Gregory Maloney, Senior Scientist at Novozymes BioAg hosted a roundtable discussion at the Partnerships in Biocontrol, Biostimulants & Microbiome Congress: USA on navigating the regulatory landscape of biological product development. We spoke to him ahead of the congress about his work.

Introduction

I work in the Application Development group of Novozymes BioAg where our job is to determine the different applications of our microbial product concepts and where they can be applied in different areas of agriculture for the greatest benefit.

Novozymes discovers biological solutions to help improve issues the world is facing, with BioAg specifically targeting agriculture and crop sciences. We’re developing microbial solutions that can help improve crop growth, crop protection, and crop yield.

My role in the department is to run the studies that help determine the mode of action of our microbial product concepts. This includes running assays, developing new assays, performing in planta experiments on the microbes to help determine how they can be of benefit to the crop. Once we determine the microbe is beneficial to a crop, we need to find out the mechanism. My responsibility is to lead those mechanistic studies to gain the basic knowledge around the strain.

What are the current challenges in terms of the regulatory environment?

Countries differ in how they regulate microbial products, as some countries regulate microbial products the same as a conventional chemical or pesticide. Specifically, the intended use and/or claim for a product could be regulated differently across countries. A product claim as a plant-growth regulator in one country could be regulated as a fertilizer or bio-yield product, but in another it is regulated as a pesticide.

Over the last few years, a new category of products called “plant biostimulants” has been getting a lot of attention. The European Union recently passed a new Fertilizing Products regulation that defines a plant biostimulant and states that plant biostimulants are distinct from plant protection products (i.e., pesticides). In the US, the term “plant biostimulant” was only recently recognized by the federal government in the 2018 Farm Bill. However, the definition within the bill as very broad, so the Ag industry trade associations are working with EPA, USDA and other agencies to develop a definition that is similar to the definition adopted in the EU. Additionally, similar discussions regarding plant biostimulants are ongoing in other parts of the world, including Brazil and India.

How do you see things potentially changing in terms of regulation?

I think we’ll continue to see growing public acceptance of microbial products and biological products, especially as more products are launched, and users experience the benefits of these types of products. Currently, we’re seeing a positive response overall in the public acceptance of biological products and their amazing potential.

I’m hoping over the next few years that this trend continues throughout the world, especially in the big market areas. If the public wants biological products and considers them as safer alternatives to conventional chemistry, as well as extremely beneficial to growers and the environment, perhaps regulatory agencies will work to make the path much more streamlined to get microbial products to market faster.

Are there any particular steps you’d like to see taken next?

The short-term tangible thing I’d love to see is a clearer differentiation of product claims based on whether they are purely nutritional or pesticidal plant growth regulators. Differentiating those groups will hopefully allow for more accurate product claims, and allow researchers to expand the search for more beneficial biological products.