Abstract
Argentina currently has a regulation for genome-editing products whose criteria were updated as consultations were received to determine the regulatory status of these products. The aim of this regulation is to consider all organisms (animals, micro-organisms and plants) under the same NBT resolution independently and without being linked to commercial Genetically Modified Organism (GMO) regulations. This gives certainty to local researchers and developers (teams of local developers and researchers), which can be seen in the number of developments and consultations carried out. It should be noted that early results showed that the speed of innovation of these technologies was increasing in a short time, giving more opportunity to local developers who showed interest in generating products in different species, crops and phenotypes.
Highlights
To begin with, modern biotechnology can be defined as the technological application of genetic engineering tools for the improvement of crops, micro-organisms, and animals of agricultural interest, with the aim of generating benefits for farmers, consumers, industry, human and animal health, and the environment
Definition of Genetically Modified Organism (GMO), understood as any living organism that possesses a new combination of genetic material obtained through the application of modern biotechnology. This new resolution includes the definition of “novel combination of genetic material” which refers to any change produced in the genome of the organism by the incorporation, in a stable and cohesive manner, of one or more genes or nucleic acid sequences that are part of a defined genetic construct. This new New Breeding Techniques (NBTs) Resolution N° 21/2021 takes into account a procedure to determine whether a product obtained by NBT could be covered by the GMO regulation or not
Efforts are still needed in international dialogues, international capacity building and accurate promotion in order to properly adopt these technologies. This regulation was a pioneer in analyzing products derived from biotechnology using NBTs
Summary
Argentina currently has a regulation for genome-editing products whose criteria were updated as consultations were received to determine the regulatory status of these products. The aim of this regulation is to consider all organisms (animals, microorganisms and plants) under the same NBT resolution independently and without being linked to commercial Genetically Modified Organism (GMO) regulations. This gives certainty to local researchers and developers (teams of local developers and researchers), which can be seen in the number of developments and consultations carried out.
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