Biostimulants are one of the bright spots in agriculture today holding the key to improved efficiency, increased yield and greater sustainability, according to the U.S. Biostimulant Coalition. “Over the next few years, the biocontrol and biostimulants market is expected to grow over 10% per year, and by 2025, it’s projected to hit a whopping $4.1 billion in sales,” says David Beaudreau, co-chair of the U.S. Biostimulant Coalition.
Yet, the rules and regs have failed to catch up with the skyrocketing popularity of these products. “The technology remains open to interpretation by state and federal regulators,” adds Beaudreau. “And this creates misunderstanding, placing these products under regulatory schemes that do not adequately account for their inherent safety or perceived risk.”
The regulatory atmosphere surrounding biostimulants remains an enormous challenge in most countries. Similar to biopesticide or biocontrol substances, regulations for biostimulants is mired in fog. Recently, some countries are beginning to shed a little light on these regulations — even though still it’s a flickering flame.
There is no question the global regulatory environment regarding biostimulants is changing rapidly and trending towards biopesticide-type registration requirements, according to Arysta. “The major challenges include lack of a clear global definition of what a biostimulant is and, consequently, significantly divergent regulation and registration requirements by country,” says Neil Stapensea, Arysta LifeScience marketing director of Plant Stress & Stimulation.
“Most countries put biostimulants into a subcategory under fertilizers, and some put it into the hormones category under agrichemicals management,” explains Haiguang (Bill) Duan, Leili Group Vice President of International Business.
On algal biostimulants, China has established clear regulation and criteria on alginic acid under the category of soluble fertilizers. The REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation in Europe, which aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances, has paved the way for such development, but it covers chemicals and excludes microorganisms, which are important categories of biostimulants.
In the U.S., there is still no agreed-upon legal definition for biostimulants. In addition, fertilizers and related products are registered and regulated at the state vs. federal level, adding to the challenge.
“Under the current U.S. regulatory framework, biostimulants are sold as low-analysis fertilizers, soil amendments, or ‘other beneficial substances,’” says Michael Totora, President & CEO of Agricen. “The use of the word ‘biostimulant’ is not allowed on the label. This is in contrast to biopesticides, which are defined and regulated at the federal level.”
Federal regulators at the U.S. EPA have acknowledged the existing gray areas with respect to this category of products. The EPA has been working with the biostimulant industry and related stakeholders to develop guidance that will help clarify some of these murky regulatory issues.
So, it stands to reason that when it comes to Intellectual Property Rights (IPR), biostimulants pose another particular set of difficulties.
“Patentability and prevention of copies or reverse engineering of the biostimulant products are often difficult,” says Patrick du Jardin, Plant Biology Unit Professor, Gembloux Agro-Bio Tech, University of Liège, Belgium. He also serves on international committees of ethics currently for the National Institute for Agricultural Research (INRA) and the Center for International Cooperation in Agricultural Research for Development (Cirad) in France.
Du Jardin explains that the originality of the product and its status of invention, as demanded by patentability, is sometimes difficult to establish, and companies tend to patent the industrial processes used for the production of biostimulants.
“Data protection mechanisms coupled to the mandatory registration of biostimulants would strengthen protection of intellectual property,” du Jardin adds. “Data sharing mechanisms linked to the registration of biostimulant substances or microorganisms would support the development of the biostimulants market by promoting industrial exchanges and partnerships.”
How crucial is IPR to the biostimulant industry? Many specialists in the industry believe it’s a complex question, including Stapensea. “Ultimately, there has to be a balance between incentives to invest in research to develop advanced crop production techniques and technologies with market access to those IPR technologies and ideas,” he says. “It has its own lifecycle, and it’s getting shorter, putting more short-term pressure on margins. Simply put, we can’t have sustainable innovation without IPR and the associated profit incentives.”
But most specialists also say the advantages for securing IPR far outweigh any disadvantages, helping the industry grow in a more healthy and sustainable manner. “Biostimulants provide different effects on crops through different mechanisms,” says Duan. “When companies like ours (Leili) research more specific mechanisms and functions, IPR is necessary to protect our investments. IPR can help growers know exactly what the real functions are from biostimulants.”
Stapensea sees IPR as one key tactic, but also believes registration, mode-of-action definition, go-to-market strategy, integration with conventional crop protection and market footprint also play roles in terms of competitive vigor. “The biostimulant category tends to consist of generally old, undifferentiated technologies, but as this segment continues to grow and gain market acceptance, development of new technologies will play an important role.”
Duan says creating mixtures is one of the most important roles in IPR, and Stapensea expects pre-formulated mixtures will become increasingly important to both differentiate and possibly reposition old active substances as well as adding application convenience for the end user.
“Different mixing on percentage, substances and materials can give different specified effects on crops.” Duan says. “But this mixing should be truly with technology and produce innovative value. Simple mixing can not survive in the market in the long run.”
For most biostimulant manufacturers, IPR is a key measure for remaining competitive. “Along with our sister company Agricen Sciences, R&D is a priority for us as we develop new technologies,” says Totora. “We want to be sure we can properly protect any intellectual property that is developed from our R&D.”
Agricen’s primary concerns relate to the ability to protect what it develops. “We want to make sure we are able to pursue proper protection, either by patent or trade secret, in both the U.S. and other countries in which we operate,” he says. “The key advantage of IP is that we believe we are developing differentiated technologies for the growers, and a proper IP protection strategy allows us to get those technologies into the market.”