The agricultural biologicals industry is entering a decisive regulatory phase in 2026 as developers expand microbial crop-protection portfolios and regulators refine how these technologies should be evaluated once they enter the environment. The issue is particularly important in the United States, where the Environmental Protection Agency has specific data requirements for microbial pesticides. Unlike conventional chemical active ingredients, bacteria, fungi, viruses and other microorganisms can remain viable and interact with living systems, meaning that efficacy alone cannot determine whether a biological product is ready for widespread agricultural use.

That distinction is central to environmental risk assessment. Microbial pesticides can offer highly specific modes of action and potentially different environmental profiles from conventional crop-protection products, but being biological does not automatically make a technology risk-free. Regulators need to understand toxicity, infectivity, pathogenicity, persistence and potential effects on non-target organisms. For biological developers, environmental assessment is therefore moving from a late-stage regulatory requirement toward an increasingly important part of product development itself.

Biologicals

Biologicals Gain Ground in Latin America, but Where Do They Really Fit in the Grower's Toolbox?

The scientific challenge begins with a fundamental difference. Traditional environmental studies of chemical active ingredients focus heavily on concentration, toxicity, degradation, mobility and exposure. With microorganisms, investigators must answer additional questions: Is the organism still alive during exposure? Can it infect a non-target species? Can it multiply? Does it persist? Could it produce an adverse biological response even when acute mortality is absent? Those questions require methodologies capable of distinguishing the behavior of a living active ingredient from that of a conventional molecule.

How environmental assessment changes with living active ingredients

Source: AgroLatam analysis based on U.S. regulatory approaches and the environmental-testing methodologies reviewed for this report.

From Fish and Daphnia to Bees: Biologicals Require a Different Testing Strategy

The testing protocols illustrate how extensive that assessment can become. The technical material reviewed by AgroLatam describes U.S. microbial pesticide studies involving 30-day freshwater fish exposures, 21-day testing with Daphnia and exposure periods of up to 30 days in honey bees, in addition to studies involving birds and beneficial arthropods such as lacewings, lady beetles and predatory insects. The objective extends beyond identifying immediate mortality: researchers need to determine whether the microorganism can infect, establish itself or adversely affect species that were never intended to be exposed to the product.

That is particularly relevant for U.S. agriculture, where biological crop protection is expanding across row crops and specialty production while environmental scrutiny remains high. Pollinators, aquatic organisms and beneficial insects are critical components of agricultural ecosystems, and a biological active ingredient must demonstrate an acceptable environmental profile within its intended use pattern. The EPA's microbial pesticide framework includes specific testing approaches for non-target organisms, making ecotoxicology an increasingly important bridge between promising laboratory discoveries and products capable of achieving commercial registration.

Testing may intentionally expose organisms to levels far above those expected under normal agricultural use. The methodologies described in the technical analysis include a maximum hazard dose, which in certain studies can reach approximately 100 to 1,000 times the estimated environmental exposure. Such concentrations should not be interpreted as normal field exposure. Instead, they provide a conservative screening scenario designed to identify possible infectivity, pathogenicity or other adverse effects before regulators determine whether more sophisticated testing is necessary.

How microbial environmental risk can be tested

Source: AgroLatam analysis based on microbial ecotoxicology methodologies reviewed for this article.

One of the most important technical issues is microbial viability during the test itself. If a microorganism rapidly loses viability after being incorporated into water or food, the nominal concentration may bear little resemblance to the actual exposure received by the test organism. That can fundamentally alter the interpretation of an experiment. Unlike a conventional chemical analysis, researchers may therefore need to repeatedly verify the number of viable organisms throughout the exposure period.

A practical example in the technical material demonstrates the magnitude of the problem. In a low-dose sucrose diet, the recoverable concentration was approximately 76% of the nominal value at the beginning of the test and fell to about 30% after 24 hours. Without measuring that decline, an apparently favorable toxicity result could partly reflect insufficient exposure rather than genuine environmental safety. Maintaining and documenting viability consequently becomes part of the scientific integrity of microbial ecotoxicology studies.

