Beyond BioAg Regulatory Headlines

Share This Article

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disciplines have advanced significantly over the past decades, rendering some of what we learned at university outdated, irrelevant, or even questionable.

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 when the relevant information may be found elsewhere in the dossier. A more holistic approach could help bridge these gaps and improve the efficiency of regulatory evaluations.

3. More safety data?
From synthetic chemicals assessments, everyone got used to answering questions with data. However, this mindset is evolving globally, with increasing acceptance of well-founded waivers. In many cases, it is not possible to generate studies to confirm or refute a specific hypothesis. Dossier preparation may need to be tailored to address regional differences in perceptions of risk and regulatory approaches.

4. Share the failures.
Generally, submitted dossiers include only the data considered valid. But inconclusive studies may hold great value in building understanding and demonstrating efforts to clarify regulatory concerns, even if the data cannot be used formally for registration purposes.

5. More pictures, please!
One picture is worth a thousand words. For example, a photo can often clarify complex explanations, such as those related to aquatic testing of hydrophobic microorganisms, better than paragraphs of text.

6. Do not forget the agronomist!
Often, agronomists are not included in safety discussions despite their critical practical knowledge. Industries like pharmaceuticals and automotive include subject-matter experts from the beginning, and our sector should follow this example to improve outcomes.

When we talk about knowledge exchange and dissemination, this is just the tip of the iceberg. The next layer is communication with growers and the food value chain. It is essential to communicate in a way that makes science accessible to a non-specialized audience. Scientists know their technology best, but communicating it clearly remains a challenge. Should this be outsourced to better communicators? Perhaps.

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

Leave a Reply

Your email address will not be published. Required fields are marked *