Abstract
The introduction to this book asks the question: why study the governance of genome editing in agrifood? We discuss current system-wide, and country specific policy changes that have increased interest in using genomic techniques to make improvements to agronomic, nutritional/functional traits and organoleptic qualities of plants used for human food and animal feed. We discuss why applying supply chain and systems approaches are useful ways to view how the pace and applications of technological innovations in this sector are tempered by the political and economic dynamics of risk governance. This introductory chapter also includes discussions of the methodology, a brief review of studies of gene editing in the agrifood system, and outlines the structure of the book.
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Keywords
- CRISPR-Cas9 and agriculture
- Regulation of gene edited agrifoods
- Agricultural Innovation Systems approach
- Multilevel perspective
- Deliberative governance
- New Breeding Techniques
1 Introduction
In 2012, a research team led by Jennifer Doudna including Emmanuelle Charpentier, Martin Jinek, Krzysztof Chyliński, Ines Fonfara and Michael Hauer at UC Davis published their findings that would revolutionize gene editing. They discovered that a protein (Cas9) within an organism’s cell could be programmed with RNA to edit its genomic DNA. In essence, the CRISPR-Cas9 technique harnessed a cell’s own repair mechanisms to make precise gene edits. When the findings were published, CRISPR’s potential and possibilities took the scientific world by storm. Unlike earlier gene editing techniques, CRISPR could perform gene editing much faster and was much more cost effective. Doudna and Charpentier would go on to win the Nobel Prize in Chemistry in 2020 for their discovery. Some have called this one of the most important discoveries in the history of biology.
The promise of CRISPR to improve the precision of plant breeding and the potential to find genetic treatments and cures for human diseases is staggering. But the initial excitement about the future benefits of gene editing in agriculture took a very different turn in 2018. A conference held in Hong Kong brought scientists together from around the world to discuss the implications of using CRISPR-Cas9 to edit genes for human health research as well as agricultural applications. During the conference, a researcher from China made a presentation that would leave a lasting impression. In this presentation, scientist He Jiankui announced that CRISPR gene editing had been used successfully on twin girls to make them resistant to HIV/AIDS infections. At the time, there were no regulations or policies in place to prevent ethically questionable uses of CRISPR-Cas9 to alter the genome of any organism, including humans. The global controversy and condemnation by the scientific community surrounding this announcement triggered a strong regulatory response in countries around the world (Asquer & Krachkovskaya, 2021: 1117). The 2018 event would have lasting effects on the trajectory of gene editing in agricultural research up until today.
The introduction of innovative technologies into the world often requires what Klerkx et al. (2010: 391) call ‘selling a good story’. The story must be told by the right people who have credibility, at the right time, in the right place and to the right people who can ‘capitalize on momentum and windows of opportunity’. If not, fear, uncertainty and outrage may dominate the narrative. It can easily be argued that gene editing, and particularly CRISPR-Cas9, was not the subject of a good story. It was instead, introduced to the world as an ethically dubious technology wielded by unscrupulous scientists to re-write the human genome without any social license to do so. The legacy of the focusing event in 2018 has had long standing implications for gene editing for research into its applications for human health, but also for how this innovation has been welcomed or resisted in the agricultural innovation space.
The governance of gene editing in agricultural research may seem unrelated to this event, but the resultant regulatory wheels that were set in motion have had significant implications for the regulation and use of gene editing in the global agrifood system. On one hand, proponents of gene editing techniques in agriculture argue that it should not be considered identical to genetically modified foods because it does not use transgenes (the SDN1 technique) and thus, should be regulated similarly to any other agrifood introduced to a country with no prior safety record—genetically edited or produced using conventional techniques. On the other, gene editing is viewed by some as ‘just another biotechnology’ that carries the same perceived risks as Genetically Modified Organisms (GMOs)Footnote 1 and should be subject to the same biosafety protocols and regulations as its genetically modified counterpart. Currently, there is no global consensus on how gene editing should be regulated in agrifood research or assessed for commercialization.
