Understanding The Conundrum Of Biocontrols

In agriculture, biocontrols refer to using natural organisms or substances to manage pests and illnesses in crops, lowering reliance on chemical pesticides. Insects, nematodes, fungi, bacteria, predators, parasites, and pathogens of pests and illnesses are among the natural organisms. Biocontrols has developed as a critical component of integrated pest management (IPM) methods as agricultural practices worldwide attempt to become more sustainable and ecologically friendly.

However, implementing biocontrol is not without its challenges. In particular, farmers in Europe and the United States, regions with highly developed agricultural sectors, face numerous constraints. These constraints include regulatory barriers, economic pressures, and the need for continuous innovation to keep up with evolving pests and diseases. This article aims to comprehensively examine these constraints and opportunities for innovation in biocontrols in both regions.

Special thanks to Patrice Sellès, Chief Executive Officer of Biotalys, for his time and insights.

The Advantage of Biocontrols

Biocontrols in agriculture offer several significant advantages. Primarily, they provide a more environmentally friendly and sustainable alternative to traditional chemical pesticides, reducing soil, water, and air pollution. In addition, by working with nature rather than against it, biocontrols can contribute to maintaining biodiversity, enhancing the resilience of agricultural ecosystems.

“We’ve trialled our newly developed solution on over 600 farms across the globe and shown consistency all along,” said Patrice Sellès, CEO of Biotalys. “Our platform enables us to choose the right protein against the targeted pest, which ultimately shortens the lead time to find the solution and avoids additional losses for the farmer.”

Additionally, biocontrols can help mitigate the problem of pesticide resistance in pests, as they often involve different modes of action for which no resistance is yet established. They also present lower health risks to farmers and consumers due to their lower toxicity than chemical pesticides.

Furthermore, biocontrols can provide more long-term and sustainable pest control, as they often involve establishing predatory or parasitic organisms that can reproduce and continue to control pests over time. Lastly, biocontrols can meet the growing consumer demand for organic and sustainably produced food, potentially opening up new market opportunities for farmers.

Regulatory Constraints

Europe

In the European Union (EU), the use of biocontrols is governed by the Plant Protection Products Regulation (EC) No. 1107/2009 and the Regulation on Invasive Alien Species (EU) No. 1143/2014. These regulations stipulate strict risk assessment and authorization procedures, which, while crucial for ensuring safety and efficacy, can be expensive and time-consuming, discouraging many potential biocontrol manufacturers and users.

Furthermore, the EU's precautionary principle—the idea that if an action or policy might cause harm to the public or the environment in the absence of scientific consensus, the burden of proof falls on those advocating for the action or policy—often means that biocontrols face more scrutiny and regulatory hurdles than chemical pesticides.

“Our company applied for European product certification during the first quarter of 2021. However, we have been informed that the results will not be available until early 2025. This timeline seems concerning given the current challenges facing the agriculture sector in Europe, such as the impact of climate change, inflation rates, and the ongoing war in Ukraine,” commented Patrice Sellès, CEO of Biotalys.

United States

The Environmental Protection Agency (EPA) regulates biocontrol agents in the United States under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Like the EU, biocontrols must pass rigorous testing to ensure their safety and efficacy. However, compared to the EU, the U.S. approach tends to be more risk-based, balancing the potential risks against the benefits of biocontrols.

“Though the process takes some time in the United States, it is more logical as it separates chemicals and biologicals. The first product based on a new source always takes more time to certify, but hopefully, the process will get easier for the next products developed on the same source,” commented Patrice.

Despite this, regulatory challenges still exist. The complexity of the regulatory process and inconsistencies in how different biocontrols are classified and regulated can cause uncertainty and discourage investment in the development and application of biocontrols.

Economic pressures on farmers

Farmers in Europe and the United States are under intense economic pressure to maximize crop yields and minimize costs. Unfortunately, this often creates a reliance on traditional chemical pesticides.

In addition, while the long-term environmental and health benefits are well recognized, these benefits often do not translate into immediate economic incentives for farmers. Many farmers operate on thin profit margins and may not have the financial capacity to invest in biocontrols, especially given the uncertainty about their effectiveness compared to chemical pesticides.

