USDA-APHIS Determines that Yield10 Bioscience’s Omega-3 Camelina Varieties May Be Planted and Bred in the United States
- Yield10 Bioscience receives USDA-APHIS approval for commercial cultivation of modified Camelina producing omega-3 fatty acids.
- Camelina offers a land-based solution for omega-3 production, addressing supply constraints and increasing demand for sustainable sources.
- Yield10 plans to build seed inventory and engage with commercial partners for the sale of omega-3 oil and meal in key markets.
- Collaboration with Rothamsted and BioMar Group strengthens Yield10's position in the omega-3 market, aiming to provide high-quality oils for aquafeed and human nutrition.
- Second-generation omega-3 Camelina lines with herbicide tolerance traits are being developed for large-scale commercial planting.
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The USDA-APHIS's decision on Yield10's genetically engineered Camelina is a pivotal moment for agricultural biotechnology. This development could significantly alter the landscape of omega-3 production. By moving away from ocean-caught fish as a primary source, we address both environmental concerns and supply chain vulnerabilities. Yield10's approach, which involves the cultivation of Camelina plants engineered to produce high levels of EPA and DHA, offers a sustainable and scalable alternative to traditional methods.
From an agricultural biotech perspective, the ability to scale up production hinges on regulatory approval. The clearance by USDA-APHIS means that these plants can be grown without the stringent oversight required for potential plant pests. This could lead to increased investment in biotech crops and a reevaluation of how we approach genetically modified organisms in the food supply chain. The potential for herbicide-tolerant traits in second-generation lines also indicates a drive towards improved crop management and efficiency in large-scale operations.
Yield10's breakthrough in omega-3 fatty acid production via genetically modified Camelina could have a profound impact on sustainability in the aquaculture and nutrition sectors. The traditional reliance on fish oil for omega-3s is fraught with issues of overfishing and ocean ecosystem disruption. By providing a land-based source of these essential nutrients, Yield10 is not only offering a solution to ecological concerns but also contributing to the resilience of global food systems.
The partnership with BioMar Group, a global aquafeed producer, suggests a strong commercial interest and potential for rapid market penetration. However, the long-term success of this initiative will depend on consumer acceptance of genetically modified products and the ability to navigate additional regulatory hurdles in different geographies. The scalability and environmental benefits present a compelling case, but market adoption will be the true test of impact.
The announcement by Yield10 Bioscience represents a significant step forward not only technologically but also financially. The transition from R&D to commercial scale production often serves as an inflection point for biotech companies. Yield10's focus on building seed inventory and engaging with commercial partners in 2024 indicates readiness for market entry, which could have a positive impact on the company's revenue streams and valuation.
Investors should monitor Yield10's progress towards finalizing a commercial license agreement and the subsequent partnership with BioMar Group. These agreements are critical for the commercialization phase and will likely serve as catalysts for the company's stock performance. Additionally, the diversification into herbicide tolerance traits suggests a strategy to capture more value within the agricultural supply chain and mitigate risks associated with single-trait crops.
-Yield10 achieves significant milestone enabling ramp-up to commercial scale production of omega-3 fatty acids in Camelina
-Omega-3 Camelina potentially represents a novel solution to the market need for omega-3 oils used in aquafeed for farmed fish and in human nutrition
WOBURN, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Yield10 Bioscience, Inc. (Nasdaq:YTEN) (“Yield10” or the “Company”), an agricultural bioscience company, today announced that USDA-APHIS’s Biotechnology Regulatory Services (“BRS”) has determined that Yield10’s Camelina sativa ("Camelina”) varieties developed using genetic engineering (modified Camelina) to produce omega-3 fatty acids are not subject to the regulations under 7 CFR part 340, and may be grown and bred in the United States. The global markets for omega-3 fatty acids include aquafeed used for salmon and trout farming, pet feed, baby formula, nutraceutical and pharmaceutical products. Most omega-3 fatty acids are produced from ocean-caught fish. Production constraints and supply volatility of traditional fish oil sources are creating gaps in supply and driving the growing demand for new sources of omega-3. Utilizing Camelina as a land-based production platform has the potential to provide a new, reliable supply for omega-3 fatty acids. Yield10’s submissions along with the USDA-APHIS BRS responses are posted on the USDA’s website.
“This regulatory milestone represents a critical step for enabling the ramp-up of Camelina planting to commercial scale in the U.S for producing omega-3 oil for key markets including aquafeed and human nutrition,” said Kristi Snell, Ph.D., Chief Science Officer of Yield10 Bioscience. “In 2024, we plan to focus on executing our development program, building seed inventory in anticipation of commercial scale planting, and engaging with potential commercial partners to enable commercial sale of omega-3 oil and meal in target markets. Use of omega-3 oil in target markets may still be subject to regulation from other regulatory authorities in target geographies.”
