Biotalys announced that the U.S. Environmental Protection Agency (EPA) has proposed to approve its first biofungicide, EVOCA. The agency will now conduct a final review, with stakeholders like growers and industry groups given 15 days to provide feedback.
The EPA also published a final rule exempting EVOCA’s active ingredient residues from tolerance limits. This means no maximum residue limits will apply, emphasizing the product’s safety profile.
EVOCA is a precision biocontrol product targeting fungal pathogens such as botrytis (grey mold) and powdery mildew in high-value fruits and vegetables. It manages these fungi without harming beneficial organisms or the environment. The product offers a new mode of action to combat resistance to existing fungicides, a benefit recognized by the Fungicide Resistance Action Committee (FRAC).
Kevin Helash, CEO of Biotalys, stated, “The EPA’s recommendation to approve EVOCA is a pivotal moment for our company. It marks the development of the first protein-based biofungicide of its kind approved in the US.” He added, “This breakthrough highlights our leadership in agricultural innovation and provides a competitive edge as a first mover in sustainable crop protection.”
Helash emphasized that the company’s protein platform could revolutionize crop protection with targeted, scalable biological solutions. He also noted that EVOCA’s approval sets the stage for Biotalys’ pipeline of fungicides and insecticides.
The approval process for EVOCA will pave the way for regulatory submission of EVOCA NG, an improved next-generation product. Since EVOCA NG contains the same active ingredient with enhanced formulation, its review is expected to be shorter.
This milestone signals a significant step toward bringing sustainable, biological crop protection solutions to US farmers.
