US agricultural bioscience company Yield10 Bioscience has filed a request for a regulatory status review (RSR) of its camelina varieties containing genes to produce the eicosapentaenoic acid (EPA) component of omega-3 oil.
The company said it had filed its request with the United States Department of Agriculture (USDA)’s Animal and Plant Health Inspection Service (APHIS)’s Biotechnology Regulatory Service (BRS) under the SECURE Rule published in May 2020. The rule exempts plants modified by genetic engineering where the modification could otherwise have been made through conventional breeding, reducing the regulatory obligation on developers of organisms unlikely to pose plant pest risks.
“This RSR filing is a key milestone for our team as we execute our strategy to develop camelina for large-scale production of omega-3 oils. As we await the response to our RSR filing, we remain focused on conducting seed scale-up activities to generate seed inventory for regulatory activities and future grower contracts,” Yield10 Bioscience chief science officer Kristi Snell said on 26 July.
In late 2020, Yield10 signed a collaboration agreement with UK-based Rothamsted Research to support the development of omega-3 oils in camelina.
The company also signed an exclusive option to sign a global, exclusive or non-exclusive license agreement to Rothamsted’s omega-3 technology.
Yield10 said it had prioritised the deployment of the EPA component of omega-3 in camelina as the initial oil profile for commercialisation.
Other plans included production of the EPA component of omega-3 co-deployed in camelina with its advanced technology for a trait package including herbicide tolerance.
The company said it planned to follow this with the development of advanced EPA plus docosahexaenoic acid (DHA) producing camelina varieties.
Under the SECURE rule, once a specific plant developed through GE is found not to require regulation, new varieties of the plant containing the same genetic modification would also not require regulation.
Camelina plants containing omega-3 traits would still be subject to regulation by the US Food and Drug Administration.
