Biotechnology has stood out as an important tool in plant breeding. Among its many applications, the best known example is the development of transgenic varieties, considered one of the greatest technological advances of the last decades. The speed with which transgenics have been incorporated into the world's productive process is unmatched. Today, less than 30 years after the emergence of the first transgenic varieties, this technology already occupies an area that exceeds 185 million hectares around the world. Despite the undeniable benefits that GMOs have brought to agriculture, the development of these GM (Genetically Modified) events requires time and effort, as well as demanding costly processes to prove the safety of their products.
Fortunately, gene engineering has evolved rapidly, and significant discoveries have occurred in the last 10 years that have allowed the development of new methods capable of accurately editing DNA, with potential for application in several areas, including genetic improvement of plants. Thus, in the current scenario, we move to a new technological era, which encompasses the Precision Breeding Innovation Precision Techniques (TIMP) of the English Precision Breeding Innovation (PBI) and also encompasses the so-called New Breeding Technologies (NBTs). Among these new technologies, special attention has been given to the CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) system. CRISPR is a genome-editing tool that allows the identification of genes of interest in the DNA of any species, and modifies it accordingly to anyone needs, without necessarily involving the inclusion of exogenous genes. The potential of the technique is unprecedented, allowing you to perform from knockout/silencing to insertions and replacements of genes and/or blocks of genes with precision.
As it allows it to change from major sequences to sequences of few nucleotides, the CRISPR system can be used to induce specific mutations, in order to generate or modify wild or mutated alleles, involving only the modification of sequences already existing in the species itself. There are already several products developed and under development through this strategy and will soon be available in the market, such as maize varieties with change in starch composition and with characteristic of drought tolerance, citrus and tomato plants resistant to bacteria and virus, soy and disease resistant cotton, among many other features being worked on.
Despite the undeniable potential of the CRISPR tool, one of the points that have been widely debated in Brazil and in the world is the issue of regulation of the products generated. Depending on the genetic alteration performed, plants developed using these gene-editing tools may in no way differ from conventional plants that have undergone natural mutations and therefore cannot be considered as transgenic organisms.
It is important that countries adopt similar classification criteria in order to avoid problems for import and export of products. Argentina, the USA, Chile and Canada have already positioned themselves so that some products from these new technologies will not be classified as transgenic. Thus, cases in which only gene modifications or DNA sequences already present in the species, or that could arise by natural mutations, occur, would be considered as non-GMOs or non-GMOs.
In Brazil, the regulatory system for GMOs, regulated by Biosafety Law No. 11,105 of 2005, was elaborated when these new methodologies had not been in existence for more than 13 years. Thus, it became urgent and necessary to adjust our legislation. The lack of a Law that is compatible as this current scenario can, in addition to the problems already mentioned, bring other disastrous consequences to the country. It is enough to draw a parallel with what happened with the emergence of RR soy, the first transgenic crop marketed in Brazil. The delay we had in the commercial release of these varieties in our country, while in neighboring countries like Argentina where the technology was already available, caused many producers to import the technology illegally, using seeds without quality guarantee and that, in most cases, were not adapted to our conditions. The consequence was enormous damage to the seed sector and to the entire production chain, not to mention the technical and scientific backwardness caused by the inhibition of investment in the area.
Given this scenario, the National Technical Biosafety Commission (CTNBio) concentrated efforts and elaborated a regulation, which was presented to the Ministry of Science, Technology, Innovations and Communication (MCTIC). After analysis and adequacy, the proposal was recently approved and published in the DOU by means of Normative Resolution (RN) No. 16, dated January 15, 2018. Through this new RN, the technical requirements for presenting and consulting CTNBio on Techniques Innovative Precision Enhancement. The proposal of this regulation is that the application of the new technologies be analyzed case by case, considering the presence or not of recombinant DNA / RNA in the final product. The approval of this proposal is a major milestone in the development and use of biotechnology in Brazil. In addition to meeting what is already happening in other countries, the possibility of using these technologies with a biosafety regulation, but not restrictive, allows public institutions and smaller private companies to become competitive in this market, which today is restricted only to a small number of large corporations.