THOUGHT LEADERSHIP SERIES
Achieving Effective ESA Consultations to Support FIFRA Registrations
Three Recommendations for Crop Protection Industry Executives
How to work with Agencies to avoid lawsuits and manage market share
Ease of compliance is not necessarily the primary objective of environmental regulations; however, if regulatory processes are ineffective, outcomes can include legal disputes, business uncertainty, and failure to deliver on the intent of the laws. These are the convoluted circumstances of the crop protection industry and compliance with the United States Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Endangered Species Act (ESA). The strategy for success going forward is to better deploy both the FIFRA and ESA authorization processes, resulting in national scale pesticide consultations that are more practically linked to the landscape. Balancing both crop and species protection is a win – for business, the environment, regulators, and society.
Our team at Creekbank Associates is developing and sharing a series of FIFRA-ESA focused articles to inform and guide needed improvements in the registration process and resulting outcomes.
Decades Old Strategies Don’t Work for Contemporary Regulatory Challenges in Crop Protection
A history of narrowly framed approaches has resulted in obstacles to pesticide registrations while not fully delivering on the intent of both the ESA and FIFRA. Ideally, the desired objective is effective registration of needed crop protection products, with equitable, well-coordinated and meaningful conservation outcomes where appropriate. Instead, however, the historical landscape reads like this: regulatory agencies do not effectively coordinate FIFRA risk assessments with ESA population-level assessments; while in the meantime, the pursuit of “no effect” conclusions for listed species through higher-tier science, label mitigation and deliberation in court has resulted in major uncertainties and inefficiencies for product registrations. These strategies are terminal and outdated. In short, change is the only way forward.
The ESA and FIFRA take different approaches to their species protection mandates. Add to that mix the distinctly different analyses used by EPA, which utilizes risk assessment methods to gauge the potential for harm to individuals of a listed species by a pesticide, and the U.S. Fish and Wildlife Service and National Marine Fisheries Service (“the Services”) who are required to evaluate the proposed actions effects on the overall population viability of each listed species under consideration so as to form their opinion. Each of these mandates and entities are siloed in their management, execution, and communication with one another.
Environmental legislation encompasses diverse laws and regulations, which are intended to work together to manage the interactions between humans and the natural world to reduce environmental threats and increase public health. It is unrealistic, however, to rely on regulating agencies to efficiently integrate their disparate regulatory processes especially in the face of declining budgets, reduced staffing, and increased administrative burden. This situation creates significant uncertainty for the crop protection industry in United States markets due to
registration process complexity, resulting risk of litigation and the overall costs of both. The trickling effects of this uncertainty include difficulty in determining meaningful project timelines and budgets, and in setting competitive strategies for product lines. The crop protection industry is already paying a high price in public perception, as well as in refining risk assessment methodologies, addressing lawsuits, and managing for lagging decisions, all leading to lost revenue. This is likely costing companies more than effective ESA Section 7 consultations and meaningful conservation outcomes.
A new era of industry leadership and investment is needed to resolve this unnecessary and costly situation, by integrating processes and linking analyses with improved conservation outcomes where appropriate. Innovative crop protection companies stepping up to frame and inform a more practical, effective process and applied outcomes will be market leaders. This challenge is not going away, and consequently new attitudes and new approaches are key to progress. Here are three recommendations we have developed to achieve progress for the crop protection industry.
Three Recommendations for Crop Protection Industry Executives
- Registrants should invest in developing expertise to understand effects to species-wide population viabilities and identify associated conservation measures needed for business and regulatory decision-making.
Evaluating implications to the substantial number of potentially affected species within the large-scale pesticide consultation action areas requires a much different technical expertise than that needed for the FIFRA registration process. Effective ESA consultation requires evaluation that integrates the complexity of species’ biology, habitat, range, population viability, as well as conservation measures necessary for national scale listed species consultations. This knowledge is essential to better prepare registrants, as applicants, to effectively navigate their ESA consultation, and for identification and delivery of any registration-associated conservation actions. Accurate evaluations and conservation actions, leveraged across product research, development, and registration phases, can inform crop protection business decisions throughout the product life cycle.
- As ESA consultation applicants, registrants must develop a productive, transparent, and collaborative working relationship with the Services. Engaging experienced professionals to guide your progress gives you a distinct advantage.
FIFRA registration and ESA consultation are dissimilar processes designed to inform respective decision-making requirements, and they are stewarded by agencies that have their own unique cultures. For much of the history of this convoluted regulatory process, ESA pesticide consultations have principally taken place between EPA and the Services without registrant involvement. However, in other industries such as energy, transportation, and construction, project applicants engage directly with the Services and often utilize professional services to inform and guide their consultation engagement and any resulting conservation actions. EPA has recently expressed support for direct collaboration between FIFRA registrants and the Services on ESA Section 7 applications. This is a significant turning point, where the door has opened for applicants to coordinate directly with the Services and consider conservation measures together, where appropriate, to reduce the potential for undesirable effects to listed species. To advance their registration-consultation progress, registrants should secure professional services with the appropriate expertise.
- Registrants should construct more effective industry-wide leadership entities to drive regulatory process improvements and to develop a program for conservation funding, cost-sharing, and delivery.
While there are numerous industry organized task forces, working groups and membership committees, these entities have not yielded the progress needed to achieve successful, durable, ESA Section 7 consultations for pesticide registration. These traditional groups have deep technical expertise specific to risk assessment, but they lack specific experience in regulatory consultations, species status and impact assessments, as well as the measurement and delivery of conservation outcomes. Industry needs new, more effective ways to organize their efforts, gain access to needed expertise, share consultation and conservation costs, and advance more holistic methods for achieving ESA compliance.
Depending on the registration at hand, ESA consultations may include one registrant or multiple registrants with diverse business priorities. In such cases, a coordinated approach among registrants is key to obtaining agreement on the ESA assessment and any associated conservation measures given the unique and shared business implications for each registrant. Needed coordination among registrants, EPA and the Services include any ESA-related label changes for avoidance and minimization measures, as well as any offset measures that would be considered in the Biological Opinion.
Jody L. Bickel, Creekbank Associates, Chief Executive Officer