Argentina based the revisions to its regulatory framework on the current global scientific advances and the country’s 30 years of experience and lessons learned, specifically on establishing the absence of new or increased risks with respect to the previously assessed genetically modified (GM) crops.
The environmental risk assessment (ERA) process went through a review-evaluation in 2020 and 2021. The following modifications were made to the ERA:
- The assessment of stacked GM crops must focus on the possibility of interaction between novelty traits and genes, considering the possibility of epistasis between introduced genes or interaction between expression products in related metabolic pathways.
- The ERA process was strengthened in consideration of the transportability of data and conclusions from confined field trials, based on the fact that these conclusions are analyzed in a wide range of environmental conditions and are transportable to other geographies regardless of the agro-climatic and agro-ecological conditions.
- Applicants have the option to report if the expression products have familiarity or a history of safe use. The aim of this revision is to avoid the redundancy of information declared in the different ERA applications.
- Applicants have the option to explain the unintended effects of insertional sites in relation to the risk of the GM crop in the agro-ecosystem according to what has been observed in the agro-phenotypic studies.
- Lastly, the insect resistance management plan was improved for the benefit of applicants and the regulatory system as a whole.
Argentina’s regulatory system has been proactive, dynamic, and science-based to maintain high biosafety standards. The continuous process of updating their policies allows the Argentinian regulators to efficiently address new challenges that may arise as the field of biotechnology advances.
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