A future scenario of the global regulatory landscape regarding genome-edited crops

Abstract

ABSTRACT. The global agricultural landscape regarding the commercial cultivation of genetically modified (GM) crops is mosaic. Meanwhile, a new plant breeding technique, genome editing is expected to make genetic engineering-mediated crop breeding more socially acceptable because it can be used to develop crop varieties without introducing transgenes, which have hampered the regulatory review and public acceptance of GM crops. The present study revealed that product-and process-based concepts have been implemented to regulate GM crops in 30 countries. Moreover, this study analyzed the regulatory responses to genome-edited crops in the USA, Argentina, Sweden and New Zealand. The findings suggested that countries will likely be divided in their policies on genome-edited crops: Some will deregulate transgene-free crops, while others will regulate all types of crops that have been modified by genome editing. These implications are discussed from the viewpoint of public acceptance.

Conventional and Molecular Techniques from Simple Breeding to Speed Breeding in Crop Plants: Recent Advances and Future Outlook

“…Unfortunately, the development of new crop varieties by genome editing has been delayed in many countries by strict GMO regulations across the globe. This is particularly true for areas obeying a process rather than a regulatory framework based on the product, like in the EU, where authorizations for new varieties developed by genome editing techniques are subject to time-and cost-intensive verification procedures [112]. A recent decision by the European Court of Justice announced the enforcement of strict GMO legislation on target genome editing tools, even if the product is entirely free of transgenes [113].…”

Genome-edited crops: how to move them from laboratory to market

“…Since last century biotechnology regulations have been ratified in most countries to ensure that crops that have been genetically modified by modern biotechnology are as safe as conventional products of traditional breeding [28] . Product-based and process-based regulation are alternative regulatory frameworks adopted in different countries and regions [29] . In product-based regulation, only the improved trait and the biological product itself are the objects of regulation; conversely, process-based regulation is based the use of a GM process.…”

A New Zealand Perspective on the Application and Regulation of Gene Editing

“…The global social and regulatory landscape surrounding GM crops remains complex with many different regulatory systems in place (Wolt et al, 2016 ; Davison and Ammann, 2017 ). The primary difference being whether a process or product driven framework is used (Ishii and Araki, 2017 ). As yet there is not a global consensus on the regulation of gene editing which was developed after current regulatory frameworks were put in place.…”