Gene editing has been used in agricultural research and product development for decades before CRISPR-Cas9. But CRISPR-Cas9 has revolutionized gene editing in a way that prior techniques have not. It has encouraged governments to critically assess, and in some cases re-think, how these techniques are regulated in research and commercialization. Today, there is a patchwork of diverse regulatory frameworks, with varying levels of acceptance of gene editing as equivalent to traditional breeding techniques. For example, Japan has commercialized two gene edited agrifoods; the GABAFootnote 2 enhanced tomato, and two types of fish for human consumption, while the United States has commercialized a soybean with improved fatty acid composition (Waltz, 2021) and American company Pairwise is set to commercially release a gene edited leafy green.
On the research side, Chinese institutions hold a significant proportion of patents for gene edited crop varieties (Bagley & Candler, 2023), but the Chinese national government has not yet publicized any regulatory protocols for commercialization of these products in the domestic market. Canadian regulatory bodies have determined that gene edited agrifoods do not present any novel risks to human, animal or environmental health compared to conventional breeding techniques, and applications for commercialization will be assessed on a case-by-case basis for health and biosafety concerns. The EU has had legislation in place since 2001 prohibiting the deliberate release of all products of New Breeding Techniques (NBTs). Gene edited crops are GMOs under Directive 2001/18/EC. But in July of 2023, the EU Commission announced that it was re-examining how ‘new genomic techniques’ (including gene editing like CRISPR-Cas9) are regulated, considering a loosening of regulatory protocols for organisms that are not transgenic (no foreign genes from other species) and have less than 20 genetic modifications.
Gene editing in agrifood research, product development and regulatory frameworks is not where it was in 2018. The global economy is also not where it was in 2018. System wide shocks such as the COVID-19 global pandemic, the Russian invasion of Ukraine and its impact on global food security, and the widespread damaging effects of climate change have put enormous stresses on the agrifood system and its global supply chains. Some experts argue that we are at the tipping point and must harness useful agricultural technologies in whatever way we can to mitigate damages to human, animal and environmental health and welfare if we are to avoid catastrophic environmental collapse and widespread hunger. Prior to the discovery of CRISPR-Cas9, gene editing techniques had been around for decades, and proponents argued for their wider adoption to help manage future challenges. But the progress of gene editing as a useful and effective tool in agrifood research and development is not where some had hoped when CRISPR-Cas9 was discovered in 2012.
The status of gene editing in the agrifood system is in a state of flux. In some ways, the technology has not lived up to its potential to provide solutions to global food insecurity and the damaging effects of climate change on the world’s food supply. But why? What is the relationship between the current status of gene editing applications and the governance of agrifood technologies? Where might the future take gene editing?
In this book, we investigate the factors that have guided science and governance discourse surrounding gene editing technologies, what has changed, and how might governance and regulatory frameworks respond to changes in the application of agrifood technologies in the future. The parameters of this study are as follows. We specifically focus on plants, with a brief discussion on gene edited microorganisms. Discussions of gene edited animals are not included in this study, however more general discussions of ‘gene editing’ techniques are analyzed in the context of crops and plant-based food & feed. Though the socio-political controversies and social movement oppositions surrounding biotechnology in agriculture are acknowledged as significant in terms of how gene editing is perceived in the public space, this book focuses on the governance of agricultural innovation of gene editing in the context of regulatory policy frameworks.Footnote 3 We discuss the influences of public perceptions of gene editing on regulatory frameworks, but our primary focus is on formalized regulations and guidelines governing the use and release of gene edited agrifoods.
