Beyond BioAg Regulatory Headlines

Knowledge Sharing and Dissemination in Regulatory Sciences — Can We Do Better?

You know those “lightbulb moments” when something suddenly becomes clear? I was attending a scientific meeting, quietly following the discussions and arguments, when it became obvious to me that we often forget to explain the basics, assuming that everyone already knows them. Dissonant views and arguments are less likely if everyone’s baseline knowledge of the topic is the same.

Every so often, I hear from industry peers about the lack of biocontrol expertise when risk assessors look at our dossiers. The limited understanding of some agencies about the technology, and how current data requirements and regulatory processes do not fit the products we are trying to bring to market creates a significant challenge.

How can we change this situation, and what can the industry do to address it? Let us set aside policy requests and the need for legislative changes—matters that are being addressed by trade associations such as IBMA and BPIA—and focus instead on the actions individual companies can take to ensure their technologies reach growers effectively.

How can applicants support risk assessors in delivering the assessments faster, while providing a better risk characterization of a biocontrol product? When you place such a question to a regulator, the answer is usually the same: better quality dossiers by the applicant. In the absence of agreed quality standards for dossiers, this is a difficult starting point to improve the current situation. What constitutes a “quality” dossier? Na ja (a German slang expression meaning “well, maybe” or “it is complicated”).

Going deep into that discussion of the quality standards, I could identify some points that might help us moving forward.

1. Explain the very basics.

Nobody knows the product better than the applicant. Today, largely due to the demands of regulatory approval systems and compliance requirements, we often overlook the importance of clearly explaining how our products work and the fundamental principles of biology and ecology that support them. This is crucial for two key reasons: (a) not all risk assessors share the same scientific background or have a practical understanding of how the product functions, and (b) certain scientific disciplines have advanced significantly over the past decades, rendering some of what we learned at university outdated, irrelevant, or even questionable.

Consider the evolution of genetics, our growing understanding of gene expression and regulation, and the emergence of epigenetics—a field that did not even exist 25 years ago. While it may seem unconventional to include fundamental scientific explanations in regulatory dossiers, doing so could streamline assessments, reduce inquiries and minimize requests for additional data.

The current dossiers are so extensive that adding more information that is not directly related to the product may seem counter-productive when the aim is faster registrations. But, we need to start somewhere and give it a try until some of the fundamentals of biological control are better understood across the entire regulatory community.

2. The right information in the right place and repeat it.

Experts tend to focus on their specific fields, with each section of a dossier written by a specialist in that area and later assessed by a corresponding expert at the regulatory agency. This often results in a “tunnel view,” where assessors seek answers within their domain—for example, within toxicology studies—when the relevant information may be found elsewhere in the dossier. In essence, we need to see the entire mountain before entering the tunnel.

If a dossier were written or reviewed by a single individual, and the same approach was applied on the agency side, I estimate that the number of questions and requests for additional data would decrease by more than 50 percent. This tunnel vision—focusing solely on data within one’s area of expertise—lies at the core of many misunderstandings during assessments.

It frequently leads to questions that cannot be addressed through available data, either because such data cannot be generated due to technical or methodological constraints, or because its generation would not provide meaningful answers. A more holistic approach—connecting insights across different technical domains, including biological efficacy data—could help bridge these gaps and improve the efficiency of regulatory evaluations.

3. More safety data?

From the synthetic chemicals assessments, everybody got used to answering questions with data, a legacy of our regulatory systems. Employing the so-called tick-the-box approach and aiming for yes or no answers to all questions, substantiated by a study, is still common practice.

We must acknowledge that this mindset is evolving globally, with increasing acceptance of well-founded waivers. However, progress has been slower than desired. In many cases, it is simply not possible to generate studies to confirm or refute a specific hypothesis through laboratory testing. This raises critical questions: Is there sufficient evidence—or a justified lack of it—to support risk assessors in determining an acceptable level of risk? What constitutes an acceptable risk, and to what extent can uncertainty be accepted?

Here, we enter a complex discussion, as different regions have varying perceptions of risk, distinct approaches to managing uncertainty and different thresholds for applying the precautionary principle. As a result, dossier preparation may need to be tailored to address these regional differences effectively.

4. Share the failures.

In general, the submitted dossiers will include the studies that are considered valid, i.e. the data that can be used to conclude on safety and efficacy of a product. How many studies have proven inconclusive, even when companies have attempted to conduct them—only to find that the required data could not be generated or that the study design did not allow for definitive conclusions?

These data are considered unusable for registration purposes, and regulators do not like to spend time looking at inconclusive data, but some of this data might be of great value to build a better understanding of the product and even provide evidence on your failed attempts to clarify certain questions.

5. More Pictures, please

One picture is worth a thousand words — two thousand in the regulatory world — because we use too many words and the 1:1,000 ratio needs an adjustment.

Can we reduce extensive text explanations by inserting more images? Consider the long-standing turbidity issue in aquatic testing for microorganisms, particularly hydrophobic ones, within the regulatory field. Explaining why placing a hydrophobic microorganism—isolated from soil—into a water tank with Daphnia is problematic often requires extensive written justification. Instead, a single photo of the test tank could visually demonstrate the issue, making it clear that any aquatic organism placed in such an environment would struggle due to insufficient oxygen and light.

This would illustrate that the observed effects are not caused by the test microorganism itself but rather by natural particulate matter also contributing to the conditions.

6. Do not forget the agronomist!

This is probably a very particular case for our industry: the leading agronomist is often not in the room when risk and safety discussions take place and decisions on product use are being made. Either they are not perceived as needed for the safety discussion, or they have no time to deal with such discussions.

Realistically, agronomists may not have the time or inclination to engage deeply with certain regulatory discussions, and some conversations might quickly deter their interest. It is noteworthy that we dedicate extensive hours to theoretical models and calculations—making assumptions about product use patterns to assess safety—only to consult agronomists at the final stage, if at all.

In contrast, across industries such as pharmaceuticals and automotive manufacturing, subject-matter experts typically lead projects from the outset, ensuring that technical expertise drives decision-making.

When we talk about knowledge exchange and dissemination, this is just the tip of the iceberg. The next layer is communication with the growers and the food value chain which requires a different approach to explain how the product works and its uses in integrated pest/disease management.

Remember that you are the person knowing best the technology you are trying to bring to the market. The best way to disseminate this knowledge and target such communication to a regulatory audience is still a challenge for most scientists.

When I brought up this topic of science communication with a fellow biocontrol (field) scientist, he told me: “You know why I decided to pursue science at school? Because I did not like to talk to other people, I was more into biological mechanisms, numbers and reading on my own.” Fair point.

Communicating science is part of a scientist’s job, but when we enter a non-specialized audience – including the regulators and growers not familiar with biocontrol – do we need to be better at it? Can we do better at talking about our own technology, or should we outsource this piece to people who like to talk to different audiences?

Disclaimer: the text expresses solely the personal thoughts and views of the author on the topic and do not necessarily reflect views, opinions, or positions of any organization to which the author is affiliated.