Transportability of Conclusions From Confined Field Trials: A Case Study Using the Virus Resistant Transgenic Bean Developed in Brazil

Abstract

The conceptual framework for Data Transportability, builds on the premise that welldesigned studies conducted for the environmental and food/feed risk assessment of transgenic crops may be transportable across geographies. Beyond individual data, provided that certain criteria are met, the general conclusions of comparative assessments of a transgenic crop with its conventional counterpart would also be transportable. In spite of this, many regulatory agencies still require in-country field trials to complete risk assessments of transgenic crops. A sub-team from ILSI Argentina's (International Life Sciences Institute, Argentina. www.ilsi.org.ar) Biotechnology Working Group tested the applicability of the transportability concept to the case of the golden mosaic virus-resistant transgenic bean, developed by EMBRAPA (EMBRAPA: Brazilian Agricultural Research Corporation). To this end, regulatory confined field trials (CFTs) carried out in Brazil to gather agro-phenotypic and compositional data were analyzed. The transportability of the conclusions of these studies to the bean cropping areas in Argentina was assessed as a conceptual exercise (with no intention to conclude on the biosafety of the common bean event). Comparative studies included the transgenic bean and its conventional parental line and were run in different agroecological environments so that any relevant differences could be observed. The main criteria to enable transportability were set by the sub-team and found to be met by the CFTs carried out in Brazil to inform a potential risk evaluation for Argentina.

Introduction and scientific justification of data transportability for confined field testing for the ERA of GM plants

“…From Argentina, Facundo Vesprini, Bayer CropScience, Argentina, made a presentation entitled “Transportability of conclusions from Confined Field Trials.” He presented a theoretical experience exploring the transportability of conclusion of the ERA from Brazil to Argentina, applied to a GM bean which was developed by Brazilian Agricultural Research Enterprise (EMBRAPA), that confers resistance to the Golden Mosaic Virus. This exercise has already been published in 2019 and tests the transportability of conclusions from EMPRAPA 5.1 field trials to bean growing regions in Argentina ( Vesprini et al, 2020 ). To assess the transportability of conclusions of agro-phenotypic (for ERA) and compositional studies (for food and feed safety assessment) carried out in Brazil, three main criteria were established: “appropriate experimental design and methodologies,” “relevance and consistency of measured endpoints across studies” and “diversity of environmental conditions selected for the CFT within the crop production zones.” It is worth noting that similarity of agroclimatic conditions is not included in the criteria.…”

“…This risk hypothesis-based approach for DT introduced during discussion of this parallel session is not entirely new but was developed by integrating the DT criteria and conditions already proposed by several authors during the session. Specifically, this approach is structured around a concept of the ERA based on problem formulation as proposed by Anderson et al, (2021) , DT of the data collected in well-designed CFT that test a clear risk hypothesis proposed by Bachman et al ( Bachman et al, 2021 ) and with transportability of conclusions from confined field trials proposed by Vesprini et al (2020) . These first two papers played a central role in structuring Dr. Simmons’s session and are also part of a “Special Issues on Genetically Modified Organisms” ( Molins, 2021 ).…”

Update of Argentina’s Regulatory Policies on the Environmental Risk Assessment

“…With these data, risk hypotheses are answered. CFTs involve plants grown side by side that are therefore subject to the same environmental conditions and agronomic management (Vesprini, et al, 2020). Data transportability builds on the premise that well-designed CFT may inform the ERA and support regulatory decision-making for GM plants being cultivated in another country (García-Alonso et al, 2014;Ahmad et al, 2016;Vesprini et al, 2020).…”

“…After years of ERA, it was evidenced that the conclusions arrived at in CFT that were analyzed in a wide range of environmental conditions can be transportable to other geographies, regardless of the agro-climatic and agro-ecological conditions (Vesprini et al, 2020). On this approach, the site selection with focus on the diversity of tested environments examined were key elements (Vesprini et al, 2020). The diversity selection of environmental conditions to perform the CFT is related to the crop production zone.…”

“…The diversity selection of environmental conditions to perform the CFT is related to the crop production zone. At the same time, as the approach comparing agro-ecological conditions, the methodology and agronomic management of the studies and the measured endpoints are relevant to consider (Vesprini et al, 2020). If these three items are met, not only the data (as an informative study) but also the conclusions of the CFT are transportable.…”