Our analysis builds on previous studies of regulatory frameworks for gene editing in agrifood (see Entine et al., 2021; Ericksson et al., 2019; Menz et al., 2020; Wolt & Clark, 2018; OECD, 2018; NASEM, 2017; Friedrichs et al., 2019a; FAO, 2022; Zarate et al., 2023). Many academic and organizational studies focus on current applications of gene editing and how they are evaluated by regulatory agencies responsible for approving gene edited agrifood products for commercialization. The governance of gene edited crops has also received attention, as new applications for gene editing techniques are discovered (Phillips & Macall, 2021; Selfa et al., 2021; Asquer & Krachkovskaya, 2021; Friedrichs et al., 2019b). Methods used to investigate the dynamics of governance include interviews or surveys designed to evaluate either consumer, government, bench scientists and/or agribusiness’ perceptions of regulations, risk, safety, benefits, and uncertainties regarding gene edited agrifoods (Lassoued et al., 2021).
The volume of research in this area has exploded over the last few years for three main reasons: the advancement of gene editing applications such as CRISPR to improve agronomic and nutritional traits in agrifoods; second, the evolution of regulatory guidelines in countries that have previously restricted the use of gene editing; and third, the global economic, political, and environmental turbulence of the last 5 years. The rapidly evolving global economic, environmental and security issues impacting everything from food and fuel costs, to climate, biodiversity and human migration have brought more attention. Climate change, rising global food and nutritional insecurity, global economic uncertainties, volatile commodity markets (which have contributed to spiraling food costs), and international armed conflicts are system-wide factors influencing the development of nascent regulatory frameworks. Of particular interest to contemporary academic study are those crops with gene edits that contribute to sustainability via improved yields (e.g., drought resistance), research investments in orphan cropsFootnote 4 and developments in improving storability traits of staple crops (FAO, 2022: 14).
New applications may have major implications for how gene editing systems are governed in the near future, which requires ongoing evaluations by scholars, but also makes it difficult to provide an up-to-date portrait of regulatory frameworks, as they are responding to change in real-time (see Entine et al., 2021; Friedrichs et al., 2019a; Genetic Literacy Project, 2023). Most discussions of gene editing as it pertains to agrifood plants includes some discussion of regulatory frameworks. The typologies are not identically worded, but they are essentially divided into three primary categories: prohibited, regulated like GMOs, and evaluated on a case-by-case basis under existing biosafety protocols (no transgenes).
Bain et al. (2020) views the typology of regulatory regimes as based on ‘three sociotechnical imaginaries’, which refers to what Macnaghten et al. (2005: 279) describe as “how gene editing is being imagined by proponents and the implicit assumptions, values and visions that they assert”. The three sociotechnical imaginaries pertaining to gene edited agrifoods are as follows: (1) equivalent to traditional plant breeding; (2) have the potential to usher in a new Green Revolution; and (3) could facilitate the democratization of agricultural biotechnologies. This typology focuses on the ideological underpinnings of the content of regulations governing gene edited agrifoods. Studies interviewing stakeholders have revealed important information about the perceptions of the safety of gene edited agrifoods and concerns about regulations, resource sharing and communication (see Selfa et al., 2021; Zarate et al., 2023). All three of these aspects are addressed throughout this book using several approaches and methods.
2 Approaches and Methods
We take a multidisciplinary systems approach, drawing insights from the natural and social sciences, including biology (agricultural science), political science (policy and institutional analyses), and agricultural economics (innovation studies, supply chain analysis). This issue area is multidisciplinary by nature, and as such, much of the current literature integrates information from scientific research on gene editing and plant breeding with perspectives from agricultural economics, public policy analysis, and/or supply chain analysis. Our analysis contributes to the recent literature examining the governance elements of regulating gene edited foods and stakeholder interactions within the broader agrifood system (Bain et al., 2020; Bogdanove et al., 2018; Eriksson et al., 2019; Gordon et al., 2021; Lassoued et al., 2021; Macnaghten et al., 2005; Philips & Macall, 2021; Schiemann et al., 2021; Sprink et al., 2020; Wolt & Clark, 2018).
