Micropep Technologies has formally submitted regulatory dossiers for its lead peptide-based biofungicide, Promisin, in both the U.S. and the European Union. While initial filings in Latin America targeted broadacre soybean diseases, the U.S. and EU applications center heavily on high-value specialty crops, specifically grapevine and potato.
Developed through the company’s proprietary Krisalix discovery platform, Promisin provides a novel mode of action aimed at helping produce growers tackle evolving disease resistance, strict retail residue requirements and shifting regulatory standards.
Navigating EPA Timelines and Tolerances
Addressing the expected timeline for U.S. market availability, Kevin Leiner, chief regulatory officer for Micropep, notes the complexities of the regulatory process.
“The timelines are very difficult to predict at EPA,” Leiner says. “The PRIA timeline — the Pesticide Registration Improvement Act — sets timelines within which review should be completed. And for a product like ours, with a tolerance exemption, that’s 20 months, and then there’s the front-end screen. So, like, the minimum it could ever take is 21 months, but realistically, it’s going to take over two years.”
He says he hopes approval will arrive within 30 months, emphasizing that Micropep “submitted a very thorough, complete, high-quality dossier that proactively addressed all of the agency’s questions through the pre-submission consultation process.”
Built for Produce Operations and Economics
Unlike many biological alternatives that demand specialized handling, Promisin is designed to seamlessly integrate into existing commercial spray schedules and tank mixes.
“We didn’t want to have something that required special application or special storage,” Leiner says. “We know that our product mixes very well. It’s compatible with many other chemical AIs ... It can be applied using the same equipment. No specialized storage or handling.”
Leiner emphasizes that the product is positioned “not as a replacement but as a complement to the existing tools that are out there because we bring a novel mode of action that can complement the modes of action that are more site-specific of some of the small molecule conventional pesticides.”
From a sustainability and environmental footprint perspective, Promisin leaves no persistent residue behind.
“It degrades within days in the environment and in soils, like chemicals which you would measure in months or years,” Leiner says.
To ensure affordability for specialty crop growers, Micropep says it is leveraging high-volume row crop acreage alongside high-value produce.
“We went after grape and potato because grape gives us that high-value specialty market, especially for wine grapes. Potato is an important staple crop, and then soy, a broadacre crop, gives us the acres and hectares that we need to increase the volumes of production, so that we can really have a product ... drive the cost of goods sold down to a level that allows us to position a product in a marketplace that the growers can realize a return on their investment from using,” Leiner says.
Future Specialty Expansion
While initial specialty targets focus on grapes and potatoes, Micropep is already eyeing future label expansions across the fruit and vegetable sectors.
“Going into the specialty crop market more heavily makes a lot of sense for a product like ours,” Leiner says, noting that pathogens like Botrytis and mildews affect a wide variety of fresh produce, including berries. Additionally, Leiner says, “As we explore future label expansions, our early research includes targeted work on cucurbit vegetables.”
