Battelle: What the Endangered Species Act means for the agrochemical and crop protection sector

Animals that are among endangered species are deserving of special consideration. It’s worth noting that the United States Environmental Protection Agency (EPA) recently announced plans to accommodate the Endangered Species Act (ESA).  It is EPA’s vision to establish a strategy and workplan to protect endangered species and wildlife from pesticides.

This plan requires significant changes and obligations for the agrochemical and crop protection sector. It will affect the registration of all new pesticide active ingredients and existing pesticides will have to be reviewed and adapted if necessary to align with new regulations concerning authorized safe use.

As an industry leader in agrochemical formulation development, Battelle provides formulation development, risk assessment and regulatory support to help pesticide companies adjust  products to the new government demands. Our U.S. Head of Regulatory Affairs, Phillip Cassidy, sheds light on the implications of these strengthened regulations in this Q&A.

How does EPA’s Plan to Protect Endangered Species affect the agrochemical sector?

On April 12, 2022, EPA announced the workplan addressing the decade-old challenge of protecting endangered species from pesticides. The workplan includes an assessment of impact to endangered species in the registration of all new pesticide active ingredients and a staged review of existing pesticides. In so doing, EPA identifies measures that reduce impact to the survival of listed species and to their critical habitats. Risks are quantified and expressed in a biological evaluation (BE). If the BE shows that listed species can be exposed to a pesticide at a sufficient level for an adverse effect, stakeholders meet with EPA to discuss mitigation measures to control the risk. The mitigation measures can include, for example, annual application rate reductions, application timing restrictions, and methods to reduce off-site movement (e.g., spray drift reduction).

What’s the process that agrochemical companies must go through to adapt their current products to meet this new workplan?

Risk assessment and the BE are based on results from the Office of Chemical Safety and Pollution Prevention (OCSPP) guideline studies, modelling, and maps of existing endangered species populations and critical habitats. Modelling for pesticide drift utilizes the aerial spray prediction model AgDRIFT(R), which embodies the computational engine found in the near-wake Lagrangian model, AGricultural DISPersal (AGDISP). Spray drift estimations calculated by this method are conservative.

Which Battelle Crop Protection services can help with ESA’s mitigation measures?

Battelle’s capabilities for pesticide drift determination and reduction are second to none. Battelle’s wind tunnels produce robust, quality data that precisely measure drift. Controlled, consistent wind direction and speed provide reliable, repeatable data. Battelle’s environmental walk-in chambers, or humidome facilities, precisely measure volatile fractions. This data accurately determines drift potential rather than relying on the conservative assumptions provided by modelling and are critical when refining risk to endangered species.

The data collected in the Battelle facilities by industry-recognized experts provide guidance on the efficacy of drift and volatility reduction technologies. Battelle can recommend changes in droplet size, nozzle selection or other variables that affect drift. Battelle also offers proprietary formulation development with drift reduction as just one variable that can be addressed. In addition, Battelle is able to provide formulation solutions for a wide range of chemistry classes, natural products, and microbes for foliar, in furrow, and on seed coatings/treatments which enhance efficacy, optimize application rates, provide sustainable solutions and extend patent life.

How does Battelle Crop Protection Solutions target these goals from its comprehensive scope to drive safe and sustainable food production?

Battelle's services are built on decades of testing and evaluation of drift and offsite movement of chemical and biological agents. Our highlight differentiated facilities and experts cannot be matched by those at other contract research labs or universities. Battelle can access a broad array of scientists and engineers with vast knowledge and expertise in providing innovative solutions. Coupled with highly specialized labs and instrumentation, Battelle provides end-to-end solutions rather than just testing data. Innovative approaches to assess pesticide drift and volatility are examples of the problem-solving excellence conducted at Battelle for the agrochemical community.

What is your advice to the agrochemical industry in terms of sequence and speed of actions to address the new ESA requirements?

It is possible to perform a preliminary ESA risk assessment. The assessment will indicate whether a substantial loss of sales can be expected due to mitigation or, potentially, whether a registration is in jeopardy. Formulations that have toxic endpoints or have drift issues will have the most significant ESA mitigation. If this is the case, drift testing becomes a higher priority. Waiting for ECSPP guidelines on drift testing to be enacted (if that ever happens) isn't appropriate as the need to address these issues is too significant. Given Battelle's unique testing capabilities, testing will most likely need to be scheduled.