European Parliament votes in favour of the European Commission proposal to introduce a new regulation on plants obtained by certain new genomic techniques (NGTs) and their food and feed.
- The Committee’s report indicates that NGTs have the ability to enhance agriculture by making crops more resilient and sustainable whilst providing unprecedented opportunities for European agriculture and food production.
- The 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 UK, North and South America, India, Australia, and Japan
- Following the positive vote, the legislation will now move to a plenary session of the European Parliament on 5th to 8th of February for a vote on adoption.
SAN DIEGO, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Cibus, Inc. (Nasdaq: CBUS), a leading agricultural technology company that develops and licenses plant traits to seed companies, welcomes the vote of the Environment Committee of the European Parliament on 24th January in favour of new legislation for New Genomic Techniques (NGTs).
The legislation is part of a package of EU proposals to ensure resilient and sustainable use of the EU's natural resources. It describes a category of NGTs, classed as targeted mutagenesis and cisgenesis, 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.
Before the vote, an open letter from 35 Nobel Laureates and over 1400 scientists urged MEPs to support the legislation in order to foster innovation, enhance food security and boost climate resilience.
After the vote, MEP and rapporteur Jessica Polfjärd said, “This proposal is critical for strengthening Europe's food safety in a sustainable manner. We finally have a chance to implement rules that embrace innovation and I look forward to concluding negotiations in the Parliament and with the Council as soon as possible.”
Tony Moran, Senior Vice President of International Development and Government Affairs at Cibus, commented, “The committee vote is an important step in the EU process for legislation that improves alignment with EU trading partners. Timely adoption would also be a significant boost for innovators particularly in academia and small and mid-sized enterprises who are actively developing NGT products that could contribute to a sustainable EU agri-food system.”
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 their elite germplasm with Cibus edits back to customers.
The traits from Cibus’ RTDS-based High Throughput Breeding System are indistinguishable from traits developed using conventional breeding or from nature. RTDS does not use any foreign DNA or transgenes. Under the European Commission current proposals, it is expected that products from Cibus’ RTDS gene editing platform such as its pod shatter reduction trait and Sclerotinia resistance traits for Canola and Winter Oilseed Rape would 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.”
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
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of applicable securities laws, including The Private Securities Litigation Reform Act of 1995. All statements, other than statements of present or historical fact included herein, including statements regarding Cibus’ operational and financial performance, Cibus’ strategy, future operations, prospects and plans, including the anticipated regulatory environment are forward-looking statements. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “intend,” “expect,” “plan,” “scheduled,” “could,” “would” and “will,” or the negative of these and similar expressions.
These forward-looking statements are based on the current expectations and assumptions of Cibus’ management about future events, which are based on currently available information. These forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and beyond the control of Cibus. Cibus’ actual results, level of activity, performance, or achievements could be materially different than those expressed, implied, or anticipated by forward-looking statements due to a variety of factors, including, but not limited to: changes in expected or existing competition; challenges to Cibus’ intellectual property protection and unexpected costs associated with defending intellectual property rights; increased or unanticipated time and resources required for Cibus’ platform or trait product development efforts; Cibus’ reliance on third parties in connection with its development activities; challenges associated with Cibus’ ability to effectively license its productivity traits and sustainable ingredient products; the risk that farmers do not recognize the value in germplasm containing Cibus’ traits or that farmers and processors fail to work effectively with crops containing Cibus’ traits; challenges that arise in respect of Cibus’ production of high-quality plants and seeds cost effectively on a large scale; Cibus’ need for additional funding to finance its activities and challenges in obtaining additional capital on acceptable terms, or at all; Cibus’ dependence on distributions from Cibus Global, LLC to pay taxes and cover its corporate and overhead expenses; regulatory developments that disfavor or impose significant burdens on gene-editing processes or products; Cibus’ ability to achieve commercial success; commodity prices and other market risks facing the agricultural sector; technological developments that could render Cibus’ technologies obsolete; changes in macroeconomic and market conditions, including inflation, supply chain constraints, and rising interest rates; dislocations in the capital markets and challenges in accessing liquidity and the impact of such liquidity challenges on Cibus’ ability to execute on its business plan; the Company's assessment of the period of time through which its financial resources will be adequate to support operations; and other important factors discussed in “Risk Factors of Cibus, Inc.” filed as Exhibit 99.3 with Cibus’ Current Report on Form 8-K, which was filed with the Securities and Exchange Commission (the “SEC”) on June 1, 2023, as updated by the supplemental risk factors included in the Company's Current Reports on Form 8-K filed on October 18, 2023 and December 12, 2023, each as may be updated by any additional “Risk Factors” identified in Cibus’ subsequent reports on Forms 10-Q and 8-K filed with the SEC. Should one or more of these risks or uncertainties occur, or should underlying assumptions prove incorrect, actual results and plans could differ materially from those expressed in any forward-looking statements. Cibus’ assessment of the period of time through which its financial resources will be adequate to support its operations is a forward-looking statement and involves such risks and uncertainties. Accordingly, the Company could use its available capital resources sooner than it currently expects.
In addition, the forward-looking statements included in this press release represent Cibus’ views as of the date hereof. Cibus specifically disclaims any obligation to update such forward-looking statements in the future, except as required under applicable law. These forward-looking statements should not be relied upon as representing Cibus’ views as of any date subsequent to the date hereof.
CIBUS CONTACTS:
Investor Relations
Karen Troeber
ktroeber@cibus.com
858-450-2636
Jeff Sonnek – ICR
jeff.sonnek@icrinc.com
Media Relations
Colin Sanford
colin@bioscribe.com
203-918-4347
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