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A regulatory roadmap for the commercialization of microbial products for agriculture

Biocontrol, Biostimulants, Microbiome

A major paradigm shift in agricultural production is required to meet the demands of a global world population projected to reach 9.7 billion in 2050. We have to increase crop productivity sustainably while preserving biodiversity, natural resources, and grower income in the context of climate change. To optimize sustainable productivity and profitability on farms, grasslands, and forests, scientists and growers must embrace a holistic, systems-level approach and focus on the complexity within phytobiomes.

The term “phytobiome” refers to a plant growing within a specific environment (or biome) and all of the micro- and macro-organisms living in, on, or around it—such as microbes, animals, insects, and other plants; and the geophysical environment, which includes soil, air, water, weather, and climate.

Global agricultural production systems are facing many challenges, among them, a rapidly changing climate, increased exposure to biotic and abiotic stressors such as pests, poor soil quality, low water availability and excessive heat. Also, there are ever more demanding regulatory restrictions that limit the tools growers may use to produce food in a sustainable, environmentally friendly manner.

Phytobiomes research

To address these challenges, we need to move away from reductionist approaches that focus on one or two disciplines and push towards a transdisciplinary understanding of plants in their biological and geophysical contexts, i.e. their “Phytobiomes”.

Phytobiomes research is a holistic systems-level approach to enhance our understanding of plants growing in a specific biological and geophysical environment (e.g., a site and its microorganisms, soils, climate, weather, animals, and other plants) and supports efforts to design and deploy the most appropriate plants, nutrients, microbes/microbial communities, and management practices for a site-specific environment.

The Phytobiomes Alliance is a non-profit alliance of industry, academic, and governmental partners, and is leading international research efforts to build a foundation of knowledge for this approach.

Agricultural Microbials

One of the most exciting opportunities for increasing sustainability in agriculture is to utilize microbial products to enhance productivity and strengthen resistance to abiotic and biotic stressors.

These products are derived from microorganisms such as bacteria, fungi, or protozoa. They have many potential benefits for agriculture: they can help protect against diseases and pests, improve root nitrogen-fixation, improve plant nutrition and plant growth, increase stress tolerance, and improve or maintain yield.

Markets and Markets predicts the agricultural microbial market will be valued at over $6 billion (USD) by 2022 and Research and Markets expects an average compound annual growth rate of 18.6% for agricultural microbials between 2019 and 2024.

Phytobiomes research that enhances knowledge of the interactions between microbes and other phytobiome components will help to further accelerate this field. This fundamental research will facilitate the development of new microbial products based on naturally occurring or synthetic microbes, or microbial communities designed to meet production challenges in specific environments.

A regulatory framework for microbials

If the agricultural microbials are not commercialized and placed into the hands of the growers, the design of these products will be for nought. While some products do not require approvals from international, national, or state regulatory agencies, most require some type of approval before the product can be sold. Regulatory agencies need a strong scientific basis to underpin the regulatory framework for international and interstate movement of agricultural microbials. In some cases, the current regulatory requirements are onerous and in other cases, the industry needs additional guidance from regulatory agencies.

A major priority for the Phytobiomes Alliance is to provide regulatory agencies with the scientific basis that they need to expedite regulatory review and facilitate the rapid commercialization of agricultural microbials.

In particular, the Alliance is working to understand the regulatory science needs of industry, academia, and governments. While we have already identified some of the gaps and are leading research to fill them, we aim to develop a broad, regulatory science roadmap that identifies further gaps, priorities, and opportunities for research. This roadmap will then be used to guide the development, funding, and implementation of research that could support changes or improvements in state, national, and international regulations.

To learn more about the Phytobiomes Alliance and its regulatory science activities, come and listen to International Phytobiomes Alliance executive director Kellye Eversole at the 4th Partnerships in Biocontrol, Biostimulants & Microbiome Congress: USA, which will be held on 4-5 November 2019 in Raleigh-Durham, North Carolina. At the meeting, she will also be hosting a regulatory roundtable during which she will be soliciting ideas regarding the gaps and priorities for regulatory science.


Kellye Eversole is Executive Director of the International Phytobiomes Alliance.


Update your understanding of biopesticides and biostimulants regulation at the 4th Partnerships in Biocontrol, Biostimulants & Microbiome Congress: USA. There is still time to book a space, so register online today.

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