Regulatory approaches for genome edited agricultural plants in select countries and jurisdictions around the world

Entine, Jon; Felipe, Maria Sueli Soares; Groenewald, Jan-Hendrik; Kershen, Drew L.; Lema, Martín A.; McHughen, Alan; Nepomuceno, Alexandre Lima; Ohsawa, Ryo; Ordonio, Reynante Lacsamana; Parrott, W. A.; Quemada, Hector; Ramage, C.; Slamet‐Loedin, Inez H.; Smyth, Stuart J.; Wray‐Cahen, Diane

doi:10.1007/s11248-021-00257-8

Cited by 109 publications

(89 citation statements)

References 66 publications

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“…Regulatory alignment and consistency will be important for the use of technologies like genome editing to be broadly adopted and applied in a manner akin to the widespread use of common plant breeding techniques like classical mutagenesis and other techniques used to introduce genetic variation into plant genomes. It has been noted and clearly articulated in the literature (Menz et al 2020;Entine et al 2021;Turnbull et al 2021) that currently, there is a lack of regulatory harmonization and consistency around the world with regard to the status of genome-edited plant products. At this point, there are emerging general trends (certain edits like deletions are generally considered to be exempt from GMO regulations), but there is clearly more global "disharmony" than harmonization in the regulatory treatment of genomeedited plant products.…”

Section: The Foundation and Principles Of Gmo Regulatory Regimesmentioning

confidence: 99%

Impacts of the regulatory environment for gene editing on delivering beneficial products

Jenkins¹,

Dobert

Atanassova³

et al. 2021

In Vitro Cell.Dev.Biol.-Plant

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Various genome-editing technologies have been embraced by plant breeders across the world as promising tools for the improvement of different crops to deliver consumer benefits, improve agronomic performance, and increase sustainability. The uptake of genome-editing technologies in plant breeding greatly depends on how governments regulate its use. Some major agricultural production countries have already developed regulatory approaches that enable the application of genome editing for crop improvement, while other governments are in the early stages of formulating policy. Central to the discussion is the principle of "like products should be treated in like ways" and the subsequent utilization of exclusions and exemptions from the scope of GMO regulations for these products. In some countries, the outcomes of genome editing that could also have been achieved through conventional breeding have been defined as not needing GMO regulatory oversight. In this paper, we provide a short overview of plant breeding and the history of plant biotechnology policy development, the different classes of current regulatory systems and their use of exemptions and exclusions for genome-edited plants, and the potential benefits of such approaches as it relates to achieving societal goals.

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Section: The Foundation and Principles Of Gmo Regulatory Regimesmentioning

confidence: 99%

Impacts of the regulatory environment for gene editing on delivering beneficial products

Jenkins¹,

Dobert

Atanassova³

et al. 2021

In Vitro Cell.Dev.Biol.-Plant

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“…The legal status of a genome editing product depends on norms established at a country level based on a discriminate process to determine whether the final product is a Living Modified Organism (LMO) or not. For countries like Argentina, Australia, Colombia, Brazil, and the United States, a variety is equivalent to conventional in the absence of a foreign DNA (Entine et al, 2021;Gatica-Arias, 2020). For details, see Table 6.…”

Section: Regulatory Approachesmentioning

confidence: 99%

Rice breeding in the new era: comparison of useful agronomic traits

Hernández-Soto

Echeverría-Beirute

Abdelnour-Esquivel

et al. 2021

Preprint

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Understanding agronomic traits at a genetic level enables the leveraging of this knowledge to produce crops that are more productive and resilient, have better quality and are adjusted for consumer preferences. In the last decade, rice has become a model to validate the function of specific genes, resulting in valuable but scattered information. Here, we aimed to identify particular genes in rice related to traits that can be targeted by different mutation techniques in the breeding of crops. We selected gain of function, misfunction, and specific mutations associated with phenotypes of agronomic interest. The review includes specific trait-related genes involved in domestication, stress, herbicide tolerance, pathogen resistance, grain number/quality/weight, plant structure, nitrogen use, and others. The information presented can be used for rice, other cereals, and orphan crops to achieve a superior and sustainable production in challenging farming conditions.

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“…At present, the regulation of genome editing is rather fragmented, uncomplete and inconsistent across countries (Entine et al 2021;Charo and Greely 2015). In the US, genome editing is regulated by the 1986 Coordinated Framework for the Regulation of Biotechnology, which was updated following the "Memorandum on Modernizing the Regulatory System for Biotechnology Products" issued by the Executive Office of the US President in 2015 and the "Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products" issued by the US President in 2019.…”

Section: The Challenge Of Regulating Genome Editingmentioning

confidence: 99%

The role of externalities and uncertainty in policy design: evidence from the regulation of genome editing

Asquer

Krachkovskaya

2021

Policy Design and Practice

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Externalities and uncertainty play an important role in the design of regulatory policies. Regulatory tools must be selected while taking into consideration the side-effects that regulated products or services have on other individuals and on the environment. This study investigates the externalities and uncertainty that arise from the use of genome editing (with specific reference to CRISPR technique) and how they relate to regulatory policy design choices. Building on evidence from genome editing regulation and on the NATO (Nodality, Authority, Treasure and Organization) policy tools framework, this study argues that a mix of regulatory tools is required to tackle externalities of genome editing applications and to cope with sources of uncertainty about their beneficial, neutral and harmful side-effects. The study provides some recommendations to policy-makers about reducing uncertainty, diversifying regulatory tools over time, and communicating to the public about features of genetically edited products.

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Regulatory approaches for genome edited agricultural plants in select countries and jurisdictions around the world

Cited by 109 publications

References 66 publications

Impacts of the regulatory environment for gene editing on delivering beneficial products

Impacts of the regulatory environment for gene editing on delivering beneficial products

Rice breeding in the new era: comparison of useful agronomic traits

The role of externalities and uncertainty in policy design: evidence from the regulation of genome editing

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