Second Workshop on Innovation and Regulation in Agriculture Addresses the Challenges of Higher-Tier Data

Laura McConnell, Bayer CropScience AG, and Alan Samel, FMC Crop Protection

The second workshop in the series “Innovation and Regulation in Agriculture” was held from 23–24 October 2017 on the Centennial Campus of North Carolina State University in Raleigh, North Carolina, and titled “Overcoming the Challenges of Incorporating Higher-Tier Data in Ecological Risk Assessments and Risk Management of Pesticides.”

Workshop participants and facilitators. First row: Laura McConnell, Geoff Scott, Marie DeLorenzo, Ted Valenti, Jennifer Lantz, Kevin Armbrust, Tamar Schlekat, Alan Ayers; second row: Catherine LePrevost, David Monks, Matt Kern, Garland Waleko, Chris Schlekat, Claire Terry, Paul Mitchell, Steve Levine, Allen Wenck, Teung Chin, Scott Jackson; third Row: Greg Cope, Jean-Jacques Dubois, George Cobb, David Fischer, Ed Odenkirchen, Spencer Mortensen, Alan Samel, Kevin Costello, David Knaebel, Keith Solomon, Chip Morgan, Jeff Giddings, Larry Roberts (Danesha Carley, not pictured)

As part of the registration process for pesticides, higher-tier (non-guideline) studies, such as innovative studies in the field, mesocosms or microcosms, are often conducted by industry and academic researchers to address uncertainties associated with screening-level testing and conservative risk assessments. Higher-tier studies are, by nature, more complex and more difficult to conduct and interpret. Some classes of compounds have been the subject of numerous higher-tier studies. These studies include water monitoring, biomonitoring, mesocosms or spray drift studies. Studies conducted by different investigators can appear to give conflicting results or conclusions. While scientists often come to agreement on technical aspects and outcomes related to a study, difficulties arise in the interpretation of sets of studies and use of these studies to support regulatory decisions.

The workshop was co-sponsored by North Carolina State College of Agriculture and Life Sciences, Bayer, North Carolina Biotechnology Center and SETAC North America. Thirty experts from the agricultural industry, federal government and academia were in attendance. The objective of the workshop was to discuss and identify ways to improve the process for designing, conducting, evaluating and using higher-tier studies for risk assessors and risk managers. Goals of the workshop were to:

Identify the greatest challenges to the use of higher-tier studies in ecological risk assessments and in risk management decisions
Develop a series of recommendations to improve the process

The first day of the workshop started with a public plenary session of opening remarks and presentations. Because pyrethroid insecticides were used as a broad case study for the workshop, the presentations included the economic benefits of pyrethroids in U.S. agriculture and urban settings, and consideration of higher-tier studies in pyrethroid risk assessments. There was also an overview of the U.S. Environmental Protection Agency (USEPA) risk assessment and risk management approach to using higher-tier studies, and an overview for using a weight of evidence framework approach that includes a quality assessment of literature used in ecological risk assessments. After the presentations, workshop participants were assigned to one of three workgroups for the formally facilitated workshop.

Workgroups were asked to discuss:

Which characteristics of higher-tier studies make them useful in a risk assessment
How the tiered risk assessment process, with respect to the use of higher-tier studies, could be improved
Which characteristics of higher-tier studies make them useful for risk management decision-making
What barriers prevent evaluating and effectively using higher-tier studies in regulatory decision-making to achieve protection goals

Workgroup outputs will be used to develop a set of recommendations aimed at creating a process that integrates higher-tier study design with risk assessment and risk management processes in an efficient and effective way that are successful in achieving environmental protection goals. An initial starting point would assess the previous use of higher-tier studies by USEPA in the decision-making process for the pesticide registration review and to consider what processes have been used in the past and can be integrated with these new recommendations from the workshop. Recommendations from the workshop will be submitted to Integrated Environmental Assessment and Management by the end of 2018.

This workshop was organized as part of a larger effort to develop a new Center for Regulatory Science in Agriculture at North Carolina State University. One of the goals of the new center is to improve engagement and collaboration between public and private entities regarding research to support technological innovation in agriculture. The center will also work to increase transparency to improve public understanding and demystify the science of risk assessment. The workshop was organized by:

Laura McConnell, Bayer (chair)
Danesha Seth Carley, NC State (co-chair)
Linda Abbot, USDA
George Cobb, Baylor University
Kevin Costello, USEPA
Jeff Giddings, Compliance Services International
Matt Kern, Waterborne Environmental
and Ed Odenkirchen, USEPA

Authors’ contact information: laura.mcconnell@bayer.com and Alan.Samel@fmc.com

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