The literature pays close attention to how some segments of civil society perceive gene edited foods as sharing the same risk profile as genetically modified foods, and how these risk perceptions have found their way into policy frameworks that do not necessarily reflect evidence from science-based research. Academic attention has also focused on exploring the ethical and social justice dimensions of governing gene edited agrifoods concerning who owns (or has access to) genetic resources and how scientization, privatization, and democratization of knowledge of gene-edited foods is playing out (Selfa et al., 2021; Kinchy, 2012).Footnote 5
This book employs aspects from the multilevel perspective and the agricultural innovation systems approaches to analyze the governance dynamics of gene edited agrifoods, as part of the broader agrifood system. The multilevel perspective analyzes the dynamics between governance structures and relevant stakeholders (international organizations, national regulatory frameworks, regulators, scientific research institutions) within the global agrifood system. The multilevel perspective consists of institutional structures of the agrifood system (environmental, socio-political, and economic). We draw from innovation system studies which views these institutional structures as ‘part of the background’ creating opportunities for innovation processes requiring input from society (de Boon et al., 2022: 407). The broader institutional context changes, albeit slowly. Environmental, socio-political, economic, or scientific shocks to the system lead to more punctuated change. Individual stakeholders do not often influence how the system changes, but innovations can alter structures over time (Geels & Schot, 2007; Klerkx et al., 2012). Interactions and dynamics between levels of decision-making (governance), as well as dynamic interactions among innovations, socioeconomics, and environmental factors, for example, can also facilitate change within the system (Geels, 2019; Smith et al., 2010).
The Agricultural Innovation Systems (AIS) approach perceives agricultural innovation as technological change but considers institutional change as a component of innovation adoption. This approach is nestled in the complex adaptive systems approach as it emphasizes interactions between heterogenous stakeholders related to multiple dimensions of agricultural innovations, including technology development, institutional change, supply chain organization, market development, and nurturing societal acceptance of the innovation (Ekboir, 2003; Spielman et al., 2009; Klerkx et al., 2010). These are defined as self-organizing systems “whose properties cannot be analyzed by studying its components separately[…] formed by many agents of different types, where each defines his/her strategy, reacts to the actions of other agents and to changes in the environment, and tries to modify the environment in ways that fit his/her goals” (Spielman et al., 2009: 400). AIS also attends to networks of actors and influential institutional structures that condition how stakeholders interact. It allows for the ability to identify network configurations of actors and their socio-institutional context determining if the institutional context hampers or supports the innovation under study (Klerkx et al., 2010, 2012; de Boon et al., 2022).
International Regulation of Gene Editing Technologies in Crops: Current status and future trends fits in the innovation systems literature. It focuses on explaining innovation pathways in relation to public policy making (Simon, 1962; Rogers, 1995; Amaral & Ottino, 2004). Together, the multilevel perspective and the AIS view innovation as technological change, but also consider how institutional change factors into adoption. We also draw from and contribute to the innovation systems literature (de Boon et al., 2022: Klerkx et al., 2012; Geels, 2019; Geels & Schot, 2007; Smith et al., 2010). Our approach is nestled in the complex adaptive systems approach as it emphasizes interactions between heterogenous stakeholders related to multiple dimensions of agricultural innovations, including technological development, institutional change, and market development (Ekboir, 2003; Spielman et al., 2009; Klerkx et al., 2010). As a branch of network analysis, AIS attends to networks of actors and influential institutional structures that condition how stakeholders interact. It allows for the ability to identify network configurations of actors and their socio-institutional context determining if the institutional context hampers or supports the innovation under study (Resnick et al., 2015).
An important concept used in this book that is both a component of multilevel perspective and AIS is ‘governance’. Governance is a horizontal approach to decision-making that includes public and private actors and the fluid dynamic between legitimacy and liability (Giddens, 1990; Majone, 1995; Moore, 2002; Kooiman, 2003). Politically, the era of governance is signified by the rise of the ‘regulatory state’ that is made up of ‘networks of flexibility’ involving both public and private actors in decision-making processes. Multiple and diverse actors involved in various stages of regulating risk make it more difficult to assign liability and blame when there is a case of regulatory failure (Moore, 2002: 122).
