Abstract
The Environmental Risk Assessment (ERA) of genetically modified (GM) crops in Argentina is carried out by the National Advisory Commission on Agricultural Biotechnology (CONABIA) and the Innovation and Biotechnology Coordination (CIyB). Both have a large experience with this assessment, since 1991, when CONABIA was created. The continuous support to biotechnology as a state policy and as part of the decision to encourage developers in the regulatory process has helped make progress in the revision of the regulations. The experience gained during the last 30 years and the worldwide scientific advances supported the bases to update the regulatory framework. Focusing on the biosafety strengthening and the improvement of the applicant’s experience in the GM crops evaluation process, during 2020 and 2021, the ERA went through a reviewing process. Some important modifications were made, such as (i) the assessment of stacked GM crops with focus on the possible interactions between transgenes and the expression products, (ii) the strengthening of the ERA taking into account the transportability of data and conclusions from the Confined Field Trials (CFTs), (iii) the adoption of Familiarity and History of Safe Use (HOSU) concepts on the risk assessment of the expression products, (iv) the special considerations for the unintended effects of insertional sites, and (v) as a post commercial release of GM crops, the Insect Resistance Management Plan (IRMP) was reformulated. These novel approaches enhance the ERA; they make it more efficient by applying the science criteria and the accumulated experience and scientific bibliography on the topic.
Highlights
Argentina was one of the first countries to have a regulatory framework for genetically modified (GM) crops for agricultural use
From the above review process, applying the Problem Formulation (PF) approach and considering the case-by-case assessment, the CONABIA and the CIyB decided that the assessment of stacked GM crops must focus on the possibility of interaction between novelty traits and genes
In the Environmental Risk Assessment (ERA) for the commercial release of GM crops, the CONABIA and the CIyB have applied some complementary approaches about the transportability of data and conclusions from Confined Field Trials (CFTs)
Summary
Argentina was one of the first countries to have a regulatory framework for genetically modified (GM) crops for agricultural use. Risk assessments are framed from the application of an analysis system based on the Problem Formulation (PF) Under this consideration, risk hypotheses that are identified linked the crop, the new phenotype, and its interaction with the agro-ecosystem, with focus on biosafety. From the above review process, applying the PF approach and considering the case-by-case assessment, the CONABIA and the CIyB decided that the assessment of stacked GM crops must focus on the possibility of interaction between novelty traits and genes. It was one of the most relevant topics of the resolution 32/2021 from the Secretary of Food, Bioeconomy, and Regional Development. As a result of this interaction assessment, the risk for the environment of planting the stacked GM crop is analyzed
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