Genome Editing in Biotech Regulations Worldwide

Abstract

Since the introduction of genome editing techniques in breeding and the first commercial products on the market, various governments or jurisdictions have attempted to clarify the legal classification of genome editing in relation to their genetic engineering regulations. Only a few countries, including Europe, fully apply their strict genetic engineering laws to genome-edited organisms or products derived from them. Most countries with liberal regulations base classification on the absence of foreign DNA in the final product (including the USA and Canada, which de facto have no specific GMO laws). Countries such as Australia and Japan have introduced subcategories when sequence templates have been used in the genome editing process. Several countries, including Europe, are in the process of revising their GMO legislation. The international legislative landscape is thus dynamic. The heterogeneity of regulatory regimes poses a challenge for international trade. This chapter summarises the status as of June 2023 and provides a brief introduction to the main legal concepts.