Academic attention has also been captured by the ethical and social justice dimensions of the governance of gene edited agrifoods concerning who owns (or has access to) genetic resources and how scientization, privatization and democratization of knowledge regarding gene edited foods is playing out (Selfa et al., 2021; Kinchy, 2012; Munawar et al., 2024). One newer area of interest is analyzing how the information economy may be influencing public debates regarding gene editing, which may have implications for how these agrifoods are regulated in the present and future. Our analysis sits within the risk governance literature, especially as it pertains to manufactured risks, of which agricultural biotechnology is considered to belong (Beck, 1992; Renn, 2008; Giddens, 1990). The deliberative element to governance—an important component of our analysis—is also derived from the literature on governance (Jasanoff et al., 2015; Macnaghten et al., 2021; Hajer, 2003). Hendriks (2009: 175) provides a succinct understanding of deliberative governance. Deliberative governance is based on the idea that, “policy making requires spaces where different institutions, agencies, groups, activists and individual citizens can come together to deliberate on pressing social issues.”
We employ qualitative analysis using primary (policy) and secondary (academic articles) documents and expert interviews (investigative triangulation). Other studies on the governance of gene editing in agriculture have employed similar methods (see Selfa et al., 2021; Zarate et al., 2023). Most recently, Ruder and Kandlikar’s (2023) study includes interviews with gene edited agrifoods experts in Canada and argues that there is resistance to deliberative elements of governance models. We conducted a series of in-depth interviews with regulatory experts and research scientists in various countries in summer 2023.Footnote 6 We interviewed public sector scientists and scientists in the non-profit sector, agricultural economists, regulators involved in policy discussions surrounding gene edited agrifoods, Non-Governmental Organization (NGO) representatives engaged in international agricultural development projects, and private sector representatives. Each interviewee had expertise and knowledge regarding the governance of gene edited agrifoods and/or gene editing technologies. The qualitative interview material expresses timely views on the state of gene editing in the agrifood system. Considering how quickly some aspects of the governance of gene edited agrifoods is moving, collecting expert opinions on current regulatory change and/or recent advancements in gene editing techniques was essential to gain a better understanding of the current governance dynamics, and also the future outlook for applications and regulations. Interviews with regulatory experts and research scientists who have practical experience in using gene editing technologies provide a rich set of insights which informs the policy recommendations we present in Chap. 6. Our analysis looks forward to future potential applications of gene editing technologies in the agrifood system and provides insights into how novel technologies on the horizon may be regulated in the future.
3 Structure of the Book
The manuscript is organized around probing two questions. Part I (Chaps. 2 and 3) seeks to answer the question: why are there so few gene edited agrifoods on the market despite the initial optimism that accompanied the Nobel Prize-winning discovery of CRISPR-Cas9 over a decade ago? It looks at the current suite of genomic techniques used in crop breeding to improve agronomic traits and nutritional profiles. Then it examines how current regulations governing the use and commercial release of gene edited agrifoods influence their adoption and commercialization. Part II (Chaps. 4 and 5) seeks to answer: what governance challenges and opportunities will shape the future applications of gene editing in the agrifood system? This part of the book explores ‘new genomic techniques’ and applications on the horizon. It also discusses how international regulatory frameworks can better respond to future genomic advancements in plant breeding by employing elements of deliberative governance. Deliberative approaches put effective, inclusive, and transformative communication at the heart of global governance.
In Part I—‘Balancing Innovation: Application and Regulation’—we discuss current dynamics of gene editing techniques and regulation frameworks. Chapter 2, ‘What is gene editing?’, begins with the basics. It explains what gene editing is, what it is not, and how different techniques are used to achieve edits in plant genomes. The chapter maps out a timeline of the development of gene editing techniques, discussing the benefits and challenges of each, with most recently CRISPR-Cas9.