“It is encouraging that Europe is moving towards a less chemical approach. However, it is important to consider what alternatives are being used in place of those chemicals. While I support the efforts to make the agriculture industry more sustainable, we must ensure that we are not burdening farmers who are already under pressure. It is crucial to equip them with the necessary tools to make this transition successfully,” adds Patrice Sellès.

Adding to the financial challenges farmers face, the recent surge in inflation rates in the past two years has significantly heightened the economic pressure on agriculture in Europe and the United States. Rising costs for essential inputs such as fuel, fertilizers, and equipment have led to higher operating costs, squeezing farmers' already thin profit margins. Moreover, global supply chain disruptions due to the COVID-19 pandemic have increased costs and delayed obtaining these inputs, further exacerbating the situation.

On the output side, while higher inflation can potentially increase the prices of agricultural products, the benefits often do not fully trickle down to farmers due to the power dynamics in the food supply chain, where processors, distributors, and retailers tend to command a larger share of the price consumers pay. Furthermore, in the international market, farmers face the challenge of price volatility and the risk of being undercut by competitors from regions with lower production costs. All these factors combine to create an economic environment where the transition to biocontrols, despite their long-term benefits, can be a daunting financial challenge for many farmers.

The dire need for solutions

Despite these constraints, there is a dire need for innovation in biocontrol. Pests and diseases continually evolve, resisting existing chemical pesticides and biocontrols. This evolutionary arms race requires constant innovation to develop new and effective biocontrols.

“Farmers face new challenges as pests continue to evolve and threaten crops. Unfortunately, traditional approaches to developing chemical solutions against these pests can take up to a decade and require significant capital investment, often upward of $300M. While developing novel biocontrols incurs significantly less cost, take the $30M-$40M estimated development cost for a new Biotalys biocontrol solution as an example. In addition, regulatory constraints and compound timeline hurdles represent a significant obstacles to attracting investors. The long registration timelines runways ultimately hinder innovation and result in falling behind,” commented Patrice Sellès, CEO of Biotalys.

In addition, climate change is altering agricultural ecosystems and the distribution of pests and diseases, necessitating innovative biocontrols that can adapt to these changing conditions.

“I fear that we may wait until we hit the wall before we take action as a society, but then it may be too late,” adds Patrice Sellès.

What Can Be Done to Improve the Innovation Pipeline?

Interdisciplinary collaboration and research can enhance the innovation pipeline for biocontrols. The complex nature of biocontrols, which involves the interaction of biological organisms with pests, crops, and the environment, requires expertise from various fields, including biology, agronomy, ecology, and data science. New ideas and approaches can be generated by fostering collaboration between these disciplines, accelerating innovation. Universities, research institutes, and industry players can create joint research programs or innovation hubs to facilitate such collaboration. In addition, policies can be implemented to encourage private-public partnerships in biocontrol research, leveraging the resources and capabilities of both sectors.

Regulatory reforms can also stimulate innovation in biocontrol. As discussed earlier, the current regulatory processes for biocontrols in Europe and the United States can be complex, costly, and time-consuming. Simplifying these processes while still ensuring the safety and efficacy of biocontrols can reduce the barriers to entry for potential innovators. The new Farm to Fork laws in Europe aims to streamline the approval and authorization of biological plant protection products, including microorganisms. The goal is to give farmers tools to replace chemical plant protection products.

“It's crucial to go through these certifications to prevent any scandals. However, taking up to five years to review a dossier that took only one year to create seems excessive to me,” said Patrice Sellès. “In Europe, there needs to be a differentiation between chemical controls and biocontrols.”

However, the microorganisms are limited by the European Union to the following: bacteria, fungi, viruses, and protozoa, and they still require testing to ensure that they are safe for use and do not represent a risk to the population. 

Conclusion

Biocontrols in agriculture offer a promising solution to the urgent need for more sustainable and environmentally friendly farming practices. However, to fully realize their potential, significant challenges need to be addressed, including regulatory constraints, economic pressures on farmers, and the need for continuous innovation. By seizing the opportunities for innovation and implementing necessary policy and regulatory reforms, Europe and the United States can foster the growth and development of biocontrols in agriculture.