Genome Edited Crops Touch the Market: A View on the Global Development and Regulatory Environment

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.

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“…This results in small deletions and no recombinant DNA, thus simplifying regulatory approval, in contrast to a prior effort to silence the genes using RNAi. Calyno oil was launched in 2019 and the genome edited soy is now grown on ~100,000 acres 77 , 80 , 81 .…”

“…Genome editing has revolutionized biotechnology, and many products are set to enter the market over the next decade, especially in farming and medicine 81 . TALENs and earlier methods can direct changes to genome locations with high fidelity, but they can be hard to design.…”

“…CRISPR/Cas9 addresses this issue, where an easily designed guide RNA directs the Cas9 nuclease to its target, leading to the replacement, deletion or insertion of genomic DNA 5 , 82 . Many products are on the way with 140 genome-edited variants of 36 crops that improve yields and nutrition, defeat infections and pests, and expand the range of conditions 81 , 83 . A better-tasting mustard green (Pairwise) or yield-improved waxy corn (Corteva) could be the first CRISPR/Cas9-constructed product to enter the food supply in 2021 84 , 85 .…”

Genome-Edited Plants: Opportunities and Challenges for an Anticipatory Detection and Identification Framework

“…Unauthorized products cause significant challenges to European authorities, as only an authorization request ensures immediate access to the regulatory information required for traceability and labeling. Situations of asynchronous authorization present challenges for detection [ 30 ], as no official information may be accessible to European regulators due to differences in national biosafety laws and the respective authorization procedures and pipelines [ 8 , 9 ]. The specifics of regulatory frameworks for biosafety operating in a number of non-EU countries may foresee that certain GMOs and, in particular, a wide range of genome-edited products will not require regulatory approval for market release [ 8 ].…”

“…At the global level, most countries have introduced biosafety laws that require premarket authorization for regulated products. Unauthorized genetically modified products covered by these regulations are subject to enforcement [ 8 , 9 ]. Consequently, analytical detection of such products and their identification are crucial elements to implement the regulatory frameworks for GMOs, particularly for the enforcement of sampling and testing food, feed and seed products [ 1 , 10 ].…”