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Navigating the regulatory landscape for agricultural products

Terry Stone has worked in agricultural products for almost 30 years and has experience in both research and regulatory affairs. He is currently President, TB Stone Solutions. He was previously Vice President of Regulatory Affairs and Sustainability Programs for Agrinos, where he worked with industry associations in the US and the EU to develop a regulatory framework for plant biostimulants. We spoke to him about his work.

What challenges do you see regarding regulation in agriculture?

Differences in regulatory requirements can be a real challenge for manufacturers. In some countries, there is almost nothing required to bring a product to market other than developing the product label. In other countries, there are numerous requirements that may include environmental and human toxicology, compositional analysis and other information.

When there are very few regulatory requirements, products with a wide range in quality can be sold in the market. And, when quality is inconsistent, it can bring down the reputation of the whole industry.

In the United States, for example, each state has their own fertilizer laws and manufacturers need to get a separate approval in all 50 states. That is a cumbersome process, especially given that regulations differ from state to state. Transporting products across state lines can also have consequences when the label on a product is not consistent with regulations in the state into which it is being sold.

In Europe there are similar issues. Currently, every member state has different fertilizer requirements and manufacturers have to meet the specific requirements of each country before going to market. It is hoped, however, the a new fertilizer regulation that was recently passed by Parliament will reduce these regulatory challenges in Europe.

Whenever there is a lack of harmonization, a lack of clarity on regulatory requirements, it makes it challenging for companies wanting to deliver safe, high-quality, consistently performing products.

In the United States particularly, one of the issues is the definition of biostimulant. How do you see that changing and developing in the future?

In 2018, industry and other stakeholders succeeded in inserting language about plant biostimulants into the US Farm Bill – it was the first time in the US that an official description has ever been included.

Please note I used the word “description” rather than “definition,” because it is now up to the USDA, EPA, the states, industry, and other stakeholders to work together to refine and formalize the definition of biostimulants as well as other information that would be used to either establish a legislative, regulatory, or non-regulatory approach to bringing products to the market.

USDA, with the input of industry and other stakeholders, will provide a document by the end of 2019 to Congress and to the president. Contained within that report will be a recommended definition, the kinds of criteria, and the standard information needed to demonstrate safety and efficacy, etc., and suggestions on how to harmonize regulation and labelling across the country.

Will that make it a lot easier in terms of regulating product labels?

Very much so. Things today are just quite undefined. Companies cannot call their product a “biostimulant” or make claims specific to their products on the label. For example, if you have an amino acid product, you can’t claim the metabolic benefits that amino acids are known to provide to plants because the product could be perceived as being a plant growth regulator, which has to be registered as a pesticide.

Being able to make specific claims for products and to call them biostimulants, and knowing there’s a standard definition underlying it, would be a tremendous advantage for many companies. Clear standards and criteria will further enable consumers and growers to have confidence that the product they’re purchasing is credible and will perform as advertised. Then, whether it’s through a non-regulatory or a formal regulatory approach, if that definition can be accepted by the states and a more uniform label adopted, it would be of tremendous help.

What do you see as the key features of greener products conducive to promoting and developing sustainable agriculture?

The beautiful thing about biostimulants and biofertilizers is that they do not contribute any inorganic nitrogen, phosphorus or potassium to the soil, and they’re not pesticides. They don’t kill insects, weeds, or diseases. What they do is support plant vigor and enable that plant to achieve more of its true yield or growth potential.

In particular, since biostimulants do not add more nitrogen to the soil – which, if it is not taken up by the plant, will be released into the atmosphere as nitrous oxide or released into waterways, lakes, rivers, or streams – the products are enabling much greater utilization.

They also decrease climate impacts. Growers are able to affect greater utilization of the inputs used to grow their crops without additional pesticide or fertilizer and to increase productivity per unit of input applied. Those benefits are very significant when you come to the overall sustainability of agriculture. There’s a great deal of soil degradation around the world and these products can help enhance the soil due to the microbials or organic matter within them.

What would you like to see happen next from a scientific perspective to make these products even more beneficial to sustainability?

I think we must have a better understanding of their mode of action, and a better understanding of the biological processes of the soil component, such as how bacteria and plants interact and how they behave. It’s like the science demonstrating how important the human microbiome is to human health.

We will see a greater understanding of modes of action in agriculture and in plant growth and health over the coming years. This will lead to products that are tailored to different soil types and crops to enhance the productivity and efficiency of the resources being used. Understanding what biostimulants do is going to provide real value to manufacturers and growers.

There will also be more innovation, and again it comes down to understanding biology. We’re moving away from synthetic-type chemical products toward a broader understanding of the biological interaction and dependence between plants and the microorganisms is the soil. We are learning how they work together to enhance productivity and long-term agricultural sustainability, and that is the future of agriculture.

Any last thoughts?

Regulation and sustainability in many respects go together. Governments all over the world are looking for products that are safe and contribute to improving the environment and sustaining agriculture. Biologicals and biostimulants really fit that bill. The sustainability aspects are what consumers are looking for and will continue to gain importance. From a regulatory perspective, having clear regulations and understanding how to bring products to the market will provide sustainable avenues for growers to produce their crops. It is all part of the same plan.


Terry Stone, Vice President, Regulatory Affairs & Sustainability Programs, Agrinos will be speaking at the 4th Partnerships in Biocontrol, Biostimulants & Microbiome Congress: USA.


Download the agenda for all the details about the event including speakers, topics, round table and panel discussions.

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