In 2023 Yield10 submitted two Requests for Regulatory Status Review (“RSR”) to the BRS under the SECURE Rule (see below). An RSR filed in July 2023 covers Camelina engineered to produce eicosapentaenoic acid (“EPA”) where the engineered omega-3 Camelina produces oil containing approximately 16
Background on Yield10’s Omega-3 Camelina Program
Currently, the primary source of the essential fatty acids EPA and DHA is ocean-caught fish, where omega-3 oil produced from anchovy harvest serves as the industry benchmark. Producing omega-3 fatty acids in Camelina represents a potential way to enable a reliable supply of high-quality omega-3 oils to meet the global demand for EPA and DHA. In 2020, Yield10 signed a collaboration agreement with Rothamsted to support Rothamsted’s Flagship Program to develop omega-3 oils in Camelina. As part of the collaboration agreement, the Company received an exclusive option to sign a global, exclusive license agreement for the technology. In October of 2023 Yield10 announced it had exercised this option and plans to finalize the global commercial license with Rothamsted. Subsequently, Yield10 and BioMar Group, a global aquafeed producer, signed a Letter of Intent (“LOI”) to form a long-term partnership to commercialize a Camelina crop containing enriched levels of EPA and DHA equal to fish oil.
In 2024, Yield10 plans to work with BioMar Group toward the signing of a partnership agreement. In addition, Yield10 plans to continue field testing and seed scale-up activities for its engineered omega-3 Camelina varieties to ramp-up seed inventory for future planting as well as to produce omega-3 oil for use in business development activities. Yield10 is also engineering second generation omega-3 Camelina lines with herbicide tolerance traits to enable weed control in large-scale commercial planting of the crop.
About the SECURE Rule
The SECURE Rule was published on May 18, 2020 and represents the first comprehensive revision of APHIS’ biotechnology regulations since 1987. The revisions enable APHIS to regulate organisms developed using genetic engineering for plant pest risk with greater precision and reduces the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. Once a specific plant developed through genetic engineering is found not to require regulation, new varieties of the plant containing the same genetic modification would similarly not be regulated. Camelina plants containing omega-3 traits are subject to regulation by the U.S. Food and Drug Administration.
About Yield10 Bioscience
Yield10 Bioscience, Inc. ("Yield10" or the "Company") is an agricultural bioscience company that is leveraging advanced genetics to develop the oilseed Camelina sativa ("Camelina") as a platform crop for large-scale production of sustainable seed products. These seed products include feedstock oils for renewable diesel and sustainable aviation biofuels; omega-3 (EPA and DHA+EPA) oils for pharmaceutical, nutraceutical and aquafeed applications; and, in the future, PHA biomaterials for use as biodegradable bioplastics. Subject to the availability of sufficient financial resources to continue operations, our commercial plan is based on establishing a grain contracting business leveraging our proprietary elite Camelina seed varieties, focusing on the production of omega-3 oils for nutritional applications and partnering or licensing our advanced Camelina gene technologies to biofuel value chain partners to support their goals of meeting the growing demand for low-carbon intensity feedstock oil. Yield10 is headquartered in Woburn, MA and has a Canadian subsidiary, Yield10 Oilseeds Inc., located in Saskatoon, Canada.
For more information about the company, please visit www.yield10bio.com, or follow the Company on X (formerly Twitter), Facebook and LinkedIn.
(YTEN-G)
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical, including, without limitation, statements regarding the ability of omega-3 Camelina and the technology being developed to provide sustainable alternatives to existing means of omega-3 oil production, expectations regarding regulatory approval for commercial production of Yield10’s Camelina product lines, the reliability, scalability and addressable market of omega-3 oils produced from omega-3 Camelina, and collaborations with potential strategic partners, including the planned completion of the global commercial license under the agreement with Rothamsted and signing of an agreement with BioMar, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, but not limited to the Company’s ability to secure adequate funding in the near term to continue operations and to remain listed on the Nasdaq Stock Market, as to which no assurance can be given, as well as the risks and uncertainties detailed in Yield10 Bioscience's filings with the Securities and Exchange Commission. Yield10 assumes no obligation to update any forward-looking information contained in this press release or with respect to the matters described herein.
Contacts:
Yield10 Bioscience:
Lynne H. Brum, (617) 682-4693, LBrum@yield10bio.com
FAQ
What milestone did Yield10 Bioscience achieve regarding omega-3 fatty acids in Camelina?
What are the potential applications of omega-3 Camelina in the market?
Who determined that Yield10's modified Camelina is not subject to regulations under 7 CFR part 340?
What percentage of eicosapentaenoic acid (EPA) does Camelina engineered by Yield10 produce?
What collaboration agreements has Yield10 signed related to omega-3 Camelina?
