Novas Técnicas Genómicas: alegações duvidosas em matéria de produtividade, sustentabilidade e segurança 51 However, neither the original nor the amended proposal has any scientific foundation. First, no scientific justification is provided for the number of mutations that are presumed safe. A single mutation in just one gene can have major consequences on gene and protein network functioning, leading to changes in a plant’s biochemistry and composition, with potentially catastrophic consequences to health or the environment. So the criterion of 20 – or even just three – permitted mutations in a gene is arbitrary, with no basis in science. Second, the unintended largescale, genome-wide random mutations that inevitably occur during the NGT/gene editing process as a whole (see Figure 1), which affect the function of large numbers of genes, are ignored. Third, mutations in a gene’s regulatory elements can dramatically alter its level of expression, which again can disrupt gene and protein network function, whereas mutations in intronic regions can result in the production of mutant mRNA and proteins, with unknown health implications (Figure 2). In sum, the original and amended criteria that define a Category 1 NGT plant have no scientific basis and only constitute a dangerous numbers game. It is the quality and not the quantity of mutations that matters. Any weakening of the regulation around NGTs ignores the mutational effects of the gene editing process and puts health and environment at risk. Such risks are recognised by expert bodies such as the French food safety agency ANSES28 and the German Federal Agency 28 https://www.anses.fr/fr/content/avis-2023-auto-0189; https://www.actu-environnement.com/media/pdf/news-43622-avis-anses-nouveaux-ogm.pdf 29 https://www.bfn.de/sites/default/files/2021-10/Viewpoint-plant-genetic-engeneering_1.pdf 30 https://ensser.org/publications/2023/statement-eu-commissions-proposal-on-new-gm-plants-no-science-no-safety/ for Nature Conservation,29 as well as the European Network of Scientists for Social and Environmental Responsibility.30 There have been no published studies assessing the health and environmental risks of any given NGT food, including those already marketed, such as the gene-edited tomatoes in Japan that are claimed to help lower blood pressure. Claims that NGT plants are as safe as conventionally bred plants are based on assumptions, not scientific evidence. In conclusion, the outcome from the application of NGTs is far from predictable, so an in-depth safety evaluation is required before marketing and the products must be labelled for the consumer. Figure 2 – Mutations in gene regulatory elements and intron regions can markedly alter levels expression and types of protein products and must not be ignored in setting criteria that define a Category 1 NGT plant. A. Illustration showing key components of a typical gene; position of expression regulatory elements (promoter, enhancer), protein coding regions (exons, green rectangles) and non-protein coding regions (introns, blue rectangles). B. Illustration of the normal removal (splicing out) of introns to produce normal mRNA and protein (left hand pathway) and abnormal splicing out of introns due to mutations within these regions to produce abnormal mRNAs and mutant proteins (right hand pathway). A suggested amendment to the criteria that will define a Category 1 NGT plant recommends that any number of unintended mutations in a gene’s regulatory regions or introns be disregarded. However, altering the level of expression of a gene and thus the amount of its protein product can have a dramatic impact on the gene and protein networks within which it functions resulting in major changes in plant biochemistry and composition. Mutations of the gene DNA sequences within introns can result in aberrant splicing out of the elements giving rise to abnormal mRNA and mutant potentially toxic proteins. Thus, the recommendation that unintended mutations in a gene’s regulatory elements or introns should be discounted from consideration is scientifically inaccurate as it ignores the risk from plant compositional changes arising from alterations in the quantity and quality of gene function.
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