GreenLight Biosciences secures US EPA registration for new bioinsecticide, Calantha, historic step towards a safer and more sustainable food system

GreenLight Biosciences (GreenLight Bio) has been granted registration by the U.S. Environmental Protection Agency (EPA) and several states for its groundbreaking Calantha™ product, designed to target and control the highly destructive Colorado potato beetle. An industry first, the registration of Calantha, an innovative bioinsecticide based on RNA, represents an historic stride forward in diversifying options for farmers and reducing reliance on conventional chemical pesticides, which can harm both the environment and human health. Following the federal and state approvals, the company has now successfully sold and shipped its first order.

"The registration of Calantha marks not just a milestone for our company, but a quantum leap for farmers, our food system and security, and people," said Andrey Zarur, Chief Executive Officer, GreenLight Bio. "This is a new day for farmers seeking to balance pest management with biodiversity protection and environmental health. Calantha embodies the promise of such a future, along with the dozens of other innovations in our product pipeline. We are thrilled to witness the impending impact of this commercial chapter of our company in creating a more sustainable future."

Calantha offers growers an additional cost-effective option to address the impacts of the mounting chemical pesticide resistance problem. Chemical pesticide resistance is estimated to cost the U.S. agricultural sector at least $10 billion each year.1 The Colorado potato beetle, which decimates plants in the nightshade family, including potatoes, develops resistance quickly to traditional pesticides. The pest accounts for more than half a billion dollars in crop loss worldwide each year. In addition, as regulatory bodies around the world move to limit the use of certain chemical pesticides, Calantha offers farmers a safe, effective and easy-to-use alternative.

"Potato growers have expressed their struggle in managing the Colorado potato beetle due to increasing resistance to currently available chemical products. They want effective products that align with their sustainability targets. Calantha is the perfect fit," said Mark Singleton, Chief Commercial Officer and General Manager of Plant Health. "I commend our team's tenacity in bringing this product to market and eagerly anticipate the future milestones we will achieve."

Calantha breaks down quickly, degrading within three days and leaving no harmful residue on plants or in the environment, soil or waterways. Consumption of the dsRNA (double-stranded ribonucleic acid) by the Colorado potato beetle – and only the beetle – causes it to stop eating and die from its own toxins. Even when tested at 100 times the rate that it will be used in agricultural fields, it has no effect on tested species other than the Colorado potato beetle. Mixed with water and applied using existing standard agricultural equipment and practices, Calantha is applied at less than one-tenth the rate at which many chemical pesticides are commonly used.

The EPA released a decision document detailing its more than four-year review of Calantha's safety and efficacy data and information submitted by GreenLight Bio, including its response to submissions received during an extensive public comment period. Calantha is the first registration of a foliar-applied product with an RNA ingredient under Section Three of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This novel RNA-based approach enables Calantha to target the Colorado potato beetle specifically. In a separate announcement earlier this year, the Insecticide Resistance Action Committee, a global public-private technical advisory group focused on resistance management, acknowledged this novelty by creating a new category, Group 35, for ledprona, the active ingredient in Calantha, in its Mode of Action classification.

Calantha is the first GreenLight Bio product to complete U.S. regulatory review and receive regulatory approval. It is also under review by regulators in other key markets around the world. The company's next solution targets control of Varroa mites, a devastating pest of honeybees, and was submitted to the EPA for regulatory review in early 2023. GreenLight Bio's breakthrough platform, capable of economically producing dsRNA, fuels its robust pipeline of additional innovative insecticides, fungicides and herbicides.

Calantha is now available to growers in the U.S. for use on potatoes in crop year 2024.