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USDA-APHIS Confirms Cibus’ Weed Control Traits in Flax and Rice Are Not Regulated Articles Under GMO RULES (7 CFR Part 340)
The first weed control traits in rice and flax bred by precision gene editing to be advanced in commercial development
San Diego – June 05, 2020 - Cibus, a pioneer in precision gene editing in agriculture, will advance herbicide tolerance traits in rice and flax crops to commercial development following United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) Biotechnology Regulatory Services (BRS) confirmation they are not regulated under genetically modified organism (GMO) rules.
This USDA-APHIS confirmation supports other global regulatory processes in which precision gene editing will not be regulated under their current GMO rules. In addition to rice and flax, Cibus has beneficial traits such as disease tolerance for canola, corn, wheat, soybean, peanut and potato in various stages of development and commercial release. Products derived using Cibus’ technologies have already been designated as non-GM or not regulated in countries including the United States, Canada, Argentina and Chile.
Currently, there is an ongoing review and revision of regulatory policy associated with these advanced breeding technologies in many regions, including the European Union (EU) and Asia. This includes a recent final ruling (May 2020) by USDA-APHIS which will be known as SECURE (SECURE). This follows the guidance from March 2018 clearly stating there was no intent to regulate new techniques that are increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods. This fits within the centerpiece of the EU’s current Farm to Fork Strategy to support revisions of advanced breeding regulations as a part of its initiative to build a more Sustainable Agriculture sector.
Cibus submitted “Am I Regulated” letters to the USDA for confirmation of regulatory status. Both crop traits were developed utilizing precision gene editing that makes targeted genetic changes without integrating recombinant DNA (foreign genetic material) at any stage in development. As a result, the USDA-APHIS BRS confirmed the plants do not meet the definition of a regulated article under 7 CFR Part 340, which enables Cibus to proceed and continue with field testing of both crops.
“We are particularly proud to have this confirmation from the USDA-APHIS BRS, as we believe we are the first company to receive clearance for the use of precision gene editing for weed control in either rice or flax,” said Peter Beetham, Ph.D., CEO and president of Cibus. “It further establishes our position as a pioneer and leader in the development of important input traits to make farming more efficient.”
Beetham added, “We are focused on producing a family of gene-edited traits in all the major crops — including disease resistance — to help farmers overcome the ever-increasing constraints on available agricultural land and making farming more sustainable. Toward those goals, these traits in rice and flax are crucial components of Cibus’ growing input trait portfolio.”
Cibus is a leading AgTech company that uses advanced breeding technologies to development novel traits for the global agricultural seed industry. Its family of technologies, known as the Rapid Trait Development System™, RTDS®, is broadly applicable to all organisms, including plants, yeast, bacteria, and algae. RTDS edits genes precisely without integrating foreign genetic material to speed development of products genetically indistinguishable from those found in nature. New traits are designed to help agriculture provide more sustainable food sources, reduce agriculture’s impact on the environment and reduce the impact of climate change. Cibus has established crop platforms in canola, rice, flax, potato, and is developing platforms in wheat, corn, soybean, and peanut. New traits provide access to multiple royalties through a well-established business model in the multi-billion-dollar global seed market. The company has subsidiaries in Europe and North America and a state-of-the-art research and development center in San Diego, California.