50 CADERNOS DE ANÁLISE E PROSPETIVA CULTIVAR N.º 30 ABRIL 2024 – Melhoramento e técnicas genómicas Another crucial distinction between the changes induced by NGTs and natural processes is the vast increase in scale. As an analysis of regulatory policy on NGTs stated: “the use of new genome editing and gene silencing techniques potentially makes biological changes at large geographical/spatial scales and across multiple species” – a type of intervention that is without precedent in nature and that brings an attendant increase in risk.24 24 https://doi.org/10.1525/elementa.2021.00086 25 https://pubmed.ncbi.nlm.nih.gov/27485388/; https://pubmed.ncbi.nlm.nih.gov/34800849/ 26 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52023PC0411 27 https://www.europarl.europa.eu/doceo/document/TA-9-2024-0067_EN.html; See Amendment 72. All genes work as part of a network or ecosystem.25 So changing just one gene can have major impacts on the biochemistry of an organism. In the case of NGTs and older-style transgenic GM, many gene functions will be altered. This will lead to changes in patterns of gene function and altered biochemistry and composition, which could include the production of novel toxins and allergens. Such unintended alterations could pose threats to health, the environment, and farmers’ productivity. Risks and science ignored in proposed deregulation The EC’s proposal to weaken the regulations around NGTs26 is making its way through the Council and Parliament. In the proposal, the EC listed the criteria that would qualify a plant as “Category 1 NGT” and thus be exempt from risk assessment for health and the environment, as well as traceability and consumer labelling requirements. Annex I stated that any NGT plant that had up to 20 sites of genetic modification at locations predicted by computing (bioinformatic) tools, including essentially any type of genetic mutation (small/large deletions, insertions and rearrangements of DNA), would qualify as Category 1. More recently, the European Parliament voted through amendments to the Category 1 criteria. One amendment stipulates that up to three alterations in the protein coding part of any gene – and any number of mutations in regions of the gene that do not code for the protein (regulatory elements and introns that separate the protein coding regions) – should be permitted.27 Figure 1 – NGTs such as gene editing are artificial laboratory-based genetic modification procedures that are highly prone to multiple types and large numbers of unpredictable, unintended mutations. Illustration of the various steps required to produce a gene edited plant. A. Isolate cells from plant (e.g. carrot) to be edited and grow in laboratory tissue culture. B. Introduce gene editing tool into plant cells (cell transformation); only some of the cells (marked yellow) will be edited. C. Change cell culture conditions to regenerate the (carrot) plants. D. Pick out edited plants from tissue culture dish and grow out in soil as usual. The plant cell tissue culture and cell transformation steps are known to produce hundreds or thousands of sites of unintended DNA damage over and above any undesirable mutations from the action of the gene editing tool. Pictures of carrot plants are by Michael C and Viktoriia Filipchenko on unsplash. com.
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