Parallel session 11: Introduction & Scientific Justification of Data Transportability for Confined Field Testing for ERA of GM plants
Tracks
Breakaway 3
| Wednesday, May 3, 2023 |
| 14:00 - 15:30 |
| Jeffersonian/Knickerbocker |
Details
Organized by Shuichi Nakai, Bayer Cropscience, Japan
Data transportability is the concept by which data generated in one geography can be transported to another to support environmental risk assessments (ERA) of GM plants. Regulatory agencies generally require local field studies prior to decision-making related to GM plant cultivation. In a small number of countries, local field studies are required even for food and feed import. For example, regulatory agencies in China and Japan require local field studies for import approvals. In recent years, several peer-reviewed scientific publications (Garcia-Alonso et al. 2014, Nakai et al. 2015, Ahmad et al. 2016, Vesprini et al. 2020, Bachman et al. 2021) have described the appropriate conditions and considerations for the transportability of field data and/or conclusions from one geography to another. Also, utilization of transportable data across geographies/products has been successfully implemented or examined in multiple countries to eliminate redundancy, create efficiencies at regulatory bodies and enable the timely realization of the benefits of GM crops. The purpose of this parallel session is twofold, first to introduce the two examples of conditions for transportability of field data/conclusions advocated in the peer-reviewed scientific publications by renowned experts. And second, to introduce examples and challenges to implement data transportability in some countries/regions such as Japan, Argentina, and Africa with their competent authorities. The parallel session is to conclude with a discussion about conditions for Data Transportability, including the applicability of trial outcomes across environments and the unique challenges in each country/region and its scientific solutions.
14:00 - 14:05 Chair: Shuichi Nakai Introduction
Data transportability is the concept by which data generated in one geography can be transported to another to support environmental risk assessments (ERA) of GM plants. Regulatory agencies generally require local field studies prior to decision-making related to GM plant cultivation. In a small number of countries, local field studies are required even for food and feed import. For example, regulatory agencies in China and Japan require local field studies for import approvals. In recent years, several peer-reviewed scientific publications (Garcia-Alonso et al. 2014, Nakai et al. 2015, Ahmad et al. 2016, Vesprini et al. 2020, Bachman et al. 2021) have described the appropriate conditions and considerations for the transportability of field data and/or conclusions from one geography to another. Also, utilization of transportable data across geographies/products has been successfully implemented or examined in multiple countries to eliminate redundancy, create efficiencies at regulatory bodies and enable the timely realization of the benefits of GM crops. The purpose of this parallel session is twofold, first to introduce the two examples of conditions for transportability of field data/conclusions advocated in the peer-reviewed scientific publications by renowned experts. And second, to introduce examples and challenges to implement data transportability in some countries/regions such as Japan, Argentina, and Africa with their competent authorities. The parallel session is to conclude with a discussion about conditions for Data Transportability, including the applicability of trial outcomes across environments and the unique challenges in each country/region and its scientific solutions.
14:00 - 14:05 Chair: Shuichi Nakai Introduction
Speaker
Dr Andrew F. Roberts
Chief Executive Officer
Agriculture & Food Systems Institute
Introduction of Key Concepts for Data Transportability
14:05 - 14:20Biography
Andrew leads the development and management of AFSI’s extensive international portfolio of biotechnology-related analytical and capacity building programs, open access resources, and relationships with key partner organizations and stakeholder groups.
Dr Abby Simmons
Senior Regulatory Manager
CropLife International
Data Transportability for Studies Performed to Support an Environmental Risk Assessment for Genetically Modified (GM) Crops
14:20 - 14:35Biography
Dr. Simmons coordinates and manages projects and teams focused on developing and implementing science-based, globally harmonized regulatory strategies for plant biology and crop protection products. Before joining CropLife International, she was an AAAS Science and Technology Policy Fellow with the United States Department of Agriculture Foreign Agricultural Service (USDA FAS) covering trade issues related to agricultural biotechnology. Dr. Simmons received her Ph.D. in biology from Stanford University, where she studied stomatal development in the model plant Arabidopsis thaliana, and her B.S. in biological sciences from Carnegie Mellon University. Dr. Simmons is based in Washington, D.C.
Prof. Kazuyuki Hiratsuka
Yokohama National University
Assoc Prof Douglas Watuku Miano
Head, Crop Protection Section
University of Nairobi
Mr Facundo Vesprini
Strategy
Bayer CropScience
Chair
Shuichi Nakai
Seeds & Traits Japan Lead
Bayer CropScience K.K./Regulatory Science
