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This book provides in-depth insights into the regulatory frameworks of five countries and the EU concerning the regulation of genome edited plants. The country reports form the basis for a comparative analysis of the various national regulations governing genetically modified organisms (GMOs) in general and genome edited plants in particular, as well as the underlying regulatory approaches.The reports, which focus on the regulatory status quo of genome edited plants in Argentina, Australia, Canada, the EU, Japan and the USA, were written by distinguished experts following a uniform structure. On this basis, the legal frameworks are compared in order to foster a rational assessment of which approaches could be drawn upon to adjust, or to completely realign, the current EU regime for GMOs. In addition, a separate chapter identifies potential best practices for the regulation of plants derived from genome editing.



Chapter 1. Introduction: Regulation of Plants Derived from Genome Editing—What Lessons To Be Learned from Other Countries?

The advent of genome editing in plant breeding and the resulting blurring of the boundaries between natural and artificially induced genetic modifications present regulators worldwide with new challenges. In such a time of regulatory uncertainty, or dispute over how to regulate genome edited plants, legislators are well advised to seek external guidance on how this issue could be addressed appropriately. Since genome edited organisms pose similar challenges to regulatory systems around the world, it seems sensible to study the practices of other jurisdictions in order to draw lessons for one’s own regulatory efforts. To be able to choose from a diverse selection of regulatory approaches, countries with differing attitudes towards genetically modified plants were chosen as research objects. Broadly speaking the studied jurisdictions can be divided into those which embrace the cultivation of GMOs (Argentina, Canada and the USA), those which are reluctant adopters of GMOs (Australia and Europe) and a de facto absolute abstainer from GM crop cultivation (Japan). Based on a comparative analysis of the regulatory frameworks and an identification of possible best practices, the conclusion is made that a consistent regulatory regime should be product-based, i.e. the risk regulation should be triggered by a plant’s traits. From a procedural point of view, an obligatory upstream procedure should be used for channelling the respective plant into the relevant regulatory framework. This process can be further catalysed by a voluntary early consultation procedure. Within such a framework the one-door-one-key principle should apply, which means that all relevant authorizations are granted upon a single application.
Hans-Georg Dederer, David Hamburger

Chapter 2. Regulation of Genome Editing in Plant Biotechnology: Argentina

Argentina is a world leader in regards to regulation and adoption of GM crops. As a consequence, the regulatory aspects of gene editing applied to agriculture were considered proactively, and a simple but sound pioneer regulation was developed.
At present, the Argentine regulatory system is fully able to establish if a gene-edited crop should be classified (and handled) either as a GM crop or a conventional new variety. To this end, the concept of “novel combination of genetic material” derived from the Cartagena Protocol is of paramount importance.
After some pilot cases that have been handled under the new regulation, applicants appreciate the ease, speed and predictability of this regulation. Moreover, it has been considered by other countries in developing their own regulations, thus acting also as a harmonization factor for the safe and effective insertion of these technologies in the global market.
Agustina I. Whelan, Martin A. Lema

Chapter 3. Regulation of Genome Editing in Plant Biotechnology: Australia

Two Australian regulatory frameworks are fundamental to the cultivation of genome edited plants and marketing of their products. These are the gene technology and food regulatory frameworks. Both frameworks rely on process triggers—that process being the use of gene technology. Unfortunately, these frameworks use different definitions of gene technology, creating the likelihood of different responses to genome edited plants, particularly to plants produced using SDN-2 or ODM.
No genome edited plants are currently cultivated in Australia but the relevant regulators are each currently undertaking reviews to determine whether some or all genome editing techniques are gene technology and how their frameworks should respond to those techniques. Final decisions are expected during 2018. In the meantime, the regulators have each adopted interim approaches to genome edited plants or their products, summarised in the first table.
Karinne Ludlow

Chapter 4. Regulation of Genome Editing in Plant Biotechnology: Canada

Gene editing technologies are the latest to emerge from the broader field of agricultural biotechnology. Canada’s science-based regulatory system was adapted for genetically modified (GM) crops in the early 1990s and has proven sufficiently robust in responding to these new plant breeding techniques, having approved two varieties of gene edited canola. Canada does not have a mandatory labelling system and the products from these crops will have seamlessly entered the food supply system in Canada.
A 2017 industry organized workshop on the future of plant breeding regulations in Canada, acknowledged the excellence of Canada’s regulatory system for GM crops. However, it was noted that Canada cannot afford to be complacent when it comes to regulatory competitiveness as multinational technology development firms are making investment decisions based on regulatory efficiency. To ensure that Canada’s regulatory framework remains efficient, a two-tiered regulatory system has been suggested as a means of leveraging the 25 years of experience and knowledge gained through the safe regulation of GM crops. To date, no regulatory changes to move in this direction have been implemented by Canadian regulatory agencies.
Stuart J. Smyth

