Managing regulatory hurdles to get growers much-needed crop protection tools

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Matt Orr is in the fast lane these days, racking up the air miles as he meets with European regulators to facilitate a series of emergency use authorizations (EUA) to get SPEAR® LEP bioinsecticide into the hands of growers. As head of regulatory affairs with Vestaron Crop Protection, Matt works with regulators to provide all the necessary information required for product approvals – a mission he takes to heart as farmers in the EU are desperately in need of a solution to protect valuable tomato crops from a devastating pest (tomato leafminer in this case). To date, EUAs have been issued for Italy, Cyprus, and Greece – with more in the works.

Growers around the world are facing converging challenges with pest resistance to traditional products, demands for more sustainable operations, and in the case of the EU, the potential loss of traditional chemical products altogether through proposed sustainability legislation. At the same time, protecting the global food supply is one of the most urgent priorities set out by the United Nations.

“We see a continued push from the consumer for more environmentally friendly technologies, and the market needs to adapt to that. However, food security is going to become a major issue. If Europe loses 50 percent of their existing pesticides, their productivity will go way down,” Matt explains, “and when that happens, it means more imports into Europe and increased clear-cut farming elsewhere in the world to supply that heightened demand.”

Founded in 2005 and headquartered in Durham, North Carolina, Vestaron R&D is producing a pipeline of powerful active ingredients based on peptides modified from the venom of spiders and other animals. SPEAR® LEP, the first insecticide with a new nerve and muscular mode of action since 2007 (IRAC Group 32), is rapidly gaining market share in U.S. specialty crops, including almonds and pistachios, and vegetables like brassicas. Highly targeted to all lepidopteran pests, it is soft on pollinators and beneficials, as well as MRL exempt.

As the first peptide-based insecticide, receiving approval has required more front-end education compared to traditional synthetic insecticides, Matt explains.   

“Education is probably the biggest challenge I face. Coming from the traditional synthetic world, the process was a little more straightforward. Peptides don’t fit neatly into any category. With every new regulator we meet … it is a lot of education, a lot of explaining what we do, where we fit in, why there’s a need for this product in the market, and why it would be beneficial to the consumers in that market to grant an approval.

It is a lot of education, a lot explaining what we do, where we fit in, why there’s a need for this product in the market …”

With SPEAR® LEP proven on 700,000-plus acres and in more than 800 field trials, Matt’s team collects and compiles the necessary data on efficacy and safety to share with regulators. “Each regulator is going to want to see that this is a product that can work in their local area. They want to see efficacy data that’s geographically and climatically similar to where we’re submitting for registration. Passionate about getting effective tools into the hands of growers, Matt says updating and streamlining the regulatory process for biocontrol products is the single biggest change that could expedite approvals for Vestaron solutions.   

“In the U.S. we are treated as a biopesticide. We are regulated through BPPD (Biopesticides and Pollution Prevention Division). Within BPPD we are specifically in the Emerging Technologies Branch that was established to focus on those cases that don’t fit neatly into any other box. The EPA’s collaborative style and science-based approach to regulatory assessment is well suited to evaluating unconventional new technologies. In other countries, there are distinct registration pathways for biological products, but we don’t qualify as a biological in most of those cases because they were defined based on a very old view of what constitutes biocontrol.”

Approvals in EU countries must be handled individually, which adds time and money to the process. “Ideally, we would like to see a more streamlined approach. It takes eight to ten years in the EU to bring a new active ingredient through the regulatory processes. Even if they were to start today, they couldn’t possibly replace all the conventional pesticides that they’re planning to eliminate by 2030 with more sustainable alternatives. On top of that, there is already a tremendous backlog of pending regulatory decisions.   What we are asking for in Europe is a defined and separate fit-for-purpose registration framework for lower risk biocontrol products.”

In addition to giving growers the tools they desperately need to protect food, developing a new biological product can be significantly quicker and less costly compared to traditional chemical products. With a robust pipeline of new AIs, Matt says Vestaron will continue to work on behalf of growers to make lasting change – a revolution in crop protection.

Ultimately, Matt believes the grower is the one who will help “move the needle fastest. They’re the producers of our food. They’re the ones that should have the strongest voice in all of this.”

With growing adoption in their key markets, and continued expansion into Europe, it doesn’t look like Matt and his team will be slowing down any time soon. But he says the opportunity to bring transformational solutions to market is a career highlight.

“We’re the plucky start-up, and everybody likes an underdog, right?”

MEDIA CONTACTS: 

Ben Cicora, SVP Sales & Marketing • 970.443.9220 • bcicora@vestaron.com
Steve Betz, VP Communications • (515).707.6096 • sbetz@vestaron.com

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