We then turn our attention to the current regulatory frameworks that govern the use and commercialization of gene edited agrifoods in Chap. 3 (How are gene editing technologies regulated in the agrifood system?). This chapter examines current governance and regulatory frameworks for gene edited agrifoods around the world. It details the risk assessment regimes of countries with biosafety regulatory frameworks, highlighting the similarities and differences. It discusses how effective governance of gene edited agrifoods requires balancing innovation with considerations of risk and benefits to the economy, society, and the environment. It also discusses intellectual property and ‘freedom to operate’ issues that arose with the proliferation of CRISPR-Cas9, and how the licensing and patent landscape has prompted some agricultural scientists to look beyond CRISPR-Cas9. In this chapter, we explore Canada’s response to regulating gene edited agrifoods as a case study in reflexive governance for innovative agricultural technologies. The chapter discusses recent system-wide economic, ecological, and geo-political shocks that have influenced some countries to rethink their position on gene editing in the agrifood system.
In Part II—‘Emerging Opportunities for Regulatory Enhancement’—we focus on emergent techniques and policy options for regulators as gene editing in agrifood continues to evolve, and new techniques emerge. Chapter 4 examines new breeding techniques (NBTs) and applications on the horizon and their applications for plants in the agrifood system. We discuss how NBTs can enable other technologies and platforms and highlight new classes of gene edited products in the pipeline. Finally, it examines how the regulatory trajectory of gene editing offers clues as to how new applications of NBTs may be assessed in the future as ecological pressures continue to stress the agrifood system.
In Chap. 5 (Governing the unknown: Regulating future technologies), we delve into the governance mechanisms for emerging breeding techniques. This chapter examines how governance structures and regulatory frameworks might respond to emergent new breeding techniques. The chapter discusses future policy options for assessing the biosafety and efficacy of NBTs. We argue that the primary determinant of the chosen pathway is rooted in how the regulatory systems assess other biotechnologies (precautionary, case-by-case, or restricted). The chapter finally explores how emergent techniques may pose challenges for regulatory frameworks and offers potential regulatory responses.
We conclude this book with a chapter examining next steps and future directions for studies in governance of gene editing and other NBTs in agriculture (Chap. 6). This chapter summarizes the challenges of governing gene editing in the agrifood system. It assesses the current landscape of regulatory frameworks and reviews what may change in the coming years and decades as climate change and food insecurity continue to stress global agrifood supply chains and the system writ large.
Notes
- 1.
GMOs are any organism that has genetic material changed through genetic engineering that does not occur naturally by mating or natural recombination. There is diversity across jurisdictions, in terms of how a GMO is defined, but many countries base their definition on the Cartagena Protocol on Biosafety definition. A ‘Living Modified Organism’ (LMO) is “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.” Regulations for any ‘novel’ agrifood product are designed to protect human, animal and environmental health, though there is wide diversity in the details of how that is achieved in the regulatory space (Entine et al., 2021: 552).
- 2.
Gamma-aminobutyric acid (GABA) is a naturally occurring amino acid that works as a neurotransmitter. Studies have shown that GABA may help reduce anxiety, depression in humans.
- 3.
For an in-depth study of the societal responses to gene editing in the agrifood system, see Selfa et al. (2021).
- 4.
Orphan crops are those which have significant potential to contribute to nutritional security, biodiversity and livelihoods but are grown by smallholders, often in subsistence farming systems, and thus deemed less lucrative investments for agbiotech firms.
- 5.
The democratization of knowledge refers to the proliferation of knowledge across the wider population beyond experts and elites. Public access to information via the Internet and libraries facilitates this effort.
- 6.
Further details of the interview methodology and a master list of interview questions are provided in Appendix A.
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Clark, L.F., Hobbs, J.E. (2024). Introduction: Why Study the Governance of Gene Edited Agrifoods?. In: International Regulation of Gene Editing Technologies in Crops. SpringerBriefs in Environmental Science. Springer, Cham. https://doi.org/10.1007/978-3-031-63917-3_1
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