Abstract
Products of genome editing as the most promising “New Plant Breeding Technology” (NPBT) have made the transition from the lab to the market in a short time. Globally, research activities employing genome editing are constantly expanding and more and more plants with market-oriented traits are being developed, and companies have already released the first genome edited crops to the market. Few countries, most of which are located in the Americas, have adapted legislations to these technologies or released guidelines supporting the use of genome editing. Other countries are debating the path to come either because there is no clarity on the legal classification or due consensus is hampered by a renewed GMO debate. In recent years (2017−2020), eight countries have introduced guidelines clarifying the legal status of genome edited products and many of those are actively committed to international harmonization of their policies. In this publication we give an overview on the current and potentially future international regulatory environment and an update on plants derived by genome editing with market-oriented traits.
Highlights
We could show that genome editing and related regulations engender growing interest in recent years in all regions of the world
The CRISPR/Cas and related systems have been used lately for almost all studies and a rising number of market-oriented traits have been addressed by genome editing
We have identified that most countries, which are active in developing market-oriented traits have such a friendly policy (e.g., United States and Japan)
Summary
The most progressive step in breeding is techniques that enable a targeted intervention in the genome with or without the integration of a transgene. Most regulations of biotechnology applications in breeding refer to the use and commercialization of conventional genetically modified organisms (GMOs) and products thereof. . .] any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology” (Secretariat of the Convention on Biological Diversity, 2000) and many national legislations use somewhat similar definitions for a GMO These definitions originate in the years before 2000 when modern biotechnology was mostly considered as insertion or deletion of recombinant DNA in organisms beyond the species border and when most genome editing methods were neither known nor applied. Countries with product-oriented regulatory concepts and long lasting GMO cultivation in the field like Canada or the United States did not change their regulatory system at all and genome edited plants passed without specific regulatory burdens. Resolution 173-2015 (Ministerio de Agricultura, Ganadería y Pesca−Argentina, Argentina.gob.ar, 2015)
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