The Long Road to Bring a Biocontrol Product to Market
By Douglas J. Guth
Darin Ebeling, Director of Agronomic Solutions with Wilbur-Ellis Agribusiness, has no interest in bringing a biological crop protection product to market if it has not gone through a rigorous discovery, testing and registration phase.
Meticulous treatment requires patience along with a willingness to, as Ebeling puts it, kiss a lot of frogs before getting to a viable product. “Launching something unsustainable doesn’t do us or the grower any good. We want to do it right, so the product life cycle lasts longer in the marketplace and provides a solution to growers’ key issues. It’s a waste of time if the grower doesn’t get a good ROI,” he says.
Biological crop protection products are derived from living or naturally occurring materials. While biologicals may never completely replace chemically synthesized innovations, pressure from regulators and consumers alike is prompting a shift toward lower chemical intensity in production.
According to the company, Romeo stimulates an induced systemic resistance, activating the plant’s internal self-defense mechanisms against foliar fungal diseases.
Biological supporters believe this strategy provides a more comprehensive approach in maximizing crop yields, improving quality, and minimizing pest resistance. Infection control is the aim of Romeo, a Wilbur-Ellis biofungicide billed as a foundational component for any disease-management program. According to the company, Romeo stimulates an induced systemic resistance, activating the plant’s internal self-defense mechanisms against foliar fungal diseases.
The continuing push for sustainable agriculture — alongside a market that either restricts or outright prohibits many chemical fertilizers — had Wilbur-Ellis seeking natural alternatives for an end user footprint that extends across the country. A burgeoning demand for fungicides further spurred the Colorado-based business to innovate its offerings, notes Ebeling.
“The fungicide area is where we are growing the most,” Ebeling says. “We have many more options there, and we’re seeing acceptance around resistance management and making biologicals part of a larger program. Farmers are looking for softer chemistries as an alternative to typical synthetic chemistries.”
“If the concept is out there already, it shortens our time frame, because we may know whether this biological is better to apply in the crop stage or at another point. Having that history could save you a year or two before going into market.”
Romeo and its fellow biofungicide Sonata are the result of a years-long development, trialing, and regulation process where bureaucratic wrangling and gathering multiple data sets are the norm. Sonata underwent years of field trials in high-value fruit and vegetable crops even before moving on to a lengthy regulatory and registration phase, Ebeling says.
“Any product takes multiple years before coming to market,” he says. “If the concept is out there already, it shortens our time frame, because we may know whether this biological is better to apply in the crop stage or at another point. Having that history could save you a year or two before going into market.”
Trials and Tribulations
Stepan Agricultural Solutions researches and develops crop protection products in areas including plant nutrition and soil health. Sustainable farming is top of mind for a company that, among other endeavors, is partnering with two French universities on new biocontrol solutions for rapeseed Sclerotinia.
“One of our big use cases is resistance, or managing resistant pests in different segments,” says Stepan Vice President of Crop Productivity David Allen. “People are rotating in biologicals to meet MRLs (maximum residue limits). As the EU tightens MRL requirements on different ingredients, we have to figure out those strategies to make crops available for export.”
“You have to be part formulator, part microbiologist, and part application tech specialist,” Allen says. “You need that intersection of three disciplines to put a useful product into the market.”
Creating a biological from scratch is a time-consuming process, Allen says. For starters, Stepan chemists must determine how active substances in a biological behave differently from those found in a typical synthetic product.
A Stepan innovation starts with a “lead candidate” — usually bacteria, fungi, or spores that can then be applied into a spray program already utilized by growers. Next is the formulation stage, which determines the crops you’re working with, the pests you want to control, and whether the application will be used as a drench or foliar spray.
Testing in the in vitro stage — meaning outside of a living organism — is followed by greenhouse trialing and field tests that generally last multiple years. Although trialing may occur in North and South America during the same growing season, Stepan mostly sticks to North America over the course of this phase.
After three to four years of trialing, the company has enough field data to climb the next rung of the ladder. A solid information set, combined with a strong safety profile and strenuously researched business case, is usually enough to begin the EPA registration process.
“There is skepticism on the grower level with some biocontrol products, because they are not as robust as those on the synthetic market,” Allen says. “But as the regulatory environment becomes more strict, growers have fewer options and have to use the new products.”
Yet even this stage has its potential obstacles, Allen says. New protections for endangered species, for instance, has the agency taking a magnifying glass to agricultural products that may threaten animals, insects, or various natural habitats.
Delays and a case backlog can add an extra year or two to the standard 18-24 months it takes for product registration. While state compliance is easier, California and other states are approaching EPA levels of scrutiny around the registration process.
Rolling with the Changes
Product registration in Europe is complicated in its own way, says Milena Stephan, group leader of global regulatory affairs at Knoell. The German regulatory service provider navigates clients through a two-step process that includes submission of a product dossier that must be approved by multiple countries. Applicants may have to submit dossier updates, not only to participating countries, but to the European Food Safety Authority as well. Years may pass by the time these parties issue a final registration judgement.
“This part of the process should take about three years, but usually takes four to eight years depending on the active substance [in the product],” Stephan says. “The process is the same for biologicals and conventionals.”
Wilbur-Ellis' Ebeling says an extended product creation-to-registration timeline is normal even with successful biologicals like the Romeo fungicide.
This kind of self-policing is another means of streamlining a tangled nest of procedures, particularly as more food companies keep a keen eye on sustainability.
“The product was being used in other countries already, so the proof of concept was there,” Ebeling says. “But it took us a couple of years to dial in the crops we were growing and the pests we were targeting. It took time for people to understand what the product’s real benefits were.”
Consistency in performance is one of the more challenging aspects of biocontrol creation, Ebeling adds. Eliminating variables like disease pressure simply cannot be rushed, with new biologicals sometimes requiring additional fine-tuning before submission for EPA compliance.
“It’s another tool in the toolbox to show we’re trying to do the right thing and provide softer chemistry for these crops while giving the grower a targeted solution based on a biological compound that fits into their program,” Ebeling says.
Douglas J. Guth is a freelance writer based in the Cleveland, OH, area.
