China is moving quickly to formalize gene editing in agriculture as part of a broader food security and innovation agenda, with the Ministry of Agriculture and Rural Affairs (MARA) serving as the key regulator for agricultural genome editing. China has built a centralized, government led review pathway intended to distinguish lower risk gene edits from […]
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Brexit has left the United Kingdom with a divided regulatory map for gene-edited crops. England has built a new approval system under the Genetic Technology (Precision Breeding) Act 2023 and the Genetic Technology (Precision Breeding) Regulations 2025. Scotland, Wales and Northern Ireland have not followed, and continue to regulate gene-edited plants under the older European
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Brazil is currently a global leader in agricultural biotechnology, rivaling the United States in both total approved products and cultivated acreage. It is the most aggressive adopter of the “product-based” regulatory approach, having approved more than 140 genetically modified (GM) events, a single insertion or edit of a gene into a specific crop’s genome, for
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All gene editing techniques are considered genetic modification and are tightly regulated. New Zealand has adopted a wait-and-see-approach with regard to updating regulations to address gene editing, monitoring how other countries, especially those New Zealand exports to, decide to regulate. No gene edited crops or food are currently grown commercially in New Zealand and no
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Regulatory approaches to gene editing are broadly divided into those that focus on the final product and those that are more concerned with the process. Like Europe, Australia had regulated all genetically engineered crops, including both transgenic and cisgenic/ gene-edited plants, based on the process used to develop gene-edited products, instead of the characteristics of
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Food produced using new breeding techniques (NBTs), including CRISPR gene editing, are held to similar standards as conventional foods. Plants produced through the use of NBTs are regulated based on the end product, not the means of creating them. Oversight of gene-editing technology is jointly managed by the U.S. Department of Agriculture, the Food and
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For more than two decades, the European Union was the global fortress of anti-GMO sentiment, governed by a “precautionary principle” that prioritized absolute safety over technological innovation. This era was defined by the 2001 GMO Directive, a rigid set of rules that made the commercialization of biotech crops nearly impossible, although the EU did import
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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.