Global Regulation of Genetically Modified Crops Amid the Gene Edited Crop Boom – A Review

Abstract

Products derived from agricultural biotechnology is fast becoming one of the biggest agricultural trade commodities globally, clothing us, feeding our livestock, and fueling our eco-friendly cars. This exponential growth occurs despite asynchronous regulatory schemes around the world, ranging from moratoriums and prohibitions on genetically modified (GM) organisms, to regulations that treat both conventional and biotech novel plant products under the same regulatory framework. Given the enormous surface area being cultivated, there is no longer a question of acceptance or outright need for biotech crop varieties. Recent recognition of the researchers for the development of a genome editing technique using CRISPR/Cas9 by the Nobel Prize committee is another step closer to developing and cultivating new varieties of agricultural crops. By employing precise, efficient, yet affordable genome editing techniques, new genome edited crops are entering country regulatory schemes for commercialization. Countries which currently dominate in cultivating and exporting GM crops are quickly recognizing different types of gene-edited products by comparing the products to conventionally bred varieties. This nuanced legislative development, first implemented in Argentina, and soon followed by many, shows considerable shifts in the landscape of agricultural biotechnology products. The evolution of the law on gene edited crops demonstrates that the law is not static and must adjust to the mores of society, informed by the experiences of 25 years of cultivation and regulation of GM crops. The crux of this review is a consolidation of the global legislative landscape on GM crops, as it stands, building on earlier works by specifically addressing how gene edited crops will fit into the existing frameworks. This work is the first of its kind to synthesize the applicable regulatory documents across the globe, with a focus on GM crop cultivation, and provides links to original legislation on GM and gene edited crops.

Sustainable use of CRISPR/Cas in fish aquaculture: the biosafety perspective

“…Regulatory and risk assessment frameworks Many countries have developed regulatory frameworks to guide approval for environmental release and/or use of GM organisms as food, feed and fiber (Ishii and Araki 2017;Turnbull et al 2021). The main element in these regulatory frameworks is a mandatory RA of human safety and environmental risks.…”

“…The European Commission (EC) is the regulatory authority in the EU, although at the Pan-European-level, each member country has respective regulatory body that liaises with the EC. Different regulatory authorities throughout the world including the EU, Argentina, Brazil, Australia, New Zealand, Canada, USA and Norway have begun discussions on how to regulate products arising from the new GE techniques (Eckerstorfer et al 2019b;Turnbull et al 2021). Overviews of regulatory frameworks have been published by Ishii andAraki, 2017 andTurnbull et al 2021.…”

“…Different regulatory authorities throughout the world including the EU, Argentina, Brazil, Australia, New Zealand, Canada, USA and Norway have begun discussions on how to regulate products arising from the new GE techniques (Eckerstorfer et al 2019b;Turnbull et al 2021). Overviews of regulatory frameworks have been published by Ishii andAraki, 2017 andTurnbull et al 2021. Box 1 provides the present state of discussions in Norway, China and the United Nations Convention on Biodiversity.…”

“…The present regulatory discussions on GE products by various authorities (Eckerstorfer et al 2019b;Turnbull et al 2021) is expected to result in the revision of the existing RA guidelines. For example, Canada recently initiated the review of its RA requirements for products arising from GE techniques (Eckerstorfer et al 2019b); the European Food Safety Authority (EFSA) has been mandated by the EU to provide an opinion on the type of risks associated with plants produced through SDN-1 and SDN-2 approaches (EFSA 2019), but has not been mandated for an opinion or revision of guidelines regarding RA of GE animals including GE fish.…”

“…An expert group -the Ad Hoc Technical Expert Group (AHTEG) has been mandatedestablished to deliberate on this, and it is expected that the outcome of the deliberation will be presented in the next meeting of the parties to the CBD in the third quarter of 2021 in China EU for example, the current GMO guidelines, which recognizes all GE products as GMOs are used (EFSA 2020). The situation is the same in Canada, the USA and China which are some of the leading countries in the production and export of both GE and GM products (Turnbull et al 2021). Several of the aquaculture end products (including fish) of CRISPR/Cas [for fish and aquaculture products currently being developed using CRISPR/Cas technique, see reviews and book chapter by (Dunham and Su 2020;Gratacap et al 2019b;Wargelius 2019)] will at some point be evaluated for commercialization.…”