Why microbial viability matters in environmental testing

Source: AgroLatam analysis based on the experimental example presented in the technical material.

Another complication is physical behavior. Microorganisms do not necessarily dissolve uniformly in water as conventional chemical substances do. They can remain suspended, settle, aggregate or become unevenly distributed. Researchers therefore need to verify suspension homogeneity and actual exposure concentrations. In terrestrial studies, the theoretical maximum dose may even be physically impossible to incorporate into feed or another test medium, requiring preliminary work to establish a concentration that is both scientifically conservative and technically achievable.

U.S. Regulation Leads the Discussion, but Latin America Is Moving Fast

For companies targeting the United States, this complexity has direct commercial consequences. The EPA uses specific guidance for microbial pesticides, including the OPPTS 885 series, and its tiered approach can move from initial laboratory screening toward additional studies when results indicate that deeper investigation is necessary. The framework recognizes that microbial active ingredients have distinct biological characteristics and that data requirements need to reflect the microorganism, intended use, exposure pathway and potential environmental effects.

This increasingly sophisticated approach is not limited to the United States. Europe has also moved toward requirements tailored more specifically to microorganisms used in plant protection. The broader regulatory trend is important for global developers: proportional regulation does not necessarily mean less rigorous regulation. Instead, it means asking questions that are scientifically appropriate for a living active ingredient rather than automatically transferring every assumption developed for synthetic molecules.

Latin America is becoming particularly important in this discussion because it is simultaneously a major agricultural production region and one of the most dynamic markets for biological inputs. Brazil stands out because of the scale of its biological crop-protection market and the evolution of its regulatory framework. Environmental evaluation is part of that process, with IBAMA involved in environmental assessment of products subject to Brazil's pesticide regulatory system, including categories associated with biological control.

How major agricultural markets are approaching biologicals

Source: AgroLatam analysis based on U.S., European and Brazilian regulatory frameworks.

For U.S. companies looking south, the Latin American market also illustrates why regulatory strategy must increasingly accompany international expansion from the beginning. Brazil, Argentina, Mexico and other agricultural markets do not necessarily apply identical definitions, registration pathways or environmental requirements. A microbial technology developed successfully for U.S. agriculture may therefore need additional characterization or studies before entering another jurisdiction. Conversely, biological technologies developed and extensively used in Latin America will face EPA requirements when developers seek access to the U.S. market.

This reality is changing how companies need to think about R&D. Environmental characterization should begin alongside efficacy, formulation, manufacturing and shelf-life development, rather than after a product has already demonstrated agronomic potential. A microorganism can deliver excellent disease or pest control and still encounter regulatory difficulties if developers cannot reliably characterize its identity, viability, environmental behavior or interaction with non-target organisms. Generating robust environmental data earlier can reduce uncertainty before significant capital is committed to commercialization.

It also raises the competitive threshold for the biologicals industry. As portfolios become larger, companies will increasingly be judged not only on discovering promising microorganisms but on their ability to manufacture them consistently, maintain viability, demonstrate field performance and build defensible environmental safety packages. Ecotoxicology could therefore become a competitive capability rather than simply a regulatory expense, particularly for companies pursuing registrations across the United States, Latin America and Europe.

The broader conclusion is that biological crop protection is not moving toward a world with less risk assessment. It is moving toward a more specialized form of risk assessment. Regulators will need methodologies sophisticated enough to recognize potentially favorable environmental profiles without assuming that natural origin alone guarantees safety. For developers, the message is equally significant: efficacy, formulation and economics will remain essential, but the next generation of successful biological products may also be defined by something that happens long before they reach the farm - the ability to demonstrate, with credible evidence, what happens when a living agricultural technology enters the environment.