Uruguay has no specific regulations for gene edited animals. In 2018, Uruguay and 12 other nations, including Argentina, Australia, Brazil and the US, issued a joint statement to the World Trade Organization supporting relaxed regulations for gene editing, stating that governments should “avoid arbitrary and unjustifiable distinctions” between organisms developed through gene editing and organisms […]
Gene-edited crops and food are regulated as conventional plants unless they contain foreign DNA, after a dossier is submitted to determine if they are exempt. Gene edited crops are assessed on a case-by-case basis by the National Commission on Agricultural and Forestry Biosafety. In 2018, Paraguay and 12 other nations, including Argentina, Australia, Brazil and the US, issued a
Gene-edited crops and food are regulated as conventional plants unless they contain foreign DNA, after a dossier is submitted to determine if they are exempt. Gene-edited crops are assessed on a case-by-case basis by the National Commission on Agricultural and Forestry Biosafety. In 2019, Paraguay published a resolution outlining what is required for crops developed using gene editing and
Paraguay: Crops / Food Read More »
Honduras, Guatemala and El Salvador have signed agreements and resolutions stating that gene-edited organisms that do not fulfill the definition of GMOs should be regulated as conventional. All three countries are actively discussing, harmonizing and deciding on a case-by-case basis how products of gene editing will be regulated. In 2018, Honduras, Guatemala and 11 other
Central America: Animals Read More »
India’s current regulatory architecture for approving novel treatments is ambiguous and assigns overlapping functions to different governmental bodies. Human germline editing and reproductive cloning are banned by the National Guidelines for Stem Cell Research, although there are no specific and enforceable laws. Research involving human germline gene therapy, reproductive cloning, and clinical trials involving “xenogeneic”
India: Germline / Embryonic Read More »
Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.
Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.
To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.
For more background on the various gene editing SDN techniques, read background articles here and here.