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Animals

Norway Map

Norway: Animals

Norway has a history of fierce opposition to transgenic biotechnology (GMOs) dating to the early 2000s. Proposed regulations state that gene-edited organisms without foreign genes do not fulfill the definition of transgenic GMOs and should be regulated as conventional. In 2018, the Norwegian Biotechnology Advisory Board proposed a tiered regulatory system in which genetic changes

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Uruguay Map

Uruguay: Animals

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

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Paraguay Map

Paraguay: Animals

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

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Africa Map

Africa: Animals

No African nation has passed regulations for gene-edited animals. It is considered a fertile region for gene editing to address a wide range of issues, including poverty, hunger and malnutrition. Transgenic GMOs are strictly regulated throughout the continent. No country has yet commercialized any GMO animals, although the issue is widely debated in scientific circles, particularly

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India Map

India: Animals

In 2020, the Department of Biotechnology published draft guidelines for gene editing regulation that require additional safety and efficacy testing for gene-edited organisms. The guidelines continue to be extensively discussed and debated. The guidelines regulate the process used to create gene-edited plants rather than focusing on the characteristics of the final products, as is typically the case in the US and many

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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.