Chapter 5. Regulation of Genome Editing in Plant Biotechnology: European Union

Plants, animals and microorganisms obtained by any type of genome editing technology (SDN-1, SDN-2, SDN-3, ODM) are regulated through the EU’s GMO regime. A judgment of the European Court of Justice in July 2018 provided regulatory certainty about their GMO status. It ended more than a decade of legal debates.
The EU’s GMO regime is harmonised at the EU level and encompasses authorisation requirements regarding contained use, field trials and the placing on the market of GMOs as well as post-market monitoring, labelling, traceability and identity preservation obligations. Thus, GMOs are governed in a comprehensive, detailed and rigorous manner. In addition, GMOs are subject to widespread political and societal rejection.
The impossibility to distinguish certain genetic alterations induced by genome editing from those that are induced naturally or by traditional breeding techniques leads to problems as yet unresolved. It might hamper GMO authorisation, the EU’s zero tolerance policy for unauthorised GMOs and GM labelling.
It cannot be excluded that amendments to the GMO framework will be introduced in the aftermath of the European Court of Justice’s judgment. Without any, it will take several years until the first genome edited plants are commercially cultivated or imported.
Brigitte Voigt, Ansgar Münichsdorfer

Chapter 6. Regulation of Genome Editing in Plant Biotechnology: Japan

To regulate the research and industrial uses of genetically modified organisms (GMOs), Japan enacted the Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms 2003. This law can be regarded as a product-based GMO regulation. To date, Japan has approved 133 GM crop varieties for cultivation, distribution, and import, thus becoming a major importer of GM crops in the world. However, no GM crops have been commercially cultivated in Japan, except one ornamental GM flower. A recent consumer survey showed that 40.7% of respondents expressed concern over the safety of GM food products. Meanwhile, some Japanese researchers have already used robust genome editing techniques, such as CRISPR-Cas9, and reported gene-disrupted apple, potato, soybean, tomato and rice. In 2017, a GM rice variety was approved as Japan’s first field trial of a genome edited crop. In contrast, some citizen groups expressed opposition to the cultivation test and demanded the regulation of genome edited crops. However, relevant ministries have not considered the regulation of any uses of genome editing in earnest. The current state of Japan does not warrant a promising future of genome edited crops.
Tetsuya Ishii

Chapter 7. Genetic Engineering in the United States: Regulation of Crops and Their Food Products

In the United States, federal administrative agencies, including the US Department of Agriculture (USDA), implement statutes and regulations that govern genetically engineered plants and their products. US regulatory measures were developed in light of genetic modification using rDNA, before the advent of new technologies, including gene editing, that offer simple, elegant paths to genetic improvement in plants. After a brief review of global and US production of GE crops, this Chapter analyzes US policy and regulation of these crops and their food products, with emphasis on the role of USDA. The Chapter addresses significant issues raised by GE crops: coexistence of GE and non-GE crops, low-level presence, tort liability, and the new US labeling law for bioengineered foods. Recent policy statements encourage modernized science-based regulation, but some uncertainty applies to regulation of crops developed with new genetic technologies. The Chapter analyzes USDA’s governance of new crop varieties with a focus on the “Am I Regulated?” process, which determines whether new organisms are subject to USDA regulation. The USDA has declined regulatory jurisdiction for a number of products of gene editing and has indicated its intention not to regulate crops developed with certain new technologies. Finally, the Chapter outlines some regulatory challenges posed by advances in biotechnology.
Margaret Rosso Grossman

Chapter 8. Comparative Analysis: The Regulation of Plants Derived from Genome Editing in Argentina, Australia, Canada, the European Union, Japan and the United States

A comparison of the cultivation of genetically modified organism (GMOs) and consumption of their products (Sect. 8.2) reveals the distinctness of each examined country’s approach towards GMOs. Not surprisingly, this finds its continuation in diverging and differing legal frameworks for their regulation. The diversity of approaches is not only reflected in different regulatory triggers and point of entries into the regulatory regime (Sect. 8.3), but also by varying labelling (Sect. 8.5) and coexistence provisions (Sect. 8.6). When taking a closer look at the regulatory status of genome edited plant varieties and the products derived from them, it becomes apparent that the differences of the regulatory frameworks manifest in the legal classification of those plants and their produce. Consequently, genome edited organisms (GEOs) are treated vastly differently by the examined legal regimes (Sect. 8.4). However, it should be borne in mind that some of the examined countries are currently working on a revision of their regulations (Sect. 8.7).
David Hamburger


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